By
Kevin E. Noonan —

From
the opening sentence of the Federal Circuit's opinion, it is clear that the Court believed that Bayer had claimed more broadly than it was entitled to and
claimed species it had not described, thus failing to satisfy the written description requirement.  Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566, 1569 (Fed. Cir. 1997).  The Court's language hies back to the Eli Lilly decision from 15 years go, where the Court speaks about limitations on "functional"
claiming rather than structure-based claiming as emphasized by the Federal
Circuit after the Eli Lilly decision.  "Bayer
got ahead of the science" according to the Court, and moreover, the
functional terminology used in the claims was inaccurate and Bayer knew it.  Indeed, "[w]hen
[Bayer] 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."

The issue here comes down to claim
construction:  the only way Bayer could prevail was to obtain a claim
construction broader than its specification supports, which the District Court
refused to do and granted summary judgment of non-infringement to defentant.  The Federal Circuit was not about to upset that judgment on appeal.

The patent at issue, U.S. Patent No.
6,153,401, relates to "genetically modifying plants in order to confer
resistance to a commonly used herbicide called 2,4-dichlorophenoxyacetic acid ("2,4-D")."  The technology involves producing a transgenic
plant whose genome encodes an exogenous 2,4-D gene wherein the plant expresses
the protein product.  The genes
encompassed by the claims arise in bacteria that can convert 2,4-D into
2,4-dichlorophenol (2,4-DCP), which is a non-toxic carbon source for bacteria
expressing 2,4-D.  Bayer
scientists cloned the 2,4-D gene from Alcaligenes
eutrophus JMP134 and provided the nucleotide
sequence of the gene.  (This was the only
gene disclosed in the patent.)  Genes
having activity against 2,4-D were then isolated by functional cloning, wherein
bacteria unable to grow on 2,4-D were transfected with DNA from a library made
with DNA from a bacteria that could grow on 2,4-D, and bacteria comprising
exogenous DNA that had transferred the growth phenotype was selected.

The '401 patent granted in 2000 but the Court notes
that Bayer did not change its nomenclature in the face of this scientific
evidence.  Claim 1 of the '401 patent
reads 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.

The Court focused on the lack of
understanding of the molecular mechanism of the catalyzed reaction, because
those mechanistic considerations informed the language the patentee used to
describe the generic class of proteins (and the genes that encode them) in
their claims:  monooxygenases.  However, as it turns out — and the evidence
showed that Bayer became aware of the true nature of the enzymes at issue well
before the '401 patent granted — the
enzyme having the desired activity is actually a dioxygenase; the distinction
is that a monooxygenase results when one atom of molecular oxygen is incorporated
into the product and another oxygen atom is incorporated into water, while
dioxygenase catalyzes incorporation of both atoms of molecular oxygen into products (and not water), citing Fukumori & Hausinger,
Alcaligenes eutrophus JMP134 "2,4- Dichlorophenoxyacetate Monooxygenase"
Is an α–
Ketoglutarate-Dependent Dioxygenase, 175 J.
Bacteriology 2083 (1993).

Dow's accused infringing articles are genetically
modified seeds resistant to 2,4-D.  Dow's
technology depends on two genes, termed aad-1 and aad-12 that encode aryloxyalkanoate
dioxygenase enzymes.  It was undisputed
that these are different genes than the genes disclosed in Bayer's patent.  Bayer's argument at trial was that these
genes "fall within the broader claim 1, which encompasses enzymes that 'hav[e]
the biological activity of 2,4-D monooxygenase.'"  Bayer defined this claim term functionally,
taking the position that "the quoted phrase 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 and even if it does not share other biological activities of the
particular enzyme whose gene Bayer sequenced."

At the District Court, the Markman
hearing resulted in judgment in Dow's
favor, based on evidence that the Court's Markman decision is consistent with
(or at least more consistent with) how the skilled worker would interpret the
claim.  The Court's basis was "plain
and ordinary meaning" if the term is interpreted consistent with "the
established scientific meaning of the term," as opposed to the claim
construction the District Court adopted, which is that a monooxygenase means "the
enzymatic activity of an enzyme, in a biological system, that causes a reaction
with 2,4-D, and two molecules of oxygen, where one molecule of oxygen is added
to 2,4-D and the other ultimately forms water."

The District Court found
non-infringement when it refused to construe the claim as Bayer advocated.  The Court also noted that, had it adopted Bayer's
construction, the claims of the '401 patent would have been invalid for failing
to satisfy the written description requirement of 35 U.S.C. § 112.

The Federal Circuit affirmed, in an
opinion by Judge Taranto
joined by Judges Prost and Bryson.  The
panel characterizes the dispositive aspect of the issue before it as claim
construction, which is reviewed de novo.  The Court further said that the question
before it "turns on whether Bayer's proposed construction of the term 'the
biological activity of 2,4-D monooxygenase' in the only independent claim
(claim 1) is correct."  Bayer's
position (its only position according to the opinion) was that the District Court erred in not construing the term to mean "bringing about the
cleavage of the side chain of 2,4-D," period.  The panel agreed with the District Court that
this reading is incorrect according to "familiar aspects of textual
analysis," i.e., the rubrics of
claim construction arising from Markman v
Westview and Cybor v FAS, and
reaffirmed in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (that
claims should be construed according to the intrinsic evidence that is the
plain meaning of the claim terms, the specification and the prosecution file
history).  The opinion also notes that to
interpret the claims as Bayer advocated "would read independent claim 1 so
broadly as to raise serious doubts about validity."  Trapped between this patent law Scylla and
Charybdis, the Court came to the conclusion that Bayer could not prevail.

The Court characterizes Bayer's
argument regarding its preferred claim construction as comprising two steps,
both of which the Court finds erroneous.  First, according to the Court, Bayer would have the Court ignore the
ordinary and plain meaning of the term "monooxygenase" in the art, as
indicating that the enzyme splits molecular oxygen into its constituent oxygen
atoms and then incorporates one of these atoms into an organic reaction product
and the other into water.  The second
step in Bayer's construction is to broaden the scope of the claim by arguing
that the Court should define the term "biological activity" regarding
the claimed nucleic acid as encoding any enzyme capable of cleaving the 2,4-D
molecule.  Both these steps "encounter
serious textual difficulties," according to the opinion.

The first and most basic difficulty
the Court finds with Bayer's construction is that this meaning of the disputed
phrase "fight a facially straightforward textual analysis" insofar as
there is no disagreement that the term "monooxygenase" is understood
in the art to encompass enzymes whose enzymatic activity results in one atom of
molecular oxygen being incorporated into water.  Taking the phrase as a whole, "biological activity of 2,4-D
monooxygenase" is most faithfully construed as encompassing only those
enzymes that cleave 2,4-D in the presence of molecular oxygen wherein one atom
of said oxygen molecules is incorporated into the cleavage product and the
other into water.  In this construction, "the
full phrase works as an integrated unit in a way that fits its structure and
the ordinary meaning of its words."

On the contrary, Bayer's
construction requires that the phrase "2,4-D monooxygenase" be "stripped"
of the accepted meaning of the term "monooxygenase."  If this is what Bayer intended to do, Bayer
had ample opportunity to do so, inter alia, in its specification or prosecution
history, because part of the right of a patentee to be its own lexicographer
includes the right to use a term contrary to its accepted meaning.  (There is nothing sinister here; for example,
the term "mouse" had a much different meaning before graphical user
interfaces requires a device for manipulating the cursor.)  There is a need for clarity, however, when a
patentee does this according to the opinion; that need encompasses at least
public notice and the requirement that a claim not be indefinite.  But the Court recognizes that any such
intentional change in how the term "monooxygenase" is interpreted
never arose; rather, "Bayer chose the language based on an unverified
belief that it accurately described its enzyme, [and] learned that the belief
was false while its application was pending."  Moreover, Bayer "had seven years before
its patent issued to alter the language, but never did," a consideration
clearly implicating the public notice function, or its breach, by Bayer.

Turning to the intrinsic evidence,
the Court finds no clear evidence that Bayer intended any variation in the
conventional meaning of the term "monooxygenase"; at best, the Court
says, the evidence is "inconsistent," and "[m]uch of it actually
reinforces the straightforward descriptive meaning of the claim terms [adopted
by the District Court]."  In
addition to failing to find clear evidence in the specification as filed of the
meaning for the term now advocated by Bayer, the court notes that the claims as
filed ("a 2,4-D monooxygenase gene … encoding a polypeptide
having the biological activity of such a monooxygenase[]") "reinforce[] rather
than undermines the ordinary descriptive meaning" of the term.

The panel is similarly unpersuaded
by Bayer's proposed construction of the term "the biological activity of."  Ignoring the structure of the phrase (which
the Court says provides the context wherein the biological activity of a
monooxygenase should be that activity that makes the enzyme a "monooxygenase" (emphasis in
opinion)), Bayer attempts to expand the definition of the term to encompass any enzymatic activity that "bring[s]
about the cleavage of the side chain of 2,4-D."  The Court rejects this construction, relying
on the but two instances where the specification recites a '"biological
activity."  In one instance, upon
which Bayer relies, the Court finds support for Bayer's construction to be
ambiguous at best.  And the other
instance "actually works against Bayer's argument," wherein the Court
interprets the disclosure in the specification (coding for a protein which has
the biological activity of the protein encoded by tfda, e.g., its
2,4-D-monooxygenase activity") to mean that there is (or can be) more than
one activity and that the activity encompassed within the scope of the claim is
its monoxygenase activity.  Concluding
this portion of the opinion, the Court says:

In short, as the district
court explained, the claim language has a strong accepted scientific meaning.  Bayer's alternative construction strips the monooxygenase half of the claim
phrase of its accepted descriptive meaning and then asserts a specification "definition"
of the biological-activity half.  We do not find enough in the specification or
prosecution history to justify those steps.

But this isn't Bayer's only problem, according to
the opinion.  Even if the Court were to
adopt Bayer's construction it would not prevail, says the Court, because the
construction Bayer advocates lacks adequate written description support in the
specification.  Typically, the Court
notes, patentees advocate a narrow claim construction in order to minimize the
risk of invalidation at trial.  Here,
Bayer argues for a broad interpretation as it must in order for Bayer to
prevail against a defendant making, using, selling or offering to sell, or
importing a species that is not encompassed within the scope of the claim if
construed according to the plain meaning of the terms in the claim.  However, this interpretation is inconsistent
with the Court's precedent regarding what must be disclosed to support a broad
genus claim limited, as in Bayer's proposed construction, only by the function
of the claimed molecule or accused infringing item.  The opinion recites the past 15 years of the Court's own jurisprudence, including Ariad
Pharms., Inc. v. Eli Lilly & Co., 598
F.3d 1336, 1351 (Fed. Cir. 2010); Carnegie Mellon Univ. v. Hoffman-La Roche
Inc., 541 F.3d 1115, 1121, 1124 (Fed. Cir. 2008); Univ. of Rochester v.
G.D. Searle & Co., Inc., 358 F.3d 916, 925 (Fed. Cir. 2004); Enzo
Biochem, Inc. v. Gen- Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) and Regents
of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566, 1569 (Fed.
Cir. 1997).  In all these cases, the Court
determined that for at least some claims there was insufficient support for the
claims in the specification.

And part of that conclusion stems
from the Court's understanding that adopting Bayer's construction "would
leave the '401 patent far from providing even an indirect structural
identification of all that would be within the claim's scope."  The functional language encompasses all
enzymes capable of cleaving 2,4-D, but the specification discloses only one
species capable of producing an enzyme having plaintiff's claim biological
activity.  This would defeat the public
policy-based patent quid pro quo,
because it would provide claims far in excess of the scope of what the patentee
had invented.  This would necessarily
include genes from all species, not just the bacterial species set forth in the
specification.  However, the Court noted
that although "Bayer has sought to mitigate this concern by expressly
arguing that any genes not derived from soil bacteria would fall outside of the
claimed genus[,] Bayer did not present a claim construction based on that
trimming effort to the district court."

Finally, the Court did not deign to
perform its own independent claim construction.  The opinion notes that Dow proposed two
alternative constructions but that the Court did not rule on them; however, the
panel did find that construction of the claim term "monooxygenase" as
it is commonly accepted in the art is "the most natural reading" of
the term.  The difficulty with this
approach is that it "reads out" of the claim the expressly disclosed
species (because there is no dispute that the disclosed enzyme is a
dioxygenase).  The Court notes that such
a decision would be "disfavored" but not prohibited.

This case illustrates the continuing
tension between claim construction and sufficiency of disclosure that has
arisen in claim drafting.  There is not
an easy answer or cookie-cutter approach to producing a specification and
claims that satisfy Section 112 while at the same time can be construed in such
a way that the claims broadly recite the subject matter at issue.  This is a balance that is continually
shifting, as claims having proper scope are the subject of efforts to design
around the protections offered by a patent.  In this case the Federal Circuit breaks no new ground but in rendering
its decision provides a reminder for courts and litigants alike by affirming
the District Court's proper refusal to broaden the scope of the '401 patent
claims outside the four corners of its written description.

Bayer
Cropscience AG v. Dow Agrosciences LLC (Fed. Cir. 2013)
Panel:
Circuit Judges Prost, Bryson, and Taranto
Opinion
by Circuit Judge Taranto