Patent Case Summaries November 11, 2020

Patent Case Summaries | Week Ending November 6, 2020

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.

Valeant Pharmaceuticals North America LLC, et al. v. Mylan Pharmaceuticals Inc., et al., No. 2019-2402 (Fed. Cir. (D.N.J.) Nov. 5, 2020). Opinion by O’Malley, joined by Newman and Taranto.

Facing an issue of first impression, the Federal Circuit addressed proper venue in patent infringement cases under the Hatch-Waxman Act.

Under the Supreme Court’s decision in TC Heartland, a corporation may be sued for patent infringement in the state in which it is incorporated and those in which it has a regular and established place of business and an “act of infringement” has occurred. The Federal Circuit held that, in Hatch-Waxman cases, an “act of infringement” occurs for venue purposes “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”

The district court had dismissed for improper venue a complaint filed by Valeant against Mylan in the U.S. District Court for the District of New Jersey. Valeant argued that it was unduly narrow to limit an “act of infringement” under the venue statute to the act of submitting an ANDA, but the district court disagreed. The court found that the ANDA was submitted from West Virginia, rendering venue proper there. The court explained that Mylan did not reside in New Jersey, the submission of the ANDA did not occur in New Jersey, and Mylan did not have a regular and established place of business in New Jersey. Valeant appealed.

On appeal, Valeant raised several arguments for the proposition that “an ANDA submission is a nationwide act of infringement based on a ‘conceptual’ aspect beyond the literal act defined in the statute.” For example, Valeant argued that the Hatch-Waxman act of infringement is “artificial” and, therefore, requires consideration of planned future conduct. The Federal Circuit disagreed: “The Hatch-Waxman Act itself never says the act that constitutes infringement is artificial, however. It speaks in real terms—submission of the ANDA is the infringing act.” The Federal Circuit thus held that, in Hatch-Waxman cases, “venue is not proper in all judicial districts where a generic product specified in an ANDA is likely to be distributed. It is proper only in those districts that are sufficiently related to the ANDA submission—in those districts where acts occurred that would suffice to categorize those taking them as a ‘submitter’ under § 271(e).”

Valeant also raised what the Federal Circuit deemed “strong policy reasons” for adopting Valeant’s reading of the statutes. But the Federal Circuit explained that, “while intuitively persuasive, these policy arguments cannot trump the plain language of” the statutes. “Congress can revise the two statutes to the extent it finds these, or other, policy concerns compelling; all we can do is give the statutes their current plain meaning.”

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Chevron U.S.A. Inc. v. University of Wyoming Research Corp., et al., No. 2019-1530 (Fed. Cir. (PTAB) Nov. 4, 2020). Opinion by Schall, joined by Lourie. Dissenting opinion by Newman.

This appeal concerns an interference proceeding under the now-discontinued statute that awarded a patent to the party who was the first to invent, rather than the first to file a patent application. Wyoming initiated the interference by copying into its pending application the claims from a pending Chevron application. The claims require “gradually and continuously changing the alkane mobile phase solvent to a final mobile phase solvent.”

The Patent Trial and Appeal Board construed this phrase consistent with Wyoming’s proposal, relying primarily on a definition of “gradually” in Chevron’s specification. The Board also found that Wyoming’s specification had adequate written description for the limitation, and the Board ultimately awarded priority to Wyoming.

On appeal, Chevron argued that the Board’s construction of “gradually” is inconsistent with the Wyoming specification because, for example, the construction “encompasses even sudden, abrupt immediate solvent switches.” The Federal Circuit disagreed with Chevron and affirmed the construction, ruling that the Board properly relied on the specification’s definition of “gradually.”

Judge Newman dissented because, in her view, the Wyoming specification “describes and claims a different method” than the Chevron method. In particular, Wyoming’s method “required an abrupt and discontinuous solvent change,” and “no Wyoming record describes a gradual and continuous solvent change, and no Wyoming inventor asserted possession of this concept of gradual and continuous solvent change.” Therefore, in Judge Newman’s view, there was no interference in fact. She explained: “The PTO erred at the threshold, in allowing Wyoming to copy Chevron’s claims, in the absence of written description and enablement of the Chevron method of gradual and continual change of solvent.”

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