The judicial censure of a patent's reference to prophetic results in a manner suggesting they were, in fact, experimental (Purdue Pharma (2005); Hoffmann-LaRoche (2003)) continues as a basis of inequitable conduct. Applicants are advised to be circumspect about the use of past-tense language used to describe prophetic examples.
In Novo Nordisk v. Bio-Technology General, No. 04-1581 (Fed. Cir. Oct. 5, 2005), the federal circuit affirmed the invalidity of Novo's `352 patent under §102(a) and the determination that the patent was unenforceable due to inequitable conduct.
Novo's '352 patent claims priority to a 1983 PCT application (based on a 1982 Danish application) and is directed to a process for producing "ripe" human growth hormone ("hGH") protein in E.Coli bacteria through the use of recombinant DNA techniques. Claim 2 recites (1) biosynthetic ripe human growth hormone produced by expressing an amino terminal extended hGH fusion protein in a microorganism, (2) enzymatically cleaving the amino terminal extension, and (3) recovering the biosynthetically produced ripe hGH. The district court found claims 1 and 2 anticipated by a 1981 article describing a method of producing hGH protein with monkey kidney cells using two different hGH genes, hGH1 and hGH2. The court also held the article was presumed to be enabled. The court's inequitable conduct finding was based on evidence showing that a prophetic example contained in the 1982 priority application written in the past tense did not produce biosynthetic hGH as claimed.
On appeal, the federal circuit rejected Novo's argument that the 1981 article did not disclose the second and third limitations of claim 2 and that the reference was nonenabling for the claimed invention. The article's conclusion that the hGH1 protein "appears identical in all respects to the major form of pituitary form of hGH" combined with the tests reported therein strongly demonstrated that the hGH1 protein disclosed had the same structure and chemical properties as pituitary-derived hGH, (i.e., the hGH1 protein contained the same 191 amino acid sequence and biological activity as pituitary-derived hGH) and thus disclosed a ripe hGH protein as claimed. The court also affirmed the finding that the 1981 reference was sufficiently enabling for the claims of the `352 patent.
The federal circuit also affirmed the finding of inequitable conduct based on evidence showing that Example 1 of the 1983 priority application, written in the past tense, was never successfully used to produce hGH. The example described the use of the LAP enzyme to cleave the bacterial portion from the pre-hGH fusion protein, resulting in "ripe" hGH. The federal circuit rejected Novo's argument that it successfully used the LAP enzyme to produce hGH after the application was filed. The evidence showed that the LAP enzyme used was contaminated with DAP 1 enzyme, an enzyme which would later be successfully used in producing hGH:
We are not prepared to accept the proposition that simply because fate interceded and Novo scientists unintentionally used LAP "contaminated" with DAP I, Novo produced ripe hGH according to the methodology of Example 1.
According to the court, Novo knew or should have known that the examiner during prosecution (and later, the Board in an interference) would have considered the prophetic nature of the data in Example 1 important in evaluating whether the claimed invention was enabled, particularly where Novo never successfully produced ripe hGH using the methodology described in Example 1.
Please visit http://media.aplf.org/rm/20051017-public/Issue2005-54.pdf for a copy of the case for your reference.
To discuss these topics further, please feel free to contact the author Michael R. Dzwonczyk, (firstname.lastname@example.org), at Sughrue Mion, PLLC in Washington DC, USA.
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