The recent appeal of Alcon Research Ltd. v. Barr Labs., Inc., No. 2012-1340 (Fed. Cir. Mar. 18, 2014) touched on several of the patent-law issues you will encounter in ANDA cases: infringement, written description, and enablement. Barr sought to market a generic version of Alcon’s glaucoma and ocular hypertension drug Travatan Z®. Alcon filed suit…
The Federal Circuit recently affirmed the District of Delaware’s rejection of a lack of written description defense in GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., No. 2013-1593 (Fed. Cir. 2014). GlaxoSmithKline sued several generic companies for infringement of U.S. Patent No. 5,565,467, which is listed in the Orange Book for Avodart (dutasteride), a treatment for enlarged…
The U.S. Food and Drug Administration (“FDA”) recently issued Draft Guidance to the Industry, titled “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products,” that proposes a change in its longstanding policy concerning 5-year new chemical entity (“NCE”) exclusivity for fixed-combination drug products. For many years, FDA’s interpretation of the word “drug” in certain provisions…
On Friday, a divided Federal Circuit confirmed that it will continue to apply a de novo standard of review to claim construction and rejected calls to give more deference to district court decisions. Lighting Ballast Control, LLC v. Philips Elecs. et al. (No. 2012-1014) (Fed. Cir. Feb. 21, 2014). The de novo review standard has…
A three judge panel of the Federal Circuit recently affirmed the District of Delaware’s judgment of infringement and validity related to U.S. Patent No. 6,197,819 (owned by Northwestern University and licensed to Pfizer) covering the drug Lyrica, which treats seizures and certain types of nerve pain. The decision effectively prevents a generic version of Lyrica…
Politicians have begun talking about the damage caused by “patent trolls” and how to deal with it. On March 7, 2014, Carlson Caspers is hosting a CLE discussing non-practicing entities, public responses to them, and how your company can respond to non-practicing entities (or monetize its own portfolio). Agenda Background: This will explain the recent…
On January 24, 2014, in In re Lamictal Direct Purchaser Antitrust Litigation, No. 12-cv-995, 2014 U.S. Dist. LEXIS 9257 (D.N.J. Jan. 24, 2014), Senior District Judge William H. Walls dismissed a putative, antitrust-class action brought against GlaxoSmithKline LLC (“Glaxo”) and Teva Pharmaceutical Industries Ltd. (“Teva”) in response to their agreement postponing the production of lamotrigine,…
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…