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Federal Circuit Affirms PTAB, Citing Recent SCOTUS Opinion On Enablement
07/06/2023On June 27, 2023, the United States Court of Appeals for the Federal Circuit (“CAFC”) affirmed a decision by the United States Patent and Trademark Office, Patent Trial and Appeal Board (“PTAB”), holding that proposed substitute claims were not patentable for lack of written description and lack of enablement under 35 U.S.C. § 112. Medytox, Inc., v. Galderma S.A., No. 2022-1165 (Fed. Cir. June 27, 2023). The CAFC panel (Dyk, Reyna, and Stark) reviewed the PTAB’s legal conclusions de novo and its factual findings for substantial evidence. In affirming the PTAB, the CAFC concluded that the substitute claims were not enabled because a skilled artisan would not have been able “to make and use all of what is claimed.”
U.S. Pat. No. 10,143,728 (the “’728 patent”) was issued to Medytox in 2018 and is directed to the use of an animal-protein-free botulinum toxin composition used to treat certain conditions. In 2019, Galderma sought post grant review of the ’728 patent, arguing that the claims were indefinite, obvious, or lacking sufficient written description. After the PTAB granted review, Medytox filed a non-contingent motion to amend seeking to cancel claims 1–10 and substitute claims 11–18, which Galderma opposed. Following “Preliminary Guidance” from the PTAB—provided under a “Pilot Program” to patent owners that request early guidance regarding the likelihood a motion to amend and substitute claims will succeed—Medytox filed a non-contingent revised motion to amend, seeking cancellation of original claim 6 and replacement of the other original claims with substitute claims 19–27.
Because Medytox had filed a noncontingent motion to amend, the PTAB analyzed the substitute claims for patentability in place of the original claims. After addressing a claim construction dispute about whether the “responder rate” limitation was a range of 50%–100% or a minimum threshold of 50% (the PTAB determined the limitation was a range in its final written decision, reversing course from its Preliminary Guidance that interpreted the limitation as a threshold) and confirming that the substitute claims were properly submitted, the PTAB concluded that the substitute claims were unpatentable for lack of written description because the full scope of the claims was not enabled. Medytox appealed to the CAFC.
On appeal, the CAFC first addressed whether the contested “responder rate” claim limitation was a range or a threshold. The CAFC concluded that there was no substantive difference between the two possibilities and accordingly affirmed the PTAB’s construction.
Next, the CAFC considered whether the claims were properly enabled. The specification of the ’728 patent includes, at most, three examples of responder rates above 50%: 52%, 61%, and 62%. Quoting a recent Supreme Court decision, the CAFC recited the requirement that “the more one claims, the more one must enable,” and that the specification must “enable the full scope of the invention as defined by its claims.” Amgen v. Sanofi, 143 S. Ct. 1243, 1254 (2023). In affirming the PTAB, the CAFC found that a skilled artisan could not have achieved higher rates than those examples in the specification, and that there was no factual or legal error in the PTAB’s determinations that the full scope of the substitute claims was not enabled.
Last, the CAFC affirmed the PTAB’s claim construction, holding that the PTAB was permitted to revise its initial claim interpretation as stated in its “Preliminary Guidance.” The revision did not violate due process or the Administrative Procedure Act, because, among other reasons, the change was not arbitrary and capricious and there was sufficient public notice with “explicit language about its non-binding and ‘initial’ nature.”
In light of Medytox and the Supreme Court’s guidance in Amgen v. Sanofi, patent applicants (and litigants) should carefully evaluate the specification’s written description and whether it is sufficient to enable the full scope of the claimed invention.
