Bayer Cropscience AG v. Dow Agrosciences LLC

Docket No. 2013-1002

September 3, 2013

Brief summary: Bayer’s functional language was held to limit claims.

Summary: Bayer appealed DC finding of no infringement of its US Patent No. 6,153,401 relating to herbicide-resistant plants. The herbicide of interest is “2,4-D” which was found to be converted to “2,4-DCP” and glyoxylate by a bacterial enzyme characterized by Bayer as a monooxygenase. The monooxygenase gene was cloned and used to provide resistance to plants. The reaction required O2 and one of the oxygen atoms combined with 2,4-D to destabilize it; the fate of the other oxygen atom was not known at the time of the invention. During prosecution of the ‘401 patent, it became clear to the scientific community (and Bayer) that the cloned enzyme was not in fact a monooxygenase but was a dioxygenase. At that time, the pending claims referred to “2,4-D monooxygenase” and this was not changed. The ‘401 patent claims “[a] recombinant gene, comprising a DNA sequence having the biological activity of 2,4-D monooxygenase….” (independent claim 1) and “the structural gene sequence of FIG. 10…” (dependent claim 4). Dow produces 2,4-D-resistant genetically modified seeds using two AryloxyAlkanoate Dioxygenase (“AAD”) genes that convert 2,4-D to 2,4-DCP. Bayer argued that its claim 1 “covers any enzyme that triggers cleaving of the side chain of 2,4-D to produce 2,4-DCP, even if it is a dioxygenase….” After a Markman hearing, the DC “concluded that the ‘plain and ordinary meaning’ requires that ‘2,4-D monooxygenase’ be read to embody the established scientific meaning of ‘monooxygenase’…where one molecule of oxygen is added to 2,4-D and the other ultimately forms water” instead of Bayer’s proposed “‘broad functional-based’ construction”. The DC therefore concluded that Dow did not infringe (also noting that Bayer’s proposed construction would not satisfy the written description requirement). The FC panel agreed with the DC, finding that “the biological activity of” and “monooxygenase” act in claim 1 “as an integrated unit in a way that fits its structure and the ordinary meaning of its words” (citing Abbott, FC 2003) (“Bayer chose the language based on a unverified belief…learned that the belief was false…[and] had seven years before its patent issued to alter the language, but never did.”) The opinion explained that the specification did not define “the biological activity” to mean “that every enzyme with [the claimed] function is a ‘2,4-D monooxygenase” (noting “[t]he use of ‘e.g.,’ rather than ‘i.e.,’, [in the statement “coding for a protein which has the biological activity of the protein encoded by tfda, e.g., its 2,4-D-monoxygenase activity”] strongly suggests that there is more than one ‘biological activity'”). The FC panel also explained that Bayer’s construction also “goes far beyond the Figure 10 enzyme, beyond monooxygenases…to capture the broad functionally defined genus of enzymes that cause cleaving of the 2,4-D side chain” which “would call into serious doubt the claim’s validity under 35 U.S.C. § 112(a)” (“[t]he enzymatic function…would be broad, yet the patent provides the DNA sequence (and hence amino-acid sequence) of just one embodiment”; citing Novozymes A/S, FC 2013, Ariad, FC 2010 and other cases). The opinion also noted that “it is hardly unknown for a patentee with an invention that could be protected to fail in securing such protection by bad choices in claim drafting” (citing Chef Am., FC 2004 and Elekta Instrument, FC 2000). Thus, the DC decision was affirmed.

This entry was posted in Claim Construction, Functional limitations, Written description. Bookmark the permalink.

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