'Prophetic example' renders patent unenforceable

The Court of Appeals for the Federal Circuit recently affirmed a finding of inequitable conduct against Novo Nordisk Pharmaceuticals regarding its patent for production of human growth hormone (hGH). This finding renders the patent unenforceable.The patent at issue in Novo Nordisk Pharmaceuticals, Inc. v. Bio-Technology General Corp. Novo claimed priority back to a 1982 Danish application. However, this application stated that hGH was produced using the enzyme leucine aminopeptidase (LAP); in the patent that eventually issued, hGH was produced using dipeptidyl aninopeptidase I (DAP I). As it turns out, Novo had never actually produced hGH using the LAP enzyme, but in its 1982 application the company merely predicted that it could be used to produce hGH. In fact, during the time the application was pending at the patent office, Novo was never able to successfully use the process described in the 1982 application to produce hGH. While often predicting the results of a particular biological process or chemical reaction is acceptable in a patent application, in this case, Novo described the use of LAP to produce hGH in the past tense, indicating that the process had already been successfully used. Even though Novo had been unable to actually use the LAP process, they pointed to that example as one of the reasons they could claim priority to the 1982 application's filing date. In addition, during an interference at the patent office, Novo did not inform the Board of Patent Appeals and Interferences that it was unable to produce hGH using LAP, even though it did present expert testimony regarding the process.This case is another reminder of the duty of candor that inventors, patent prosecutors, and anyone substantively involved with the invention or prosecution of the patent have before the patent office. Not only does the duty of candor involve a duty to disclose all material prior art of which those involved are aware, but also includes informing the patent office of anything else that is material to the examination of the application. It is best to err on the side of disclosure, particularly given the drastic consequences that can result upon a finding of inequitable conduct, as shown by this case.For the complete decision, log on to: http://fedcir.gov/opinions/04-1581.pdf


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