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
On May 21, the U.S. Court of Appeals for the District of Columbia Circuit upheld the right of pharmaceutical manufacturers to place at least some restrictions on the shipment of 340B drugs to contract pharmacies of 340B...more
Section 340B of the Public Health Service Act has grown significantly since its enactment in 1992 – both in the number of covered entities eligible to participate and in the volume of drugs purchased through the program. The...more
As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more
In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more
As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more
In two recent landmark decisions, Novartis v. Abacus (C‑147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union (CJEU) strengthened the position of drug manufacturers against repackaging...more
Americans spend on average about $1,300 per person per year on prescription drugs, which represents only about 13.3% of the total paid-for drugs in the US. Private insurers, Medicare, and Medicaid pay another 81.8%. ...more
NOVARTIS PHARMACEUTICALS CORP. V. HEC PHARM CO., LTD. Before Moore, Hughes, and Linn (dissenting). Appeal from the United States District Court for the District of Delaware. Summary: Silence regarding the presence or...more
避而不谈可能支持否定性权利要求限定 - 在 Novartis Pharmaceuticals 诉 Accord Healthcare Inc. 一案（上诉案件编号：21- 1070）中，联邦巡回上诉法院认为，一项对药物“速效剂量”避而不谈的专利申请，为要求不存在此类剂量的否定 性权利要求限制提供了书面说明支持。 ...more
記述がないことがクレームの否定的限定のサポートと解釈できる場合がある Federal Circuit は、Novartis Pharmaceuticals v. Accord Healthcare Inc. (Appeal No. 21-1070) に おいて、薬剤の「初回負荷用量」についての記述がない特許出願は、そのような用量がないことを要 求するクレームの否定的限定に記述によるサポートを提供していることになると判示した。 ...more
January 2022 Federal Circuit Newsletter (Japanese) January 2022 Federal Circuit Newsletter (Chinese) Silence May Support Negative Claim Limitation In Novartis Pharmaceuticals v. Accord Healthcare Inc. Appeal No. 21-1070, the...more
NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. Before Moore, Linn, and O’Malley. Appeal from the United States District Court for the District of Delaware. Summary: A patent application that was silent about a...more
On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled...more
The intravitreal (eyeball) injection drug Beovu hasn’t even been on the market for two years, but its history has been eventful. This medication was meant to help patients with an eye problem known as wet age-related...more
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more
Other recent notable industry transactions: Thermo Fisher Scientific Inc. completed the acquisition of Henogen SA, Novasep's viral vector manufacturing business in Belgium for approximately €725 million in cash....more
On 9 September 2020, the French Competition Authority (“FCA”) issued an infringement decision sanctioning Novartis and Roche with record fines for the pharmaceutical sector in France, totaling 444 million euros, for having...more
Cadent Therapeutics, a Cambridge, Massachusetts-based, privately held clinical stage biopharmaceutical company focused on the development of therapies for the treatment of cognitive, mood, and movement disorders, announced on...more
Case Name: Novartis Pharms. Corp. v. Accord Healthcare Inc., No. 18-1043-KAJ (D. Del. August 10, 2020) (Jordan, J.)... Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 9,187,405 (“the ’405...more
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more
I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more
Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more