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Forward v. Biogen: Biogen Prevails in MS Drug Patent Appeal in Federal Circuit

Reports Patent

FWP IP ApS v. Biogen MA, Inc., 2018 U.S. App. LEXIS 29943 (Fed. Cir. Oct. 24, 2018), opinion hosted by Court of Appeals for the Federal Circuit.

On October 24, 2018, the Federal Circuit Court affirmed a Patent Trial and Appeal Board ("PTAB") decision that determined FWP IP ApS ("Forward") was not entitled to a patent on a multiple sclerosis treatment method using a specific dosage of compounds known as fumarates. This decision has immediate impact on Biogen's commercialization of its MS drug Tecfidera, as well as holds significance for the intellectual property implications of broad-purpose patents.

The question is whether Forward or Biogen should maintain the rights to a treatment method for multiple sclerosis (“MS”) that incorporates a specific dosage of fumarates (480 mg/day) for treatment. MS is an autoimmune disease that negatively affects the central nervous system by degrading the myelin sheaths around neural axons. This results in communication malfunctions between the brain and the rest of the body, leading to symptoms including severe pain, inability to control the limbs, permanent loss of vision, and cognitive dysfunction.

The issue in this case arises from a patent interference ruling made by the PTAB. Appellant Forward’s patent application, which had an earlier priority date, broadly disclosed the controlled release compositions of fumarates. In contrast, Biogen’s application described a specific dosage (480 mg/day) of fumarates for treatment of MS. Forward supports its patent claim by arguing that its application included a range of fumarate dosages, including the 480 mg/day dosage, that could potentially treat a myriad of different medical conditions, including MS.

Biogen motioned for, and PTAB granted, summary judgment based on the notion that Forward’s application was not supported by adequate written description to justify specific rights to the treatment.

After reviewing the case, the Federal Circuit Court affirmed and maintained judgment in favor of Biogen to dismiss Forward’s claims for rights to the specific treatment. The Federal Circuit Court stated there was substantial evidence supporting PTAB’s finding that Forward’s application does not adequately disclose a method of treating MS with 480 mg/day of fumarates. Because Forward's patent application describes the use of fumarates in broad generalities across various medical conditions, Forward’s senior patent application should not maintain rights over any and all specific treatments that would be a possible permutation under the sweeping claim.

As a consequence of this ruling, Biogen is now free from having to pay royalties on its blockbuster drug Tecfidera. If the court had reversed PTAB’s decision in favor of Forward, Biogen would have been required to pay royalties of 10 percent of net U.S. sales of Tecfidera from 2021 to 2028. In a statement, Forward Pharma expressed its “disappointment” at the outcome, noting that a ruling in its favor was “among the conditions that must be satisfied for future royalties from the net sales of Tecfidera.”

The limitation on Forward’s senior patent is important for incentivizing patent applications to be precise in their declaration of property rights. The case’s ruling is significant because it substantiates a well-known and generally defended view by intellectual property courts that granting broad intellectual property rights through patents disincentivizes research into more specific forms of innovation. Specific innovation has considerable effect on human welfare, especially in healthcare. Minimizing broad patents allows for researchers and innovators to seek more specific solutions while remaining confident that their work will not constitute infringement. In this case, Biogen would likely not have invested the resources to produce this medical treatment had they believed their work would ultimately be attributed to a separate company with broad claims over fumarates more generally.