In a unanimous panel decision, the Federal Circuit found that Hanmi Pharmaceutical Co. Ltd.’s esomeprazole (Nexium®) does not infringe two AstraZeneca patents listed in the Orange Book for its Nexium® product. AtraZeneca v. Hanmi Pharmaceuticals, No. 13-1490, 2013 U.S. App. LEXIS 25199, (Dec. 19, 2013). AstraZeneca appealed Judge Pisano’s finding from the United States District…
Last week, in a ruling that could be a boon to generic drug makers, the Federal Circuit invalidated claims covering the 0.3% concentration of Differin® (adapalene) acne gel as obvious. Galderma Labs. v. Tolmar, Inc. (Fed. Cir. Dec. 11, 2013). In doing so, the Federal Circuit set forth a potentially far-reaching rule: when a patent…
Nautilus Inc. says yes, according to its certiorari petition, seeking Supreme Court review. The Federal Circuit concluded that Biosig Instrument’s patent claims were sufficiently definite. Nautilus’s petition, along with the petition from amici Electronic Frontier Foundation and Public Knowledge, argue the Federal Circuit’s use of the “insolubly ambiguous” test for determining definiteness is nearly impossible…
The FDA recently issued draft guidance in the Federal Register setting forth the circumstances in which the FDA will refuse to receive an ANDA. [Guidance for Industry ANDA Submissions] The draft guidance is subject to a 30-day public comment period.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…