[Ip-health] RE: MASHELKAR REPORT

[charlesclift@tiscali.co.uk]

http://www.managingip.com/default.asp?page=3D9&PubID=3D198&SID=3D671455&ISS=
=3D23218&LS=3DEMS117111


NB Mashelkar Report http://www.ipindia.nic.in/ipr/patent/mashelkar_committe=
e_report.doc




Indian panel opposes patent law plans
Peter Ollier, Hong Kong

A government-appointed panel of IP specialists has concluded that India's
patent law would not comply with the TRIPs Agreement if it limited the gran=
ting
of patents to new chemical entities.

The Indian Ministry of Commerce appointed five IP academics to a panel in
April 2005 to consider whether more changes should be made to the country's
newly-amended Patent Act.

In particular, the panel ? the Technical Expert Group on Patent Law Issues
? was asked if the country could limit the grant of patents for pharmaceuti=
cal
substances to new chemical entities and still meet its TRIPs obligations.
It also examined whether India could exclude micro-organisms from patenting=
.

The group was led by R A Mashelkar, former head of the Council of Scientifi=
c
and Industrial Research.

The panel's report was published over the weekend. In it, the authors compa=
red
Article 27 of TRIPs to India's Patent Act.

Article 27 of TRIPs says that patents should be available to "any invention=
s,
whether products or processes".

Section 3(d) of India's patent act clarifies what is not patentable. The
exceptions include: "the mere discovery of a new form of a known substance
which does not result in the enhancement of the known efficacy of that subs=
tance,
the mere discovery of any new property or new use for a known substance,
and the mere use of a known process, machine or apparatus ? unless that pro=
cess
results in a new product or employs at least one new reactant."

In its report, the panel says that this part of Indian patent law means tha=
t
a new form of a known substance would not be patentable "unless it differs
significantly in properties with regard to efficacy". It concludes that thi=
s
section does not comply with TRIPs.

Using the US Food and Drug Administration's definition of a new chemical
entity as "a drug that contains no active moiety that has been approved by
the FDA in any other application," the panel decided that limiting grants
to new chemical entities, and excluding new forms of crystals and polymorph=
s,
if they are patentable, would not be TRIPs compliant.

Pravin Anand, a partner of Anand and Anand, described the report as "a fant=
astic
report, good for innovation".

India is one of the world's largest centres of generic drug manufacturing,
and the report will come as a blow to the industry. The authors were, howev=
er,
careful to distinguish between "incremental innovations" (developments that
build on the value of a patented product) and "ever-greening" (extending
the life of a patent by making inconsequential changes).

The authors recommend that the government formulate detailed guidelines to
prevent the granting of frivolous patents.

Annex IV of the report supports the case for allowing incremental innovatio=
ns
to be granted patent protection in India by detailing the number of PCT app=
lications
filed by Indian pharmaceutical companies concerning different forms of the
same substance.

India's newly-revised patent law has caused controversy among many multinat=
ional
pharmaceutical companies. Novartis went to court in May 2006 to challenge
the Indian Patent Office's decision to refuse to grant a patent for its can=
cer-treating
drug Glivec. In its lawsuit, Novartis claims that Section 3(d) of the India=
n
Patents Act, does not comply with TRIPs.

Despite pressure from humanitarian organization M=E9decins Sans Fronti=E8re=
s
(MSF), the Swiss company has not backed down. The next hearing in the case
is scheduled for January 29 at the Chennai High Court.

No official from MSF was available to comment on the panel's report. A spok=
esperson
for the Indian Pharmaceutical Alliance, an association of generic pharmaceu=
tical
manufacturers, told MIP Week by email that there was "hardly any" evidence
in the report to support the panel's conclusions.

It also pointed out that the panel's report did not refer to a submission
by Frederick Abbott, an academic at Florida State University who has advise=
d
developing countries during TRIPs negotiations at the WTO, which had been
arranged by the Alliance.

On micro-organisms the report says that TRIPs allows the patenting of those
involving human intervention. Excluding micro-organisms per se from patent
protection would therefore violate the TRIPs Agreement.

MIP Week welcomes your feedback on this or any other story. Please email
the author with your comments. Letters may be published online.

This article is FREE access as part of MIP Week


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