US court rules Teva patent invalid

A US court has ruled that an Israeli company’s patent for a multiple sclerosis (MS) drug is invalid, paving the way for rivals to market a generic version.

In a ruling at the US Court of Appeals for the Federal Circuit on Friday, July 26, Teva Pharmaceuticals was told one of its patents protecting the Copaxone drug was invalid. The patent in question was due to expire in 2015; other patents at issue were upheld by the court, but these expire in 2014.

Copaxone, which is linked to MS treatment, has been the source of litigation between Teva and generic companies that have been keen to produce their own cheaper versions of the drug. 

Swiss-based Novartis AG, US companies Momenta Pharmaceuticals and Mylan, and Natco Pharma from India, have all previously indicated interest in selling generic versions of Copaxone.

Legal proceedings started when Novartis and Mylan informed the US Food and Drug Administration (FDA) of their intentions to bring out a generic version.

Teva successfully blocked the move at the US District Court for the Southern District of New York last year.

However, the ruling was appealed, leading the Court of Appeal to overrule the district court.

The decision means a generic version could be produced next spring.

Jeremy Oczek, partner at Bond, Schoeneck & King Attorneys in New York, said he was not surprised by the decision to overturn the ruling.

“The Federal Circuit reviewed the definiteness as a de novo – meaning brand new – issue, as opposed to some of the other issues on appeal, such as infringement and obviousness, which it reviewed for error. Therefore, it’s not surprising the court came to a different conclusion on the definiteness issue,” Oczek said.

“The ruling on the asserted patent claims was based on several issues including the method for calculating molecular weight, of which there are at least three different ways to calculate. However, the court found that the claims on the patent were ‘indefinite’ as to how that would be done and ruled those claims invalid,” he added.

Teva said it was “disappointed” by the decision and highlighted concerns about proposed generic versions.

“Given the complexity of Copaxone, Teva believes unpredictable differences between a proposed generic product and Copaxone could lead to immunogenic effects in patients,” it said in a statement.

Teva added it would be considering an appeal to the Supreme Court.

However, Oczek indicated this would be tricky path to take.

“Teva is entitled to appeal, but I think it would be tough. Around 10,000 cases get petitioned to the Supreme Court each year, but it only hears around 75 to 80,” he said.

“Furthermore, this case involved a fact-specific issue – namely, the meaning of ‘molecular weight’ – and the Supreme Court is usually reluctant to hear cases involving fact issues. The court seems to be primarily concerned with cases where there is split in the law."

Heather Bresch, chief executive of Mylan, said in a statement that it was “very pleased” with the ruling and that the company planned to launch its generic version of Copaxone on May 25, 2014.