George Gordan

George Gordan

Dechert LLP

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FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval

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

3/13/2014 - Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars FDA FTC Pharmaceutical

Follow-on Biologics: Working with the Federal Trade Commission

In this Presentation: - Agenda - BPCIA Refresher - FDA Developments - Purple Book, FDA Review of Applications, Draft Guidance, Abbott Petition - The Naming Issue - State Substitution Laws -...more

2/6/2014

FTC Orders Greater HSR Reporting of Patent Licenses in the Pharmaceutical Sector

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

11/11/2013 - Compliance FTC Hart-Scott-Rodino Act Patents Premerger Notifications Reporting Requirements

U.S. Supreme Court Rejection of the “Scope of the Patent” Test in FTC v. Actavis Has Wide-Ranging Implications

Key Points: - Patent settlements must be analyzed under the rule of reason, requiring a full analysis of the net competitive effects - Payments to an alleged infringer may be permissible if justified by, for...more

6/20/2013 - Actavis Inc. FTC FTC v Actavis Generic Drugs Hatch-Waxman Patents Prescription Drugs Reverse Payment Settlement Agreements Settlement

Pending Bill Would Expand FTC Powers Over Drug Patent Settlements and Alter the Legal Test

Key Points: - 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

2/14/2013 - Drug Manufacturers Enforcement FTC Infringement Patents Penalties Pharmaceutical Preserve Access to Affordable Generics Act Presumption of Illegality Reverse Payment Settlement Agreements SCOTUS

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