Star Scientific v. R.J. Reynolds Tobacco (Fed. Cir. 2008)
After a bench trial, the district court held that Star’s tobacco curing patents were unenforceable due to inequitable conduct during prosecution and invalid as indefinite. This post will discuss the inequitable conduct issues.
The Star patents are directed at a method of making healthier tobacco (same nicotine, but fewer nitrites and other chemicals). Higher end organic or green tobacco is perhaps the only growth market in the lagging US market. The inequitable conduct issues in this case revolve primarily around a letter received by the prosecuting attorneys from a Star scientist indicating that Chinese tobacco already had lower levels of nitrites due to “their use of old [radiant heat] flue-curing techniques.” Neither the letter nor a set of similar data were ever disclosed to the PTO.
An accused infringer can defang a patent by showing the patentee guilty of inequitable conduct during prosecution. To successfully prove inequitable conduct, the accused infringer must present “evidence that the applicant (1) made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information, and (2) intended to deceive the [PTO].” An issued patent is presumed valid and enforceable – thus, the “burden of proving inequitable conduct lies with the accused infringer. The patentee need not offer any good faith explanation unless the accused infringer first carried his burden to prove a threshold level of intent to deceive [and materiality] by clear and convincing evidence.” Further, “[e]ven if a threshold level of both materiality and intent to deceive are proven by clear and convincing evidence, the court may still decline to render the patent unenforceable.”
“The need to strictly enforce the burden of proof and elevated standard of proof in the inequitable conduct context is paramount because the penalty for inequitable conduct is so severe, the loss of the entire patent even where every claim clearly meets every requirement of patentability.
. . .
[C]ourts must ensure that an accused infringer asserting inequitable conduct has met his burden on materiality and deceptive intent with clear and convincing evidence before exercising its discretion on whether to render a patent unenforceable.
. . .
If a threshold level of intent to deceive or materiality is not established by clear and convincing evidence, the district court does not have any discretion to exercise and cannot hold the patent unenforceable regardless of the relative equities or how it might balance them.
Specific Intent: As the CAFC held the 1995 Molins case, the intent requirement is “specific intent to . . . mislead or deceiv[e] the PTO.”
“Rather, to prevail on the defense, the accused infringer must prove by clear and convincing evidence that the material information was withheld with the specific intent to deceive the PTO.”
When circumstantial evidence is used to prove intent, that evidence “must still be clear and convincing” and intent to deceive the PTO must be “the single most reasonable inference able to be drawn from the evidence.” As a flat rule, information is not material if it is cumulative to that already disclosed.
In this case, prosecution was begun at the Sughrue Mion firm and then moved to the Banner Witcoff firm. RJR’s theory of intent was that the firm switch was necessary to avoid disclosing the letter. Star’s witness stated that the “reasons behind the replacement of the Sughrue firm were that a key partner passed away and that [the witness] observed a Sughrue attorney perform unsatisfactorily in an unrelated prosecution.” The district court, however, rejected that testimony as unbelievable. On appeal, however, the CAFC reversed:
“[E]ven if Star’s explanations are not to be believed, it remained RJR’s burden to prove its allegation regarding the reason for the Sughrue firm’s dismissal. RJR cannot carry its burden simply because Star failed to prove a credible alternative explanation.”
Here, the court found that RJR had simply not proven its case:
“RJR failed to elicit any testimony or submit any other evidence indicating that Star knew what the Burton letter said prior to replacing the Sughrue firm, or that the letter was a reason for changing firms. RJR admitted at oral argument that it failed to even ask [Star’s] executives about these critical facts, and RJR failed to identify any testimony or other evidence when specifically asked by us to do so in supplemental briefing. Further, a review of the record shows that Williams actually testified, in response to a different question, that he had never seen the Burton letter prior to his deposition in the present litigation. This statement was never impeached, questioned, or explored by RJR’s counsel. RJR identified Perito, Star’s chairman, as the officer who made the decision to terminate the Sughrue firm, but Perito was never asked whether he had knowledge of the Burton letter or whether it played any role in his decision to change firms.
In the end, the court concluded, that RJR had simply failed to provide sufficient facts to support an inference of intent to deceive. Reversed and Remanded.
- The decision gave Star’s stock (STSI) a nice bump:
Of course, there is no “legal” impact, but I query the importance of the fact that both prosecution firms (Sughrue Mion and Banner Witcoff) are well known and well respected in the legal communities.