FTC Sets New Rules for Pharma Licenses and Antitrust Approvals

MurinoFeatured Expert Column

Andrea Agathoklis Murino, Wilson Sonsini Goodrich & Rosati

Certain transfers of exclusive patent licenses in the pharmaceutical sector will face new antitrust scrutiny from the Federal Trade Commission (“FTC”).*  In a change to long-standing policy, the FTC announced that the transfer of a license providing an exclusive licensee with “all commercially significant rights” over a patent within a therapeutic area will be reportable under the HSR Act.

Under the old scheme, only the transfer of licenses giving the licensee a right to make, use, and sell the product were subject to the provisions of the HSR Act.  This meant that in cases where a licensor retained the right to manufacture the patented pharmaceutical product, even if the licensee had the exclusive right to use and sell the patented pharmaceutical product, the transfer was deemed non-exclusive and thus non-reportable.  The shift means that parties will need to prepare the HSR Act filing itself, observe the mandatory waiting period before closing (typically 30 days), and, of course, be prepared to respond to any competitive concerns raised by the FTC.  Continue reading “FTC Sets New Rules for Pharma Licenses and Antitrust Approvals”

FDA Proposed Rule on Generic Drug Preemption May Violate Its Statute

FDALast Friday just prior to the Veterans’ Day weekend, the Food and Drug Administration (FDA) issued a highly anticipated notice of proposed rulemaking which addresses the U.S. Supreme Court’s 2012 decision, PLIVA v. Mensing. The proposal, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, was introduced by Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in an FDA Voice blog post. The proposal, according to her, is “intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients.”

As emphasized in a New York Times story about the proposal, “The rule would also pave the way for lawsuits from patients who could now claim that generic companies did not sufficiently warn them of a drug’s dangers.”

As WLF’s Rich Samp argued here last August in Can FDA Lawfully Overrule SCOTUS Generic Drug Preemption Decision Through Regulation?, WLF doubts that FDA has the authority under federal law to take such an action. We look forward to participating in the regulatory process and the accompanying debate that will intensify now that FDA has formally proposed the rule.