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Court Settles Inventorship Dispute

June 23, 2003

Decision icon Decision

Last Month at the Federal Circuit - June/July 2003

Judges: Lourie (author), Rader, and Linn

In Board of Education v. American Bioscience, Inc., No. 02-1109 (Fed. Cir. June 23, 2003), the Federal Circuit affirmed the district court’s removal of an inventor from U.S. Patent No. 5,780,653 (“the ‘653 patent”) assigned to American BioScience, Inc. (“ABI”), reversed the district court’s removal of two inventors from the patent, and vacated the district court’s holding that the patent was unenforceable for inequitable conduct.

VivoRx Pharmaceuticals, Inc. (“VivoRx”), ABI’s predecessor company, filed the ‘653 patent application naming Patrick Soon-Shiong, Neil Desai, Chunlin Tao, and Paul Sandford as inventors. The patent covers three compounds used for anticancer applications, which are analogs of the compound taxotere (generically known as docetaxel).

Prior to joining VivoRx, Tao, a chemist, worked with Professor Robert Holton’s research group at Florida State University (“FSU”) as a postdoctoral research assistant. Tao, along with Professor Dr. Li-Xi Yang and another doctoral research assistant, Dr. Hossein Nadizadeh, was involved in a collaborative project to develop chemotherapeutic radiosensitizing taxanes (“CRTs”) from taxol (generically known as paclitaxel) analogs for anticancer applications. The taxol analogs were made using a semisynthetic process, beginning with a natural product known as baccatin III.

At approximately the same time, Dr. Soon-Shiong, the CEO of VivoRx, and Dr. Neil Desai, VivoRx’s senior research scientist, contemplated creating radiosensitizers that they believed would be more potent than taxol by using taxotere instead of taxol as a core structure.

After completing his postdoctoral research at FSU, Tao was hired by Soon- Shiong and Desai to work on the taxotere project at VivoRx in late 1994. Desai assigned to Tao the task of creating chemotherapeutic radiosensitizing taxotere analogs using 10-deacetylbaccatin (“10- DAB”), a compound similar to baccatin III, but having the 10-hydroxy group of taxotere rather than the 10-acetoxy group of baccatin III and taxol. After Tao had made several compounds, the results of his research were forwarded to a patent attorney, who then filed the ‘653 patent application.

FSU sued Tao in the U.S District Court for the Northern District of Florida in September 1998, seeking to add Holton, Yang, and Nadizadeh to the ‘653 patent as inventors and to remove Soon Shiong, Desai, and Sandford. FSU also sought a DJ that the patent was unenforceable due to inequitable conduct. Following a bench trial, the district court found, inter alia, that (1) Tao had used confidential information that he learned at FSU in synthesizing three compounds that are claimed in the ‘653 patent; (2) the ‘653 patent specification disclosed general concepts regarding attaching certain substituents to a taxane to impart radiosensitizing properties that were developed by Yang; and (3) because 10-DAB and baccatin III are essentially interchangeable starting materials, Nadizadeh and Holton obviously knew that 10-DAB could have been used to create one of FSU’s taxol analogs. The district court also concluded that Soon-Shiong, Desai, and Sandford did not contribute to the inventions claimed in the ‘653 patent and removed them as inventors. The district court also added Holton, Yang, and Nadizadeh to the patent as coinventors and concluded that Soon-Shiong and Desai had accordingly engaged in inequitable conduct by not disclosing Tao’s former employment at FSU.

On appeal, the Federal Circuit agreed with ABI and ruled that the district court had erred in concluding that Soon-Shiong and Desai were not coinventors, because there was no evidence of record that the idea of making taxol analogs having both a 10-hydroxy group (i.e., taxoteres) and a nitro functional group came from anyone other than Soon-Shiong and Desai.

As to the FSU scientists, the Federal Circuit reversed the district court’s decision and ruled that they were not inventors. The Court held that general knowledge regarding the anticipated biological properties of groups of complex chemical compounds is insufficient to confer inventorship status with respect to specifically claimed compounds. Invention requires conception, and here, the Court stated, there was no evidence that FSU’s inventors conceived any of the claimed compounds. The Court explained that having in mind specific portions of a claimed compound is not the same as conceiving the compound with all of its components.

Because the district court’s conclusion of inequitable conduct was based on its finding that Soon-Shiong and Desai had failed to disclose to their attorney that Tao formerly worked at FSU, but the Federal Circuit had determined that the FSU scientists were not inventors, the Court vacated the district court’s decision on inequitable conduct.