Kaye Scholer Antitrust Partner And Former FTC Assistant Director Claudia Higgins Comments On New FTC Rules For Pharma Patent Licensing Transactions

November 8, 2013

Washington, DC: Earlier this week, the FTC adopted rules that will expand the number of pharmaceutical patent licensing transactions that are subject to HSR filings and review by the FTC.

“The new FTC rules will apply only to pharmaceutical licensing, an approach that raises questions about why the agency would single out this industry for heightened regulatory scrutiny under the Hart-Scott-Rodino Act.  Although the FTC asserts that it supports efforts to get new cost-effective medicines out to patients sooner, the implementation of these new rules will result in an increased number of HSR filings for pharmaceutical licensing transactions, adding cost and delay to a significant number of agreements for which Agency review is neither necessary nor mandated by the Act,” said Claudia R. Higgins, formerly a FTC Assistant Director,  who is now an Antitrust Partner at Kaye Scholer’s Washington office. 

“The rules will apply to patents covering products whose manufacture and sale would produce revenue in the following areas: medical and botanical manufacturing, pharmaceutical preparation manufacturing, in-vitro diagnostic substance manufacturing and biological product (except diagnostic) manufacturing.”

To schedule an interview with Claudia or talk further about the potential impact for the pharma industry, please contact  You can also learn more by reading Kaye Scholer’s Client Alert on the topic here.

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