Federal court issues rulings in favor of Teva in MS drug case

Case to go to trial Sept. 7

JERUSALEM — A federal court has acted in favor of Teva Pharmaceutical Industries in the drug maker's patent infringement case against several generic drug companies seeking to market versions of its multiple sclerosis drug.

Teva said the U.S. District Court for the Southern District of New York issued a set of claim construction rulings in its patent infringement case against Sandoz and Momenta Pharmaceuticals, and Mylan and Natco regarding the drug Copaxone (glatiramer acetate) that favored Teva; the two parties are each seeking to market generic versions of the drug. A claim construction decision is when a U.S. District Court examines evidence from all parties on the meanings of relevant words used in a patent claim; the court's interpretation of those words affects how it assesses patent infringement and validity.

The trial is set to begin on Sept. 7.

What sets the case apart from typical patent-infringement cases involving branded and generic drug makers is the nature of Copaxone. Though approved as a pharmaceutical drug, its molecular complexity places it more in league with biotech drugs, which makes the development of a generic version more challenging.

A similar case was that of Sanofi's blood-thinning drug Lovenox (enoxaparin sodium), also a complex molecule approved as a pharmaceutical; Sandoz now markets a generic version of that drug. According to some analysts, such cases could help shape the Food and Drug Administration's regulations concerning follow-on biologics, now that the agency must draft them thanks to the regulatory approval pathway created by the Patient Protection and Affordable Care Act.

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