Supreme Court to hear Teva appeal

Posted: April 02, 2014

The U.S. Supreme Court on Monday helped Teva Pharmaceutical Industries Ltd. by saying it would review an appeals court decision on the company's top-selling drug. The move could delay introduction of generic competitors to Teva's Copaxone and might eventually change patent litigation in other industries.

"This could potentially be a huge decision," Rutgers-Camden law professor Michael Carrier wrote Monday via e-mail. Carrier, who focuses on antitrust and patent law, wrote a friend-of-the-court brief in a 2013 Supreme Court case that reshaped how brand-name drug companies and their generic competitors must operate when they negotiate with each other over patents.

Teva is based in Israel but has several facilities in the Philadelphia suburbs, including its Americas headquarters in North Wales.

Teva built its business on selling generic versions of medicines whose patents have expired. When patents expire, original manufacturers face competition in the market, and prices usually drop. But in recent years, Teva has relied more on profit from some of its own patent-protected drugs. Copaxone, a multiple sclerosis drug, had $4.3 billion in sales in 2013 and accounts for more than 40 percent of Teva's profits.

While some of Copaxone's patents expire in May, one had not been set to expire until September 2015. But generic competitors, including the Novartis subsidiary Sandoz and Pittsburgh-based Mylan, won a decision in the U.S. Court of Appeals for the Federal Circuit, which ruled the 2015 patent invalid.

With Monday's development, a company that begins selling a generic Copaxone in May might eventually have to pay Teva for lost sales if the Supreme Court rules in Teva's favor. Such a decision might not come until June 2015.

The current justices have taken greater interest in patent laws, and Teva's appeal could have impact beyond its industry.

The Federal Circuit handles appeals cases focused on patents. Unlike other federal appeals courts, which decide mainly whether a district judge made a clear error, the Federal Circuit often ignores lower court rulings and reviews factual issues from scratch. Teva won its case on the 2015 patent in District Court, and asked the Supreme Court to require the Federal Circuit to be more deferential to the lower court judge's ruling, as occurs with most other appeals.

"If the bar were raised," Carrier wrote, patent appeals would "fall dramatically," because of greater certainty that the lower court decision would stand. A spokeswoman said Novartis continues to "believe the U.S. Federal Circuit Court of Appeals correctly invalidated several patents asserted by Teva. . . . We look forward to marketing an affordable, high-quality generic version of Copaxone at the earliest possible opportunity."


dsell@phillynews.com

215-854-4506 @phillypharma

www.inquirer.com/phillypharma

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