Dimminaco A.G. v.

Controller of Patents: Vaccine Patentability

Facts of the Case:

 Dimminaco A.G. filed a patent application for an invention relating to a process for
the preparation of Infectious Bursitis Vaccine.
 The Patent Office Examiner, under section 12 of the Patent Act, 1970 (P.A.), found
that the claimed invention did not constitute an invention under section 2(i)(i) of P.A.
and that the substance prepared could be used as Food/Drug under section 5(a)/5(b) of
P.A.. However, the examination report lacked specific reasons for why it did not
constitute an invention.
 The Assistant Controller of Patents & Designs upheld the Examiner's objection and
refused the patent application. The Assistant Controller reasoned that a process for
preparing a vaccine containing a living entity (live virus) could not be considered a
"manufacture".
 The Assistant Controller was of the opinion that if "manufacture" was given a wide
meaning, it would lead to problems with patenting every new process with foreign
technology.
 The Assistant Controller relied on the recommendation of Justice Rajagopalan
Iyenger on the earlier Patent Bill, 1953, stating that the definition of "invention" in
section 2(i)(i) of P.A. was substantially identical to that recommendation.
 The Assistant Controller further held that a vaccine with a living organism could
not be considered a "substance," stating that an inanimate object is a "thing" or
"item," not a living one, and that living micro-organisms cannot be physically or
chemically converted to another product.
 Dimminaco A.G. appealed this decision, arguing that there is no bar under Indian law
against patenting a process for preparing a product, even if it contains a live virus.
They contended that the Examiner's objection under section 2(i)(i) was baseless and
that administrative policies could not override statutory definitions.
 Dimminaco A.G. also argued that their claimed process for preparing the vaccine was
a new process involving specific scientific conditions and chemical steps, making it
patentable under section 5 read with section 2(i)(i) of the Act. They emphasized that
they were claiming a patent for the process, not the vaccine itself.
 During the proceedings, Dimminaco A.G. presented evidence of other patent
applications in biotechnology involving live cells, viruses, and micro-organisms that
had been accepted by other branches of the Patent Office. They specifically cited
Gazette Notifications showing patents granted where the end product contained a
living organism, such as Lactobacillus reuteri cells.
 The respondents argued that in the granted patents cited by the appellant, while the
process might involve living organisms, the end product did not contain any living
entity or that a process of lyophilizing (freeze-drying) was understood to cause the
death of the living organism. This explanation was supported by a definition from
Chamber's Dictionary of Science and Technology. However, this was later
contradicted by information from Willy's Encyclopedia of Food Science and
Technology, which stated that lyophilizing is a preservation technique that retains
biological activity and does not kill microorganisms.

Issue of the Case:

Judgement of the Case:

The High Court at Calcutta allowed the appeal and quashed the order of the Assistant
Controller. Justice Asok Kumar Ganguly delivered the judgment, holding the following:

 The court found that the Controller erred in law by holding that the presence of a
live virus in the end product automatically disqualified the process from being
considered a "manner of manufacture".
 Since the term "manufacture" is not defined in the Patents Act, 1970, the court held
that its normal dictionary meaning should be accepted, especially when the end
product is a commercial entity or "vendible commodity". The court stated that the
dictionary meaning of "manufacture" does not exclude processes preparing vendible
commodities containing living substances.
 The court applied the "vendibility test," stating that if the invention results in the
production of something that can be bought and sold, the process leading to its
manufacture is an invention. The Infectious Bursitis Vaccine was considered a
vendible product.
 The court noted that there is no statutory bar in the Patents Act, 1970, to accepting a
manner of manufacture as patentable even if the end product contains a living
organism.
 The court rejected the respondents' argument that lyophilizing the cells results in
their death, citing Willy's Encyclopedia of Food Science and Technology to show that
it is a preservation technique that retains biological activity. This reinforced the fact
that the end products in some previously granted patents did contain living organisms.
 The court emphasized the object of patent law is to encourage scientific research,
new technology, and industrial progress, citing the Supreme Court case of M/s.
Bishwanath Prasad Radhey Shyam vs. M/s. Hindustan Metal Industries. It also
referred to the explanation of "manufacture" by Chief Justice Abbott in R. vs.
Wheeler, which includes useful and vendible things and new processes.
 The court found that the Assistant Controller's view that a vaccine with a living
organism cannot be a "substance" was also unacceptable, especially since the process
led to a vendible product.
 The court noted that the Examiner's report lacked proper reasoning and that the
Assistant Controller had not adequately addressed all the arguments raised by
Dimminaco A.G..
 The court directed the concerned authority to reconsider the patent application of
Dimminaco A.G. in light of the observations made in the judgment and after hearing
the parties, within two months.

In essence, the judgement established that a process for the preparation of a vaccine
containing a live virus could be patentable in India if it is new, useful, and results in a
vendible product, as the term "manufacture" under the Patents Act, 1970, is broad enough to
encompass such processes.