MS Drug Patent Rulings Give Biogen Win, Acorda Loss in Separate Suits

Xconomy Boston — 

Biogen has won a patent case concerning its top-selling multiple sclerosis drug, allowing the company to keep exclusive rights on the pill without paying royalties to a European biotech that made claims on the drug. But in a separate case also decided today, Acorda Therapeutics lost four patents covering its flagship drug, a potentially significant blow that could open the company up to generic competition as early as next year.

In the Biogen (NASDAQ: BIIB) case, the Cambridge, MA-based company was challenged by Denmark-based Forward Pharma (NASDAQ: FWP) over which company was the first to discover the MS drug dimethyl fumarate (Tecfidera), a dispute called a patent interference. Biogen’s drug was approved in 2013, and has gone on to become its top seller. In 2016, dimethyl fumarate accounted for $3.9 billion of the company’s $11.1 billion in revenue.

In January, Biogen paid Forward Pharma $1.25 billion to settle a patent infringement claim that the Danish biotech filed over dimethyl fumarate. Forward was researching dimethyl fumarate at the same time as another company that Biogen acquired in 2006. In 2014, Forward sued Biogen, claiming that the company was infringing on its patents. While the January settlement covered those claims, it left unresolved the interference dispute in the U.S. and a separate patent opposition suit in Europe.

Citing court documents from the case, Jefferies analyst Brian Abrahams wrote in a research note that Biogen won the interference. He said that the earlier settlement with Forward was a hedge; the interference win now means that Biogen won’t owe royalties to Forward and will keep patent exclusivity on dimethyl fumarate through 2028. But it’s possible, though not likely, that Biogen may still owe Forward royalties in Europe, Abrahams wrote. Each company withdrew its opposition to the other’s patents last week, suggesting that they have reached some sort of an agreement, according to the note.

Biogen shares climbed about 1.6 percent on Friday, while Forward’s shares plummeted about 20 percent.

The Acorda (NASDAQ: ACOR) case concerned five patents for dalfampridine (Ampyra), its top revenue driver. Acorda became profitable because of dalfampridine, a drug that helps improve the walking ability of MS patients. But the Ardsley, NY, company has had a tough time trying to prove the drug’s worth for other medical conditions. Last November, its longstanding efforts testing the drug in stroke victims fell short. That had already amped up the pressure on Acorda to successfully diversify, which the company has been trying to do by acquiring a group of Parkinson’s drugs through different deals. Just this week, the company announced it would file for approval of CVT-301, an inhalable form of the Parkinson’s drug levodopa, by the end of the second quarter.

But the heat could nonetheless be on Acorda even more in the wake of today’s district court ruling. Acorda said that the court upheld only one dalfampridine patent—one that covers its formulation. Four other patents on the drug were invalidated. Its shares fell more than 21 percent on Friday.

The single upheld patent won’t offer Acorda much protection. In a research note, Leerink Partners analyst Paul Matteis wrote that this patent expires in the middle of 2018, which means generic competition could come sometime next year. Acorda said it would appeal the court ruling. In a statement, CEO Ron Cohen said that the company believes it demonstrated “novel and unexpected findings in our Ampyra development program that led to the issuance of valid patents.”

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