Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
Webinar: Orange Book listing sheets under the microscope
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
New Drug Applications and 505(B)(2) Applications - This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
Exeltis USA, Inc. and other parties (Exeltis) recently prevailed against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) in a patent infringement suit brought in the District of Delaware. After a three-day bench trial, the...more
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more
The listing of patents in the Orange Book has an important role in intellectual property protection for pharmaceuticals. Patents listed in the Orange Book can include, without question, patents covering compositions or...more
In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist five patents from the Food and Drug Administration (FDA)’s Approved Drug Products...more
In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...more
On Nov. 7, 2023, the Federal Trade Commission (FTC) announced it is disputing the listing of more than 100 patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,”...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Prescription drug prices have long been a source of frustration for the American public and the subject of intense political debates about the best way to lower them without stifling innovation. One of the most significant...more
On February 10, in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed a district court’s holding that Adapt’s methods of treatment of opioid overdose is invalid as obvious. The...more
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
Federal District Court Cases That Are Filed Pursuant To The Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more
Please see full Chart below for more information....more
In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting “excluding” specific patients from treatment...more
Introduction: The Opioid Crisis - Every day in the United States, more than 130 people die after overdosing on opioids, such as prescription pain relievers, heroin, and fentanyl. These deaths are part of the ongoing,...more
Case Name: Amgen Inc. v. Amneal Pharms. LLC, Civ. No. 16-0853 (MSG), 2018 U.S. Dist. LEXIS 125631 (D. Del. July 27, 2018) (Goldberg, J.)....more
One of the most significant obstacles to drug competition is a patent listed in FDA’s “Orange Book.” The mere listing of a patent can delay competition for months, or even years, and drive up expense for competitors....more
Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was...more
In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more
Case Name: Roxane Labs., Inc. v. Vanda Pharms., Inc., No. 16-0179, 2016 U.S. Dist. LEXIS 175785 (S.D. Ohio Dec. 20, 2016) (Marbley, J.). Drug Product and Patent(s)-in-Suit: Fanapt® (iloperidone); U.S. Patents Nos....more
Case Name: Sanofi v. Glenmark Pharms. Inc., Civ. No. 14-264-RGA (Consolidated), 2016 U.S. Dist. LEXIS 116950 (D. Del. August 31, 2016) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Multaq® (dronedarone); U.S....more
Case Name: Apotex, Inc. v. Daiichi Sankyo, Inc., C.A. Nos. 12-cv-9295, 15-cv-3695, 2016 U.S. Dist. LEXIS 2126 (N.D. Ill. Jan. 8, 2016) (Coleman, J.)... Drug Product and Patent(s)-in-Suit: Benicar® and Benicar® HCT...more
Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more
After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more