Sean McConnell – Duane Morris Life Sciences Law

February 15, 2024 by Duane Morris

FTC Voices Support for March-In Rights on Patents to Help Control Drug Prices

The Federal Trade Commission (FTC) has announced its support of the federal government’s use of “march-in rights” as a mechanism to control the price of pharmaceuticals. The National Institute of Standards and Technology (NIST) late last year issued its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” that would fundamentally change the use of march-in rights by allowing the government to exercise price control under the Bayh-Dole Act, which the FTC announced its support for last week. This shift is the latest effort by federal agencies to lower drug prices in the wake of President Joe Biden’s Executive Order on Promoting Competition in the American Economy.

Read the full Alert on the Duane Morris LLP website.

December 12, 2023December 12, 2023 by Sean P. McConnell

Sanofi Abandons Licensing Deal With Maze Therapeutics After FTC Challenges The Proposed Transaction

On December 11, 2023, Sanofi released a statement that it will terminate its proposed $755 million licensing agreement with Maze Therapeutics (Maze) shortly after the Federal Trade Commission (FTC) issued an administrative complaint and authorized filing a complaint for preliminary injunction in the United States District Court for the District of Massachusetts to block the deal.

Under the terms of the proposed licensing agreement between Genzyme Corporation, a wholly-owned subsidiary of Sanofi, and Maze, Sanofi would acquire an exclusive license to Maze’s glycogen synthase 1 products and related technology, including its candidate MZE001, a drug in development to treat the potentially fatal genetic order Pompe disease. According to a statement by Jason Coloma, Ph.D., Maze’s CEO, the FTC’s challenge “is the first time ever the FTC has moved to block a license of a Phase 1 investigational medicine.” The challenge seems consistent, however, with revised draft merger guidelines proposed by the FTC and Department of Justice that indicate that transactions “should not entrench or extend a dominant position” by, for example, “[e]liminating a nascent competitive threat.”

Continue reading “Sanofi Abandons Licensing Deal With Maze Therapeutics After FTC Challenges The Proposed Transaction”

November 9, 2022 by Duane Morris

Board Directors Beware: U.S. Antitrust Agencies Ramp Up Enforcement of Interlocking Directorates

The Antitrust Division of the Department of Justice (DOJ) has indicated a recent interest in enforcing Section 8 of the Clayton Act, which prohibits individuals from serving on boards of competing corporations, known as “interlocking directorates.” (See 15 U.S.C. § 19.) Assistant Attorney General Jonathan Kanter has called Section 8 an “important but underenforced” antitrust law. After DOJ announced a focus on Section 8, the agency reported that seven board members announced their resignations in response. Since then, DOJ has continued its focus on Section 8, issuing civil investigative demands and confidential investigation letters to firms, including private equity funds and investors. Life sciences companies, and companies that invest in the life sciences industry, should be on the lookout for interlocking directorates, as there is empirical evidence suggesting that the industry is particularly at risk of a Section 8 investigation.

Read the full text of this Alert on the firm website.