When the U.S. Supreme Court agreed late last month to hear arguments in Teva Pharmaceuticals USA v. Sandoz Inc., commentators focused on how the case could usher in a new era of deference to trial judges in patent cases. That may be true, but Teva reminded the high court on Monday that its bottom line is at stake in the case as well.
In a 20-page motion, Teva’s lawyers asked the high court to put on ice a decision by the U.S. Court of Appeals for the Federal Circuit that permitted generic drug companies to sell low-cost versions of Teva’s drug Copaxone as early as May 24, more than a year before Teva says they should be able to. “This court’s intervention is needed before that date, to ensure that its decision on the merits next term will not come effectively too late to prevent irreparable harm to Teva,” wrote the company’s lawyers at Goodwin Procter, Kirkland & Ellis and other firms.
Teva derives about $4 billion in revenue per year from Copaxone, which is used to treat multiple sclerosis. Many of Teva’s patents on the drug expire in May 2014, but it also holds a key patent that doesn’t expire until September 2015. Generic drug companies including Sandoz and Mylan Pharmaceuticals Inc. kicked off the litigation in hopes of invalidating those patents.
U.S. District Judge Barbara Jones in Manhattan upheld all of Teva’s patents in June 2012, handing a big win to Teva’s lead trial counsel, Elizabeth Holland of Kenyon & Kenyon. Jones also issued an injunction barring Sandoz and Mylan from selling generic versions of Copaxone before September 2015, when the last of Teva’s patents on Copaxone expires.
For the Federal Circuit oral argument, Holland squared off against Deanne Maynard of Morrison & Foerster and Evan Chesler of Cravath, Swaine & Moore, who represented Sandoz and Mylan, respectively. In a July 2013 ruling, the appeals court partially reversed Jones and invalidated the patent that expires in September 2015, shaving 15 months off of Teva’s period of market exclusivity and sending the company’s stock price into a slump. The Federal Circuit also vacated Jones’s injunction, setting the stage for generic Copaxone to hit pharmacies as early as next month.
In its bid to convince the high court to take the case, Teva’s lawyers argued that the Federal Circuit should have showed deference to Jones’ interpretation of Teva’s patent claims. The standard of review for claim construction rulings has long been a hot-button issue in patent law circles, as a recent Federal Circuit case known as Lighting Ballast highlighted. The Supreme Court, which apparently can’t get enough patent law these days, granted cert on March 31. Several attorneys are listed on Teva’s cert petition, including William Jay of Goodwin Procter, Jay Lefkowitz of Kirkland & Ellis and famed law professor Alan Dershowitz.
Teva pleaded in Monday’s filing for the Supreme Court to restore the injunction blocking generic Copaxone before it’s too late. “The Federal Circuit’s insistence on putting its mandate into effect and prematurely lifting the district court’s injunction is threatening irreparable injury to Teva,” the company wrote. “It would allow respondents to launch infringing products and irreversibly reshape the relevant market before this court can review the Federal Circuit’s decision on the merits.”