• where experts go to learn about FDA
  • Hatch-Waxman

    • ACI’s 5th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIASeptember 16th, 2025

      The American Conference Institute’s (ACI’s) virtual 5th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is scheduled to take place from October 14-30, 2025 (Eastern Standard Time).  The virtual training series is specifically designed for attorneys, regulatory affairs professionals, and industry executives …

    • New Report on Patent Litigation Settlements Says that they are Critically Necessary to Ensure Prompt Generic and Biosimilar Market EntryJune 26th, 2025

      Earlier this month, the Association for Accessible Medicines and its Biosimilars Council (“AAM”) announced (here and here) the release of a report, titled “Assessment of the Impact of Settlements,” examining the effects of patent litigation settlements on patient savings and access to generic drugs and …

    • Here FTC Goes Again on Its OwnJune 9th, 2025

      It was about a year and a half ago that we first proclaimed mass hysteria when FTC crossed streams into FDA territory, but perhaps our cries were premature.  As we mentioned last year, a large number of the drug companies targeted by FTC in its …

    • Injunction Junction, What’s Your Function under the Patent Safe Harbor?May 29th, 2025

      In yet another installment of the drama that is Jazz v. Avadel, the Federal Circuit recently reviewed a decision from the U.S. District Court for the District of Delaware that addressed the scope of an injunction under the patent safe harbor imposed on Avadel’s Lumryz …

    • The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic DrugsApril 9th, 2025

      The FDA Reduction-in-Force (Termination)—or “RIF(T)”—announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIF’d.  As the dust begins to settle and we all assess what this means for the future of FDA and the public health, …

    • ACI’s 23rd Advanced Summit on Life Sciences PatentsApril 8th, 2025

      Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institute’s 23rd Advanced Summit on Life Sciences Patents, which is scheduled to take place from May 19-20, 2025 at the New York Bar Association in New York, …

    • The Preserve Access to Affordable Generics and Biosimilars Act: It’s Back! And Bigger and Bolder than Before!April 2nd, 2025

      Last week, U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) announced the introduction of two bills we’ve seen before: (1) S. 1096, the Preserve Access to Affordable Generics and Biosimilars Act; and (2) S. 1095, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation …

    • The Issue with Reissue: PTE EditionMarch 19th, 2025

      Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product.  Even though the PTE provisions established in the Drug Price Competition and …

    • ACI’s 21st Annual Paragraph IV DisputesMarch 13th, 2025

      The American Conference Institute’s 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY.  Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the …

    • What’s in a Claim? The Federal Circuit Rules on Orange Book Patent ListingsJanuary 8th, 2025

      Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing.  …

    • Saving the Skinny Label Through the Skinny Label, Big Savings ActJanuary 2nd, 2025

      Since the induced infringement finding in GSK v. Teva, the generic industry has feared the death of the skinny label (admittedly stoked by alarmist headlines like my own, see Ding Dong is the Skinny Label (Effectively) Dead?).  This is because, at a minimum, if a …

    • After a Hiatus, the BLOCKING Act is Back!December 11th, 2024

      We learned earlier this week that an allision (a runner-up to Merriam-Webster’s 2024 Word of the Year, polarization) may be poised to occur—perhaps within a fortnight (another runner-up to Merriam-Webster’s 2024 Word of the Year thanks to Taylor Swift)—as Congress considers various pieces of healthcare …

    • “If You’ve Got Legitimate Suspenders, Don’t Have an Unconstitutional Belt:” Federalist Society Panel’s Take on Jarkesy and the Preserve Access to Affordable Generics and Biosimilars ActDecember 4th, 2024

      On August 30, 2024, we posted on what was then the most recent version of S. 142, the Preserve Access to Affordable Generics and Biosimilars Act.  Some version of the bill, which addresses patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their …

    • As Jurisprudence Under Loper Bright Develops, Early Scorecard is MixedNovember 4th, 2024

      Back in July, the United States Supreme Court turned the world of administrative law on its head, adding new layers of judicial oversight to what might have previously been thought of as fairly non-descript Federal agency functions. One of those cases was Loper Bright v. …

    • Skinny-Label Lives to See Another DayOctober 17th, 2024

      Further talks of the Skinny Label’s demise may be premature, as demonstrated by a new decision from the District Court for the District of Columbia upholding FDA’s interpretation of the “same labeling” provisions of the Hatch-Waxman Amendments.  That is not to say that concerns about …