StarLac Decision A Tough Pill For Takeda To Swallow

Posted on | December 16, 2009 | No Comments

2010-1104 Takeda v Teva
D/DE 07-cv-331
Judge Sue Robinson

Takeda and Ethylpharm appeal from the judgment following a bench trial before Judge Sue Robinson that Teva's ANDA filing for a generic form of PREVACID Solutab^tm does not infringe 5,464,632 related to a pharmaceutical formulation for an oral disintegrating tablet.  These tablets allow the oral administration of an active ingredient in tablet form but without the typical requirement of water to assist in swallowing. 

The claim limitation at issue provided "wherein said mixture of excipients comprises a disintegrating agent and swelling agent."  The court (Opinion, pp. 9-13) construed this as requiring at least one substance that causes disintegration and at least one substance that causes swelling.  The court further concluded that these must be different agents.  The court also discussed the distinction made in the specification and prosecution history between agents that "cause" disintegration versus those that merely "facilitate" it.

Turning then to infringement, the court found that the ANDA's disintegrating tablet mechanism–a product known as STARLAC from Meggle Gmbh and Roquette Frères, did not infringe.  STARLAC offers rapid disintegration through a combination of starch and lactose.  After sifting through the testimony of competing experts, the court found that this combination did not infringe (id. at 13-17).  Lactose is not a swelling agent and, because of prosecution history statements and perception in the art, could not be a disintegrating agent.  While starch is a swelling agent and could also possible be a disintegrating agent, the claim did not allow for the ingredient to be both the disintegrating agent and the swelling agent. 

2010-1104 Opinion

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