US Supreme Court upholds Copaxone patent


The ruling means Teva's flagship multiple sclerosis treatment's patent remains valid until September 2015.

The US Supreme Court has ruled in favor of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) patent claim on multiple sclerosis treatment Copaxone. The Supreme Court decided by 7 judges to 2 to reverse the Federal Circuit Courts judgment of invalidity of Tevas 808 patent for Copaxone. The Supreme Court remanded the case to the Federal Circuit for further review "in light of the applicable standard the Supreme Court laid out for appellate review of claim construction."

The meaning of the decision is a delay in generic Copaxone coming onto the market and that the company's flagship drug will have patent protection until at least September 2015. Investors have been watching the case closely because Copaxone has annual sales of $4 billion, and some sources suggest it contributes as much as 60% of the drug-maker's profits. Teva has said in the past that every month's delay in generic competition for Copaxone is worth $78 million net profit to the company or $0.08 per share.

Teva president and CEO Erez Vigodman said, We are encouraged by the US Supreme Courts decision and look forward to the Federal Circuits review. We will continue to explore all available avenues to protect our intellectual property for Copaxone 20mg/mL. Copaxone 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 products lifecycle.

The US Supreme Court heard oral arguments in Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. on October 15, 2014 to determine if claim construction rulings in patent cases are entitled to deference when the district court makes factual findings in the process.

A ruling last year by the US Court of Appeals for the Federal Circuit upheld four Teva patents that expired in May 2014, while invalidating another patent (the 808 patent) that is set to expire on September 1, 2015. Prior to the appellate courts decision, in July 2012 the US District Court for the Southern District of New York ruled in favor of Teva and upheld the 808 patent for Copaxone 20 mg/mL.

Teva president and CEO global specialty medicines Rob Koremans said, There is currently no FDA-approved follow-on version of Tevas Copaxone. We are encouraged by the FDAs willingness to date to have dialogue regarding the complexities of Copaxone 20 mg/mL and the potential limitations and other unknowns of purported follow-on versions.

Teva launched a less frequent dosing formulation, 40 mg/mL three-times-a-week, in the US in Jan 2014. This version has a patent until 2030.

The firm of Eitan, Mehulal & Sadot comments: "The United States Supreme Court decision in the Teva v Sandoz case has vindicated Tevas persistence and its enormous efforts and investment in protecting its Copaxone patent in United States courts, in order to prevent generic competitors from entering the market before the patent is due to expire in September 2015.

"A large majority of the judges determined that the Federal Circuit Court of Appeals is not entitled to second guess District Courts claim interpretations in patent cases.

"The case has been returned to the Court of Appeals to decide the validity of Tevas Copaxone patent, this time giving due weight to the District Court determination in Tevas favour, that the meaning of specific wording in the patent that Sandoz challenged as indeterminate is clear."

Pearl Cohen Zedek Latzer Baratz senior partner and chair of the Life Science Group Mark Cohen said, "Teva Pharm USA v Sandoz is an important case as it sets a new standard and impacts litigation strategy on appeals to the Federal Circuit. Specifically, the Supreme Court held that if you lose at the district court level, you will not get a second shot at claim construction at the Federal Circuit unless there is clear error. This means it will be harder to overturn a case if you are on the losing end at the district court level on claim construction."

Published by Globes [online], Israel business news - - on January 20, 2015

Copyright of Globes Publisher Itonut (1983) Ltd. 2015

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