Last month, in FWP IP ApS v. Biogen MA, Inc., the Federal Circuit affirmed a decision by the U.S. Patent and Trademark Office's Patent Trial and Appeal Board granting Biogen's motion that FWP's U.S. Application No. 11/576,871 did not provide an adequate written description under 35 U.S.C. § 112 for claims directed to a method for treating multiple sclerosis. The MS treatment at dispute involves administering a specific daily dosage (480 mg) of fumarates, specifically dimethyl fumarate (DMF) and/or monomethyl fumarate (MMF), to a subject.
The appeal arose from an interference proceeding involving the above method for treating multiple sclerosis. U.S. Patent No. 8,399,514, owned by Biogen, describes and claims such a method. The '871 application, which was assigned to FWP by original Appellant Forward Pharma A/S after the appeal was docketed, discloses controlled release compositions of fumarates. In the interference proceeding, Forward argued that the '871 application describes the treatment method in dispute. Although the Board determined that the '871 application had an earlier priority date than the '514 patent, it granted Biogen's motion that the MS treatment method Forward sought to claim was not supported by an adequate written description.
The '871 application is a U.S. national phase filing of a PCT application that was filed on October 7, 2005, and which claims priority to a Danish patent application filed on October 8, 2004. The '514 patent claims priority to a U.S. provisional patent application filed on February 8, 2007. During prosecution of the '871 application, Forward cancelled all pending claims and added claims that closely tracked the claims that issued in the '514 patent. The Board declared an interference between the '871 application and '514 patent, designating Forward as the senior party with a constructive reduction to practice date of October 8, 2004.
Finding that the focus of the '871 application was on "controlled release fumarate compositions" and that "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," the Board granted Biogen's motion that the claims of the '871 application were not supported by an adequate written description. The Board pointed to claim 69 of the '871 application as representative:
69. A method of treating a subject in need of treatment for multiple sclerosis comprising
(a) a therapeutically effective amount of dimethyl fumarate and
(b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate is about 480 mg per day.
Looking to claim 69, the Board distilled the claimed treatment method at issue into three limitations: (1) an MS treatment, (2) by oral administration of a therapeutically effective amount of DMF and/or MMF, at (3) a dosage of 480 mg per day. With respect to the first limitation, the Board determined that the '871 application lists over twenty diseases and conditions, that MS is not identified as a disease or condition of particular interest, and that the application instead focuses on psoriasis and conditions associated with psoriasis. Regarding the third limitation, the Board determined that while the 480 mg/day dosage is expressly mentioned in the specification, 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 Forward's arguments based on Snitzer v. Etzel, 465 F.2d 899 (CCPA 1972); Falkner v. Inglis, 448 F.3d 1357 (Fed. Cir. 2006); and Streck, Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269 (Fed. Cir. 2012). The Board determined that unlike the invention in Snitzer, Forward's case required the selection and combination of claim elements from more than a single limited list, and that unlike Falkner and Streck, the '871 application did not provide the blaze marks necessary to guide a skilled artisan to the claimed invention. The Board concluded that even though each required claim element is mentioned separately in the '871 application, the specification did not disclose the claimed invention in a manner that adequately describes the claimed MS treatment to a skilled artisan, and therefore, that the claims of the '871 application failed to meet the written description requirement.
On appeal, Forward argued that the interference count was disclosed in an up-scale table in the '871 application, which Forward argued (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 up-scale table describes scaling up the daily dosage level of fumerates over a nine-week period, with the 480 mg/day dosage occurring during week seven, and is designed to minimize the side-effects of ingesting fumarates by increasing the dose gradually over time to allow the patient to acclimate. The Federal Circuit, however, stated that it was not persuaded by Forward's argument, and agreed with the Board that "the '871 application does not disclose the now-claimed MS treatment as a unified whole."
With respect to the 480 mg/day dosage, the Federal Circuit noted that this dosage is an interim dosage, and that Forward failed to present persuasive evidence as to why a skilled artisan would have understood the week seven interim dosage to be therapeutically effective. The Court also noted that Biogen's expert testified that because MS is a chronic disease, a skilled artisan would not have viewed a one week, interim dosage in the middle of a nine week up-scale schedule as an adequate treatment dosage, let alone one for a particular disease such as MS.
In affirming the Board's decision, the Federal Circuit stated that "[g]iven the brief references to MS and the lack of recognition of 480 mg/day as a therapeutically effective daily dosage, we agree with the Board’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. . . .'" The Court was also unpersuaded by Forward's attempt to use the prior art to supply the link between the therapeutically effective dose of 480 mg/day and MS, noting that "even if we allow Forward to 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."
The Federal Circuit also rejected Forward's argument that the original claims of the '871 application adequately describe the MS treatment that it was seeking to claim. According to the Court, "Forward's argument is premised on piecing together elements of several of the claims." In rejecting this argument, the Court explained that:
Th[e original] claims are mainly directed to controlled release compositions of numerous fumarates and pharmaceutically acceptable salts. Some claims recited numerous possible dosing schedules (claims 30–32) and dosages (claims 33–38). And others replicate the laundry list of diseases and conditions enumerated in the specification (claims 44 and 45). This large number of disease conditions, dosages, dosing schedules, active ingredients, pharmaceutical formulations for controlled release, and combinations thereof covered by the original claims detracts from Forward's argument that it possessed and invented the now-claimed, specific MS treatment. . . . Rather, what the scale of the claims demonstrate 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 a number of diseases and conditions, one of which was MS, using almost any possible daily dosage.
Finding that "the '871 application does not disclose 480 mg of fumarates per day as a therapeutically effective dose for treating MS," the Federal Circuit determined that substantial evidence supported the Board's finding that the MS treatment Forward sought to claim was not supported by an adequate written description under 35 U.S.C. § 112. The Federal Circuit therefore affirmed the Board's decision.
FWP IP ApS v. Biogen MA, Inc. (Fed. Cir. 2018)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Wallach and Chen
Opinion by Circuit Judge Chen
