Breyer turns down generic firms’ plea
on Jan 27, 2015 at 12:01 pm
Supreme Court Justice Stephen G. Breyer on Tuesday refused to order a quick release of the Court’s new ruling in the Copaxone drug patent case, but he left open the option for the generic companies to ask another Justice to take the step. Breyer did not issue an opinion as he denied prompt implementation of the ruling last week in Teva Pharmaceuticals USA v. Sandoz. (An earlier post on this dispute is here.)
In turning down the request to cut short the usual twenty-five-day period for formal implementation of a decision, Justice Breyer did so “without prejudice.” Under the Court’s Rule 22, when that is the form of a denial of an application to an individual member of the Court, a new application may be submitted to a different Justice. That left it up to the generic companies to try again. If they do, it is up to them to choose the Justice to whom they want to submit the renewed application.
The generic companies are hoping to get permission soon from the Food and Drug Administration to put their own version of Copaxone, a very profitable drug used mainly to treat multiple sclerosis patients, on the market. Teva’s current patent on that brand-name drug is due to expire on September 1.
The Teva case is due to return to the U.S. Court of Appeals for the Federal Circuit, to take another look at the validity of Teva’s remaining patent. Earlier, the Federal Circuit found the patent invalid, but the Supreme Court overturned that result last week, without deciding whether the patent is or is not valid. It ordered the Federal Circuit to reconsider, using a different review standard.
The generics want the normal time period for releasing a new ruling shortened so that the new proceedings at the Federal Circuit can proceed promptly. Teva wants to be able to ensure that its patent monopoly remains intact while those proceedings continue. It has said it will be asking a federal trial judge in New York City to ensure that that happens.
