Monsanto Co. v. Bayer Bioscience N.V.

• Decision Date: 30 March 2004
• Docket Number: No. 03-1201.,03-1201.
• Citation: 363 F.3d 1235
• Parties: MONSANTO COMPANY, Plaintiff-Appellee, v. BAYER BIOSCIENCE N.V. (formerly known as Aventis CropScience N.V.), Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

363 F.3d 1235

MONSANTO COMPANY, Plaintiff-Appellee, v. BAYER BIOSCIENCE N.V. (formerly known as Aventis CropScience N.V.), Defendant-Appellant.

No. 03-1201.

United States Court of Appeals, Federal Circuit.

DECIDED: March 30, 2004.

Rehearing and Rehearing En Banc May 6, 2004.

John F. Lynch, Howrey Simon Arnold & White, LLP, of Houston, TX, argued for plaintiff-appellee. With him on the brief were Susan K. Knoll, Richard L. Stanley, Steven G. Spears, and Connie Flores Jones. Of counsel on the brief was Joseph P. Conran, Husch & Eppenberger, of St. Louis, MO.

Eric H. Weisblatt, Burns, Doane, Swecker & Mathis, L.L.P., of Alexandria, VA, argued for defendant-appellant. With him on the brief were Susan M. Dadio, R. Danny Huntington, Ronni S. Jillions, Barbara Webb Walker, and Bruce T. Wieder.

Before NEWMAN, BRYSON, and PROST, Circuit Judges.

BRYSON, Circuit Judge.

Monsanto Company filed an action in the United States District Court for the Eastern District of Missouri, No. 4:00CV1915, seeking a declaratory judgment that its transgenic corn products did not infringe four patents owned by Aventis CropScience N.V., a predecessor of appellant Bayer BioScience N.V. The patents at issue claim a variety of methods and products relating to the insertion of bacterial DNA into plants to give the plants resistance to certain insects. Besides contending that it did not infringe any of the four patents, Monsanto alleged that the four patents were unenforceable and that various claims of the patents were invalid. Aventis counterclaimed, alleging that Monsanto infringed certain claims of each of the four patents.

I

The bacterium Bacillus thuringiensis ("Bt") produces a protein that is toxic to certain insects. Plant Genetic Systems, N.V., a predecessor of both Aventis and Bayer, developed a way to genetically engineer plants to produce a truncated version of that protein and obtained the four patents in suit relating to that invention. The first, U.S. Patent No. 5,545,565 ("the '565 patent"), is directed to chimeric genes having a DNA fragment encoding a truncated insecticidal protein. The second, U.S. Patent No. 5,767,372 ("the '372 patent"), is also directed to chimeric genes as well as plant cells and plants that produce the insecticidal protein. The third, U.S. Patent No. 6,107,546 ("the '546 patent"), is directed to methods of protecting plants by altering the plants' genetic codes so that they produce the insecticidal protein. The fourth, U.S. Patent No. 5,254,799 ("the '799 patent"), is directed to plants and cells that produce the insecticidal protein. All four patents are related, the first three being the product of divisional applications of the application that ultimately matured into the '799 patent.

As described in the largely overlapping specifications of the four patents, the invention took advantage of a known system for introducing foreign DNA into a plant cell's genome by using the bacterium Agrobacterium tumefaciens ("Agrobacterium"), which has the natural capacity to transform the genome of certain plants. The specification describes a process starting with plant cells that are susceptible to genetic transformation by Agrobacterium. The Agrobacterium is then transformed so that its genome contains a chimeric gene comprising a DNA fragment that encodes a truncated form of the Bt insecticidal protein. The transformed Agrobacterium is then used to modify the plant cell's genome so that the plant cell will express an insect-controlling amount of the Bt polypeptide toxin.

Monsanto sells genetically altered corn seeds that produce corn that expresses a Bt toxin at insecticidal levels. After Monsanto filed this action for declaratory relief and Aventis filed its counterclaim, Monsanto filed motions for summary judgment requesting that the four patents in suit be held unenforceable, invalid, and not infringed.

The district court granted Monsanto's summary judgment motions. With respect to the broadest motion, the court held all four of the patents unenforceable because of inequitable conduct during the prosecution of the parent application that led to the issuance of the four patents. In addition, the court held that the collateral estoppel effect of a prior decision on a similar patent required the court to hold that all of the asserted claims of the '546 patent and two of the asserted claims of the '372 patent were invalid, and that Monsanto did not infringe any of the asserted claims of the '799 patent. Finally, based on its construction of the claim term "Bt2," the court held that Monsanto was entitled to summary judgment of noninfringement as to all of the asserted claims of the '565 patent and one of the asserted claims of the '372 patent.

Bayer appeals from each of those three rulings. We hold that the district court improperly granted summary judgment on Monsanto's inequitable conduct claim, on its collateral estoppel claim, and on its noninfringement claim based on the construction of the claim term "Bt2." Accordingly, we reverse the summary judgment against Bayer and remand for further proceedings.

II

A

The district court granted summary judgment for Monsanto on the issue of inequitable conduct based on what the court concluded was a false declaration filed with the Patent and Trademark Office ("PTO") during the prosecution of the '799 patent. The court ruled that the false declaration rendered all four of the patents in suit unenforceable.

During prosecution, the examiner rejected certain claims as not being enabled. The examiner pointed out that the claims were directed to a truncated Bt gene for an insecticidal protein expressed in any plant, even though in the examiner's view the specification enabled the gene only in tobacco plants. To overcome that rejection, the applicants submitted a declaration by entomologist Stefan Jansens, an employee of Bayer's predecessor, Plant Genetic Systems, N.V., the assignee of each of the applications at issue in this case. In the declaration, Mr. Jansens attested that "any truncated Bacillus thuringiensis (`Bt') gene could be expressed in generally any plant to provide an insect controlling amount of its encoded Bt polypeptide toxin in the so-transformed plant as disclosed in this application...." Along with his declaration, Mr. Jansens presented the results of tests conducted under his supervision. In addition, he attested that he knew of "no test results which are contrary to or inconsistent with the test results [submitted to the PTO] or which would lead to different conclusions from those expressed" in the declaration.

In the district court proceedings, Monsanto sought summary judgment on its inequitable conduct claim, arguing that Mr. Jansens was aware of test results that were inconsistent with the statements in his declaration and that he intentionally withheld those test results from the PTO.

Bayer responded to Monsanto's summary judgment motion by submitting an affidavit from Mr. Jansens in which he explained why he did not submit the allegedly inconsistent test results to the PTO. Mr. Jansens attested that the unsubmitted test results were not inconsistent with his representations during prosecution, because the purportedly negative results in those tests were actually inconclusive for various reasons. With respect to several of the tests, he explained that the data provided an insufficient basis from which to draw any reasonable conclusion as to whether the invention worked in the types of plants being tested. Moreover, he asserted that in some of the tests that did not show lethal levels of toxin production, the results showed growth inhibition in the target insects, which was consistent with the representations in his declaration that the invention could be made to work in plants generally and that he was aware of no test results supporting the contrary conclusion.

Mr. Jansens analyzed each of the test results cited by Monsanto and explained why the results in each case were not contrary to his declaration. In the case of the experiments on cotton plants, he explained, the level of mortality and growth inhibition for insects on the control plants was too high to allow a reasonable interpretation of whether there was an insect-controlling amount of Bt protein produced in the plants transformed with a Bt gene. Nonetheless, he added, despite the high background level of mortality in the controls of many of the cotton tests, some of the tests on cotton plants transformed with a truncated Bt gene still showed insect growth inhibition, indicating the possible production of insect-controlling amounts of Bt toxin.

With respect to the tests on plants of the Brassica genus (including cabbage), Mr. Jansens asserted that only a limited number of tests were run on those plants and that most of the results from those tests were insufficient to draw any reasonable general conclusion as to the transformed plants' capacity to express the Bt toxin. Nonetheless, as in the case of the experiments on cotton plants, Mr. Jansens explained that data from several of the tests on Brassica plants showed insect growth inhibition.

Mr. Jansens further explained that only a limited number of tests were performed with potato and corn plants, and that the data from those tests did not provide a sufficient basis from which to draw any reasonable scientific conclusions. Once again, however, he noted that the tests on the transformed potato plants showed insect growth inhibition, indicating the possible production of insect-controlling amounts of Bt toxin. As to Monsanto's allegation that an experiment involving a single transformed tomato plant failed to show that truncated Bt genes conferred insect control in tomato plants, Mr. Jansens stated that other tomato plants transformed with the same truncated Bt gene were shown to be lethal to the same target insect.

More generally, Mr. Jansens explained that to obtain a plant transformed with a truncated Bt gene that...