Apotex, Inc. et al. v. UCB, Inc. et al.

Docket No. 2013-1674

August 15, 2014

Brief Summary: Patent unenforceable due to inequitable conduct by inventor and through his prosecuting attorney and expert witness, including an admission at trial that experiments described in the application were “made up in his head.”

Summary: Apotex appealed DC decision that its US 6,767,556 relating to the ACE inhibitor moexipril magnesium was unenforceable due to inequitable conduct; it is judicially estopped from alleging infringement of the patent; indefiniteness; disclaimed claim scope; and is barred by laches from recovery of pre-suit damages. The FC affirmed the inequitable conduct decision. The magnesium composition was made to improve stability by reacting moexipril or its acid addition salts with an alkaline magnesium compound in the presence of a solvent (wet granulation, known since at least the 1980s). The claims encompass that process “so as to convert greater than 80% of the moexipril or moexipril acid addition salt to moexipril magnesium”. Dr. Bernard Charles Sherman (founder and CEO of Apotex) wrote the ‘556 patent and is the sole inventor. In multiple responses to prior art-based rejections, the Dr. Sherman’s attorney argued that it only showed the combination, but not the actual reaction, of moexipril and magnesium. An expert declaration was also submitted which “explained that the function of a stabilizer is to inhibit or prevent reactions that would degrade the active ingredient, and that a stabilizer needs to be unreacted to perform this function” and the skilled artisan “would therefore not expect a reaction to occur between the ACE inhibitor and the alkaline stabilizer” of the prior art. The attorney and the expert also argued that the prior art moexipril Univasc product was made by a prior art process and only produced a stabilized product. After a subsequent telephonic interview, the Examiner agreed to allow claims requiring “greater than 80%” coversion of moexipril, stating in the reasons for allowance that the prior art only teaches conversion of a “portion (if any)” of the drug is converted in the prior art and that the stable product results from stabilization, not conversion. The DC concluded Dr. Sherman knew Univasc was made by the ‘556 patent (conceded “strong suspicion”/“belief” product was made by the claimed process, handwritten notes regarding stability, “detailed mass spectrometry” confirmed “Univasc is ‘mainly present’ as moexipril magnesium”), concealed that knowledge from the PTO, otherwise misrepresented that knowledge during prosecution (“purposely shielding an expert from relevant information to obtain a declaration that misinformed”), withheld relevant prior art and submitted results of experiments that he never conducted (“lied in the application…Dr. Sherman admitted at trial that the experiments were made up in his head.”) The DC also concluded “that the single most reasonable inference that could be drawn from the evidence was that Dr. Sherman intended to deceive the PTO.” The FC panel therefore affirmed (statements “were not mere advocacy for a preferred interpretation; his statements were factual in nature and contrary to true information he had in his possession.”)

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