Aps v. Biogen Ma, Inc.
| Decision Date | 24 October 2018 |
| Docket Number | 2017-2109 |
| Parties | FWP IP APS, Appellant v. BIOGEN MA, INC., Appellee |
| Court | U.S. Court of Appeals — Federal Circuit |
NOTE: This disposition is nonprecedential.
Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. 106,023.
KATHLEEN M. SULLIVAN, Quinn Emanuel Urquhart & Sullivan, LLP, New York, NY, argued for appellant. Also represented by CATHERINE MATTES, ERIC C. STOPS; KEVIN ALEXANDER SMITH, San Francisco, CA.
CHARLES E. LIPSEY, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Reston, VA, argued for appellee. Also represented by BARBARA CLARKE MCCURDY, PIER DEROO, Washington, DC.
Before PROST, Chief Judge, WALLACH and CHEN, Circuit Judges.
This appeal arises from an interference proceeding1 at the united States Patent and Trademark Office, Patent Trial and Appeal Board (Board) and involves a treatment method for multiple sclerosis with a particular daily dosage—480 mg—of fumaric acid esters (fumarates). Appellee Biogen MA, Inc. (Biogen) owns U.S. Patent No. 8,399,514, which describes and claims this method of treatment. Appellant FWP IP ApS (Forward)2 is the assignee of U.S. Patent Application No. 11/576,871, which discloses controlled release compositions of fumarates. Forward argues that its patent application describes the specific treatment method in dispute. While the Board found that Forward's '871 application had an earlier priority date than Biogen's '514 patent, it granted Biogen's motion for judgment that the MS treatment Forward now seeks to claim is not supported by adequate written description under 35 U.S.C. § 112 (2006). Because substantial evidence supports the Board's finding that Forward's '871 application does not adequately disclose a method of treating MS with 480 mg of fumarates per day, we affirm.
Multiple sclerosis (MS) is an autoimmune disease affecting the central nervous system. The disease attacks the myelin sheath around neural axons, causing visual loss, weakness, numbness, loss of coordination, and cognitive dysfunction among other symptoms. Treatment of MS seeks to reduce this neurodegeneration.
The MS treatment in dispute involves administering a specific daily dosage (480 mg) of fumarates, specifically dimethyl fumarate (DMF) and/or monomethyl fumarate (MMF). Forward argues that it was the first to discover and claim this method of treatment and that it has been conducting research on the use of DMF for treating "inflammatory and neurological indications, including multiple sclerosis."3 J.A. 9094. Forward and its predecessor Aditech Pharma AB filed several patent applications, one of which is the '871 application. The '871 application is the U.S. national phase of Forward's Patent Cooperation Treat (PCT) application. The PCT application was filed October 7, 2005, and claims priority to a Danish patent application filed on October 8, 2004. Biogen, for its part, owns the '514 patent, which covers this particular method of MS treatment, and markets its drug as Tecfidera®. The '514 patent, which issued on March 19, 2013, claims priority to a provisional application filed on February 8, 2007.
On December 3, 2013, Forward filed an amendment to the '871 application, canceling all pending claims and adding claims 55-70 that closely tracked Biogen's then recently issued '514 patent claims. The Board declared an interference between Forward's application and Biogen's '514 patent on April 13, 2015. It designated Forward as the senior party with a constructive reduction to practice date of October 8, 2004.
On March 31, 2017, the Board granted Biogen's motion for a judgment that Forward's claims are not supported by adequate written description under 35 U.S.C. § 112. The Board 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." J.A. 3. Using Forward's newly-added claim 694 as illustrative, the Board distilled the claims 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. The Board then addressed each limitation in turn.
Reviewing the 871 application, col. 1, ll. 1-2. The specification teaches that administering fumarates can cause certain undesired gastro-intestinal effects, such as "fullness, diarrhea, upper abdominal cramps, flatulence and nausea." Id. at col. 2, ll. 35-36. Forward's '871 application purports to address these gastro-intestinal side effects by teaching pharmaceutical compositions designed to "release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastro-intestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastrointestinal related side-effects." Id. at col. 1, ll. 4-10. The specification is replete with examples of detailed controlled release compositions (pH controlled release, pH independent release, release over gradually shifting pH, etc.) for both single and multiple daily administration. Id. at col. 14 l. 17-col. 35 l. 19.
As to the treatment of specific diseases and conditions, the Board found that Forward's specification lists over twenty diseases and conditions, and MS is not identified as of any particular interest. This laundry list of diseases and conditions includes psoriasis; psoriatic arthritis; neurodermatitis; inflammatory bowel disease; neurodermatitis; autoimmune diseases (including MS as one of the eleven listed); pain associated with radibulopahty, neuropathy, or sciatica; organ transplantation; sarcoidosis; necrobiosis lipoidica; and granuloma annulare. Id. at col. 37 l. 17-col. 38 l. 17. The only diseases that the '871 application discusses in any detail, however, are psoriasis and conditions associated with psoriasis. The two commercial compositions of fumarates the specification identifies are Biogen's Fumaderm® and TioFarma's Fumaraat 120®, both of which can be used for treating psoriasis. Id. at col. 1, ll. 13-15. The '871 application's specification defines "controlled release composition" as "a composition that is designed to release the fumaric acid ester in a prolonged, slow and/or delayed manner compared to the release of the commercially available product Fumaderm®." Id. at col. 4, ll. 25-27.
And with respect to the fumarate content, the Board 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.
As for the claimed 480 mg/day dosage, the '871 application's specification refers to a 480 mg/day dosage three times, twice in a paragraph teaching possible daily dosages and once as an interim dose in an "up-scale" table. See id. at col. 36 l. 1. The daily dosage paragraph teaches that the dosage can be from 240 to 360 mg, 360 to 480 mg, 480 to 600 mg, 600 to 720 mg, 720 to 840 mg, 840 to 960 mg, or 960 to 1080 mg, given in one to three administrations. Id. at col. 36 ll. 13-23. The 480 mg/day dose thus is identified as both the low and high end of ranges within a broader, overall disclosed dosage range of 240 to 1080 mg/day. Id. Importantly, this paragraph specifically teaches that the daily dosage to be administered "depends on a number of factors, among which are included, without limitation, weight and age and the underlying causes of the condition or disease to be treated, and is within the skill of a physician to determine." Id. at col. 36 ll. 13-16. The disclosed up-scale table, on the other hand, is designed to minimize the side-effects of ingesting fumarates by increasing the dose gradually over time to allow the patient to acclimate. The table proposes scaling up the daily dosage level over a nine-week period, with the 480 mg/day dosage occurring during week seven. Id. at col. 35 l. 21-col. 36 l. 5. So, while 480 mg/day dosage is expressly mentioned three times in the specification, 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." J.A. 22.
Next, the Board rejected Forward's arguments based on Snitzer v. Etzel, finding that, unlike the invention in Snitzer, Forward'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 dosages. 465 F.2d 899, 903 (CCPA 1972). "[S]uch necessary picking and choosing to arrive at the claimed invention . . . does not indicate it was described." J.A. 27. The Board also rejected Forward's arguments based on Falkner v. Inglis, 448 F.3d 1357, 1366-68 (Fed. Cir. 2006), and Streck, Inc. v. Research & Diagnostic Sys., Inc., 665 F.3d 1269, 1285-87 (Fed. Cir. 2012), for using the prior art to satisfy gaps in the written description. Forward pointed to publications to establish that the treatment of MS with fumarates was well known as of 2004. In Forward's view, a skilled artisan would have realized that the disclosure of the 480 mg/day dose in an up-scale table tied the dose, active ingredient,...
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