Authored by Sheila Mortazavi and Malorie Ruggeri

In Medytox, Inc. v. Galderma S.A, the Federal Circuit affirmed a Final Written Decision of the Patent Trial and Appeal Board (“Board”) that found Medytox’s proposed substitute claims invalid and denied Medytox’s motion to amend substitute claims.¹ On appeal, Medytox challenged the Board’s findings on claim construction, new matter, enablement, and written description.² Medytox also challenged the Board’s Pilot Program regarding motion to amend practice and procedures under the Administrative Procedure Act (“APA”) and on due process grounds, in view of the Board’s change in claim construction between the Preliminary Guidance issued under its Pilot Program and the Final Written Decision.³

The patent at issue, U.S. Patent No. 10,143,728 (the “’728 patent”), is directed to the use of an “animal-protein-free botulinum toxin composition that exhibits a longer lasting effect in the patient compared to an animal-protein-containing botulinum toxin composition.”⁴ The claimed composition “can be used to treat both cosmetic and non-cosmetic conditions from glabellar lines and lateral canthal lines to chronic migraines.”⁵

At issue on appeal were proposed substitute claims 19-27.⁶  Substitute claim 19 amended original claim 1 to further recite “wherein said greater length of effect is determined by physician’s live assessment at maximum frown and requires a responder rate at 16 weeks after the first treatment of 50% or greater.”⁷

Appellee Galderma filed a petition requesting post-grant review of claims 1-10 of the ’728 patent in 2020, which the Board granted on all challenged claims.⁸ Subsequently, Medytox filed a non-contingent motion to amend seeking to cancel claims 1-10 and substitute claims 11-18, and requested that the Board issue a Preliminary Guidance in accordance with the Board’s Pilot Program.⁹ Galderma opposed the motion, arguing that the claims added new matter because they covered compounds with a responder rate between 50% and 100%, whereas the original specification only disclosed responder rates up to 62%.¹⁰

In its Preliminary Guidance, the Board found that Medytox had not shown a “reasonable likelihood that it satisfied the statutory and regulatory requirements for filing a motion to amend.”¹¹ The Board also provided its “preliminary view” that Medytox’s proposed responder rate limitation “did not add new matter” and “should not ‘necessarily be interpreted as a specific range of 50% to 100%’ as opposed to simply 50% or greater.”¹²  The Board nevertheless emphasized that “‘the views expressed in this Preliminary Guidance are subject to change upon consideration of the complete record, including any revision to the Motion filed by Patent Owner.’”¹³

Medytox subsequently filed a non-contingent revised motion to amend, attempting to cancel original claim 6 and to replace the other original claims with substitute claims 19-27.¹⁴ Galderma opposed and again argued that the responder rate limitation of “50% or greater” was not “sufficiently enabled or described in the specification.”¹⁵ Medytox urged that the responder rate limitation be interpreted as a clinical threshold, rather than a range.¹⁶

The oral hearing took place on March 19, 2021.¹⁷  During the hearing, the Board asked the parties to explain how the responder rate limitation should be interpreted and to “identify specific examples from the specification that would satisfy the written description requirement” for those claims.¹⁸

The Board issued its final written decision on July 16, 2021.¹⁹ First, the Board cancelled original claims 1-5 and 7-10, because with a non-contingent motion to amend, the Board provides a final decision only on the patentability of substitute claims, not the patentability of the corresponding original claims.²⁰ The Board primarily focused on the parties’ dispute about whether the responder rate should be construed as a range of 50%-100%, as Galderma argued, or as a minimum threshold of 50%, as Medytox argued.²¹ The Board also evaluated whether Medytox’s proposed substitute claims were reasonable in number, responsive to the grounds of unpatentability set forth in trial, and “improperly broader” than the original claims.²²

The Board found that the proposed substitute claims “impermissibly introduced new matter with the inclusion of the responder rate limitation and thus, failed to meet the requirements for a revised motion to amend.”²³  The Board ultimately determined that the substitute claims were unpatentable because they first, lacked written description, and second, were not enabled.²⁴ The Board reasoned that “a skilled artisan would not have been able to achieve higher than 62% for the responder rate limitation when reading the specification,” without undue experimentation.²⁵ Despite its earlier-expressed and contrary “preliminary view,” the Board rejected Medytox’s argument that the responder rate limitation only requires a threshold of 50% and instead interpreted the limitation as a range with an upper limit of 100%.²⁶ Accordingly, the Board denied Medytox’s revised motion to amend.²⁷

The Federal Circuit first addressed the Board’s claim construction of the responder rate limitation.²⁸ Medytox argued that the “responder rate limitation should be construed as ‘yes-or-no inquiry’ such that it is a threshold for determining whether the claimed animal-protein-free composition has a ‘greater length of effect’ than BOTOX®.”²⁹ The court found that the responder rate limitation has an “inherent upper limit.”³⁰ If explicitly stated as a range of 50%-100%, the upper limit of the range is clearly 100%, and if the limitation is viewed as a threshold, there is a natural upper limit of 100%.³¹ Therefore, the court found “no substantive difference in the claim constructions proposed by the parties,” and affirmed the Board’s claim construction of the limitation as a range.³²

The Federal Circuit next evaluated the parties’ evidence regarding enablement.³³ Medytox argued that the specification does not need to include a working example of “every possible embodiment to enable the full scope of the claims,” citing to expert testimony that no undue experimentation is required to practice the claims because it is “‘routine to clinically confirm’ that similar compositions meet the limitation.”³⁴ The court held that although caselaw does not necessitate disclosure of every possible working example of responder rates, Medytox provided only three examples, 52%, 61%, and 62%.³⁵ Citing the Supreme Court’s recent Amgen Inc. v. Sanofi decision—which states that “[t]he more one claims, the more one must enable”³⁶—the Federal Circuit found Medytox’s disclosure of only three examples inadequate to satisfy the enablement requirement because a skilled artisan “‘would not have been able to achieve’ responder rates higher than the limited examples provided in the specification.”³⁷ Accordingly, the court affirmed the Board’s determination of lack of enablement for the substitute claims.³⁸

Third, the court addressed Medytox’s argument that the Board violated the APA when changing its claim construction of the responder rate limitation between its Preliminary Guidance and Final Written Decision.³⁹ Medytox contended that the Board did not analyze new evidence when revising its claim construction.⁴⁰ Medytox claimed the Board offered “‘inconsistent conclusions on a nearly identical record,’ render[ing] its decision arbitrary and capricious.”⁴¹ The USPTO Director, Katherine Vidal, intervened in the appeal to respond to Medytox’s APA challenges.⁴² She stated that “the Board’s Preliminary Guidance is exactly as its name suggests: preliminary.”⁴³ Moreover, she emphasized that the Board’s Preliminary Guidance explicitly stated that the opinions offered were “‘initial, preliminary, and non-binding.’”⁴⁴ Director Vidal also pointed to the difference in the standard of the burden of persuasion on Medytox for the Board’s Final Written Decision, preponderance of the evidence, as opposed to the standard for the Preliminary Guidance, reasonable likelihood.⁴⁵ Director Vidal stated that this difference is “indicative of the nature of the determinations reached in the Preliminary Guidance.”⁴⁶ The Federal Circuit found that “the extrinsic record was developed between the Board’s issuance of its Preliminary Guidance and the Final Written Description.”⁴⁷ Thus, the Federal Circuit concluded that the Board was well within its discretion to rely on this evidence in reaching its ultimate decision, and that the Board’s change in claim construction for the responder rate limitation was not arbitrary and capricious.⁴⁸

Medytox lastly asserted that it was prevented from a full and fair opportunity to litigate the case because the Preliminary Guidance did not suggest that the Board might later rule differently.⁴⁹ In response, Director Vidal relied on the Federal Register, where the notice on the Pilot Program was published, which again emphasizes the “‘preliminary, non-binding’ nature of the guidance.”⁵⁰ Likewise, during Oral Argument, Director Vidal made it clear that the Preliminary Guidance was “designed to be an ‘initial discussion,’” and noted that the Board’s Preliminary Guidance included language about the non-binding nature of the Board’s views.⁵¹ Therefore, the Federal Circuit held that the Board did not violate due process or the APA, as Medytox should have been well aware that Board’s decision in the Preliminary Guidance was only preliminary.⁵²

The Federal Circuit concluded that the Board’s claim construction and finding of lack of enablement for the substitute claims were reasonable and supported by substantial evidence.⁵³ Additionally, the court found that the Board’s Preliminary Guidance for the Pilot Program did not violate the APA, and the Board’s actions did not constitute a due process violation.⁵⁴ Therefore, the court affirmed the Board’s denial of Medytox’s revised motion to amend.⁵⁵

Practitioners should keep in mind that the Preliminary Guidance received from the Board under the Pilot Program is subject to change based on further development of the record, and should present their arguments accordingly whether seeking or opposing a motion to amend claims.