A federal court has endorsed the Federal Trade Commission’s authority to adopt regulations under the Hart-Scott-Rodino (HSR) Act that target specific industries. In Pharmaceutical Research and Manufacturers of America v. Federal Trade Commission, the court rejected a challenge to the legality of a new FTC rule that subjected pharmaceutical patent licensing transactions to unique reporting requirements.

As we wrote in an earlier e-alert in November 2013, the FTC has adopted a rule that expanded the HSR reporting requirements for licensing transactions involving pharmaceuticals and biologics where the licensor retains manufacturing rights or other co-rights (e.g., co-marketing or co-commercialization rights). The new rule became effective on December 16, 2013. Previously, the transfer of a pharmaceutical patent license was reportable only if it involved the exclusive right to use a patent (or part of a patent) to develop a product, manufacture the product, and sell that product without restriction.

Shortly before the new rule became effective, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit against the FTC claiming that the HSR Act does not permit the FTC to issue rules that discriminatorily expand the scope of reporting requirements for specific industries. Deciding the parties’ cross-motions for summary judgment, the court sided with the FTC that the agency is entitled to Chevron deference for its interpretation that the HSR Act grants authority to promulgate industry-specific rules. Finding that Congress did not restrict the FTC’s authority to target specific industries, the court reasoned that the purpose of the HSR Act is not uniform application among industries, but the prevention of anticompetitive mergers.

PhRMA may appeal the decision to the U.S. Court of Appeals for the District of Columbia Circuit, but in the meantime, transfers of patent rights that satisfy the new rule must continue to be reported to the FTC. Companies engaging in pharmaceutical and biotechnology licensing transactions should consult HSR counsel to make an informed decision about their reporting obligations. The FTC has not indicated that it will promulgate rules for patent licensing in other industries, but the rationale of this decision could support such action.

Attorneys in Ballard Spahr’s Antitrust Group regularly advise on the reportability of transactions under the HSR Act. For more information, please contact Leslie E. John at 215.864.8212 or john@ballardspahr.com, Jason A. Leckerman at 215.864.8266 or leckermanj@ballardspahr.com, or Marcel S. Pratt at 215.864.8287 or prattm@ballardspahr.com. 

Copyright © 2014 by Ballard Spahr LLP.
(No claim to original U.S. government material.)

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, including electronic, mechanical, photocopying, recording, or otherwise, without prior written permission of the author and publisher.

This alert is a periodic publication of Ballard Spahr LLP and is intended to notify recipients of new developments in the law. It should not be construed as legal advice or legal opinion on any specific facts or circumstances. The contents are intended for general informational purposes only, and you are urged to consult your own attorney concerning your situation and specific legal questions you have.