False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Case Name: Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., No. 2023-1247, 2023 WL 3335538 (Fed. Cir. May 10, 2023)(Circuit Judges Dyk, Bryson, and Prost presiding; Opinion by Dyk, J.) (Appeal from D. Del., Connolly, J.)....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
Case Name: Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., Nos. 22-7528, 22-7529 (CCC), 2023 WL 1883357 (D.N.J. Feb. 10, 2023) (Cecchi, J.) - Drug Products and Patent(s)-in-Suit: Hetlioz® (tasimelteon); U.S. Patent No....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
The US Court of Appeals for the Federal Circuit vacated the district court’s grant of judgment as a matter of law (JMOL) of non-infringement where substantial evidence supported the jury’s verdict of induced infringement by...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
Section viii of the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(A)(viii), allows a generic applicant to “carve out” indications and other use information from its labeling that are protected by patents listed in FDA’s Orange Book...more
What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...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
In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in Mayo v. Prometheus, and found them...more
Case Name: Endo Pharms. Inc. v. Teva Pharms. USA, Inc., Fed. Cir. Nos. 2015-2021, -2022, -2023, -2024, -2025, -2026, -2028, -2031, -2033, -2034, -2035, -2041, -2042, -2046, -2047, -2049, -2059, -2060, 2016-1025, -1060, -1117,...more
This month, we highlight significant developments in June 2018, including a Supreme Court decision regarding the PTAB, a federal court affirmation in Impax Laboratories Inc. v. Lannett Holdings Inc., and new legislation...more
The US District Court for the Northern District of Texas found that venue was not proper under 28 USC § 1400(b) because Teva Pharmaceuticals USA did not commit any act of infringement in the Northern District of Texas, nor...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: Allergan Sales, LLC v. Teva Pharms. USA, Inc., Civ. No. 2:15-cv-01471-FRG-RSP, 2017 U.S. Dist. LEXIS 127886 (E.D. Tex. July 25, 2017) (Payne, M.J.). Drug Product and U.S. Patent: Delzicol® (mesalamine); U.S....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
The US Court of Appeals for the Federal Circuit reversed the district court and found that a Supply and Purchase Agreement between Helsinn and third-party MGI Pharma, Inc. (MGI) before the critical date of the asserted...more
FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more
The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes...more
Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., 15-1455-WCB, 2017 U.S. Dist. LEXIS 4545 (E.D. Tex. Jan. 12, 2017) (Bryson, J.). Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic solution); U.S....more
On May 1st, the Federal Circuit ruled that the America Invents Act (AIA) did not change the statutory meaning of “on sale” where the existence of a sale was publicly announced prior to patenting, even if the sale did not...more