Two SCOTUS Petitions Could Clarify Written Description Requirements for Biotech and Pharma Industry
By Pat Halloran | August 29, 2022
In Juno Therapeutics, Inc. v. Kite Pharma., 10 F.4th 1330 (Fed. Cir. 2021), a FC panel reversed the DC’s decision that Juno’s claimed chimeric antigen receptors (CARs) in U.S. Pat. No. 7,446,190 including a “binding element that specifically interacts with a selected target” (e.g., scFv that binds CD19) did not satisfy the written description (WD) requirement, including the DC’s award of over $1.2 billion in damages for infringement by Kite’s YESCARTA® product. The FC panel wrote that “[f]or genus claims using functional language, like the binding function of the scFvs claimed here, the written description ‘must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus’” (not satisfied by “[t]he disclosure of one scFv that binds to CD19 and one scFv that binds to a PSMA antigen”; citing Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010); Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011); Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005); and Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)). 10 F.4th at 1335, 1337. It “agree[d] with Juno that a patent specification need not redescribe known prior art concepts” (Immunex Corp. v. Sandoz Inc., 964 F.3d 1049, 1064 (Fed. Cir. 2020)). 10 F.4th at 1338. Juno’s petition for certiorari to SCOTUS filed on June 13, 2022, questioned whether the WD requirement is as presented by the statute (e.g., “full, clear, concise, and exact terms as to enable” the skilled artisan to make it) or under the FC’s test (“possession” of “the full scope of the claimed invention,” including all “‘known and unknown’ variations”). Juno Petition at i, 1.
In Biogen Int’l GmbH v. Mylan Pharm., 18 F.4th 1333 (Fed. Cir. 2021) (reh’g en banc denied (28 F.4th 1194(Mem) (Fed. Cir. 2022)), an FC panel affirmed the DC’s finding that claims to methods of treating multiple sclerosis with 480 mg per day dimethyl fumarate (DMF) invalid for lack of WD in US Pat. No. 8,399,514. The FC panel wrote, e.g., that Biogen’s specification “casts a wide net for a myriad of neurological disorders” and that “[s]ave for one paragraph in the specification, the disclosure does not teach potential dosage levels for DMF”, including a range of “[e]ffective doses” of “from about 480 mg to about 720 mg per day” (“the one and only reference to DMF480 in the entire specification”), that it “defines the term ‘effective’ within a therapeutic, rather than drug-discovery, context”, introduced MS-related claims only “after gathering the Phase III results that demonstrated therapeutic efficacy of DMF480”, and that Biogen’s expert “conceded during cross examination that the sole DMF-dosage paragraph in the specification did not teach a POSA that DMF480 would be therapeutically effective for treating MS”. Id. at 1337-40. Citing Nuvo Pharm. (Ireland) Designated Activity Co. v. Dr. Reddy’s Labs. Inc., 923 F.3d 1368 (Fed. Cir. 2019), it wrote that “[a]n inventor need not ‘prove that a claimed pharmaceutical compound actually achieves a certain result’”, but that here, the DC “did not clearly err in finding that a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS, particularly because the specification’s only reference to DMF480 was part of a wide DMF-dosage range and not listed as an independent therapeutically efficacious dose” and Biogen’s later establishment of “the therapeutic efficacy of DMF480 is of no import to the written-description analysis.” 18 F.4th at 1343. Judge O’Malley dissented, writing that the DC decision should be remanded for reconsideration of the “distinction between clinical and therapeutic effects”. Id. at 1346. Biogen’s petition for certiorari to SCOTUS filed on June 14, 2022, questioned whether, to meet the WD requirement, “the specification also disclose data that demonstrates the claimed invention is ‘effective’ and emphasize the claimed invention by singling it out and describing it more than once”. Biogen Petition at i. Mylan’s Brief in Opposition filed on August 15, 2022, argued that “this case is a poor vehicle for the Court to address Section 112’s WD requirement” as the decision “was fact-bound, and it correctly applied longstanding law to the specific patent at issue.” Mylan Brief at 31.
Whether SCOTUS agrees to review either of these decisions will be of great interest to those in the biotechnology and pharmaceutical industries. Regardless of whether SCOTUS takes one or both of these decisions up for review, the questions raised emphasize the need to prepare patent specifications with as much information as possible, while balancing that need with what is actually known or may become known in the future (e.g., the number of species described, focus of the application, general efficacy vs. therapeutic efficacy).