Hart-Scott-Rodino Act Pharmaceutical Industry

The Hart-Scott Rodino Antitrust Improvements Act is a United States federal statute enacted in 1976 establishing the federal premerger notification program. Under the Act, parties contemplating mergers or... more +
The Hart-Scott Rodino Antitrust Improvements Act is a United States federal statute enacted in 1976 establishing the federal premerger notification program. Under the Act, parties contemplating mergers or acquisitions must notify the Department of Justice and the Federal Trade Commission prior to completing the transaction. Once notified, the DOJ and FTC investigate and make a determination as to whether the proposed transaction will adversely impact U.S. commerce and competition within the market. less -
News & Analysis as of

District Court Upholds FTC Hart-Scott-Rodino Rules for Pharmaceutical Patent Transfers

A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We...more

Court Endorses FTC Authority To Require Special Reporting for Pharmaceutical Licenses

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....more

FTC’s Reporting Rule for Pharmaceutical Patent Transfers Upheld

On May 30, 2014, the U.S. District Court for the District of Columbia ruled in favor of the Federal Trade Commission (FTC) in a dispute with the Pharmaceutical Research and Manufacturers of America (PhRMA) regarding the...more

District Court Upholds HSR Rulemaking on Pharmaceutical Patent Licensing Transactions

The transfer of certain patent rights in the pharmaceutical industry will remain subject to the premerger notification rules under the Hart-Scott-Rodino Act (HSR Act) after a federal judge rejected a challenge brought by the...more

FTC Targets Reporting of Licensing of Pharmaceutical Patents With Special Rules for Premerger Notification: What You Need to Know

On November 15, 2013, the Federal Trade Commission (“FTC”) adopted special rules for determining whether “exclusive” licenses of pharmaceutical patents are required to be reported to the FTC and the Antitrust Division of the...more

HSR Act Allows Pharmaceutical Licensing Transactions To Be Subject to Unique Reporting Requirements, FTC Tells Court

The Federal Trade Commission (FTC) has asked a federal court to find that the agency has authority under the Hart-Scott-Rodino Act (HSR Act) to promulgate reporting requirements that apply solely to transfers of patent rights...more

Pharmaceutical Association Calls Out FTC in Filing Seeking to Enjoin New Rule Targeting the Industry

Last November, the Federal Trade Commission (“FTC”) with the “concurrence” of the Antitrust Division of the Justice Department, and over the strenuous objection of Pharmaceutical Research and Manufacturers of America...more

"Antitrust and Competition: Surveying Global M&A Enforcement Trends"

US: Agencies Continue Aggressive Enforcement - Despite changes in leadership at the U.S. Department of Justice’s (DOJ) Antitrust Division and the Federal Trade Commission (FTC) (collectively, the Agencies) in 2013, the...more

FTC Expands Scope of Hart-Scott-Rodino Reporting Rules for Pharmaceutical Patent Rights Transfers

The Federal Trade Commission has broadened the rules dictating when pharmaceutical companies must report a transfer of exclusive patent rights to the U.S. Department of Justice and FTC for antitrust review and approval. Under...more

New FTC Rules for Exclusive Pharmaceutical Patent Licenses

The Federal Trade Commission (FTC) has issued final rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) relating to the transfer of exclusive patent rights in the pharmaceutical industry. These new...more

FTC Announces Amendments to Hart-Scott-Rodino Rules Regarding Pharmaceutical Patent Licenses

The Federal Trade Commission (FTC) has announced revisions to the rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) that will apply to certain transactions involving the transfer of patent rights in...more

FTC Finalizes Amendments To HSR Rules Regarding Transfer Of Exclusive Patent Rights In The Pharmaceutical Industry

The Federal Trade Commission (FTC) has finalized certain amendments to the Hart-Scott-Rodino (HSR) premerger notification regulations clarifying the scope of reportable transactions involving transfers of patent rights in the...more

FTC Expands the Scope of Pharmaceutical Licensing Transactions That Will Be Subject to Premerger Review

The Federal Trade Commission (FTC) recently announced that it has finalized amendments to the premerger notification rules (HSR Rules) that provide a framework for determining when a transaction involving the transfer of...more

FTC Broadens Notification Requirements for Transfers of Pharmaceutical Patent Rights

The Federal Trade Commission (FTC) has revised the rule for determining when a transfer of exclusive rights to a patent in the pharmaceutical industry (including biologics and medicine manufacturing) results in a potentially...more

Finalized Amendments to Premerger Notification Rules Will Impact Pharma Companies

Pharmaceutical companies that use exclusive patent licenses to bring drugs and medicines to market must now notify the U.S. antitrust agencies of more of these types of licensing transactions and await approval before...more

FTC Issues Premerger Notification Review Changes for Pharmaceutical Patent License Transfers

The Federal Trade Commission (FTC) issued final changes to the premerger notification rules to expand the circumstances that require pharmaceutical industry companies to report proposed acquisitions of exclusive patent rights...more

Final FTC Rules Will Generate More HSR Filings for Transfers of Pharmaceutical Patent Rights

The U.S. Federal Trade Commission (FTC) announced final changes to the Hart-Scott-Rodino (HSR) Act premerger notification rules that will broaden the circumstances under which parties must file premerger notifications in...more

FTC Investigations of Pharma and Medical Device Transactions – Am I at Risk?

A recent article in the Antitrust Law Journal titled “A Survey of Evidence Leading to Second Requests at the FTC,” by Darren S. Tucker, an attorney advisor to a FTC Commissioner who reviewed non-public information on the...more

New FTC/DOJ Position Will Require Heightened Regulatory Reporting of Pharma, Biological and Diagnostic Licenses -- October 25,...

The Federal Trade Commission and Department of Justice recently announced revisions to the Hart-Scott-Rodino (HSR) Act’s premerger notification rules to require enhanced reporting of transactions (including licenses) relating...more

FTC proposes framework for the transfer of patent rights in the pharmaceutical industry

The FTC has proposed amendments to the premerger notification Rules to codify prior FTC guidance concerning when a transaction involving the transfer of rights to a patent in the pharmaceutical and medicine manufacturing...more

FTC Seeks Comments on Proposed HSR Rule Amendments Related to the Transfer of Exclusive Patent Rights in the Pharmaceutical...

The Federal Trade Commission (“FTC”) recently announced and asked for comments on proposed changes to the premerger notification rules under the Hart-Scott-Rodino Act (“HSR Act”). The proposed rules would require...more

FTC Sights Set on Pharma Deals – Calls for Additional Hart-Scott-Rodino Reporting

The Federal Trade Commission has proposed expanding Hart-Scott-Rodino reporting and waiting period obligations for certain pharmaceutical, biologics and medicine manufacturing licenses. The new rules are subject to public...more

FTC Flexes Healthcare Regulatory Muscle

Proposed rule includes new requirements for reporting pharmaceutical patent transfers. On August 13, the Federal Trade Commission (FTC) released proposed amendments to the premerger notification rules (the Proposed...more

Yet Another Turn of the Screw: The FTC Again Targets Pharmaceutical Industry, This Time Through the HSR Act

Fresh from its victory in the Third Circuit on “pay-for-delay” deals involving brand name and generic pharmaceutical companies, the Federal Trade Commission (“FTC”) has announced yet another initiative aimed at the...more

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