[Ip-health] Indian Patent Office proposal - mandatory for drug firms to disclose the WHO-assigned generic names of drugs, while applying for patents

leena menghaney leenamenghaney at gmail.com
Thu Nov 28 05:25:43 PST 2013

*Government mulls stricter norms for patents in pharma space*

By Soma Das, ET Bureau | 27 Nov, 2013, 04.00AM IST

NEW DELHI: In a move that could usher in more transparency in the pharma
patent landscape, the Indian Patent Office is considering a proposal that
seeks to make it mandatory for drug firms to disclose the WHO-assigned
generic names of drugs, whenever known, while applying for their patent.

The proposal, if accepted, will make India the first country in the world
to mandate such a condition.

Experts say the move will make it easy for patent examiners, generic drug
makers and public health groups to block 'frivolous' incremental patents
from being granted. It will also make it difficult for innovator drug firms
to get patents for incremental innovations, which do not show any
enhancement in efficacy of an existing therapy.

The move comes at a time when Indian patent regime is already under severe
criticism from the US and Europe for deviating from global norms and
implementing unique policies customised for the needs of the developing
world population. "We are currently consulting key stakeholders on the
feasibility of mandating disclosure of WHO-assigned INN (international
non-proprietary names) in the pharma patent applications, wherever
applicable," an official at the Indian Patent Office told ET on condition
of anonymity. "A final decision, however, has not yet been taken on the

The official added that inputs from the stakeholders would now be discussed
with the Department of Industrial Policy and Promotions before a final call
is taken on the issue.
While top law firms, mainly those representing big pharmaceutical
companies, said the move is not feasible and would violate the country's
obligations on Trade Related Aspects of Intellectual Property Rights
(Trips), global patent experts and public health groups said it would help
sieve frivolous incremental innovations from valid ones and prevent grant
of patents to them.

Terming the Indian Patens Office's move an "important step indeed", Carlos
Correa, global patent expert and professor at the University of Buenos
Aires, said: "Patent applicants seem to deliberately conceal the known INN
to discourage oppositions (before and after a patent is granted) and
challenges to the patent's validity. The absence of this information also
complicates procurement of drugs and local production since it is difficult
to know when a patent can be infringed."

Leena Menghaney, who works with global public health group Medecins Sans
Frontieres, said the move could prove to be a key second generation reform
related to limiting the practice of 'evergreening' of patents in India. She
said, at present, multiple patent applications are filed for the same drug,
which does not cite the common INN. This makes it difficult to identify
which patent claims relate to which medicines out of the thousands of
applications that are filed.
But law firms representing pharma multinationals argue that the patent
office is trying to put the cart before the horse.

"There are only three criteria for patentability - novelty, utility and
non-obviousness. INN cannot be included as a fourth requirement," said
Archana Shanker, senior partner at Anand and Anand. She said any
administrative guideline, which mandates such disclosure, would violate
both the law of the land and TRIPS obligations of the country.

Ashwin Julka <http://economictimes.indiatimes.com/topic/Ashwin-Julka>,
managing partner at Remfry & Sagar, said: "Generally INN is not available
at the time of filing a patent application and the same are assigned later.
Therefore, in case disclosure of INNs is made mandatory, the applicant
would have to keep track of the assignment of an INN to each and every
compound mentioned in the patent application or patent, which in itself is
a cumbersome process and may not be feasible for the applicant."

This could be true of new drugs, counter public health groups, but most of
the patents filed today are secondary in nature as the new drugs pipeline
has dried up significantly and this disclosure can always be made mandatory
for cases where INN has already been assigned.

Ramesh Adige, former executive director at Ranbaxy
said IUPAC ( International Union of Pure and Applied
should be preferred over INN, as the former is more of a chemical
nomenclature, allocated much before an INN. Maintaining that mandating such
disclosure is not feasible for new chemical entities, he said: "India can
mandate INN or IUPAC for incremental innovation in pharmaceuticals to help
patent office examiners expedite search."

Law firms ET spoke to also said patent claims of a specific type, called
Markush structure that involves a large number of compounds, would become
infeasible to file here.

Early this year, the Indian patent regime was slammed, particularly by its
western counterparts, for proactively implementing a policy that seeks to
ensure that incremental innovations, which don't increase efficacy of an
existing therapy, are not granted monopoly rights. It has also drawn flak
from the same quarters for granting the country's first compulsory licence
last year to make available a cheaper version of a cancer drug. However, a
few of these "deviant" moves have found support among emerging economies
like Brazil and South Africa, which are in the process of adopting some of
India's policy innovations.

Leena Menghaney (MSF Access Campaign India)
K-30 Jangpura Extension
New Delhi – 110014
Ph: +91-11-41823783/84
Mobile: 9811365412

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