Drugs

WLF Brief Seeks High Court Review of Patent Settlement Case

Washington Legal Foundation (WLF) has filed an amicus brief calling on the U.S. Supreme Court to review and overturn a 6/2016 decision by the U.S. Court of Appeals for the Third Circuit that “requires exacting antitrust scrutiny for virtually any agreement between a brand-name drug company and a generic drug company to settle patent-infringement litigation.” The brief argues that the appeals court decision expands antitrust law dramatically and makes it almost impossible for litigants to settle drug-patent disputes. WLF’s brief was joined by the Allied Educational Foundation.

The 6/26 appeals court ruling in King Drug Co. v. SmithKline Beecham found that in addition to reverse cash payments, a settlement in which the innovator drug manufacturer agrees to relinquish its right to produce an “authorized generic” of the drug that would compete with a first-filing generic’s drug during the generic’s 180-day market exclusivity period could also be challenged as anticompetitive. The panel of judges said the “no authorized generic agreement ... falls under Actavis’s rule because it may represent an unusual, unexplained reverse transfer of considerable value from the patentee to the alleged infringer and may therefore give rise to the inference that it is a payment to eliminate the risk of competition.”

WLF contends that the high court’s Actavis decision held that a patent-litigation settlement is subject to antitrust scrutiny if the settlement includes a large and unexplained “payment” from the brand-name company to the generic company. “The Third Circuit dramatically expanded that ruling by holding that any benefit (even exclusive patent licenses) provided by the brand-name company triggers antitrust scrutiny,” the group says. It further argues that the appeals court’s decision conflicts with Actavis and will make it virtually impossible for parties to settle drug-patent disputes.

“Settling lawsuits ought to be encouraged because it is more economically efficient than having trials and saves judicial resources,” WLF concludes.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome