In the recent decision, Vectura Ltd. v. GlaxoSmithKline LLC, Appeal. No. 2020-1054 (Fed. Cir., November 19, 2020), the panel dealt with an appeal by GlaxoSmithKline LLC (“GSK”) from a district court decision that found infringement of Vectura’s claims directed to “composite active particles” of the type used to deliver drugs via dry powder inhalers. Claim 1 of U.S. Pat. No. 8,303,991 reads:

“1. Composite active particles for use in a pharmaceutical composition for pulmonary administration, each composite active particle comprising a particle of active material and particulate additive material on the surface of the particle of active material, wherein the composite active particles have a mass median aerodynamic diameter of more than 10 um and wherein the additive material promotes the dispersion of the composite active particles upon activation of a delivery device.”

Without going into a lot of detail, the Glaxo inhalers feature one or more “blisters”, which are sealed “receptacles” containing a single active ingredient, an excipient and, optionally “additive material,” which in these blisters use magnesium stearate as the additive and lactose as the excipient, along with a variety of actives, including fluticasone. In the preparation step, small particles of the active are deposited onto the larger lactose particles, which are already coated with small particles of magnesium  stearate. Glaxo attempted to avoid infringement by arguing that the district court erred in finding that Vectura had presented sufficient evidence that its composite particles  met the “dispersion limitation.”  As construed by the court that limitation required that the composite active particles exhibited increased dispersion upon administration as compared to unmodified particles of the active. The Fed. Cir. panel rejected the attempt by Glaxo to denigrate Vectura’s comparative test data, and went on to find lots of extrinsic evidence that Glaxo was aware that the drug particles coated with magnesium stearate exhibited less stickiness than uncoated particles.

The second argument Glaxo presented was that the court had erred in holding that “composite active particles” claimed by Vectura were not required to be made by the “high energy milling process” disclosed in the specification. Glaxo argued the intrinsic record demonstrated Vectura’s disavowal of any other process because Vectura had provided no alternative preparation methods and had argued during prosecution that the composite particles could only be prepared using the disclosed method, in order to distinguish the prior art. The panel reviewed this finding de novo.

The panel felt that this case “falls between two prior cases from this court:”  Continental Circuits v. Intel, 915 F.3d 788 (Fed. Cir. 2019) and Andersen Corp. v. Fiber Composites LLC, 474 F.3e at 1373-74 (Fed. Cir. 2007) where “[i]n both cases we 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.’” Of course, the question collapses to whether or not a process disclosed in the specification—but not in the claim—to make the claimed product crosses the line between “preferred” to become an “essential” part of the product. As the panel put it: “In Anderson, we emphasized that the specification used ‘language of requirement not preference.’” In Continental, the panel “found that the specification ‘merely indicate[d] a preference for using’ the apparatus-producing process.”

These standards may seem to be facially clear but, of course, we have already been told that this case falls somewhere in between the two standards, and what is this “language of requirement”? The panel began by simply stating that, while there some statements in the specification suggesting that the high-energy milling is required, they are outweighed by the “numerous statements indicating that the milling process is merely preferred.” The panel gave no weight to the fact that Vectura had denigrated other methods, and found that this fact did not “rise to the level of clear disavowal.” The panel also gave Vectura a pass on its statements differentiating a prior art “wet process’ from the description of Vectura’s process, on the basis that the prior art process was not one “including particulate additive material on the surface of the active particles” and therefore does not “disclose the particles claimed in the present application.” I think this could have gone either way – just read para. 1 at page 15 of the slip opinion.

What take-aways are to be found here, that might improve the prep/pros attorneys’ odds of falling on the right side of precedent?  (1) Keep the Background Section of the specification short and don’t denigrate prior art processes; (2) Distinguish the prior art structurally. Don’t distinguish the prior art by arguing that the process to make or use is specific or essential to the claimed composition; (3) Before you file, review the specification and remove statements that the process is required rather than simply preferred. I know that may not always be possible but inhale some of the lessons of this case before you file.