Month: October 2006
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As we previously reported in brief, Eisai recently won summary judgment of patent validity of U.S. Patent No. 5,045,552 in its lawsuit against Teva over generic Aciphex (rabeprazole sodium). In a separate opinion handed down the same day, the court also denied in part and granted in part Eisai's motion for summary judgment of no…
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This morning the Supreme Court denied Ferring B.V.’s cert petition in Ferring v. Barr, a closely-watched inequitable conduct case. The case concerns Barr’s ANDA to market a generic version of DDAVP (desmopressin acetate), a treatment for diabetes insipidus with annual sales of $200 million. Last February, the Federal Circuit affirmed a district court decision holding,…
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KV Pharmaceutical Company recently filed a citizen petition asking the FDA to relist U.S. Patent No. 5,246,714 for 100 mg and 200 mg Toprol XL in the Orange Book. In the same petition, KV asked the FDA to refrain from approving any ANDA for 100 mg and 200 mg Toprol XL filed after KV's ANDA…
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Amgen dodged a bullet last week when Judge William G. Young of the U.S. District Court for the District of Massachusetts denied Hoffman-LaRoche’s motion to dismiss Amgen’s complaint alleging infringement of its patents on erythropoeitin (EPO). Hoffman-LaRoche based its motion to dismiss on the assertion that all of the allegedly infringing activities fell under 35…
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Ortho-McNeil Neurologics, a unit of Johnson & Johnson, announced in a press release today that it won a preliminary injunction against Mylan in its patent infringement case aimed to protect Topamax (topiramate) from generic competition. Topamax, indicated for the treatment of epilepsy and migraines, had U.S. sales of $1.4 billion last year. Judge Stanley R.…
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The FTC and Warner Chilcott have settled antitrust charges alleging anticompetitive behavior involving Warner Chilcott’s popular birth control drug Ovcon 35. The FTC filed the case to nullify a non-compete agreement between Warner Chilcott and Barr Laboratories that would have prevented Barr from launching a generic version of Ovcon 35 until May, 2009. According to…
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Pfizer announced in a press release today that the Federal Circuit has denied Ranbaxy’s request for rehearing in the Lipitor patent case between the two companies. On August 2nd of this year, a panel of the Federal Circuit invalidated one of two Pfizer patents on atorvastatin, the active ingredient in Lipitor, but upheld the other…
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Dr. Steven Galson, Director of the Center for Drug Evaluation and Research (CDER) at the FDA, recently announced a new "First Generics" policy for review of ANDAs. Under the agency’s current "First-In, First-Reviewed" policy, CDER reviews ANDAs in the order in which they are received. Under the new policy, FDA will make exceptions to the…
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Mylan Laboratories announced today that the U.S. District Court for the Western District of Pennsylvania has granted its motion to dismiss U.S. Patent No. 4,572,909 from its case against Pfizer concerning Mylan’s ANDA for generic Norvasc (amlodipine besylate). Pfizer’s U.S. Patent No. 4,879,303 is still in the case. According to Mylan’s press release, the court…
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The U.S. District Court for the Southern District of New York issued an Order earlier this week dismissing the patent case Purdue Pharma brought against Teva to protect Oxycontin from generic competition. Oxycontin, a controlled-release formulation of oxycodone, is a widely-prescribed pain killer with annual sales of $2 billion. The court dismissed the case because…
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