Trial Opinion Issues In Suboxone® ANDA Case

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Reckitt Benckiser Pharmaceuticals Inc., et al. v. Watson Laboratories, Inc., et al., C.A. Nos. 13-1674-RGA; 14-422-RGA, June 3, 2016.

Andrews, J. Trial opinion finding the asserted claims in one patent invalid and certain products would infringe if valid; the asserted claims of a second patent are valid and infringed; the asserted claims of a third patent are valid but not infringed. A 4-day bench trial was held in November and December, 2015.

Suboxone® sublingual film is used in the treatment of opioid dependence. There are three patents-in-suit. With respect to the ‘832 patent, the court finds that the term “local pH” is indefinite as there is no explanation of the volume or type of solvent to be used to measure local pH or when to measure it. It further finds that the asserted claims are obvious, and secondary considerations do not render them non-obvious. Some asserted claims would be infringed if the patent were valid.  With respect to the second patent, defendants did not demonstrate a reasonable expectation of success in making the claimed invention. That patent is not obvious and is valid under section 112.  Two defendants’ products infringe this patent. As for the third patent, the asserted claims are not invalid. However, defendants do not infringe the asserted claims.

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