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