By Brent Kendall And Ashby Jones
The U.S. Supreme Court on Tuesday reversed an appeals court
ruling that invalidated a Teva Pharmaceutical Industries Ltd.
patent on the blockbuster multiple-sclerosis drug Copaxone, giving
the drug maker a new opportunity to forestall generic
competition.
The ruling breathes new life into Teva's efforts to keep generic
competitors from entering the Copaxone market until the September
patent expiration.
It also serves as yet another rebuke by the Supreme Court to the
Federal Circuit, a specialized court that hears the vast majority
of the nation's patent appeals.
In recent years, as patents have played an increasingly
prominent role in the U.S. economy, the Supreme Court has taken up
an unprecedented number of patent appeals, and reversed many of the
Federal Circuit's rulings. In the term that ended last year, for
instance, the Supreme Court heard six appeals of Federal Circuit
decisions, the most ever, and reversed five of them.
The court, in a 7-2 opinion by Justice Stephen Breyer, said on
Tuesday that the Federal Circuit must be more deferential in
reviewing factual determinations made by trial judges who preside
over patent infringement litigation.
In the Copaxone dispute, a New York trial judge in 2011 upheld
the validity of a Teva patent on the drug that didn't expire until
September 2015. The judge barred generic-drug challengers including
Novartis AG's Sandoz unit and Mylan Inc. from entering the market
until the patent expired. The U.S. Court of Appeals for the Federal
Circuit reversed that ruling in 2013 and found the patent
invalid.
The Supreme Court sent the case back to the lower courts for
more proceedings.
"We are encouraged by the U.S. Supreme Court's decision and look
forward to the Federal Circuit's review," said Erez Vigodman,
president and chief executive of Teva, in a statement. Teva has
been trying to migrate patients to a higher-dose Copaxone that is
covered by patents that don't expire until 2030.
Representatives for Novartis and Mylan didn't immediately
respond to requests for comment.
Justices Clarence Thomas and Samuel Alito dissented in Tuesday's
decision.
Write to Brent Kendall at brent.kendall@wsj.com and Ashby Jones
at ashby.jones@wsj.com
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