Vectura Limited v. GlaxoSmithKline LLC et al.
PROST, BRYSON, WALLACH
November 19, 2020
Brief Summary: DC finding that GSK’s inhaler composition infringe Vectura’s patent and the ~$90 million damages award affirmed. Summary: GSK appealed jury finding it infringed Vectura’s US 8,303,991 directed to “[c]omposite active particles for use in a pharmaceutical composition for pulmonary administration” that include magnesium stearate, and the damages award. Vectura alleged infringement by GSK’s Ellipta-brand inhalers (the Breo, Anoro, and Incruse devices) and awarded almost $90 million in damages (3% royalty on $2.99 billion in sales). GSK’s “accused inhalers feature one or more ‘blisters,’ which are sealed receptacles containing a single active ingredient, an excipient, and, optionally, additive material” (vilanterol, umeclidinium, or fluticasone deposited onto magnesium stearate-coated lactose particles). The DC construed the claim phrases “promotes the dispersion of the composite active particles” as being “compared to the same composition” but including “unmodified active particles”, and “composite active particles” as being those in which “the active and additive particles do not separate in the airstream”. GSK argued that Vectura did not present substantial evidence that “the accused inhalers use additive material that ‘promotes the dispersion’ of the active material” and that “composite active particles” was misconstrued. The FC panel opinion reviewed Vectura’s evidence and concluded that the jury’s finding was supported by substantial evidence. The DC’s construction of “composite active particles” was based only on intrinsic evidence and the FC panel therefore applied de novo review (Teva, US 2015). GSK argued that the term “should be construed to include a process limitation” which the panel explained “falls between two prior cases from this court:” Continental Circuits (FC 2019) and Anderson (FC 2007) (e.g., Continental “merely indicated a preference” for the process while Anderson’s “specification made it clear that a process was an essential part of the apparatus claim” (“language of requirement, not preference”), confirmed by the prosecution history). The FC panel found the ‘991 patent specification to be “more like the specification in Continental Circuits than the specification in Andersen” (e.g., “few statements suggesting that its high-energy milling is required”, “outweighed by the numerous statements indicating that high-energy milling is merely a preferred process”, criticism of other methods “not dispositive” (AstraZeneca, FC 2013)). The FC panel also found that GSK’s prosecution arguments distinguishing the prior art were “based on the unique structure of the claimed composite particles, not the disclosed milling method”. The FC panel also found that the DC “did not abuse its discretion in denying GSK’s motion for a new trial on damages” based on, e.g., properly considered expert testimony regarding a “hypothetical negotiation”.