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The Latest in Copaxone Patent Appeal: Supreme Court Denies Stay

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By Gabriella Khorasanee, JD on April 22, 2014 3:57 PM

Less than a month ago the Supreme Court granted cert in Teva v. Sandoz, a case where the Court must determine the proper standard of review when reviewing a patent inventor's claim. While most other federal appeals courts review a trial court's conclusions to see if they are "clearly erroneous," the Federal Circuit has had a practice of reviewing an inventor's claims using de novo review, reports SCOTUSblog.

The Court is no longer accepting cases for this term, so Teva is on the October 2014 docket. Because there are patents at issue that may expire before the Court decides the case, there is uncertainty as to what the companies should do, and they are seeking guidance from the Court.

The Federal Circuit Decision

Under the Federal Circuit's ruling generic manufacturers could start selling generics this May, however a decision in Teva's favor would keep the patents alive until September 2015. Annual U.S. sales of Copaxone make up more than half of Teva's profit, and reach over $3 billion annually, so there is much at stake for both Teva, and generic manufacturers, reports Blooomberg.

Teva Asks For Stay, Respondents Ask for Bond

On April 4, 2014, Teva filed an application to recall and stay the mandate of the Federal Circuit's decision, effectually preventing a generic from entering the market until a decision is handed down. In response, the generic drug manufacturers asked to be permitted to start selling the generic version of Copaxone in May, 2014, or if not, then for Teva to be required to post a bond to compensate them for the loss of a delayed launch in the event the Court ruled in their favor, reports SCOTUSblog.

To Bond, or Not to Bond?

Last Thursday, Teva filed its response stating that no bond was required, but noted, "If a bond is ordered, Teva is prepared to post a bond of up to $500 million at the earliest practicable time, but in no event later than May 24, 2014." Teva added that the $500 million proposed "bond would fully protect both respondents for many months of sales even under their most wildly optimistic projections."

Chief Justice John Roberts "has the authority to act on his own, or share the issue with his colleagues," reports SCOTUSblog. On Friday, Justice Roberts did just that. He issued a one-page opinion denying Teva's request for a stay , effectively opening the doors for the generic manufacturers to get generic versions of Copaxone to market, pending government approval, reports Reuters.

Though the Chief Justice found that Teva "has shown a fair prospect of success on the merits," the company did not satisfy the element of showing a "likelihood of irreparable harm from denial of a stay." Because, as respondents argued in their brief, Teva, if successful, could sue for damages for recovery of past patent infringement, the Chief Justice stated that "the extraordinary relief that Teva seeks is unwarranted."

Under Court rules, Teva could ask another Justice for a stay, but "such requests are rarely granted," says Reuters, and SCOTUSblog notes that "getting a favorable result from that maneuver is not a strong prospect."

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