Plant Genetic Systems, N v. (Now Known as Aventis Cropscience n.v.), and Biogen, Inc. v. Dekalb Genetics Corporation

315 F.3d 1335
CourtCourt of Appeals for the Federal Circuit
DecidedFebruary 20, 2003
Docket02-1011
StatusPublished
Cited by49 cases

This text of 315 F.3d 1335 (Plant Genetic Systems, N v. (Now Known as Aventis Cropscience n.v.), and Biogen, Inc. v. Dekalb Genetics Corporation) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit 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. (Now Known as Aventis Cropscience n.v.), and Biogen, Inc. v. Dekalb Genetics Corporation, 315 F.3d 1335 (Fed. Cir. 2003).

Opinion

MICHEL, Circuit Judge.

Plant Genetic Systems, N.V. (“PGS”) appeals the September 7, 2001 decision of the United States District Court for, the District of Connecticut, Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 175 F.Supp.2d 246 (D.Conn.2001), entering judgment for the accused infringer, De-Kalb Genetics Corporation (“DeKalb”), on all counts of the complaint in this patent infringement suit. The case was tried to the bench for thirteen days.. At the end of the trial, the district court concluded that claims 1-5 and 10-11 of PGS’ patent, U.S. Pat. No. 5,561,236 (“the '236 patent”), were invalid for lack of enablement and that claims 8-9 and 12-15, the remaining asserted claims, were not infringed. Id. at 270. Because as to enablement, the defendant established a need for undue experimentation and as to non-infringement, that the properly construed claims did not cover the defendant’s products, we affirm.

BACKGROUND

This case involves only one patent, the '236 patent, which claims a priority date of March 11, 1987. The patent issued on October 1,1996 to inventors from PGS and Biogen Corporation and is directed to transgenic plant cells, plants, and seeds. DeKalb makes and sells transgenic corn seeds. PGS sued DeKalb for patent infringement the day the '236 patent issued.

The '236 patent and DeKalb’s transgenic corn products relate to the herbicide-resistant characteristics of a plant or plant cell. Non-selective herbicides may indiscriminately kill most plants by blocking an essential biochemical process of these plants — metabolizing ammonia via the action of glutamine synthetase. Thus, these herbicides are also called glutamine synthetase inhibitors. Two structurally-related compounds, bialaphos and glufosi-nate, are such herbicides. It has been desirable to obtain food plants that are resistant to non-selective herbicides. Herbicide-resistant plants can grow in the presence of the herbicide that kills other unwanted plants or weeds.

The '236 patent teaches a plant cell, or a plant or seed containing such a cell, that is genetically engineered so that the cell can produce a protein that prevents herbicides such as bialaphos or glufosinate from blocking the function of glutamine synthe-tase. The mechanism of the engineering is to incorporate into the genome of the plant cell a gene (today called either the bar gene or the pat gene) 1 the protein *1338 product of which can inactivate a gluta-mine synthetase inhibitor.

The claims in issue are claims 1-5 and 8-15. Claims 1-5 and 10-11 include the cell, tissue and culture claims and are referred to, post, as “the cell claims.” This group of claims all depends on claim 1, which reads:

A plant cell having a heterologous DNA stably integrated into its genome; said DNA comprising a heterologous DNA fragment encoding a protein having an acetyl transferase activity which inactivates a glutamine synthetase inhibitor in said cell.

Claims 8-9 and 12-15 are referred to by the parties and herein as the “plant and seed claims.” Claim 8 is representative of this group of claims and reads:

A plant which consists of the cells of claim 1 and which is susceptible to infection and transformation by Agrobacteri-um and capable of regeneration thereafter.

A key issue of this case is the scope of both sets of the claims, i.e., what kind of plants or plant cells are covered by the claims. Flowering plants can be broadly categorized as monocotyledons (“mono-cots”) and dicotyledons (“dicots”), depending on whether the initial development of the seed produces one leaf (monocot) or two leaves (dicot). In the '236 patent, all the working examples are dicots, for example, tomato, potato, and tobacco plants. However, the accused infringing product made and sold by DeKalb is corn — a mo-nocot. Additionally, the scientific community was not able to transform monocots until after it first transformed dicots. Thus, it is disputed whether the cell claims of the '236 patent, which are agreed by the parties literally to cover all plant cells, were enabled for monocots on March 11, 1987. It is also disputed whether the plant and seed claims are correctly interpreted to exclude monocots, therefore leaving De-Kalb’s corn products outside the scope of these claims.

The district court, at its thirteen-day bench trial, heard evidence on various transformation techniques and the chronology of scientific progress regarding mono-cot transformation. Plant Genetic Sys., 175 F.Supp.2d at 255-64. At the end, the court found that despite the teachings of the specification, practicing stable gene transformation for monocot cells in 1987 required undue experimentation and, thus, the cell claims of the '236 patent were proven invalid for lack of enablement. Id. at 265.

The district court also construed the limitation “susceptible to infection and transformation by Agrobacterium and capable of regeneration” that was added to the plant and seed claims during prosecution to overcome the Examiner’s rejection for non-enablement. The court held that a person skilled in the art at the time the parent application was filed would have understood the plant and seed claims to exclude monocots. Id. at 266-68. The court additionally considered trial testimony that no methodology existed as of the effective filing date of the '236 patent by which monocots could be infected and transformed by Agrobacterium to produce plants capable of regeneration. Id. at 268-69. The court viewed this testimony as further supporting • its claim construction. Thus, the court held that DeKalb’s transgenic corn products could not infringe the plant and seed claims because corn is indisputably a monocot. Id. at 269-70.

Both the invalidity and non-infringement holdings have been appealed.

*1339 DISCUSSION

Enablement is ultimately a question of law which this Court reviews de novo. Durel Corp. v. Osram Sylvania Inc., 256 F.3d 1298, 1307 (Fed.Cir.2001). However, the factual findings underlying the legal conclusion are reviewed for clear error. PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564 (Fed.Cir.1996). Claim constructions are reviewed de novo. Cybor Corp. v. FAS Techs., 138 F.3d 1448, 1454-55 (Fed.Cir.1998) (en banc).

I

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