IP News

Federal Circuit Rules That Novo Nordisk Misled USPTO

In Novo Nordisk Pharms, Inc. v. Bio-Technology General Corp., No. 04-1581, 2005 WL 2443857 (Fed. Cir. Oct. 5, 2005), the U.S. Court of Appeals for the Federal Circuit affirmed the lower court's decision that U.S. Patent 5,633,352 (“the '352 patent”) is unenforceable due to inequitable conduct. The Federal Circuit also affirmed the district court's decision that claim 1 of the '352 patent was invalid due to anticipation and vacated the judgment of invalidity with respect to claim 2.

The '352 patent covers a process for producing human growth hormone (“hGH”) protein in E. Coli bacteria using the enzyme DAP I through recombinant DNA techniques. The '352 patent issued from U.S. Application 402,286 (“the '286 application”), filed on March 10, 1995, which claimed priority to a 1983 PCT application, which in turn claimed priority to a Danish application filed on Dec. 10, 1982. The 1983 PCT application discloses the use of an enzyme, known as LAP, to produce hGH from a pre-hGH fusion protein. On Nov. 12, 1982, Novo Nordisk (“Novo”) filed U.S. Application 07/959,856 (“the '856 application”), which was the first in a series of applications that claimed priority to an application filed on Dec. 10, 1982.

On July 7, 2000, the Board of Patent Appeals and Interferences of the U.S. Patent and Trademark Office (the “Board”) declared an interference involving Novo's '352 patent and Bio-Technology General Corp.'s (“BTG”) U.S. Application No. 09/023,248, which involves a process for producing biosynthetic hGH protein via recombinant DNA techniques. Eventually, BTG appealed the decision of the Board to the district court in Delaware. The court reversed the decision of the Board that awarded priority to Novo and ruled that the 1983 PCT application was not enabled.

In 2002, Novo sued BTG and Teva Pharmaceuticals USA, Inc. for infringement of the '352 patent. After a bench trial, the district court found that claim 1 of the '352 patent was anticipated by a December 1981 article and that the '352 patent was unenforceable because of inequitable conduct during both the prosecution of the '856 application and the interference proceeding.

The district court based its inequitable conduct decision on the fact that the applicant had used the past tense to describe the production of hGH in Example 1 of the 1983 PCT application, when, in fact, the inventors had not successfully prepared hGH with the LAP enzyme when the application was filed. The district court further found that Novo did not successfully synthesize hGH until it discovered the DAP I enzyme, which led to the filing of a 1986 PCT application. During prosecution of the U.S. counterpart to the 1986 PCT application (“the '230 application”), in response to an obviousness rejection, Novo argued that references that disclose LAP are distinguishable because LAP has been proven not to be effective in producing hGH. After it could not overcome the obviousness rejection, Novo eventually abandoned the '230 application. On Nov. 12, 1992, Novo filed the '856 application disclosing a process for producing hGH using the DAP I enzyme. In a preliminary amendment, Novo amended the specification to indicate that the application was entitled to a priority date of Dec. 10, 1982, based on the 1983 PCT application claiming priority back to the 1982 Danish patent application. This was done to precede the 1983 priority date of an invalidating reference. A central issue was whether the 1983 PCT application was enabling. Novo pointed to Example 1 as being “specifically directed to hGH.” The examiner accepted this amendment and Novo was allowed to claim priority to Dec. 10, 1982.

The district court found that Novo had failed to disclose to the examiner that the steps described in Example 1 had not been performed. Further, the district court found materiality because the examiner relied upon Example 1 in deciding whether the 1983 PCT application was enabling. The district court determined that the intent requirement was satisfied because “Novo … knew or should have known that the examiner would have considered the fact that Example 1 contained prophetic data important in evaluating whether the [U.S. counterpart to the 1983 PCT application] enabled the '856 application.”

On appeal, the Federal Circuit agreed with the district court's findings and rejected Novo's arguments that the district court had committed errors with regard to its conclusions on inequitable conduct.

Federal Circuit Rules That Novo Nordisk Misled USPTO

In Novo Nordisk Pharms, Inc. v. Bio-Technology General Corp., No. 04-1581, 2005 WL 2443857 (Fed. Cir. Oct. 5, 2005), the U.S. Court of Appeals for the Federal Circuit affirmed the lower court's decision that U.S. Patent 5,633,352 (“the '352 patent”) is unenforceable due to inequitable conduct. The Federal Circuit also affirmed the district court's decision that claim 1 of the '352 patent was invalid due to anticipation and vacated the judgment of invalidity with respect to claim 2.

The '352 patent covers a process for producing human growth hormone (“hGH”) protein in E. Coli bacteria using the enzyme DAP I through recombinant DNA techniques. The '352 patent issued from U.S. Application 402,286 (“the '286 application”), filed on March 10, 1995, which claimed priority to a 1983 PCT application, which in turn claimed priority to a Danish application filed on Dec. 10, 1982. The 1983 PCT application discloses the use of an enzyme, known as LAP, to produce hGH from a pre-hGH fusion protein. On Nov. 12, 1982, Novo Nordisk (“Novo”) filed U.S. Application 07/959,856 (“the '856 application”), which was the first in a series of applications that claimed priority to an application filed on Dec. 10, 1982.

On July 7, 2000, the Board of Patent Appeals and Interferences of the U.S. Patent and Trademark Office (the “Board”) declared an interference involving Novo's '352 patent and Bio-Technology General Corp.'s (“BTG”) U.S. Application No. 09/023,248, which involves a process for producing biosynthetic hGH protein via recombinant DNA techniques. Eventually, BTG appealed the decision of the Board to the district court in Delaware. The court reversed the decision of the Board that awarded priority to Novo and ruled that the 1983 PCT application was not enabled.

In 2002, Novo sued BTG and Teva Pharmaceuticals USA, Inc. for infringement of the '352 patent. After a bench trial, the district court found that claim 1 of the '352 patent was anticipated by a December 1981 article and that the '352 patent was unenforceable because of inequitable conduct during both the prosecution of the '856 application and the interference proceeding.

The district court based its inequitable conduct decision on the fact that the applicant had used the past tense to describe the production of hGH in Example 1 of the 1983 PCT application, when, in fact, the inventors had not successfully prepared hGH with the LAP enzyme when the application was filed. The district court further found that Novo did not successfully synthesize hGH until it discovered the DAP I enzyme, which led to the filing of a 1986 PCT application. During prosecution of the U.S. counterpart to the 1986 PCT application (“the '230 application”), in response to an obviousness rejection, Novo argued that references that disclose LAP are distinguishable because LAP has been proven not to be effective in producing hGH. After it could not overcome the obviousness rejection, Novo eventually abandoned the '230 application. On Nov. 12, 1992, Novo filed the '856 application disclosing a process for producing hGH using the DAP I enzyme. In a preliminary amendment, Novo amended the specification to indicate that the application was entitled to a priority date of Dec. 10, 1982, based on the 1983 PCT application claiming priority back to the 1982 Danish patent application. This was done to precede the 1983 priority date of an invalidating reference. A central issue was whether the 1983 PCT application was enabling. Novo pointed to Example 1 as being “specifically directed to hGH.” The examiner accepted this amendment and Novo was allowed to claim priority to Dec. 10, 1982.

The district court found that Novo had failed to disclose to the examiner that the steps described in Example 1 had not been performed. Further, the district court found materiality because the examiner relied upon Example 1 in deciding whether the 1983 PCT application was enabling. The district court determined that the intent requirement was satisfied because “Novo … knew or should have known that the examiner would have considered the fact that Example 1 contained prophetic data important in evaluating whether the [U.S. counterpart to the 1983 PCT application] enabled the '856 application.”

On appeal, the Federal Circuit agreed with the district court's findings and rejected Novo's arguments that the district court had committed errors with regard to its conclusions on inequitable conduct.