In the Northern District of Illinois, Judge Sharon Coleman recently dismissed for lack of subject matter jurisdiction Apotex’s declaratory judgment action alleging invalidity or non-infringement of U.S. Patent 6,878,703 directed toward the treatment of hypertension with a chemical compound. Apotex, Inc. v. Daiichi Sankyo, No. 12-9295, 2014 U.S. Dist. LEXIS 3156 (N.D. Ill. Jan. 9,…
In the District of Delaware, Judge Leonard Stark recently issued a final judgment and permanent injunction in Cadence Pharms., Inc. v. Exela Pharma. Scis., LLC, No 11-733, 2013 U.S. Dist. LEXIS 166097 (D. Del. Nov. 14, 2013), which prevents defendant Exela Pharmaceutical, Inc. from manufacturing its generic version of OFIRMEV®, an injectable liquid acetaminophen composition. …
The U.S. Food and Drug Administration (FDA) on December 4, 2013 issued new draft guidance on bioequivalence studies for drugs submitted under an Abbreviated New Drug Application (ANDA). In light of the relatively few substantive changes from previous guidance, the main purpose in issuing the new draft appears to be the separation of such guidance…
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The FDA recently issued draft guidance in the Federal Register setting forth the circumstances in which the FDA will refuse to receive an ANDA. [Guidance for Industry ANDA Submissions] The draft guidance is subject to a 30-day public comment period.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.…