Supreme Court Sides With Teva in Patent Case on Copaxone -- 2nd Update

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 [e-mail] and Ashby Jones at [e-mail]

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