The FDA recently issued draft guidance in the Federal Register setting forth the circumstances in which the FDA will refuse to receive an ANDA. [Guidance for Industry ANDA Submissions] The draft guidance is subject to a 30-day public comment period.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. […]
A 3-judge panel of the Federal Circuit (Federal Circuit Judges Timothy Dyk, Kathleen O’Malley and Evan Wallach) affirmed an appeal of a Southern District of Florida decision from Watson Pharmaceuticals, Inc. The per curiam order affirmed a 2011 decision that found valid Valeant’s four patents covering a particular salt formation of the antidepressant bupropion. No. 10-20526, […]
The Federal Circuit recently issued an opinion that reminds us of the importance of being consistent in our statements to the FDA and in patent matters. What matters for the sake of infringement analysis is the product specified in the ANDA filing. The case, Sunovion Pharmaceuticals., Inc. v. Teva Pharmaceuticals USA, Inc. et al. (Fed. […]
In Leo Pharmaceutical Products, Ltd. v. Rea (Fed. Cir. Aug. 12, 2013), the Federal Circuit by Judge Rader, with Judges O’Malley and Reyna, found Patent No. 6,753,013 non-obvious, reversing a decision by the Board of Patent Appeals and Interferences. Significantly, the opinion implies that prior art loses its significance for obviousness determinations with time. The […]
Everyone who works in the pharmaceutical area has heard of the patent cliff for blockbuster pharmaceuticals. The patent cliff has caused generic pharmaceutical companies to re-think how they approach litigation. With potential profits being less, generic pharmaceutical companies are looking for ways to save costs. One key cost of a generic drug entry is the […]
The federal government recently filed its amicus brief with the United States Supreme Court in Medtronic, Inc. v. Boston Sci. Corp. At issue is who should bear the burden of proof when a licensee says it does not infringe a licensed patent and, therefore, no royalties are due to the licensor. The Federal Circuit (Judges […]
The Federal Circuit recently expanded the role of secondary considerations, or objective indicia, of non-obviousness in the obviousness calculus. In Plantronics, Inc. v. Aliph, Inc., the district court held claims directed to a headset stabilizer invalid as obvious. No. C09-1714, 2012 U.S. Dist. LEXIS 40172 (N.D. Cal. Mar. 23, 2012). On appeal, the Federal Circuit […]