Case Summary
**Case Summary: Therasense, Inc. v. Becton, Dickinson and Company, Docket No. 2600769**
**Court:** United States Court of Appeals for the Federal Circuit
**Date:** 2011
**Case Number:** 2010-1408, 2010-1410
**Background:**
In the case of Therasense, Inc. v. Becton, Dickinson and Company, Therasense challenged the validity of a patent held by Becton Dickinson regarding glucose monitoring devices that were integral to diabetes management. The dispute arose after Becton Dickinson accused Therasense of infringing its patent rights. Therasense countered by alleging that Becton Dickinson had committed inequitable conduct in obtaining the patent.
**Legal Issues:**
The primary legal issues in this case centered around the doctrine of inequitable conduct which pertains to the obligation of patent applicants to disclose information that is material to patentability. Therasense argued that Becton Dickinson misled the Patent and Trademark Office (PTO) by failing to disclose relevant prior art and making misleading statements during the patent prosecution process.
**Key Findings:**
The Federal Circuit established a higher standard for proving inequitable conduct. Specifically, the court held that both the intent to deceive the PTO and the materiality of the information not disclosed must be demonstrated with clear and convincing evidence. The court determined that a mere failure to disclose relevant prior art does not automatically constitute inequitable conduct, but rather requires evidence of specific intent to deceive.
The court ultimately concluded that Therasense had failed to prove that Becton Dickinson had acted with the requisite intent to deceive. As a result, the claims of inequitable conduct were rejected, and the Becton Dickinson patent was upheld.
**Conclusion:**
The Therasense v. Becton case significantly clarified the standard for proving inequitable conduct in patent cases. The ruling underscored the necessity for clear and convincing evidence of both materiality and intent to deceive, thereby making it more challenging for defendants to assert inequitable conduct as a defense in future patent infringement litigations.
**Significance:**
This case is often cited for its clear directive regarding the high bar for proving inequitable conduct, influencing subsequent patent litigation strategies and the behavior of patent applicants during prosecution.