PATENT ELIGIBILITY OF SUBJECT

MATTER
UNDER PATENT LAW WITH
REGARD
TO EXCLUDED SUBJECT MATTERS

KULDEEP BAIRWA
 DIFFERENCE BETWEEN PATENT
ELIGIBILITY AND PATENTABILITY

• PATENT ELIGIBILITY IMPLIES THAT WHETHER A

PATENT PARTICULAR SUBJECT MATTER IS WITHIN THE
ELIGIBILITY PURVIEW OF PATENT LAW OR NOT.

• PATENTABILITY IMPLIES THAT WHETHER A

PARTICULAR PATENT ELIGIBLE SUBJECT MATTER
PATENTABILITY FULFILLS THE CRITERIA FOR THE GRANT OF PATENT
SUCH AS NOVELTY, INVENTIVE STEP ETC,
 Patent is an exclusive right conferred by Patent Office on inventor to
exploit his invention subject to the provision of the Patent Act 1970
for a limited period of time.
 Patent is a statutory right : Patent Act.
 Patent relates to Invention.
 Telemecanique & Controls (I) Limited v. Scheider Electric industries
SA 2002, Delhi HC observed that patent created a statutory
monopoly protecting the patentee against any unlicensed user of
the patented device
 Patent is granted for an invention which may be product or process.
 Justice Sakaria observed in Bishwanath Prasad Radhey Shyam v.
Hindustan Metal Industries 1979 : the object of patent law Is to
encourage scientific research, new technology and industrial
progress. Ground of exclusive privilege to own, Youth or sell the
method or the product patented for a limited, stimulated new
inventions of commercial utility. The price of the grant of the
monopoly is the disclosure of invention at the patent office which
after the expiry of the fixed period monopoly, passes into the public
domain.
Is it mandatory to get a patent?
 Not mandatory
 Inventor may prefer to keep his invention keep secret
instead of applying for patent by disclosing it.

Shining industries v. Shri Krishna Industries 1975.

Allahbad HC held that an invention is not a property right
unless it has been patented.
WHAT IS AN INVENTION ?

Novelty or New
Invention Section 2 (l)

Inventive Step or
Non- Obviousness
Section 2(ja)

Capable of Industrial
Application
Section 2 (ac)
 DEFINITIONS
 INVENTION:

Section 2 (j) of the Indian patent Act :

“Invention means a new product or process involving an inventive step and capable of industrial application.”

INVENTIVE STEP:

Section 2(ja) of the Indian Patent Act:

"inventive step" means 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;

NEW INVENTION:

Section 2 (l) of the Indian Patent Act:

“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;
JURISDICTIONS

INDIAN
PATENT LAW

US PATENT
LAW

EUROPEAN
PATENT LAW
INDIAN PATENT LAW

SECTION 3 – WHAT
ARE NOT INVENTIONS

EXCLUDED SUBJECT
MATTER
SECTION 4 –
INVENTIONS
RELATING TO ATOMIC
ENERGY NOT
PATENTABLE
 INDIAN PATENT LAW

 SECTION – 3 OF THE PATENT ACT: The following are not the inventions within the meaning of this Act:

a) AN INVENTION WHICH IS FRIVOLOUS OR WHICH CLAIMS ANYTHING OBVIOUSLY CONTRARY

TO WELL ESTABLISHED NATURAL LAWS;

An invention that lacks utility because it serves no purpose or use is called frivolous invention.

In Indian Vacuum Brakes Co. v. E.S. Luard’s case it was held that patent for making in one-piece articles which
were formerly prepared in two or more pieces could not be called to be a valid patent and was frivolous. Mere
usefulness is not sufficient to support the patent.

Recently there has been a floodgate of frivolous patent in pharmaceutical sector. Section 3(d), Indian Patent Act is
an attempt to stop frivolous patent .
 Example of frivolous nature and contrary to the natural law:
1. A machine purporting to produce perpetual motion (hypothetical
machine that can work without external energy).
2. A machine alleged to be giving output without input.
3. A machine allegedly giving 100% efficiency.
 SECTION 3 (b) OF INDIAN PATENT ACT

b) AN INVENTION THE PRIMARY OR INTENDED USE OR COMMERCIAL EXPLOITATION OF WHICH

COULD BE CONTRARY TO PUBLIC ORDER AND MORALITY OR WHICH CAUSES SERIOUS
PREJUDICE TO THE HUMAN, ANIMAL, OR PLANT LIFE OR HEALTH OR TO THE ENVIRONMENT;

 No universally accepted notion of ordre public.

 Article 27.2 of the TRIPS indicate that the concept of ordre public and morality is not limited to the security
reasons, it also relates to the protection of human, animal, or plant life or health and may be applied to
inventions that may lead to serious prejudice to the environment.
 Article 53 of EPC states “ inventions the commercial exploitation of
which would be contrary to ordre public or morality; such
exploitation shall not be deemed to be so contrary because it
prohibited by law and regulation in some or all of the contracting
state”
 Adecision T1553/15 by one of the technical boards of appeal of the
European Patent Office involving the issue of animal suffering was
released. The invention referred to a pharmaceutical composition
obtained from nucleic acids and amino acids that were in the skin
of rabbits injected with a virus. Since the preparation of 50ml of the
pharmaceutical solution required the killing of 6-12 rabbits, a
commercial exploitation of the invention would have entailed the
slaughter of a staggering number of rabbits. Moreover, the
analgesic effects of the drug could already be obtained by using
other compounds. Therefore, the Board of appeals decided that
the alleged benefits of the drug did not justify the suffering caused
to the animals and thus the patent had been duly denied for being
contrary to public order or morality (Art.53 – European Patent
Convention).
 Another type of inventions that were formerly excluded from
patentability as contrary to morality or public order in the Western
world are those relating to sexuality and contraception. Currently,
Patent Offices, at least in the Western world, receive and grant
thousands of patent applications on sex toys and contraceptive
devices and compositions.
 But in India, IPO in its decision, it claimed that the sex toy was not
patentable according to Section 3(b) of the Indian Patents Act
since its use would affect “public order” and “morality”. Claiming
that sex toys were neither “useful” nor “productive”, it went on to
brand sex toys as “obscene” objects and state that the sale and
import of them would be illegal under Section 292 of the IPC.
 Likewise, one might wonder if inventions on human cloning or the
use of human embryos with industrial purposes, today considered as
contrary to morality, will be patentable in the future?
 Example
1. Any device, apparatus or machine or method for committing theft.
2. Any machine or method for counterfeiting of currency notes.
3. Any device or method of gambling.
4. An invention the use of which can cause serious prejudice to
human beings, plant and animals.
5. An invention the primary or proposed use of which would disturb
the public order e.g. aa device for house breaking;
6. An instrument used for picking pocket or artificial sexual device.
 SECTION 3 (c) OF INDIAN PATENT ACT
c) DISCOVERIES OF SCIENTIFIC PRINCIPLES AND NATURAL PHENOMENON:

 Discoveries having no way of carrying them into effect, mere ideas, mere schemes and plans, scientific
theories and mathematical algorithms have traditionally been regarded as not per se patentable, because they
do not exhibit the requirements of a manner of a manufacture.

 The logic behind excluding discoveries is evident from the discussion in Vitamin technologists Inc. v.
Wisconsin Alumni Research Foundation wherein it was held that ‘ultraviolet light is a natural form of
energy…ultra violate rays is the property of all mankind…it could be a monstrous thing if the energy itself
could be made the subject of monopoly.’

 This would have the effect of deterring further research, inhibit competition and deprive the public of a
knowledge that had always existed, only waiting to be uncovered.
 SECTION 3 (c) contd…
 Distinguishing product of nature from invention, the supreme Court held in America Wood Paper Co. v.
Fiber Disintegrating Co. that refined cellulose, consisting of purified pulp derived from the wood and
vegetable was un-patentable because it was an extract obtained by the decomposition of disintegration of
material substance.

 Molecular Pathology v. US Patent and Trademark Office (Myriad’s Case):

The US Supreme Court held that cDNA was patent eligible but genomic DNA(and fragments thereof including
oligonucleotides) was not. A naturally occurring DNA segment is a product of nature and not patent eligible
merely because it has been isolated.
 SECTION 3 (d) OF INDIAN PATENT ACT
 (d) THE MERE DISCOVERY OF A NEW FORM OF A 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 OF 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 ATLEAST ONE NEW REACTANT:

To comply with the TRIPS requirements, India amended its patent law in 2005, allowing new chemical entities to
be patented. The amendment also sought to prevent the ‘ever -greening’ by making small modifications to the
chemical entity, thus extending the patented life of the drug.

 Novartis Ag v. Union of India, (2007)4 MLJ 1153 – The amendment was challenged by the Novartis. The
Indian Government rejected the patent application filed by Novartis for beta crystalline from Glivec, Imatinib
Mesylate on the ground that Glivec is not a new entity because forms of it were known before 1995, and
Glivec does not show any enhancement of efficacy.
❖ On an appeal, the Intellectual Property Appellate Board ruled that Novartis was not entitled for the patent on
two grounds-

 It fails to satisfy the requirements under section 3(d), Indian Patent Act which requires that in order to be
patentable, a pharmaceutical derivative must demonstrate significantly enhanced efficacy over and above the
prior known molecule.

 On an appeal, Supreme Court of India upheld the verdict of Appellate Board and held that – ‘ the mere
change of form with properties inherent to that form would not qualify as “enhancement of efficacy” of a
known substance. Increased bioavailability alone may not necessarily lead to an enhancement of therapeutic
efficacy. Whether or not an increase in bioavailability leads to an enhancement of therapeutic efficacy in any
given case must be specifically claimed and established by the research data.
 SECTION 3(e) OF THE PATENT ACT

 A SUBSTANCE OBTAINED BY A MERE ADMIXTURE RESULTING ONLY IN THE AGGREGATION

OF THE PROPERTIES OF THE COMPONENTS THEREOF OR PROCESS FOR PRODUCING SUCH
SUBSTANCE :

By ‘mere mixture of known ingredients’ is meant a mixture exhibiting only the aggregate of the known
properties of the ingredients. Not only must the ingredient be known, but the property that makes the ingredients
useful for the purpose of the invention must also be known. If the result achieved by the invention is more than
might be expected from a mere mixture, the invention is patentable. E.g. Soap, lubricant etc.

 a mixture of sugar and some colorant in water to produce a soft drink is aggregation of the properties.
 M/s stanipack Pvt. Ltd. M/s Oswal Trading Co. Ltd.
 The defendant challenged the validity of the patent of plaintiff For
the invention for the manufacture of pouch for storage and
dispensing of a liquid search as lubricating oil. The Delhi HC while
revoking the patent on the ground that the invention was not new
and not an invention within the meaning of Section 3, Observed:
 thickness of the plastic film/ layer depends upon the tolerance of
the content of the pouch thus the same is merely an arrangement
And rearrangement of the mixture of the material and can not be
termed as a novel concept and does not have any novelty. Such
arrangement and re-arrangement of mixture of the material
cannot become an invention, for it is only an improvement by
adding microns as per the strength of the layers.
 SECTION 3(f) OF THE INDIAN PATENT ACT
 THE MERE ARRANGEMENT OR REARRANGEMENT OR DUPLICATION OF KNOWN DEVICES,
EACH FUNCTIONING INDEPENDENTLY OF ONE ANOTHER IN A KNOWN WAY:

The concept of “manner of manufacture” also includes a threshold inventiveness requirement that would exclude an
invention that was merely a new use of an old substance, involving old integers without a working interrelationship
producing a new or improved result or was otherwise obvious on the face of the specification.

When two or more features of apparatus or device are known and they are placed together without any
interdependence on their functioning they should be held to have been already known, e.g. an umbrella with fan ,
bucket fitted with tourch.

 Commissioner of Patents v. Microcell, a rocket projectors of known design manufactured from reinforced
synthetic resinous plastic material were held by the court as not eligible for patent protection. The Court found
that there was in truth nothing but a claim for the use of a known material for the purpose of which its known
properties make the material suitable.
Polar Industries v. Jay Engineering 2000, If a machine or device is
known before, by mare changes in the position of parts , no new
product is created.
SECTION 3 (h) OF THE INDIAN PATENT LAW
 METHOD OF AGRICULTURE OR HORTICULTURE:

The main aim of excluding methods of agriculture from protection was to alleviate
poverty and also to ensure that there would be self- sufficiency in food sector.

e.g.

A method of producing a plant, even if it involved a modification of the conditions

under which natural phenomena would pursue their inevitable course (like
greenhouse)

A method of producing mushrooms .

 SECTION 3 (i) OF THE INDIAN PATENT LAW
 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:

❑ Indian patent office interprets the method of medical treatment exclusion in a wider manner than the EPO and
the UK patent courts, consequently excluding a large number of such inventions from patentability.

❑ Eli Lilly and company’s Application a claim for a novel manner of use of old chemical compound for the
treatment of human disease has been held to be not patentable.

❑ Calmic Eng. Co. Ltd.’s Application Patent was refused for a method of purifying blood by removing toxic
substance form blood by dialysis.
 SECTION 3 (i) CONTD…
 Any process for the medicinal, surgical, curative, prophylactic (diagnostic, therapeutic) or other treatment;

 The process or the treatment should be directed to either live human being or live animals; and

 The process or the treatment should be such as to render either the human being or animals free of disease
or possessed of increased economic value for themselves or their products.

Even if one of the criteria were absent, Section 3(i) cannot apply, it was held that the claimed invention did
not satisfy any of the above mentioned criteria and was therefore not excluded under section 3 (i) of the Act.

 M/s Signature R&D Holdings LLC’s Patent Application:

In a matter dealing with the enhancement of therapeutic efficacy, the patent office has held that claims such as
improvement of insolubility, reducing toxicity and improving of crossing blood brain carrier are not as such
excluded under section 3 (i). The examiner accepted the argument of the applicant who submitted that
enhancement of therapeutic qualities did not amount to a method of treatment.
 SECTION 3(i) CONTD…
 The phrase ‘other treatment’ in section 3 (i) has also generated controversy regarding inclusion of cosmetic
intervention.

 M/s. Galderma Research and Development S.N.C.’s Patent Application:

The claim involved was a method of improving the appearance of the body or hair, which comprises the
application to the body or hair of a cosmetic agent comprising a compound as defined in the claims. The
examiner held that the above claims fell within section 3(i) as it involved the treatment of skin using the cosmetic
agent.

 Allied questions dealing with whether life style disorders can be considered as a ‘disease’ are equally
pertinent to the enquiry under this provision. In a patent application dealing with a method of discovering
compounds suitable for the treatment and or prophylaxis of obesity…, the patent examiner concluded that it
is a method of diagnosis and treatment and hence not patentable under section 3(i).
 SECTION 3 (j) OF THE INDIAN PATENT ACT
 PLANTS AND ANIMALS IN WHOLE OR ANY PART THEREOF OTHER THAN MICRO-ORGANISM
BY INCLUDING SEEDS, VARIETIES AND SPECIES AND ESSENTIALLY BIOLOGICAL PROCESS
FOR PRODUCTION OR PROPAGATION OF PLANTS AND ANIMALS;

Plants varieties were originally excluded from the patentable subject matter because, as ‘product of nature’, they
did not meet the requirements of new, non-obvious subject matter, and because they could not be described with
enough specificity to meet the patent statute written description requirements.

 Indian Patent Act, 1970 excludes plants and animals in whole from patent protection.
 SECTION 3 (j) CONTD…
 The protection of Plant varieties and Farmer’s Right Act, 2001 of India now allows protection of a new and
distinct varieties of plants that satisfy the requirements of the Act.

PATENTING OF MICRO-ORGANISM:

Under the provisions of the TRIPS agreement, microorganism have to be given a patent protection. Indian Patent Act
has also excluded microorganism from the list of non-patentable inventions.

 Diamond v. M. Chakrabarty:

it was held in this case that microorganism produced by genetic engineering are not excluded from patent protection
by 35 USC Section 101. The relevant distinction was not between living and inanimate things but between product of
nature, whether living or not, and human made invention.
 SECTION 3 (j) CONTD…
 DIMMINACO AG V. CONTROLLER OF PATENTS:

❑ In this case the application was for a patent on a process that resulted in the manufacture of the live vaccine that
was useful as a cure for infectious bursitis in poultry. The patent office has rejected the application as the vaccine
was a living vaccine and that the definition of the ‘manufacture’ did not include a process that resulted in a living
organism.

❑ The Calcutta High Court has set aside the decision of the controller and found that the Patent Act did not prohibit
the patenting of “Biotechnological Inventions”.
 SECTION 3 (l) OF THE INDIAN PATENT LAW
 A LITERARY, DRAMATIC, MUSICAL OR ARTISTIC WORK OR ANY OTHER AESTHETIC CREATION
WHATSOEVER INCLUDING CINEMATOGRAPHIC WORKS AND TELEVISION PRODUCTION:

The subject-matter of a literary, dramatic, musical, or artistic work is protectable under the Copyright Act. The
protection given is for the original expression of the idea and not for the idea.

SECTION 3 (M) OF THE INDIAN PATENT LAW

A MERE SCHEME OR RULE OR METHOD OF PERFORMING MENTAL ACT OR METHOD OF PLAYING
GAME:

Cooper’s Application, it was held that you cannot have a patent for a mere scheme or a plan – a plan for becoming
rich, a plan for the better government of a state; a plan for the efficient conduct of the business.
 SECTION 3(m) CONTD…
 Wang re, Application:

Aldous J.- “ The fact that the scheme, rule or method is part of a computer program and is therefore converted into steps
which are suitable for use by a person operating the computer does not matter. What is excluded from being patented is
a scheme, rule or method for performing mental act, whatever mental steps or process is involved.

SECTION 3 (n) OF THE INDIAN PATENT LAW

A PRESENTATION OF INFORMATION:

Mere presentation of the information can be considered as an original expression of an idea which is within the ambit of
protection of the copyright system.

Thus any manner any manner, means or method of expressing information whether visual, audible or tangible by words
codes, signals, symbols, diagrams, or any other mode of representation is not patentable
 SECTION 3 (n) CONTD…
 HILLER’S APPLICATION:

The application was for an improved plan for subterranean utility distribution scheme. It was held that, “the
issuance of instructions to a gang of workmen to dig excavations and lay conduits as indicated on a plan of a site
cannot of itself constitute any development in a useful art… patentability does not attach to any novelty or ingenuity
which can be asserted for such a plan.

SECTION 3(o) OF THE INDIAN PATENT LAW

TOPOGRAPHY OF INTEGRATED CIRCUITS:

Integrated circuits are protected by the Semiconductor Integrated Circuits Layout- Design Act, 2000 and is not a
patentable subject matter.
 SECTION 3 (p) OF THE INDIAN PATENT LAW
 AN INVENTION WHICH IN EFFECT, IS TRADITIONAL KNOWLEDGE OR WHICH IS AN
AGGREGATION OR DUPLICATION OF KNOWN PROPERTIES OF TRADITIONALLY KNOWN
COMPONENT OR COPONENTS.

The current IPR system cannot protect the TK for three reasons:

❑ The current system seeks to privatize ownership and is designed to be held by individuals or corporations,
whereas the TK has collective ownership.

❑ This protection is time- bound, whereas the TK is held in perpetuity from generation to generation.

❑ It adopts a restricted interpretation of inventions which should satisfy the criteria of novelty, and be capable
of industrial application, whereas the traditional innovation is incremental, informal and occurs over time.
 SECTION 4 OF THE INDIAN PATENT LAW
 INVENTIONS RELATING TO ATOMIC ENERGY NOT PATENTABLE:

No patent shall be granted in respect of an invention relating to atomic energy falling within sub section (1) of section
20 of the Atomic Energy Act, 1962 (33 of 1962).

❑ Section 20, Atomic Energy Act makes special provision as to inventions that are useful or relate to Atomic energy.
The Act requires that the patent shall not be granted to such inventions.

❑ The controller of the patent has to refer the application to the Central Government for direction as to whether the
invention is related to Atomic Energy.

❑ The decision of the Central Government is final.

❑ The Atomic Energy Act has a derogatory provision which states that notwithstanding anything contained in the
Indian Patent Act, the decision of the Central Government on points connected with or arising out of Section 20
shall be final.
Thank you…