By Alan M. Kirschenbaum & Kurt R. Karst – Last Thursday we reported on the release by the House of H.R. 3962, the health care reform bill that will soon be considered on the House floor. As we have done with other health care reform …
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Hatch-Waxman
- HPM Posts Summary of H.R. 3962 Provisions Directly Affecting Drug and Device ManufacturersNovember 2nd, 2009
- The Medicines Company Continues Lobbying Push for ANGIOMAX Patent Term Extension Legislative Fix; Latest Iteration of the “Dog Ate My Homework Act” Maintains $65 Million Late FeeOctober 26th, 2009
By Kurt R. Karst – The Medicines Company is reportedly continuing its multi-year and multi-million dollar lobbying effort to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), an anticoagulant drug product FDA first approved on December …
- FDA Racks Up Another Win in Bioequivalence Litigation; This Time Over Generic EFUDEXOctober 19th, 2009
By Kurt R. Karst – Consistent with recent wins concerning generic PROGRAF (tacrolimus) and generic ZOSYN (piperacillin sodium; tazobactam sodium) Injection (here and here), the U.S. District Court for the Central District of California recently ruled that FDA’s April 2008 denial of a citizen petition and decision …
- Senators Introduce Access to Affordable Medicines Act to Close Labeling Change “Loophole”; Companion Bill to Senate Drug Price Competition Act of 2009 Introduced in HouseOctober 15th, 2009
By Kurt R. Karst – On October 14, 2009, Sens. Jeanne Shaheen (D-NH) and David Vitter (R-LA) announced the introduction of S. 1778, the Access to Affordable Medicines Act. The bill would amend the FDC Act’s ANDA provisions at § 505(j) to add a new …
- District Court Orders Patent Use Code Change; Novo Nordisk AppealsOctober 8th, 2009
By Kurt R. Karst – In what could shape up to be a very interesting (and important) precedent, the U.S. District Court for the Eastern District of Michigan (Southern Division) recently ruled and issued an Order and Injunction requiring Novo Nordisk, Inc. (“Novo”) to change an Orange …
- Another Court Rules Against Preemption in Generic Drug Case; Cornyn Preemption Amendment Would Shield Generic Manufacturers from LiabilityOctober 5th, 2009
By Kurt R. Karst – Last week, the U.S. District Court for the District of New Hampshire ruled in a 67-page opinion that various state law tort claims brought against generic drug manufacturer Mutual Pharmaceutical Company, Inc. (“Mutual”) are not preempted by Title I of the …
- Senate Judiciary Committee Adopts Amendment to Reverse Payment BillSeptember 24th, 2009
By Kurt R. Karst – At a September 24th Senate Judiciary Committee Executive Business Meeting, Senator Herb Kohl’s (D-WI) substitute amendment to S. 369, the Preserve Access to Affordable Generics Act, was adopted by unanimous consent. As we previously reported, the amendment makes significant changes to …
- Hatch-Waxman 25th Anniversary Trivia – The AnswersSeptember 24th, 2009
By Kurt R. Karst – Many thanks to all of those who participated in our little Hatch-Waxman trivia contest. Although no single person was able to correctly answer all of the questions, just about all of them were correctly answered through your collective knowledge. The answers are provided …
- Wyeth Sues FDA over Generic ZOSYN Approvals; Lawsuit Challenges FDA Inactive Ingredient Policy and Same Labeling RequirementSeptember 23rd, 2009
By Kurt R. Karst – Late yesterday (Sept. 22nd), Wyeth Pharmaceuticals (“Wyeth”) sued FDA in the U.S. District Court for the District of Columbia over the Agency’s recent decision to approve two ANDAs for generic versions of ZOSYN (piperacillin sodium; tazobactam sodium) Injection. Both ANDAs …
- Happy 25th Anniversary Hatch-Waxman!! How Well do you Know the Law and its History?September 23rd, 2009
By Kurt R. Karst – September 24, 2009 is the 25th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act (Public Law No. 98-417) – commonly known as “Hatch-Waxman” or “Waxman-Hatch” depending on when you became familiar with the law. …
- FDA Applies a Presumption in Favor of NCE Status for Pancreatic Enzyme ProductsSeptember 17th, 2009
By Kurt R. Karst – A few months ago after FDA’s approval of an NDA for the Pancreatic Enzyme Product (“PEP”) CREON (pancrelipase) (amylase; lipase; protease) we queried whether FDA might apply a presumption in favor of New Chemical Entity (“NCE”) status for all PEPs, such …
- FDA Grants Petitions and Approves Generic ZOSYN; Petition Decision Reaffirms FDA Policy on Inactive Ingredient ChangesSeptember 16th, 2009
By Kurt R. Karst – On September 15, 2009, FDA issued its long-awaited decision responding to several citizen petitions submitted in 2005 and 2006 (available here, here, here, and here) concerning the approval of ANDAs for generic versions of Wyeth Pharmaceuticals’ ZOSYN (piperacillin sodium; tazobactam sodium) …
- Change is Afoot in Senate Reverse Payment BillSeptember 15th, 2009
By Kurt R. Karst – At a September 10, 2009 Senate Judiciary Committee Executive Business Meeting, Senator Herb Kohl (D-WI) stated his plans to pursue a substitute amendment to S. 369, the Preserve Access to Affordable Generics Act, that would make significant changes to the …
- FDA Resolves Eligible/Ineligible First Applicant 180-Day Exclusivity Forfeiture Issue in the Context of Generic STARLIX (Nateglinide) TabletsSeptember 10th, 2009
By Kurt R. Karst – Since the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”), Hatch-Waxman scholars have wondered how FDA might answer the following question: “What is the effect of a forfeiture of 180-day exclusivity eligibility due to the …
- The Stage is Set . . . . Federal Circuit to Hear Oral Argument Regarding PTE EligibilitySeptember 3rd, 2009
By Kurt R. Karst – On Tuesday, September 8, 2009 (just shy of the 25th anniversary of the September 24, 1984 enactment of the Drug Price Competition and Patent Term Restoration Act – i.e., the “Hatch-Waxman Act”), the U.S. Court of Appeals for the Federal …