Momenta Pharmaceuticals, Inc. (MNTA)

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Teva Pharmaceutical Industries Ltd. fell as much as 6.3 percent after a U.S. agency invalidated two of the patents protecting Copaxone, a multiple sclerosis drug that generates 20 percent of its revenue.
The patents are among three being challenged at the U.S. Patent Trial and Appeal Board. The agency is scheduled to issue a final decision on the other one no later than Thursday.

The three patents expire in 2030 and specifically cover administering the drug in a 40-milligram dosage three times a week. The original version of Copaxone, consisting of 20 milligrams taken every day, began facing generic competition last year.

Novartis AG and Momenta Pharmaceuticals Inc. jointly sell a cheaper version of the daily shot. Even with the generic-drug competition, Teva has been able to maintain sales by switching about 80 percent of patients to the 40-mg injection.

Teva American depositary receipts, each representing one ordinary share of the Israeli-based company, dropped $2.35 to $50.85 at 3:37 p.m. after falling as low as $49.87. Momenta jumped as much as 8.3 percent.
While Teva expressed confidence in its patents, analysts have said generic competition could wipe out as much as $3.2 billion in sales by 2019.

The ruling from the patent office is just one step in a difficult process for the generic-drug manufacturers. A September trial is scheduled in Wilmington, Delaware, in the civil case Teva filed with a ruling expected early next year. It’s harder to invalidate a patent in district court than the patent office.

Both the patent office challenges and any ruling from the district court will head to the same appeals court in Washington, one that specializes in U.S. patent law. Even though the patent office invalidated the patents, generic-drug makers typically wait until the U.S. Court of Appeals for the Federal Circuit rules before entering the market.

The would-be competitors also have to make it through the U.S. Food and Drug Administration approval process. It took Momenta seven years to obtain regulatory permission to sell its 20-mg version, while others including Mylan have yet to receive approval.

http://www.bloomberg.com/news/articles/2016-08-24/teva-s-250-patent-on-copaxone-is-invalid-patent-office-says