Precedential Federal Circuit Opinions

  1. CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC. [OPINION] (2021-1154, 11/05/2021) (PROST, CHEN, and HUGHES)  Prost, J.  This is a case about venue and pleading under the Hatch-Waxman Act.  The Court affirmed a decision of the U.S. District Court for the District of New Jersey dismissing claims against U.S.-based defendants for improper venue and dismissing claims against a foreign-corporation defendant for failure to state a claim for which relief can be granted.  Regarding venue, the Court first considered the location of the alleged act of infringement under the Hatch-Waxman act.  The Court explained that under 35 U.S.C. § 271(e)(2), submitting an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) is the alleged act of infringement.  The Court held that this alleged act of infringement did not occur in New Jersey.  The court noted that “[f]or Hatch-Waxman cases, …venue is proper ‘where an ANDA-filer submits its ANDA to the FDA,' not ‘wherever future distribution of the generic is contemplated.'”  In reaching this conclusion, the Court also rejected the plaintiff's argument that mailing an ANDA notice letter to the plaintiff in New Jersey was an alleged act of infringement in New Jersey, because mailing a notice letter is not part of submitting an ANDA.  In addition, the Court held that the U.S. defendants did not have a “regular and established place of business” in New Jersey, where some of their employees lived in New Jersey.  The Court explained that “the employee-associated locations are not a regular and established place of business of the defendants under [28 U.S.C.] § 1400(b).”  Finally, regarding the dismissal of the foreign-corporation defendant, Mylan N.V., the Court held that the plaintiff had not adequately alleged that Mylan N.V. was involved in submitting the allegedly infringing ANDA, and thus had not alleged a sufficient basis for an infringement claim against Mylan N.V.
  2. UNIVERSITY OF STRATHCLYDE v. CLEAR-VU LIGHTING LLC [OPINION] (2020-2243, 11/04/2021) (REYNA, CLEVENGER, and STOLL)  Stoll, J. The Court affirmed the district court's judgment that all claims of four patents generally directed to “securing electronic payment transactions” were ineligible for patenting under 35 U.S.C. § 101. For the first two patents, the Court explained that the claims merely recite “conventional actions in a generic way … without improv[ing] any underlying technology” (quotation marks omitted). For the third patent, the Court explained that the claims are directed an abstract idea—specifically, “multi-factor authentication of a user's identity using two devices to enable a transaction”—and merely recite “conventional” components without “sufficient specificity.” For the fourth patent, the Court again explained that the claims are not patentable subject matter because “the claims simply recite conventional actions in a generic way without purporting to improve the underlying technology.” The Court concluded that “all claims of the asserted patents are directed to an abstract idea and that the claims contain no additional elements that transform them into a patent-eligible application of the abstract idea.”

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