While the Federal Circuit continues to set the bar high for establishing inequitable conduct, this case is a reminder of one’s duty of candor in dealing with the PTO and that substantially overstating your case may ultimately get you in trouble. After all, this one took the Federal Circuit to bring it back from the depths of unenforceability at the district court.
Background / Facts: This case involves a claim for treating Type II diabetes with combination therapy using two well-known monotherapy drugs, specifically: “[a] method for treating noninsulin dependent diabetes mellitus (NIDDM) comprising administering to a patient in need of such treatment [A] repaglinide in combination with [B] metformin.” It was apparently well-known in the art that two drugs having different mechanisms for attacking diabetes may be more effective than one, and so drugs were often tested in combination therapy after demonstrating effectiveness in monotherapy. The Examiner therefore issued an initial obviousness rejection that was not overcome until the filing of experimental data along with an expert declaration attesting to unexpected results. As it turns out, however, the expert and the patent attorney may have overstated the results of the experiments to the PTO in an effort to convince the Examiner.
Issue(s): Whether the patentee’s overstatements during prosecution rose to the level of inequitable conduct.
Holding(s): No. While the court found slightly “troubling” the expert’s decision to omit his original test protocol from the declaration in favor of a later developed protocol that produced better numbers, it held that this fails the “but for” materiality test for establishing inequitable conduct because sufficient data was nevertheless provided for the Examiner to draw her own conclusions. “Dr. Sturis disclosed the results of his original protocol to the examiner, allowing her the opportunity to weigh the significance of the different p-values he calculated.” Similarly, the court found the patent attorney’s statements and omissions troubling, but not material. Despite strong statements that the declaration provides “clear evidence” of “synergistic and surprising results achieved by the claimed combination therapy in humans” accompanied by e-mails that surfaced during discovery painting a less clear picture, the court held that “[patent attorney] Dr. Bork’s characterization of the Sturis Declaration employed carefully-chosen language which tracked the qualified nature of Dr. Sturis’s opinions. For instance, whereas Dr. Sturis said his results ‘indicated’ and ‘strongly suggest[ed]’ synergy, Dr. Bork referred to Sturis’s test results as ‘evidence’ rather than ‘proof’ of synergy.”