Patent Case Summaries July 5, 2023

Patent Case Summaries | Week Ending June 30, 2023

A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

Medytox, Inc. v. Galderma S.A., et al., No. 2022-1165 (Fed. Cir. (PTAB) June 27, 2023). Opinion by Reyna, joined by Dyk and Stark.

Galderma filed a petition requesting post-grant review of a Medytox patent related to use of an animal-protein-free botulinum toxin composition having a longer lasting effect than known compositions. Medytox filed a non-contingent motion to amend seeking to cancel and replace claims 1–10 of the patent, and Medytox requested that the Patent Trial and Appeal Board issue Preliminary Guidance in accordance with the Board’s pilot program for motion to amend practice and procedures. Galderma opposed the motion, arguing (among other things) that a limitation in the amended claims requiring “a responder rate at 16 weeks after the first treatment of 50% or greater” added new matter.

The Board issued Preliminary Guidance finding that the responder rate limitation did not add new matter. The Board also construed the limitation to require only a minimum threshold of 50% (as argued by Medytox) rather than a range of 50% to 100% (as argued by Galderma). Nonetheless, the Board found that Medytox had not shown a reasonable likelihood that it satisfied the requirements for filing a motion to amend. Medytox then filed a revised motion to amend, which Galderma again opposed on a variety of grounds.

In a final written decision, the Board denied Medytox’s revised motion to amend. The Board found that the responder rate limitation in the substitute claims introduced new matter and should be construed as a range from 50% to 100% (thus reversing its Preliminary Guidance as to both rulings). The Board then found that the proposed substitute claims were unpatentable for lack of written description and lack of enablement. Medytox appealed the Board’s findings on claim construction, new matter, written description, and enablement. Medytox also brought an Administrative Procedure Act challenge to the Board’s pilot program and raised a due process claim.

The Federal Circuit affirmed the Board’s construction of the responder rate limitation as a range because the parties identified no substantive difference between their respective proposals. The Federal Circuit also affirmed the Board’s finding that the full scope of the amended claims was not enabled. The specification contained only three examples of responder rates above 50%, and undue experimentation would be required to practice the full claimed range of 50% to 100%. Because the Federal Circuit affirmed the Board’s finding of no enablement, the court did not address the written description issue.

Lastly, the Federal Circuit upheld the Board’s decision to change its claim construction because the construction was based on evidence developed after the Board had issued its Preliminary Guidance. The Federal Circuit also rejected Medytox’s due process argument that it had been denied a full and fair opportunity to litigate the case due to the Board’s rulings that departed from the Preliminary Guidance. The Preliminary Guidance expressly stated that the findings were preliminary in nature. Similarly, the notice of the pilot program published in the Federal Register made clear that Preliminary Guidance under the pilot program is preliminary and non-binding. Thus, the Board did not violate due process or the APA.

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