By Suresh Pillai --
Caraco Motion for Summary Judgment in Prandin® Case Denied
The U.S. District Court for the Eastern District of Michigan has denied a motion for summary judgment brought by Caraco Pharmaceutical Laboratories Ltd. and Sun Pharmaceutical Industries Ltd. (the majority shareholder of Caraco) in their patent suit with Novo Nordisk over Prandin®, a drug for the treatment of diabetes. Novo Nordisk originally filed suit in 2005 following Caraco's ANDA filing with the U.S. Food and Drug Administration in which Caraco sought to market a generic version of Prandin®. The patent-in-suit, U.S. Patent No. 6,677,358, covers a method for treating Type II diabetes using repaglinide in combination with metformin. In 2007, following the filing of the suit, the FDA granted tentative approval to Caraco to manufacture and market a generic repaglinide product. In 2008, however, Caraco submitted an amended ANDA in which, Novo claimed, Caraco stipulated to infringement of the '358 patent.
In December 2008, Caraco filed its motion for summary judgment, contending that an FDA ruling that Caraco need not reference the Novo patented repaglinide-metformin combination at launch effectively nullified Caraco's stipulation of infringement of the '358 patent. While the District Court disagreed with Caraco's contention, the Court did not issue a written opinion.
Injunction Granted in Crescendo Suit Against Ethicon
The U.S. District Court for the Southern District of Ohio has granted a temporary injunction sought by Ethicon Endo-Surgery Inc. (a subsidiary of Johnson & Johnson) that prevents a former Ethicon employee from selling or licensing patent applications for ultrasonic surgical blade technology in the wake of a jury awarding the company $2.1 million in damages. In the original suit, a jury found the employee and former inventor at Ethicon, Jean M. Beaupre, in breach of an invention assignment agreement entered into between the inventor and his former employer -- Beaupre had assigned U.S. Patent Publication Nos. 2006/0100652 and 2007/0016236, and a provisional application ("Balanced ultrasonic curved blade") to Crescendo Technologies LLC. Beaupre had worked for Ethicon for eight years prior to founding Crescendo. The jury also found Crescendo liable for tortious interference.
Although the jury awarded damages to Ethicon, it failed to determine which party owns the rights to the applications-in-suit. The temporary injunction will remain in effect until the District Court has determined ownership.
Summary Judgment Awarded in Sanofi-Aventis Eloxatin® Generic Suit
The U.S. District Court for the District of New Jersey has awarded summary judgment to generic drug drug manufacturers Sandoz, Inc., Mayne Pharma Inc., Teva Pharmaceutical Industries Ltd., and Hospira Inc. in their patent infringement dispute with Sanofi-Aventis US LLC over Eloxatin®, a colon cancer drug. Sanofi originally filed suit in 2007, alleging that the generic drug companies had infringed U.S. Patent No. 5,338,874, Sanofi's patent covering HPLC-derived oxaliplatin, the active ingredient in Eloxitan® (see "Court Report," July 30, 2007). Sanofi had licensed this patent to another plaintiff in the suit, Debiopharm SA. Sanofi's suit followed Sandoz's ANDA filing with the FDA in which Sandoz sought to manufacture and market generic Eloxatin®. Included in the ANDA was a Paragraph IV certification stating that both the '874 patent and another Sanofi patent, U.S. Patent No. 5,716,988, were invalid and noninfringed. Sanofi then filed suit, disputing the claim, and the generic manufacturers filed their motion for summary judgment.
The District Court concluded that the patents-in-suit were not infringed because the products made by the defendants were not derived from the method of production disclosed in the '874 patent. However, the Court denied the defendants' motion for summary judgment of invalidity on the grounds that, in light of the noninfringement finding, such a determination would be moot.
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