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
With six more decisions, the U.S. Supreme Court decided no fewer than 11 cases in two business days last week, following 12 others over the previous two weeks. In other words, summer vacation is upon us, as the Court’s...more
On January 21, the Supreme Court heard arguments in a case addressing who may challenge Food and Drug Administration (FDA) marketing denial orders for new tobacco products....more
Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more
Since the Supreme Court’s decision in TC Heartland (137 S. Ct. 1514 (2017)), the venue statute for patent cases, 28 U.S.C. § 1400(b), has been interpreted to mean that venue is proper only where the defendant “resides” or...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
The Hatch-Waxman Act provides a cause of action for infringement based on the submission of an abbreviated new drug application (ANDA) to FDA. 35 U.S.C. § 271(e)(2). Following the Supreme Court’s ruling in TC Heartland LLC v....more
Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more
On March 4, 2021, we posted “Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers.” Multiple plaintiffs had filed class action lawsuits in jurisdictions around the country alleging that baby food...more
For the first time since the U.S. Supreme Court’s TC Heartland decision, the U.S. Court of Appeals for the Federal Circuit addressed the issue of venue specific to Hatch-Waxman litigation, pursuant to which branded...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
On November 5, 2020, the Federal Circuit issued a precedential opinion deciding a patent venue question concerning Hatch-Waxman cases left open after the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Grp. Brands...more
BECAUSE PLAINTIFFS FAILED TO SHOW SPECIFICALLY HOW DEFENDANTS COMMITTED ANY ACT OF INFRINGEMENT IN NEW JERSEY—PARTICULARLY BY FILING AN ANDA IN WEST VIRGINIA WITH THE FDA IN MARYLAND—OR THAT ANY FUTURE, INTENDED ACTS WERE A...more
On August 13, 2019, the United States District Court for the District of New Jersey, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 18-cv-14305, held that venue was not proper in New Jersey over...more
On April 17, 2019, Judge Gilstrap of the United States District Court for the Eastern District of Texas, in Apicore v. Beloteca, No. 19-cv-00077, held that while the court could exercise personal jurisdiction over a generic...more
The issue of venue—where geographically a case can be brought—and jurisdiction are a pair of principles to determine in which forum a case can properly be brought. Jurisdiction in personam concerns whether a particular party...more
Addressing venue in the context of Hatch-Waxman litigation, the US District Court for the District of Delaware held that venue is proper in Delaware if a generic drug company has permanent and continuous presence in Delaware...more
SCOTUS Narrows Opportunity For ITC Section 337 Jurisdiction Over Imported Biosimilars Based On 180-Day Notice Provision - In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58 (Fed. Cir. 2015), the Federal Circuit held that...more