Executive Summary: Federal Trade Commission v. Wyndham Worldwide Corp.
A U.S. District Court has ruled this week that the Federal Trade Commission (FTC) has authority under Section 5 of the FTC Act to bring enforcement...more
As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal...more
In this Presentation:
- BPCIA Refresher
- FDA Developments - Purple Book, FDA Review of Applications, Draft Guidance, Abbott Petition
- The Naming Issue
- State Substitution Laws
Background. One item on the negotiation checklist for patent licenses in the pharmaceutical sector is compliance with the U.S. Hart-Scott-Rodino (“HSR”) Premerger Notification Rules. The HSR rules require that certain patent...more
- This month several U.S. Senators introduced the Preserve Access to Affordable Generics Act. There is no similar bill pending in the U.S. House.
- The Act revives legislative efforts to wipe out the...more
The U.S. Federal Trade Commission (“FTC”) issued a data report on January 4 regarding its horizontal merger investigation and enforcement action record over the past fifteen years. The report shows, sector by-sector, the...more