Antitrust agencies amend premerger notification rules to clarify reporting of acquisitions of pharmaceutical patent rights

By Paolo Morante and Laura M Kam

The US Federal Trade Commission, with the concurrence of the Antitrust Division of the US Department of Justice, has amended the premerger notification rules to clarify when a transfer of exclusive rights to a patent or part of a patent in the pharmaceutical industry is reportable under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.

The new rules require that transfers of ‘all commercially significant rights’ (typically in the form of an exclusive licence) to a patent or part of a patent in the pharmaceutical industry, including biologics, be reported to the antitrust agencies at least 30 days in advance of closing of the proposed transfer, assuming the HSR Act’s other statutory thresholds are met.

The new rules may cause an uptick in premerger notification filings in the pharmaceutical industry by expanding the reportability of certain licence transactions in which the licensor retains limited rights to ‘make’ the drug at issue for the licensee or assists the licensee in the sale of the drug. The new rules clarify that premerger notification reporting is required even where the licensor retains limited rights to manufacture for the licensee and co-rights to co-develop, co-promote, co-market or co-commercialise with the licensee…

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