MIke Cowie

MIke Cowie

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

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

FTC Report Shows that Oil Sector and Pharmaceutical Sector Mergers Are Under the Antitrust Spotlight

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

1/23/2013 - FTC Horizontal Mergers Oil & Gas Pharmaceutical

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