The U.S. Court of Appeals for the Federal Circuit announced it would reconsider, en banc, its January 2010 decision on inequitable conduct in Therasense v. Becton Dickinson (see IP Update, Vol. 13, No. 2) and vacated the earlier panel decision. In its order, the Court made clear it was prepared to take a new look at both the “materiality” and “intent” issues. Therasense Inc. v. Becton, Dickinson & Co., Case No. 08-1511 (Fed. Cir., Apr. 26, 2010) (Dyk, J.).

During prosecution before the United States Patent and Trademark Office (USPTO), the patentee made certain representations to the examiner regarding the patent claims and the prior art that were clearly inconsistent with statements made to the European Patent Office (EPO). In the panel decision the Federal Circuit found that the patentee’s actions rose to the level of inequitable conduct.

The Court has now granted a petition for rehearing en banc from Therasense (now Abbott Diabetes Care), ordering the parties to file new briefs addressing the following issues:

1.Should the materiality-intent-balancing framework for inequitable conduct be modified or replaced?

2.If so, how? In particular, should the standard be tied directly to fraud or unclean hands? See Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S. 806 (1945); Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238 (1944), overruled on other grounds by Standard Oil Co. v. United States, 429 U.S. 17 (1976); Keystone Driller Co. v. Gen. Excavator Co., 290 U.S. 240 (1933). If so, what is the appropriate standard for fraud or unclean hands?

3.What is the proper standard for materiality? What role should the USPTO’s rules play in defining materiality? Should a finding of materiality require that, but for the alleged misconduct, one or more claims would not have issued?

4.Under what circumstances is it proper to infer intent from materiality? See Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (en banc).

5.Should the balancing inquiry (balancing materiality and intent) be abandoned?

6.Whether the standards for materiality and intent in other federal agency contexts or at common law shed light on the appropriate standards to be applied in the patent context.

Briefs of amici curiae may be filed without leave of court. The USPTO was also invited to file as amicus curiae.

Practice Note: Based on the questions presented, it would appear that the Court is prepared to finally settle the law of inequitable conduct and may be prepared to overturn some of its earlier panel decisions that are factually difficult to reconcile with each other.