On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological...more
On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are...more
On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et...more
On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government in federal court over the Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices...more
6/13/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
First Amendment ,
Free Speech ,
Health Insurance ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Merck ,
Pharmaceutical Industry
The United States Patent and Trademark Office (USPTO) published an update to the AIA Trial Practice Guide (‘‘Trial Practice Guide’’) in August 2018 to revise guidance on practices before the Patent Trial and Appeal Board...more
9/4/2018
/ Administrative Procedure ,
Administrative Proceedings ,
America Invents Act ,
Cross Examination ,
Expert Testimony ,
Motion to Exclude ,
Motion To Strike ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Petitioner Reply Briefs ,
Trial Practice Guidance ,
USPTO
On May 14, 2018, several important revisions to regulations of the Bayh-Dole Act (University and Small Business Patent Procedure Act of 1980, codified as 35 U.S.C. § 200) went into effect. The final revisions were published...more
Introduction – Is Patenting Cannabis Legal?
Early protection of intellectual property is a critical component in any business’s efforts to secure a competitive advantage in the marketplace. In the cannabis space, efforts...more
4/25/2018
/ Controlled Substances Act ,
Decriminalization of Marijuana ,
Design Patent ,
Federal v State Law Application ,
Intellectual Property Protection ,
Marijuana ,
Marijuana Related Businesses ,
Patent Applications ,
Patents ,
Power Plants ,
Trade Secrets ,
Treatment Method Patents ,
USPTO ,
Utility Patents
Lundbeck Pharmaceutical Company, headquartered in Denmark, recently announced the acquisition of Prexton Therapeutics B.V. for $1.1 billion (U.S.). Lundbeck is a publicly traded company focusing on psychiatric and...more
When most people think of cattle, they think of Ferdinand the Bull and their favorite steakhouse. The reality of beef production is far from most consumers’ radar. However, as of 2016, less than 2% of the U.S. population...more
In a recent development with the ongoing complex litigation involving Janssen Biotech’s arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, Celltrion’s partner Pfizer has filed a suit against...more
Sovereign immunity refers to the doctrine that the government cannot be sued without its consent. Specifically, the 11th Amendment precludes federal courts from exercising jurisdiction over states in suits brought by private...more
10/18/2017
/ Dismissals ,
Eleventh Amendment ,
Exclusive Licenses ,
Inter Partes Review (IPR) Proceeding ,
IP License ,
Joint Ownership ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Sovereign Immunity ,
State Universities ,
Tribal Governments
Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more
Before Prost, O’Malley, and Wallach. Appeal from the District of Connecticut (nonprecedential).
On August 2, 2017, the Federal Circuit affirmed a decision by the U.S. District Court for the District of Connecticut granting...more
The sale of a product prior to filing a patent application, or “on-sale bar,” has long been a potential barrier to obtaining a patent in the United States. Especially in the biotechnology space, which can involve a long...more
Written by Daniel A. Kamkar and Eric Furman, Ph.D. After the United Kingdom voted to leave the European Union, dubbed “Brexit” by the press, many have called into question whether the UK would ratify the Unitary Patent...more
On November 21, 2016, the U.S. Court of Appeals for the First Circuit upheld a 2014 jury verdict for AstraZeneca (AZ) and Ranbaxy regarding a 2012 payment of $700 million from AstraZeneca for Ranbaxy to abandon its challenge...more
12/5/2016
/ Antitrust Violations ,
Appeals ,
Generic Drugs ,
Hatch-Waxman ,
Jury Verdicts ,
Pay-For-Delay ,
Pharmaceutical Patents ,
Popular ,
Reverse Payment Settlement Agreements ,
Rule-of-Reason Analysis ,
Summary Judgment
Unitary patents in Europe -
The European unitary patent and Unitary Patent Court (UPC) are slated to go into effect in early 2017. These monumental changes will have a significant impact on the ways patent rights are...more
9/7/2016
/ Biotechnology ,
EU ,
European Patent Convention ,
European Patent Office ,
Intellectual Property Protection ,
Member State ,
Patent Cooperation Treaty ,
Patents ,
Popular ,
Supplementary Protection Certificate ,
UK Brexit ,
Unified Patent Court ,
Unitary Patent
On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion vacating the summary judgment of invalidity of U.S. Patent No. 7,604,929 (“the ’929 Patent”) and sent the case back to the District Court...more