Month: April 2007
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Mylan Labs. et al. v. Leavitt et al., No. 07-579 (D.D.C. 2007) In an April 18 decision, the FDA determined that Pfizer is entitled to six months of pediatric exclusivity on Norvasc (amlodipine besylate), that Mylan may continue to sell its generic version of Norvasc, that FDA will approve Apotex’s generic Norvasc ANDA if and…
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KSR Int’l v. Teleflex, 550 U.S. ___ (2007) In a unanimous decision released this morning, the Supreme Court reversed the Federal Circuit’s decision in KSR v. Teleflex. The Court rejected the Federal Circuit’s rigid application of its "Teaching, Suggestion or Motivation" ("TSM") test in this particular case, but stopped short of discarding the test entirely. …
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Synthon IP v. Pfizer, No. 05-1267 (E.D. Va. 2007) Last month the Federal Circuit invalidated three key claims of Pfizer’s Norvasc patent and currently a district court in Washington, D.C. is deciding whether to allow a flood of Norvasc generics on the market. But the news for Pfizer hasn’t been all bad lately. Though it…
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Apparently not too many companies other than Pfizer are happy with the FDA’s decision last week regarding Norvasc (amlodipine besylate) exclusivity. On Monday, Mylan, Apotex, and Teva all filed motions with the U.S. District Court for the District of Columbia for injunctive relief from FDA’s decision. Today, everyone filed briefs in opposition to each others’…
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Purdue Pharma has been fighting in court for nearly a decade to protect OxyContin–a blockbuster painkiller and by far Purdue’s best-selling drug product–from generic competition. Purdue settled its patent litigation with Endo and Teva last year, and with Impax a few weeks ago. Recently, Purdue filed complaints against Mallinckrodt and KV Pharma. Purdue’s case against…
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In re Omeprazole Patent Litigation, No. 04-1562 (Fed. Cir. 2007) In a 2-1 decision released today, the Federal Circuit affirmed a 2004 district court decision finding AstraZeneca's U.S. Patent No. 6,013,281 invalid as inherently anticipated. The '281 patent covers a process for making Prilosec, Astra's blockbuster anti-ulcer medication. The case arose from the efforts of…
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Abbott Labs v. Sandoz, No. 05-5373 (N.D. Ill. 2007) This past Monday, Judge David H. Coar of the U.S. District Court for the Northern District of Illinois granted Abbott’s motion for a preliminary injunction to stop Sandoz from selling a generic version of Biaxin XL (clarithromycin extended release tablets). Abbott earns about $300 million each…
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Ever since March 22, when the Federal Circuit invalidated claims 1-3 of Pfizer’s last remaining unexpired patent on Norvasc–U.S. Patent No. 4,879,303–Pfizer, Mylan and other ANDA filers have been scrambling. On March 23, Mylan, the first ANDA filer, launched its generic version of Norvasc and Pfizer responded by launching an authorized generic. On March 26,…
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A number of interesting news reports concerning follow-on biologics have been published in recent days: “Hopes for Speedy Action on Generic Biologics Fade in Senate“–Biologic Drug Report 4/16/07 “Lobbyists Take Aim at Generic Biologics“–Boston Globe 4/16/07 “Senate HELP Panel to Review Comprehensive FDA Measure“–BioWorld Today 4/16/07 “Eyeing a Lucrative Drug Market“–NJBiz.com 4/16/07 “Biologics Legislation Will…
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