The FDA recently issued draft guidance in the Federal Register setting forth the circumstances in which the FDA will refuse to receive an ANDA. [Guidance for Industry ANDA Submissions] The draft guidance is subject to a 30-day public comment period. The 21-page FDA Guidance seeks to improve the quality of ANDA submissions and allow efficient…
The Federal Circuit recently rejected Baxter International’s request for an en banc rehearing of the Federal Circuit’s decision from July voiding Baxter’s infringement award against Fresinius USA after a jury finding in Baxter’s favor. The case involved the question of whether a reexamination decision of invalidity by the PTO trumps a district court decision upholding…
Last week the Federal Circuit affirmed a ruling that an AstraZeneca method of use patent was invalid as obvious. AstraZeneca LP v. Breath Ltd. (Fed. Cir. Oct. 30, 2013). At trial two patents were at issue: one was held to be not infringed, the other was held to be anticipated and obvious in light of…
Recently, some commentators have suggested that the Federal Circuit has increased the significance of the role secondary considerations play in obviousness determinations. This claim, however, appears to be misplaced. One case used to justify a claim of the change in the law is Transocean Offshore Deepwater Drilling Inc. v. Maersk Contractors, 617 F.3d 1296 (Fed.…