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  • Hatch-Waxman

    • Patent Settlement Agreements: The Next BarrageSeptember 17th, 2012

      By Kurt R. Karst –       In our recent post, “Hot Ticket Item – Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning patent settlement agreements (or “pay-for-delay” agreements if you prefer that term – we don’t).  It’s …

    • The Brand-Name Side of the Exclusivity Equation; Exclusivity Under FireSeptember 10th, 2012

      By Kurt R. Karst –    In the world of Hatch-Waxman, disputes over 180-day generic drug exclusivity have been commonplace for well over a decade now.  Indeed, in 2012 alone there have already been a few lawsuits filed against FDA concerning generic ACTOS and generic PROVIGIL …

    • The Coming 505(q) Citizen Petition Cliff and Some Interesting Petition StrategiesSeptember 4th, 2012

      By Kurt R. Karst –       As we patiently await FDA’s next annual report to Congress on 505(q) citizen petitions (see our previous posts on FDA’s annual reports here, here, and here) we thought we would take a minute to share with our readers some observations …

    • Hot Ticket Item – Patent Settlement Agreement ChallengesAugust 30th, 2012

      By Kurt R. Karst –       It seems that hardly a day goes by without something new happening concerning patent settlement agreements.  They are generally referred to as “pay-for-delay” agreements; however, that’s a bit of a loaded term, and one we try to avoid.  We just …

    • FDA Gears Up for GDUFA Implementation and ANDAgeddonAugust 23rd, 2012

      By Kurt R. Karst –       In a pair of Federal Register notices (here and here) set for publication on August 27, 2012, and in a pair of draft guidance documents released ahead of their announcement in the Federal Register next week (here and here), FDA …

    • Congressional Interest in FDA Remains High, Even After the Enactment of FDASIAAugust 20th, 2012

      By Kurt R. Karst –       Just before Congress recessed for the month of August, and less than a month after the July 9th enactment of the FDA Safety and Innovation Act, several FDA-related bills were placed in the hoppers in the U.S. Senate and U.S. House …

    • Push for 12-Year Biologics Exclusivity in TPP Agreement Continues as the Next Round of Negotiations ApproachesAugust 16th, 2012

      By Kurt R. Karst –       Efforts to include a 12-year period of exclusivity for biological products in the Trans-Pacific Partnership (“TPP”) agreement chapter on intellectual property rights are alive and well as folks ramp up for the 14th negotiating round of the TPP, which will take …

    • FDA is Sued Again Over Pre-MMA 180-Day Exclusivity; This Time the Drug is Generic ACTOSAugust 15th, 2012

      By Kurt R. Karst –       It’s been nearly nine years since the enactment of the Medicare Modernization Act (“MMA”), which, among other things, changed the regime for 180-day generic drug marketing exclusivity from a “patent-by-patent” approach (under which shared exclusivity can exist for cross-Paragraph IV filers …

    • Running Into a Glass Door (or Window); a Problem With the New “Window ANDA” Forfeiture ProvisionAugust 13th, 2012

      By Kurt R. Karst –       That’s the picture conjured up when we plugged some dates into the new model for calculating forfeiture of 180-day generic drug marketing exclusivity for certain ANDAs – what we are calling “window ANDAs” – covered by Section 1133 of the recently …

    • Federal Circuit Rules That Hatch-Waxman “Safe Harbor” is Quite Broad in Dispute Over Enoxaparin Method PatentAugust 7th, 2012

      By Kurt R. Karst –       We were eager to delve into the Federal Circuit’s recent 2-1 decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Docket Nos. 2012-1062, -1103, -1104) concernng the scope of the Hatch-Waxman “safe harbor” provision at 35 U.S.C. § 271(e)(1), particularly in …

    • “Big RLD” Versus “Little rld” – What’s the Difference?August 6th, 2012

      By Kurt R. Karst –       There’s a lot of parlance (legal and scientific) bandied about in the food and drug world, and perhaps nowhere more so than in the world of Hatch-Waxman.  Things can get confusing.  Take, for example, the term “Reference Listed Drug,” or “RLD.”  FDA’s …

    • Supreme Court Asked to Take Up Post-Mensing Bartlett Generic Drug Labeling Preemption DecisionAugust 2nd, 2012

      By Kurt R. Karst –       Ever since the U.S. Court of Appeals for the First Circuit issued its opinion in May 2012 in Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012) denying Mutual Pharmaceutical Company’s (“Mutual’s”) appeal of …

    • STOPP Act Would Establish New Requirements for Tamper-Resistant DrugsJuly 24th, 2012

      By Kurt R. Karst –       Last week, Representative William Keating (D-MA) announced the introduction of new legislation – the Stop Tampering of Prescription Pills Act of 2012, or STOPP Act (H.R. 6160) – that is intended to direct companies “to invest in research and production to …

    • FDASIA Enacted; HP&M Issues Detailed Summary and AnalysisJuly 11th, 2012

      Earlier this week, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (“FDASIA”) (usually pronounced “fuh-day-zha”).  In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDASIA establishes new user fee statutes for …

    • Judge Supports FDA Decision Approving Generic BromfenacJuly 10th, 2012

      By Douglas B. Farquhar – In a long-awaited ruling, a federal judge has upheld FDA’s decision to grant approval to the generic version of Xibrom®, an ophthalmic product for treatment after cataract surgery (active ingredient: bromfenac). The opinion was issued Monday by Judge James Gwin of the …