False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
After the Federal Circuit vacated and remanded the district court’s non-obviousness determination, the district court again found that Teva failed to show, by clear and convincing evidence, that the claims of Janssen’s patent...more
On July 8, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Janssen Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA, Inc. affirming the district court’s finding that patent claims to a...more
Invega Sustenna® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., Civ. Nos. 18-734, 19-16484, 2024 WL 5135666 (D.N.J. Dec. 17, 2024) (Cecchi, J.) Drug Product and Patent(s)-in-Suit:...more
Antibody-drug conjugate (ADC) is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration (FDA) approval and rapidly growing market size as discussed in previous articles in this series. This...more
On March 4, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade name...more
In a crowded pharmaceutical art, the deficiencies thereof being so patent that the FDA encouraged industry to address and correct them, concerning a formulation developed to address the opioid crisis raging earlier in this...more
Ranges for Interdependent and Interactive Components Can Be Tricky to Derive - In Modernatx, Inc. v. Arbutus Biopharma Corporation, Appeal No. 20-2329, the Federal Circuit held that a presumption of obviousness based on...more
BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS. Case Name: Valeant Pharms...more
In OSI Pharmaceuticals LLC v. Apotex, Inc., the Federal Circuit reversed the PTAB’s determination that a Tarceva® patent was invalid as obvious because the decision was not supported by a reasonable expectation of success....more
In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not unpatentable on three separate grounds. Shortly thereafter, Novartis filed suit...more
In Bayer v. Watson, the panel throws out Bayer’s patent to its Staxyn erectile dysfunction drug as being obvious, noting that the district court focused too heavily on the commercial availability of the prior art. The panel...more
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more
Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more
On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the...more
In three separate but related final written decisions in the first successful defense of a pharmaceutical patent in an inter partes review (IPR), the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board...more
Sanofi-Aventis Deutschland GMBH v. Glenmark Pharmaceuticals Inc. - Addressing the obviousness of combining two known hypertension medications, the U.S. Court of Appeals for the Federal Circuit upheld a ruling of...more
“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the...more