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
The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more
Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint (1-24-cv-00816) on July 12 against Alnylam Pharmaceutical Inc. (“Alnylam”) in the U.S. District Court for the District of Delaware, alleging incorrect inventorship of...more
Many life science companies are using AI/ML to identify new disease targets and new therapeutics, predict the efficacy and toxicity of potential clinical therapeutic candidates, design clinical trials and dosing or treatment...more
AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more
AI is vaulting drug discovery forward leaps and bounds—and now regulators are beginning to catch up, with the United States Patent and Trademark Office recently issuing new guidelines on the patentability of AI-assisted...more
Section 112 of the Patent Act contains multiple requirements that relate to the adequacy of an inventor’s disclosure within a patent application. The Supreme Court has offered some clarity to inventors seeking to patent...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
Generative AI (GenAI) surged to the forefront of corporate agendas and public policy debates last year, promising to boost productivity and innovation. What’s in store for AI in 2024?...more
ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more
Artificial intelligence is transforming drug design — but it could also disrupt intellectual property law. To realize AI’s full promise, the US may have to reconsider its approach to issuing patents....more
Introduction - Generative artificial intelligence (GenAI) has dominated headlines for nearly all of 2023 and demonstrated that it has the potential to disrupt the economic landscape by displacing jobs and creating remarkable...more
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board - Summary: Federal Circuit confirms low bar for evidence corroborating prior inventorship...more
ACI’s 21st Advanced Summit on Life Sciences Patents returns to New York City, this May, to provide practical insights on how to maximize your patent term and develop strategies to enhance global protections for your patent...more
Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine. ...more
In three previous blog posts, we have discussed recent inventorship issues surrounding Artificial Intelligence (“AI”) and its implications for life sciences innovations – focusing specifically on scientist Stephen Thaler’s...more
Striking a blow to patent applicants seeking to assert inventorship by artificial intelligence (“AI”) systems, the U.S. District Court for the Eastern District of Virginia ruled on September 3, 2021 that an AI machine cannot...more
The question whether an artificial intelligence (“AI”) system can be named as an inventor in a patent application has obvious implications for the life science community, where AI’s presence is now well established and...more
In IBSA Institut Biochimique v. Teva Pharmaceuticals USA, Inc. a valuable lesson was learned about relying on a translation of a non-English patent application. The IBSA Institut Biochimique (IBSAIB) hired an Italian patent...more
In Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceutical Co. Ltd, the Federal Circuit held that two scientists, Dr. Gordon Freeman and Dr. Clive Wood, should be included as joint inventors, along with Dr. Tasuku Honjo for...more
Patentees and inventors of cannabis compounds may be happy to learn a district court in Colorado recently held that, based on the record before it, U.S. Patent No. 9,730,911, entitled “Cannabis extracts and methods of...more
On-Sale Bar Is No Bar for Selling Manufacturing Services to the Inventor - Addressing what constitutes an invalidating “sale” under § 102(b), the US Court of Appeals for the Federal Circuit sitting en banc affirmed the...more
In the latest chapter of a year-long battle between an individual inventor and two companies, Lisa Duer (“Duer”), a resident of Woodstock, Georgia, filed her Third Amended Complaint alleging patent infringement, trademark...more
On July 2, 2015, the Court of Appeals for the Federal Circuit held that a patent owner’s use of a contract manufacturer (CMO) to prepare validation batches of a drug formulation for submission to FDA created an invalidating...more
Sir Isaac Newton’s Third Law of Motion states, loosely, that for every action there is an equal and opposite reaction. A force exerted by one body upon another causes an equal reaction by the second body. Want an...more
Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more