[Ip-health] Indian generics welcome KSR decision

[Benjamin Krohmal]

http://pharmalot.com/2007/05/i_hear_a_lawsuit_india_loves_t.php

May 16, 2007
I Hear A Lawsuit: India And The Supremes

India's generic drugmakers hope to get a bigger piece of the US
market and reap a windfall from the recent Supreme Court decision
that requires more stringent proof of inventiveness for patents, The
Red Herring writes.

The Court=92s unanimous April 30 ruling makes it easier to invalidate
patents and raises the threshold for obtaining new patents. Calling
it a =93very positive move=94 for the Indian pharma industry, Dilip G.
Shah, secretary general of the Indian Pharmaceutical Alliance in
Mumbai, says =93the court decision will pose an enhanced threat to an
existing patent should it be challenged.=94

Indian drugmakers, which produce over 22 percent of the world=92s
generic drugs, according to the consulting firm KPMG, already spend
enormous effort challenging patents in order to sell in the US
market. FDA figures show about a dozen Indian companies - led by
Aurobindo Pharma, Ranbaxy, Wockhardt, and Dr. Reddy=92s Laboratories -
account for 23 percent of generic approvals since December 2006.

The Supreme Court ruling means patent challenges could become an even
more viable business strategy for generics producers. Dr Reddy=92s,
India=92s second-largest drug company, says it has filed 33 patent
challenges in US courts. Ranbaxy, Cipla, Sun, Glenmark, Cadila
Healthcare, and others also have filed several challenges.

The Court ruling may make it easier to win those challenges, which,
for regulatory reasons, are usually brought when the patent nears its
expiration date. Even before the ruling, big pharma had been
expecting losses from patent expiration in excess of $100 billion
between 2007 and 2010.

Still, some analysts say it=92s too early to say which side will gain
more from the Court ruling - big pharma or generics - since generic
drugmakers are also known to file for patents that could be deemed
frivolous. =93I think any ruling works both ways,=94 says Sanjiv Kaul,
managing director of New Delhi-based PE fund ChrysCapital. =93What=92s
good for the goose is good for the gander.=94


Source: The Red Herring

Posted by Ed Silverman