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Patents
Background
Ayyangar Committee
Patent Eligibility
S. 3(a)
S. 3(b)
S. 3(c)
S. 3(d)
S. 3(e)
S. 3(f)
S. 3(h)
S. 3(i)
S. 3(j)
S. 3(k)
S. 3(p)

Background
The law of patents often pertains to the knowledge behind an invention. For the consumer,
this knowledge is usually inaccessible, whereas the inventor is the possessor of the
knowledge. Whether such knowledge should be in the public domain is a policy question
→ creation of an environment inducing an inventor to disclose.
Patent v. Trade Secret [Disclosure v. Secrecy]

Protection for a specified term v. in perpetuity (as long as it remains a secret)

guaranteed monopoly even if for a short term v. Risk of discovery — depends on

success of protection

statutory v. contractual protection

right in rem v. right in personem

The greatest benefit of a patent is that it results in disclosure which enriches the
knowledge basket — society benefits as a whole. For a trade secret however, there is
knowledge and only consumption

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 TS is advisable if a secret can be maintained for a long time or one is certain that their
product can never be reverse engineered or produced by others (biriyani example)
In the absence of a statute, a contract is insufficient to protect a patent because —

A contract only bestows rights and obligations on the parties (privity of contract)

privity would only be between the state and the patent holder → no right of
enforcement against third-party infringers

A patent is a territorial right limited to the jurisdiction of a country

After disclosure and application in India, it may be extended to other countries within
12 months under the PCT regime

Slightly different process under the Paris Convention system

Difference between patent and copyright:

Copyright is a natural right which exists by virtue of creation — need not be

registered. A patent is a statutory right that must be granted

Originality v. Novelty (higher threshold)

Period of protection (20 v. 60)

What is a Patent?
A patent is essentially an incentive to disclose (not to invent). It involves a certain
element of quid pro quo as it trades monopoly or exclusivity for disclosure that would
enrich the repository of knowledge in society and distribute it amongst the people.
Disclosure alone may not suffice, and must be accompanied by a disclosure of the means
and methods of applying the information. This is why patent licenses are often
accompanied by Technology Transfer Licenses.

The First Patent — 1449

In 1449 King Henry VI of England authorised the Flemish glassmaker John

Utynam to produce stained glass windows for Eton and King’s Colleges in
exchange for teaching his craft / technique to apprentices at these two institutions.
The King signed a royal order on April 3, 1449, and Utynam was granted a
monopoly of the process, which had been hitherto unknown in England, for
twenty years. In exchange for this monopoly, John Utynam was required to
instruct Englishmen in the craft.

Monopoly as quid pro quo for disclosure AND training. The obligation to train
here adds to the wealth of knowledge — no societal benefit otherwise if

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 monopoly is just granted to one person without dissemination of knowledge and
information

The first modern patent statute was enacted by the Senate of Venice in 1474

“And should it be provided, that the works and contrivances invented

by them, others having seen them could not make them and take their
honor, men of such kind would exert their minds, invent and make
things which would be of no small utility and benefit to our State.
Therefore, decision will be passed that, by authority of this Council,
each person who will make in this city any new ingenious
contrivance, not made heretofore in our dominion, as soon as it is
reduced to perfection, so that it can be used and exercised, shall give
notice of the same to the office of our Provisioners of Common. It
being forbidden to any other in any territory and place of ours to
make any other contrivance in the form and resemblance thereof,
without the consent and license of the author up to ten years.”

“works and contrivances invented by them” → shows that an invention proposes a

technological advancement, i.e., it must further existing technological levels

“others… honor” → reference to the inventor’s honour demonstrates how replicating

an invention encroaches on their identity and dignity. Respect for the intellectual
labour invested by one person as a protection of their honour which is embodied in
the invention is the backbone of IP. Their invention is viewed as an extension of their
personality.

“would be of no small utility and benefit to our State” → Venice sought to attract
brain power in their state and the Patent system was used for the first time as a means
of attraction (incentive). An invention must thus have some utility or application and
provide benefit to the society. Here, the benefit can just be adding to the repository of
knowledge or any tangible benefit provided by an invention. However, this does not
mean that an invention must be overly complex or technical — all that matters is it
contributes to society. E.g: a safety pin

“any new indigenous contrivance” → an invention must be novel and unique and
never created before. Unlike in copyright, the idea-expression dichotomy cannot be

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 exploited here since an invention must always be unique and new — mere new forms
of expression do not warrant patent protection

“not made heretofore in our dominion” → territorial evaluation of novelty. However,

novelty today is a global concept — knowledge of a proposed invention must not
exist anywhere in the world. The system usually grants patents and leaves room for
opposition at every stage, given the logistical burden of evaluating an invention
against the extensive existing knowledge of the world

“forbidden to any other … thereof” → a patent creates a monopoly in the inventor’s

favour. There is no natural monopoly but one that is provided and protected by law. It
is thus an artificial creation and external support. One is also precluded from making
any contrivance similar to or resembling the invention.

“without the consent and license of the author” → third-party exploitation of patented
inventions/knowledge is permissible if it is with the consent and authority of the
inventor — licensing

Term → 10 years (20 years today)

Justification for Patent Law: Report of the Swan Committee, 1944

“The theory upon which the patent system is based is that the
opportunity of acquiring exclusive rights in an invention stimulates
technical progress in four ways: first, that it encourages research
and invention; second, that it induces an inventor to disclose his
discoveries instead of keeping them as a trade secret; third, that it
offers a reward for the expenses of developing inventions to the stage
at which they are commercially practicable; and fourth, that it
provides an inducement to invest capital in new lines of production
which might not appear profitable if many competing producers
embarked on them simultaneously.”

The Patent system provides an opportunity of acquiring exclusive rights in an invention

and stimulates progress in four ways:

1. encourages research and innovation

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 while a patent does not guarantee the success of an invention in the market, if it
does find commercial success, it is possible that part of the proceeds will be
reinvested in research

moreover, the opportunity to get a patent encourages research

the risk/chance factor — tradeoff for a monopoly which is expected to be

successful

the idea that research will lead to a commercially exploitable invention is also
only a possibility

2. induces disclosure of an inventor’s discoveries, rather than keeping it as a trade

secret

3. offers a reward for the expenses of developing inventions to the point where they
are commercially exploitable

while an invention may not always be capable of application for commercial

purposes, a patent system provides two-levels of incentive: first - to file for a
patent, and second- to develop a patented invention for the market

4. incentive to invest capital in new lines of production which might not appear
profitable if many competing producers embarked on them simultaneously

this area is yet to be explored and is more futuristic — refers to future inventions
that have not been anticipated and are entirely new

in these cases, the prospect of a patent would induce investment in an area which
is otherwise unknown

the possibility of a patent offsets the risk in such investment and gives a
competitive edge to the first producer who would be ahead of the curve.

Ayyangar Committee
Post-independence, the Tek Chand Committee or the Patents Enquiry Committee
was formed in 1948 to review the Indian patent law. The 1911 Act was amended in
1950 in relation to working of inventions and compulsory licensing/revocation. In
1952, an amendment was introduced to provide for compulsory license in relation to
patents on food and medicines, insecticide, germicide or fungicide and a process for
producing substance or any invention relating to surgical or curative devices.

In 1957, the Government of India appointed the J. Ayyangar Committee to examine

revisions to the patent law.

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 The erstwhile patent system fell short of stimulating research and invention, and
only allowed commercial exploitation.

This is because we had blindly conformed to and adopted the Western system in
the absence of a better alternative.

I entirely agree with the views of the Patents Enquiry

Committee(1948) that “the Indian Patent system has failed in
its main purpose, namely, to stimulate invention among
Indians and to encourage the development and exploitation of
new inventions for industrial purposes in the country so as to
secure the benefits thereof to the largest section of the
public.”

The Ayyangar Committee was appointed by the government of India to endow

the country with a proposal for reworking the 1911 Act which was in operation
then and advise the government on the same. The report was submitted in 1959.

The Report had recommended retaining the patent system despite its
shortcomings along with major changes.

“With all the handicaps which the system involves in its

applications to under-developed countries, there are no
alternative methods for achieving better results. At present
there is no country in the world that does not adopt the patent
system of rewarding inventors”

Recommendation (1)

by defining with precision inventions which should be patentable and

by rendering unpatentable certain inventions, the grant of patents, to
which will retard research, or industrial progress or be detrimental
to national health or well-being

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 For uniformity, both the points in this recommendation were inserted in legislation, so as
not to leave it to the subjective evaluation of the examiners — in two provisions:

1. S.2(1)(j): What is an invention? (Patentability criteria)

2. S.3: What is not an invention (Patent eligibility)

ARTICLE 27 TRIPS — defines what constitutes patentable subject matter:

...patents shall be available for any inventions, whether products or

processes, in all fields of technology, provided that they are new,
involve an inventive step and are capable of industrial application.

These three requirements (novelty, inventive step and capable of industrial application),
have been incorporated into the definition of an invention in the Patents Act, 1970.

“invention” means a new product or process involving an inventive

step and capable of industrial application

The Patent Office is obliged to grant a patent if it is satisfied that an “invention” exists
(shall). Thus, the Committee also insisted on an explicit enumeration of what is not an
invention — hence, in India (as opposed to the US, rejection is the rule and acceptance is
the exception).

This is because the impact is greater in the event of an erroneously granted patent
for a non-patentable invention — which affects the whole population’s freedom
— as opposed to the consequences of rejecting a patentable application which
only affects the inventor’s incentive

💡 In the United States, non-patentable inventions come about from case law, and
are not enumerated in the statutes (which only considers merit). Thus,
acceptance is more liberal. This is because of (a) greater qualifications of
patent examiners, and (b) specialisation of examiners in niche fields. These
attributes decrease the likelihood of a patent being wrongfully granted as the
judgment of the examiner is considerably reliable.

S.3 of the Act seeks to add further precision in the definition of an invention. This
provision categorises non-patentable inventions on the basis of their intended effect (ex:
being detrimental to national health) — this impact assessment is made post facto, after

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 an application is examined for these consequences. The application is de-classified after
the invention is studied (cannot be pre-conceived). This limits the examiner’s discretion
ARTICLE 27 TRIPS — also states that patents must be available for products and
processes “in all fields of technology”. Thus,

there is no discrimination based on technology

the same standard is adopted for all fields

there is also no discrimination based on where the patent is invented and whether it is
imported or locally produced

Recommendation (2)

by expanding the scope of “anticipation” so as to comprehend not

merely what is known or published in this country, but also what is
known or published outside India;

The Committee suggested the adoption of a global standard of novelty — should not be
pre-existing in any knowledge system.
As evinced by the definition of a ‘new invention’ — this may be documentary or non-
documentary knowledge

“new invention” means any invention or technology which has

not been anticipated by publication in any document or used in
the country or elsewhere in the world before the date of filing of
patent application with complete specification, i.e., the subject
matter has not fallen in public domain or that it does not form
part of the state of the art.

ANTICIPATION → refers to knowledge that is a part of the prior art/state of the art —
examiners must consider whether the invention can be anticipated from prior art in their
assessment of novelty
state of the art → refers to common general repository of knowledge. Novelty is
destroyed when ANY information has been disclosed or published (even voluntarily) prior
to filing. For inventions created in India, the Patent Office also requires for the patent to
be filed in India first.

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 inventive step → an inventive step implies a degree of novelty, but is still in an
independent consideration — one cannot be implied from the other

Recommendation (3)

by providing remedies for the evils which India, in common with

other countries, experiences from foreign owned patents which are
not worked in the country, but which are held either to block the
industries of the country or to secure a monopoly of importation;

This recommendation suggests including provisions for combating certain ‘evils’ resulting
from the non-working of a patent.
Getting a patent does not imply that there is a ready market for the invention which will
respond to its introduction. Inventors/commercial enterprisers might create demand and
manufacture markets by withholding a product or invention from release, which
simultaneously also blocks other companies or industries from applying the patent →
fosters monopoly over import
The Committee sought to limit this, especially from the perspective of foreign-owned
patents

Recommendation (4)

by providing special provisions as regards the licensing of patents

for inventions relating to food and medicine

This provision, for licensing of patents related to food and medicine was exploited from
1970 — 2005, until the TRIPS Agreement was fully and finally incorporated into Indian
law.
Before TRIPS, product patents in the pharmaceutical industry were prohibited — this is
because patents, especially for lifesaving drugs, must also benefit the people +
considering the public interest in limiting the cost of healthcare

The Tek Chand Committee found that the price of lifesaving drugs was highest in
India in the pre-independence period. Thus, to provide the medicines and access
to healthcare to even the common man in the post-Independence era, there was no
product patent at all granted to the pharmaceuticals.

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 💡 TIME FRAME

Before 1970 — All patent in all fields

Between 1970 to 1995 –— No product patent in pharma

Between 1995 to 2005 — No product patent but merely EMR in pharma

→ due to TRIPS transition period

After 2005 — All patent in pharma allowed

The Ayyangar Committee Report also discusses the tussle between the interest of the
inventor and national interest, observing that “Patent systems are not created in the
interest of the inventor but in the interest of national economy. The rules and regulations
of the patent systems are not governed by civil or common law but by political economy.”

National interest needs to be addressed, merely the patentee’s monopoly need not
be exploited.

This national interest will be secured in two ways. Firstly, through disclosure,
such that the technology is in public domain. Secondly, the working of the patent
in the Indian market.

Herein, the patentee would exploit the market once he has been granted the
patent (wherein he would attain the rights associated with that patent).

If a person has merely applied for the patent, then if another person files a similar
patent subsequently, the only remedy available would-be compensation and not
injunction, because the former is merely an applicant and not a patentee.

What was the national economy interest to disallow product patent in pharma in
India?

1. Excessive prices on the life-saving drugs

2. It will hurt the livelihood of the people — thus prohibition only on food and
medicine

Only process patent would be allowed – This is because Indian drug

manufacturers could reverse engineer the same via a different process.

Recommendation (5)

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 by providing remedies for other forms of abuse resorted to by
patentees, to secure a more extended monopoly or a monopoly for a
longer duration than what the statute grants

S.3 is comprehensive in its restrictions and exclusions, in a manner that controls any
abuse or misuse of patent protections. Art. 27(2) TRIPS clarifies that countries are
allowed to exclude certain inventions, in the interest of “ordre public or morality,
including to protect human, animal or plant life or health or to avoid serious prejudice to
the environment, provided that such exclusion is not made merely because the exploitation
is prohibited by their law.”
Section 3 covers in its scope, concepts like ‘ever-greening’ → whereby patent holders
make minor modifications to their existing patented inventions and re-apply to prolong
their protections. [S.3(d)]
The Act also provides sanctions against not working a patent and only focusing on
exports, which effectively leads to a monopoly of the manufacture with no public interest
quid pro quo

Genentech v. Wellcome, 1995

The UK Court of Appeal rejected a patent on production of a substance, human tissue
(t-pa), an invention which was useful in treating thrombosis by using recombinant
DNA technology.
Sought a patent even though it was a naturally occurring protein that Genentech
merely produced in commercial quantities.
It was held that there was no inventive step and the patent was refused. Mere
discovery of naturally existing substance cannot be patented. It also stated that t-pa
would not be an invention (almost like a fourth criteria) However, this case begs the
following questions:

1. Should knowledge be granted as patent?

Genentech merely produced an already existing human tissue, thus it can be

categorised as knowledge.

However, this knowledge was introduced by the inventor, and thus he has
contributed to the knowledge basket.

But the contention is whether the inventor has merely identified it/informed
the public about it or he has invented it — Court upheld the former

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 2. Can information be patented?

No, information cannot be patented, because it would hinder all the further
research and innovation in the field.

However, if a composition has undergone a specific process, then the process

can be patented but not the information.
Biogen v. Medeva, 1997
Biogen developed a synthetic molecule of Hepatitis B and a detection kit. Biogen
Inc. commenced patent infringe­ment proceedings against Medeva plc respecting a
patent for an artificially con­structed molecule of deoxyribonucleic acid (DNA)
carrying a genetic code which, when introduced into a suitable host cell, would
cause the cell to make antigens of the hepa­titis B virus (HBV).

The House of Lords established that in order to be granted a patent, one only
needs to establish the three ingredients of novelty, inventive step and industrial
application. There is no fourth criteria of an invention — these factors in itself
constitute an invention as per Art. 27 TRIPS

The research in this case took place over levels:

1. Level 1: identified what is responsible for Hepatitis B (information) → at this

stage it is merely knowledge so based on Genentech, it would not have been
granted patent.

2. Level 2: make a synthetic molecule from the information → no longer

dependent on the natural source

3. Level 3: • made a detection kit (straightaway commercially exploitable) →

at this stage, it is invention and hence the application of the knowledge will
now be granted patent.

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 💡 Patent in Software:

Copyright is merely awarded for monopoly in reproduction, translation,

etc. There is no monopoly over use in copyright.

However, in patent the monopoly exists in the usage of the invention.

Hence, the software industry is in favour of applying patent and not
copyright.

But if we monopolise a software, which effectively states how to use

library resources, then it might lead to monopolisation of information,
along with the application, which will be problematic. Thus, currently in
India there is no system of granting patent in software.

Patent Eligibility
TRIPS Art. 27(1) → Every invention shall be granted patent
An invention has been defined in Art. 27 as well as in §2(1)(j) of Patent Act, which mentions
invention is a product or process which involves:

1. Novelty

2. Inventive step

3. Industrial application

"invention" means a new product or process involving an inventive step

and capable of industrial application

TRIPS Art. 27(2) → provides for the existence of certain exceptions at the discretion of
member states — whereby certain inventions are not patentable at all, regardless of the merits
of the invention (as per the 3 factor test). In India, these exceptions have been embodied in
Section 3 which can be understood as the patent eligibility criteria, after which one can
deploy 3 factor test to determine ‘invention’. However, this hierarchy is not followed by
patent examiners, who examine the 3 factors as well as the exclusionary provisions of S.3
simultaneously.

S. 3(a)

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 an invention which is frivolous or which claims anything obviously
contrary to well established natural laws;

There is no definition for the term ‘frivolous’. Thus, the determination of frivolity is
unclear — the answer can be very subjective depending on the examiner. Ex: patent
on a sealed crustless sandwich

Thus, it needs to be determined what is ‘frivolous’, otherwise it will be very

subjectively applied.

However, it needs to be understood, that during the initial phase, Patent Office was
worried that it would be flooded with frivolous applications and thus this phrase in
S.3(a) was added to the Act.

Patent in Musical notes →

An inventor had claimed, improved delineation of musical notes along with

improved music, using those notes.

At that point of time, the patent has been allowed.

Patent in a machine which displays time in metric system

Herein, the machine displays 100 seconds as minute, etc.

This can be denied patent on frivolous grounds.

Anything obviously contrary to well established natural laws

This includes, for example, a machine purporting to produce perpetual motion, a

machine alleged to be giving output without any input, a machine allegedly
giving 100% efficiency

This can be problematic because time and again science has developed and has
contradicted the established norms.

However, again this will be problematic because you never absolutely deny that
some invention cannot exist which defies the established natural laws.

S. 3(b)
an invention the primary or intended use or commercial exploitation
of which could be contrary to public order or morality or which
causes serious prejudice to human, animal or plant life or health or
to the environment

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 Art. 27(2) TRIPS states that

“Members may exclude from patentability inventions, the prevention

within their territory of the commercial exploitation of which is
necessary to protect ordre public or morality, including to protect
human, animal or plant life or health or to avoid serious prejudice to
the environment, provided that such exclusion is not made merely
because the exploitation is prohibited by their law.”

Thus, a member state cannot use the law to prohibit the exploitation of an invention in the
market as it would be unfair. Exclusion can only be on the grounds of public order,
morality and for the protection of plant, human or animal life. Member states have
significant discretion in this regard.
Art. 53 of the EPC also reflects this principle:

EXCEPTIONS TO PATENTABILITY
European patents shall not be granted in respect of:

(a) inventions the publication or exploitation of which would be

contrary to ordre public or morality, provided that the exploitation
shall not be deemed to be so contrary merely because it is prohibited
by law or regulation in some or all of the Contracting States;
(b) plant or animal varieties or essentially biological processes for
the production of plants or animals; this provision does not apply to
microbiological processes or the products thereof.

The wording of this provision is almost identical across different statutes

Patent on vibrator: In the patent examination report by the Patent Office, it is

mentioned that the ‘vibrator’ use could be contrary to ‘public order’ and ‘morality’,
and thus falls under §3(b) of the Patent Act.

Method of determination: Vibrators have been granted patents in other

jurisdictions

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 There can be no supporting documents to further the case that the impugned
invention is contrary to ‘public order’ or ‘morality’, as opposed to some
inventions which are harmful to environment, etc.

If there is no definition of ‘public order’ or ‘morality’, then it will be

dependent on the biases or subjective interpretation of the examiner.

Implication: The vibrator was denied patent based on its obscenity, as defined in
S.292 IPC —

obscenity has been extended to interpret the ‘public order’ or ‘morality ’

under S.3(b) – which does not appear to be the intended effect of the statute.

Moreover, ‘public order’ clause cannot be usually implemented in this kind

of an invention, where the usage is private.

Thus, one needs to determine a reasonable threshold to gauge how to

classify an invention, which runs contrary to ‘public order’ or ‘morality’.

Onco-Mouse
Harvard submitted a claim detailing a transgenic laboratory rodent that had been
genetically altered via recombinant DNA methods, to carry the ‘oncogene’ which
increases its predisposition to cancer, making it suitable for oncological research and
development.

Possible oppositions to the patent:

1. involves animal cruelty — covered in wording of Art. 27(2)

2. threat to environment — independent study

3. immorality — subjective threshold

4. animal variety — cannot monopolise a variety or breed of the non-human

mammal. However, for this objection to be sustained it needs to be proved
that it’s a variety (variety meaning a new group which is stable). → rejected
by the EPO

5. commercialisation of animal — however it again gets murky because the

impact of the invention cannot be anticipated

6. discovery (not invention) — herein the mammal would have been found in
the nature — since it is genetically introduced, it cannot be termed as
discovery

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 7. method of treatment (for cancer) — at this stage it cannot be treated as a
method, nor it can be qualified as a treatment as it is infusing the mammal
and making it susceptible to cancer.

8. lack of industrial application — mammal itself can be sold and satisfy the
threshold. Also, there is no immediate need to be industrially applicable →
the mammal can help in developing a drug which can be ultimately sold.

Result

It was initially refused, on the basis that the EPC excludes animals from the
realm of patentability. However, the Board of Appeal ultimately found in
favour of the patent, holding that the Convention’s exclusions under Article
53(b) applied to animal varieties and not animals as such

Morality clause: introduced the application of the “utility balancing test” —

The examiners considered the issues of animal suffering (caused to the mice
who were injected with cancerous genes) and environmental danger (due to
risk of exposure to the mice population), and weighed it against the potential
benefit to human beings in cancer research. — accordingly, the benefit was
found to outweigh the risks

The Patent Office (of any country) is not equipped to set standard for morality
(this is the reason why TRIPS does not mandated the exclusion based on ‘public
order’ and ‘morality’, but only gives it as an option).

Ayyangar Committee, para 385:

There is no provision corresponding to section 10 (2) of the U.K.

Act, 1949 dealing with cases where the primary or the intended
use of an invention is lawful, but there is the possibility of the
invention being put to a use which is either contrary to law or to
morality. In such cases, the U.K. Act vests the Controller with a
discretion to accept the application, provided the applicant
disclaims the unlawful use of the invention. Cases where
advantage has been taken of this provision have been few but
notwithstanding this, there is no doubt that this is a useful
provision and might be added.

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 Relaxin
The Howard Florey Institute submitted an application for a patent for relaxin, a
hormone which relaxes the uterus during childbirth, and which, it was hoped, could
have medical application in reducing the need for caesarean deliveries in difficult
pregnancies.

DNA technology was used to isolate and clone the gene, which was used to
produce synthetic relaxin • which will be extremely helpful in cases where in
absence of the production of relaxin, caesarean deliveries have to be
conducted

Unquestionably satisfies the three-factor test of patentability

The claim was for synthetic relaxin and not naturally occurring relaxin -
NOVEL

Regardless of whether the method used to isolate the DNA is

conventional, the product itself involved an INVENTIVE STEP

Other oppositions:

Discovery: Weak claim because the monopoly is being claimed over the
synthetic relaxin and not the naturally occurring hormone.

Morality or ordre public:

This argument arises from the source, which was that of the pregnant
women who actually sourced the gene for producing relaxin. Thus,
this kind of argument will arise in all kinds of biotechnology
inventions.

However, the test is — whether the public would deem it abhorrent

in extreme circumstances.

It was contended that isolating a gene from tissue taken from a

pregnant women was an affront to human dignity, as it used the
pregnancy for a technical profit-oriented process. — no issue
however, if the consent of the woman is taken

Patenting human genes “amounts to a form of modern slavery since

it involves the dismemberment of women and their piecemeal sale to
commercial enterprises” — this is an extreme argument → Human
genes can be dissociated from the human, w.r.t the invention. This
cannot prevent the genes from being monopolised.

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 The EPO’s response:

This gene sequence was itself novel, as it was in the form of

complementary DNA, which does not exist in nature. The form of
relaxin that it coded for was also unknown until the inventor isolated it
for the first time.

As the inventor was providing to the public for the first time a product
whose existence was previously unknown, the method used to obtain it
was immaterial.

A discovery of a substance freely occurring in nature was not patentable;

but if the substance was newly isolated and characterized, then it was not
a mere discovery; it was an industrially applicable technical solution to a
technical problem.

It would not be viewed by the public as too abhorrent to be patentable.

The tissue was donated with consent within the framework of

gynaecological operations. Many life-saving substances were isolated in
this way, patented and welcomed by the public;

Gene patents do not confer any rights over individual human beings.
There was no dismemberment of humans since the point of the invention
was to synthesise the hormone;

"The patenting of a single human gene has nothing to do with the

patenting of human life. Even if every gene in the human genome were
cloned it would be impossible to reconstitute a human being from the sum
of its genes". No moral distinction was seen between the patenting of
genes and the patenting of other important human substances, such as
adrenaline.

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 Ref: EU Directive 98/44/EC on Biotechnological Inventions.
Article 6

1. Inventions shall be considered unpatentable where their commercial exploitation

would be contrary to ordre public or morality; however, exploitation shall not be
deemed to be so contrary merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following, in particular, shall be considered

unpatentable:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;

Patents 20
 (d) processes for modifying the genetic identity of animals which are likely to
cause them suffering without any substantial medical benefit to man or animal,
and also animals resulting from such processes.

Herein, it is important to note that as per Article 6(2), the EU has defined the
contours of morality to some extent. Also in 2(d) it accounts for a situation
like the Onco Mouse. But, it remains to be seen whether some explanation
like this exists in Indian patent law or not.

Article 7
The Commission's European Group on Ethics in Science and New Technologies
evaluates all ethical aspects of biotechnology.

This indicates that patent office is not equipped with answering the ethical
questions regarding the inventions.

However, the relationship between the patent office and this committee is
important to consider such that the former acts only as an advisory or its
opinions are binding on the latter.

Bursitis Vaccine Case

In a historic ruling from 2001, the Calcutta High Court permitted the patenting of a
method for creating a live Bursitis vaccine. The application was initially refused by
the patent examiner on the basis that the process culminated in an end product
containing a living organism (a live vaccine), thus making it unpatentable. The Patent
Controller, held that process for preparation of vaccine which has living entity cannot
be considered ‘manufacture’

However, in most production of vaccines it is based on living entity.

Also, the inventor can argue with the list of all the patents which have been
granted on living entity in the past – as to rebut the claim of the patent officer.

However, the Court considered the issue from a “vendibility” perspective and
concluded that patents can be granted for processes that result in vendible items. This,
however, was limited to process patents.

Novartis

“We are fully conscious of the Appellant’s benevolent GIPAP

program for free distribution of GLEEVEC to certain cancer
patients. But as per information furnished in its written counter–

Patents 21
 argument by R3 that when the Appellant was holding the right as
EMR on GLEEVEC it used to charge Rs.1,20,000/- per month for
a required dose of the drug from a cancer patient, not disputed by
the Appellant, which in our view is too unaffordable to the poor
cancer patients in India. Thus, we also observe that a grant of
product patent on this application can create a havoc to the lives
of poor people and their families affected with the cancer for
which this drug is effective. This will have disastrous effect on
the society as well. Considering all the circumstances of the
appeals before us, we observe that the Appellant’s alleged
invention won’t be worthy of a reward of any product patent on
the basis of its impugned application for not only for not
satisfying the requirement of section 3(d) of the Act, but also for
its possible disastrous consequences on such grant as stated
above, which also is being attracted by the provisions of section
3(b) of the Act which prohibits grant of patent on inventions,
exploitation of which could create public disorder among other
things

Article 27 of TRIPS as well as S.3(b) of the Act, had the objective that Member
States could prevent patentability of inventions based on their impact affecting
public order or morality or harm to animal or human life.

In this case, when Novartis charged Rs. 1.2 lakhs under EMR, it is likely to
charge more if patent is granted

Why should the patent office be concerned about the price and impact of an
invention?

Access to healthcare (based on high prices) is different than the impact of the
invention on public order, morality, etc.

If exclusion is based on apprehension of such exorbitant pricing of the

invention, then the patent office would be basing its objection on a larger
public policy concern which is neither based out of Article 27(2) of TRIPS
nor under S.3(b) of the Indian Patent Act.

Patents 22
 However, the patent was ultimately rejected on the grounds of S.3(d) of the
Act, thus the ratio of Novartis doesn’t involve S.3(b) of the Act.

Price regulation is the main concern of the Drug Controller’s Office and not
the Patent’s Office, hence pricing concerns cannot be brought in by backdoor
with the aid of S.3(b) of the Act.

Guidelines For Examination Of Biotechnology Application For Patent

This does not have the sanctity of a legislation or directive, it is merely an

administrative document for the aid of the Patent office.

Biotechnology deals with living subject matters and involves

alteration of genomic materials of an organism. Such change
may influence or may have a deep impact upon the
environment or the human, animal or plant life or may involve
serious questions about morality. Hence, adequate care should
be taken while examining the inventions vis-a-vis their
primary or intended use or commercial exploitation and it
should be carefully dealt so that the subject-matter must not
be contrary to public order, morality or causes serious
prejudice to human, animal or plant life or health or to the
environment. A few non limiting examples may further clarify
the issues: (a) a process for cloning human beings or animals;
(b) a process for modifying the germ line of human beings; (c)
a process for modifying the genetic identity of animals which
are likely to cause them suffering without any substantial
medical or other benefit to man or animal, and also animals
resulting from such process; (d) a process for preparing seeds
or other genetic materials comprising elements which might
cause adverse environmental impact; (e) uses of human
embryos for commercial exploitation.

Patents 23
 The examples in (a) to (e) replicate the EU directive. However, the directives
regarding public order have not been adopted in India. In such a case, when
India has already adopted a narrow standard of ‘public order’ as opposed to
‘ordre public’ it cannot bring the policy concerns like pricing as based in the
latter to be interpreted in the former

Tek-Chand Committee on pricing issue:

It also observed that the Patent Act should contain a clear

indication that food and medicine and surgical and curative
devices were to be made available to the public at the
cheapest price commensurate with giving reasonable
compensation to the patentee.

Thus, the Committee wanted to balance the interest of the inventor as well as the
public. The Patent office cannot reject patents on the grounds of excessive
pricing, however post grant of patents it can either resort to compulsory licensing
or revocation of patents, to balance the interests of the public.

Marijuana based product?

How do we decide “primary or intended use” or the extent of commercial

exploitation of such a product?

The Note – “Dude where’s my patent” considers what role, if any, illegality
should play in a determination of patentable utility by examining the
patentable utility of marijuana strains and marijuana-related inventions. The
Note proposes illegality should not affect the patentable utility of an
invention because such a rejection would be inconsistent with the goals of
the patent system.

For example — a sports drink which gives extra boost can be patentable, but
it can be deemed illegal in some sports.

So, patentability must be kept separate from illegality

Terminator seed (which expires after one year)?

Until and unless consumption of such a seed is harmful, the seed must be
patentable.

Patents 24
 However, in case of an agrarian economy, seed might not be patented as it’s
not a marketable commodity, and thus such a terminator seed would affect
the livelihood of the people. In such a scenario it must be answered, whether
such a terminator seed would exclude patentability based on ethical concerns
as per S.3(b)?

Under the Patent Office’s Guidelines, it is mentioned the following will

exclude patentability under S.3(b) of the Act:

a process for preparing seeds or other genetic materials comprising

elements which might cause adverse environmental impact

Thus, if those seeds affect the environment, then definitely it will be barred
by S.3(b)

Legal prohibition in India cannot be a cause for denying patent under S.3(b)
— based on Article 27(2) TRIPS.

Nevertheless, in India, the seed industry is largely not covered within the
patent regime as per S.3(j) — (The provision is category-wise
declassification, irrespective of the impact of the invention).

S. 3(c)
the mere discovery of a scientific principle or the formulation of an
abstract theory or discovery of any living thing or non-living
substance occurring in nature

The term discovery is preceded by “mere” — would it be defined by law or the patent
office?

“Scientific principle” — not invented but identified and demonstrated

Scientific theory must be in public domain, but an application based on it can be

accepted.

“Occurring in nature” — relates to ‘products of nature’ — for this, living or non-

living, no patent can be granted, even when they add to the existing repository of
knowledge.

Essentially, significant human intervention would be required in order to make an

invention patentable → in a way, by clearing S. 3(c), an invention also satisfies the
inventive step criterion

Patents 25
 This has an interesting intersection with patents in the field of biotechnology

Diamond v. Chakrabarty, 1980

Facts: Ananda Mohan Chakrabarty, while working for General Electric, developed a
bacterium capable of breaking down crude oil, which he proposed to use in treating oil
spills. This was not a naturally occurring bacterium.
It is interesting to note that in US Patent Law (Title 35), a patent is granted to an
invention OR a discovery → no difference.
The patent claims were for:

1. Process claims for the method of producing the bacteria

2. Claims for an inoculum comprised of a carrier material floating on water

3. Claim for the bacteria themselves

Level 1: Patent Examiner:

The Patent examiner allowed the claims falling into the first two categories, but
rejected those belonging to the third based on two grounds: first, that micro-
organisms are a “product of nature” and second, that as living things they are not
patentable subject matter under S.101 of Title 35, which states:

“Whoever invents or discovers any new and useful process,

machine, manufacture, or composition of matter, or any new and
useful improvement thereof, may obtain a patent therefore, subject
to the conditions and requirements of this title.”

Level 2: Patent Office Board of Appeals

They dismissed the first ground, based on the reading that,

In choosing such expansive terms as "manufacture" and

"composition of matter," modified by the comprehensive "any,"
Congress contemplated that the patent laws should be given wide
scope, and the relevant legislative history also supports a broad
construction. While laws of nature, physical phenomena, and
abstract ideas are not patentable, respondent's claim is not to a

Patents 26
 hitherto unknown natural phenomenon, but to a non-naturally
occurring manufacture or composition of matter.

However, they affirmed the examiner’s findings on the second ground that living
beings are not covered by US Patent Law.
Level 3: Court of Customs
The Court of Customs and Patent Appeals then reversed the decision, holding that
“the fact that microorganisms…are alive…(is) without legal significance" in patent
law.” As per the law, only novelty, inventive step and industrial application are
required. Hence, the invention can be patented

They also took cues from the plant variety patents, wherein living or non-living
thing determination is irrelevant.

Level 4: Supreme Court

Agreed with the Court of Customs and held that a live, human- made microorganism
is patentable subject-matter under S.101 and that the respondent's microorganism
constitutes a "manufacture" or "composition of matter" within that statute
As per Art. 1(8) of the US Constitution — Congress has the power to “promote the
progress of science and useful arts, by securing for limited times to authors and
inventors the exclusive right to their respective writings and discoveries.” — patent
law facilitates progress of science and hence provides incentive for making
inventions. In this case, the synthetic bacterium was reducing oil spillage which no
other naturally occurring bacteria could do → hence it is in progress of science and
arts.
The Court also made reference to Thomas Jefferson’s philosophy that ingenuity
should receive a liberal encouragement.

The court also relies on the fact that Congress intended statutory subject matter to
‘include anything under the sun that is made by man’ for patentability. Thus, it means
that exclusion should be an exception. It does not mean it is to be taken literally and
that S.101 has no limits or that it embraces every discovery. The laws of nature,
physical phenomena (for example simple mixtures like salt and water), and abstract
ideas (mere theoretical ideas which cannot be executed in reality) have been held not
patentable.
The terms ‘manufacture’ and ‘composition of matter’, especially in combination with
the comprehensive ‘any’ in Section 101 are both interpreted with a wide scope to
enlarge the application of patent laws. ‘Manufacture’ is taken to mean “the production

Patents 27
 of articles for use from raw or prepared materials by giving to these materials new
forms, qualities, properties, or combinations, whether by hand- labor or by
machinery.” ‘Composition of matter’: is taken to include “all compositions of two or
more substances and… all composite articles, whether they be the results of chemical
union, or of mechanical mixture, or whether they be gases, fluids, powders or solids.”
Following these large definitions, in the view of the Court the respondent's
microorganism qualifies as patentable subject- matter since it is not a hitherto
unknown natural phenomenon but a non-naturally occurring manufacture or
composition of matter and thus a product of human ingenuity

S. 3(d)
the mere discovery of a new form of a known substance which does
not result in the enhancement of the known efficacy of that substance
or the mere discovery of any new property or new use for a known
substance or of the mere use of a known process, machine or
apparatus unless such known process results in a new product or
employs at least one new reactant

Recall: 5th Recommendation of Ayyangar Committee → preventing abuse of patents.

Patent-holders might file another application after making minor modifications to

earlier inventions to extend their monopoly (from 20 years).

An existing invention can lead to the development of:

a new form

a new property

or new use

While new forms may be incentivised, properties of inventions should not

be used to extend the time period of protection

S.3(d) operates to prevent this → discourages “evergreening” — practices that have

developed in certain jurisdictions wherein a trifling change is made to an existing
product, and claimed as a new invention — and prevented such derivative or other
forms of the already patented product being granted patent unless the derivatives or
other forms “differed significantly in properties in regard to efficacy”.

Patents 28
 S.3(d) was introduced alongside the TRIPS changes in 2005 whereby product patents
in pharma were allowed → to balance the interests.

The State wants to provide incentive to keep on researching in the field of science, to
give impetus to the discovery of new forms, new properties or new usage of the
existing invention.

Per S.3(d), the State has incentivised only the ‘new form’ of a known substance,
provided that it results in enhancement of efficacy. Nevertheless, for ‘new property’
and ‘new use’ of a known substance, there is no scope for grant of patent.

Thus, ‘new form’, ‘new use’, and ‘new property’ are not at par under the Indian
law, with respect to their patent protection.

However, any chemist/scientist would suggest that ‘form’, ‘property’ and ‘use’
are closely interlinked.

Herein, it is also important to note that India has deliberately not defined
‘enhancement’ or ‘known efficacy’, thus leaving it to the patent examiner to
determine whether the new form has the enhancement in known efficacy or not.

It must be noted that after Novartis case, India has published a list of patents running
into 100s of pages, which again call into question the efficacy of S.3(d) altogether.

Patent protection can be granted to a known substance, only its new form which has
enhancement of known efficacy. In order to understand this exception → Novartis Case

Novartis A.G. v. Union of India

Background: Novartis International AG filed an application as per the TRIPS
agreement before the Chennai Indian patent office for the grant of a patent for an
anticancer drug 'Glivec' which is used to treat Chronic Myeloid Leukemia (CML) and
Gastrointestinal Stromal Tumours (GIST).

This drug is invented from a Beta crystalline form of Imatinib mesylate → used
in the treatment of cancer and the same is patented in more than 35 countries.

The application was filed in 1998 but put in a mail-box as per the TRIPS
Agreement till 2005 when India allowed product patents in pharmaceuticals.

In 2005, the Madras Patent Office rejected the application on the ground that the
drug was anticipated by prior publication and failed to satisfy the requirement of
novelty and non-obviousness, further declaring the alleged invention as un-
patentable under the provision of S3(d) as the said drug did not exhibit any major

Patents 29
 changes in efficacy over its pre-existing form i.e. the Zimmermann patent (the
original form is IM)

Novartis subsequently filed 2 writs in the Madras HC that:

1. challenged section-3(d) of Patent Act, 1970 as unconstitutional because it is

not in compliance with TRIPS agreement and also violates Article-14

2. challenged the MPO’s order

The Madras HC transferred the case to the IPAB, which dismissed the appeal.

Novartis then approached the Supreme Court in 2009 by SLP, against the order
passed by IPAB.

Arguments:
Novartis contended that the Beta crystalline form of IM was much more effective than
the earlier Zimmerman Patent. However, the patent examiner was hesitant in granting
a new monopoly of 20 years on an already existing drug with just improved efficacy,
fearing that it would lead to evergreening of patents.

Patents 30
 💡 National Innovation Bill, 2008

In 2008, the National Innovation Bill was tabled, but it never saw the light
of day. Innovation was defined as:

“Innovation” means a process for incremental or

significant technical advance or change, which provides
enhancement of measurable economic value, and shall
include:

(a) introducing new or improved goods or services

(b) implementing new or improved operational
processes; and

(c) implementing new or improved organizational /

managerial processes;

Explanation: measurable value enhancement or

economic significance may include one or more of the
following:
(i) increase in market share;

(ii) competitive advantage;

(iii) improvement in the quality of products or
services;

(iv) reduction of costs.

Under this Bill, innovation also includes incremental inventions,

whereas such incremental inventions has been blocked in S.3(d).

The Bill was clear to incentivise those inventions which even though
are not significant but they provide some measurable enhancement
either through technology or of market share.

On these lines, Novartis had argued that their drug had enhanced the
efficacy of IM

Patents 31
 Level 1: Patent Examiner
The Assistant Controller held that:

1. the invention claimed by the appellant was anticipated by prior publication, i.e.,
the Zimmermann patent; (lack of novelty)

2. the invention claimed by the appellant was obvious to a person skilled in the art
in view of the disclosure provided in the Zimmermann patent specifications; (no
inventive step)

3. the patentability of the alleged invention was disallowed by S.3(d) of the Act (not
eligible)

Novartis was granted EMR in 2003, it charged exorbitant prices for the drug (ref.
to notes on S.3(b))

In 1997, when the appellant filed its application for patent, the
law in India with regard to product patent was in a transitional
stage and the appellant’s application lay dormant under an
arrangement called “the mailbox procedure”. Before the
application for patent was taken up for consideration, the
appellant made an application (Application No. EMR/01/2002)
on March 27, 2002, for grant of exclusive marketing rights
(EMR) for the subject product under section 24A of the Act,
which was at that time on the statute book and which now
stands deleted. The Patent Office granted EMR to the
appellant by order dated November 10, 2003.

Level 2: Madras HC and Reference to IPAB

Novartis appealed the examiner’s report in the Madras HC and also challenged the
validity of S.3(d) for unconstitutionality and non-compliance with TRIPS

On Constitutionality:

Novartis argued that S.3(d) added a layer of limitation on the grant of

patents that specifically discriminated against pharmaceutical products in

Patents 32
 violation of Art. 14. Also, there is no definition of ‘enhancement’ and
‘efficacy’ and thus it will allow arbitrariness by the patent examiner.

The HC dismissed this challenged on the following grounds:

There is no express mention that S.3(d) will be used only against

pharma products, and hence it cannot be struck down on this basis

The Controller has always had power to grant or reject patents,

however, the power is rationalised by giving recorded reasons for the
rejection of patents, which can be scrutinised by the judicial
authorities and it can be appealed. Thus, the Patent Controller,
cannot be said to have arbitrary power, irrespective of the lack of
definitions

On TRIPS Compliance — held that HC was not the right forum to address
this issue

On the merits of the patent application — This issue was transferred from the
HC to the newly constituted Intellectual Property Appellate Board (IPAB). It’s
findings were as follows:

IPAB reversed the Controller’s findings on the issues of anticipation and

obviousness. It stated that ingredients for grant of patent novelty and non
obviousness to person skilled in the art were present in the application.

However, it rejected the application on the ground that the drug is not a
new substance but an amended version of a known compound and that
Novartis was unable to show any significant increase in the efficacy of
the drug and it, therefore, failed the test laid down by S.3(d)

S.3(d) Analysis of the IPAB

A patent is not granted on every improvement of a known substance —

would defeat the inventive step criteria as it would not lead to any
significant development guaranteeing a technological advancement.

Only a “significant enhancement” in efficacy will be allowed to be

patented as per S.3(d) [explanation] — based on this, it can be logically
concluded that either the patent application will violate both ‘inventive
step’ and S.3(d), or it will be allowed under both. ‘Inventive step’ is
defined as:

Patents 33
 a feature of an invention that involves technical advance
as compared to the existing knowledge or having
economic significance or both and that makes the
invention not obvious to a person skilled in the art

Thus, non-obviousness ipso facto refers to a significant enhancement from

the previously known substance, from the perspective of a POSITA (in
this case, a pharmacologist) — it appears that if it is satisfied that the
patentable matter is ‘a significant enhancement’ then it would qualify the
threshold of ‘inventive step’ as well as the enhancement of efficacy under
S.3(d).

Level 3: Supreme Court by SLP

Why was Novartis allowed to bypass the HC?
The patent if granted on appeal would expire by 2018 and thus any further appeal
at that stage would be pointless. Considering this urgency and the need for an
authoritative decision on S.3(d) (other cases on this issue were pending before
various High courts), the Supreme Court granted special leave to bypass the High
Court appeals process and come directly before it.

However, we, wish to make it clear that any attempt to

challenge the IPAB order directly before this Court, side-
stepping the High Court, needs to be strongly discouraged
and this case is certainly not to be treated as a precedent in
that regard.
S. 3(b) of the Patent Act (ref earlier notes)

It was argued that the excessive pricing, which existed in the EMR, would
threaten public order and morality and hence it would be violative of S.3(b).
However, ultimately the court did not address the issue under S.3(b), and rejected
the patent based on S.3(d).

Nonetheless, it must be understood that this argument is not on the impact of the
drug on health or environment, but on the accessibility of the drug, which is a
public policy concern not present within the ambit of ‘public order’, rather in
‘ordre public’ — but the latter is not part of our statute.

S. 3(d) of the Patent Act

Patents 34
 The Court made monumental contributions in defining the contours of ‘efficacy’
under S.3(d)

What is “efficacy”? Efficacy means “the ability to produce a

desired or intended result”. Hence, the test of efficacy in the
context of section 3(d) would be different, depending upon the
result the product under consideration is desired or intended to
produce. In other words, the test of efficacy would depend upon
the function, utility or the purpose of the product under
consideration. Therefore, in the case of a medicine that claims to
cure a disease, the test of efficacy can only be “therapeutic
efficacy”. The question then arises, what would be the parameter
of therapeutic efficacy and what are the advantages and benefits
that may be taken into account for determining the enhancement
of therapeutic efficacy? With regard to the genesis of section
3(d), and more particularly the circumstances in which section
3(d) was amended to make it even more constrictive than before,
we have no doubt that the “therapeutic efficacy” of a medicine
must be judged strictly and narrowly. Our inference that the test
of enhanced efficacy in case of chemical substances, especially
medicine, should receive a narrow and strict interpretation is
based not only on external factors but there are sufficient internal
evidence that leads to the same view. It may be noted that the text
added to section 3(d) by the 2005 amendment lays down the
condition of “enhancement of the known efficacy”. Further, the
explanation requires the derivative to “differ significantly in
properties with regard to efficacy”. What is evident, therefore, is
that not all advantageous or beneficial properties are relevant,
but only such properties that directly relate to efficacy, which in
case of medicine, as seen above, is its therapeutic efficacy.

Patents 35
 The question that arises, is what is the desired or intended result in producing the
Beta crystalline form of IM? On a prima facie understanding, both treat cancer.

The difference is noted through the test of efficacy — differences in terms of the
function, utility or purpose of product. This test would vary from product to
product.

In case of medicine the test of efficacy would be → therapeutic efficacy.

In the present case, bio-availability was increased by 30% in the Beta

crystalline form.

Nonetheless, the court, based on facts, stated that it did not significantly
enhance efficacy.

Novartis wanted the court to set a limit or percentage after which it

would be considered as enhancement in efficacy, however the court
refused to define this limit.

It must be underscored, that a narrow interpretation, through introduction of

concepts like therapeutic efficacy will lead to rejection of more patents, whereas a
broader interpretation would allow more patents.

Prof Shamnad Basheer — broader interpretation of efficacy:

argued that safety or significantly reduced toxicity should also be taken

into consideration to judge enhanced therapeutic efficacy of a
pharmaceutical product in terms of S.3(d)

However, the court pushed for a higher and narrower standard of efficacy –
with the interpretation of therapeutic efficacy.

Mr. Grover — difference between bioavailability and efficacy:

Mr. Grover further submitted that in pharmacology, efficacy is

distinct from affinity, potency and bioavailability. Affinity, a
pharmacodynamics property, “is the tendency of a molecule to
associate with another”. The affinity of a drug is its ability to
bind to its biological target (receptor, enzyme, transport
system, etc.). Potency is “the dose of drug required to produce
a specific effect of given intensity as compared to a standard
reference”. Bioavailability, on the other hand, is a

Patents 36
 pharmacokinetic property. It “is the term used to indicate the
fraction extent to which a dose of drug reaches its site of
action or a biological fluid from which the drug has access to
its site of action” [Goodman and Gilman in CPAA
compilation, volume…, internal page 4]; or “the degree to
which a drug or other substance becomes available to the
target tissue after administration” [Dorland’s Medical
Dictionary in Novartis’ volume B, at page 65]. A
demonstration of increase in bioavailability is not a
demonstration of enhanced efficacy.

efficacy must be based on pharmacodynamic property, whereas the bioavailability

is a pharmacokinetic property — bioavailability merely indicates the extent of the
drug reaching the site of action and it does not reflect ‘enhanced efficacy’.

💡 EU Directive (2001/83/EC) on Community code relating to medicinal

products for human use – Defines Pharmacodynamics and
Pharmacokinetics

Pharmacodynamics — “variations caused by the medicinal product in the

functions of the physiological systems, whether these functions are normal
or experimentally modified.” — biological response of the body to the
drugs, drug action on the body

Pharmacokinetics — “
study of the fate of the active substance within the organism and covers the
study of the absorption, distribution, biotransformation and excretion of
the substance” — body’s action on the drug or alteration of a drug by the
body, or the movement of drugs throughout the body

Pharmacokinetics is “what the body does to the drug”. On the other hand,
Pharmacodynamics is “what the drug does to the body”.

Court’s Analysis:

Patents 37
 On the importance of bioavailability —

In whatever way therapeutic efficacy may be interpreted, this

much is absolutely clear: that the physico-chemical properties
of beta crystalline form of Imatinib Mesylate, namely (i) more
beneficial flow properties, (ii) better thermodynamic stability,
and (iii) lower hygroscopicity, may be otherwise beneficial but
these properties cannot even be taken into account for the
purpose of the test of section 3(d) of the Act, since these
properties have nothing to do with therapeutic efficacy.

merely physico-chemical properties of a new form (like Beta crystalline

form) will not be considered for patent, as they are not concerned with
therapeutic efficacy, and thus do not fall within the ambit of S.3(d). Thus,
even a 30% increase in bioavailability will not be therapeutic efficacy — the
percentage did not matter here since bioavailability itself was deemed an
inadequate point of analysis

However, the Court also noted that S.3(d) is not meant to restrain any incremental
inventions:

We have held that the subject product, the beta crystalline

form of Imatinib Mesylate, does not qualify the test of Section
3(d) of the Act but that is not to say that Section 3(d) bars
patent protection for all incremental inventions of chemical
and pharmaceutical substances. It will be a grave mistake to
read this judgment to mean that section 3(d) was amended
with the intent to undo the fundamental change brought in
the patent regime by deletion of section 5 from the Patent Act.

S.3(d) was not meant to go back to the earlier position of not granting
product patent in pharma.

Moreover, the court states S.3(d) is not a bar to all incremental inventions.
However, it must be noted that for such incremental inventions, it must

Patents 38
 qualify inventive step (one of the 3 factors), but that might not happen if it is
merely incremental, thus incremental invention in itself is oxymoronic.

It must be clear that the standard under S.3(d) is ‘significant enhancement’

and under the S.2(ja) is ‘non-obvious’ — must be read at par, such that the
incremental invention which satisfies ‘inventive step’ and ‘significant
enhancement’ will become patentable

💡 Efficacy vis-à-vis Inventive step

‘efficacy’ is involved in the test of inventive step as defined under

S.2(1)(ja) — inventive step requires one to check technological
advancement against existing knowledge, and even S.3(d) mandates
new form with significant enhancement of efficacy

Had the Parliament not included S.3(d) via an amendment, we could

still have operated with the definition of ‘inventive step’. However,
for the sake of easier application by the Patent Office, S.3(d) was
introduced.

Analysis of the EMR Period:

Coming back to the case of the appellant, there is yet another

angle to the matter. It is seen above that in the US the drug
Gleevec came to the market in 2001. It is beyond doubt that
what was marketed then was Imatinib Mesylate and not the
subject product, Imatinib Mesylate in beta crystal form. It is
also seen above that even while the appellant’s application for
grant of patent lay in the “mailbox” awaiting amendments in
the law of patent in India, the appellant was granted Exclusive
Marketing Rights on November 10, 2003, following which
Gleevec was marketed in India as well. On its package, the
drug was described as “Imatinib Mesylate Tablets 100 mg”
and it was further stated that “each film coated tablet
contains: 100 mg Imatinib (as Mesylate)”. On the package

Patents 39
 there is no reference at all to Imatinib Mesylate in beta
crystalline form. What appears, therefore, is that what was
sold as Gleevec was Imatinib Mesylate and not the subject
product, the beta crystalline form of Imatinib Mesylate.

The court points out that only IM was marketed in the sold drug, and its Beta
crystalline form was not marketed at all — under the garb of the Beta
crystalline form, only IM was being sold

Swiss Type Claim

In case of new use or new property of a known substance, there is no grant of patent.
In a “Swiss”-style claim however (which as the name suggests, were originally
approved in Switzerland), patents over new use based on new formulation of known
substance can be allowed
This was meant to be a mechanism to allow for protection of a new therapeutic use of
a known compound.

In Swiss type claims, the formulation was for a specified new and inventive
therapeutic application, even where the process of manufacture did not differ from
known processes using the same active ingredient.

For example — Aspirin treats headache and fever, but its new formulation is
used as blood thinner → Thus, a new use of Aspirin is blood thinner.
However, mere consumption of Aspirin from the market would not result in
the new use as blood thinner.

The novelty here, is not of the compound itself, but its purpose. The composition is
part of ‘state of the art’ but not the method.
However, such patents are not granted in India due to fear of evergreening — ‘new
use’ is straight away not patentable + also intersects with exception of ‘method of
treatment’ in S.3(i)
In the EU,

Art. 54 of the EPC defines novelty:

(1) An invention shall be considered to be new if it does not

form part of the state of the art.

Patents 40
 State of the art → anything made available to the public by means of a written or
oral description, by use or otherwise

Only usage that is known forms part of the SoA — so long as the usage is not
in SoA, its patentability is protected

Using the aspirin example, in this case, the state of the art is

the drug aspirin

its use as an analgesic (pain-killer)

While fear of evergreening might persist, excluding every new usage from patent
protection is unreasonable

Method of Treatment, S. 3(i)

Swiss claims are drafted as “Use of compound X in the manufacture of a formulation

for the treatment of medical condition Y”.

manufacture of a formulation → differentiates a swiss claim from an MoT

claim

This provision has nothing to do with manufacturing — difference between MoT and
swiss claim
United States
S.101 of Title 35 deems ‘any new and useful improvement’ to be patentable
Known Process

Mere use of a known process cannot be patented if it does not result in a new
product —

Ex: creation of a drug X, using chemical process Y. Mere use of chemical

process Z to create X does not give rise to a patent claim (when both
processes are known)

S. 3(e)
a substance obtained by a mere admixture resulting only in the
aggregation of the properties of the components thereof or a process
for producing such substance;

Here, if ingredients combine and react to form something new, it can be patentable.
However, a mere amalgamation will not be patentable.

Patents 41
 Lack of inventive step

Alloy Claim

A claim for an alloy comprising metals a, b, c in proportions x, y, z → if forms

new metal ?

EPO examiners take a strict approach to the assessment of alloy claims, often
insisting that a claim to an alloy is worded using closed language. This can lead
to problems associated with the strict EPO added matter rules and can lead to a
narrow claim which could be easily avoided by a competitor. Such problems can
be averted by careful drafting of the patent application.

Biotech Guidelines

Example: (read with 3(b)) One drug curing fever and another drug curing headache is
mixed and a separate drug is created which has both of these properties. This would
not fall within natural phenomena, however, it is a mere admixture and can be
rejected on the grounds of inventive step (because it will be obvious).

Need for 3(e) exclusion —

However, there was no need for such exclusion in S.3(e), because this admixture
can be outrightly rejected on the basis of inventive step — undermining the
competency of the patent examiner, who would not be able to ascertain that this
defies inventive step.

S. 3(f)
the mere arrangement or re-arrangement or duplication of known
devices each functioning independently of one another in a known
way.

Patents 42
 Merely placing side-by-side old integers so that each performs its own function
independently of the others is not a patentable combination, for example, a flour mill
provided with sieving means
When two or more features of an apparatus or device are known, and they are juxtaposed
without any interdependence in their functioning, they should be held to have been
already known, e.g., an umbrella with fan, bucket fitted with torch, a hat with a torch —
not patentable

Narayan Chandra Das v. Jolly Guhathakurata and

Controller of Patents
Facts: "Head scarf cum neck covering apparel" for women was granted a patent, even
though the invention involved merely stitching of a head scarf and muffler together.
The basic object of the invention is to provide for a head scarf cum neck covering for
woman, which would on one had provide for the desired covering for the head, ear
and neck of women such as required for protection from cold conditions
Decision: Held that the invention lacks novelty and it is not patentable under Section
3(f). It was obviously a mere combination of known components working independent
of each other. It was publicly known/publicly used by the Respondent's own design
before filing of the patent application, and therefore, the alleged invention was not
patentable.

S. 3(h)
a method of agriculture or horticulture;

A method of agriculture or horticulture is not patentable since India is a primarily

agrarian society — monopoly over these methods is undesirable — for example:

practices like stilt farming or drip irrigation would not be granted patent.

other inventions like agricultural machines would be patentable

Research in Agriculture

New plant varieties can receive IP protection under the Plant Varieties Act.

Plant Genetic System — 1995, EPO

Plant cells resistant to pesticide made through genetic engineering.

Greenpeace opposed on ordre public – prejudice to environment

Patents 43
 Board of Appeal – Patent granted – opposition not substantiated .

A method of agriculture starts from preparation of the field for agriculture. Examples:

A method of producing improved soil.

A method of producing mushroom plant

Herein, plant is also not patentable.

However, the plant variety is protected under Plant Variety Act.

A method for cultivation of an algae.

Post production stage (downstream activity) in case of agriculture is not hit by S.3(h).
— So long as the plants or crops are in the field, any method like preventing them
from pests will be hit by S.3(h). However, once the plant is plucked or extracted,
methods for preserving the juice, etc., it will no longer be hit by S.3(h). Examples:

process of extracting silk

device for feeding poultry feeds

method for preparing banana juice

sugarcane harvesting knife

S. 3(i)
any process for the medicinal, surgical, curative, prophylactic
(diagnostic, therapeutic) or other treatment of human beings or any
process for a similar treatment of animals to render them free of
disease or to increase their economic value or that of their products

A method of treatment is excluded from patentability because the method is essentially

skill-based, and hence the efficacy will vary even if that method is licensed to other
parties.
For instance,

Pharmaceutical product to control blood pressure – would be patentable

Instrument to measure blood pressure – patentable

Method of measuring blood pressure ??

process of administering medicine and not process of manufacturing medicine is

what is covered by MoT

Patents 44
 EPC Art. 53

(c) methods for treatment of the human or animal body by surgery or

therapy and diagnostic methods practised on the human or animal
body; this provision shall not apply to products, in particular
substances or compositions, for use in any of these methods.

This exception is much stricter and well-defined than that present in TRIPS or Patent Act
S.(3(i)). Hence, it makes them non-patentable.
It clearly specifies that the method must be practiced on the human body which is not
mentioned in the Patent Act, but can be logically implied.
Different Methods of Treatment

Surgical → stitch free cataract operation

Curative → Method of preventing decaying of teeth

The existence of curative pre-supposes a disease.

However, in case of cosmetic treatments, which are not medicinal or curative in

nature — not covered within the exclusion u/s.3(i).

Prophylactic → Method of vaccination, not vaccine itself (preventive)

Diagnostic → Method of identifying jaundice, not the kit itself

Therapeutic →Method of curing from disease

VLCC Patents

VLCC – Patent Application for a medicine (both product and process) to reduce
weight

VLCC – Patent Application for a machine to reduce weight

VLCC – Patent Application for a method for reducing weight (combination of using
medicine, application of gel, using a machine, specific work out and unique food
supplement)

Would the method of preservation of blood be patentable?

Yes, since it is not a procedure that is performed ‘on’ the body.

The EPC suggests that a ‘method of treatment’ for the purpose of patent eligibility is
a method that is practiced on the human and animal body

Patents 45
 While the Indian Patent Act, does not mention it explicitly — this can be reasonably
implied

Would the method of whitening teeth be patentable?

Yes. A method of whitening teeth is a cosmetic procedure rather than a method of

treatment. However, this would fall under a grey area if it is proved to be a medical
treatment for an ailment. The same applies for any method of losing weight.
Ultimately, it depends on the objective with which the treatment is undertaken, which
may not always be clear or explicit.

Non-invasive prenatal genetic diagnostics → would also not be patentable when

performed on the body.

S. 3(j)
plants and animals in whole or any part thereof other than micro-
organisms but including seeds, varieties and species and essentially
biological processes for production or propagation of plants and
animals

Plants and animals have been kept outside the scope of protection. It would have made
sense if they were only excluded when they are ‘product of nature’. However, all plants
and animals even when genetically modified have been declassified.

Dimminaco AG v. Controller of Patents

this case was decided before the 2002 and 2005 Amendments
Facts: Dimminaco filed patent for an invention relating to a process for preparation of
the Bursitis vaccine.
Arguments: It was the contention of the applicant that under the present state of law
in India, there is no bar against allowing the process for preparation of any product
which is a patented commodity even if the process contains live virus.
It was also contended that there is no bar under the present state of law against
granting patent to an end-product, the manufacture of which involves the live virus
and the grant of patent cannot be denied on the basis of any administrative
policies. It was further stated that administrative policies can not be allowed to prevail
over the statutory definition under the act as that will be a negation of a rule of law
inasmuch as no administrative policy can override the statutory provision.
Patent Office

Patents 46
 Patent examiner held that the application did not constitute invention. Controller
of Patents held that process for preparation of vaccine which has living entity
cannot be considered ‘manufacture’.

The Patent examiner’s reasoning was premised on the ground that if the
preparation involves ‘living organism’, which is in the case of vaccine, it will not
be deemed as ‘manufacture’.

“invention” is defined as a new and useful (…) “substance produced by

manufacture and includes any new and useful improvement of any of them and an
alleged invention”

‘manufacture’ is central to determining invention.

💡 Nonetheless, in the new amended definition of the Patent Act in 2005,

the term ‘invention’ has been defined to include only the 3 factor test –
novelty, inventive step, and industrial application. This has removed
all the ambiguities with respect to ‘manufacture’, ‘article’,
‘substance’, etc.

Manufacture was understood only in terms of inanimate objects — if the term

“manufacture” is to be given such a wide meaning, there will be further problems
as ever going new process with foreign sophisticated technologies will have to be
patented in India

It was also held that vaccine with live organism cannot be considered as
substance. — “the process has to result either in an article or a substance. And a
vaccine with the living organism has not been considered a substance.”

However, the appellant contended that ‘manufacture’ cannot be read so narrowly —

the definition of “manufacture” does not mean and include a living organism and a
substance as defined in the Act means and includes only non-living substance and
does not include a living organism
The test of manufacture as propounded by the appellant was that manufacture meant
only the process through which a material has undergone change, to result in a
different material.
Decision: The Calcutta HC reversed the Patent Office’s decision and held that since
‘manufacture’ has not been defined, it cannot be given a restrictive meaning. There is
no statutory bar to accept a manner of manufacture as patentable merely because the
end product contains a living organism.

Patents 47
 Applied the vendibility test — patents can be granted for processes that result in
vendible items — the process of preparing a vendible commodity containing a living
substance is not excluded from the purview of the word, ‘manufacture’ and that the
controller erred in denying patent protection to the vaccine just because it contained a
live virus
The end product was novel, capable of industrial application and was useful for
protecting poultry against contagious Bursitis infection, thus making the process an
invention.
Monsanto v. Nuziveedu Seeds
Facts: Patent for genetically modified Bt Cotton seeds with a novel nucleic acid
sequence (NAS). The patent was for the NAS and the process of developing it, but not
for the seeds.

💡 Monsanto Technology LLC (Monsanto) registered patent no. 214436

for Nucleotide Acid Sequence (NAS) containing the gene Bacillus
thuringiensis (Bt gene). On insertion into DNA of cotton seeds, NAS
killed bollworms from inside the seed and therefore reduced the
dependence of farmers on insecticides and pesticides.

Monsanto held the patent for the NAS Bt Cotton seeds → licensed to Nuziveedu.
Licensee was found to be using the patented product even after the discontinuation of
the license agreement. Infringement suit filed.
Nuziveedu counter-sued for revocation of Monsanto’s patent
Para 26 of SC Judgment → remanded back to Single Judge HC

The defendants in their written statement inter alia contended that

their rights were protected under the Protection of Plant Varieties
and Farmers’ Rights Act, 2001 (hereinafter referred to as ‘the
PPVFR Act’). The suit patent was bad because claims 1­24 were
“process claims” concerning genetic engineering or
biotechnology method to insert “Nucleic Acid Sequence” (NAS)
into a plant cell as in claim 25­27 practiced in laboratory
conditions, unlike the complete biological process adopted by the
defendants. The NAS was a chemical composition incapable of

Patents 48
 reproducing itself and was thus not a micro­organism. Only on
insertion into a plant, a living organism, it imparts Bt.trait
(insect resistance) to the living organism.

India has opted for sui generis protection of plant variety under Art. 27(3) TRIPS → 1.
Novelty 2. Uniformity 3. Stability 4. Distinctiveness
Patent Office:

Granted the patent on both the process and the chemical compound.

It was asserted that NAS was only a chemical compound with relevance in a
living organism only.

Particulars of the Claim:

Monsanto was aware that the seed could not be monopolised in India’s agrarian
economy → decided to claim patent over the NAS, not the seed or the plant
variety

In this case, the invention is the NAS and the target of the
invention is its use in a plant cell. The property of the NAS is
what makes the plant produce and localize the toxin protein in
a specific location in the plant cell so as to make the toxin
protein present throughout the plant, in pesticidal effective
levels and still produce agronomically stable plants.

NAS however, cannot be sold separately and has to be used in a plant cell.

S.3(j) only prohibits seeds, plants and animals → prima facie appears that NAS is
not prohibited, but its intended use in a plant cell complicates matters.

As the subject matter of patent application herein, NAS, was not clearly within or
outside the ambit of S.3(j), the SC ultimately remanded the matter to the lower
court.

Patents 49
 💡 What is NAS?

Responsible for storing genetic information — A nucleic acid sequence

is a succession of bases signified by a series of a set of five different letters
that indicate the order of nucleotides forming alleles within a DNA (using
GACT) or RNA (GACU) molecule. By convention, sequences are usually
presented from the 5' end to the 3' end. For DNA, the sense strand is used.

NAS is a DNA Construct → construct was inserted into a plant which

confers the trait of insect tolerance to the plant.

NAS is not a process → the method of injecting NAS is intrinsically linked

with the insertion into the plant, and so it is not capable of commercially
exploitation. It is not being commercially exploited as a product in a bottle
or vial, rather it is always injected into the plant, which is ultimately
commercially viable. However, once it is linked with the plant it will be
rejected based on the fact that it will be hit by S.3(j) of the Act.

In both these cases, NAS is not available in a solitary state (in a bottle),
and thus its preclusion is argued under both process and product patent.
This is yet to be decided by the Single judge bench, on the basis of merit of
the patent application.

Arguments

Monsanto’s seeds had high demand:

The seeds from the plaintiffs’ patented technology were the highest selling
compared to similar other seeds. The plaintiffs have no intention to sue any
Indian farmer for violation of patent.

Thus, the plaintiffs intended to argue that Monsanto will not file cases
against the farmers for violation, so the agrarian population will not be
impacted. Rather they will gain from the highly-in-demand seeds.

Kapil Sibal → ‘gene’ =/= ‘plant variety’

a chemical/gene/DNA construct is not a plant variety, and is not eligible

for protection under the PPVFR Act. A gene cannot be a plant variety and

Patents 50
 it would be denied such registration on account of lack of fulfilment of the
conditions precedent (…)

A gene cannot be a “plant grouping”, “within a single botanical taxon of the

lowest rank”, which in simple terms means that it cannot belong to the lowest
rank of a plant, namely a species

Datar → ‘genetic structure’ v. ‘chemical’

product claim for NAS as a chemical is false —

any chemical that is inserted into a plant is not capable of being passed on to
the seeds of that plant and to the future progeny as the chemical will be
metabolized by the plant itself and will never be transmitted to its seeds.

NAS is a genetic structure — as it penetrates into the seed and is reflective in

future progeny

The NAS gene inserted into the plant becomes an

inseparable part of the plant at the sub­cellular level by an
irreversible biological process. It exists in every cell of the
transformed plant. It not only expresses in the plant to
produce endotoxin but also inherits into progeny plants in
perpetuity. It does not result in a “product” which can be
put into a vial and sold as such.

India as a nation bars any genetic manipulation in plants and animals, it is

only allowed in micro-organisms → cautious approach

NAS cannot be sold as a product

cannot be sold as a ‘product’, which can be put in a vial and sold, unlike a
vaccine. → must be awarded the patent

Defendant argued that it grew the patented variety alongside its own
proprietary cotton variety.

Bt Cotton in one lane and proprietary cotton in the adjacent lane

Cross pollination between the patented variety and the proprietary variety →
hybrid variety which defendant began selling

Monsanto argued that this hybrid variety contained the BT cotton’s

properties, and hence even after the license agreement had ended, Nuziveedu

Patents 51
 continued to use the BT cotton variety

Prashant Bhushan → NAS is not ‘capable of industrial application’

NAS is not “capable of industrial application” unless it becomes a part of the

plant cell where it is expressed by the plant cell through essentially biological
processes of transcription, translation, and replication, to produce the desired
protein

For the usage of NAS, only cultivation of plants is required, there is no

‘industry’ involved, because NAS is utilised only upon injection into the
plant.

Hybrid varieties are produced as per essentially biological process, without

any human intervention. However, if one specific hybrid variety is selected
and grown into a separate field, then it will constitute as human intervention.

Biodiversity Act → Lack of permission

no permission was taken for infusing of the Bt variety with the Indian
variety, in order for it to grow in India

The Biodiversity Act which prohibits the“use” of any biological resources

occurring in India for commercial utilisation and which includes genes used
for improving crops and livestock through genetic intervention necessitates
prior permission from the National Bio Diversity Authority which has not
been taken by the plaintiffs. The NAS only adds a trait to a plant leading to
development of a transgenic variety creating donor seeds. The seeds are not
patentable under Section 3(j) of the Act though the plaintiffs may be entitled
for benefit sharing under the provision of the PPVFR Act as defined under
Section 2(h) of the PPVFR Act

Also, it was held that the seeds are not patentable, as they are hit by S.3(j).

Furthermore, it is said that the plaintiffs might have secured a plant variety
right, under the Plant Variety Act, but, the plaintiffs will not get patent as
NAS will not be regarded as a patentable product.

Decisions:

Single Judge Bench: Upheld

It held that the patent is valid, as it would otherwise lead to an infringement

of the license agreement.

Patents 52
 Considering the existing patent registered under Section 48 of the Act, it was
ordered that during the pendency of the suit, the parties shall remain bound
by their respective obligations under the sub­licence agreement and that the
licence fee/trait value payable by the defendant shall be governed by the laws
in force.

Division Bench: Rejected

The Division Bench dismissed the plaintiffs’ appeal upholding the defendants’
contention with respect to patent exclusion under Section 3(j) of the Act and
that the plaintiffs were at liberty to claim registration under the PPVFR Act,
as the two Acts were not complementary, but exclusive in the case of all
processes and products falling under Section 3(j) of the Act. Consequentially,
the defendants’ counter claim succeeded.

Herein, once the patent is hit by S.3(j) → cannot go back into Plant variety,
as novelty will be lost.

💡 TLDR: For the applicability of Section 3(j) to transgenic plants, the

Supreme Court seemingly adopted a pro-patent approach in Monsanto
Technology LLC v. Nuziveedu and Ors. In this case, which involved hybrid
BT cotton seeds that had undergone genetic modification, the Supreme
Court affirmed the Delhi High Court's decision finding the seeds to be
patentable. The Court seemingly indicates the existence of a grey area for
artificially-generated biotechnology inventions which may be protected.
However, there are two caveats while considering the value of this
judgment. First, seemingly Monsanto’s patent in this case was not
regarding the seed itself (which they knew they could not monopolise), but
the Nucleic Acid Sequence (NAS) which stored the genetic information.
This point has been remanded for reconsideration. Second, the Supreme
Court does not take any substantive decision on the issues involved, but
merely restores the order of the Single Judge Bench. There is no clear-cut
conclusion, even now.

Association for Molecular Pathology v. Myriad

Genetics
Facts
Myriad had discovered the precise location and sequence of two human genes –
BRCA1 and BRCA2, mutations of which can increase the risks of breast and ovarian

Patents 53
 cancer. Before Myriad’s discovery of the BRCA1 and BRCA2 genes, scientists knew
that heredity played a role in establishing a woman’s risk of developing breast and
ovarian cancer, but they did not know which genes were associated with those
cancers.

Patent cannot be granted at the stage of identification of the genes and their
location alone → merely knowledge

Based on these discoveries, Myriad developed medical tests to detect BRCA1 and
BRCA2 gene mutations, the presence of which would indicate an increased risk of
cancer. The tests involved two processes. The first process involved separating
segments of DNA containing the sequences of nucleotides (which comprise the
“ladder rungs” in the double helix of DNA) typically found in the BRCA1 and
BRCA2 gene sequences. The second process involved creating a copy of the original
natural DNA sequence that contains only exons (i.e., nucleotides that code for amino
acids, the building blocks of proteins), called cDNA.
After it identified the location and sequence of BRCA1 and BRCA2 genes, Myriad
obtained a number of patents. The patents covered the act of isolating the genes and
the creation of cDNA. When other institutions offered BRCA testing, Myriad claimed
infringement, which brought into question the validity of its own patent as a counter-
claim.
Three primary patent claims were in question:

1. Isolated DNA coding for a BRCA1 polypeptide → the DNA code (process of
identification)

2. Isolated DNA of Claim 1

3. The cDNA → synthetic gene created

Effect of the Claims

­Myriad’s patents would, if valid, give it the exclusive right to isolate an

individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more
nucleotides within the genes) by break­ing the covalent bonds that connect the
DNA to the rest of the individual’s genome.

The patents would also give Myr­iad the exclusive right to synthetically create
BRCA cDNA. In Myriad’s view, manipulating BRCA DNA in either of these
fashions triggers its “right to exclude others from mak­ing” its patented
composition of matter under the Patent Act.

Patents 54
 This would give them monopoly over isolation of the genes and the synthetic
creation of the genes, i.e BRCA cDNA, both in terms of process and the eventual
product that has been created.

However, they ultimately sought the claim only on product patent of both the
isolated genes and the synthetic genes (cDNA), as the process in their opinion
was somewhat not novel.

Level 1: Patent Office

Granted Myriad the patent over the isolated gene and the synthetic cDNA
Level 2: Federal District Court
Held that the impact of such patents would result in the patenting of “products of
nature” → denied patent to all — the gene sequence, the isolation and the synthetic
cDNA.
Level 3: Court of Appeals for the Federal Circuit
Reversed the findings of the lower court, holding both the isolated DNA strands and
cDNA to be patentable
Level 4: Supreme Court

“laws of nature, natural phenomena, and abstract ideas are not patentable,” they
are the tools of innovation necessary for science and technology

Held that cDNA is patentable, while segmented/isolated natural DNA is not.

Isolated DNA

Although Myriad “found an important and useful gene, … separating that

gene from its surrounding genetic material is not an act of invention.”

Myriad's patents' descriptions explained the iterative process and extensive

efforts that led to the identification and isolation of the gene sequences.

However, the process of discovery does not necessarily yield a patentable

product where the discovered item is naturally occurring.

Myriad attempted to argue that the act of severing chemical bonds to isolate
the DNA creates a non-naturally occurring molecule.

However, the patent asserted by Myriad covered any segment containing the
relevant sequence of nucleotides, not a specific molecule with a certain
chemical composition.

cDNA

Patents 55
 cDNA is not naturally occurring. In cDNA, “The noncoding regions have
been removed.”

even though the cDNA follows the nucleotide sequence of the natural DNA
segment and retains its naturally occurring exons, the cDNA is a new
creation and, therefore, patentable.

cDNA does not present the same obstacles to patentability as naturally

occurring, isolated DNA segments. Its creation results in an exons-only
molecule, which is not naturally occurring. Its order of the exons may be
dictated by nature, but the lab technician unquestionably creates something
new when introns are removed from a DNA sequence to make cDNA .

ℹ️ It is important to note what is not implicated by this decision.

there are no method claims before this Court.
Had Myriad created an innovative method of manipulating genes while
searching for the BRCA1 and BRCA2 genes, it could possibly have sought
a method patent. But the processes used by Myriad to isolate DNA were
well understood by geneticists at the time of Myriad’s patents, “were well
understood, widely used, and fairly uniform insofar as any scientist
engaged in the search for a gene would likely have utilized a similar
approach,”

Determination of a product of nature:

the quantity and quality of human intervention

degree of differentiation from the naturally-occurring substance

Gene Patents in India

DNA is the most fundamental structure of life which is both a product of nature
and the law of nature regardless of whether it is inside our bodies or sitting in the
bottom of a test tube.

Genes are identified as the discrete units of DNA sequence that encode individual
proteins. Genes are a common universal possession representative of
humankind’s collective heritage and thus not a subject matter for which
Intellectual property rights should be granted.

Patents 56
 The patenting of genes and gene sequence may interfere with privacy rights as it
permits an interference with a bodily part. Critics of gene patenting cite the
privacy infringement inherent in assigning ownership interests in which every
individual is a part owner merely be virtue of being human.

S.3(j) does not exclude ‘genes’ explicitly — whether ‘any part thereof’ includes a
‘gene’

If it is accepted, then any gene whether naturally occurring or modified by human

intervention like cDNA will be precluded from patent.

However, a range of inventions have been granted patent in Indian law, showing
that a ‘gene’ is not altogether excluded from protection → rights may be asserted
over DNA sequences that have been isolated and purified

Nonetheless, the amount or threshold of human intervention in the gene to get the
patent protection, has not been jurisprudentially determined, because we cannot
rely on previous patents for precedents (it is the application of law by patent
office and not by judiciary).

However, like in the case of Dimminaco, we can present a list of previous patents
granted on same subject matter to strengthen your case.

Essentially biological process

Patents 57
 Under S.3(j), essentially biological processes are excluded from patent
Essential biological process – have no human intervention. For example – if a plant
variety XX is planted along with another variety YY, it is bound to form hybrid
varieties like – XX, XY, YX, YY – which is part of natural selection through cross-
pollination. This is an essentially biological process, which will not be patented.
For cDNA → it is not • a product of nature, as its creation results in an exons-only
molecule, which is different from the naturally occurring DNA sequence → eligible
for patent
EU Biotech Directive

Article 4

1. The following shall not be patentable:

(a) plant and animal varieties;

(b) essentially biological processes for the production of
plants or animals.

2. Inventions which concern plants or animals shall be

patentable if the technical feasibility of the invention is not
confined to a particular plant or animal variety.

3. Paragraph 1(b) shall be without prejudice to the patentability

of inventions which concern a microbiological or other
technical process or a product obtained by means of such a
process

Article 5

1. The human body, at the various stages of its formation and

development, and the simple discovery of one of its elements,
including the sequence or partial sequence of a gene, cannot
constitute patentable inventions.

Patents 58
 2. An element isolated from the human body or otherwise
produced by means of a technical process, including the sequence
or partial sequence of a gene, may constitute a patentable
invention, even if the structure of that element is identical to that
of a natural element.

3. The industrial application of a sequence or a partial sequence

of a gene must be disclosed in the patent application.

As per Article 5(2), the isolation of gene or DNA sequence might make it patent-
eligible, however it would still have to satisfy 3-factor test of novelty, inventive step
and industrial application.

S. 3(k)
a mathematical or business method or a computer program per se or
algorithm

There are essentially four elements barred under this provision:

1. Mathematical Methods

2. Business Method

3. Computer Programme

4. Algorithms

Recall: Diamond v. Chakraborty: The majority noted that while the words indicated that
Congress intended for the patent laws to be given a "broad scope", this scope was not
unlimited and that, under the Court's precedents, "laws of nature, physical phenomena,
and abstract ideas" were not patentable.

This is not to suggest that § 101 has no limits, or that it embraces

every discovery. The laws of nature, physical phenomena, and
abstract ideas have been held not patentable

Patents 59
 A method of calculation, etc. per se fall under the realm of abstract ideas, and are
hence not patentable.

Allowing business methods to be patented may unnecessarily cut competition and

promote monopoly, which may ultimately give rise to unnecessary litigations

Algorithms are excluded in all forms including but not limited to — a set of rules or
procedures or any sequence of steps or any method expressed by way of a finite list
of defined instructions, whether for solving a problem or otherwise, and whether
employing a logical, arithmetical or computational method, recursive or otherwise

These are all not patentable, per se — by themselves

Computer Programs
A computer program consists of a set of instructions, and its sequence, structure, and
organization determine how those instructions are executed.

Patents 60
 ℹ️ Copyright Protection
A computer program may get copyright protection as a
literary work, for which it must be an original expression and must be fixed.
However, the idea-expression dichotomy creates difficulties in protecting
software that monopolizes an idea, as US copyright law prohibits ideas and
theories. For example, in case of a software to play the game ludo, a program
cannot be protected as it will lead to monopolisation of idea.

Infringement is determined by the look and feel of a program (

Whelan v. Jaslow) and is subject to the Abstraction/Filtration/Comparison test
(Computer Associates v. Altai). For example, if two people write a paper on
cricket, one would need to abstract the common theme, filter out the irrelevant
portions and then compare the works to check for infringement.

Abstraction, Filtration Comparison (from IPR VII Sem)

So far as the application of copyright laws to computer programs is
concerned, the US courts have generally maintained that the purpose for
which the program was created would constitute the idea and that the
mode in which a program operates, controls and regulates the computer in
performing various functions such as receiving, assembling, calculating,
retaining, correlating, and producing useful information would constitute
the expression of the idea.
However, many have criticised the underlying assumption that a computer
program has only one underlying idea which once identified, must be
demarcated from everything else in order to qualify as expression. To
overcome this, the Abstraction-Filtration-Comparison (AFC) test was
developed in the case of Computer Associates Int. Inc. v. Altai Inc..

In this case, Computer Associates International (CAI) alleged that

the defendant Altai Inc. had utilized substantial portions of the
former’s program while developing their own software program,
and therefore, was liable for copyright infringement.

It was held that proving copyright infringement requires proving

both ownership of the copyright and that copying took place.
Actual copying can be proved either by direct evidence, or by
demonstrating: 1) the defendant had access to the copyright
material and 2) there is substantial similarity between the
copyrighted work and the defendant's work.

Patents 61
 The Court of Appeals for the Second Circuit envisaged a three-
step test to determine the magnitude and scope of the idea-
expression dichotomy and the determination of substantial
similarity

The AFC Test is a method of identifying substantial similarity for

the purposes of applying copyright law. In particular, the AFC test
is used to determine whether non-literal elements of a computer
program have been copied by comparing the protectable elements
of two programs.

Abstraction:

In a computer program, the lowest level of abstraction,

the concrete code of the program, is clearly expression,
while the highest level of abstraction, the general
function of the program, might be better classified as the
idea behind the program.

This would involve dissecting the program code and

separate different level of abstraction, such as: the object
code (the collections of 0s and 1s) source code (a type of
programming code), algorithms, modules, data
structures, high level functions, overall purpose,
programmers comments etc

Filtration:

The second step involves removal of aspects of the

program which are not legally protectable by copyright
consideration. The analysis is done at each level of
abstraction identified in the previous step.

Examine the structured components at each level of

abstraction. Identify if they are unprotectable, such as:
idea, theory, formula, incorporated for programming
efficiency, taken from public domain, taken from open
source program, required by external factors like
machine compatibility, hardware specifications,
interoperability, market demands, standard programming
techniques etc.

Patents 62
 The court identifies three factors to consider during this
step: elements dictated by efficiency (which are
eliminated since efficient expressions are conflated with
ideas), elements dictated by external factors (by
application of the scenes a faire doctrine), and elements
taken from the public domain (which cannot be
protected)

What remains following filtering out the un-protectable

elements are protectable expression.

Comparison

The final step is to consider the elements of the program

identified in the first step and remaining after the second
step, and for each of these compare the defendant's work
with the plaintiff's to determine if the one is a copy of the
other.

In addition, the court will look at the importance of the

copied portion with respect to the entire program.

The method of calculation cannot be copyrighted, as it cannot be monopolized.

While software designed for calculations may provide faster solutions, the
underlying calculation method itself cannot be monopolized, resulting in
limited effectiveness for software protection. Moreover, software that utilizes
the method based on an algorithm cannot be protected effectively, but products
based on the calculation, like a calculator, can be granted monopoly.
Therefore, under copyright law, it is difficult to protect computer programs.

Can a computer program be patented?

Any software that is not strictly a computer program may be allowed patentability. This
means that if a software has a technical aspect, it may still be protected, if it is not strictly
technical. However, if the software is only a computer program, it will not be allowed
patentability. For example, a software that simply shows the fuel levels in an engine is
excluded. Therefore, a software without the algorithm may be protected, but this would
only grant a person with very limited monopoly.

FeridAllani v. Union of India & Ors. [2019]

Claim:

Patents 63
 The applicant, FeridAllani, filed for a patent for “a method and apparatus for
accessing information sources and services on the web.” The objective of the
invention is to provide easy, quick and direct access to required sources and services
on the internet (web) without wasting precious network resources, such as bandwidth.
The company intentionally sought patents on "method" and "device" to create the
impression that they were patenting hardware, when in fact they were seeking patents
for software.

Patent office:
The IPO analysed the application and granted an FER where the technique requests
were challenged for being supervised to a computer program itself in Section 3(k) and
the machine claims were disputed for inventive step and requiring novelty over the
previous arts mentioned in the FER. Despite the applicant’s response, the IPO
declared that the application suffered from lack of novelty and patentability under
S.2(1)(j) and S.3(k) of the Act

The applicant filed a writ petition before the Delhi HC questioning the conflicts
generated under the IPO’s order, which directed the IPO to reconsider the matter. On a
second rejection, FeridAllani approached the IPAB against the IPO’s declaration.
IPAB dismissed aforementioned appeal on the grounds that, the application does not
disclose any technical effect or technical advancement.
The applicant thereafter filed a writ petition before the Delhi HC in view of such
dismissal:

Delhi HC:
The applicant contended that“the invention is more than a mere software that is
loaded onto the computer and the application does disclose a technical effect and
technical advancement”.
To begin with, the Court clarified that the patentability bar only applies to
“computer programs per se,” not all inventions based on computer programs.
The Court held that the assertion that all computer programs are not patentable would
be regressive, given the prominence of computer programs in modern devices such as
ovens, automobiles, and refrigerators. Inventions based on artificial intelligence,
blockchain, and other digital products would not be patentable if this were the case: “it
is rare to see a product which is not based on a computer program … the effect of
such programs in digital and electronic products is crucial in determining the test of
patentability.”

Patents 64
 Moreover,Section 3(k) has a long legislative history and
various judicial decisions have also interpreted this provision.
The bar on patenting is in respect of computer programs per
se....' and not all inventions based on computer programs. In
today’s digital world, when most inventions are based on
computer programs, it would be retrograde to argue that all such
inventions would not be patentable. Innovation in the field of
artificial intelligence, blockchain technologies and other digital
products would be based on computer programs, however the
same would not become non- patentable inventions - simply for
that reason. It is rare to see a product which is not based on a
computer program. Whether they are cars and other automobiles,
microwave ovens, washing machines, refrigerators, they all have
some sort of computer programs in-built in them. Thus, the effect
that such programs produce including in digital and electronic
products is crucial in determining the test of patentability.

The court also stated that an invention is patentable if it displays a technological

effect or contribution, even if it is based on a computer program. S.3(k) does not
apply to all discoveries involving computer programs or software.

The bar under §3(k) is only on computer programs per se and not on the
inventions (product like cars, ovens, etc.) which are based on these computer
programs.

The Delhi HC directed the IPO to reexamine the case

IPAB (again)
After further repeated challenges, in 2020, the IPAB finally granted the patent:

The IPAB discussed the technical solution intended in the patent application.
The IPAB identified a key feature of the invention that is

forms a well-constructed query which is to be emitted to the internet, which

solves a technical problem of prior art technologies producing a technical
effect of “reduction of bandwidth by the structured query” —

Patents 65
 it also reduces the mean time duration for accessing the searched
information by users. As a matter of fact, user need not spend time in
selecting and reviewing multiple search results as disclosed by other
technologies in 1999.

it is also economical, as the internet bandwidth is consumed only once per

search resulting in increased quality of internet services to users.

The IPAB observed that one has to first construe the claims, then
identify technical contribution provided by the claims.

Most of the inventions are based on computer programs” and “it would be
retrograde to argue that all such inventions would not be patentable”.

The IPAB held that the patent ought to be granted, after considering the settled
jurisprudence in conjunction with the Computer Related Inventions, 2013 (CRI
Guidelines).

Therefore, “without appreciating the technical effect produced by the present

invention, the mere fact that a computer program is used for effectuating a part
of the present invention, does not provide a bar to patentability.”

Thus, the invention MUST be examined as whole and the following factors are to
be considered while deciding upon the patentability of such inventions —

1. technical effect achieved by it, and its

2. technical contribution.

If the invention demonstrates a “technical effect” or a “technical contribution”, it

is patentable even though it may be based on a computer program.

Patents 66
 ℹ️ Why would a programmer not be satisfied by copyright protection?
A programmer may not be satisfied by copyright protection because —

It only protects the expression of a computer program, and not its

functionality. The expression of a program can be easily modified by
changing the set of instructions. This means that there is limited
monopoly, as a competing work can easily circumvent the protections.

Additionally, fair use exceptions can render copyright protection

ineffective.

Copyright also only protects the right of reproduction, not the right of
usage, whereas patent law provides the right to usage.

However, patenting a computer program has its own challenges. The

protection under Art. 27 of TRIPS is only granted to products and processes,
and a computer program is neither. If the program is embedded in hardware,
such as a car, the patent would be sought on the car, not the program. It is
unclear what happens when a computer program is part of a process.

Diamond v. Diehr

Claim
The application was for the invention of a process for “molding raw, uncured
synthetic rubber into cured precision products.”
Process:

This process was initially carried out manually by the labourers, but
determining the point at which the rubber was cured was quite uncertain as
the system was not very efficient.

The existing process used well-known time, temperature, and cure

relationships to calculate when to open the press,

The respondents held that their invention allows one to exactly measure the
temperature inside the mold which was so far an uncontrollable variable in the
process.

The machine was fitted with sensors that transmitted data to a computer
program that utilized the Arrhenius equation to open the lid and obtain 100%
pure rubber, resulting in no waste as the program was more effective.

Patents 67
 Achieving the perfect cure depends upon several factors
including the thickness of the article to be molded, the
temperature of the molding process, and the amount of time
that the article is allowed to remain in the press. It is
possible using well- known time, temperature, and cure
relationships to calculate by means of the Arrhenius
equation.
This innovation would enable the industry to obtain hitherto impossible,
uniformly accurate cures by constantly measuring the temperature inside the
mold and feeding the data into a computer which then uses an existing
equation to calculate the optimal cure time.

Nonetheless, according to the respondents, the industry

has not been able to obtain uniformly accurate cures
because the temperature of the molding press could not
be precisely measured, thus making it difficult to do the
necessary computations to determine cure time.

Respondents characterize their contribution to the art to

reside in the process of constantly measuring the actual
temperature inside the mold. These temperature
measurements are then automatically fed into a computer
which repeatedly recalculates the cure time by use of the
Arrhenius equation.

This is the relevant technological advancement

Patents 68
 Patent Office
The patent examiner rejected this invention as un-patentable subject matter under 35
U.S.C. 101 — the steps performed by the computer involved an equation and a
computer program → non-statutory subject matter

⚠️ Here, the examiner relied on the case of Gottschalk v. Benson to reject the
patent. This case involved a patent for a method of converting binary-
coded decimal (BCD) numerals into pure binary numerals on a general-
purpose digital computer. It was held that a process claim directed to a
numerical algorithm, as such, was not patentable because "the patent
would wholly pre-empt the mathematical formula and in practical effect
would be a patent on the algorithm itself.”

Rejected the patent as it involved equation and computer program, and thus there
was a reference of non-statutory subject matter under US law.

This is very similar to the rejection in Diamond v. Chakravarty, because therein also
bacteria was not allowed the patent, because living things were not considered to be
protected by the law.

The patent examiner rejected the respondents' claims on the sole

ground that they were drawn to non-statutory subject matter

Patents 69
 under 35 U. S. C. §101.

The PTO Board of Appeals agreed with the examiner. The Court of Customs and
Patent Appeals reversed, arguing that a claim drawn to a subject matter otherwise
patentable does not become non-patentable because a computer is involved.

Supreme Court
The Court repeated its earlier holding that mathematical formulas in the abstract are
not eligible for patent protection. But it also held that a physical machine or process
which makes use of a mathematical algorithm is different from an invention which
claims the algorithm, as such, in the abstract.
It noted that the transformation and reduction of an article 'to a different state or thing'
is the clue to the patentability of a process claim that does not include particular
machines.” It confirmed that a process "is not un-patentable because it contains a law
of nature or a mathematical algorithm" and that in judging whether a claim or an
invention at hand represent patentable subject matter, they need to be considered as a
whole rather than being dissected into their various elements. The decisive factor in
determining the patentability of a process under § 101 then is whether it, being
considered as a whole, is performing a function which the patent laws were designed
to protect: e.g. transforming or reducing an article to a different state or thing.
Thus, if the invention as a whole meets the requirements of patentability—that is,
it involves "transforming or reducing an article to a different state or thing"—it
is patent-eligible, even if it includes a software component.
In the present case, the Court found that the respondents did not seek to patent a
mathematical formula, but rather a protection for a process of curing synthetic
rubber including a formula.

In contrast, the respondents here do not seek to patent a

mathematical formula. Instead, they seek patent protection for a
process of curing synthetic rubber. Their process admittedly
employs a well-known mathematical equation, but they do not
seek to pre-empt the use of that Rather, they seek only to
foreclose from others the use of that equation in conjunction
with all of the other steps in their claimed process. These include
installing rubber in a press, closing the mold, constantly

Patents 70
 determining the temperature of the mold, constantly recalculating
the appropriate cure time through the use of the formula and a
digital computer, and automatically opening the press at the
proper time. Obviously, one does not need a "computer" to cure
natural or synthetic rubber, but if the computer use incorporated
in the process patent significantly lessens the possibility of
"over- curing" or "undercuring," the process as a whole does
not thereby become unpatentable subject matter.

Their claim is not on the equation or the computer program itself, but rather on the
process as a whole. The process merely employs the Arrhenius equation and a
computer program but the patent would not bar anyone from using either — they
would remain in the public domain. The monopoly was sought only on the process
which involves all of them combined in a sequential manner. The computer program
is merely improving the efficiency, and based on the mere inclusion of computer
program and equation, the whole process cannot be disqualified from patent.

Arrhenius' equation is not patentable in isolation, but when a

process for curing rubber is devised which incorporates in it a
more efficient solution of the equation, that process is at the very
least not barred at the threshold by § 101.

Thus, the Court held that the process would not be barred from general patentability
and software-related inventions or business models are patentable when they are
embedded in a proper claim and do not preempt abstract ideas — controlling the
execution of a physical process, by running a computer program did not preclude
patentability of the invention as a whole.

Patents 71
 ❓ What if the Diamond v. Diehr case comes to India
The claim would not be barred by section 3(k) of the Act, as it would be
allowed as a process patent since it is not solely on the computer program
itself. However, the term "per se" is not defined in section 3(k) with
respect to computer programs. In the previous Patents (Amendment)
Ordinance of 2004, the section was more specific, stating that computer
programs with technical applications to industry or those combined with
hardware could be protected.

(k) a computer programme per se other than its technical

application to industry or a combination with hardware;

This meant that if a computer program had a technical application or was

connected to hardware, it would not be considered a computer program per
se and would not be affected by section 3(k). However, this specific
wording was removed in the current act, which only mentions computer
programs per se without defining the term.

IBM Document Abstraction Application – EU Case of

1990
IBM filed a patent on document abstraction application in 1990 → This was for a
software which was being used for abstraction (abridging a 90pg document into a pg
document)

The EPO rejected the application on three grounds:

1. The program was merely a mental act with enhanced efficacy

2. It lacked any technical contribution→ the software did not materially contribute
anything useful to the industry

3. There was no change → the conversion was merely from document to document

Essentially, any computer program can be eligible for a patent, but it is necessary to
demonstrate a technical contribution.

However, suppose there is a software installed in a car that transmits a signal to alert
the driver when the fuel tank is empty, then it can be considered as a technical

Patents 72
 contribution and may qualify for a patent.

Yahoo v. Controller – IPAB, 2011

The claim was on a ‘system and method for influencing a position on a search result
listing generated by a computer network search engine’.

IPAB concluded that it is a business method, and thus not covered under patent law
→ pure business methods are not patentable in India

Indian patent law does not provide for a patent even if the business method includes
technical effects

However, even if it had been classified as a ‘computer program’, it would still be a

computer program per se (with no technical contribution) and hence not protected.

The indistinguishability between process and mathematical method is why it is

unlikely that space trajectories can be patented in India.

S. 3(p)
an invention which, in effect, is traditional knowledge or which is an
aggregation or duplication of known properties of a traditionally
known component or components

The government has prepared Traditional Knowledge Digital Library (TKDL) in which
traditional knowledge has been documented to a great extent — useful database for the
patent office to find out whether a particular invention is based on traditional knowledge
As per §3(p), any invention that seeks to monopolise traditional knowledge is
prohibited → prohibition of BIO-PIRACY
For example, if the medicinal properties of turmeric are already known and an invention
seeks to monopolise its use for medicinal purposes, it will be hit by §3(p). However, if a
new use of turmeric is identified, it can be claimed as an invention, provided that it does
not violate §3(d) which prohibits the patenting of a new use of a known substance. It is
important to note that the objective of §3(p) is not to restrict the patentability of
inventions based on traditional knowledge, but rather to prevent the monopolisation of
traditional knowledge itself. Therefore, if a new use is identified and developed based on
traditional knowledge, it can be patented.

Inventions based on traditional knowledge may be patented if there is value

addition

Patents 73
 Dhanpat Seth v. Nilkamal Plastic Crates Ltd.

👉🏽 TLDR: The revocation was granted on the Ground that “Kilta” a device
used for the purpose of storage or collection of agricultural produce does
not qualify as an invention as it does not include any “inventive step” and
as a result does not lead to any technological advancement or any
economic significance. It was held by the Hon’ble Court that mere
replacement or substitution, of, the patented product, reinforcingly, does
not either add or enhance, the traditional knowledge, with, respect to
manufacturing of Kilta. The “Kilta” which was patented by the plaintiffs’
was a traditional knowledge, which the plaintiffs’ have converted into a
new form without any enhancement in its efficacy.

Facts:
The plaintiffs filed a suit against the defendants for infringing their patent. The patent
had been granted in respect of a device used for “manually hauling of agricultural
produce.”

The impact of grant of such patent is that it implies that the invention did not exist
before. However, the device was already in public domain.

Herein, if the patent is wrongly granted, then defendants like Nilkamal Plastics
would be prohibited from exploiting the market, and thus the consequence of
wrongly granting it is much more than the rejection of a valid patent.

It was granted a patent for its specifications as well as design. The inventor of the
device was Mr. Dhanpat Seth. The defendants, Nilkamal Plastic Ltd. are
manufacturers of various plastic products and supplied its products in various states
across India. The defendant started manufacturing and selling a device which was
similar to the plaintiffs patent and hence this suit. The defendant’s in turn, challenged
the validity of the patent.

Arguments
The defendant claimed that the invention is neither novel nor consists of an inventive
step

It is submitted that the patent is bad for want of subject matter at

the first instance itself. The plaintiffs failed to define the nature

Patents 74
 of invention and to disclose the process which produces results
to be aimed at. The subject matter is neither a matter of new
manufacture nor art. There is no novelty or inventiveness in the
subject matter of the patent as opposed to what was already
known before the relevant date. Pith and essence of the alleged
invention as compared to the pith and essence of traditionally
known Kilta (long Basket) is identical/similar in each respect.
The device does perform the function of hauling. It is nothing but
simply a long basket. The device does not produce any new result
or a new article of manufacture or art than before.

The defendants argued that the device manufactured by the plaintiffs were neither new
manufacture nor art and that the pith and substance of the traditionally used device
Kilta were very identical and similar to the invented device in each respect. No new
result is obtained by the invented device as compared to the traditional Kilta. It was
further argued that the plaintiffs cannot claim a monopoly over a simple basket and
that the plaintiff can only claim rights over a product if it is inventive, novel and
industrious.

Decision
The Court was not convinced that the device had any novelty or inventive steps. The
patented product was bearing resemblance and similarity to the traditionally used
device Kilta and that it is a mere discovery of a new form of a known substance.
Further, the plaintiffs could not establish that the invented device results in the
enhancement of efficacies of the traditionally used device Kilta.
The device developed by the appellants was essentially a Kilta, but instead of
bamboo, it was made of synthetic polymeric material (which is widely
acknowledged as plastic). The only noticeable distinction is that the device now
being produced has adjustable buckled nylon straps. The nylon straps currently
attached were practically iterations of even the ropes employed in the traditional Kilta.
The simple implementation of buckles does not lead to an invention or advanced
stimulation being considered a new device. In addition, the appellants were unable to
prove that the patented device had the effect of improving the functionality of the
historically used Kilta device.

Patents 75
 Any orthopaedic superiority could not be proved by the plaintiffs as no orthopaedic
surgeon supported the same on evidence. It was further observed that Kilta has been
used in agriculture since times immemorial and that the said invention could not be
said to be novel.
It was also noted that, since prehistoric times, Kilta has been utilized in agriculture to
transport agricultural products in hill regions, in particular in the State of Himachal
Pradesh, and that it could not be claimed that the invention was new and innovative.
At first sight, pictorial comparisons of the three products show that the products
created by the appellants and the defendant are simulated replicas of the conventional
Kilta. The invention was a part of the transparent neology provided under Sec 3(p) of
the Patents Act and thus was not an invention.
Moreover, being traditional knowledge, the factum of inventive step is also negated.
While plastic is the raw material used, the invention is merely a replication of Kilta
and reinforces its established characteristics. Thus, the patent was revoked.

“the device developed by the plaintiffs is in fact the result of

traditional knowledge and aggregation/duplication of known
products such as polymers and, therefore, cannot be said to be an
invention”

⚠️ It should be noted that even without the presence of §3(p), any invention
that attempts to monopolize traditional knowledge may still be subject to
novelty and inventive step requirements. However, due to concerns
regarding the competency of patent examiners, a separate section was
included for this purpose.

Patents 76
 ℹ️ 3(o) → topography of integrated circuits;
Can the topography of integrated circuits be patented?

No, patent is not viable in this case, as ICs are developed rampantly.

A protection can be availed in the Layout of Semiconductor Act – a sui

generis protection system.

However, protection cannot be extended under patent, as dual protection is

barred.

3(n) → a presentation of information;

Presentation of information is through database, but it is already protected under
copyright, based on the originality threshold. Thus, no patent protection is granted.
3(l) → a literary, dramatic, musical or artistic work or any other aesthetic creation
whatsoever including cinematographic works and television productions
All of these are protected under copyright, and hence no patent protection.
3(m) → Method of performing mental act not patentable
Examples include:

Method of performing square roots or other calculations.

Method of playing scrabble — The method of game cannot be patented,

however, the board itself might be patented. The board game was not
copyrighted in this case because of idea-expression merger.

Method of doing yoga

Patents 77