Juno’s SCOTUS Petition Could Clarify Written Description Requirements for Biotech and Pharma Industry
By Pat Halloran | October 13, 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.
Juno’s Petition has been distributed for conference on October 14, 2022. The Court recently declined to take up the Federal Circuit’s decision in Biogen Int’l GmbH v. Mylan Pharm., 18 F.4th 1333 (Fed. Cir. 2021), which would have presented an opportunity to address written description issues similar to those raised in Juno’s Petition.
Whether SCOTUS agrees to review Juno is of great interest to those in the biotechnology and pharmaceutical industries. Regardless of whether SCOTUS takes the case, 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).