In the wake of recent mass layoffs at the U.S. Food and Drug Administration (“FDA”), the FDA is likely to have fewer resources to manage its regulatory responsibilities. One area that may be significantly impacted by such...more
Amid increasing economic tensions with the United States, China recently announced that it would ban Illumina, a U.S.-based company and the world’s leading producer of gene-sequencing machines, from importing its gene...more
As has been widely reported, including in our year-end summary of the current state of artificial intelligence (“AI”)-related copyright litigation, AI providers are currently facing a wave of lawsuits1 from copyright owners...more
The life sciences industry experienced a dynamic year in 2024. As the public markets gained traction, IPO activity and venture investment saw a resurgence, signaling renewed investor confidence and reflecting sustained...more
Intellectual property (“IP”) policy does not weigh heavily on most voters’ minds, and so is not often addressed in presidential campaigns. This past campaign was no different – President-elect Donald Trump did not expressly...more
1/13/2025
/ Antitrust Division ,
Artificial Intelligence ,
Bayh-Dole Act ,
CFTC ,
Corporate Counsel ,
Cryptocurrency ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Machine Learning ,
NIST ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pending Legislation ,
Trump Administration ,
U.S. Commerce Department ,
USPTO
More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more
1/10/2025
/ Biotechnology ,
Business Strategies ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Investigational New Drug Application (IND) ,
Licensing Rules ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Pricing ,
Regulatory Reform ,
Regulatory Requirements ,
Variable Rates
In April 2024, we published a summary of the then current state of artificial intelligence (“AI”)-related copyright litigation. Since that publication, new theories for complaints and defenses have emerged in this space. As...more
The future of controlled digital lending (“CDL”), the digital equivalent of traditional library lending, is uncertain after the United States Court of Appeals for the Second Circuit’s judgment in Hachette Book Group, Inc. v....more
11/12/2024
/ Authorship ,
Compensation ,
Copyright ,
Copyright Infringement ,
Digital Services ,
Fair Use ,
First Sale Doctrine ,
Internet Archive (IA) ,
Lending ,
Right of Reproduction ,
The Copyright Act