In Vectura Limited v. Glaxosmithkline LLC, [2020-1054] (November 19, 2020), the Federal Circuit affirmed the district court determination that U.S. Patent No. 8,303,991, directed to the production of “composite active particles” for use in pulmonary administration, was not invalid and was infringed. The jury awarded $89,712,069 in damages, and after unsuccessful motions for JMOL and a new trial, Glaxosmithkline appealed.

The construction of two claim terms were relevant to the appeal. First, the court construed the phrase “promotes the dispersion of the composite active particles” (the dispersion limitation) to mean “wherein a composition that contains one or more composite active particles has increased dispersion of the active material upon activating a delivery device for inhalation into the lungs by a patient, as compared to the same composition wherein unmodified active particles are substituted for the composite active particles.”

Second, the court construed the term “composite active particles” to mean “[a] single particulate entit[y/ies] made up of a particle of active material to which one or more particles of additive material are fixed such that the active and additive particles do not separate in the airstream.”

The parties agreed that, under the district court’s construction of the dispersion limitation, Vectura needed to prove that the use of magnesium stearate in the accused inhalers improves the dispersion of the active ingredient compared to identical products in which only the lactose excipient is coated with magnesium stearate. On appeal, GSK argued that there was no substantial evidence of infringement as to that limitation because Vectura staked its case on a defective scientific test. However the flaw in GSK’s position was that Vectura did not rely exclusively on the allegedly defective tests.

While the allegedly defective test was not perfect, the Federal Circuit said that a jury could conclude that despite its drawbacks, the study generally supported the view that coating the active ingredient with magnesium stearate improves dispersion of the active ingredient. The Federal Circuit said that regardless of any infirmities in the test, there was ample other evidence at trial indicating that magnesium stearate improves the dispersion of active ingredients.

GSK also challenged the district court’s construction of the claim term “composite active particles,” contending that the court should have construed that term to require that the composite particles be produced by the “high-energy milling” process referred to in the specification. The Federal Circuit noted that GSK’s argument falls between two prior cases: Continental Circuits LLC v. Intel Corp., 915 F.3d 788 (Fed. Cir. 2019), and Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361 (Fed. Cir. 2007). In Andersen, the Federal Circuit construed an apparatus claim to include a process limitation. In Continental Circuits, the Federal Circuit declined to import a process limitation into an apparatus claim. In both cases, the Federal Circuit recognized that “process steps can be treated as part of the product claim if the patentee has made clear that the process steps are an essential part of the claimed invention.”

The Federal Circuit noted that although the ’991 patent contains a few statements suggesting that its high-energy milling is required, those statements are outweighed by the numerous statements indicating that high-energy milling is merely a preferred process. The Federal Circuit thus concluded that the specification of the ’991 patent does not make its milling method an essential part of apparatus claim 1. The Federal Circuit also rejected also reject GSK’s argument that the prosecution history requires “composite active particles” to be construed to include a process limitation, and affirmed the district court’s claim construction.