Biogen Rebuffed by Supreme Court in Bid for Royalties on Rebif

(Bloomberg) -- The Supreme Court declined to consider a bid by Biogen Inc. to revive a case in which it was seeking billions of dollars in royalties from the sale of Merck KGaA’s Rebif multiple sclerosis drug.

Biogen said it invented a way to genetically engineer and administer a protein known as beta-interferon, which slows the physical deterioration caused by multiple sclerosis. The company, which makes the MS drug Avonex, claimed it lost billions of dollars when Merck’s EMD Serono Inc. and then-partner Pfizer Inc. entered the market with their competing medication Rebif.

A jury in New Jersey invalidated Biogen’s patent, but a judge overturned that verdict and granted a new trial. The U.S. Court of Appeals for the Federal Circuit, the nation’s top patent court, ordered the original verdict reinstated, saying the patent wasn’t a new idea. 

Biogen argued the Federal Circuit erred in ruling that the treatment using a genetically engineered version of the protein was little different from what had been done with the human protein. Earlier research promoted the use of the natural protein as an MS treatment, “but such treatments were unworkable because the naturally occurring protein could not be harvested in sufficient quantities,” Biogen argued.

“If not corrected, the decision will have severe adverse consequences for biomedical research and development,” said Biogen, adding that more than 140 genetically engineered proteins are approved for use in therapeutics, and that analysts estimate the annual global market is over $90 billion.

Merck’s EMD Serono said others had obtained patents on the way to replicate the protein by combining genetic sequences, and that there was nothing novel to Biogen’s treatment idea, since the native protein had been used “to treat the same diseases in the same way.”

MS, for which no cure exists, affects almost 1 million people in the U.S., according to the National Multiple Sclerosis Society. The disorder causes the immune system to attack myelin, a fatty substance that coats and protects nerve fibers.

Had Biogen invented a new method for making or using beta interferon, it may have been entitled to a patent, Serono said.

“Here, the product is old and the method is old, and so the jury was entitled to find that there was nothing ‘new’ about Biogen’s claims,” Serono said.

The case is Biogen MA v. EMD Serono, 20-1604.

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