Plant Genetic Systems v. Dekalb Genetics Corp.

• Decision Date: 07 September 2001
• Docket Number: No. 3:96CV2015 (DJS).,3:96CV2015 (DJS).
• Citation: 175 F.Supp.2d 246
• Court: U.S. District Court — District of Connecticut
• Parties: PLANT GENETIC SYSTEMS, N.V. & BIOGEN, INC. v. DEKALB GENETICS CORP.

175 F.Supp.2d 246

PLANT GENETIC SYSTEMS, N.V. & BIOGEN, INC. v. DEKALB GENETICS CORP.

No. 3:96CV2015 (DJS).

United States District Court, D. Connecticut.

September 7, 2001.

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Eric D. Daniels, Craig A. Raabe, Bradford S. Babbitt, Robinson & Cole, Hartford, CT, John F. Sylvia, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C., Boston, MA, R. Danny Huntington, Eric H. Weisblatt, Regis E. Slutter, Barbara W. Walker, George A. Hovanec, Jr., Bruce Jeferson Boggs, Jr., H. Jonathan Redway, Burns, Doane, Swecker & Mathis, Alexandria, VA, for Plaintiffs.

John C. Yarvis, Jr., Francis J. Brady, Murtha Cullina LLP, Hartford, CT, Thomas A. Miller, Houston, TX, Susan M. Dadio, Burns, Doane, Swecker & Mathis, Alexandria, VA, John F. Lynch, Wachtell, Lipton, Rosen & Katz, New York City, H H. Kewalramani, Howrey Simon Arnold & White, LLP, Houston, TX, Daniel T. Shvodian, Howrey Simon Arnold & White, LLP, Menlo Park, CA, James A. Wade, Craig A. Raabe, Bradford S. Babbitt, Robinson & Cole, Hartford, CT, Randall S. Rapp, Andrew L. Reisman, Foley & Lardner, Chicago, IL, for Defendant.

MEMORANDUM OF DECISION

SQUATRITO, District Judge.

In this action, the plaintiffs claim, inter alia, that the defendant's products infringe certain claims of United States Patent No. 5,561,236 (hereinafter `the '236 patent'). After a thirteen day bench trial before the undersigned, the Court now articulates its findings of fact and conclusions of law. For the reasons that follow, the Court concludes that (1) Claims 1-5 and 10-11 (the cell claims) of the '236 patent are invalid for lack of enablement and that (2) the exclusivity of Claims 8-9 and 12-15 (the plant and seed claims) is limited to dicotyledonous plants and does not extend to monocotyledons such as the accused corn products. Accordingly, judgment is entered for the defendant on all counts.

I. Introduction

This case concerns the right to make, use, sell or offer for sale certain types of genetically engineered plants and seeds — specifically corn. The defendant sells a variety of genetically engineered corn products. The central issues at trial were whether the defendant's sale of certain corn seeds or its research activities involving corn seeds and plants infringed the claims of the '236 patent.

A. Scientific Background

Since Neolithic man first began to cultivate crops, humans have had both economic and social incentives to create and enhance the properties of food plants.¹ "The largest single step in the ascent of man is the change from [a] nomad[ic] lifestyle to village agriculture." Jacob Bronowski, The Ascent of Man 64 (1973). A civilization that could secure a reliable source of food was best equipped to become both a political and military power in its geographic region.

Scientists postulate that the shift of human societies from a nomadic existence toward more centralized, agrarian cultures was catalyzed by a natural act of genetic engineering. Wild wheat, a grassy plant of little agricultural value, naturally crossed with goat grass to produce, for the first time, a fertile wheat hybrid with a full head of grain that could be easily harvested. Id. at 65-67.² The case at bar involves genetic engineering of a decidedly more deliberate nature.

As man developed his agricultural skills, he began to use crude herbicides to enhance his efforts. The earliest farmers used sea salt, a strategy still employed by modern organic gardeners. Late in the 19th century, the selective control of broad leaf weeds became possible. A major development in modern weed control was the introduction in 1945 of the so-called `organic' herbicides. These compounds were revolutionary because their high toxicity allowed for effective weed control at very low dosages. Id. Since modern herbicides were first employed, scientists have worked to increase their selectivity. The ideal herbicide kills only the undesirable plant, and has no adverse effects on either the desirable plants or the consumers of those plants.

There are conceptually at least two approaches to developing a useful herbicide. First, a herbicide could be developed that selectively kills only certain types of undesirable plants. In this model, the selectivity feature would be incorporated into the chemical structure of the herbicide. Alternatively, the selectivity feature could be incorporated into the plant itself so that it would be resistant to a non-selective herbicide. In this model, the herbicide would kill a broad spectrum of plant life except for certain genetically modified plants. This case involves the latter approach.

Plants create ammonia as a by-product of their biochemical processes. While the production of ammonia is a natural phenomenon, it presents the plant with a problem. High levels of ammonia are inevitably toxic to plants. Plants remove the ammonia they produce via the action of an enzyme, glutamine synthetase. Glutamine synthetase, as its name plainly suggests, synthesizes glutamine by metabolizing the ammonia and another substance, glutamate. Unlike ammonia, glutamine is not toxic to plants.

In the early 1980's, researchers discovered that the biochemical action of glutamine synthetase could be inhibited — that is the plant could be prevented from converting ammonia to glutamine — by either bialaphos³ or glufosinate,⁴ two structurally related compounds isolated from certain species of Streptomyces bacteria. In the presence of either of these compounds, toxic levels of ammonia build up in the plant and it eventually dies. In light of the effect that these substances have on all plants, several different herbicides were developed.⁵ These herbicides are non-selective and indiscriminately kill most plants with which they come into contact.

With the use of any non-selective herbicide, a commercial advantage can be obtained if a desirable food plant could be developed that would be resistant to the effect of the non-selective herbicide. The non-selective herbicide could then be indiscriminately applied to a field of crops. This would result in the destruction of all non-resistant plants, which in theory would only be the unmodified, non-food plants. Thus, after application of the non-selective herbicide, the only plants that would remain viable would be the desirable food plants. The plaintiffs in this case claim such an invention.

It was discovered that a certain species of bacteria from the Streptomyces genus possess a gene (called either the bar or pat gene) that encodes for the production of a protein that inactivates the herbicidal substance, such as bialaphos, from inhibiting the action of glutamine synthetase.⁶ This is the biochemical equivalent of a linguistic double negative. The bar gene produces a substance that prevents the active ingredient in the non-selective herbicide from itself inhibiting the plant's ability to metabolize ammonia. The plaintiffs claim that they could genetically modify desirable food plants so that these plants would now contain a foreign gene that would render the transformed plant impervious to the effects of certain glufosinate-based herbicides. Thus, the modified plants would now be able to fend off the biochemical attack of the non-selective herbicide and would survive while their less genetically robust compatriots (i.e., the non-desirable weeds) would perish.⁷

The key issue at trial was a dispute concerning the scope of the patent claims. The defendant does not contest that the plaintiffs possess patent rights with respect to the modification of certain types of plants and plant cells. For example, modified tomato, potato and tobacco plants are undisputedly covered by the '236 patent. The defendant contends, however, that the plaintiffs' patent rights extend only to this general category of plants.

Flowering plants are phenotypically broken down into two broad categories: monocotyledons and dicotyledons, commonly called monocots and dicots. The distinction is based on whether the cotyledon, or the initial growth produced by the seed, contains one leaf (monocot) or two leaves (dicot). The seedlings of other plants, such as pine trees and many gymnosperms, can produce more than two leaves and are called polycotyledons or polycots. As is discussed in greater detail below, the working examples in the '236 patent are all dicots, while the accused product in this case is corn___ undisputedly a monocot.

In addition to endowing transformed plants with resistance to certain herbicides, the bar gene is also widely used as a selectable marker. A selectable marker is a gene that allows researchers to determine whether other genes have also been incorporated into a plant. Thus researchers who have identified a gene that confers another desirable trant to plants, for example the ability to resist certain species of harmful insects, will link that new gene to the bar gene, and then attempt to incorporate this entire gene construct into the target plant. They can determine whether their efforts have been successful by testing for the presence of the selectable marker. If the bar gene is used as the selectable marker, simply spraying the plants with glufosinate will kill those plants that do not possess the selectable marker. Those plants that survive are likely to contain both the bar gene and the target gene of interest which in this example is a gene for insect resistance.

B. The '236 Patent

In general, the owners of the '236 patent claim the legal ability to exclude others from making, using, selling or offering for sale modified plants, seeds and plant cells containing the bar gene. The defendant sells various corn products and conducts research in which the corn plant cells contain the bar gene, in some cases serving in the capacity as a selectable marker. Specifically, the plaintiffs allege that the defendant's products infringe claims 1-5, 8-9, and 10-15 of the '236 patent. This group of claims break down into two...