As news surfaced on February 27 that Congress is punting long-debated pharmacy benefit manager reforms, the community pharmacy lobby demanded CMS immediately take enforcement action against improper PBM practices that the lobby says could cause nearly a third of independent pharmacies to shutter this year. […] Jonathan Swichar, partner for Duane Morris and the chair ..read more

Senator Tammy Baldwin (D-WI) sent letters this week to companies warning of improper Orange Book listings of patents for inhalers, following up on the FTC’s focus on potential anticompetitive harm of improper listings. According to Senator Baldwin’s letters, the recipients of the letters were warned by the FTC in November regarding the listing of inhaler ..read more

“Has your institution received government funding? Is government funding behind your patents? Are you licensing patents that were developed with government support? If so, you really should listen to this informative webinar. Your rights and economic interests could be dramatically impacted by March-In Rights.” Discover the nuances of March-In Rights in patent law through a ..read more

Today, the Federal Trade Commission (“FTC”) and Department of Justice (“DOJ”) (collectively, the “Agencies”) jointly released the 2023 Merger Guidelines .  The 2023 Merger Guidelines outline the “factors and frameworks the agencies utilize when reviewing mergers and acquisitions,” including both horizontal and vertical transactions. The 2023 Merger Guidelines finalize the draft merger guidelines that were ..read more

On December 11, 2023, Sanofi released a statement that it will terminate its proposed $755 million licensing agreement with Maze Therapeutics (Maze) shortly after the Federal Trade Commission (FTC) issued an administrative complaint and authorized filing a complaint for preliminary injunction in the United States District Court for the District of Massachusetts to block the ..read more

Following enactment of the Inflation Reduction Act, which provides for Medicare drug price negotiations, the White House has announced new actions to lower drug costs, including the release of a proposed framework for agencies to exercise march-in rights under the Bayh-Dole Act to promote public accessibility to tax-payer-funded drugs. If adopted, the framework would make it easier ..read more

Today, FDA announced updated guidance regarding its MoCRA rollout. FDA  does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements. To read the full text ..read more

On November 7, 2023, the Federal Trade Commission (“FTC”) announced that it had issued notice letters to 10 life sciences companies regarding 100 patents that the FTC contends are improperly listed in the Orange Book, the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. The announcement comes of the heels of the FTC’s policy statement ..read more

Daniel R. Pierce, Corporate and IP partner in the Boston office, recently spoke with Chris Barden, CEO of firm client Treventis, about his background, his company’s research into misfolded proteins to develop cures for central nervous system diseases like Alzheimer’s, as well as Chris’ thoughts and experience at the BIO Conference. Can you tell us ..read more

In Episode 35 of the  Class Action Weekly Wire podcast,  host Jerry Maatman interviews Duane Morris associate Kelly Bonner about the Modernization of Cosmetics  Regulation Act (MoCRA). Watch the episode below ..read more