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
This week’s case of the (recent) week could serve as a crash course in several areas of patent law. It touches on Hatch-Waxman litigation and the Orange Book, claim construction, anticipation/obviousness, written description...more
Roku, Inc. v. Universal Electronics, Inc., Appeal No. 2022-1058 (Fed. Cir. Mar. 31, 2023) In this week’s Case of the Week, the Federal Circuit affirmed the U.S. Patent Trial and Appeal Board’s (PTAB’s) final written...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
It has long been understood that claim construction can, and frequently is, dispositive in patent litigation. This truism was the basis for the Federal Circuit affirming the District Court's decision against a generic drug...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
Biodelivery Sciences Intl. v. Aquestive Therapeutics, Inc. (No. 2017-1265, -1266, -1268, 7/31/18) (Newman, Lourie, Reyna) - Newman, J. Remanding IPRs so the Board can consider non-instituted claims and grounds per the...more
PATENT CASE OF THE WEEK - Polara Engineering Inc. v. Campbell Company, Appeal Nos. 2017-1974, -2033 (Fed. Cir. July 10, 2018) In this wide-ranging opinion, the Court provided a rare and lengthy opinion on the public use...more
The past decade or so of U.S. patent law has been characterized by a consistent theme between Federal Circuit decisions and the Supreme Court's invalidation of them (and sometimes can be discerned even in those rare instances...more
Case Name: AstraZeneca LP v. Breath Ltd., 2015-1335, 2015 U.S. App. LEXIS 7525 (Fed. Cir. May 7, 2015) - Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation suspension); U.S. Patent No....more
The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more
Are claims that recite a “solvate” of a chemical compound invalid for lack of written description if the patent does not describe any specific solvates? In GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., the Federal Circuit...more
In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found...more