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17 August 2023BiotechnologyLiz Hockley

Fed Circ affirms invalidation of two cancer treatment patents

Judges uphold PTAB decision invalidating Incept patents related to use of biodegradable filler in radiation treatment | Swedish firm Palette had challenged patents through inter partes review.

An appeals board decision to strike down two patents relating to cancer treatment—owned by Incept, a life sciences investment firm—has been upheld by the federal circuit.

In the judgment handed down yesterday, August 16, the US Court of Appeals for the Federal Circuit confirmed the Patent Trial and Appeal Board (PTAB)’s earlier decision, which said the patents were unpatentable due to prior art.

Despite one circuit judge dissenting in part from the majority opinion, the panel ended Incept’s hopes of reviving US patents 8,257,723 and 7,744,913.

The patents had been challenged through inter partes review by Palette Life Sciences, a subsidiary of Swedish firm Pharmanets.

The patents-in-suit relate to improved methods of treating cancer, particularly prostate, using radiation. They describe methods of introducing a filler between radiation target tissue and other tissue to decrease the amount of radiation received by non-targeted tissue.

Specifically, the claims of both patents cite a filler gel that is biocompatible, injectable, biodegradable or removable by biodegradation, and introduced between a radiation target and a nearby tissue.

In its petitions for IPR, Palette said certain claims of the patents would have been anticipated by US patent 6,624,245 (Wallace), which describes a method for the “rapid formation of a biocompatible gel . . . at a selected site within a patient’s body” and others obvious in view of it.

The PTAB held that Palette had established the claims to be unpatentable on these grounds.

‘A patchwork approach’

Incept told the appeals court that the Board had taken a “patchwork approach” which involved “picking and choosing” from Wallace’s different teachings to piece together the elements of the ‘723 patent claims.

The firm said that Wallace teaches “a complex, multi-step process for its gel” which describes “millions, if not billions, of different possible compositions”. It argued that the Board failed to identify a teaching in Wallace that any of its compositions are “entirely removable by biodegradation”, or placed between an organ and a nearby tissue.

Regarding the obviousness determination, Incept contended that the PTAB “merely reiterated its anticipation analysis”, “disregarded statements in Wallace that teach away from the claimed biodegradable compositions”, and “improperly disregarded Incept’s evidence of commercial success”, among other claims.

No legal error’

The judges disagreed that the Board had engaged in “picking and choosing”, and agreed with its finding that Wallace described the same compositions, with the same purpose, as those referred to in the ‘723 patent.

They were not persuaded that the Board’s finding of biodegradability was insufficient, and found “no legal error” in its anticipation analysis.

This was also the case for the obviousness analysis. “Wallace discloses, and thereby renders obvious, the use of a gel that is both biocompatible and biodegradable,” Judge Schall wrote.

The judges were also unpersuaded by Incept’s argument that its evidence to show commercial success was sufficient, and affirmed the Board’s final written decisions.

Remand for redetermination

The patents-in-suit contained either one or two independent claims, followed by 23 dependent claims each. One judge—96-year-old Circuit Judge Pauline Newman—took issue with how all the claims in the patents had been analysed.

Judge Newman agreed with the panel that claim 1 of the two patents were invalid, “for these broadest claims can be reasonably read to include prior art”.

However, for the other dependent claims, she concluded that “neither the Board nor the panel majority adequately determined patentability of their claimed inventions as a whole”.

“My concern is with the invalidation of the dependent claims, without analysis of these claims’ additional limitation in view of prior art”, the judge wrote.

“I would vacate the Board’s decisions as to the subordinate claims, and remand for redetermination of anticipation and obviousness on correct law”.

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