The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more
On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (CAFC) revived the Regents of the University of California’s (Regents) challenge to the Broad Institute’s CRISPR-Cas9 patents, overturning a 2022 decision by...more
7/3/2025
/ Appeals ,
Biotechnology ,
CAFC ,
CRISPR ,
Life Sciences ,
Patent Litigation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patents ,
Popular ,
Remand
We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...more
On October 7, 2024, the 2024 Nobel Prize in Physiology or Medicine was jointly awarded to two American scientists, Victor Ambros (of UMass Medical School) and Gary Ruvkun (of Harvard Medical School), for their discovery of...more
As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more
7/17/2024
/ Antitrust Provisions ,
Class Action ,
Consumer Protection Laws ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Orange Book ,
Patent Infringement ,
Patents ,
Unfair Competition ,
Warning Letters
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
3/18/2024
/ Antitrust Violations ,
Biotechnology ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Unfair Competition ,
Warning Letters
On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more
Manufacturers of e-cigarettes find themselves in a challenging regulatory environment to obtain U.S. Food and Drug Administration (FDA) marketing approval of flavored products. On October 12, 2023, the FDA denied premarket...more
On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC (collectively, “Shire”) asked the Supreme Court to review an Eleventh Circuit ruling involving the interplay between state tort law and FDA...more
On April 21, 2023, the Supreme Court granted a stay in Alliance for Hippocratic Medicine v. FDA, a case concerning the Food and Drug Administration’s approval of and access to the widely used abortion pill mifepristone. The...more
On October 11, 2018, the USPTO published a Final Rule in the Federal Register, adopting a new standard for interpreting claims in trial proceedings before the patent trial and appeal board (PTAB)....more
11/1/2018
/ America Invents Act ,
Appeals ,
Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Covered Business Method Proceedings ,
Final Rules ,
Inter Partes Review (IPR) Proceeding ,
International Trade Commission (ITC) ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Phillips Standard ,
Post-Grant Review ,
Prior Art ,
USPTO
On July 18, 2018, the FDA released a Biosimilar Action Plan that is aimed at promoting competition and affordability across the market for biologics and biosimilar products. The Plan uses four key strategies to accomplish...more
In recent years, market interest in meat substitutes has aligned with advances in cell culture techniques to support the emergence of lab-grown meat or ”cultured meat” as an alternative to farm-grown meat products. A product...more
On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more
5/29/2018
/ Applications ,
China ,
Clinical Trials ,
Data Protection ,
Draft Guidance ,
Drug Pricing ,
Drug Safety ,
Food and Drug Administration (FDA) ,
Marketing Exclusivity Periods ,
Orphan Drugs ,
Pharmaceutical Industry ,
Public Comment ,
Public Information
On November 7, 2016, the U.S. Supreme Court declined to review an appeal from a Third Circuit decision finding that a settlement between GlaxoSmithKline (GSK) and Teva Pharmaceutical Industries Ltd. (Teva) involving the...more
11/15/2016
/ Anti-Competitive ,
Antitrust Violations ,
Appeals ,
Denial of Certiorari ,
FTC v Actavis ,
Generic Drugs ,
GlaxoSmithKline ,
No-AG Agreement ,
Pay-For-Delay ,
Popular ,
Product Exclusivity ,
Reverse Payment Settlement Agreements ,
Rule-of-Reason Analysis ,
SCOTUS ,
Solicitor General ,
Teva Pharmaceuticals
On September 15, 2016, the U.S. Food and Drug Administration approved once-daily YOSPRALA™, a tablet that combines the anti-platelet agent, aspirin, with the anti-acid drug, omeprazole for decreasing the risk of...more