2nd UPDATE: US Patent Office Orders Re-Exam Of Plavix Patent
August 18 2009 - 3:51PM
Dow Jones News
The U.S. Patent and Trademark Office has ordered a
re-examination of the patent for the blockbuster anti-clotting drug
Plavix, citing new questions about the drug's patentability.
A lawyer for Canadian generics manufacturer Apotex Inc. had
requested the re-exam in June, saying that certain drug research
conducted prior to the Plavix patent's 1989 issuance should render
the patent invalid.
Sanofi-Aventis SA (SNY) of Paris and New York-based
Bristol-Myers Squibb Co. (BMY) co-market Plavix, which last year
had about $8.6 billion in global sales, ranking it as the second
best-selling prescription drug in the world behind Pfizer Inc.'s
(PFE) Lipitor cholesterol pills. Sanofi, which discovered the drug,
owns the patent.
Spokespeople for Bristol-Myers and Sanofi-Aventis said the
patent is valid and enforceable. A Sanofi spokesman said a court
injunction barring generic Plavix remains in effect, and Sanofi
will respond to the patent office re-exam "in due course."
An Apotex spokesman declined comment.
It's the latest attempt by Apotex to overturn the Plavix patent
to clear the way for it to sell cheaper generic copies of the drug
before the patent expires in 2011 (market exclusivity is scheduled
to last into 2012 due to an extension for having studied the drug
in children).
Previous attempts by Apotex to overturn the Plavix patent in
federal court have been unsuccessful. In December, the U.S. Court
of Appeals for the Federal Circuit upheld a lower court's ruling
that the patent is valid and enforceable. Apotex has appealed to
the U.S. Supreme Court.
In its request for a re-exam, Apotex said claims in the U.S.
Plavix patent should be reconsidered because so-called "prior art"
anticipated the claims, including information in Sanofi's
application for a Canadian drug patent. This prior art would have
taught anyone skilled in the art of drug development how to invent
Plavix, Apotex claims.
The patent office mailed its decision to re-examine the Plavix
patent to Sanofi on Monday, according to the patent office's
Website.
Historically, the patent office has granted most requests for
patent re-exams, but a minority of such exams result in the
cancellation of all of a patent's claims. The re-exam process can
take up to two years. Recently, the patent office also ordered the
re-exam of the U.S. patent for Merck & Co.'s (MRK) blockbuster
allergy and asthma drug Singulair.
Apotex briefly sold generic Plavix in the U.S. in 2006, flooding
the market with enough pills to hurt sales of branded Plavix for
months, but was ordered to stop by the U.S. judge overseeing the
patent dispute. A proposed settlement of the patent litigation in
2006 had fallen apart, and eventually led to U.S. criminal charges
against Bristol and a former executive due to a side deal in the
proposed settlement. The fiasco led to the ouster of Peter Dolan as
Bristol's chief executive in 2006.
Bristol shares rose 10 cents to $21.77; Sanofi's American
depositary shares fell 2 cents to $31.70.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com