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 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
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Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more
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