The District of New Jersey recently refused to compel the return of inadvertently produced privileged documents despite a clawback provision in the protective order where the producing party relied on key word computer searches to screen for privilege without any further attorney review. In Shire LLC v. Amneal Pharmaceuticals, LLC, 2:11-cv-03781 (D.N.J. January 10, 2014), […]
The Federal Circuit ruled last week that the Patent Office had incorrectly calculated the patent term adjustments for patents owned by Novartis and opened the door to longer patent terms. 35 U.S.C. § 154 provides for patent term adjustments if, save for certain limitations, an application is pending before the PTO for more than three […]
Carlson Caspers, a top-ranked intellectual property law firm based in Minneapolis, recently won a significant victory on behalf of its client Teva Pharmaceuticals USA, Inc. In a decision handed down this week, U.S. District Judge Sidney Stein of the U.S. District Court for the Southern District of New York ruled that Teva, the world’s biggest […]
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The U.S. Food and Drug Administration (FDA) on December 4, 2013 issued new draft guidance on bioequivalence studies for drugs submitted under an Abbreviated New Drug Application (ANDA).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 […]