Thursday, October 06, 2005

CAFC affirms inequitable conduct as to Nordisk's US 5,633,352

Nordisk's '352 patent discloses production of ripe human growth hormone protein by recombinant DNA techniques.

There was an issue of inherent anticipation and a question of presumed enablement of a non-patent reference. Further, there was mention of the different enablement standards for 102 and 112, citing to Rasmusson, 413 F.3d 1318. Yes, the CAFC cited SmithKline, 403 F.3d at 1344 ("The '196 patent suffices as an anticipatory reference if it discloses in enabling manner the production of PHC hemihydrate.") The CAFC did not address the presumed enablement argument because it found that the reference was enabled.

Of inequitable conduct, the CAFC cited Bruno v. Acorn, 394 F.3d 1348. The inequitable conduct was based on Novo Nordisk's failure to inform the PTO that Example 1 of a 1983 PCT application had not been performed. Example 1 was worded in the past tense, which indicates the work has been done. Novo argued FMC v. Manitowoc, 835 F2d 1411 ("impossible to disclose the unknown") Biotechnology in turn argued that "knowledge of the law is chargeable to the inventor" and "inventors represented by counsel are presumed to know the law," citing Brasseler, 267 F3d 1370. The CAFC agreed with Biotechnology and referred to Nordisk's argument as circular.

The inequitable conduct issue in Nordisk reminds one of the Purdue Faulding case (Purdue knew that it did not have ‘scientific proof’ of its ‘discovery,’ yet repeatedly asserted its ‘discovery’ to the [U.S. Patent Office] in precise, quantified, past-tense language.") and the earlier Hoffmann-La Roche, Inc. v. Promega Corp., 323 F3d 1354 (CAFC 2003) [because the patent specification described the results of an example formulation’s steps and results in the past tense, the description misrepresented the results as actually having been performed]

The Novo Nordisk case did not cite either the Purdue Faulding case or the Hoffmann-La Roche case. Nordisk argued that there was no evidence that the drafter of Example 1 (a scientist) subsequently learned "that the drafting of a prophetic example in the past tense was not a good procedure at the PTO." The Hoffmann case shows that the text "not a good procedure" is a bit of an understatement.

Curiously, one finds in footnote 12 that the scientist did not intentionally breach his duty of candor and good faith. The use of the past tense was merely an oversight. However, the teachings of the MPEP on the point of use of "past tense" are merely common sense. If one says that one "did" something, then the inference is that it was done, not merely contemplated. When Jan-Hendrik Schon of Bell Labs said he performed experiments, when he in fact did not, other scientists were upset.

By the findings in footnote 12, the door was opened for Novo Nordisk to make the argument that because the scientist did not know about the MPEP rules, there was no intent. The CAFC got around this by considering events AFTER example 1 was written and filed.

The CAFC reduced the Novo Nordisk argument to

--> the failure of the scientist to tell the attorneys about the prophetic nature of Example 1 was all right because without the attorney's consultation the scientist did not know the information was material

--> the attorney's failure to disclose the truth about Example 1 is excused because the scientist failed to tell the attorney

The reality of the situation is that the attorney had an obligation to determine that the experiments of any example placed in the past tense were actually done. Further, common sense would inform a scientist that placing something in the past tense means it was done, whether one is reporting the result in a patent or in a publication or in a lab notebook.


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