By Kurt R. Karst – Every once in a while we receive a series of similar questions from various quarters such that a critical mass has been reached justifying a blog post on the topic. This is one of those posts. And it has to do …
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Hatch-Waxman
- When is 5-Year NCE Exclusivity Less Than 5 Years?January 9th, 2013
- A Pre-MMA 180-Day Exclusivity Punt? What Gives?January 8th, 2013
By Kurt R. Karst – Although the number of cases involving 180-day exclusivity under the version of the FDC Act in effect before the December 8, 2003 enactment of the Medicare Modernization Act (“MMA”) is nearing an end, the pre-MMA statute, and the handling of it …
- FDA and Ranbaxy Prevail in Dispute Over Generic DIOVAN 180-Day Exclusivity; Court Grants Motions for Summary JudgmentJanuary 2nd, 2013
By Kurt R. Karst – Last week in a post-Christmas decision, Judge John D. Bates of the U.S. District Court for the District of Columbia granted both FDA’s and Intervenor-Defendant Ranbaxy Laboratories Limited’s (“Ranbaxy’s”) Motions for Summary Judgment and denied Mylan Laboratories Limited’s and Mylan …
- HP&M’s Dave Clissold to Speak at Management Forum Conference on Drug Regulatory Strategy MattersDecember 21st, 2012
Hyman, Phelps & McNamara, P.C. Director David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products. The conference, titled “EU and US Regulatory Issues for IP Professionals,” will take …
- “No-AG” Agreements are Not “Reverse Payments” Subject to Antitrust Scrutiny Says District Court in LAMICTAL LitigationDecember 17th, 2012
By Kurt R. Karst – Excitement over the U.S. Supreme Court’s recent decision to hear Federal Trade Commission v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), a drug patent settlement agreement (a.k.a. “reverse payment” or “pay-for-delay agreement”) case involving ANDROGEL (testosterone gel) (see our previous post …
- Actelion’s Preemptive Strike Over REMS and Biostudy Product Availability Draws Antitrust Counterclaims, Another Drug, and Another Company Into the MixDecember 5th, 2012
By Kurt R. Karst – Things are heating up in litigation in the U.S. District Court for the District of New Jersey initiated by Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) in September 2012, which, according to Actelion, “concerns the fundamental right …
- Endo Sues FDA; Seeks Court Orders for FDA Determinations on the Discontinuation of “Old” Opana® ER and With Respect to Approved and Pending ANDAsDecember 2nd, 2012
By Kurt R. Karst – Last Friday afternoon, Endo Pharmaceuticals Inc. (“Endo”) filed a Complaint and a Motion for Preliminary Injunction in the U.S. District Court for the District of Columbia seeking declaratory and injunctive relief concerning the company’s non-crush-resistant formulation of Opana® ER approved …
- ASBM Says Distinct USAN Names for Biosimilars are NeededNovember 30th, 2012
By Kurt R. Karst – The Alliance for Safe Biologic Medicines (“ASBM”), a self-described “organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of …
- Apotex Seeks Exclusivity-Triggering Court Decision in Declaratory Judgment Action Over Generic BENICAR PatentNovember 27th, 2012
By Kurt R. Karst – In a recent Complaint for Declaratory Judgment filed in the U.S. District Court for the Northern District of Illinois (Eastern Division), Apotex Inc. (“Apotex”) is attempting to trigger 180-day exclusivity for generic versions of the hypertension drug BENICAR (olmesartan medoxomil) Tablets, …
- “Product Hopping” Antitrust Lawsuit Takes on a Heightened Profile with Proposed FTC Amicus BriefNovember 25th, 2012
By Kurt R. Karst – A Complaint filed earlier this year by Mylan Pharmaceuticals Inc. (“Mylan”) in the U.S. District Court for the Eastern District of Pennsylvania alleging that Warner Chilcott and Mayne violated Sections 1 and 2 of the Sherman Act by engaged in …
- Cumberland Sues FDA After the Agency Denies Citizen Petition and Approves Generic ACETADOTENovember 16th, 2012
By Kurt R. Karst – Earlier this week, Cumberland Pharmaceuticals Inc. (“Cumberland”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s November 7, 2012 denial of a Citizen Petition (Docket No. FDA-2012-P-0507) and approval of InnoPharma, Inc.’s (“InnoPharma’s”) ANDA …
- HP&M’s Dave Clissold to Speak at Management Forum Conference on Orphan Drug, Regulatory Strategy Matters, and MoreNovember 15th, 2012
Hyman, Phelps & McNamara, P.C. is pleased to announce that David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products. The conference, titled “EU and US Regulatory Issues for …
- With Briefing Over, Post-Mensing Generic Drug Preemption Appeal Awaits Word From the Supreme CourtNovember 14th, 2012
By Kurt R. Karst – Back in August, we posted on a Petition for Writ of Certiorari filed by Mutual Pharmaceutical Company, Inc. (“Mutual”) appealing a May 2, 2012 decision from the U.S. Court of Appeals for the First Circuit in Bartlett v. Mutual Pharmaceutical …
- Does a Hatch-Waxman Patent Delisting Counterclaim Terminate a 30-Month Litigation Stay?November 8th, 2012
By Kurt R. Karst – From time to time throughout Hatch-Waxman history the question has come up: What court decisions terminate a 30-month litigation stay arising as a result of a timely filed patent infringement action in response to a Paragraph IV certification (in either …
- “New” CDER Exclusivity Board Focuses on Clarity and Consistency of Exclusivity DecisionsNovember 6th, 2012
By Kurt R. Karst – FDA recently announced that the Agency has established within the Center for Drug Evaluation and Research (“CDER”) an Exclusivity Board “to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of …