Past Tense Prophetic Example Kills Patent

In Novo Nordisk Pharmaceuticals, Inc., et al. v. Bio-Technology General Corp., et al. (Fed. Cir. October 5, 2005) the court affirmed that Novo acted with deceptive intent in failing to disclose the prophetic nature of Example 1 to the PTO or the Board.

Example 1 described the production, purification, and evaluation of a fusion protein. It also described treatment of the fusion protein with the LAP enzyme in order to obtain ripe hGH and stated that standard tests indicated that the disclosed methodology produced ripe hGH protein that was 98% pure. Speaking in the past tense, the example states that "[t]he fusion product was purified from this extract," that "[t]he purified fusion protein was evaluated to be more than 98% pure," and that "[t]his . . . product was then treated with leucine aminopeptidase."

According to Circuit Justice Schall:

It is undisputed that Dr. Christensen was aware that Example 1 was prophetic and that Novo never successfully produced ripe hGH through the use of "pure LAP" enzyme. It also is undisputed that, during prosecution of the '856 application, Dr. Christensen was one of four Novo representatives present during the January 7, 1994 interview with the examiner, during which one of the issues addressed was enablement of the 1983 PCT application, of which the ’081 application was the U.S. counterpart. As noted, other representatives included Novo’s in-house patent attorney and in-house patent advisor.

Thus, Novo asks us to hold, on the one hand, that the failure of Dr. Christensen and his co-inventors to disclose the truth about Example 1 to Novo’s attorneys absolves them of their duty to disclose this information to the PTO or the Board, because without their attorney’s consultation, they could not have known that this information was material. At the same time, Novo asks us to hold that its counsel’s failure to disclose the truth about Example 1 to the PTO or Board is excused because the inventors failed to fully inform them of the details surrounding Example 1.

As we have done in similar situations in the past, we reject the "circular logic" of this request. See Brasseler, 267 F.3d at 1380 ("We refuse to pursue the circular logic of Brasseler’s request and decline to carve out an exception to the inequitable conduct law to shield those guilty of inequitable conduct from responsibility for their actions."); see also Molins, 48 F.3d at 1178 (stating that the knowledge and actions of an applicant’s representatives are chargeable to the applicant (citing FMC Corp., 835 F.2d at 1415 n.8)). Accordingly, the district court correctly concluded that Novo knew or should have known that the PTO and the Board would have considered the information relating to Example 1 important in evaluating whether the 1983 PCT application was enabled.

In the U.S., simulated or predicted test results and prophetical examples (paper examples) are permitted in patent applications. Working examples correspond to work actually performed and may describe tests which have actually been conducted and results that were achieved. Paper examples describe the manner and process of making an embodiment of the invention which has not actually been conducted. Paper examples should not be represented as work actually done. No results should be represented as actual results unless they have actually been achieved. Paper examples should not be described using the past tense. Hoffman-La Roche, Inc. v. Promega Corp., 323 F.3d 1354, 1367, 66 USPQ2d 1385, 1394 (Fed. Cir. 2003).