Mylan wins round in fight with Teva over multiple sclerosis drug

WASHINGTON (Reuters) - Pharmaceutical company Mylan NV has won a round in its fight with Teva Pharmaceutical Industries Ltd at the U.S. Patent and Trademark Office, which said on Wednesday that two patents for the multiple sclerosis drug Copaxone sold by Teva were, after a review process, considered unpatentable.

A decision on a third patent for Copaxone is due by Sept. 1. Teva sells Copaxone based on patents licensed from Yeda Research & Development Co Ltd.

Teva spokeswoman Denise Bradley said that the company would appeal the decision. An appeal would go to the U.S. Court of Appeals for the Federal Circuit.

The patents, which expire in 2030, cover a 40-milligram injection of Copaxone that patients administer three times a week.

Mylan has filed with the U.S. Food and Drug Administration to bring out a version of the 40 mg drug. It said that IMS Health, a healthcare information company, estimates sales of the drug to be $3.3 billion annually.

Teva has maintained its dominance in the market by switching patients over to the 40 mg version from its original, 20 mg daily dosage, which began facing generic competition last year.

Mylan petitioned the patent office to review the Copaxone patents’ validity last year. Mylan told the agency that a less-frequently administered drug was obvious and not deserving of legal protection. “(R)educing the number of injections is simply common sense,” the company said in its petition.

Mylan Chief Executive Officer Heather Bresch said the decision was “comprehensive, well-reasoned, and highly persuasive in detailing the bases for the invalidity of Teva’s 40 mg patents.”

The patent office litigation comes as a lawsuit against several generic manufacturers over Copaxone is set to begin in federal court in Delaware next month.