The U.S. Food and Drug Administration (“FDA”) recently issued Draft Guidance to the Industry, titled “New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products,” that proposes a change in its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,…