Apotex Inc. and Apotex Corp. (collectively, “Apotex”) appealed the decision of the United States District Court for the Southern District of Florida finding that Apotex’s U.S. Patent No. 6,767,556 (“the ’556 patent”) is unenforceable due to inequitable conduct. Apotex likewise appealed the district court determination that the asserted claims were indefinite, that they disclaimed coverage of the accused products from the scope of the ’556 patent’s claims, and any recovery of pre-suit damages was barred by laches. In an opinion authored by Judge Reyna (with Judges Wallach and Hughes joining), the United States Court of Appeals for the Federal Circuit determined that the district court did not abuse its discretion in finding inequitable conduct, and on that basis alone, affirmed the district court’s judgment. See Apotex, Inc. v. UCB, Inc. (August 15, 2014).

The ’556 patent is generally directed to a process for manufacturing moexipril tablets. Moexipril is an angio-tensin-converting enzyme (“ACE”) inhibitor used to treat hypertension. To improve stability, the ’556 patent discloses a process of making moexipril tablets consisting mostly of moexipril magnesium obtained by reacting moexipril, or its acid-addition salts, with an alkaline magnesium compound.

The two accused products in this case, Univasc and Uniretic, were prior art to the ’556 patent. Both products are moexipril tablets that have been sold in the United States since 1995 and 1997, respectively. Univasc and Uniretic are made in accordance with the process described in U.S. Patent No. 4,743,450 (“the ’450 patent”), which Defendant UCB, Inc. licenses from Warner-Lambert.

The district court ruled that the ’556 patent was unenforceable because Dr. Sherman was aware that Univasc was made according to his claimed process, concealed this knowledge from the PTO, and misrepresented the nature of Univasc and the prior art through his counsel’s arguments and through an expert declaration submitted to support his misrepresentations, which was filed by a Dr. Lipp. The district court also found that Dr. Sherman withheld relevant prior art and submitted results of experiments that he never conducted.

The Federal Circuit agreed that Dr. Sherman engaged in material misconduct, for at least three reasons.

1. Dr. Sherman was actively involved in the prosecution of the ’556 patent and instigated the representations made on his behalf by his counsel and Dr. Lipp. Dr. Sherman directly instructed his counsel to continue pressing arguments he knew to be fallacious and to bolster them through an expert declaration.
2. Dr. Sherman made affirmative misrepresentations because Apotex’s own internal tests showed that moexipril in Univasc is “mainly present” as moexipril magnesium.
3. The Examiner’s rejections were based on the very same prior art that is the subject of Dr. Sherman’s misrepresentations, therefore, Dr. Sherman’s misrepresentations were “but for” material to the Examiner’s ultimate decision to issue the patent.

With respect to intent, the Federal Circuit explained that the evidence demonstrated that Dr. Sherman was aware that at least some of the assertions he made in the specification regarding the prior art were misleading, if not completely inaccurate. Furthermore, Dr. Sherman admitted that he never performed the experiments described in the ’556 patent, and yet he still drafted the examples in the specification entirely in past-tense language. Dr. Sherman also directed his counsel to bolster the misrepresentations by procuring and submitting the declaration of an expert who was deliberately shielded from the truth. All of this showed a clear intent to deceive the Patent Office.

Tags: CAFC, Federal Circuit, inequitable conduct, inequitable conduct doctrine, patent, patents

This entry was posted on Tuesday, August 19th, 2014 at 21:09 and is filed under CAFC, Patent Issues, Patent Prosecution, posts. You can follow any responses to this entry through the RSS 2.0 feed. You can skip to the end and leave a response. Pinging is currently not allowed.