US Supreme Court agrees to hear Copaxone appeal

The US Supreme Court has agreed to hear Teva’s appeal against a Federal Circuit decision that invalidated a patent covering its $4.3 billion-a-year Copaxone (glatiramer acetate) drug, allowing Sandoz, Mylan and Natco to produce generic versions.

The development comes just in time for Teva as the Federal Circuit’s July ruling would have allowed the generic drug makers to enter the market with their own versions of relapsing-remitting multiple sclerosis (RRMS) injection Copaxone next month, after the remaining patents covering the drug expire.

The Federal Circuit’s ruling, which reversed a district court decision, invalidated Teva’s US patent 5,800,808, which covers a process for manufacturing Copaxone’s active ingredient.

The ‘808 patent expires in September 2015.

The court will determine: “Whether a district court’s factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Federal Rule of Civil Procedure 52(a) requires.”

Teva said it was pleased that the court agreed to hear the appeal and that it “remains committed to pursuing all options to protect its IP for Copaxone.”

Mylan and Natco said in individual statements that they continue to believe the ‘808 patent is invalid for indefiniteness.

In January, Teva launched a new three times weekly formulation of Copaxone to extend the product’s lifecycle.