Tag: FTC
PhRMA Seeks to Eliminate Pharma Antitrust Reporting Requirements
Background.
On February 7, 2014, the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry group composed of research-focused pharmaceutical and biotechnology companies, filed a motion in the U.S. District Court for the District of Columbia to invalidate the Premerger Notification; Reporting and Waiting Period Requirements Final Rule (Rule) promulgated by the Federal Trade Commission.
As we discussed on December 16, 2013, this new Rule adopts an “all commercially significant rights” test to determine whether a transfer of assets has occurred in an exclusive patent license agreement. The new Rule applies only to the pharmaceutical industry.
PhRMA’s Complaint.
PhRMA filed a Complaint seeking injunctive relief against the FTC, No. 1:13-cv-01974-BAH, (D. D.C. 2013), just days before the final rule took effect on December 16, 2013. The Complaint alleges the following: (1) the new Rule exceeds the FTC’s statutory authority under the Hart Scott Rodino (HSR) Act; (2) … Read More »
FTC Amendments to Premerger Notification Rules: The Who, What & Why
On November 6, 2013, the Federal Trade Commission released final amendments to the Hart-Scott-Rodino Premerger Notification Rules to clarify when a transaction involving the transfer of rights to all or part of a pharmaceutical (including biologics) patent is reportable under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”).
The final rule, which is the same as the proposed rule circulated a year ago for public comment, codifies an “all commercially significant rights” test to determine whether a transfer of rights has occurred in an exclusive patent license agreement. Under that rule, if a patent licensor transfers all commercially significant rights to the patent, the transaction may be reportable. The final rule states that if “limited manufacturing rights” are retained by the licensor, then the transaction may also be reportable under the Act.
The final rule, which takes effect on December 16, 2013, is available … Read More »
2013 Should Bring Clarity to Analysis of Settlements of Pharmaceutical Patent Litigation
The Federal Trade Commission (FTC) recently filed a brief with the U.S. Supreme Court in a case that promises to bring some clarity to the analysis of settlements of pharmaceutical patent litigation. Under the Hatch-Waxman Act, a generic drug manufacturer can file an application with the Food and Drug Administration (FDA) stating that a pioneer manufacturer’s patent is invalid or that its generic drug does not infringe the patent. By statute, such an application is a technical act of patent infringement, permitting the pioneer manufacturer to file patent litigation. Some of these patent infringement suits are resolved by settlements that include a payment by the pioneer manufacturer to the generic manufacturer, which agrees to refrain from producing its generic drug for a specified period. The FTC refers to these settlement agreements as “reverse payment agreements” or “pay-to-delay” agreements.[1]
The legality of … Read More »