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
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
The European Parliament has adopted an amended European Commission proposal to regulate plants engineered using techniques such as CRISPR/Cas and ban any patenting of plants, plant parts, material, genetic information, or...more
2/20/2024
/ Biotechnology ,
CRISPR ,
European Commission ,
European Parliament ,
European Patent Convention ,
GMO ,
Intellectual Property Protection ,
Life Sciences ,
New Regulations ,
Patent Applications ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Plant Based Products ,
Public Health ,
Regulatory Reform
In Short -
The Situation: The transition to the new so-called Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"), which establish new rules for the placing on the market of medical devices...more
On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more
5/12/2017
/ Biosimilars ,
EU ,
European Commission ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Regulatory Standards ,
UK Brexit