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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
Crunch time is rapidly approaching in Roquette?s long-running patent dispute with SPI Pharma, with the case scheduled to go to trial on 4th October 2010.
Crunch time is rapidly approaching in Roquette’s long-running patent dispute with SPI Pharma, with the case scheduled to go to trial on 4th October 2010.
The case began in 2006 when Roquette first alleged that SPI’s Mannogem EZ spray dried mannitol product infringed one of Roquette’s patents (Patent No. 5,573,777), which was filed in 1993 to protect a new physical form of mannitol that maximizes performance as a directly compressible excipient in the pharma industry. Later on, Roquette also accused SPI’s Pharmaburst products of patent infringement.
In the most recent development of the case, the court has issued a ruling that narrowly defines several key phrases in the claims of Roquette’s patent.
According to a press statement issued by Roquette, the court “construed eight of the ten disputed claim terms consistent with the meanings proposed by Roquette”. Only two of the terms, which apply to a secondary form of spray dried mannitol sold by SPI, were consistent with definitions by SPI.
According to Roquette, the claim construction ruling “further solidifies Roquette’s claim of infringement and clears the way for trial in October”.
However, SPI Pharma is viewing the ruling in a different light, claiming in its own press statement that the ruling “narrowly” defines the key phrases in Roquette’s patent claim and deals a “significant blow” to Roquette’s allegations.
Despite Roquette’s confidence however, there may still be a fierce battle ahead. In its own press statement, SPI Pharma’s President, Rana Kayal, said: “SPI Pharma will continue to defend itself against Roquette’s baseless allegations of patent infringement. We look forward to presenting our case to the jury at the trial to be held in October.”