Biotech giant Biogen is locked in a fight with a Danish company over a crucial patent that protects a nearly $3 billion multiple sclerosis drug.
Cambridge-based Biogen is battling with Copenhagen-based Forward Pharma, and both have filed a patent for treating multiple sclerosis with daily doses of 480 mg of dimethyl fumarate. The U.S. Patent Trial and Appeal Board declared an "interference" yesterday — signalling it will address overlapping patents filed by separate parties.
"It is essentially enormously important to have that protection," said Josh Lerner, a professor at Harvard Business School. "When you look at the price trajectory of what happens when you have drugs go off-patent, you typically get a dramatic drop in terms of price, in your ability to monetize the drug."
Forward Pharma's patent was filed in 2005. Biogen's patent was filed in 2012, and is the basis for Tecfidera, Biogen's blockbuster drug that was responsible for $2.9 billion in sales last year.
Still, the filing date of the patent is less important than when the actual invention was made. The PTAB will hold a hearing to determine which company invented the treatment first, and award them the patent.
Catherine Falcetti, a spokeswoman for Biogen, said the company's sales, along with its customers and patients, are not affected.
"Our ability to market it is not impacted, and patients can still get Tecfidera," Falcetti said. "We intend to aggressively defend this portfolio."
Forward Pharma's patent has led to the creation of its own MS drug, which is still in development.
"This is a key step in advancing our intellectual property in the U.S. covering the use of 480 mg per day of DMF in MS," said Peder Andersen, chief executive of Forward Pharma, in a statement. "We look forward to the start of the interference proceeding and additional progress with our five other pending patent applications in the U.S. and in Europe covering the 480 mg daily dose of DMF."
Lerner said the dispute will likely not reach a conclusion.
"In many of these cases, there's some sort of settlement reached," he said. "There's some sort of licensing deal and payments made."
Other industry analysts said an acquisition of Forward Pharma by Biogen or other companies is among the potential resolutions.
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