Board of Educ. v. American Bioscience
| Decision Date | 23 June 2003 |
| Docket Number | No. 02-1109.,02-1109. |
| Citation | 333 F.3d 1330 |
| Parties | The BOARD OF EDUCATION (for and on behalf of the BOARD OF TRUSTEES OF FLORIDA STATE UNIVERSITY), MDS Research Foundation, Inc., and Taxolog, Inc., Plaintiffs-Appellees, v. AMERICAN BIOSCIENCE, INC. (formerly known as Vivorx Pharmaceuticals, Inc.), Defendant-Appellant, and Chunlin Tao, Defendant. |
| Court | U.S. Court of Appeals — Federal Circuit |
Jeffrey T. Thomas, Gibson, Dunn & Crutcher LLP, of Irvine, CA, argued for plaintiffs-appellees. With him on the brief was Mark J. Carlozzi. Of counsel on the brief was Sidney L. Matthew, Gorman & Matthew, P.A., of Tallahassee, Florida.
Martin B. Sipple, Ausley & McMullen, P.A., of Tallahassee, FL, argued for defendant-appellant. With him on the brief was Robert N. Clarke, Jr. Of counsel on the brief were Joseph F. Coyne, Jr. and Phillip A. Davis, Sheppard, Mullin, Richter & Hampton, LLP, of Los Angeles, California.
Before LOURIE, RADER, and LINN, Circuit Judges.
American BioScience, Inc. ("ABI") appeals from the decision of the United States District Court for the Northern District of Florida in an inventorship action brought by the Board of Education (for and on behalf of the Board of Trustees of Florida State University), MDS Research, Inc., and Taxolog, Inc. (collectively, "FSU"). That decision removed three inventors from U.S. Patent 5,780,653, retained one inventor, added three other inventors, and declared the patent unenforceable for inequitable conduct. Bd. of Educ. ex rel. Bd. of Trs. of Fla. State Univ. v. Am. Bioscience, Inc., No. 4:99cv131/RV, 2001 U.S. Dist. LEXIS 19480, 2001 WL 34104924 (N.D.Fla. Oct. 31, 2001). Because the district court erred in its determination of inventorship and inequitable conduct, we affirm-in-part, reverse-in-part, and vacate-in-part.
Taxol (paclitaxel)1 is a natural compound found in the bark of the Pacific yew tree (Taxus brevifolia). Over the last several decades, taxol has received considerable attention in the scientific and medical communities as an anti-cancer drug. Bd. of Educ., 2001 U.S. Dist. LEXIS 19480, at *4. In the early 1990s, scientists discovered that taxol is not only an effective chemotherapeutic agent, but that it also enhances the effectiveness of radiation therapy for killing cancer cells, especially oxygen-starved ("hypoxic") cancer cells that are ordinarily resistant to radiation. A 1992 paper published by researchers at Columbia University disclosed the dual activities of taxol as a simultaneously cytotoxic and radiosensitizing agent. See Roy B. Tishler et al., Taxol: A Novel Radiation Sensor, 22 Int'l J. Radiation Oncology.Biology.Physics 613-17 (1992). The structural formula of taxol is shown below.
NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE
The '653 patent, filed in the names of Chunlin Tao, Neil Desai, Patrick Soon-Shiong, and Paul Sandford, and assigned to Vivorx Pharmaceuticals, Inc., claims three compounds. Those compounds are analogs of taxotere (docetaxel),2 a compound that differs from taxol in two respects. First, taxotere has a 10-hydroxy (-OH) group in place of taxol's 10-acetoxy (-OCOCH3, also abbreviated as "-OAc") group. Second, taxotere has a tert-butoxycarbonyl (-COOC(CH3)3, abbreviated as "-COO-tBu") group attached to its 3' nitrogen atom, in place of taxol's benzoyl (-COC6H5) group. The structural formula of taxotere is shown below.
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The following history sets forth the events that led to the filing of the '653 patent application.
At the time these events began to unfold, Professor Robert Holton had been conducting a research group at FSU working with taxols. Chunlin Tao, a chemist, joined that group as a post-doctoral research assistant in July 1992. Bd. of Educ., 2001 U.S. Dist. LEXIS 19480, at *7. Dr. Tao worked on two projects in the Holton group. First, he was part of a team of researchers who in December 1993 completed the total synthesis of taxol. Id. He was also part of a team that made taxol analogs using a "semi-synthetic" process beginning with baccatin III, a natural product found in the needles of a European yew variety (Taxus baccata). As shown below, baccatin III has a hydroxy group in place of taxol's side chain, but is otherwise identical to taxol.
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The semi-synthetic process requires relatively few steps, and it appears that that process was at that time the standard method for making taxol and its analogs.3
While he was at FSU, Tao apparently also developed a close relationship with a visiting faculty member, Dr. Li-Xi Yang. Id. at *18-19. Dr. Yang is a radiation biologist who arrived at FSU in March 1993 as a "courtesy professor." Id. at *12. Yang had in the past developed several compounds having increased radiosensitivity for anti-cancer applications, and his research focused on increasing the radiosensitivity of hypoxic cells. Id. at *13. Several months after arriving at FSU Yang visited Holton and proposed a collaborative project to develop "chemotherapeutic radiosensitizing taxanes" ("CRTs"). Id. Holton agreed, and he assigned one of his post-doctoral research assistants, Dr. Hossein Nadizadeh, the responsibility of synthesizing taxol analogs that Holton and Yang believed would prove to be effective CRTs. Holton and Yang focused particularly on the attachment of "nitro electron affinic groups," which were known to be radiosensitizing, in an attempt to increase taxol's radiosensitivity. Id. at *14-15. Even before Yang's arrival, however, members of the Holton group had already synthesized a number of nitro-taxols, and some of those were also given to Yang for testing. The structural formula of one such pre-synthesized compound, referred to as "PNIP," is shown below.
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One should note that PNIP has the 10-acetoxy group of the taxols. PNIP showed potential in Yang's earliest tests in January 1994, and Yang testified that he had told Tao at around that time that PNIP was the most effective radiosensitizer among the compounds that he tested. Id. at *19.
There is no evidence that Tao ever synthesized PNIP himself. However, the method for making PNIP was apparently the subject of numerous discussions within the Holton group during Tao's tenure at FSU because, prior to Tao's joining the Holton group in 1992, Dr. Nadizadeh had developed a "secret" method for making a beta-lactam compound used to attach a side chain to baccatin III to make PNIP. Id. at *10-11. Nadizadeh's method differed from a published prior art method of making beta-lactams in two respects: in the ordering of its four steps, and in the use of acid hydrolysis rather than base hydrolysis in one of those steps. Id. at *11.4
In 1992, Dr. Patrick Soon-Shiong, a transplant surgeon, was the CEO of VivoRx Pharmaceuticals, Inc., as ABI was then known, and of VivoRx, Inc. ("VivoRx"), a related company focused on diabetes research. Id. at *21-22. In 1994, Dr. Soon-Shiong became the CEO of ABI. Id. at *22 n. 13. Dr. Neil Desai is an organic chemist, and was VivoRx's Senior Research Scientist in 1992. That year, Drs. Soon-Shiong and Desai filed a patent application directed to a method of encapsulating taxol analogs for direct delivery to tumors. They subsequently attended the "Second NCI Workshop on Taxol and Taxus," a conference at which they heard presentations regarding the effectiveness of taxol analogs, the use of taxol as a radiosensitizer, the use of nitro groups to enhance radiosensitization, and the use of the taxol side chain's 3'-position as a point for attachment of functional groups to the taxol structure. Among the speakers at the conference was Holton, who spoke about the synthesis of taxol. Soon-Shiong has said that he "was probably present" during Holton's presentation. Id. at *23 n. 14. After the conference, apparently based on what they had learned there and from the existing scientific literature regarding taxol and radiosensitization, Soon-Shiong and Desai discussed the possibility of creating radiosensitizers that they believed would be more potent than taxol by using taxotere instead of taxol as a core structure. Id. at *23.
In 1994, Soon-Shiong directed Desai to begin creating analogs of taxotere. Shortly thereafter, Desai attended a conference in India, where he learned of a source of 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. Id. at *26 n. 18.
At around the same time, Tao was finishing his post-doctoral research at FSU, and Soon-Shiong and Desai interviewed him for a job at VivoRx. During his interview, Tao presented details of his taxol analog research. Id. at *25. Looking to expand their work in cancer research, and apparently realizing that Tao could help them to finally pursue the ideas that they had discussed after the 1992 conference, Soon-Shiong and Desai hired Tao to work on the taxotere project. Id.
Upon Tao's arrival at VivoRx in December 1994, Desai discussed the published literature on radiosensitizers with Tao, and assigned to him the task of creating chemotherapeutic radiosensitizing taxotere analogs with modified side chains, using the 10-DAB supplied by his Indian contact. Id. at *27. Desai was responsible for making the final decisions as to which compounds to pursue. Id. After Tao had made several compounds, Desai and Soon-Shiong forwarded information concerning those compounds to ABI's patent attorney, Dr. Stephen Reiter. Id. at *31-32.
Reiter then filed a patent application naming Tao, Desai, Soon-Shiong, and Dr. Paul Sandford as inventors. He initially filed thirteen claims, including six to a method of making a compound, six to compounds, and one to a...
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