[Ip-health] News story on linkage debate within India

[Mike Palmedo]

http://www.business-standard.com/common/news_article.php?autono=3D321993&le=
ftnm=3D3&subLeft=3D0&chkFlg=3D

Ministry wants patent units off drug sale approvals

Joe C Mathew
Business Standard
New Delhi May 5, 2008

The Drug Controller General of India's (DCGI's) plans to seek help from
the patent offices to deny marketing approval to copycat versions of
patent-protected medicines may not succeed as the commerce ministry =97
the administrative ministry for intellectual property matters =97 does not
want patent offices intervening in the drug approval process.

Commerce ministry officials say grant of patents cannot be a criterion
to decide a medicine's marketing eligibility.

"Neither is in the job of the patent offices to suggest if a medicine
should be given manufacturing/marketing approval," said an official.

Officials say marketing approval to a low-cost version of a patented
drug does not amount to patent infringement.

"The drug authority's approval only indicates the safety and efficacy of
a medicine. It has nothing to do with patents. If any generic-drug maker
decides to market his version of patent-protected product in the
country, there are provisions to legally challenge the move," he added.

The DCGI had recently asked the industry for details of the patents
granted for their new medicines. Its intention was to pass on the patent
details of the medicine to the patent office for an opinion whenever a
second applicant applies for marketing approval for a similar product.

The move was triggered by an ongoing litigation involving domestic drug
firm Cipla and Swiss multinational Roche. Roche had taken Cipla to court
alleging infringement after the Indian company launched a low-cost
version of Roche's patented-medicine. The DCGI wants to avoid such
instances and the patent linkage plan is a part of that effort.

"There is no need to involve the patent office for ascertaining the
patent status of a product. It's all there online in the public domain,"
said a commerce ministry official.

The Indian Pharmaceutical Alliance (IPA), the association of leading
domestic drug firms, says the DCGI move may harm the "genuine" interests
of Indian drug makers by preventing them from marketing the low-cost
versions of medicines that enjoy doubtful patent protection.

"If the patent-linkage system is introduced, the domestic industry will
not be able to introduce low-cost variants of patented products even at
the risk of litigation. It could delay the entry of cheaper alternatives
of patented medicines by years," said IPA secretary general DG Shah.

The US is among the very few countries that provide "patent linkage" in
drug marketing approvals. Under the US law, a generic manufacturer may
submit along with its ANDA (abbreviated new drug application), a
declaration that the medicine does not infringe on any patent.

If the innovator company files a patent infringement action against the
generic firm within 45 days, the application gets an automatic 30-month
stay. The generic firms get marketing approval after this (30-month) period=
.

Domestic industry feels if the Indian drug regulator rejects low-cost
applications of patent medicines without such a timeline, it may
indefinitely delay the entry of cheaper alternatives in the market.

--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu