The US Federal Trade Commission ("FTC") proposes to adopt a new rule designed to increase the likelihood that transfers of pharmaceutical patent rights including biologics will be reportable under the Hart-Scott-Rodino Act ("HSR Act") pre-merger notification regime. The FTC's new rule would replace the current "make, use and sell" standard for analyzing the transfers with a new "all commercially significant rights" standard. The proposed rulemaking will increase the number of pharmaceutical exclusive rights transfers which will be reportable under the HSR Act (or if not reported, then subject to the harsh daily penalty for non-reporting). The principal practical change is that the transfer of exclusive manufacturing rights no longer is required to make the transfer potentially reportable under the new standard.
The FTC is inviting public comments on this new rule. The deadline for providing comments to the FTC is October 25, 2012. The proposed rule can be viewed on the FTC's website at ftc.gov/os/2012/08/120813hsr-ipnprm.pdf. We provide a brief description of the contrast between the FTC's current rule and its new rule, and describe how to comment on the FTC's proposed rule.
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