Rehearing Ordered En Banc in Therasense, Inc. v. Becton, Dickinson and Company on Six Issues Including the Proper Standard for Materiality in Cases of Inequitable Conduct

April 27th, 2010

The Federal Circuit on April 26, 2010, ordered a rehearing en banc in Therasense, Inc. v. Becton, Dickinson and Company,  Docket Nos. 2008-1511, 1512, 1513, 1514, 1595 (Fed. Cir. April 26, 2010), involving the law of inequitable conduct. The Court requested that six issues be addressed in the rehearing. Of particular interest to reexamination practice is the proper standard for materiality, to which the Court posed the following questions: 

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 of the claims would not have issued?

Inequitable conduct is intertwined with reexamination practice in many ways. Third-party requesters may file a reexamination request for the purpose of having the PTO find that a particular document raises a valid SNQ, which finding may be cited at trial for the materiality element in an inequitable conduct defense. The duty of disclosure attaches to the patent owner in reexamination (but not the third-party requester).

Complying with that duty can be problematic for even the most diligent and forthright patent owner, especially after the Notice of Intent to Issue a Reexamination Certificate (NIRC) has issued and before the Reexamination Certificate has published. A patent owner with a large portfolio of pending patent applications that are related to the patent under reexamination has to be especially careful and diligent.

Reexamination counsel is a prime target for a charge of violating of the duty of disclosure in a parallel patent litigation.  A violation can create subsequent issues for reexamination counsel before the Office of Enrollment and Discipline.  These and other concerns make this en banc rehearing relevant to reexamination practice.

The Federal Circuit stated that briefs of amicus curiae will be entertained in the en banc rehearing. Four amicus briefs, including one from the PTO, were filed with the petition for rehearing en banc.  It is expected that there will be many additional amicus filings in this case.

Under the current briefing schedule, it is expected that the Federal Circuit will hear arguments in the case next October or November.

Download the Order

Therasense Inc v Becton Dickinson and Company (Fed Cir April 26 2010)(en banc)