Incept LLC v. Palette Life Sciences, Inc., Appeal Nos. 2021-2063, -2065 (Fed. Cir. Aug. 16, 2023)

In the Federal Circuit’s only precedential opinion this week, the Court affirmed inter partes review findings that challenged claims of Incept’s U.S. Patent Nos. 8,257,723 and 7,744,913 were invalid as anticipated or obvious over the prior art. Incept’s patents were generally directed to methods of radiation treatment for cancer involving the use of a “filler” injected into the treatment site to put distance between the tissue to be irradiated and surrounding organs, such that the surrounding organs receive less radiation than they would without the filler.

As relevant to the appeal, independent claims 1 of both patents required the filler to be “biodegradable” and “removable by biodegradation in the patient.”  Petitioner Palette’s primary prior art reference, Wallace, disclosed biocompatible gels with “biodegradable segments” that may be “distributed throughout the polymer’s molecular structure,” and which “degrade so as to break covalent bonds” in the filler polymer.  However, Wallace also disclosed that polymers are “essentially nondegradable in vivo over a period of at least several months,” and that its disclosed compositions are “not readily degradable,” which Incept argued taught away from the “biodegradable” and “removable by biodegradation” limitations.

The majority rejected that argument, finding that “the Board could reasonably read those statements as not contradicting the Board’s finding that Wallace teaches compositions that have the only biodegradability properties required by the claims at issue,” which for the independent claims did not require the filler to degrade within any specified period of time or be “readily” biodegradable.  Coupled with Palette’s expert testimony explaining what a skilled artisan would have taken from Wallace, the Court found that substantial evidence supported the Board’s anticipation determinations.

Incept also took issue with what it argued was the Board’s failure to separately consider the obviousness of certain dependent claims, some of which did require certain time limits for the claimed biodegradation.  However, the majority noted that Palette had identified the presence of these limitations in its asserted prior art references; that Palette’s expert had otherwise testified that a skilled artisan would have known how to configure Wallace’s compositions to biodegrade within a predetermined time; and that in any event, Incept had not separately argued for the patentability of the dependent claims in the proceedings below.  The majority reaffirmed that “[w]here a party does not raise any arguments with respect to any other claim limitation, nor does it separately argue the dependent claim, the dependent claim stands or falls together with the independent claim” (cleaned up), quoting Genentech, Inc. v. Hospira, Inc., 946 F.3d 1333, 1340 (Fed. Cir. 2020).

The majority also found no error in the Board’s discounting of Incept’s evidence of objective considerations of non-obviousness, for example because certain annualized sales data did not distinguish between sales of the patented product and free samples or replacement products, and because the Board found Incept’s expert’s estimate of the proportion of cancer treatments using the product to be insufficiently supported by evidence.  As such, the majority affirmed the Board’s final written decision finding all challenged claims to be anticipated or obvious.

Judge Newman filed a separate opinion concurring in part and dissenting part.  While Judge Newman agreed that the independent claims were properly found to be anticipated by Wallace, she would have remanded the case for further consideration of the patentability of the dependent claims, and also argued that Incept’s evidence of commercial success was not permissibly discounted by the Board.

The opinion can be found here.

By Jason Wrubleski

This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.