Patent Case Summaries | Week ending March 18, 2022 – Intellectual Property

A weekly summary of previous patent-related opinions issued by the Court of Appeals for the Federal Circuit and designated previous or informative opinions by the Patent Trial and Appeal Board.

Almirall, LLC c. Amneal Pharmaceuticals LLC, et al., no. 2020-2331 (Fed. Cir. (PTAB) March 14, 2022). Opinion of Lourie, joined by Chen and Cunningham.

Amneal filed an IPR application for a patent held by Almirall relating to methods of treating dermatological conditions using a topical pharmaceutical composition. The claimed composition requires about 2% w/w to about 6% w/w of a polymer viscosity builder comprising an acrylamide/sodium acryloyldimethyltaurate (A/SA) copolymer. The claims also mentioned that the composition “does not include adapalene”.

Amneal asserted that the claims were obvious to the combination of “Garrett”, which discloses an overlapping concentration range but for a different viscosity adjuvant, and either “Nadau-Fourcade” or “Bonacucina”, both of which disclose A/SA viscosity builders. In response, Almirall argued that Garrett’s overlapping range could not create a presumption of obviousness because the presumption only applies when a single reference discloses the full range. Almirall also argued that even though Garrett’s compositions did not include adapalene, more than mere absence was needed to establish disclosure of a negative limitation. The Patent Trial and Appeal Board disagreed and concluded that the contested claims would have been obvious. Almirall appealed.

The Federal Circuit confirmed. First, the court held that the Board did not err in applying a presumption of obviousness based on overlapping ranges. The court credited the Board’s factual findings and reliance on expert testimony explaining that Garrett’s viscosifiers and A/SA agents at issue perform the same function and are interchangeable. The court further noted that the issue of overlapping ranges was not determinative, stating that the combination of evidence involved “merely a case of substitution of one known gelling agent for another”.

Regarding the claim requirement that the composition “does not include adapalene”, the Federal Circuit cited recent precedent that “[a] the reference need not state the absence of a feature to disclose a negative limitation. “The court found it reasonable for the Commission to conclude that skilled craftsmen would interpret Garrett as “discloses[ing] a complete formulation – excluding the possibility of an additional active ingredient. “Because Garrett’s formulations lacked adapalene, the Board” did not err in finding that Garrett discloses the negative limitation of the adapalene claim. “

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BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organization, no. 2020-1415, -1416, -1919, -1920 (Fed. Cir. (ED Va.) March 15, 2022). Opinion of Taranto, joined by Chen. Dissenting opinion in part by Newman.

From 2008 to 2010, BASF and CSIRO collaborated on research into genetically modified plants for fish feed. In 2018, CSIRO filed claims against BASF and its marketing partner, Cargill, alleging infringement of six patents relating to the engineering of plants, specifically canola, to produce specified oils not native to plants. BASF asserted, as a defense to infringement, that it was a co-owner of the claimed patents under a 2008 contract between it and CSIRO. Cargill requested the dismissal for lack of personal skill and inappropriate location, but the district court denied his requests.

The parties claimed infringement of five of the six patents, and a jury found infringement of the claimed claim of the sixth patent. The jury also rejected invalidity challenges, including a challenge that four of the patents were not accompanied by an adequate written description. The jury found that BASF only co-owned one of the patents. The district court ruled that the evidence would not support a finding of will, so the jury did not consider the matter. As a remedy, the district court denied an injunction but granted an ongoing royalty for the five non-co-owned patents.

BASF and Cargill appealed the jury’s verdicts of adequate written description and non-joint ownership of five of the patents, and Cargill appealed the proper venue determination. CSIRO appealed the jury’s decision that BASF was co-owner of one of the six patents as well as the district court’s refusal to submit the jury’s will to the jury, refusal to allow CSIRO to present evidence relating to the royalty rate, the refusal to impose an injunction and the calculation of the royalty rate.

The Federal Circuit first upheld the proper venue finding with respect to Cargill. An agreement between BASF and Cargill “was tantamount to a partnership”, and the deposit of seeds by BASF at the ATCC in the Eastern District of Virginia, for patent-related purposes, was characterized as an act of infringement.

With respect to the written description, the Federal Circuit upheld the finding that the canola plant claims had sufficient written description, but reversed the finding of sufficient written description for the broader claims any plant. In particular, the Federal Circuit credited CSIRO expert testimony that positive test results in Arabidopsis plants would be predictive of results in canola plants, but argued that these results would not be predictive of positive test results in any plant.

As to ownership, the Federal Circuit found that BASF did not co-own any of the six patents. The court thus upheld the jury’s verdict of no co-ownership of BASF on five patents, but reversed the verdict of co-ownership of BASF on the sixth. Specifically, the court held that the subject matter of the disputed patents was not described in the agreement between BASF and CSIRO, as it could give rise to co-ownership, but was developed by CSIRO “by drawing lessons of joint work.

With respect to the appeal, the Federal Circuit asserted that there was no will because knowledge by BASF of the claimed patents was a necessary, but not sufficient, part of a finding of will. Finally, the Federal Circuit referred the issues of denial of an injunction and calculation of remedies to the district court due to the new scope of valid and infringed claims, CSIRO’s entry into the commercial market as a result of the District Court’s decision and the District Court’s inconsistent use of licenses to establish a baseline for negotiating an appropriate royalty rate.

Judge Newman dissented on setting aside the co-ownership of the sixth patent. She explained that the contested claims set out DNA sequences corresponding to genes provided by BASF, as set out in the research agreement, and that CSIRO did not dispute this. Therefore, a reasonable jury could have found co-ownership of the patent.

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