UPDATE Tuesday 10:22 a.m.  Chief Justice John G. Roberts, Jr., has told the generic companies to file a response to Teva’s application by 5 p.m. next Monday.   No action is expected until that document is filed, but then could come at any time.

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Faced with the prospect in about six weeks of competition from lower-cost versions of its highly valuable drug Copaxone, Teva Pharmaceuticals USA, Inc., asked the Supreme Court on Monday to put back into effect a federal judge’s order blocking the generic alternatives.  The application (13A1003) came in a case that the Court has granted (13-854) for decision at its next Term.

Copaxone, which produced more than $4 billion in revenue for Teva in a recent year, is used to treat relapses in patients with multiple sclerosis.  Some of Teva’s patents on the drug are due to expire on May 24, and another is to extend until September of next year.

The U.S. Court of Appeals for the Federal Circuit — the specialized federal appellate tribunal for patent cases — nullified what Teva calls its “key patent” on Copaxone, and that court has already put its decision into effect.  Chief Justice John G. Roberts, Jr., refused in November to postpone that decision.

However, those developments came before the Supreme Court a week ago granted Teva’s plea to overturn the Federal Circuit decision, on the theory that the appeals court had wrongly chosen to make its own judgment about the facts in the case, rather than deferring to the federal district court judge who had upheld Teva’s patents against a challenge by generic manufacturers.  The Court is to review the Teva case at its next Term, starting in October.

The plea to block the Federal Circuit’s decision was filed by Teva with the Chief Justice, who serves as the Circuit Justice for that appeals court.  The Chief Justice has the authority to act on the application on his own, or share it with his colleagues.

With its first patents due to expire on May 24, Teva said in its new plea, its would-be generic competitor companies “have publicly declared their intent to launch generic versions of Teva’s product — which indisputably would infringe the ‘808 patent — as soon as the other patents expire in May.” (The ‘808 patent is the one that Teva calls its “key” patent, and it is the one due to expire in September 2015.)

The application added:  “Such a launch would result in irreparable injury to Teva, including irreversible price erosion, changes to the reimbursement rates insurers would pay for Copaxone, and consequent reductions in support and education for Copaxone.”

Presumably, the generics will have a chance to reply to the application before the Chief Justice or the full Court acts on it.  If Teva’s request is granted, the Federal Circuit ruling presumably would be put on hold until the Supreme Court decides whether to uphold or overturn it, sometime next year.

Posted in Teva Pharmaceuticals USA v. Sandoz, Featured, Merits Cases

Recommended Citation: Lyle Denniston, Teva seeks to head off generic rivals (UPDATED), SCOTUSblog (Apr. 8, 2014, 10:29 AM), http://www.scotusblog.com/2014/04/teva-seeks-to-head-off-generic-rivals/