Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more
On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals that impacts Orange Book (OB) listings for patents...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
Case Name: Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., Civ. No. 24-4404 (SRC), 2024 WL 3966314 (D.N.J. Aug. 28, 2024) (Chesler, J.)....more
On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more
The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more
Today, the Supreme Court again disregarded the views of the Federal government regarding whether to grant certiorari, here in Teva Pharmaceuticals USA v. GlaxoSmithKline LLC, and in some ways the only positive outcome is that...more
The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more
After the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States regarding Teva Pharms USA, Inc. v. GlaxoSmithKline LLC, et al., the Solicitor General filed its brief amicus...more
On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva...more
Coreg® (carvedilol) - Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Circuit Judges Prost, Newman, and Moore presiding; Opinion by Newman, J.; Dissent by Prost, C.J.)...more
BECAUSE A SKILLED ARTISAN WOULD HAVE RECOGNIZED THE LIMITATIONS OF ONE PRIOR-ART REFERENCE AND WOULD HAVE BEEN MOTIVATED TO SELECT THE TEACHINGS OF ANOTHER REFERENCE TO OVERCOME THEM, THE PATENTS-IN-SUIT WERE OBVIOUS. Case...more
THE ASSERTED CLAIMS OF 1% IVERMECTIN FORMULATION ARE INVALID ON THE BASIS OF ANTICIPATION IN LIGHT OF A PRIOR ART REFERENCE THAT TEACHES APPLICATION OF 1-5% IVERMECTIN FORMULATION FOR TREATMENT OF THE SAME INDICATION. Case...more
The Court Denied Defendant’s Motion To Enforce Its Settlement Agreement With Plaintiff After The At-risk Launch And Subsequent Settlement Of Another Defendant. ...more
Case Name: Teva Pharms. U.S.A., Inc. v. Azar, C.A. No. 18-2394 (RDM), 2019 U.S. Dist. LEXIS 30346 (D.D.C. Feb 26, 2019) (Moss, J.)....more
Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229, 139 S. Ct. 628 (Jan. 22, 2019) (Thomas, J. delivered the opinion for a unanimous Court), on cert. from the Federal Circuit, 855 F.3d 1356. ...more
Case Name: Galderma Labs., L.P. v. Teva Pharms USA, Inc., Civ. No. 3:17-cv-01076-M (N.D. Tex. Nov. 11, 2017) (Lynn, J.). Drug Product and Patent(s)-in-Suit: Soolantra® (ivermectin); U.S. Patents Nos. 8,815,816 (“the ’816...more
Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc., Civ. No. 17-275(FLW), 2017 U.S. Dist. LEXIS 78002 (D.N.J. May 23, 2017) (Wolfson, J.)....more
Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356, 2017 U.S. App. LEXIS 7650 (Fed. Cir. May 1, 2017) (Circuit Judges Dyk, Mayer, and O’Malley presiding; Opinion by Dyk, J.) (appeal from D.N.J.,...more
Case Name: Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., No. 2015-2067, 2017 U.S. App. LEXIS 555 (Fed. Cir. Jan. 12, 2017) (Circuit Judges Prost, Newman, and Dyk presiding; Opinion by Prost, C.J.) (Appeal from S.D....more
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more
This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more
The Supreme Court denied certiorari today in Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., thereby leaving intact the Federal Circuit's fractured precedent on the question of whether post-approval...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
Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more