FTC Expands Scope of Reportable Pharma Patent Licenses under the Hart-Scott-Rodino Act
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- The FTC has revised the Hart-Scott-Rodino rules to require a pre-transaction filing if a patent license in the pharmaceutical, including biologics, and medicine manufacturing industry gives the licensee “all commercially significant rights,” i.e., the exclusive right to use the patent in a particular therapeutic area or a specific indication within a therapeutic area.
- Under the revised rules, a license is considered to convey “all commercially significant rights” even if the licensor retains the right to manufacture the product(s) solely for the licensee, and/or to assist the licensee in developing and commercializing the product(s).