By Donald Zuhn --
On Monday, the Court of Appeals for the Federal Circuit decided that the appeal in Therasense, Inc. v. Becton, Dickinson & Co. warrants en banc consideration. In the Court's per curiam order, it noted that the panel that heard the appeal considered the petition for rehearing submitted by Plaintiffs-Appellants Abbott Diabetes Care, Inc. (formerly Therasense, Inc.) and Abbott Laboratories; requested a response from Defendants-Appellees Becton, Dickinson & Co., Nova Biomedical Corp., and Bayer Healthcare LLC; granted Plaintiffs-Appellants leav to file a reply; and granted the Washington Legal Foundation, Nine Intellectual Property Law Professors, Hon. Bruce A. Lehman and the International Intellectual Property Institute, and Ole K. Nilssen and Geo Foundation, Ltd. leave to file amici briefs. The petition, response, reply, and amici briefs were then referred to the other Circuit Judges, a poll on whether to rehear the appeal en banc was requested and taken, and the Court decided to hear the appeal en banc and vacate the panel's January 25, 2010 opinion.
The parties have been asked 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 United States Patent and Trademark Office’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.
Plaintiffs-Appellees must file their brief by June 10, 2010, and Defendants-Appellees must file their response 30 days from the date of service of Plaintiffs-Appellees' brief. Plaintiffs-Appellees' reply would be due 10 days from the date of service of Defendants'-Appellees' response. The Court noted that it would entertain briefs of amici curiae, and invited the U.S. Patent and Trademark Office to submit an amicus brief.
Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2010)
Order, per curiam