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 certain 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.
Tuesday's decision helped Teva's American depositary shares,
which rose 1.2% during trading on the New York Stock Exchange.
Copaxone, an injection for multiple sclerosis, is the company's
most profitable and top-selling product, according to analysts.
During the first nine months of last year, Copaxone notched $3.1
billion of Teva's $15.1 billion revenue.
"We are encouraged by the U.S. Supreme Court's decision and look
forward to the Federal Circuit's review," Teva Chief Executive Erez
Vigodman said in a statement. He said Teva would keep exploring
"all available avenues to protect" Copaxone from knock-offs.
The version of Copaxone at issue is sold in 20 milligrams per
milliliter. Last year, Teva launched a Copaxone at double the dose,
which can be taken less frequently. Teva has been trying to migrate
patients to the higher-dose version, which is covered by patents
that don't expire until 2030.
"We continue to believe that [Teva's] patent is invalid...and we
will address that issue with the Federal Circuit Court of Appeals,"
said Mylan Chief Executive Heather Bresch in a statement. A
spokeswoman for Novartis declined to comment.
The Supreme Court sent the case back to the lower courts for
more proceedings.
Jonathan D. Rockoff contributed to this article.
Write to Brent Kendall at brent.kendall@wsj.com and Ashby Jones
at ashby.jones@wsj.com
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