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US Supreme Court backs Teva in Copaxone patent case

Published on 28/01/15 at 05:02pm
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Teva has won a US Supreme Court judgement allowing it to continue marketing its multiple sclerosis drug Copaxone without challenge from rival company’s generics.

The decision means Teva has had its patent case against manufacturers of generic Copaxone (glatiramer acetate) sent back to the US Court of Appeals for the Federal Circuit for reconsideration.

The appeals court had ruled in 2013 that five of Teva’s patents relating to Copaxone were invalid. But Teva argued successfully that when making the decision, the US Court of Appeals for the Federal Circuit should not have second-guessed factual findings made by a federal district court ruling, which had previously sided with Teva.

The judges ruled 7-2 that the federal appeals court had wrongly overturned the patents for Copaxone.

The court documents state: “After considering conflict­ing expert evidence, the District Court concluded that the patent claim was sufficiently definite and the patent was thus valid.”

The latest decision means that - for the meantime - Teva can continue to benefit from patent protection for Copaxone without the threat of being undercut by cheaper generic versions of its top-selling MS drug. The patent is set to expire in September.

Two companies are working on generic forms of Copaxone: Novartis’ generic arm Sandoz is partnering with Momenta Pharmaceuticals, while Mylan and Natco Pharma are working on another.

There will eventually be a generic version of Copaxone but Teva looks to have staved off the end of the patent for now. Having gained a temporary reprieve, the firm is now switching MS patients to a new version of Copaxone that is stronger, taken less frequently and – more importantly for the Israeli company’s profits – has a longer patent.

Copaxone generates around $4 billion in annual sales for Teva, and in a statement Erez Vigodman, president and chief executive of Teva naturally says that the company is encouraged by the ruling.

“We will continue to explore all available avenues to protect our intellectual property for Copaxone,” before adding that the drug “will remain a proprietary, global market leading product for the reduction in the frequency of relapses in patients with relapsing forms of MS over the product’s lifecycle”.

Robert Brunelli, an attorney at innovation law firm Sheridan Ross, says the case Supreme Court’s ruling in the Teva case could increase the cost and further complicate patent cases for pharma companies in the US.

He adds: “The Teva decision more clearly than ever before shows that Federal District Courts will be given significant discretion in deciding disputed facts upon which the purely legal issues of patent law are based. 

"Accordingly, I expect litigants will in the future spend more time and resources researching all factual issues that may be relevant to a legal patent issue and then seek to present to the reviewing Court those factual points believed to advance their cause. 

“The practical result of this shift in judicial philosophy is that fewer cases will settle early, with parties opting to wait until after a District Court has resolved relevant factual disputes before considering negotiated resolutions. This in turn means that litigants will need to expend more resources earlier in a case to first develop and then present factual issues to the involved Court.”

Lilian Anekwe

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