IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more
Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more
The District Court of Delaware dismissed a generic drug company’s declaratory judgment counterclaims of non-infringement and invalidity, finding that the court no longer had subject matter jurisdiction after the generic...more
On September 27, 2022, Judge Richard Andrews of the District of Delaware granted Novartis’s motion to dismiss declaratory judgment (“DJ”) counterclaims raised by two generic drug manufacturers in the ongoing litigation...more
Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more
Federal Circuit Summaries - Before Prost, Lourie and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: When another patent for a drug issues after an ANDA is filed, there can...more
Ruckus Wireless, Inc. v. Innovative Wireless Solutions (No. 2015-1425, 1438, 5/31/16) (Prost, Reyna, Stark) - May 31, 2016 3:11 PM - Reyna, J. Affirming summary judgment of non-infringement of patents based on...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Instead of applying admittedly neutral Jumara factor arguments, Defendants urge the court to transfer instead based on the singular fact that the Maryland court had rendered a decision on a related patent and, thus, any forum...more
Case Name: Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., Nos. 14-935-LPS, 2015 U.S. Dist. LEXIS 4056 (D. Del. Jan. 14, 2015) (Stark, C.J.). Drug Product and Patent(s)-in-Suit: Ampyra® (dalfampridine); U.S. Pats. Nos....more
Case Name: Forest Labs., Inc. v. Amneal Pharms. LLC, Civ. No. 14-508-LPS, 2015 U.S. Dist. LEXIS 23215 (D. Del. Feb. 26, 2015) (Burke, M.J.). Drug Product and Patent(s)-in-Suit: Namenda XR® (memantine hydrochloride); U.S....more
Case Name: Eli Lilly & Co. v. Mylan Pharms., Inc., Civ. No. 14-cv-00389-SEB-TAB, 2015 U.S. Dist. LEXIS 30175 (S.D. Ind. Mar. 12, 2015) (Barker, J.). Drug Product and Patents-in-Suit: Effient® (prasugrel hydrochloride);...more
Case Name: Senju Pharm. Co., Ltd. v. Metrics, Inc., Civ. No. 14-3962-JBS/KMW, 2015 U.S. Dist. LEXIS 41504 (D.N.J. Mar. 31, 2015) (Simandle, J.) ....more
Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more
Addressing threshold jurisdictional issues of a petition for inter partes review (IPR), the U.S. Patent and Trademark Office’s (USPTO) Patent Trial and Appeal Board (PTAB or Board) determined that a d/b/a name does not create...more
This is an ANDA case relating to generic dalfampridine extended-release tablets. The court finds, following that the Daimler decision, that neither the parent nor subsidiary defendant are “at home” in Delaware for purposes of...more
“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the...more