IP Update, Vol. 10, No. 1 (5 April 2012)

Editors: Marc S. Weiner, Esq. and Nicholas P. Godici

District Court Rules That the Therasense Patent is Unenforceable Due To Inequitable Conduct

United States District Court Judge William Alsup issued an Order on Remand Regarding Inequitable Conduct on March 27, 2012 holding that inequitable conduct was committed during the prosecution of the Therasense patent, even under the heightened standards for materiality and intent recently defined by the Federal Circuit.

In May 2011, the Federal Circuit issued an en banc panel decision redefining the standards for materiality and intent required to support a finding of inequitable conduct in Therasense, Inc. v. Becton Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011). In their decision the Federal Circuit stated, "This court now tightens the standards for finding both intent and materiality in order to redirect a doctrine that has been overused to the detriment of the public". The court further stated that the accused infringer must prove by clear and convincing evidence that the applicant knew of the reference, knew it was material, and made a deliberate decision to withhold it. The materiality standard was defined as the "but-for" standard. The Federal Circuit then vacated the earlier District Court finding of inequitable conduct and remanded the case to the District Court for further consideration in view of the new standards set forth in the en banc decision.

On March 27, 2012 District Court Judge Alsup issued his Order holding that the Therasense patent attorney and research director had indeed committed inequitable conduct in procuring the Therasense patent. The court found that Therasense submitted arguments and a declaration interpreting their own prior art reference as requiring a protective membrane while deliberately withholding contradictory material information in the form of briefs submitted to the EPO in a counterpart foreign application in which the same prior art was argued as optionally have a protective membrane. Judge Alsup stated that even under the tightened standards defined by the Federal Circuit, the Therasense patent was unenforceable due to the failure to submit the EPO briefs which were material under the "but-for" standard and withheld with intent to deceive the PTO.

Summary provided by Nicholas P. Godici

Return to top