Plant Genetic Systems, N v. & Biogen, Inc. v. DeKalb Genetics Corp.

175 F. Supp. 2d 246, 2001 U.S. Dist. LEXIS 21254, 2001 WL 1598346
CourtDistrict Court, D. Connecticut
DecidedSeptember 7, 2001
Docket3:96CV2015 (DJS)
StatusPublished
Cited by6 cases

This text of 175 F. Supp. 2d 246 (Plant Genetic Systems, N v. & Biogen, Inc. v. DeKalb Genetics Corp.) is published on Counsel Stack Legal Research, covering District Court, D. Connecticut primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Plant Genetic Systems, N v. & Biogen, Inc. v. DeKalb Genetics Corp., 175 F. Supp. 2d 246, 2001 U.S. Dist. LEXIS 21254, 2001 WL 1598346 (D. Conn. 2001).

Opinion

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 *251 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 gluta-mine synthetase could be inhibited— that is the plant could be prevented from converting ammonia to glutamine— by either bialaphos 3 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 *252 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.

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175 F. Supp. 2d 246, 2001 U.S. Dist. LEXIS 21254, 2001 WL 1598346, Counsel Stack Legal Research, https://law.counselstack.com/opinion/plant-genetic-systems-n-v-biogen-inc-v-dekalb-genetics-corp-ctd-2001.