Case Summary
**Case Summary: Therasense, Inc. v. Becton, Dickinson & Co.**
**Docket Number:** 2601381
**Court:** United States Court of Appeals for the Federal Circuit
**Decided:** May 25, 2011
**Overview:**
This case addresses issues of patent law, specifically regarding the standards for proving inequitable conduct in the context of patent procurement. Inequitable conduct occurs when a patent applicant fails to disclose material information or makes misleading statements during the patent application process, which can render a patent unenforceable.
**Facts:**
Therasense, Inc. developed a blood glucose meter and held several patents related to their diabetes management technology. Becton, Dickinson and Company (BD) accused Therasense of infringing on their patents. In response, Therasense alleged that BD's patents were obtained through inequitable conduct, claiming that BD failed to disclose material information regarding prior art that was relevant to the patent examination process.
**Legal Issue:**
The central issue in this case was whether BD had committed inequitable conduct by failing to disclose certain prior art references to the U.S. Patent and Trademark Office (USPTO). The court also examined the standard for proving inequitable conduct, especially concerning the requirements of materiality and intent.
**Ruling:**
The Federal Circuit redefined the standard for proving inequitable conduct, emphasizing that the conduct must be both material and intentional. The court clarified that the materiality standard requires a clearer demonstration that the undisclosed information would have been significant to the patent examiner’s decisions. The intent to deceive must also be proven with clear and convincing evidence, meaning that mere negligence or failure to disclose is insufficient for an inequitable conduct claim.
The court ultimately found that Therasense did not sufficiently prove that BD had engaged in inequitable conduct in obtaining its patents. As a result, BD's patents were upheld, and Therasense's claims were rejected.
**Significance:**
The Therasense ruling is significant for the patent law landscape as it heightened the burden of proof required to establish inequitable conduct. This decision is intended to prevent abuse of the inequitable conduct defense and ensure that patents remain enforceable unless there is clear evidence of wrongdoing. The ruling has implications for both patent applicants and litigants in patent disputes, clarifying how courts will assess conduct in the patent application process.