By Joseph Arshawsky, J.D.
A patent application with an earlier priority date did not disclose a treatment for multiple sclerosis ("MS") using a 480 mg/day dosage of a fumarates, and therefore, the MS treatment that FWP IP ApS ("Forward") sought to claim was not supported by adequate written description under 35 U.S.C. § 112, the United States Court of Appeals for the Federal Circuit ruled, affirming the Patent Trial and Appeal Board’s decision in favor of Biogen MA, Inc.’s ("Biogen"). The PTAB properly found that Forward’s application did not adequately disclose a method of treating MS with 480 mg of fumarates per day (FWP IP APS v. Biogen MA, Inc., October 24, 2018, Chen, R.).
Biogen owns U.S. Patent No. 8,399,514 (the ’514 patent), which describes and claims a method of treatment for MS with a particular daily dosage – 480 mg – of fumaric acid esters (fumarates). Forward is the assignee of U.S. Patent Application No. 11/576,871 (the ’871 application), which discloses controlled release compositions of fumarates. On December 3, 2013, Forward filed an amendment to the ’871 application, canceling all pending claims and adding claims that closely tracked Biogen’s then recently issued ’514 patent claims. The PTAB declared an interference between Forward’s application and Biogen’s ’514 patent on April 13, 2015. The PTAB designated Forward as the senior party with a constructive reduction to practice date of October 8, 2004. On March 31, 2017, the PTAB granted Biogen’s motion for a judgment that Forward’s claims were not supported by adequate written description under 35 U.S.C. § 112. The PTAB found that the ’871 application’s focus on "controlled release fumarate compositions" and "general teaching of applicability of the fumarates to the treatment of a variety of possible disease or conditions and the teaching of a broad range of possible dosages would not have conveyed possession or description of the specific treatment of MS that [Forward] now claims." Forward appealed and the Federal Circuit affirmed.
Inadequate written description. The interference count between Biogen and Forward comprised three limitations: (1) a treatment for MS that involves administering (2) DMF, MMF, or a combination of the two fumarates at (3) a dosage of 480 mg per day. On appeal, Forward argued that the count is disclosed as a unified whole in the up-scale table because the up-scale table (1) discloses a 480 mg/day dosage, (2) is reasonably directed at using DMF to treat the listed conditions, and (3) is linked to the treatment of MS. The Federal Circuit was not persuaded and agreed with the PTAB that the ’871 application does not disclose the now-claimed MS treatment as a unified whole.
"The Board’s interpretation is more than reasonable in light of the ’871 application’s own disclosure stating that the up-scale table is designed to help patients in ‘situations where increasing dosage is required over time,’" the court said. The 480 mg/day disclosure in week seven is an interim dosage, and Forward did not present persuasive evidence why a skilled artisan would have understood the week seven interim dosage to be therapeutically effective. Substantial evidence supported the PTAB’s finding that Forward’s ’871 application lacked adequate written description support for the claimed treatment method. Moreover, the Federal Circuit noted that the ’871 application states that its compositions and kits are merely "contemplated to be suitable to use in the treatment of one or more of the following conditions." The court said that a "reasonable understanding of this statement is that the inventors of the ’871 application had not yet firmly concluded that fumarates at a particular daily dosage were in fact effective for treating the entire list of enumerated conditions, which included MS, particularly in light of the disparate pathophysiologies of the listed diseases and the wide variability of the organ systems affected by them."
In the 67-page application, MS is mentioned only a handful of times, three times as part of a list of over twenty diseases and twice in the original claims. There was no mention of the symptoms or etiology of MS. The only conditions the ’871 application’s specification discusses in any detail are psoriasis and conditions associated with psoriasis. Given the brief references to MS and the lack of recognition of 480 mg/day as a therapeutically effective daily dosage, the Federal Circuit agreed with the PTAB’s finding that there "is no discussion in the ’871 application that would guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day."
Even if Forward could rely on the prior art for establishing a prior, known link between MS and fumarates, the prior art does not teach the key limitation of the count: the 480 mg daily dosage. In addition to the dosage amount problem, even if the link between MS and fumarates had been known in the prior art, that does not necessarily mean that a skilled artisan would have understood the ’871 application as demonstrating that the inventor contemplated using fumarates to treat MS, given the application’s open-ended language that fumarates are merely "contemplated to be suitable to use in the treatment of one or more" of several listed conditions. "Forward’s prior art-based argument does not undermine the substantial evidence that supports the Board’s finding that the ’871 application does not disclose 480 mg of fumarates per day as a therapeutically effective dosage for treating MS," the court said.
The original claims. Forward briefly argued that the ’871 application’s original claims—which it canceled and replaced with new claims to provoke the interference proceeding—adequately describe the MS treatment it now sought to claim. Specifically, Forward’s argument was premised on piecing together elements of several of the claims—claims 27, 28, 30, 32, 33, 37, and 44. Substantial evidence supported the PTAB’s finding that such picking and choosing among claims was improper. Rather, what the scale of the cancelled claims demonstrated is that Forward possessed, as of the 2004 critical date, a mere wish for obtaining some type of fumarate formulation to treat any one of many diseases and conditions, one of which was MS, using almost any possible daily dosage. The original claims, now cancelled, were drafted in a way that is barred by the Patent Act. The PTAB reasonably found that these original claims did not provide a basis for a written description of the now-claimed subject matter.
This case is No. 17-2109.
Attorneys: Kathleen M. Sullivan (Quinn Emanuel Urquhart & Sullivan, LLP) for FWP IP APS. Charles E. Lipsey (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP) for Biogen MA, Inc.
Companies: FWP IP APS; Biogen MA, Inc.
MainStory: TopStory Patent FedCirNews
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