US Patent Office Orders Re-Examination Of Plavix Patent
August 18 2009 - 10:41AM
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 and Apotex declined immediate comment,
and a Sanofi spokesman couldn't immediately be reached.
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; Apotex has appealed its most
recent loss to the U.S. Supreme Court.
Historically, the patent office has granted most requests for
patent re-exams, but a minority of such exams result in all of a
patent's claims being canceled. 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 fell 4 cents to $21.63; Sanofi's American
depositary shares fell 3 cents to $31.69.
-Peter Loftus; Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com