Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more
4/9/2025
/ Artificial Intelligence ,
Drug Pricing ,
Earn-Outs ,
Federal Funding ,
Foreign Aid ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Private Equity ,
Trump Administration ,
USPTO
The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration's ("FDA" or "Agency")...more
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and regulating the safety and effectiveness of medical devices utilizing generative...more
The Situation: The Supreme Court's ruling in Universal Health Services, Inc. v. U.S. ex rel. Escobar, 136 S. Ct. 1989 (2016), opened the door to more materiality defenses under the False Claims Act ("FCA"), but without making...more
3/4/2020
/ Defense Strategies ,
Deficit Reduction ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
False-Certification of Conformance ,
Materiality ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Relators ,
Summary Judgment ,
Universal Health Services Inc v United States ex rel Escobar