[Ip-health] Op-ed by KM Gopakumar in Economic Times: When patenting is in question

[Thiru Balasubramaniam]

http://economictimes.indiatimes.com/Opinion/When-patenting-is-in
question/articleshow/5040331.cms?curpg=3D1

When patenting is in question
22 Sep 2009, 0204 hrs IST, K M Gopakumar,


Patent controversy.

Prof. Carlos Correa, an intellectual property law expert has revealed
that the TEG report has misinterpreted his quotes, on the basis of
which its recommendations have been made.

Four years after it was set up by the Government in 2005 when
Parliament amended India=92s patent law to comply with its obligations
under the TRIPS Agreement, the TEG submitted the =91final version=92 of
its report in March 2009. News reports indicate that the government
accepted the Report in August 2009.

While the report covers several issues, this piece examines the
conclusions of the TEG in response to the first question in its Terms
of Reference (ToR) i.e. =93Whether it would be TRIPS compatible to limit
the granting of a patent for a pharmaceutical substance to a new
chemical entity (NCE) or to a new medical entity (NME) involving one
or more inventive steps=94.

The TEG concludes that =93linking the grant of patents to new chemical
entity or to a new medical entity may prima facie amount to excluding
the field of technology=94 and therefore would not be TRIPS compliant.
In arriving at its conclusions, the Report cites the following
reasons: Firstly, Article 27 of TRIPS (which defines =91patentable
subject matter=92) states that patents must be available for inventions
in all fields of technology.

According to the TEG limiting the grant of pharmaceutical patents to
NCEs or NMEs would result in the exclusion of a field of technology
from patent protection. Secondly, it states that under =91normal
circumstances=92 the flexibilities under Articles 7 and 8(1) of TRIPS do
not override Article 27 and are therefore of little use in solving the
question referred to TEG i.e., the TRIPS compatibility of limiting
patent protection to new chemical entities. Thirdly, the flexibilities
mentioned in the Doha Declaration on Public Health cannot be used to
exclude pharmaceutical inventions from patent protection.

In arriving at the above conclusions, the TEG quotes from a research
paper by Prof. Carlos Correa entitled, =93Integrating Public Health
Concerns into Patent Legislation in Developing Countries=94 published in
2000 by the South Centre. At the beginning of the paper, Prof. Correa
explores the question of whether pharmaceutical patents or a specific
group like essential medicines can be excluded from patentability and
concludes, =93Literally interpreted, Article 27.1 does not permit the
exclusion from patentability of medicines in general or arguably, of
specific groups thereof. Under this interpretation WTO members could
not exclude from patentability even the =91essential=92 medicines listed
by the World Health Organization (WHO).=94

He argues that one of the possibilities for excluding pharmaceuticals
from patenting would be in the case of emergencies. Thus, Prof. Correa
notes: =93Emergency cases could trigger the application of a different
test of =92inconsistency=91(as provided for under Article 8.1) or qualify
as a situation not =92conducive to social and economic welfare=91(as
provided for under Article 7). In such a case, a suspension or
exclusion from patentability might be linked to and justified by a
specific emergency. Once the emergency subsides, the TRIPs requirement
of patentability could be restored.=94

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru@keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997