Teva Loses Appeal Over Four Patents for MS Drug Copaxone

(Bloomberg) -- Teva Pharmaceutical Industries Ltd. lost an appeals court bid to revive four U.S. patents on its top-selling multiple sclerosis drug Copaxone.

A trial judge was correct to invalidate the four Teva patents, the U.S. Court of Appeals for the Federal Circuit said Friday in an opinion on its electronic docket. In a companion decision, the court also upheld a Patent Trial and Appeal Board decision that came to the same conclusion on three of the patents.

The rulings are a victory for generic-drug makers including Novartis AG and its partner Momenta Pharmaceuticals Inc., as well as Mylan NV and its partner Natco Pharma Ltd.

Copaxone is Teva’s biggest product, generating $3.8 billion in 2017 sales, although North American revenue declined 46 percent in the second quarter because of competition from generics. The patents relate to the dosing formula for the drug, and Teva had been counting on the patents to ward off the copycats until 2030.

Multiple sclerosis is an autoimmune disease related to the fatty substance known as myelin that surrounds nerves. The body mistakes the myelin as foreign and attacks it. Copaxone is a synthetic protein designed to block the T-cells that damage myelin.

The generic-drug companies successfully argued that the dosage -- an injection of 40-milligrams of the active ingredient three times a week -- is not all that different than simply doubling the earlier daily dosage of 20 milligrams and giving it every other day.

“Researchers were pursuing less frequent dosing regimens while recognizing there are a limited number of days in a week on which to test frequency,” the three-judge Federal Circuit panel wrote.

Teva’s now relying on a new treatment for migraines as a key part of its turnaround plans, though it’s embroiled in a patent fight with Eli Lilly & Co. over the underlying technology behind the drug.

The cases decided Friday are Teva Pharmaceuticals USA v. Sandoz Inc., 17-1575, and Yeda Research & Development v. Mylan Pharmaceuticals Inc., 17-1595, both U.S. Court of Appeals for the Federal Circuit (Washington).

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