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Latest From Legal Issues

Argentina Rejects Key Sofosbuvir Patent Application

Argentina’s patent office, INPI, has rejected an application for a key patent relating to Gilead’s hepatitis C drug Sovaldi (sofosbuvir).

South America Argentina

Biosimilar Sponsors Are Not Liable Under State Law For Declining Patent Dance

US Federal Circuit finds in Amgen v. Sandoz that the BPCIA preempts innovator companies from seeking penalties under state law against a biosimilar sponsor that does not engage in the 'patent dance.'

BioPharmaceutical Policy

PhRMA Sues To Block 'Unprecedented' California Price Reporting Law

Ban on WAC price increases violates Commerce Clause and reporting requirement violates First Amendment, PhRMA contends; complaint says state officials have not clarified whether law is retroactive.

BioPharmaceutical Policy

US FDA May Clarify When Execs Can Be Criminally Prosecuted Under Park Doctrine

Agency is considering whether a breach of duty to act or correct violations under the Food, Drug and Cosmetic Act must occur before criminal charges are brought, Chief Counsel Rebecca Wood says; clarity on FDA's view of 'vicarious criminal liability' would be welcome news to the pharma industry and suggests an early priority for the agency's new top lawyer.

Legal Issues Policy

Taking Sides On Mohawk IPR: Generic And High Tech Industries Vs. Law Profs

Groups weigh in on Tribe's request for Patent Trial and Appeal Board to drop inter partes review of Restasis patents; Deva Holding says pending Allergan infringement suit shows Allergan and Tribe have same interests.

Intellectual Property Legal Issues

Amarin Not Giving Up On Omega-3 Trade Battle

Amarin asks Federal Circuit Court to direct US ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs. Company questions FDA's request for policy deference given resource constraints and says Supreme Court rulings show compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information renders a product an unapproved drug or represents false advertising.

Consumer Drug Approval Standards
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