By Kurt R. Karst – One recent afternoon we returned to our office from a meeting to find the new (2012) nine-volume set of Title 21 of the Code of Federal Regulations (“CFR”) placed on our desk chair. There’s a special place on our desk …
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Prescription Drugs and Biologics
- The Obesity Epidemic: FDA’s Growing Waistline!September 3rd, 2012
- 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 …
- IOM Issues Report on “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network”August 27th, 2012
By Alexander J. Varond – The Institute of Medicine (“IOM”) recently issued a paper titled “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary.” The IOM paper summarizes the “Maximizing the Goals of the Cures Acceleration Network to …
- 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Karst – In a pair of Federal Register notices (here and here) set for publication on August 27, 2012, and in a pair of draft guidance documents released ahead of their announcement in the Federal Register next week (here and here), FDA …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 …
- FDA Rescinds Orphan Drug Exclusivity for Wilate; A First-of-its-Kind DecisionAugust 8th, 2012
By Kurt R. Karst – There’s a first time for everything! And on August 8th, 2012, FDA decided, for the first time since the enactment of the Orphan Drug Act, to rescind a period of 7-year orphan drug exclusivity. The decision came in the form of …
- 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 …
- PDUFA V Begins With Relatively Modest Changes to User Fee RatesJuly 31st, 2012
By Kurt R. Karst – In two Federal Register notices (here and here) scheduled for publication on August 1st, FDA will announce the Fiscal Year (“FY”) 2013 user fee rates pursuant to the fifth iteration of the Prescription Drug User Fee Act (“PDUFA”) and pursuant to …
- The Regenerative Sciences – FDA Court Struggle Ends . . . For NowJuly 25th, 2012
By William T. Koustas – We have been following the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA for over two years (see here, here, here, here, and here. On Monday, the United State District Court for the District of Columbia ruled in favor of FDA …
- 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 …