Patent Case Summaries March 23, 2022

Patent Case Summaries | Week Ending March 18, 2022

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

Almirall, LLC v. Amneal Pharmaceuticals LLC, et al., No. 2020-2331 (Fed. Cir. (PTAB) Mar. 14, 2022). Opinion by Lourie, joined by Chen and Cunningham.

Amneal petitioned for IPR of a patent owned by Almirall directed 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 polymeric viscosity builder comprising acrylamide/sodium acryloyldimethyl taurate copolymer (A/SA). The claims also recited that the composition “does not comprise adapalene.”

Amneal asserted that the claims were obvious over the combination of “Garrett,” which discloses an overlapping concentration range but for a different viscosity builder, 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 applies only when a single reference discloses the complete range. Almirall also argued that although Garrett’s compositions did not include adapalene, more than mere absence is needed to establish disclosure of a negative limitation. The Patent Trial and Appeal Board disagreed and found that the challenged claims would have been obvious. Almirall appealed.

The Federal Circuit affirmed. First, the court ruled 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 viscosity builders and the A/SA agents at issue perform the same function and are interchangeable. The court further noted that the issue of overlapping ranges was not controlling, stating that the obviousness combination involved “simply a case of substituting one known gelling agent for another.”

With respect to the claim requirement that the composition “does not comprise adapalene,” the Federal Circuit cited recent precedent that “[a] reference need not state a feature’s absence in order to disclose a negative limitation.” The court deemed it reasonable for the Board to find that skilled artisans would interpret Garrett as “disclos[ing] a complete formulation—excluding the possibility of an additional active ingredient.” Because Garrett’s formulations lacked adapalene, the Board “did not err in concluding that Garrett discloses the negative adapalene claim limitation.”

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BASF Plant Science, LP v. Commonwealth Scientific & Industrial Research Organisation, Nos. 2020-1415, -1416, -1919, -1920 (Fed. Cir. (E.D. Va.) Mar. 15, 2022). Opinion by Taranto, joined by Chen. Opinion dissenting in part by Newman.

From 2008 to 2010, BASF and CSIRO collaborated on research relating to genetically modified plants to be used for fish food. In 2018, CSIRO filed claims against BASF and its commercialization partner, Cargill, alleging infringement of six patents relating to the engineering of plants, particularly canola, to produce specified oils not native to the plants. BASF asserted, as an infringement defense, that it co-owned the asserted patents by virtue of a 2008 contract between it and CSIRO. Cargill sought dismissal for lack of personal jurisdiction and improper venue, but the district court denied its motions.

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

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

The Federal Circuit first affirmed the finding of proper venue with respect to Cargill. An agreement between BASF and Cargill “amounted to a partnership,” and BASF’s deposit of seeds at the ATCC in the Eastern District of Virginia, for patenting-related purposes, qualified as an infringing act.

With respect to written description, the Federal Circuit affirmed the holding that the claims directed to canola plants possessed sufficient written description, but reversed the holding of sufficient written description for the broader claims directed to any plant. In particular, the Federal Circuit credited CSIRO’s expert testimony that positive test results in Arabidopsis plants would be predictive of results in canola plants, but held that such results would not be predictive of positive test results in any plant.

As to ownership, the Federal Circuit held that BASF was not a co-owner of any of the six patents. The court thus affirmed the jury verdict of no BASF co-ownership of five patents, but reversed the verdict of BASF co-ownership of the sixth. Specifically, the court held that the subject matter in the contested patents was not outlined in the agreement between BASF and CSIRO, as might give rise to co-ownership, but was developed by CSIRO “drawing on the lessons” of the joint work.

Regarding the remedy, the Federal Circuit affirmed the holding of no willfulness because BASF’s knowledge of the asserted patents was a necessary, but not sufficient, part of a willfulness finding. Finally, the Federal Circuit remanded the issues of the denial of an injunction and the calculation of the remedies to the district court due to the changed scope of the valid and infringed claims, CSIRO’s entry into the commercial market following the district court’s decision, and the district court’s inconsistent use of licenses in setting a baseline for negotiation of a proper royalty rate.

Judge Newman dissented as to the reversal of the holding of co-ownership of the sixth patent. She explained that the disputed claims recite DNA sequences corresponding to BASF-provided genes, as recited in the research agreement, and that CSIRO did not dispute this. Accordingly, a reasonable jury could have found co-ownership of the patent.

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