27 January 2015Americas

Generics urge US Supreme Court to implement Copaxone ruling

Generic drug makers Sandoz, Mylan and Natco have asked the US Supreme Court to immediately put into effect its ruling on the validity of a patent covering Teva’s multi-billion dollar multiple sclerosis drug Copaxone.

Last Tuesday (January 20) the top court ruled that the US Court of Appeals for the Federal Circuit had incorrectly invalidated the patent, vacating its decision and remanding the case for further review.

The case centred on claim construction for US patent number 5,800,808.

In their reply brief filed yesterday (January 26), the generic companies, which are all seeking to market versions of the blockbuster drug after the patent expires in September this year, asked the Supreme Court to immediately put into effect its decision so the Federal Circuit can make a ruling on whether the patent is invalid.

They asked that the top court does not wait the usual 25 days to put its decisions into effect, and said that a delay is “materially significant given the short life remaining in th[e] patent.”

They added: “The Federal Circuit needs to begin remand proceedings immediately so that the remand does not effectively moot the merits of this case.”

Teva had already asked a federal trial judge to put back into effect a formal court order that blocks generic drug companies from putting their versions on the market before the ‘808 patent has expired.

The company argued that the Supreme Court justices should not implement their order until after the federal judge has restored the marketing injunction, because otherwise the federal judge would lose jurisdiction. The generic companies would not be harmed because they still do not have approval to market their Copaxone versions, Teva said.

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