FWP IP APS v. Biogen MA, Inc.

Docket No. 2017-2109

October 24, 2018

Brief summary: Board interference decision of no WD of claimed MS treatment in FWP’s specification affirmed (e.g., “the inventors…had not yet firmly concluded”).

Summary: FWP appealed Board interference decision that while FWP’s ‘871 application had an earlier priority date than Biogen’s ‘514 patent (regarding Biogen’s Tecfidera®), the “‘871 application does not adequately disclose a method of treating MS [multiple sclerosis] with 480 mg of fumarates per day” (§ 112 (2006)). FWP’s “illustrative” independent claim 69 (added by amendment) is directed to “[a] method of treating a subject in need of treatment for [MS] comprising (a) a therapeutically effective amount of dimethyl fumarate and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount…is about 480 mg per day.” Biogen’s motion to the Board for a judgment that FWP’s claims are not supported by adequate written description (WD) was granted. In considering these arguments, the Board first considered the MS treatment limitation and found that the “specification lists over twenty diseases and conditions, and MS is not identified as of any particular interest” (a “laundry list of diseases and conditions”). The Board also found that “while the ‘871 application’s specification teaches the active ingredient can be any fumarate, it does separately identify DMF, MMF, and their combination for use in treatment formulations such that a skilled artisan would have recognized that the inventors had considered those fumarates to be significant.” Regarding the “480 mg per day” limitation, “the Board found that there ‘is no discussion that would guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day, or any other therapeutically effective dose within the ranges disclosed.” The Board also “rejected” FWP’s “arguments based on Snitzer v. Etzel” (CCPA 1972), “finding that, unlike the invention in Snitzer, [FWP’s] case requires selection and combination of claim elements from more than a single limited list: selection of MS from a list of diseases and selection of 480 mg/day from a large range of possible doses” (“[S]uch necessary picking and choosing to arrive at the claimed invention…does not indicate it was described”). It also rejected FWP’s arguments regarding “using the prior art to satisfy gaps in the written description” because “the specification itself” must “provide the blaze marks necessary to guide a skilled artisan to the claimed invention” (Falkner, FC 2006 and Streck, FC 2012 (“prior art was used to show that a generic claim element was well-known”); Ariad, FC 2010). Thus, the Board found FWP’s specification did not adequately describe the claimed method. The FC panel reviewed the Board’s WD decision (a question of fact) for substantial evidence (ULF Bamberg, FC 2016; Redline, FC 2015; In re Jolley, FC 2002 (“supported by substantial evidence even if the record would reasonably support contradictory conclusions”)). The FC panel agreed with the Board’s decision since, e.g., “the ‘871 application states that its compositions and kits are merely ‘contemplated to be suitable to use in treatment of one or more of the following conditions’” meaning that “the inventors…had not yet firmly concluded that fumarates at a particular daily dosage were in fact effective for treating the entire list of enumerated conditions” and “the prior art does not teach the key limitation of the count: the 480 mg daily dosage”. Regarding FWP’s original claims, the FC panel found that “the scale of the claims demonstrate…that Forward possessed…a mere wish” (e.g., “[t]he task for locating the now-claimed subject matter within the original claims is made uncommonly more difficult by the original claims themselves, which are written in a cascading, multiple dependencies manner such that many of them generically refer back to any one of the preceding claims” (Victor Talking Mach., 2nd Cir. 1916); “claims and their intermixing dependencies…[are] disconnected from a [WD] that is far more limited in its disclosure”). Thus, the Board decision of no WD was affirmed.

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