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  • Hatch-Waxman

    • Is the Listing of REMS Patents in the Orange Book Patently Anticompetitive?November 18th, 2022

      FTC sure thinks so.  And the FTC said as much in a recent Amicus Brief (“Brief”) in paragraph IV litigation between Avadel CNS Pharmaceuticals (“Avadel”) and Jazz Pharmaceuticals Inc. (“Jazz”).  This type of statement from the FTC is unprecedented; not only is the FTC Brief …

    • FUFRA Enacted; HP&M Issues Detailed Summary and AnalysisNovember 9th, 2022

      On September 30, 2022, President Biden signed into law the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, Division F of which is titled the “FDA User Fee Reauthorization Act of 2022” (“FUFRA”).   In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several …

    • New Lawsuit Challenges FDA’s Authority to Compel Patent CertificationsAugust 11th, 2022

      For years, FDA has been wrestling with questions about what patents should be listed in the Orange Book, but, as we have reported, FDA has made little to no progress on addressing those questions.  One of those pressing questions that remains unanswered involves the listing …

    • ACI’s Paragraph IV Disputes Master Symposium – September 21-22, 2022 (Chicago)August 5th, 2022

      Join members of the Judiciary and leading pharmaceutical patent litigators from brand name and generic drug companies at the American Conference Institute’s 8th Annual Paragraph IV Disputes Master Symposium taking place September 21-22, 2022, in Chicago! As the industry prepares to address the fallout of global …

    • Teva Gets Knocked Down, But It Gets Up Again—and Petitions SCOTUSAugust 4th, 2022

      Teva may be down, but it’s not out yet.  By now, the ongoing Teva v. GSK litigation— concerning induced infringement of patents covering the use of carvedilol in decreasing mortality caused by congestive heart failure in a patient—is well-worn territory (see our multiple posts on …

    • Everything You Wanted to Know About the Orange Book But Were Too Afraid To AskJuly 26th, 2022

      In its second Orange Book Guidance in as many days, FDA is addressing all of your burning questions about the Orange Book—and boy are we excited at the Agency’s efforts to make the Orange Book accessible for everyone!  The Guidance is a Frequently Asked Questions …

    • TE Codes 101: FDA Guidance Teaches Basics of Therapeutic Equivalence CodesJuly 24th, 2022

      The Orange Book’s Therapeutic Equivalence Codes (TE Codes) play a critical role in our drug distribution and payment system.  All states have “automatic substitution” laws that require prescriptions to be filled using a generic where available (unless otherwise ordered by the physician), and those substitutions …

    • Is FDA Going to Get A Little Help From Its Friends at the PTO?July 21st, 2022

      Drug pricing has been a hot button issue in the U.S. for decades, and patent protections have been cited as a source of “gamesmanship” allowing brand companies to keep drug prices high.  Yet, as long as FDA and FTC have been trying to address anticompetitive …

    • Here It Goes, Here It Goes, Here It Goes Again: The Build Back Better Act (Redux)July 14th, 2022

      The Build Back Better Act—the food and drug law implications of which we discussed last year—has popped up again in Congress, and it is just as dense as ever.  With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. As we explained …

    • In Bid to Curtail 180-day Exclusivity, FDA Alters Longstanding Practice and Newly Declares that Converted OTC Products Are Not “Listed Drugs”June 21st, 2022

      Readers of this blog surely are familiar with FDA’s repeated efforts to rein in Congress’s 180-day exclusivity reward to the first generic applicant that challenges an NDA holder’s patent monopoly (most recently by lobbying Congress to effectively end 180-day exclusivity together – see our prior …

    • Not So Retro: FDA Says IRTNMTA Cannot Be Retroactively AppliedJune 14th, 2022

      Market exclusivities—patent or otherwise—are a critical part of the Hatch-Waxman compromise, intended to encourage continued innovation in spite of the introduction of generic competition.  Even a month of market exclusivity is financially lucrative enough to fight for, so it is no surprise that a company …

    • Prescription Drug User Fees Ex-PAND-ed to PANDAs (PANDA-monium Part II)June 2nd, 2022

      A little less than a year ago, it was PANDA-monium at FDA when the Agency created a new category of drug applications called the PANDA—or the Pre-Hatch-Waxman Abbreviated New Drug Application—which referred to abbreviated drug applications submitted and approved prior to the enactment of the …

    • The FDLI Annual Conference is Back Live!June 1st, 2022

      On June 14-15 in Washington, DC, the Food and Drug Law Institute (FDLI) will hold its first in-person Annual Conference since 2019.  The conference brings together leading regulators and a wide range of stakeholders to discuss current issues and trends of importance to FDA-regulated industries.  …

    • FDA in the Multiverse of 180-Day Exclusivity Madness: Is an “Incursion” in the Cards for our “Exclusivity Earth-616”?May 26th, 2022

      Thanks to years of watching @eavoss of New Rockstars, we have a pretty good handle on the Marvel Cinematic Universe (“MCU”).  We know that Earth-199999, known in-universe as Earth-616, is the designated universe number for the main MCU; that there are a multitude of other …

    • A New Report Takes an Evidence-Based Approach to Analyzing the BLOCKING ActMay 25th, 2022

      Over the past few years, this blogger – in prior blog posts (here, here, here, and here) and in Congressional testimony – has been pretty critical of efforts to significantly revise and weaken the 180-day generic drug exclusivity incentive and framework first established with the passage of the 1984 …