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Late Submission of Article Renders Patent Unenforceable

April 15, 2003

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Last Month at the Federal Circuit - May 2003

Judges: Prost (author), Clevenger, and Schall

In Bristol-Meyers Squibb Co. v. Rhone-Poulenc Rorer, Inc., No. 02-1280 (Fed. Cir. Apr. 15, 2003), the Federal Circuit affirmed a district court’s decision holding U.S. Patent Re. 34,277 (“the ‘277 patent”) unenforceable for inequitable conduct.

The ‘277 patent and its parent, U.S. Patent No. 4,924,011 (“the ‘011 patent”), concern a semisynthesis of taxol, a cancer chemotherapeutic agent, and are owned by Rhone-Poulenc Rorer, Inc. and its affiliated companies (collectively “RPR”). On November 3, 1987, the inventors submitted what became an article published in the Journal of the American Chemical Society (“the JACS article”) to a patent agent employed by RPR in France. Among other things, the article stated that the synthesis of taxol could be successfully achieved only with specific protective groups and under unique reaction conditions. The agent prepared a corresponding French patent application and filed it on April 6, 1988. But, the French patent application did not specify which protective groups could be used in the synthesis. The patent agent later sent a copy of the French application to a colleague in the United States for the preparation of a U.S. application; however, he did not send the JACS article. During the prosecution of the U.S. application, the Examiner requested a computer search, which found the JACS article; however, the Examiner did not initial next to the article on the search report. On May 8, 1990, the ’011 patent issued.

On November 1, 1991, RPR filed the ’277 reissue patent application without discussing the JACS article. In July 1992, the patent agent in France sent a copy of the JACS article to the patent attorney prosecuting the reissue application with the comment that it, and several other references, were irrelevant. Finally, on December 15, 1992, the U.S. attorney filed an Information Disclosure Statement with the PTO disclosing the JACS article. The ‘277 patent issued on June 8, 1993.

The district court — relying on a SM — ruled that the JACS article was material to the examination. In particular, the district court found that a reasonable patent examiner reviewing the patent application would have expected the use of the protecting groups to yield significant amounts of taxol, but that a review of the JACS article would have raised doubts that the use of protecting groups would produce taxol in more than trace amounts. And, after a four-day hearing on the issue of intent, the district court held that RPR had committed inequitable conduct in processing the ‘277 patent. In upholding the district court’s finding of materiality, the Federal Circuit ruled that the district court had not erred in concluding that the statements in the JACS article would have raised the question of enablement in the mind of a reasonable examiner. The Court rejected RPR’s argument that the Examiner must have determined that the JACS article was immaterial because he likely considered the article during the ’011 patent prosecution and still allowed the patent. Although the Examiner did not initial the search report containing the JACS article, RPR argued that this was his regular practice and did not indicate the article had not been reviewed. The Federal Circuit concluded, however, that the Examiner likely had not considered the JACS article because he did not initial the search report. Had the Examiner been performing his duties regularly, the Court reasoned, he would have initialed and dated the search report as instructed in the MPEP.

The Federal Circuit also rejected RPR’s argument that the JACS article was not material because the Examiner considered the JACS article during the ’277 reissue prosecution, but did not reject any claims using it. The Court found this probative, but not persuasive, because a reference is not necessarily immaterial simply because the claims were eventually deemed by an examiner to be patentable thereover.

Concerning the issue of intent, the Federal Circuit held that because the patent agent in France was intimately familiar with the JACS article — he approved the article for publication — and the article was in his possession while he was drafting the French patent application, the determination that he knew of the significance of the article, in combination with the finding that he knew of the duty to disclose, was sufficient to establish intent.

Accordingly, the Federal Circuit held that the district court did not abuse its discretion in finding the ’277 patent unenforceable because RPR had obtained the ’011 and ’277 patents by inequitable conduct.