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FEDERAL CIRCUIT HOLDS PATENT UNENFORCEABLE FOR NONDISCLOSURE OF ARTICLE RAISING QUESTIONS ABOUT ENABLEMENT
Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc.
Decided, Federal Court of Appeals for the Federal Circuit, April 15, 2003

The Federal Circuit ruled that a patent for synthesizing the cancer treatment taxol was unenforceable due to the failure of the inventors to disclose to the U.S. Patent and Trademark Office (“PTO”) an article authored by the inventors that raised doubt about two elements claimed in the patent.

The article in question was published in the "Journal of the American Chemical Society" (“JACS Article”) approximately four months following the filing of the original patent application. While neither the inventors nor their patent attorneys disclosed the JACS Article to the PTO, the JACS Article was listed on a search report ordered by the Patent Examiner. However, the Examiner never initialed and dated the JACS Article on the search report, and the Court found that no objective evidence existed proving that the Examiner reviewed the JACS Article during prosecution.

The original patent was the subject of a reissue prosecution, during which the attorney for the inventors listed the JACS Article on the Information Disclosure Statement submitted to the PTO. Although the Patent Examiner considered the JACS Article and allowed the reissue patent, the Court specifically refused to hold that the JACS Article was not material.

This Court affirmed the finding of the District Court that the inventor intentionally withheld the JACS Article from the PTO with the intention of misleading the Examiner. The Court based its finding of intent on the determination that the inventor knew of the significance of the JACS Article while also knowing of the duty to disclose.

The Court noted that even assuming the inventors believed that the disputed claims in the patent were enabled when the patent was filed, the JACS Article itself, which was authored by the inventors, did not state such a belief. The Court held that the inventors’ beliefs regarding whether the claims were enabled was not relevant; rather, the inventors’ intentions regarding failing to disclose the JACS Article to the PTO was relevant.

What impact might this opinion have on the patent process?

· The opinion reinforces the burden on inventors to be certain that publications that cast doubt about elements of a patent are properly disclosed to the PTO, even if the inventor did not believe that the doubt existed at the time of the filing of the patent.

· While writing articles, inventors should be aware of the possible impact that negative statements in publications could have on patent prosecution.

· Diligence is important during all phases of prosecution. When material information intentionally is not disclosed during the prosecution of a patent, the omission may not be corrected during a reissue prosecution.

©2003 Patricia A. Wenger