Par prevails on obviousness defense; courts finds no inequitable conduct
Santarus Inc., et al. v. Par Pharmaceutical, Inc., C. A. No.07-551-GMS, April 14, 2010.
Sleet, C. J. The court enters judgment in favor of defendant after a bench trial on the issue of invalidity due to obviousness. The court further rules that the patents-in-suit are not unenforceable due to inequitable conduct, and that an award of attorneys fees is not warranted. It also finds the claims of the ‘772 patent are invalid for lack of written description, and other claims are not entitled to the filing date of earlier applications because do not meet the written description requirement.
After the 4th day of a 5-day bench trial, the court in a previous decision found the accused products infringed. In this opinion, the court finds the patents-in-suit to be invalid as obvious. Published studies using omeprazole/sodium bicarbonate solutions render the patents-in-suit obvious, rejecting plaintiffs’ argument that the art teaches away from the patented invention because of rapid washout of omeprazole. References in two prior art patents also render the invention obvious. Furthermore, evidence on secondary considerations does not undermine the court’s determination of obviousness. Zegerid has not achieved commercial success. While the sales figures in isolation show growth, they remain dwarfed in comparison to those of others four years after the product launched and the growth appears to have leveled off. The nexus of the sales is tied to preferential pricing and sales tactics unconnected to the merits of the invention. Unmet need, if any, was not for advancements on existing prior art, but rather for recognition of what already existed in the prior art. The court is not persuaded by a statement offered as skepticism because the person who made the statement was not a witness in the litigation. The statement was read into evidence by an expert and the context was never presented at trial. Nor did the patented composition produce unexpected results. Assuming defendant’s reverse-engineering of the patented drug constitutes “copying,” it is not persuasive evidence of non-obviousness. There is insufficient evidence of industry recognition or acceptance. As for inequitable conduct, the court finds that while defendant has met its burden with respect to materiality, it did not establish the requisite intent to deceive.
