Docket No. 2022-1165 (PGR2019-00062) (https://cafc.uscourts.gov/opinions-orders/22-1165.OPINION.6-27-2023_2148484.pdf)
DYK, REYNA, STARK
June 27, 2023
Brief Summary: Board post-grant review (PGR) decision denying entry of Medytox’s amended claims during an IPR for lack of enablement affirmed, and that decision found not violate the APA. Summary (ChatGPT4): Medytox, Inc. appealed the Board’s PGR FWD that denied its revised motion to amend certain claims of its ‘728 patent directed to an animal-protein-free botulinum toxin composition with a longer-lasting effect compared to compositions containing animal-derived products. Medytox challenged the Board’s findings on claim construction, written description, and enablement, as well as the Board’s Pilot Program concerning motion to amend practice and procedures. Galderma S.A. filed a petition for post-grant review of certain claims of the ‘728 patent and Medytox filed a non-contingent motion to amend the claims and requested a Preliminary Guidance under the Pilot Program. The Board issued a Preliminary Guidance expressing its initial views on the motion and Medytox then filed a revised motion to amend. The Board cancelled certain original claims, found the responder rate limitation (“at least 50%”) to mean 50-100%, and found that the substitute claims introduced new matter, lacked written description, and were not enabled (e.g., “a skilled artisan would not have been able to achieve higher than 62% for the responder rate limitation”). Regarding claim construction, Medytox argued that the responder rate limitation should be construed as a “yes-or-no inquiry” or a threshold, while Galderma argues for a range construction. The FC panel found no substantive difference between the two constructions proposed by the parties and affirmed the Board’s construction of the responder rate limitation as a range with “a natural upper limit of 100%”. The FC panel explained that while its “caselaw may not require disclosure of every possible working example of responder rates, …here, there are at most three examples of responder rates above 50% at 16 weeks: 52%, 61%, and 62%” (Wyeth, FC 2013; MagSil, FC 2012; Amgen, US 2023), and it found no legal error in the Board’s non-enablement determination. Medytox also arguee that the Board’s revision of its claim construction between the Preliminary Guidance and the Final Written Decision (FWD) violated the Administrative Procedure Act, but the FC panel disagreed finding the Board’s decision not arbitrary and capricious, and that Medytox had a full and fair opportunity to litigate the case (Trivascular, FC 2016; In re Magnum, FC 2016; Fanduel, FC 2020). The Board decision was therefore affirmed.