MODULE 3: PATENTING OF THE PHARMACEUTICALS INVENTIONS

AND NEW CHALLENGES

After TRIPS agreement 1995, the member states modified their patent law, in consonance
with the agreement. Article 27 of TRIPS dealing with Patentable subject matter, under its
clauses 2 and 3 excludes certain subject matter from the scope of patentability.
Article 27(2) clearly provides that even though certain inventions are commercially
applicable but if their commercial exploitation is against public order or morality or causes
serious prejudice to human, animal, plant, health or environment, then that can’t be patented.
Article 27(3) further provides that member may also exclude from patentability:

a Diagnostic, Therapeutic, and Surgical Methods for the treatment of humans or animals;
b Plants and animals, other than micro-organisms and essentially biological processes for
the production of plant or animals other than non-biological and micro-biological
processes. However members shall provide for the protection of plant varieties either by
patents or by an effective sui generis system or by any combination thereof.

I. PROTECTION OF PLANT VARIETIES IN INDIA

In compliance of TRIPS Agreement, Indian parliament passed legislation in the name of

Protection of Plant varieties and farmers rights act, 2001 to provide protection to farmer
rights and to protect the plant varieties.
The act doesn’t make any provision for the patenting of plant varieties or any farmers right;
as mode of agriculture already comes under the category of excluded subject matter forming
state of art so it gives certain license and through that provides protection to the plant
varieties and farmers’ rights.

II. PATENTABILITY OF GENETICALLY MODIFIED ORGANISM AND GENETIC MATERIALS

Case: Aruna Rodrigues v Union of India (2005)

The main issue of this case was about introducing genetically modified organism in the open
market. Concern was raised that GMO are reproduced in the market without proper
examination of the bio-safety concerns. Similarly, GMO were also used for open field testing.
Held: The Supreme Court showed activist approach and directed to constitute a committee
consisting of at least 2 scientists and once of whom must be agricultural scientist. With
respect to the constitution of committee, SC pointed out that two members i.e. P.N. Bhargava
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and M.S. Swaminathan must be the member of that committee and once that committee
approves about the concerned GMO, only after that the product must be made open for open
field testing.

III. PATENT IN ADDITION OR DOUBLE PATENTING OR EVER-GREENING OF PATENT

Section 3(d) of Patent Act impliedly prohibits the ever greening of patents; similarly patent
in addition is also not allowed. Concept of evergreening was discussed in detail in the famous
case of F Hoffman La Roache Ltd. v Cipla Ltd. Further, Novartis Pharmaceutical
Company case is also very important on this point.

MODULE 4

I.

There are certain limitations on the exclusive rights of the patentee:

1. Experimental Use
2. Bolar Exception
3. Educational and Research Exception
4. Parallel Importation
5. Compulsory Licensing
6. Offensive and Defensive Protection of tribal community intellectual property rights.

A. EXPERIMENTAL USE

Use for the purpose of further experimentation is permitted almost throughout the globe and
that doesn’t constitute any infringement on the rights of patentee. Before 1984, under certain
jurisdiction, experimental use was not even permitted, but after that it has been incorporated
almost under all the jurisdictions.

B. BOLAR EXCEPTION

Roche Products Inc. v Bolar Pharmaceutical Company is very important with respect to
BE. BE came into picture as a limitation on the exclusive rights of patentee after the
judgement of this case.
Facts: In this case, there was a drug which was developed by Roche Product Inc. and patent
was granted with respect to that under USA. Bolar Pharma Inc was desirous to bring generic

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drug of the same medicine soon after the expiry of patent to bring the generic drug into the
market, Bolar Pharmaceutical Inc. started experimentation over the concerned drug during
the sustenance of the patent itself. Intention of BP Inc. was to take the approval of food and
drug dept just after the expiry of term of patent. In furtherance of that, BP Inc. also started
using the ingredients involved in that particular drug.
With respect to such experiment objections were raised by RP Inc. and finally the matter
came before the court under United States Drug Price Competition and Patent Term
Restoration Act, 1984 (aka Hatch-Waxman Act). Under § 271, this enactment provided that
“Marketing using and selling of patented inventions during the sustenance of patent
constitutes infringement of the right of patentee” This provision was not subjected to any
exception at that point of time.
Held: The court decided the case as per the above give provision and action of BP Inc. was
held as infringement of the rights of RP Inc.
This enactment in the Bolar case came into great controversy after this judgement --- Hatch-
Waxman Act, 1984 was amended 4 times after the judgement --- the amended provision
provides that it shall not be an act of infringement to make, use, sell a patented invention
solely for the uses relating to development, submission of information under a federal law
which regulates the manufacture, use, or sale drugs. --- this amended provision is called as
Bolar Exception.

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