Last Week in the Federal Circuit (November 29 - December 3): COVID-19 Vaccine Patents at the PTAB

Last week the Federal Circuit was gearing up for its December argument sitting, but the Court still found time to issue several decisions. Below we provide our usual weekly statistics and our case of the week—our highly subjective selection based on whatever case piqued our interest.

Precedential opinions: 3

Non-precedential opinions: 3

Rule 36: 0

Longest pending case from argument: Tie between Biogen International GmbH v. Mylan Pharmaceuticals Inc., No. 20-1933, and Mylan Pharmaceuticals Inc. v. Biogen MA Inc., No. 20-1673 (357 days each)

Shortest (non-Rule 36) pending case from argument: Tie between Moderna TX, Inc. v. Arbutus Biopharma Corporation, No. 20-2329, and Moderna TX, Inc. v. Arbutus Biopharma Corporation, No. 20-1184 (55 days each)

Case of the week: ModernaTX, Inc. v. Arbutus Biopharma Corporation, No. 20-2329

Panel: Judges Lourie, O’Malley, and Stoll, with Judge Lourie writing the opinion

You should read this case if: you have a matter involving (1) standing in an appeal from an IPR decision or (2) a presumption of obviousness based on overlapping ranges in the prior art.

This week’s case brings us another dose of COVID-19 news, this time with the RNA technology used in some COVID-19 vaccines making its way to the Federal Circuit’s patent docket. Our case mainly involves the presumption of obviousness that typically applies “when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”

Arbutus’s patent involved nucleic acid lipid particle compositions for delivery of nucleic acids—such as small interfering RNA—into cells. The claimed composition comprised four main lipid components: cationic lipid, phospholipid, cholesterol, and conjugated lipid. Each lipid component made up a certain range of mol % of the total lipid in the particle.

Moderna petitioned for an IPR of Arbutus’s patent, asserting that all claims were unpatentable for obviousness. The dispute before the Board focused on the phospholipid range. Moderna conceded that the prior art did not expressly disclose the claimed phospholipid range “from 4 mol % to 10 mol %.” But it contended that the range could have been calculated based on the fact that all mol % must total 100% or by routine optimization. The Board rejected Moderna’s obviousness arguments, and Moderna appealed.

The Federal Circuit affirmed. The Court began by holding that Moderna had standing to pursue its appeal based on the risk of Arbutus filing an infringement suit. Back in 2017, Arbutus asserted that it had extensive patent coverage over virtually all nanoparticle delivery systems. Moderna provided evidence describing its work on mRNA technology, delivery techniques, and COVID-19 vaccine manufacturing techniques, as well as Arbutus’s refusal to grant a covenant not to sue on its patent. The Court concluded that this record adequately showed a risk that Arbutus would bring an infringement lawsuit against Moderna. But the Court rejected Moderna’s alternative argument that it had standing to appeal based on its current status as a licensee of the challenged patent. The Court addressed this issue in more detail in another opinion released the same day (No. 20-1184).

On the merits of the obviousness challenge, the Court held that a presumption of obviousness did not apply because the phospholipid range was not expressly disclosed in the prior art. The Court declined to decide whether the presumption of obviousness due to overlapping ranges could ever apply when the prior art had no express disclosure of a range. Instead, the Court focused on Moderna’s failure to show that the prior art actually taught the overlapping range.

The Court rejected Moderna’s theory that all four lipids must add up to 100 mol % and that a person of ordinary skill could derive the phospholipid range based on simple subtraction. According to the Court, it was “contrary to logic” to assume that lipid components could be increased or decreased in the corresponding amounts to maintain a total of 100%. The Court explained that the claimed particle should be considered as a whole rather than focusing on each component separately. That is because the lipid components are interdependent and had unpredictable interactions.

This lipid interdependence was also key to the Federal Circuit’s rejection of Moderna’s argument that a skilled artisan could have obtained the claimed ranges through routine optimization using starting points disclosed in the prior art. The Court concluded that evidence of general considerations for each component was not enough to show obviousness, as Moderna failed to address the interdependence of the lipid components and how adjustments would affect the entire particle.