Life sciences and biopharma companies often rely on clinical trial results and "clinically proven effective" language in patent claims, but this approach carries significant risks if key details are publicly disclosed before...more
10/2/2025
/ Bayer ,
CAFC ,
Clinical Trials ,
Life Sciences ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Applications ,
Patent Invalidity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
Pharmaceutical companies are increasingly concerned about the prospect that the Food and Drug Administration (FDA) will be delayed in its consideration of pending New Drug Applications (NDAs) and Biologics Licensing...more
10/1/2025
/ Administrative Procedure Act ,
Biologics ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Supply Chain ,
Tariffs ,
Trump Administration
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
A new interim process for the acting director to exercise discretion as to whether to institute an inter partes review ("IPR") or a post-grant review ("PGR") was announced on March 26, 2025, in which discretionary...more
4/4/2025
/ Administrative Procedure ,
Director of the USPTO ,
Filing Deadlines ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Proposed Rules ,
USPTO
The U.S. Patent and Trademark Office ("USPTO") raised patent fees and introduced new surcharges....more
The U.S. Patent and Trademark Office ("USPTO") has withdrawn its proposed rule regarding terminal disclaimer requirements....more
The Supreme Court denies Cellect LLC's petition for certiorari to consider whether patent term adjustment ("PTA") should be included in patent term for obviousness-type double patenting ("ODP") purposes....more
10/15/2024
/ Denial of Certiorari ,
Double Patent ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patents ,
Petition for Writ of Certiorari ,
SCOTUS ,
USPTO
The Situation: The Committee on Foreign Investment in the United States ("CFIUS," or the "Committee") recently published draft regulations implementing the Foreign Investment Risk Review Modernization Act ("FIRRMA"), which...more
10/31/2019
/ Biotechnology ,
CFIUS ,
Cross-Border Transactions ,
Data Collection ,
Draft Guidance ,
Export Administration Regulations (EAR) ,
Export Controls ,
FIRRMA ,
Foreign Investment ,
ITAR ,
Life Sciences ,
National Security ,
Personal Data ,
Real Estate Transactions