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  • Hatch-Waxman

    • HP&M’s Sara Koblitz to Present on Integrating FDA Regulatory Law into an IP Law PracticeApril 13th, 2021

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Sara W. Koblitz will be discussing the fundamentals of FDA law as it relates to Intellectual Property law in a remote program hosted by the DC Bar.  The program, titled “FDA Law for IP Lawyers: Tips …

    • Bills, Bills, Bills: Congress Advances Bills to Address Drug CompetitionApril 2nd, 2021

      There’s no question that drug pricing is one of the most important issues in health care right now, and while such pricing considerations are outside FDA’s statutory mandate, it has not stopped FDA from trying to address pricing issues through enhancing drug competition (see, for …

    • When Is Skinny Not Skinny Enough?March 17th, 2021

      Perhaps when you’re carving out a patented method of use?  Well, at least that’s what GSK is arguing.  As the now-infamous GSK v. Teva case makes its way through the Federal Circuit once again to address what many have called the death-knell to skinny-labeling (also …

    • ACI’s 36th FDA Boot Camp (Virtual Conference)February 9th, 2021

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 36th iteration – is scheduled to take place from March 24-25, 2021 (Eastern Time).  The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult …

    • Orange Book Modernization Act: Congress Largely Codifies FDA’s Existing Orange Book Practices, But Also Brings PTAB Decisions Into the FoldJanuary 14th, 2021

      Those of you keeping up with the Orange Book know that FDA has been considering changes to patent listing requirements, many of which industry has been requesting for decades.  Now, Congress is trying to facilitate effective administration of the Orange Book.  On January 5, 2021, …

    • Federal Circuit Limits Venue in Hatch Waxman Patent LitigationDecember 9th, 2020

      The FDA Law Blog may appear to have become a little patent-heavy over the last few months, but you can thank the Federal Circuit for that.  It just can’t stop changing the landscape for Hatch-Waxman litigation.  In October, the Federal Circuit, for all intents and …

    • FDA Law Alert – December 2020December 4th, 2020

      To close out 2020, Hyman, Phelps & McNamara, P.C. is pleased to present the latest issue of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and enforcement …

    • Makin’ Copies: FDA Revises RLD and RS GuidanceNovember 2nd, 2020

      Identification of and comparison to a Reference Listed Drug (“RLD”) and Reference Standards (“RS”) are the lynchpin of generic drug development and approval.  It’s therefore no surprise that, upon significantly updating the Orange Book in January 2017, FDA dedicated an entire guidance to fundamental definitions …

    • Did the Federal Circuit Just Kill ANDA “Skinny Labeling”? – GSK v. TevaOctober 14th, 2020

      2020 was supposed to be a year remembered for the 40th anniversary of the publication of the Orange Book—a celebration of one aspect of the Hatch-Waxman Amendments—but it could turn out that 2020 is remembered as the year in which the Hatch-Waxman Amendments took a …

    • Californovation? California is Set to Become a Drug ManufacturerSeptember 16th, 2020

      Californovation (sung to the tune of the Red Hot Chili Peppers’ Californication, obviously): the new portmanteau seems appropriate for California, who just keeps coming up with new ideas to address the many hurdles consumers face with respect to access to affordable medicines.  Last year, we …

    • PTE Countdown (Or Not?!?): 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (Read to a Funky Soundtrack and Vocals by The Pointer Sisters)September 3rd, 2020

      For those of us of “a certain age,” the original “Sesame Street” recalls fond memories: Mr. Hooper, Mr. Snuffleupagus (when only Big Bird could see Snuffy), and those catchy songs like “C Is For Cookie” and, of course, “Pinball Countdown” – those animated segments with …

    • Tick Tock, Goes The Clock . . . October 1st is Fast-ApproachingSeptember 2nd, 2020

      No, “Tick Tock, Goes The Clock” is not a reference to Doctor Who poetry, Ke$ha (TiK ToK), or to that “TikTok” destination for mobile videos that’s been in the news recently.  We’re talking about the countdown to October 1, 2020, when the Fiscal Year 2021 …

    • ACI’s 14th Annual Paragraph IV Disputes (Virtual Conference)September 2nd, 2020

      The American Conference Institute (“ACI”) is sponsoring its 14th Annual Paragraph IV Disputes Conference on October 6 – 7, 2020 (Eastern Daylight Time).  Like a lot of conferences this year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference. ACI’s Paragraph …

    • 2 Become 1: MAPP on Consolidation of ANDAsAugust 26th, 2020

      Every so often, FDA revisits a policy set forth in FDA’s Manual of Policy and Procedures (“MAPP”) to reflect the Agency’s current practices.  Though MAPPs really only govern the actions of the Agency, their content is important to understanding how FDA will approach certain requests.  …

    • California Dreaming Part 3: It’s No Longer Just a DreamAugust 7th, 2020

      When California first passed its Pay for Delay bill, AB 824: Preserving Access to Affordable Drugs, we questioned whether the law could withstand a constitutional challenge, and indeed, the Association for Accessible Medicines (“AAM”) brought such a challenge in November 2019.  For those of you …