[Ip-health] Pharmalot: India Looks To Tighten Rules For Filing Pharma Patents

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Tue Dec 3 03:17:48 PST 2013


Pharmalot
India Looks To Tighten Rules For Filing Pharma Patents
Posted Mon, 12/02/2013 - 8:06am by Ed Silverman

http://www.pharmalive.com/india-looks-to-tighten-rules-for-filing-pharma-patents

In a move that is likely to concern brand-name drugmakers, the Indian
Patent Office is considering a proposal that would require the generic drug
names assigned by the World Health Organization to be disclosed on patent
applications, according to The Economic Times. And if the proposal is
approved, India would become the first country to mandate this condition.

The requirement would make it easier for patent examiners, generic
drugmakers and patient advocates to block what some call ‘frivolous’
incremental patents from being granted and also make it more difficult for
brand-name drugmakers to receive patents for incremental innovations, which
some argue do not demonstrate any increased effectiveness for an existing
medicine, the paper writes.

“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 the Economic Times. "A final decision,
however, has not yet been taken on the matter."

The proposal comes as India is already under fire for its handling of
patents. In particular, the pharmaceutical industry has been critical of a
decision last spring by the Indian Supreme Court, which rejected a patent
sought by Novartis for its Gleevec cancer medication. A previous government
ruling denied its request after deciding a new form of the drug did not
meet a standard for enhanced efficacy.

Patient advocates argued a Novartis (NVS) victory would have amounted to
evergreening, a reference to patent extensions based on minor changes, and
inhibit access to Gleevec since generic drugmakers would be prevented from
making copycats. Novartis countered that the decision will inhibit
incentives to pursue innovation (back story).

India has also sustained ongoing criticism for issuing compulsory licenses
for some drugs used to treat cancer or HIV (look here, here and here). The
government has maintained it has the right to do so under the Trade Related
Aspects of Intellectual Property Rights, or TRIPS, since the cost of the
medicines is out of reach of many of its citizens and other countries, such
as Brazil and South Africa, are considering the same step (see this and
this).

But attorneys who represent the pharmaceutical industry tell the paper that
the latest patent proposal is not feasible and would violate obligations
under the TRIPS agreement. But patent experts and patient advocates argue
the move will help sort frivolous incremental innovations from valid
innovations.

This is an “important step,” Carlos Correa, a global patent expert and
professor at the University of Buenos Aires, tells the paper. "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."

And Leena Menghaney, who works with Doctors Without Borders, tells the
Times, multiple patent applications are filed for the same drug, but do not
cite the common INN. And this makes it difficult to identify which patent
claims relate to which medicines out of the many applications that are
filed.

Attorneys, however, discount the maneuver. “There are only three criteria
for patentability - novelty, utility and non-obviousness. INN cannot be
included as a fourth requirement," Archana Shanker, senior partner at Anand
and Anand tells the paper. She adds that any administrative guideline that
requires such a disclosure would violate both Indian law and TRIPS
obligations.

And Ashwin Julka, managing partner at Remfry & Sagar, says: "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."

But patient advocates say that, while this may be true of new drugs, most
patents filed are secondary and the disclosure can be required for cases
where INN has already been assigned.



Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan

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