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23 February 2015Americas

Pharma companies ask Federal Circuit for validity ruling on Copaxone patent

Pharmaceutical companies Teva, Momenta, Mylan and Sandoz have asked the US Court of Appeals for the Federal Circuit for an expedited ruling on the validity of Teva’s patent covering its Copaxone (glatiramer acetate) drug.

The patent, US number 5,800,808, is the last of nine US patents covering Teva’s blockbuster multiple sclerosis drug.

Teva originally filed cases against generic drug makers Sandoz, Momenta and Mylan at the US District Court for the Southern District of New York to stop them launching generic versions of the $4 billion-a-year drug.

After the district court upheld the patent in July 2013, the generic companies appealed against the decision to the Federal Circuit.

Upon reviewing the patent claim construct de novo, the Federal Circuit invalidated the ‘808 patent because one of the claims was ambiguous.

Last month, the US Supreme Court threw out that judgment, finding that the court had reviewed the construction of the patent’s claims improperly.

The Supreme Court later remanded the case for further review and the Federal Circuit received the case last Thursday (February 19).

In their filing a day later, the four companies added that they needed to be able to address the effects of the Supreme Court’s ruling on their case.

Teva confirmed the filing but declined to comment further. Momenta and Sandoz said that they do not comment on pending litigation. Mylan did not respond to LSIPR’s request for comment.

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