09/03/2013

Bayer v. Dow: Subsequent Scientific Discovery Limits Claim Scope


 
 
 By: Jesus Hernandez, Blog Editor/Contributor 
 
TitleBayer Cropscience AG v. Dow Agrosciences LLC, No. 2013-1002 (Fed. Cir. Sept. 3, 2013).
Issue“Bayer’s position from the outset has been that the phrase ["biological activity of 2,4-D monooxygenase "] covers any enzyme that triggers cleaving of the side chain of 2,4-D […], even if it is a dioxygenase [which is the later-discovered correct term for the enzyme] and even if it does not share other biological activities of the particular enzyme […].” Bayer Cropscience at *6 (text added).
Holding“Like the district court, we see two problems with [Bayer's] position: (A) familiar aspects of textual analysis [such as ordinary meaning and the intrinsic record] point strongly the other way [toward a narrow construction]; and (B) [interpreting per Beyer’s suggestion] would read independent claim 1 so broadly as to raise serious doubts about validity [for lack of written description].” Bayer Cropscience at *7-8 (text added).
 


Procedural History“In December 2010, Bayer brought suit accusing Dow’s seeds of infringing the ’401 patent. […] After holding a Markman hearing with witness testimony and receiving cross-motions for summary judgment, the district court entered judgment in Dow’s favor. […] Bayer appeals.” Bayer Cropscience at *6-7.
 
Legal Reasoning (Prost, Bryson, Taranto)
Background on "Monooxygenases" and "Diooxygenases" terms
Claim 1"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 […]" Bayer Cropscience at *5.
Initial Reliance on "Monooxygenases" in Spec“[E]nzymes 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-monooxygenase”—in the 1989 continuation-in-part application that eventually issued as the ’401 patent. […]” Bayer Cropscience at *5.
Discovering "Diooxygenases" is proper term after patent filing date“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. […] 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.” Bayer Cropscience at *5.
Claim Construction of "biological activity of 2,4-D monooxygenase"
Ordinary Meaning Controls“[A]ll agree that the word “monooxygenase” has long had a clear meaning—i.e., an enzyme catalyzing a reaction in which one oxygen atom is incorporated into water and the second is incorporated into something other than water. […] Putting “2,4-D” in front of “monooxygenase,” then, appears to be simply the standard way of conveying what the monooxygenase acts on, namely, 2,4-D. And “the biological activity of,” in turn, is naturally understood to refer to the activity that makes the identified enzyme a monooxygenase that acts on 2,4-D: the attachment of one oxygen atom to the 2,4-D molecule to trigger cleaving with the other atom of O2 going to water. Under this reading, the full phrase works as an integrated unit in a way that fits its structure and the ordinary meaning of its words.” Bayer Cropscience at *8-9.
Policy Considerations“Familiar claim-construction policies regarding public notice and patentee drafting duties make it appropriate to demand such clarity here: Bayer chose the language based on an unverified belief that it accurately described its enzyme, learned that the belief was false while its application was pending, had seven years before its patent issued to alter the language, but never did.” Bayer Cropscience at *9.
Intrinsic Record“Nothing in the intrinsic record affirmatively indicates that, if the phrase “2,4-D monooxygenase” is descriptive, the “mono” part is to be ignored. Perhaps Bayer should have recognized that its background assumption that “mono” was accurate was unverified, and initially used a different phrase. But given its reliance on that assumption, one would hardly expect the 1989 written description to contain a redefinition to override the “mono” meaning.” Bayer Cropscience at *9.
Ordinary Meaning cannot be Trumped by Brief Statements“The specification uses the phrase “biological activity” just twice. Bayer focuses heavily on the first appearance, which says: “The tfdA gene codes for 2,4-D monooxygenase, a polypeptide having the biological activity of bringing about the cleavage of the side chain of 2,4-D.” ’401 patent, col. 2, lines 25-27 (as corrected by certificate of correction). That language does not have the form of, or otherwise convey that it is, a definition of “the biological activity.” It describes something that a “2,4-D monooxygenase” does, but it does not say that every enzyme with that function is a “2,4-D monooxygenase.” [...]. More is needed for a term with an established scientific meaning to be redefined in the specification.” Bayer Cropscience at *11-12.
Raising Validity Issues During Claim Construction To Reinforce Interpretations
Standard“[I]t is both possible and sensible to find that […] grave doubts reinforce the textual objections to Bayer’s [the patentee's] proposed construction. This court’s decision in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005), while observing that “validity analysis is [not] a regular component of claim construction,” leaves room for reliance on this bolstering consideration where, as here, the record on invalidity is sufficiently developed to establish grave validity doubts under the court’s standards. […]” Bayer Cropscience at *12-13.
Adopting A Broad Interpretation Would Raise 112 Written Description Issues“[N]either the patent nor the knowledge in the art showed that what Bayer offered in place of a description of the shared structure—the growth test—correlated closely with an enzyme’s structure. The patent provided what was “[a]t best . . . a roadmap [that would] ‘leav[e] it to the . . . industry to complete [the] unfinished invention.’” Novozymes, 2013 WL 3779376, at *14. Moreover, the “roadmap” told a person of ordinary skill how to find some, perhaps even many, but not all members of the genus claimed under Bayer’s broad construction, because enzymes not found in soil bacteria may catalyze 2,4-D-degrading reactions but could not be dis- covered (reliably or perhaps at all) using the growth test.” Bayer Cropscience at *14.
Conclusion
“Neither party has presented us with a reason to go beyond rejecting Bayer’s proposed claim construction. Our rejection of Bayer’s construction settles the question of non-infringement and thus provides us with sufficient grounds for affirming summary judgment in Dow’s favor.” Bayer Cropscience at *15.
 
 
 
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