Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020)

In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Grp. Brands LLC, 137 S. Ct. 1514 (2017). Specifically, the Court answered the question about how the patent venue statute, 28 U.S.C. § 1400, applies to cases brought under the Hatch-Waxman Act.

The Hatch-Waxman Act provides a regime for generic pharmaceutical companies to apply for FDA approval after a new drug has been released to market. Under the Act, the filing of an application with the FDA for approval of the generic version of a drug covered by a patent qualifies as an act of infringement. See 35 U.S.C. § 271(e). But the sales take place in the future. Meanwhile, the patent venue statute allows a patent owner to sue “where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.” That raises the question of where the plaintiff may sue if sales of the generic drug are purely prospective.

In this case, Valeant sued Mylan in New Jersey, where Mylan intended to sell the generic drug at issue. Mylan moved to dismiss on the basis of improper venue. The district court granted the motion to dismiss. Valeant appealed. 

The Federal Circuit recognized differing opinions by the district courts in how to determine where venue applies in a Hatch-Waxman case.

The Federal Circuit started by analyzing the patent venue statute. The Court noted that the language in the patent venue statute generally referred to past acts as the infringing acts by which venue would be determined. The Court then decided that the relevant act of infringement for a case brought under the Hatch-Waxman Act is the submission of an application to the FDA. That is because Section 271(e)(2) makes it “an act of infringement to submit [an ANDA] for a drug claimed in a patent.” Thus, the relevant act of infringement, consistent with the language of Section 271, is the submission of the new drug application, not the future sales of that drug.

Following that analysis, the Federal Circuit held that venue was appropriate over one of the Mylan defendants—a foreign entity—in New Jersey. That is because foreign defendants may be sued in any judicial district. But venue over the U.S.-based Mylan entities was improper in New Jersey, and the dismissals against them were affirmed. 

The opinion can be found here.

By: Nika Aldrich

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Chevron U.S.A. Inc. v. University of Wyoming Research Corporation, Appeal No. 2019-1530 (Fed. Cir. Nov. 4 2020)

In this appeal from an interference proceeding before the Patent Trial and Appeal Board, the Court affirmed the Board’s assignment of priority to the University of Wyoming. The Court affirmed the Board’s claim construction of the terms “gradually and continuously,” holding the Board properly relied on the definitions of those terms explicitly contained in Wyoming’s claims. Since Chevron’s earliest corroborated conception coupled with diligence date was after the priority date of Wyoming’s relevant applications, the Court affirmed the Board’s finding of Wyoming as the senior party and affirmed the Board’s judgement of interference in Wyoming’s favor. Judge Newman dissented, opining that the Board “erred at the threshold” by initiating the interference proceeding because the patents at issue claimed different inventions.

The opinion can be found here.

By: Bazsi Takacs