Precedential Federal Circuit Opinions
- 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.
- UNIVERSITY OF STRATHCLYDE v. CLEAR-VU LIGHTING LLC [OPINION] (2020-2243, 11/04/2021) (REYNA, CLEVENGER, and STOLL)
Stoll, J. The Court reversed an IPR decision that four patent claims were unpatentable as obvious under 35 U.S.C. § 103. The patent at issue is directed to a method of “photoinactivation” for killing bacteria without using a “photosensitizing agent” on the bacteria. The PTAB found that the claimed method was obvious based on a combination of prior art references. The Court determined, however, that “neither the [PTAB’s] finding that the prior art disclosed all claim limitations nor its finding of a reasonable expectation of success is supported by substantial evidence.” The Court explained that neither of the two cited references “teaches or suggests” inactivating any bacteria without using a photosensitizer. In addition, regarding the lack of a reasonable expectation of success, the Court explained: “[N]ot only is there a complete lack of evidence in the record that any bacteria were inactivated after exposure to 407–420 nm blue light without using a photosensitizer, there is also evidence showing that others had failed to inactivate [the claimed bacteria] without using a photosensitizer. . . . We have found that such failures undermine a finding of a reasonable expectation of success.”
