It appears that generic
companies need to coin more innovative patent challenge
strategies and strengthen their legal expertise while
taking on patented molecules. The year 2004 did not fare
well for patent litigation indicating a tough time for
the generic players who thrive on patent challenges, pointed
out a CLSA report on Asia-Pacific markets. This is because
most of the newer patent challenges are on composition
of matter patents and method of use patents which are
difficult to invalidate, it said.
While September first week witnessed Dr Reddy's loss in
Lamisil patent challenge, the generic biggie Teva of Israel
lost three cases in the second half of August this year.
The next big litigation is Zyprexa where Dr Reddy's and
Ivax have challenged Eli Lilly on the composition of matter
patents.
Over the next 15 months lower court decisions on two cases
are expected, these being Lipitor for Ranbaxy and Zyprexa
for Dr Reddy's. It is believed that Eli Lilly would prevail
in Zyprexa and generic would lose. A loss would further
worsen the outlook, but a win could re-ignite hope, the
report says.
The report says that Ranbaxy and Dr Reddy's have a robust
pipeline of patent challenges and CLSA continue to believe
that these companies would win some of their many patent
challenges.
''Seeing is believing,'' quips the report. The key patent
challenges of Ranbaxy include Lipitor (Pfizer - patent
expiry 2006/10), Valtrex (GSK-February 2007), Pravachol
(BMS April 2006), Zocor (Merck July 2006), Imitrex (GSK
2006/08), Aricept (Eisai Inc November 2010), Detrol (Pfizer
January 2012) and Actos (Abbott January 2011).
The patent challenge pipeline of Dr Reddy's comprises
of Zofran (GSK December 2006), Zyprexa (Eli Lilly April
2011), Lamisil (Novartis July 2004), Avandia (GSK august
2008), Actos (Abbott January 2011), Aciphex (Eisai Inc
September 2008), Avelox (Bayer June 2009), Tequin (BMS
December 2007), Zoloft (Pfizer June 2006) and Risperdal
(J&J December 2007).
According to the CLSA report on Asia-Pacific markets 2004
was not a good year in litigation for generic companies.
Of the 11 key patent litigation during the year 2004 there
were nine unfavourable and two favourable decisions, say
six losses, three reversals (vacated) and two wins.
Dr Reddy's lost two cases, one is on Lamisil against Novartis
and the other Norvasc against Pfizer. Teva lost two cases
as well, viz; Zofran (GSK) and Accupril (Pfizer). The
two other patent losses this year were Milan Vs J&J
on Duragesic and Impax Vs Aventis on Rilutek.
The reversals against generic companies include Teva Vs
Abbott for Vicoprofen, Teva Vs Schwarz for Univasc and
Andrx Vs Elan for Naproxen.
Apotex has won in the patent challenge against GSK on
Paxil and Teva/Endo received favourable decision on Oxycontin
by Purdue. There were other minor setbacks like fluconazole
and cefpodoxime proxteil for Ranbaxy but these were expected
to go against generics, said the CLSA report.
An FTC study in 2002 had shown that generics win about
three in four patent challenges in the lower court. "Since
it is difficult to take a call on individual patents challenges,
this high probability factor has been used as a comfort
factor to apply a portfolio approach to patent challenge
pipelines," points out the report. A look at the
data shows that the probability factor has worsened in
2004 to two in eleven.
Patent challenges have been an integral part of the generic
business models and CLSA estimates that there would be
more than 100 patent challenges currently where in 50
comes from Indian pharmaceutical players.
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