Federal Circuit Affirms Inequitable Conduct Against Apotex

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.


Catching up with Bob Stoll

On July 19, 2012, I interviewed Bob Stoll, former Commissioner for Patents of the United States Patent and Trademark Office.  The interview took place in a conference room at Drinker Biddle on K Street in Washington, D.C.  After 29 years working for the USPTO and a total of 34 years working for the government, Stoll retired on December 31, 2011.  He then started his new, second career as a private citizen and all-around patent specialist at Drinker Biddle in the firm’s Intellectual Property Group.

In his 29 years with the USPTO, Bob Stoll held several leadership posts, including training foreign officials on all aspects of intellectual property (IP), overseeing the Office of Enforcement, and directing federal legislative priorities for the Agency. In his tenure as Commissioner for Patents, Stoll was in charge of implementing initiatives to improve the speed and quality of the patent review process, was instrumental in reducing the patent application backlog, and undertook an initiative to clean out the oldest cases on the USPTO docket.


The Impact of Therasense On Patent Reform

Scott McKeown, Partner at Oblon Spivak and Practice Center Contributor, sent in this article discussing the practical impact of the “but for” standard of Therasense and why Supplemental Examination as proposed in the pending patent reform legislation is not necessarily the best procedure to cure inequitable conduct.


Did Therasense Moot Supplemental Examination?

Supplemental Examination, as currently proposed in the patent reform legislation, would enable Patentees to effectively cure inequitable conduct for all but the most offensive conduct. This reform provision was designed to combat the plague of inequitable conduct charges that existed prior to the Therasense decision.

Supplemental examination would enable the Patentee to have the USPTO consider, reconsider, or correct information believed to be relevant to its patent if the information presented a substantial new question of patentability (SNQ).  If an SNQ is found to exist, the supplemental examination would include a full examination of the claims. (not just limited to patents and printed publications as in current reexamination practices).  Once Supplemental Examination concludes, the issues brought before the Office in the second examination cannot serve as a basis for an inequitable conduct defense. (more…)

Facebook’s Inequitable Conduct Case After Therasense

Our friends at Reexamination Alert sent in this article discussing the Tele-Publishing, Inc. v. Facebook, Inc., et al..  Has Facebook figured out a way to successfuly prove inequitable conduct even in light of the but-for standard for materiality now required by Therasense?

In January, Reexamination Alert reported on the case Tele-Publishing, Inc. v. Facebook, Inc., et al., No. 1:09-cv-11686-DPW, in which Facebook is accused of infringing U.S. Patent No. 6,253,216 entitled “Method and Apparatus for Providing a Personal Page.”  Facebook defended by requesting reexamination of the ‘216 patent, asserting that it was invalid over an earlier patent to de Hond.  The PTO granted reexamination.  An initial rejection of all claims issued in April, 2010, and a final rejection issued in August of that year. An appeal is currently pending at the PTO Board.

What will interest reexamination lawyers, however, is Facebook’s allegation that the ‘216 patent is unenforceable because of applicant’s inequitable conduct during the prosecution of that patent.  Facebook asserts that the ‘216 applicant was aware of the de Hond patent because that reference was cited and distinguished in several related applications, and that the applicant intentionally withheld de Hond in the ‘216 prosecution.

How does Facebook’s inequitable conduct defense stand up in light of the but-for standard for materiality now required by Therasense?  Pretty well, actually.   The CAFC described the materiality standard inTherasense as calling for a court to “determine whether the PTO would have allowed the claim if it had been aware of the undisclosed reference.”  The CAFC seemed almost to have reexamination in mind when it added that “the court should apply the preponderance of the evidence standard and give the claims their broadest reasonable construction” (emphasis added).  The closest answer to the CAFC’s hypothetical question – what would the PTO have done with the undisclosed reference – might be found in reexamination. (more…)

Patentees Rejoice — But Will Therasense Stand?


The following post comes courtesy of Brandon Baum, of Baum Legal and Practice Center Contributor.

The Federal Circuit’s split decision in Therasense is being hailed by some as the end to the “absolute plague” of inequitable conduct claims in patent cases. After all, the decision raises the bar for proving inequitable conduct. But before the champagne goes flat and the confetti is swept away, the Therasense case may prove to have been exactly the wrong horse for patentees to ride.

The problem with the majority decision in Therasense is that it is long on policy, short on the facts. In the ivory towers of the Federal Circuit (which does not have the usual diet of criminal cases, fraud cases, and other bad conduct), the fact that patent prosecutors are frequently accused of acting inequitably to obtain patents is unseemly. To the rest of the world, of course, the news that lawyers and/or inventors might try to “game the system” for financial advantage is purely “dog bites man.” (more…)