After two weeks, another panel of the Federal Circuit revisited the issue of inequitable conduct in the context of another case. The Ferring B.V. et al. v. Barr Laboratories case involved a patent directed to the compound desmopressin and methods for administering the same.
The issue of inequitable conduct in the Ferring case involved several declarations that were submitted by Ferring during the prosecution of the patent. On summary judgment, the trial court held that the patent was unenforceable due to the inequitable conduct of the patent applicants during the prosecution of the application. The Federal Circuit affirmed in a 2-1 decision the finding of inequitable conduct, and a rehearing in this case was denied.
During the prosecution of the patent at issue, the Patent Office had repeatedly rejected the application as unpatentable over the prior art. Finally, in response to the examiners earlier suggestion that applicants submit “evidence from a noninventor“ to support Ferrings assertion that the prior art did not teach the oral administration of desmopressin, Ferring submitted five declarations.
After seven years of prosecution, the examiner proceeded to allow the application on the basis of these declarations. One declarant was Ferrings former preclinical research director, a paid Ferring consultant both before and after his employment with Ferring, who received Ferring funding for his own lab.
The second declarant also served as a Ferring consultant and received Ferring funding for his own desmopressin research. The district court found that these facts satisfied both the materiality and intent elements of inequitable conduct inquiry.
The Federal Circuit court affirmed the trial courts finding that the declarations were highly material and that the declarants previous relationships were significant. Because the declarations and the omissions therein were highly material, less proof was required of the intent corresponding to the omissions. Accordingly, the court deemed the patent unenforceable, and subsequently, a rehearing in this case was denied.
On April 10, 2006, another panel of the Federal Circuit addressed the issue of inequitable conduct in the Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc. case, involving patents related to low molecular weight herapin, which is used to prevent blood clots (Lovenox).
The trial court found on summary judgment that the patent was unenforceable due to the failure of the patent applicants to disclose certain material information during the prosecution of the application. The Federal Circuit reversed the trial courts determination and remanded the case to the trial court for further proceedings with respect to Aventis intent to deceive.
During the prosecution of the patents at issue in the Aventis case, the examiner asserted a European patent as destroying the patentability of the invention. To overcome the rejection as to that European patent, Aventis made a comparison of the product, allegedly covered by its application, at one dose to the prior art product at a different dose, without identifying the fact that the products were being compared at different doses.
Although the applicants did not expressly represent that the comparison was being made at the same dose, the applicants did repeatedly compare the data as if they were. The appeals court found the omission was material and that it was insufficient to submit underlying data without dosage information and to later argue that the examiner could have requested that.
With respect to Aventis intent to deceive, the district court found it irrelevant whether a comparison at different doses was reasonable and held that the facts supported a strong inference of intent to deceive. The appeals court held that although the district courts inference was reasonable, it was not the only reasonable inference.
Another inference would be that if the comparison between different doses was reasonable, then the failure to disclose the doses may have been an inadvertent omission. Accordingly, the court remanded the case to the district court for further proceedings with respect to determining whether there was an intent to deceive the Patent Office and thereafter for the balancing necessary to reach a conclusion that the patent should be unenforceable, based on the equities.
The Federal Circuit has rendered several opinions recently regarding the issue of inequitable conduct and patent validity, highlighting the need to fully disclose the nature of any relationship between the patent owner and a declarant arguing for patentability on its behalf, as well as whether any alleged surprising discoveries are based on actual and appropriately compared data or merely speculation.
For this reason, it is essential to take a very broad approach with respect to disclosure of information to the Patent Office.