Federal Circuit Nixes APA Challenge to PTAB Pilot, Cites Amgen in Enablement Analysis

Yesterday, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Medytox, Inc. v. Galderma S.A. affirming a final written decision by the Patent Trial and Appeal Board (PTAB) invalidating Medytox’s patent claims covering methods for treating patients with botulinum toxin and denying a revised motion to amend patent claims. On appeal, the Federal Circuit rebuffed several challenges, including an Administrative Procedures Act (APA) challenge to the PTAB’s motion to amend pilot program, holding that the PTAB’s change in claim construction was not arbitrary or capricious, nor did it prevent Medytox from litigating construction issues.

PTAB Changes Claim Construction Following Preliminary Guidance on Motion to Amend

The patent-at-issue in this appeal is U.S. Patent No. 10143728, Long Lasting Effect of New Botulinum Toxin Formulations. Issued to South Korean pharmaceutical company, Medytox, in December 2018, the ‘728 patent claims the use of an animal-protein-free botulinum toxin for cosmetic applications, such as treating glabellar frown lines, and non-cosmetic applications, such as treating chronic migraines. The claimed formulation also provides longer lasting effects than commercially available animal-protein botulinum toxins like BOTOX, which provides such effects for three months.

Nine months after the issue of the ‘728 patent, Switzerland-based dermatological treatment company Galderma filed a petition for post-grant review (PGR) proceedings at the PTAB to challenge the validity of Medytox’s patent claims. During PGR proceedings, Medytox sought to amend all 10 claims of the ‘728 patent and obtained preliminary guidance on proposed substitute claims under the motion to amend pilot program at the PTAB. While the PTAB’s guidance indicated that Medytox had failed statutory requirements for filing a motion to amend, it found that new language claiming “a responder rate at 16 weeks after the first treatment of 50% or greater” did not add new matter nor did it indicate a range of responder rates. Galderma had opposed Medytox’s substitute claims, noting that the ‘728 patent’s specification only disclosed responder rates in clinical trials up to 62% whereas Medytox’s claim language covered a range of responder rates from 50% up to 100%.

Despite the PTAB’s preliminary guidance, the Board issued a final written decision in the PGR proceedings in which it found that Medytox’s substitute claims impermissibly introduced new matter through the responder rate limitation. Medytox had argued throughout its motion to amend that the 50% responder rate was claimed as a minimum threshold and not a range. However, upon consideration of the full record, the PTAB now found the substitute claim language to be invalid for indefiniteness as a skilled artisan would have to engage in undue experimentation in order to achieve responder rates greater than 62%.

Inherent Upper Limit to Claimed Range Not Disclosed by Specification’s Data Tables

On appeal to the Federal Circuit, Medytox challenged the PTAB’s construction of the responder rate limitation, which Medytox argued should be understood as a simple yes-or-no inquiry into whether the claimed formulation has a greater length of effect than BOTOX. However, the Federal Circuit found that there was no meaningful claim construction dispute between the parties. Inherently, a claimed range of “50% or greater” has an upper limit, and Medytox’s own expert testimony acknowledged that responder rates of 80% or 90% would meet the claimed limitation.

The Federal Circuit cited the U.S. Supreme Court’s recent landmark decision in Amgen v. Sanofi (2023) when nixing Medytox’s challenge to the PTAB’s lack of enablement determination. Under Amgen, “[t]he more one claims, the more one must enable,” and the Federal Circuit noted that data tables included with the ‘728 patent’s specification only disclosed responder rates of 52%, 61% and 62%. While case law doesn’t require disclosure of every possible working example, the Federal Circuit found that the PTAB did not err in determining that a skilled artisan would not have been enabled by the specification to reach responder rates higher than those disclosed by the specification.

APA, Due Process Claims Fall Flat Due to Non-Binding Nature of Preliminary Guidance

Medytox did not fare any better with arguments that the PTAB’s about-face on the construction of the responder rate claim limitation was arbitrary and capricious in violation of the APA. The patent owner contended that the PTAB’s preliminary guidance on the motion to amend and the final decision dismissing the motion were inconsistent decisions based on a nearly identical record. However, the Federal Circuit found that the extrinsic record in the PGR was further developed following the preliminary guidance, particularly at the PGR’s oral hearing during which Medytox’s expert witness acknowledged the upper range of responder rates meeting the claimed limitation.

Finally, Medytox raised due process concerns, alleging that the PTAB prevented it from enjoying a full and fair opportunity to litigate the case as the PGR’s final written decision was based solely on the changed construction of the responder rate limitation. U.S. Patent and Trademark Office Director Kathi Vidal, an intervenor in Medytox’s appeal, argued Federal Register notices on the motion to amend pilot established that preliminary guidance issued under the pilot is non-binding on PTAB decisions. Even if the PTAB were required to provide notice of claim construction changes following preliminary guidance on a motion to amend, the Federal Circuit noted several opportunities afforded Medytox to develop arguments on its motion to amend. The PTAB had amended the PGR’s scheduling order for additional claim construction briefing following Galderma’s opposition to Medytox’s motion to amend, and Medytox had further opportunity to address claim construction arguments on its request for Director review or panel rehearing, which was denied by the PTAB in September 2021.

Image Source: Deposit Photos
Image ID: 84022156
Author: gustavofrazao