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
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
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
Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more
In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc. 2023-1952 (Fed. Cir. April 11, 2024), this case involves appellate review of a district court’s findings regarding patent obviousness and infringement in...more
Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision. On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more
The US Court of Appeals for the Federal Circuit dismissed an appeal from a final written decision in an inter partes review (IPR) proceeding, finding that the petitioner lacked standing because it suffered no injury in fact....more
The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more
On Friday, August 25, 2023, the U.S. Court of Appeals For The District Of Columbia Circuit affirmed dismissal of an antitrust action brought by the Federal Trade Commission regarding Endo Pharmaceuticals’s grant of an...more
In United Therapeutics Corporation v. Liquidia Technologies, Inc., the U.S. Court of Appeals for the Federal Circuit held that a claim to a method of treatment for pulmonary hypertension was not invalid for lack of enablement...more
On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more
The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method...more
On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit, in Jazz Pharmaceuticals, Inc., v. Avadel CNS Pharmaceuticals, LLC, Case No. 23-1186, affirmed a decision from the District Court of Delaware directing...more
In a case where the cast of characters on both sides of the v. evolved during the lead-up to the litigation as the litigants negotiated third-party deals and formed new entities, the US Court of Appeals for the First Circuit...more
The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny...more
Addressing venue in the context of a Hatch-Waxman case, the US Court of Appeals for the Federal Circuit explained that sending a paragraph IV notice letter to a company in the district is insufficient to establish venue....more
On November 5, 2021, the U.S. Court of Appeals for the Federal Circuit in Celgene Corp. v. Mylan Pharmaceuticals Inc., Case No. 21-1154, affirmed a decision from the District Court of New Jersey dismissing a suit brought by...more
The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent,...more
Belcher Pharmaceuticals, LLC v. Hospira, Inc., Appeal No. 2020-1799 (Fed. Cir. Sept. 1, 2021) - In an appeal from the United States District Court for the District of Delaware, the Federal Circuit affirmed the district...more
Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific...more
Whether you are pursuing patents on your new technology, thinking about bringing patent infringement litigation or defending patent infringement claims in court, knowing the important developments in patent law will help you...more
Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more
We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Today, a Federal Circuit panel (Judges Prost, Wallach, and...more
In a holding that could significantly broaden the antitrust inquiry in the context of the Hatch-Waxman regulatory scheme, on February 13, 2020, the U.S. Court of Appeals for the First Circuit issued an opinion that may have...more
PATENT CASE OF THE WEEK - Persion Pharms. LLC v. Alvogen Malta Operations Ltd., Appeal No. 2018-2361 (Fed. Cir. Dec. 27, 2019) - In this week’s Case of the Week, the Federal Circuit affirmed a district court judgment...more
BUT FOR A CLERICAL ERROR TO BE ADDRESSED ON REMAND, THE FEDERAL CIRCUIT AFFIRMS FINDINGS OF INELIGIBLE SUBJECT MATTER AND NON-INFRINGEMENT. Case Name: INO Therapeutics LLC v. Praxair Distribution Inc., 2019 U.S. App. LEXIS...more
Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more