Defendants are enjoined from marketing generic cinacalcet hydrochloride tablets
Brigham and Women’s Hospital Inc., et al. v. Teva Pharmaceuticals USA, Inc., et al., Civil Action No. 08-464-HB, January 7, 2011.
Bartle, J. (by designation) Court finds patents-in-suit are valid and enjoins defendants from manufacturing and selling their generic cinacalcet hydrochloride tablets prior to the expiration of the patents.
This is an ANDA case regarding generic cinacalcet hydrochloride tablets. The parties had stipulated that the accused tablets would infringe if the patents were found to be valid. After a 3-day bench trial, the court issued its findings of fact and conclusions of law. It found that defendants proved by clear and convincing evidence that a prior patent application was material and not disclosed to the examiner. However, defendants failed to prove there was intent to deceive the examiner. Thus they failed to prove by clear and convincing evidence that the patent committee or inventors engaged in inequitable conduct. Defendant’s claim that the court should invalidate two patents for obviousness-type double patenting is also rejected. In this case, the legal changes to the patent terms, the timing of the applications, and the length of the prosecution caused the species patent to expire before the genus. Thus, the later-filed, later-issued patent could not create an unjustified timewise extension. The court further rejected a second inequitable conduct claim where defendants failed to prove that the inventors owed or breached a duty to inquire with respect to a patent application where there was no evidence they were aware of the application. Finally, defendants’ anticipation argument was rejected where defendants’ expert did not convincingly explain why one skilled in the art would envisage compounds containing two non-preferred right side substituents and ignore the preferred compounds.
