In Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., the defendant failed to disclose that a 2-hour data point was not part of a test protocol and that a correction factor had not been applied to that p-value. This data point was the only one to produce a p-value of less than .05. The invention, however, went on to say that there was statistical support for synergy. In fact, Sturis said in a declaration to the examiner that the evidence “strongly suggests” synergy. However, he did not disclose statements that by his own standards, neither the rat study nor the Moses study established synergy in humans.
The court held that there was clear and convincing evidence that the opinions Sturis offered regarding synergy was material to the patentability of the claim at issue. This, because they refuted or were inconsistent with the opinions expressed in his Declaration in support of patentability. 37 C.F.R. §1.56(b)(2). The examiner would have wanted to know about this negative view on synergism, as this view was inconsistent with a later “strongly suggests synergy” declaration which the examiner most likely relied on to overcome obviousness.
The take-home message here is that you need to disclose what a reasonable examiner would have wanted to consider, be it qualifications or reservations held by the scientists concerning the conclusions he expressed in his Declaration.
Additionally, the Bork statement was also an example of inequitable conduct. After Sturis’ declaration, Bork represented this to the examiner:
Applicant therefore submits that the data presented in the application, in combination with the data presented in the Declaration of Dr. Sturis, provides clear evidence of synergy for the use of the claimed combination of repaglinide and metformin in the treatment of type II diabetes.
The court held that Bork’s representations to the examiners, to get around the final rejection, went beyond aggressive advocacy, in light of what he knew. Sturis’ “strongly suggests” was much more than Bork’s “clear evidence” of synergy.
Bork then got an email from Sturis containing explicit contrary information. The court noted that the duty to disclose to the examiner lasts until the issuance of the patent. 37 C.F.R. §1.56(a).
The take-home message from Bork is a message I learned while in the class Professional Responsibility: you have to stay within the reasonable limit of aggressive advocacy. Even though you may want something very badly for your client, it should never take precedence over the code of ethics that you have agreed to abide by.
In conclusion, Sturis and Bork both had an intent to deceive the Patent Office. Sturis, by withholding his opinions; Bork, by misstating key conclusions by his exaggerations. This inequitable conduct made the patent at issue unenforceable. Basically, this patent was invalidated on two fronts today. Rest in peace ‘358 patent, rest in peace.