Supreme Court Denies Sanofi Appeal In Lovenox Patent Case
27 Avril 2009 - 4:37PM
Dow Jones News
The Supreme Court on Monday declined to hear an appeal by
Sanofi-Aventis SA (SNY), ending the company's six-year effort to
protect a patent on its $3 billion-a-year blood thinner.
Sanofi wanted the court to declare that the patent for Lovenox
was still intact despite lower court rulings saying a company
scientist intentionally mislead the U.S. Patent Office about the
drug. Sanofi has reason to fight hard to protect the patent as
Lovenox, a version of heparin, brought the company more than $3.5
billion in sales last year.
Sanofi competitors vying to take a piece of Lovenox's market
will likely welcome the court's refusal but the decision doesn't
guarantee that generic versions of the blood thinner will reach
consumers soon as the Food and Drug Administration hasn't approved
any. Amphastar Pharmaceuticals Inc., Teva Pharmaceutical Industries
Ltd. (TEVA), Hospira Inc. (HSP), Momenta Pharmaceuticals Inc.
(MNTA) and a Novartis AG (NVS) unit are seeking FDA approval for
generic Lovenox. Momenta and Novartis' Sandoz unit are
partnering.
The court's refusal also dashes hopes that it will clarify a
controversial area of patent law called inequitable conduct. Under
inequitable conduct, a company's patent becomes unenforceable if a
court finds that a company intentionally withheld important
information from the U.S. Patent Office.
The Supreme Court for years stayed away from taking patent
cases. But in recent years as patent reform legislation has stalled
in Congress, the court has taken cases to overrule what it sees as
poor precedents in patent law.
In the case of Sanofi, a federal appeals court last year found a
company scientist intentionally withheld evidence from the Patent
Office to support extending Lovenox's patent. Sanofi says federal
courts have been too liberal in finding inequitable misconduct,
applying it in cases where people made serious mistakes, not
calculated schemes to defraud.
Weakening or ending the use of inequitable conduct as grounds
for challenging drug patents has become a sticking point in pending
congressional legislation to overhaul patent law. The Senate's
Patent Reform Act is the focus of an expensive lobbying campaign by
the brand-name pharmaceutical industry and biotechnology groups,
who want to limit generic drug companies' ability to make cheaper
versions of medicines.
California-based Amphastar Pharmaceuticals, which specializes in
generic drugs, was the first company to file for a generic version
of Lovenox. The first company to file for a generic version of a
drug gets 180-days of marketing exclusivity, where it can gobble up
market share before competitors can sell their products.
Amphastar's exclusivity period came and went before the FDA
approved the company's generic version of Lovenox, meaning it's
unclear which company will first get its product to patients first.
The companies expect a decision from the FDA this year. The FDA
doesn't comment on whether and when it will approve products.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com