Bayer Cropscience Ag v. Dow Agrosciences LLC

728 F.3d 1324, 108 U.S.P.Q. 2d (BNA) 1071, 2013 WL 4712725, 2013 U.S. App. LEXIS 18215
Court of Appeals for the Federal Circuit·Decided September 3, 2013·No. 20-1107·Published·Cited by 6 cases

Opinion

TARANTO, Circuit Judge.

When the inventors applied for the patent at issue, they had sequenced one gene coding for one enzyme, using a test purportedly capable of finding other, similar genes. In writing its claims, the owner— now Bayer CropScience AG—decided to claim a broad category based on the function of the particular enzyme, defining the category by using a term with an established scientific meaning. In doing so, Bayer got ahead of the science: experiments had not confirmed that the term even applied to the particular enzyme whose gene Bayer’s inventors had sequenced. Soon science showed that it did *1325 not, and Bayer knew as much years before its patent issued—but did not change its claim language. When it ultimately sued Dow AgroSciences for infringement, Bayer recognized that the term used, in its established scientific meaning, did not cover the accused product (itself different from the particular enzyme whose gene Bayer’s inventors had sequenced), so it argued for a broad functional claim construction.

Applying our decisions about the potentially unwelcome consequences of a paten-tee’s chosen claim language, the district court rejected Bayer’s argument, explaining particularly the great breadth of the asserted functional construction, and entered summary judgment of non-infringement. We too are unpersuaded by Bayer’s proposed claim construction. Because Bayer has presented no argument for reversing the non-infringement judgment independent of our adopting that construction, we affirm.

Background

A

The patent at issue concerns genetically modifying plants in order to confer resistance to a commonly used herbicide called 2.4-dichlorophenoxyacetic acid, or “2,4-D” for short. The process works by inserting a particular DNA segment—a segment containing the sequence of nucleotides identified as the gene coding for a particular enzyme—into plant cells, which then reproduce to create new cells that contain that gene. The plant cells produce the enzyme that then catalyzes a biochemical reaction with the 2,4-D herbicide in which the herbicide is broken down into something harmless to the plant. A plant with the gene can thereby survive application of the herbicide while surrounding weeds do not.

Bayer owns U.S. Patent No. 6,153,401, entitled “Microorganisms and Plasmids for 2.4-Dichlorophenoxyacetic Acid (2,4-D) Monooxygenase Formation and Process for the Production of These Plasmids and Strains.” The application that eventually led to this patent was filed in the late 1980s. By that time, scientists had discovered that certain bacteria found in soil could grow on 2,4-D. To do so, those bacteria first convert 2,4-D into a substance called 2,4-dichlorophenol, or “2,4-DCP,” which the bacteria, far from finding toxic, use as a “source[ ] of carbon and energy.” '401 patent, col. 3, lines 22-24; see id., col. 30, lines 34-36. Scientists hoped that, if they identified genes in such bacteria that coded for enzymes that catalyze 2,4-D-to-2.4-DCP reactions, they could then transfer the “ability to inactivate 2,4-D” to plants. Id., col. 2, lines 27-30.

The inventors of the '401 patent were the first “to isolate, to clone, and to characterize” a gene that had that property, a gene from the soil bacterium strain Alcali-genes eutrophus JMP134. Id., col. 1, lines 41-61. The patent sets forth the nucleotide sequence in Figure 10. It is the only gene identified in the '401 patent.

The specification explains the “growth test” used to isolate the identified gene. First, the inventors created a mutant strain of the bacterium that lacked the ability to grow on 2,4-D or convert it into 2.4-DCP. Id., col. 22, line 56, through col. 25, line 42. Next, they fragmented the DNA of a non-mutant strain, which could still break down 2,4-D. Id., col. 24, line 18, through col. 25, line 42. They then inserted the fragments into cells of the mutant strain, with (roughly speaking) no two fragments in the same cell, and placed the cells on 2,4-D. When they identified cells that grew, they concluded that the DNA fragment that had restored the ability to grow on 2,4-D contained a gene producing an enzyme that caused the conversion of 2.4-D into 2,4-DCP. Id., col. 25, lines 38-42. They used known sequencing tech- *1326 ñiques to identify the nucleotide sequence of the successful fragment. Id., col. 27, line 37, through col. 29, line 4. 1

Although this work led the inventors to the Figure 10 gene sequence, they did not fully understand the enzymatic reaction that they were studying. In particular, the reaction requires the presence of the oxygen molecule, 02, but the inventors did not know where one of the two oxygen atoms wound up. There was no doubt about the first: it combines with 2,4-D to create an unstable, hydroxylated 2,4-D, which then spontaneously splits apart into 2,4-DCP and a compound called glyoxy-late. The patent describes this process as “bringing about the cleavage of the side chain of 2,4-D.” Id., col. 2, lines 25-27. As for the second oxygen atom, however, the inventors at best simply shared the scientific community’s unverified belief that this atom was incorporated into water. As was established beyond dispute in the district court in this case, enzymes catalyzing a reaction in which one oxygen atom ends up in water and the second is incorporated into a product other than water are called monooxygenases, and the '401 patent uses the term “monooxygenase” throughout the specification to characterize the enzyme whose gene it sequenced. And Bayer used the term “monooxygenase” in its claims— both alone and as part of “2,4-D-monoox-ygenase”—in the 1989 continuation-in-part application that eventually issued as the '401 patent. U.S. Patent Application No. 07/322,604, pp. 66-70 (filed Mar. 10, 1989).

Bayer’s reliance on an unverified belief about its enzyme soon proved wrong. In 1993, when Bayer’s application was still pending, scientists determined that it was incorrect to refer to Bayer’s enzyme as a monooxygenase because the second oxygen atom does not actually end up in water. It was, instead, a dioxygenase, because both oxygen atoms are incorporated into products other than water. See Fumiyasu Fukumori & Robert P. Hausinger, Alealigenes eutrophus JMPl34 “2,4-Di-chlorophenoxyacetate Monooxygenase” Is an a Ketoglutarate-Dependent Dioxyge-nase, 175 J. Bacteriology 2083 (1993). Yet, despite the announcement of this discovery in the very title of the article, and Bayer’s knowledge of the article, Bayer did not alter the claims of its application— which did not mature into a patent until seven years after the 1993 discovery. Accordingly, the '401 patent issued in 2000 with independent claim 1 reciting an artificially constructed gene as follows:

A recombinant gene, comprising a DNA sequence encoding a polypeptide having the biological activity of 2,4-D monooxygenase which is capable of being expressed in a plant, operably linked to
a heterologous promoter capable of promoting the expression in a plant of a structural gene operably linked thereto.

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Bayer Cropscience Ag v. Dow Agrosciences LLC, 728 F.3d 1324, 108 U.S.P.Q. 2d (BNA) 1071, 2013 WL 4712725, 2013 U.S. App. LEXIS 18215 (Fed. Cir. 2013).

728 F.3d 1324 (Bayer Cropscience Ag v. Dow Agrosciences LLC) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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