US Supreme Court split on Teva case

The US Supreme Court was split yesterday (October 15) after hearing arguments in a high-profile case that will determine whether generic drug companies are free to market a cheaper version of Teva’s blockbuster multiple sclerosis drug.

Teva is fighting against Sandoz, Mylan, Momenta Pharmaceuticals and Natco Pharma to try to stop them from launching a generic version of its drug Copaxone (glatiramer acetate).

The Supreme Court agreed to hear the case after the US Court of Appeals for the Federal Circuit overturned a district court’s decision that ruled in favour of Teva, meaning it lost patent protection for the drug.

According to Reuters, the Supreme Court’s nine justices appeared unsure about to what extent the federal circuit, which hears all patent appeals, should have leeway to second-guess findings made by a district court judge.

While some justices said the current system of offering leeway to appeals courts should not be altered, others were concerned about the growing power of appeals courts and said that district court decisions should be respected, the news agency noted.

The dispute centres on Teva’s US patent 5,800,808, which covers a process for manufacturing Copaxone’s active ingredient, glatiramer acetate. The patent was due to expire in September 2015.

At $4 billion-a-year, Copaxone accounts for half of Teva’s profits.

The Supreme Court, which agreed to hear Teva’s appeal in May this year, declined to stay the appeal court’s ruling pending a further appeal, meaning Copaxone currently has no patent protection and the generic companies could be free to market their own cheaper versions.

Mylan has said it plans to launch a generic version of the drug as soon as it has government approval. Sandoz and Momenta declined to comment on when they expect their products to be available.

A ruling is due by the end of June next year.