By Kurt R. Karst – The voice of Michael Corleone – “Just when I thought I was out . . . they pull me back in” – played over and over again in our heads today when we learned that Apotex, Inc. filed a Petition for …
Menu
Hatch-Waxman
- It Lives!! Apotex Asks the Supreme Court to Review Generic COZAAR/HYZAAR 180-Day Exclusivity Decision (Our 1,000th Post)October 5th, 2010
- WSJ Stakes Out Position on Patent Settlements; Takes Issue with the FTC’s “Evangelical Zeal”October 5th, 2010
By Kurt R. Karst – In a short, but scathing opinion piece published in the October 5th Wall Street Journal (“WSJ”), the editors take on the Federal Trade Commission (“FTC”) and those Members of Congress who want to ban patent settlements between brand-name and generic drug …
- HP&M Attorney to Speak at CBI Paragraph IV Disputes ConferenceOctober 5th, 2010
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be speaking at the Center for Business Intelligence’s (“CBI’s”) 3rd Annual Life Sciences Congress on Paragraph IV Disputes, which is scheduled for October 18-19, 20109 at the Hilton Alexandria Old Town in Alexandria, Virginia. This popular …
- Flare-Up Over Generic Herpes Drug Could be Short-LivedSeptember 27th, 2010
By Kurt R. Karst – Just two days after Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th approval of Watson Laboratories, Inc.’s ANDA No. 78-278 for a generic version of the herpes …
- Novartis Sues FDA Over Generic FAMVIR; Alleges that FDA Failed to Require a Split CertificationSeptember 23rd, 2010
By Kurt R. Karst – On September 22, 2010, Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th approval of Watson Laboratories, Inc.’s ANDA No. 78-278 for a generic version of the herpes …
- Senators Vigorously Object to the Inclusion of Patent Settlement Provisions in FY 2011 Appropriations BillSeptember 21st, 2010
By Kurt R. Karst – Last Friday, a group of Republican Senators (Sens. Jeff Sessions (R-AL), Tom Coburn, (R-OK), John Cornyn (R-TX), and John Thune (R-SD)) sent a letter to Senate Republican leaders expressing their “vigorous objection” to the inclusion of the “Preserve Access to …
- OGD Has Put the Brakes on ANDA Supplement Reviews; Will it Help Push Generic Drug User Fees Along?September 17th, 2010
By Kurt R. Karst – Do you have an ANDA prior approval supplement pending at FDA? How long has it been pending – 6 months? One year? 18 months? Well it might still some time until there is any action on it. Over the …
- ViroPharma Sues FDA Over Generic VANCOCIN; Alleges that FDA Violated the APA in Effectively Amending Bioequivalence RegulationsSeptember 13th, 2010
By Kurt R. Karst – It was not a question of whether ViroPharma Incorporated (“ViroPharma”) would sue FDA in connection with the approval of ANDAs for generic versions of the company’s antibiotic drug of last resort, VANCOCIN (vancomycin HCl) Capsules, but when. In addition …
- All Eyes are on APP’s Intervention Motion as the Government Bows Out of ANGIOMAX PTE LitigationSeptember 9th, 2010
By Kurt R. Karst – Earlier today (September 9th), in a notice filed with the U.S. District Court for the Eastern District of Virginia (Alexandria Division), the government informed the court that “the Solicitor General has, at this time, elected against appeal” of Judge …
- Psych! Second Circuit Denies Rehearing Petition in CIPRO Patent Settlement Litigation after Panel Invites PetitionSeptember 9th, 2010
By Kurt R. Karst – Earlier this week, the U.S. Court of Appeals for the Second circuit denied without comment a Petition for Rehearing and Rehearing En Banc filed on behalf of certain plaintiffs-appellants in In Re Ciprofloxacin Hydrochloride Antitrust Litig,, an antitrust challenge to …
- Report Predicts Tough Road Ahead for Some Generics After Federal Circuit Patent Use Code DecisionsSeptember 3rd, 2010
By Kurt R. Karst – A recent report issued by Morgan Stanley, titled Pharmaceuticals – Potential Selective Upside for Industry post Prandin Ruling, predicts “increasing probability for the innovative pharmaceutical industry to successfully delay US generic approval of select innovative drugs” following a pair of rulings …
- APP Moves Forward With Appeal Notice in ANGIOMAX PTE Litigation in Light of PTO/FDA IndecisionSeptember 2nd, 2010
By Kurt R. Karst – The long-running dispute over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) may be far from over. On September 1st, APP Pharmaceuticals, LLC, which previously submitted an amicus brief …
- District Court Denies Apotex Declaratory Judgment Motion on Generic ARICEPT; Does Not Accept “Prompt Launch” and “Indefinite Delay” Jurisdiction TheoriesSeptember 1st, 2010
By Kurt R. Karst – Some drugs, it seems, are destined for Hatch-Waxman controversy and lore. Eisai, Inc.s’ ARICEPT (donepezil HCl) Tablets is one of those drugs. As the battle over pre-Medicare Modernization Act shared 180-day exclusivity takes off – with a recent citizen …
- D.C. District Court Denies Preliminary Injunction in Generic LOVENOX Case; Is the Juice Worth the Squeeze for Sanofi to Appeal?August 26th, 2010
By Kurt R. Karst – When we attended the August 17th hearing in Sanofi-aventis U.S. L.L.C.’s (“Sanofi’s”) challenge to FDA’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 77-857 for a generic version of Sanofi’s LOVENOX (enoxaparin sodium injection), it seemed as …
- Patent Expiration, Pediatric Exclusivity, and Generic Drug Approval – Some Interesting Tensions Between the FDC Act and Patent LawAugust 18th, 2010
By Kurt R. Karst – When does a patent expire? When does pediatric exclusivity begin and end? And when can FDA approve ANDAs (or 505(b)(2) applications)? These are some interesting questions touched on in some recent court decisions. But before we get to those …