UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEBRASKA
Plaintiff,
v.
BASF CORPORATION,
Defendant,
and
MONSANTO COMPANY,
Intervening Plaintiff,
and
SYNGENTA CROP PROTECTION, INC.,
Intervening Defendant. / Case No. 4:04 CV 3356 RGK/DLP
intervening defendant syngenta crop protection INC.’s trial brief
INTRODUCTION
While the underlying technology in this case is complicated, the basic issue is not: A deal is a deal. Sandoz Agro, Inc. (“Sandoz”), now Syngenta, and the University of Nebraska-Lincoln (“UNL”) made a deal that they would work together to develop the technology at issue in this case. Sandoz lived up to its obligations. The University did not. Instead, encouraged by profit motive, it disavowed it obligations to Sandoz and, instead, the University twice auctioned the fruits of the parties’ joint labor off to the highest bidder—first UAP and then later Monsanto. As a result, the University has enjoyed a windfall while Sandoz was denied the benefits of its bargain.
Syngenta intervened in this action to protect its non-exclusive license rights under the contract between Sandoz Agro, Inc. and UNL (the “Contract”), and its ownership rights to the dicamba-resistance technology under the Contract and under the patent laws. Under the patent law, Syngenta is entitled to joint ownership of the patents at issue if its employees substantially contributed to the development of those patents. These rights are independent of any contractual obligation, but as a joint inventor, Syngenta is entitled to sole ownership of those patents under the terms of the Contract. By contrast, the Contract provides broader ownership rights for inventions jointly made by Sandoz and UNL, even if they do not rise to the level of “joint inventorship” under the patent law. Under either theory or both theories, Syngenta is the owner.the result is the same. Syngenta requests that the Court require UNL to abide by the terms of the Contract and the patent laws, and provide Syngenta with the fruits of the Contract.
ARGUMENT
- UNDER THE UNDISPUTED TERMS OF THE SANDOZ/UNL CONTRACT, SANDOZ IS THE OWNER OF THE TECHNOLOGY DEVELOPED UNDER THE CONTRACT
That UNL made a deal with Sandoz is uncontroverted. Nor is there a dispute as to the basic terms of that deal. UNL entered into a contract under which Sandoz funded Dr. Weeks’ lab in exchange for a non-exclusive license to the technology as well as ownership of that technology under two scenarios: (1) If Sandoz and UNL were joint inventors on any patents arising out of their work, then Sandoz would own those patents; and (2) if Sandoz and UNL scientists jointly made inventions (not limited to patents) through their collaboration then Sandoz would own those inventions.
The evidence will show that by the time the Contract expired in March 1997, UNL and Sandoz had made significant progress toward the goal of producing dicamba-resistant plants. In fact, some of Sandoz’s progress and contributions to this goal, as discussed in greater detail below, are reflected in what became the claims in the Weeks patents held by UNL. By late 1996, Sandoz divested its U.S. and Canadian dicamba business by selling specified assets to BASF under an Asset Purchase Agreement.[1] At the same time, however, Sandoz retained robust post-expiration rights under the Contract, including the ownership rights it acquired as a joint inventor, as a joint developer, and as a non-exclusive licensee to the technology.
When UNL learned that Sandoz did not intend to renew its funding, it began to shop around its technology. In 1997, it opened the bidding to UAP and BASF, taking the highest bid from UAP.[2] At approximately the same time, UNL began to seek patent protection for the technology it had developed with Sandoz. Weeks immediately recognized that, under the terms of the Contract, UNL had a duty to provide Sandoz with copies of the materials relevant to its patent applications. The undisputed evidence will show that Dr. Weeks acknowledged, in an internal memorandum sent to Vice Chancellor Don Hellmuth, that the University was obligated to provide Sandoz a complete written disclosure of its invention. Yet, no disclosure was ever made to Sandoz or BASF. UNL, apparently seduced by the prospect of huge profits flowing to the University, decided to say nothing.
The evidence will show that neither before nor after the divestitutre did Sandoz know that UNL was applying for patents on work that had been performed by Sandoz and only Sandoz. Had Sandoz known what was in these applications, it could have addressed that issue at the time in front of the Patent Office under a preponderance of the evidence standard, rather than before the Court under a clear and convincing standard. Aware of that fact, the clear conclusion is that UNL remained silent because it did not want to risk losing its unjustified windfall.
Yet, at the same time UNL seeks to avoid its contractual obligations, it contends that it is entitled to continue making use of DI-6 bacterium, which Sandoz had permitted UNL to use during the term of the Contract. The use of DI-6 is covered by a Sandoz patent. UNL and Monsanto cannot have it both ways. They cannot disavow the Contract while simultaneously seeking shelter in its provisions.
- SANDOZ AND DR. WEEKS/UNL COLLABORATED EXTENSIVELY OVER THE YEARS TO JOINTLY DEVELOP AND INVENT THE SUBJECT MATTER OF THE CLAIMS OF THE ‘896 PATENT
But that is precisely what Plaintiffs Monsanto and UNL are attempting to do in this case. Plaintiffs want to renege on the deal by taking the litigation-induced position that all of Sandoz’s contributions to the development of the dicamba-resistance technology should be ignored either because: (1) they predate the Contract between the parties and were not, therefore, made pursuant to the Contract; (2) they came after conception of the claimed inventions; (3) to the extent they came before conception, because they were “routine” or publicly known; or (4) that Sandoz scientists are not joint inventors because they did not complete conception. These post hoc rationalizations focus on hypertechnical—and incorrect—legal assertions to justify UNL’s behavior, but the real proof comes from what Dr. Weeks, UNL, Sandoz and the Patent Office did and said long before this lawsuit came to fruition.
The evidence will show: that Dr. Weeks and UNL relied heavily on Sandoz’s prior work with DI-6; that there was extensive collaboration and communication between UNL and Sandoz during the term of the Contract and its extensions; and that Sandoz was the first to achieve the results required by many of the claims of the ‘896 Patent.
- Sandoz Conducted the Foundational Work on Dicamba Resistance During the 1980s While Dr. Weeks Was at Sandoz
A party may rebut the presumption that the named inventors are the true and only inventors by providing clear and convincing evidence that it should be a named inventor. Checkpoint Systems, Inc. v. All-Tag Sec. S.A., 412 F.3d 1331, 1338 (Fed. Cir. 2005). “Conception is the touchstone for determining inventorship,” Fina Oil, 123 F.3d at 1473, which requires a definite and permanent idea of how to solve a particular problem. Burroughs Wellcome, 40 F.3d at 1228. A joint invention is “simply the product of a collaboration between two or more persons working together to solve the problem addressed.” Fina Oil, 123 F.3d at 1473. The contribution to that collaboration can be experimental, Id., and can be to as little as a single limitation of a single claim. Eli Lilly and Co. v. Aradigm Corp., 376 F.3d 1352, 1361-62 (Fed. Cir. 2004); Stern v. Trustee of Columbia University, 434 F.3d 1375, 1378 (Fed. Cir. 2006). Collaboration need not be extensive but requires a minimal quantum of awareness of each other’s work. Kimberly-Clark Corp. v. Proctor & Gamble Distrib., 973 F.2d 911, 917 (Fed. Cir. 1992).
In the mid-1980s, Sandoz scientists Krueger, Butz and Atallah discovered and characterized a strain of bacteria known as DI-6, which has the ability to metabolize the broad-leaf herbicide dicamba. Dr. Weeks, the lead named inventor of the ‘896 Patent, became involved in the DI-6 project at Sandoz. Sandoz’s initial work on DI-6, including work by Dr. Weeks as an employee of Sandoz, continued for several years. During this time, the Sandoz team made the critical breakthroughs suggesting the feasibility that the DI-6 bacteria could be used to transform higher plants to impart dicamba resistance. The Sandoz team proceeded to map out a strategy for how it would isolate the genes responsible for degrading dicamba and transform plants to make them resistant to the herbicide.
Funding for the dicamba project at Sandoz dried up in the late eighties, and Dr. Weeks left Sandoz to join the faculty at UNL in late 1989. The evidence will show that when he left, Dr. Weeks took many of the confidential, internal research reports related to Sandoz’s work on dicamba-resistance, including the documents outlining the strategy for imparting dicamba-resistance in plants. The evidence will show that Dr. Weeks used those materials to continue work on the dicamba project at UNL.
The work of Sandoz during the 1980s significantly contributed to the subject matter of the claims that later issued in the ‘896 Patent. Plaintiffs argue that Sandoz’s contributions during the 1980s should not count for purposes of determining whether Sandoz is a joint inventor or developer of the ‘896 Patent[3] because those contributions pre-date the Sandoz-UNL Contract. This argument is flawed for at least two reasons. First, statutory joint inventorship rights exist independent of any contractual rights. 35 U.S.C. § 116. Nothing in the statute requires that two or more persons are joint inventors only if their inventive contributions were made pursuant to a contract. Indeed, contributions that differ in kind, scope or time can all be sufficient to qualify as contributions to joint inventorship. Monsanto Co. v. Kamp, 269 F.Supp. 818, 824 (D. D.C. 1967). Second, nothing in the contract limits the possibility that each of the parties would bring pre-existing information that would facilitate further inventions made during the term of the agreement. Indeed, it was Sandoz’s pre-existing knowledge relating to dicamba that Dr. Weeks sought when he asked to partner with them.
Plaintiffs further argue that Sandoz’s work in the 1980s should not count because it later became public. This is both factually and legally incorrect. Sandoz’s contributions were not limited to the information that was publicly disclosed, but included the knowledge and experience necessary to achieve the objective of developing dicamba-resistant plants. If all of Sandoz’s knowledge had been in the public domain, UNL would not have needed the substantial technical assistance that Sandoz provided. Furthermore, it is legally wrong. A co-inventor’s contribution is not negated by public disclosure of that information. Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998).
- Dr. Weeks Sought and Obtained Funding and Research Assistance from Sandoz
- Sandoz Substantially Contributed to the Conception of the DI-6 Oxygenase DNA Sequence
In addition to the monetary support, Sandoz provided specific, technical contributions to the conception of claims 1, 2 and 5 of the ‘896 Patent both during the 1980s (as described above) and also under the Contract. For instance, the evidence will show that prior to conception, Sandoz contributed to the isolation and sequencing of the oxygenase gene by advising UNL on protein purification. In addition, Patricia Herman, who was the individual in Dr. Weeks’ lab responsible for identifying the oxygenase sequence, did not have a definite and permanent idea—that is, conception—of the final gene sequence until April 30, 1996. Prior to that time, Sandoz provided assistance to Dr. Herman by identifying errors in the nucleotide sequence for the oxygenase gene. In particular, Sandoz performed restriction digests in preparation for building expression constructs for the oxygenase gene. It then performed in vitro experiments to establish that the cloned gene fragment not only produced a protein, but a protein of the anticipated length. This work encouraged UNL to continue further sequencing the gene fragment and to ultimately obtain the full sequence.
Plaintiffs argue that Sandoz is not a joint inventor of the ‘896 Patent because no one from Sandoz was present when the final, complete gene sequence was isolated. Plaintiffs’ argument is legally flawed. Plaintiffs mistakenly read the law which states that conception of a DNA sequence is not complete until it has been fully isolated and identified with the notion that the only contribution of import is the moment that the final sequence is isolated. This is wrong. Just because a contribution occurs prior to the moment of conception does not mean that an inventor loses his status as a joint inventor. Rhone-Poulenc Agro v. Monsanto Co., 445 F. Supp.2d 531, 547 (M.D.N.C. 2006); Fina Oil & Chem. v. Ewen, 123 F.3d 1466, 1474 (Fed. Cir. 1997). Sandoz’s work in providing a road map of how to isolate the gene sequence through protein purification and in assisting with the identification of the DI-6 oxygenase gene sequence were substantial contributions that should not be negated merely because Sandoz inventors were not present when Dr. Herman obtained the final oxygenase sequence.
- Sandoz Substantially Contributed to the Conception of the Claims Pertaining to the Expression of Oxygenase in Transgenic Host Cells and Plants
Sandoz also made significant contributions to the remaining claims of the ‘896 Patent. Claims 3, 4, 6 and 7 of the ‘896 Patent claim priority to the provisional application filed by UNL. They are directed to the detection of oxygenase expression in host cells. Prior to the filing of the provisional application of the ‘896 Patent, on April 4, 1997, UNL had not detected expression of the oxygenase gene in host cells. The evidence will show that after it filed the ‘896 Patent application, UNL was unable to detect the expression of oxygenase in host cells even though Sandoz had succeeded in achieving the results required by claims 3, 4, 6 and 7 and communicated the results of its work to UNL a year before UNL filed its patent applications. Without any acknowledgement of Sandoz’s contribution, UNL claimed credit for this work in the Patent Office.
The same is true of the claims directed to plants. As of the filing of the provisional application, UNL had not: (1) transformed a single plant with the oxygenase gene as required by claims 9 and 10; (2) prepared constructs to express the oxygenase gene in plants as required by claims 8, 11 and 12; or (3) selected for plant cells by either using a medium containing dicamba as required in claim 13. The evidence will show that Sandoz had either accomplished or removed major obstacles to accomplishment of these milestones prior to the time UNL filed its patent applications in April 1997.
Plaintiffs do not dispute that Sandoz achieved these milestones prior to the time that it filed the ‘896 provisional application. Rather, Plaintiffs contend that Sandoz’s myriad contributions, which were explicitly claimed as inventions by UNL in the ‘896 Patent, should not count because the only real “inventive” activity was obtaining the sequence for the oxygenase gene. To wit, Plaintiffs contend that conception was complete once UNL had the DNA sequence and that all of the contributions made by Sandoz after the sequence was identified were “routine” and therefore not worthy of joint inventorship.
The evidence will also show that the patent examiner who was involved in the prosecution of the ‘896 Patent was reluctant to allow the claims of the patent because the field of genetic engineering is unpredictable and, therefore, conception requires the results required by the claims. Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206 (Fed. Cir. 1991). Indeed, Dr. Herman admitted that, short of actually inserting a bacterial gene into a plant, there can be no definite and firm idea of how to achieve the results required by the claims.
In order to overcome the patent examiner’s concerns, the evidence will show that UNL was required to provide proof of the same kind of work that Sandoz had completed—but had not been disclosed to the Patent Office—prior to filing. UNL knew that the claimed results could be achieved precisely because Sandoz had already demonstrated such success.
Although Plaintiffs now claim that the DNA sequence—by itself—was sufficient to enable a person of ordinary skill in the art to reduce to practice the remaining claimed inventions, and hence evidence conception, the contemporaneous facts belie that assertion. Proof of conception requires “a definite and permanent reflection of the complete idea as it will be used in practice.” Burroughs Wellcome Co. v. Bar Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994); Invitrogen v. Clontech Labs., Inc., 429 F.3d 1052, 1064 n.8 (Fed. Cir. 2005).
The facts will show that even after Sandoz had achieved success in obtaining expression of oxygenase in transgenic host cells before UNL filed, UNL was unable to obtain expression of the oxygenase gene when they prepared their own expression construct after the filing of the ‘896 Patent application. It is disingenuous for Plaintiffs to now argue that the contributions provided by Sandoz were “routine” when Dr. Weeks and UNL could not reduce those claims to practice without significant experimentation. (“A conception is not complete if the subsequent course of experimentation, especially experimental failures, reveals uncertainty that so undermines the specificity of the inventor’s idea that it is not yet a definite and permanent reflection of the complete idea as it will be used in practice.” Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1064 (Fed. Cir. 2005) (quoting Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1229 (Fed. Cir. 1994).