Reliance on Experiment That Never Worked Was Inequitable Conduct

Case: Novo Nordisk Pharmaceuticals, Inc. v. Bio-Tech. General Corp. , No. 04-1581 (Fed Cir. 10/5/05)

The One Sentence Summary:The panel affirmed district court rulings after a bench trial that (1) a patent claim for synthetic human growth hormone was anticipated by an article discussing an alternate formulation method; and (2) the patent was unenforceable due to inequitable conduct in not disclosing that an experiment in an earlier application used to establish priority had never been successfully performed.


What They Were Fighting About: Plaintiff Novo Nordisk held a patent for synthetic human growth hormone (hGH) with the amino acid sequence and biological activity of natural hGH and a process for producing it by cleaving an e-coli grown fusion protein with an enzyme. After a bench trial, the district court held that the claims were anticipated by a published article pursuant to 35 U.S.C. § 102(a) and that the patent was invalid due to inequitable conduct.
Federal Circuit Holdings:

• The district court properly held that the claim for hGH was anticipated and enabled by the article which described synthetic hGH and a method to test it. Enablement under 102(a) is a different standard than under 35 U.S.C. § 112(a). One of ordinary skill in the art must be able to practice the invention without undue experimentation, and suggestions in the prior art need not be actually performed in order to anticipate.


• The panel stated the inequitable conduct standard as follows: ”Inequitable conduct occurs when a patent applicant breaches his or her “duty of candor and good faith” to the PTO. 37 C.F.R. § 1.56(a) (2004); Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs., Ltd., 394 F.3d 1348, 1351 (Fed. Cir. 2005). Inequitable conduct includes “affirmative misrepresentation of a material fact, failure to disclose material information, or submission of false material information, coupled with an intent to deceive.” CFMT, Inc. v. YieldUp Int’l Corp., 349 F.3d 1333, 1340 (Fed. Cir. 2003) (quoting Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed. Cir. 1995)). Materiality and intent must be established by clear and convincing evidence. Id. Once materiality and intent have been established, the district court must weigh these factors in light of all of the circumstances to determine whether a finding that inequitable conduct occurred is warranted. Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1363 (Fed. Cir. 2003) (citing Purdue Pharma L.P. v. Boehringer Ingelheim GMBH, 237 F.3d 1359, 1366 (Fed. Cir. 2001)). We have stated that “when balanced against high materiality, the showing of intent can be proportionally less.” Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1234 (Fed. Cir. 2003) (citation omitted).”


• The district court properly found inequitable conduct in Novo’s use of an example from a 1983 PCT application for establishing priority when in fact that example technique had never been successfully performed.


• The district court properly found that Novo had intended to deceive the patent office by not disclosing the fact that the example was prophetic and had never been performed. The inventors knew that the example had not been performed, and they should have told their attorney.


• The district court properly held that the information withheld from the examiner was material. Evidence of the inventor’s failure to perform the invention at the time of the filing of the application is relevant to non-enablement.