In Novo v. Bio-Technology, Novo appealed the final judgment of the U.S. District Court for the District of Delaware, which held two claims of Novo’s U.S. Patent No. 5,633,352 (the ‘352 patent) invalid by reason of anticipation and unenforceable due to inequitable conduct. The U.S. Court of Appeals for the Federal Circuit affirmed the judgment of invalidity with respect to claim 1 of the ‘352 patent, as well as the judgment that the patent is unenforceable. The Court also vacated the judgment of invalidity with respect to claim 2 of the ‘352 patent.
Novo’s ‘352 patent is directed to a process for producing “ripe” human growth hormone (hGH) protein in E.Coli bacteria through the use of recombinant DNA techniques. The hGH protein has a specific sequence of 191 amino acids and is secreted by the anterior pituitary gland. Until the mid-1980’s, hGH could be obtained only from the pituitary gland of a human cadaver, known as “pituitary-derived hGH.” However, use of pituitary-derived hGH carried a high risk of contamination and infection for the patient. Prior to the ‘352 patent various attempts were made to produce synthetic hGH but were unsuccessful. In one example, an hGH having 192 amino acids resulted instead of the 191 amino acids found in “pituitary-derived hGH.” The additional amino acid resulted in an hGH variant not functioning in the same way as the pituitary derived hGH.
The ‘352 patent discloses the production of ripe hGH protein having 191 amino acids and traces priority back through a series of continuation applications to a 1983 PCT application. The 1983 PCT application traces priority back to a 1982 Danish patent application filed on December 10, 1982. The ‘352 patent issued from U.S. Application Ser. No. 402,286 filed on March 10, 1995.
On July 7, 2000 the Board of Patent Appeals declared an interference involving Novo’s ‘352 patent and Bio-Technology’s ‘248 application. Novo filed a preliminary motion in the interference seeking the benefit, for purposes of priority, of the filing date of the 1983 PCT application. On March 12, 2002, the Board issued its final decision, awarding priority to Novo.
On April 1, 2002, Bio-Technology appealed the final decision of the Board to the U.S. District Court for the District of Delaware. The district court reversed the Board’s decision, ruling that the 1983 PCT application was not enabled. On April 30, 2002 Novo filed a complaint in the District of Delaware and on June 12, 2002 Bio-Technology filed its answer to the complaint and asserted a counterclaim for a declaratory judgment that the ‘352 patent is invalid and unenforceable. Following the trial, the district court found (a) claim 1 was anticipated by a December 1981 article and (b) held that the ‘352 patent was unenforceable based on inequitable conduct during prosecution of the application.
On appeal, the Federal Circuit held claim 1 anticipated by the article since the article disclosed the limitations of claim 1 of the ‘352 patent. Specifically, the Federal Circuit found that the article disclosed the production of ripe hGH protein in an enabling manner because it discussed particular materials and a particular methodology to produce the ripe hGH protein.
Regarding the issue of inequitable conduct, the court held that the 1983 PCT application disclosed the use of a LAP enzyme to produce ripe hGH. The district court also found that when the 1983 PCT application was filed, the inventors had not successfully prepared hGH with LAP. Novo made several attempts between the filing of the PCT and March 7, 1984 to synthesize hGH using LAP. Finally, on March 7, 1984, Novo successfully synthesized hGH using commercial LAP, unbeknownst to Novo at the time, that the LAP contained DAP I enzyme. On October 18, 1984 Novo scientists concluded that the active component in LAP was not LAP itself but a contaminating substance, in this case DAP I enzyme. The discovery that this contaminating substance was DAP I led to the filing of a 1986 PCT application. On October 3, 1986, Novo filed U.S. Patent Application No. 06/910,230 claiming priority to the 1986 PCT application. During prosecution of the ‘230 application, the claims were rejected and eventually the ‘230 application was abandoned. Over the next several years, Novo filed a number of U.S. applications describing the use of the DAP I enzyme to produce ripe hGH and claiming priority to the 1986 PCT application. Then, on November 12, 1992, Novo filed the ‘856 application and in a preliminary amendment, Novo amended the specification to indicate that the application was entitled to a priority date of December 10, 1982, based upon the 1983 PCT application claiming priority to the 1982 Danish application. Initially the Examiner did not accept the new priority claim and a rejection issued. Later on, the examiner held a personal interview with Novo attorneys and two of the inventors, discussing where in the priority documents enablement was present. Novo followed the interview addressing the issue of whether the 1983 PCT application was enabled and the examiner allowed the application. However, Novo failed to disclose to the PTO that an example of the 1983 PCT application, producing ripe hGH, had never been actually performed and the examiner relied upon such example to grant the priority of the 1983 PCT application. Because Novo failed to disclose to the PTO that the example of the 1983 PCT application, producing ripe hGH, had never been actually performed and the PTO relied upon such example to grant the priority of the 1983 PCT application, the Federal Circuit held that the ‘352 patent was unenforceable based on inequitable conduct during prosecution of the application.
A copy of this case can be found at Novo Nordisk Pharmaceuticals v. Bio-Technology General, 424 F.3d 1347 (Fed. Cir. 2005).
Significance of Case For Application Drafting
This case is one of many that discuss the need for applicants to clearly describe examples when presented in an application since these examples are evidence Examiners rely upon to distinguish over the prior art. Under existing law, when presenting examples in the body of the specification, it is important to distinguish between speculative examples, which have not been performed, as opposed to an example which was performed. E.g., Hoffmann-La Roche Inc. v. Promega Corp., 66 USPQ2d 1385 (Fed. Cir. 2003)(Inequitable conduct found based upon specification described example in past tense even though never performed). Under Novo Nordisk, this rule has been extended to situations where the example, while performed, was not presented accurately. In this situation, the applicants are under a duty to clarify the example so as to not mislead the Examiner about the scope of the invention disclosed and supported by the example.