The Federal Circuit Court of Appeals in many ways is the “final word” on patent law. Unlike appeals in trademark or copyright cases, all patent appeals go to it, to benefit from its expertise in this complex area. Thus, Therasense, Inc. v. Becton, Dickenson & Co. is all the more important in “defining” the troubled law of inequitable conduct in applicant’s dealings with the US Patent and Trademark Office (USPTO). These troubles have led to increased litigation costs, complexity, case backlog and uncertainty. Dealing with this issue at one time was viewed as a "cottage industry" within the broader confines of patent litigation.
The doctrine is rooted in federal case law, but has struggled in the tensions between requiring honesty in dealings with the USPTO and determining the appropriate standard of review of decisions regarding such conduct. This tension centered on standards of review of the applicant’s intent in dealings with the USPTO and the materiality of misleading statements made in these dealings.
Lending predictability to future litigators and patent prosecutors, the Court of Appeal set out two bright line tests. To qualify as inequitable conduct during prosecution to obtain a patent, there must be a showing by clear and convincing evidence of, first, specific intent to deceive, based on evidence of knowing and deliberate decision to deceive as the “single most reasonable inference able to be drawn from the evidence.” Second, there must also be a material deception, proved by clear and convincing evidence. The deception is only material if the USPTO would not have allowed the claim if it had been aware of the undisclosed information. These of course are difficult standards to meet, making the defense more problematic for defendants than was the case before.
Clients are constantly advised that patent attorneys must take care not to mislead the USPTO in seeking to obtain issuance of their patents. While issues remain, Therasense gives counsel and clients greater reassurance of what will and will not be permitted in communications with the USPTO.