Two Years After SG Said Wait, Standard For Inequitable Conduct Back at High Court

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May 4 — Apotex Inc. wants to know whether the time is ripe for the Supreme Court to review the controversial Therasense ruling on inequitable conduct in securing a patent, and it filed a petition for writ of certiorari April 30 asking the court to do just that.

In 2011, the U.S. Court of Appeals for the Federal Circuit, in a 6-5 vote by the full court, tightened the intent and materiality standards for a district court—in the context of a patent infringement case—to find a patent unenforceable due to misrepresentations to the Patent and Trademark Office during procurement.

The high court asked for the views of the Office of the Solicitor General on that approach two years later, but the government recommended that the court wait for a case challenging both prongs, and the Supreme Court denied that petition.

Apotex's current petition arises out of its infringement complaint against UCB Inc.'s Univasc and Uniretic moexipril tablets used in the treatment of hypertension and is as focused on materiality as the earlier petition.

But the government had also said that two years of district court rulings under Therasense was not enough, so the question is whether the Supreme Court justices will see four years as the appropriate amount of time.

Seeking Patent on Competitor's Drugs

The decision against Apotex here followed the Federal Circuit's en banc ruling in Therasense Inc. v. Becton Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc). Therasense adopted a but-for materiality standard, requiring the challenger to show that “the PTO would not have allowed a claim had it been aware of the undisclosed prior art.”

Apotex's patent at issue claims a process for making moexipril magnesium by reacting moexipril with alkaline magnesium (U.S. Patent No. 6,767,556). The listed inventor, Bernard Charles Sherman, filed the patent application in 2000, at least three years after Univasc and Uniretic were first marketed.

The Federal Circuit affirmed a district court's judgment that Sherman acted with intent to deceive the PTO through material misrepresentations of Apotex's tests on UCB's drugs (Apotex, Inc. v. UCB, Inc., 763 F.3d 1354 (Fed. Cir. 2014).

According to Apotex's cert. petition, though, Sherman merely had “suspicions” of UCB's process, and the Federal Circuit held “unenforceable a patent on a previously unknown process for producing a drug, because its inventor did not disclose that a competitor might be using the process in secret.”

The questions presented are:

1. Whether the secret process used to make an existing product is material prior art that must be disclosed to the PTO in a later inventor’s application to patent a similar or identical process.

2. Whether alleged misconduct that does not induce the PTO to issue a patent can render that patent unenforceable.


“Although the Federal Circuit has tried several times (most recently in Therasense) to establish clear rules for inequitable conduct, this case confirms that its efforts have failed—and that this Court’s guidance is needed,” according to the petition.

Steffen N. Johnson of Winston & Strawn LLP, Washington, filed the petition. Adam Gahtan of White & Case LLP, New York, represented UCB before the Federal Circuit. A response is due June 1.

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