In a decision issued by the Federal Circuit on October 24, 2018, the court affirmed a finding by the Patent Trial and Appeal Board (PTAB) that a multiple sclerosis (MS) treatment claimed in an application owned by FWP IP APS (FWP) was not supported by adequate written description under 35 U.S.C. § 112. While the non-precedential nature of the decision might have indicated to some that the dispute was not all that important, the claims in dispute relate to Biogen’s blockbuster drug Tecfidera, which accounted for over a billion in sales for Biogen last year. As a result of the Federal Circuit’s ruling, Biogen’s patent for Tecfidera remains intact and FWP will not be able to realize its goal of collecting future royalty payments on sales of Tecfidera from Biogen. In addition, the opinion itself serves as a reminder for patent practitioners that laundry lists and kitchen sinks are better suited for households than patent applications.
The case arises from an interference between the named parties, FWP and Biogen. Biogen owns U.S. Patent No. 8,399,514 (the ʼ514 patent), which describes and claims a specific method of treating MS with a daily dosage of 480 mg of fumaric acid esters (fumarates). Prior to the filing of Biogen’s application that issued as the ʼ514 patent, FWP filed a patent application (U.S. Application No. 11/576,871 (the ʼ871 application)) disclosing controlled-release compositions of fumarates. Upon issuance of Biogen’s ʼ514 patent, FWP canceled the then-pending claims in the ʼ871 application and added new claims that closely tracked to Biogen’s ʼ514 patent claims. The PTAB declared an interference between FWP’s application and Biogen’s ʼ514 patent.
The PTAB distilled the interference count down to three main limitations: (1) an MS treatment, (2) by oral administration of a therapeutically effective amount of dimethyl fumarate and/or monomethyl fumarate, at (3) a specific dosage of 480 mg per day. Biogen moved the PTAB for a judgment that FWP’s claims were not adequately supported by the ʼ871 application’s specification. The PTAB ruled in Biogen’s favor and held that, even though each of the claim limitations were generally mentioned in FWP’s specification, the specification did not disclose the claimed invention in a manner that adequately described the claimed MS treatment to a skilled artisan and thus, the ʼ871 application did not meet the written description requirement. FWP appealed.
The Federal Circuit’s Decision
Not surprisingly, the Federal Circuit affirmed the PTAB’s decision. While the court agreed with the PTAB that the ʼ871 application identified dimethyl fumarate and/or monomethyl fumarate as useful for treating a large number of described conditions (including MS) and that a dosage of 480 mg per day was generally disclosed, the court held that the ʼ871 application did not adequately teach a specific treatment of MS at a dosage of 480 mg per day.
In addressing the treatment of MS, the court noted that the ʼ871 application merely states that the fumarates in general are “contemplated to be suitable to use in the treatment of one or more of the following conditions.” While the “following conditions” were further described to include over 20 diseases and conditions including, for example, psoriasis, psoriatic arthritis, inflammatory bowel disease, and autoimmune diseases (including MS as one of the 11 listed), the only conditions discussed in any detail in the ʼ871 application were psoriasis and conditions associated with psoriasis. The court determined that, based on the laundry list of diseases and conditions discussed and the wide variability of the pathophysiologies of each of those listed diseases and conditions, the inventors of the ʼ871 application had yet to definitively conclude at the time of invention that fumarates and, more specifically, dimethyl fumarate and/or monomethyl fumarate, were effective for treating all of the 20 diseases and conditions identified.
The court came to a similar conclusion with respect to the dosage requirement. FWP argued that a table in the ʼ871 application expressly discloses a dosage of 480 mg per day during the seventh week of a contemplated nine-week scale-up period and a skilled artisan would have recognized that all of the listed dosages in the table are therapeutically effective dosages for all of the conditions and diseases listed. However, the court disagreed and determined that FWP failed to provide any persuasive evidence why a skilled artisan would have understood that a dosage for only one of the weeks in the nine-week scale-up period would be therapeutically effective for treating MS. Rather, the court determined that the table was simply providing guidance on gradual dosing to help patients’ gastrointestinal systems acclimate to the side effects of fumarates.
Interestingly, in a last attempt to save the claims, FWP further argued that the original claims, which FWP canceled and replaced with new claims to provoke the interference, provided sufficient support for the claims in the interference. Like the PTAB, the court found that the large number of disease conditions, dosages, active ingredients, and pharmaceutical formulations covered in the original claims detracted from FWP’s argument that it possessed and invented the claimed, specific MS treatment. Moreover, the court took issue with the improper multiple dependent format in which the original claims were written, stating “[f]inding a treatment for MS with 480 mg of DMF and/or MMF per day in the morass of possible combinations of the impermissibly drafted original claims would … take ‘the patience of a yogi to decipher their meaning, as they stand.’”
In view of the lack of specificity in the ʼ871 application with regard to a treatment for MS with a precise dosage of 480 mg per day using specific fumarates, the Federal Circuit affirmed the PTAB’s finding that the claimed MS treatment was not supported by the application’s specification as required by 35 U.S.C. § 112.
The court’s holding serves as an important reminder that the written description requirement requires more than the mere mention of a claim limitation in the specification. While FWP’s patent application described the use of fumarates in a broad fashion across a variety of medical conditions, there was not sufficient detail in the disclosure such that a person of ordinary skill in the art would be able to appreciate any and all specific treatments that might be possible permutations (including the specific MS treatment claimed in Biogen’s patent). Had FWP’s application described MS in more detail and included one or more working examples of treating MS patients with dosages at or around 480 mg per day of fumarates, the outcome may have been different for FWP.