Month: October 2006
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Janssen Pharmaceutica, a division of Johnson & Johnson, won its patent infringement case against Mylan and Dr. Reddy’s over generic Risperdal (risperidone), an antipsychotic medication with worldwide sales of $3 billion annually. Judge John C. Liflind of the U.S. District Court for the District of New Jersey held a four-day bench trial in June, and…
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There’s been a lot of news lately in pharmaceutical patent cases. Summaries are below. I’ve updated the Hatch-Waxman Tracker to include the new lawsuits. New lawsuits filed: Biovail Laboratories filed a new lawsuit against Andrx Pharmaceuticals over Andrx’s attempt to market generic Cardizem. Novartis sued Par Pharmaceuticals, the third and most recent company to file…
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ACI’s 7th annual Maximizing Pharmaceutical Patent Life Cycles conference will take place October 23-24, 2006, at the Helmsley Park Lane hotel in New York City. This should be an excellent meeting, with the following presentations: Striking a Balance: Reconciling the Needs and Interests of Brand Name and Generic Pharmaceutical Companies With Public Policy From Product…
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Via SCOTUSblog, the Supreme Court today denied review of Apotex v. Pfizer, in which Apotex had asked the Court to consider whether listing patents in the Orange Book creates a justiciable controversy, thereby allowing a generic drug company to file a declaratory judgment action for noninfringement or invalidity. Last May, the Court asked the Solicitor…
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Continuing their collaboration on new laws relating to pharmaceuticals, Senators Herbert Kohl (D-WI) and Patrick Leahy (D-VT) recently introduced legislation to stop perceived abuses of the FDA’s citizen petition procedure that result in delaying approval of generic drugs. The bill is entitled the Citizen Petition Fairness & Accuracy Act of 2006. According to Sen. Leahy’s…
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The FDA announced last Friday that it recently began using the Division File System (DFS) for reviewing and archiving Abbreviated New Drug Applications electronically. According to the FDA’s press release: This system will now allow electronic archiving of ANDA documents for better tracking and search capabilities. It will also enable reviews to become part of…
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Rep. Henry Waxman (D-CA), Sen. Charles Schumer (D-NY), and Sen. Hillary Rodham Clinton (D-NY) introduced the “Access to Life-Saving Medicines Act” last Friday. If enacted, the legislation would establish an abbreviated application process for biological products. According to the proposed bill, a generic biological product is “comparable,” and therefore approvable in an abbreviated application “if…
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