Therasense, Inc. v. Becton Dickinson & Co
To help clients understand and prepare for the potential impact of Therasense, Inc. v. Becton Dickinson & Co., a Federal Circuit decision that may significantly change the law of inequitable conduct, as related to patent procurement and enforcement, Banner & Witcoff offers the following content as a resource to monitor and analyze developments in the case. Background
On January 25, 2010 a Federal Circuit Court of Appeals three judge panel affirmed a district court conclusion of inequitable conduct in the case Therasense, Inc. v. Becton Dickinson & Co. The conclusion was specifically that a patent related to disposable diabetes blood test strips was unenforceable because statements made in international patent prosecution were not disclosed to the US PTO in the corresponding US case.
On April 26, 2010 the Federal Circuit Court of Appeals granted a petition to rehear Therasense, Inc. v. Becton Dickinson & Co. en banc, posing the following questions to the parties that foreshadow potential for a substantial narrowing of the doctrine of inequitable conduct:
- Should the materiality-intent balancing framework for inequitable conduct be modified or replaced?
- If so, how? In particular, should the standard be tied directly to fraud or unclean hands? If so, what is the appropriate standard for fraud or unclean hands?
- What is the proper standard for materiality? What role should the US PTO'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?
- Under what circumstances is it proper to infer intent from materiality?
- Should the balancing inquiry (balancing materiality and intent) be abandoned?
- 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.
On May 25, 2011, the Court of Appeals for the Federal Circuit issued a decision in Therasense v. Becton Dickinson.
Webinar
On June 22, 2011, the lawyers of Banner & Witcoff, Syracuse University Law Professor Lisa Dolak, and Chief Intellectual Property Counsel for Johnson & Johnson, Philip Johnson, led a panel discussion that provided analysis and insight on the Federal Circuit’s decision in Therasense v. Becton, Dickinson.
Click here to view the 90-minute recorded program.
Important Dates
- May 25, 2011 -- CAFC Issues a Decision
- November 9, 2010 -- CAFC Oral Argument
Court Documents
- CAFC En Banc Decision (May 25, 2011)
- Transcripts of the CAFC oral argument
- Intellectual Property Law Association of Chicago Amicus Brief (Filed by Charles Shifley of Banner & Witcoff, August 2, 2010)
- En Banc Order (April 26, 2010 )
- Federal Circuit Court of Appeals Decision (January 25, 2010)
Media
Banner & Witcoff attorneys are available to answer questions and discuss the Therasense v. Becton Dickinson & Co. case. Media inquiries should be directed to Colleen Strasser at (312) 463-5465 or cstrasser@bannerwitcoff.com.
related news
08.03.2011 | Patent Law Update: The US PTO Proposes to Adopt Therasense Materiality Standard for Practice in the US PTO
11.19.2010 | Charles W. Shifley discusses the Federal Circuit oral argument in Therasense v. Becton Dickinson in a BNA article
04.26.2010 | Patent Law Update: Federal Circuit Signals Big Changes on Inequitable Conduct Likely By Year End 2010
related library documents
11.30.2011 | Therasense - Does It Make Sense? Has the Federal Circuit Finally Fixed Inequitable Conduct Law? And Associated Matters of Ethics and Practice; Banner & Witcoff Intellectual Property Article. 11/30/2011. (Shifley, Charles W.)
08.03.2011 | The US PTO Proposes to Adopt Therasense Materiality Standard for Practice in the US PTO; Banner & Witcoff Intellectual Property Alert. 08/03/2011. (Shifley, Charles W.)
08.01.2011 | International Prosecution Strategy after Therasense: What You Need to Know Now; Bloomberg Law Reports. 07/18/2011. (Gorman, Shawn P.; )
05.25.2011 | Therasense on Patent Inequitable Conduct – The Decision of the Federal Circuit “Fixes” Inequitable Conduct Law; Banner & Witcoff Intellectual Property Alert. 05/25/2011. (Shifley, Charles W.)