PTAB Issues Rare Sua Sponte Order in Botox PGR


In a rare sua sponte action, the Board issued an order providing notice that the patent owner’s amended claims in an ongoing PGR may be unpatentable. Galderma S.A. v. Medy-Tox, Inc., PGR2019-00062, Paper 54 (Feb. 24, 2021). The Board found that Medy-Tox’s use of the trademark “BOTOX®” in the only independent claim of its U.S. Patent No. 10,143,728 (“the ’728 Patent”) provided potential grounds for finding the claims indefinite.

The underlying PGR began in September 2019 when Galderma filed a petition challenging the validity of the ’728 patent, which generally relates to using an animal-protein-free botulinum toxin composition, instead of an animal-protein-containing botulinum toxin composition, to reduce glabellar lines, or face wrinkles. The ’728 patent claimed that the animal-free toxin had a longer lasting effect than animal-containing botulinum toxins.

Galderma argued, among other things, that the claims were unsupported by the written description and lacked enablement under 35 U.S.C. § 112. The Board instituted the PGR, and in its Patent Owner Response, Medy-Tox moved to amend the claims of the ’728 patent to address issues raised in the Board’s Institution Decision. Specifically, Medy-Tox proposed amending the claims to recite the animal-free toxin was limited to “a serotype A botulinum toxin” composition. The Board then provided nonbinding preliminary guidance regarding the proposed amended claims under the PTAB’s Motion to Amend Pilot Program.[1]

Specifically, the Board acknowledged that the specification contains two examples comparing an animal-free toxin to BOTOX®, but noted that those examples do not contemplate varying doses and that BOTOX® is not the only animal-containing toxin available. These deficiencies, the Board stated in its nonbinding preliminary guidance, likely support a finding that Medy-Tox’s proposed amended claims were broader than the support provided in the specification.

In response, Medy-Tox filed a revised motion to amend, proposing narrower substitute claims. The new set of proposed claims specifically referenced “BOTOX®” instead of the broader “animal-protein-containing botulinum toxin” language.

Upon receipt of the revised amended claims, the Board issued the sua sponte order. The Board’s order notes that Medy-Tox’s use of a trademark, i.e., BOTOX®, in its claim language could render the claims indefinite. Although not per se improper, the Board noted that the use of a trademark in a claim to identify a particular material or product could render the claim indefinite under 35 U.S.C. § 112(b), citing MPEP § 2173.05(u). The Board further explained that this case was one of the rare circumstances in which there is a readily identifiable ground of unpatentability, allowing the Board to itself provide notice of the issue and allow the parties an opportunity to address the matter. See Nike, Inc. v. Adidas AG, 955 F.3d 45, 51 (Fed. Cir. 2020) (holding that the Board must give parties an appropriate opportunity to respond to issues raised sua sponte).

The order serves as a reminder that, even when the Board suggests that a party narrow claims in a particular way during an AIA trial proceeding, practitioners should pay close attention to the relevant MPEP guidance governing patent prosecution.

[1] More information on the first year of the PTAB’s Motion to Amend Pilot Program can be found at….

© 2021 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
National Law Review, Volume XI, Number 76

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