On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more
7/24/2025
/ Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements ,
Research and Development
With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more
Targeted protein degradation (TPD) is transforming drug discovery by leveraging the cell’s natural protein disposal systems to eliminate disease-causing proteins. Innovators are making rapid and successful advancements in the...more
In 1910, German scientist Paul Ehrlich introduced a groundbreaking concept to the world: chemical compounds could be engineered to interact with unique receptors on disease-causing cells while avoiding interaction with...more
4/9/2025
/ Acquisitions ,
FDA Approval ,
Innovation ,
Inter Partes Review (IPR) Proceeding ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more
2/13/2025
/ Artificial Intelligence ,
Compliance ,
Corporate Counsel ,
Data Integrity ,
Digital Health ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
As 2024 draws to a close, several crucial developments — some aimed at modernizing long-standing legal practices, others addressing emerging challenges — have reached patent law.
Originally published in Law360 - December...more
12/23/2024
/ Administrative Procedure Act ,
Alice/Mayo ,
Appeals ,
Artificial Intelligence ,
Chevron Deference ,
Design Patent ,
Graham Factors ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Inventions ,
Inventors ,
Loper Bright Enterprises v Raimondo ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
Rulemaking Process ,
SCOTUS ,
Statutory Interpretation ,
Tariff Act of 1930 ,
USPTO ,
Utility Patents
As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified...more
8/22/2024
/ Amgen v Sanofi ,
Corporate Counsel ,
Disclosure ,
Enablement Inquiries ,
Inventions ,
Patent Invalidity ,
Pharmaceutical Patents ,
Prior Art ,
Priority Patent Claims ,
Sanofi-Aventis ,
SCOTUS ,
Unified Patent Court
Following the U.S. Supreme Court’s invalidation of a counterpart U.S. patent in the same family for lack of enablement (21-757 Amgen Inc. v. Sanofi (05/18/23) (supremecourt.gov)), the UPC has now rendered a decision on its...more
The United States Patent and Trademark Office (USPTO) recently published new guidance on subject-matter eligibility as related to Artificial Intelligence (AI), opening a written comment window to respond with a deadline of...more
7/22/2024
/ Abstract Ideas ,
Alice/Mayo ,
Artificial Intelligence ,
Executive Orders ,
Foreign Jurisdictions ,
Intellectual Property Protection ,
Inventors ,
New Guidance ,
Patent-Eligible Subject Matter ,
Patents ,
Research and Development ,
SCOTUS ,
Training ,
UK ,
USPTO