Insmed, Tercica Head To Court Over Growth Hormone Patents
This article was originally published in The Pink Sheet Daily
Executive Summary
A San Francisco federal court denied four of Insmed’s five motions for summary judgment, sending the dispute over iPlex and Increlex to trial in November.
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Tercica and Insmed will go to trial in November in a patent dispute regarding Tercica's Increlex and Insmed's iPlex growth hormones. A San Francisco federal court denied four of Insmed's five motions for summary judgment June 30, paving the way for the companies to face off in the courtroom. Both firms market orphan-designated growth hormone therapies for children. Despite their similarities, FDA determined Insmed's iPlex (mecasermin rinfabate [rDNA origin] injection) and Tercica's Increlex (mecasermin [rDNA origin] injection) to be separate new molecular entities (1 (Also see "Insmed Growth Treatment iPlex Enters Market" - Pink Sheet, 25 May, 2006.)). Both products constitute insulin-like growth factor-1, though Increlex' is "free" and iPlex' is "bound" because it contains IGF binding protein 3. iPlex' May approval brought the product to market roughly six months after Increlex. The two firms have been tangled in litigation this year. In the present case, Tercica filed an infringement suit against Insmed regarding patent no. 6,331,414 (IGF-1 production process), patent no. 5,187,151 (method of use), and patent no. 5,258,287 (BP-3 production process). Tercica said July 5 that the court granted both of its motions for partial summary judgment, ruling that Insmed's process for making iPlex literally infringes three claims of the '414 patent and that the '151 patent "was valid over the prior art, and as a consequence, Insmed will have no prior art defense to challenge the patent's validity at the trial." The court also denied four out of five of Insmed's motions for summary judgment, including two in which Insmed petitioned the court to find that iPlex does not infringe the '414 and the '151 patents. "In two other motions, [Insmed] requested that the court find that the '414 patent was invalid based on written description and utility defenses. Again, the court denied these motions," Tercica said. The court granted Insmed's fifth motion, "to exclude from this case any liability of Celtrix, Insmed's predecessor, for its actions prior to its acquisition by Insmed." Tercica asserted that to prevail at trial, "the jury need only find that Insmed infringed a single valid claim from the '414, the '151 or the '287 patent." Insmed said July 5 that the "court's rulings do not fully resolve all of the pending issues regarding any of the three patents" and that "the court's interpretations seriously call into question the validity of the '414 patent." The trial is set to begin Nov. 6. A separate trial brought by Tercica accusing Insmed of false advertising was dismissed recently (2 (Also see "Tercica’s False Advertising Suit Against Insmed Is Dismissed In California" - Pink Sheet, 13 Jun, 2006.)). -Kathleen Michael |