Bayer loses case against Dow on U.S. Patent No. 6,153,401
Bayer loses in Bayer v. Dow:
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 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 recog- nized that the term used, in its established scientific meaning, did not cover the accused product (itself differ- ent from the particular enzyme whose gene Bayer’s inven- tors had sequenced), so it argued for a broad functional claim construction.
Applying our decisions about the potentially unwel- come consequences of a patentee’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.
Reliance on unverified belief:
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, Alcaligenes eutrophus JMP134 “2,4- Dichlorophenoxyacetate Monooxygenase” Is an α- Ketoglutarate-Dependent Dioxygenase, 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 (...)
At district court:
Instead, the [district] court concluded that the “plain and ordinary meaning” requires that “2,4-D monooxygenase” be read to embody the established scien- tific meaning of “monooxygenase,” which involves one oxygen atom going to water, and that the whole phrase therefore 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.” Id. at *4; see id. at *3-8. Under that construction, there was no dispute that Dow’s products do not infringe because they are dioxygenases, even though they “create 2,4-D resistant plants” through an enzymatic activity that produces cleaving of the side chain of 2,4-D to yield 2,4- DCP. Id. at *2.
Having rejected Bayer’s “broad functional-based” con- struction, id. at *8, the court went on to explain that, if it had concluded otherwise, it still would have granted summary judgment for Dow, just for a different reason. Id. at *8-10. Specifically, the court ruled that the claim so construed would “fail[] to satisfy the written description requirement of 35 U.S.C. § 112” because disclosing one gene and the test used to find it was not enough to cap- ture the large genus that Bayer purported to have claimed. Id. Bayer appeals.
Interesting wording by the CAFC:
To begin with, these efforts fight a facially straight- forward textual analysis. As the district court recognized, all 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.
As to not using a term in its customary sense:
Arguing against this textual analysis, Bayer proposes a construction that first requires stripping the phrase “2,4-D monooxygenase” of the scientifically accepted descriptive content of the term “monooxygenase.” Adopting Bayer’s position, we think, would require that the ’401 patent, or its history, make reasonably clear that Bayer was not using the term in its established descriptive sense. See, e.g., Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343, 1355 (Fed. Cir. 2003). 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.
The patent and its history, however, do not clearly indicate that the patent uses the language at issue without its accepted scientific descriptive meaning. On the con- trary, Bayer’s usage in the intrinsic record is at the very best inconsistent. Much of it actually reinforces the straightforward descriptive meaning of the claim terms.
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 assump- tion, one would hardly expect the 1989 written description to contain a redefinition to override the “mono” meaning.
Phillips is mentioned:
Bayer’s construction has not only textual problems. It goes far beyond the Figure 10 enzyme, beyond monooxy- genases, beyond enzymes produced by bacteria found mainly in soil, to capture the broad functionally defined genus of enzymes that cause cleaving of the 2,4-D side chain. This broad reading would call into serious doubt the claim’s validity under 35 U.S.C. § 112(a). See Bayer, 2012 WL 4498527, at *8-10.
In this case, which is not one in which a patentee in- vokes invalidity considerations to support a narrowing construction, Bayer seeks a broad construction of its own patent, and the alleged infringer Dow has raised invalidi- ty problems with that construction. A record regarding those problems was extensively developed at the same time as the record for claim construction. In these cir- cumstances, it is both possible and sensible to find that such grave doubts reinforce the textual objections to Bayer’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. Id. at 1327- 28.3
Bayer’s proposed construction broadly covers a class of enzymes defined by their function of causing cleaving of the side chain of 2,4-D, while its written description structurally identifies just one gene sequence and the enzyme it encodes. We have not articulated a comprehen- sive and precise formulation for identifying when such a combination runs afoul of Section 112(a)’s written- description requirement; indeed, we have counseled against “bright-line rules” in this area. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). But we have indicated the primacy of structural identification for inventions in certain areas like the one at issue here, and when we have adverted to the possibil- ity of other means of identification, we have focused on whether such alternative means sufficiently correlate with structure. See, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, No. 2012-1433, 2013 WL 3779376, at *14 (Fed. Cir. July 22, 2013); Ariad, 598 F.3d at 1350; 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) (“functional descriptions of genetic mate- rial can, in some cases, meet the written description requirement if those functional characteristics are ‘cou- pled with a known or disclosed correlation between func- tion and structure, or some combination of such characteristics’”) (quoting Enzo Biochem, Inc. v. Gen- Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002));
AND
skilled artisans would readily understand the expla- nation here, namely, Bayer’s initial mistaken belief about its enzyme’s properties and then its insistence on retain- ing claim language reflecting that belief even after it was known to be false.
Lamb-Weston is cited (Ohio's wheelbarrow is not):
Moreover, 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 draft- ing. See, e.g., Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004); Elekta Instrument S.A. v. O.U.R. Scientific Int’l, Inc., 214 F.3d 1302, 1308-09 (Fed. Cir. 2000).
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 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 recog- nized that the term used, in its established scientific meaning, did not cover the accused product (itself differ- ent from the particular enzyme whose gene Bayer’s inven- tors had sequenced), so it argued for a broad functional claim construction.
Applying our decisions about the potentially unwel- come consequences of a patentee’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.
Reliance on unverified belief:
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, Alcaligenes eutrophus JMP134 “2,4- Dichlorophenoxyacetate Monooxygenase” Is an α- Ketoglutarate-Dependent Dioxygenase, 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 (...)
At district court:
Instead, the [district] court concluded that the “plain and ordinary meaning” requires that “2,4-D monooxygenase” be read to embody the established scien- tific meaning of “monooxygenase,” which involves one oxygen atom going to water, and that the whole phrase therefore 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.” Id. at *4; see id. at *3-8. Under that construction, there was no dispute that Dow’s products do not infringe because they are dioxygenases, even though they “create 2,4-D resistant plants” through an enzymatic activity that produces cleaving of the side chain of 2,4-D to yield 2,4- DCP. Id. at *2.
Having rejected Bayer’s “broad functional-based” con- struction, id. at *8, the court went on to explain that, if it had concluded otherwise, it still would have granted summary judgment for Dow, just for a different reason. Id. at *8-10. Specifically, the court ruled that the claim so construed would “fail[] to satisfy the written description requirement of 35 U.S.C. § 112” because disclosing one gene and the test used to find it was not enough to cap- ture the large genus that Bayer purported to have claimed. Id. Bayer appeals.
Interesting wording by the CAFC:
To begin with, these efforts fight a facially straight- forward textual analysis. As the district court recognized, all 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.
As to not using a term in its customary sense:
Arguing against this textual analysis, Bayer proposes a construction that first requires stripping the phrase “2,4-D monooxygenase” of the scientifically accepted descriptive content of the term “monooxygenase.” Adopting Bayer’s position, we think, would require that the ’401 patent, or its history, make reasonably clear that Bayer was not using the term in its established descriptive sense. See, e.g., Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343, 1355 (Fed. Cir. 2003). 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.
The patent and its history, however, do not clearly indicate that the patent uses the language at issue without its accepted scientific descriptive meaning. On the con- trary, Bayer’s usage in the intrinsic record is at the very best inconsistent. Much of it actually reinforces the straightforward descriptive meaning of the claim terms.
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 assump- tion, one would hardly expect the 1989 written description to contain a redefinition to override the “mono” meaning.
Phillips is mentioned:
Bayer’s construction has not only textual problems. It goes far beyond the Figure 10 enzyme, beyond monooxy- genases, beyond enzymes produced by bacteria found mainly in soil, to capture the broad functionally defined genus of enzymes that cause cleaving of the 2,4-D side chain. This broad reading would call into serious doubt the claim’s validity under 35 U.S.C. § 112(a). See Bayer, 2012 WL 4498527, at *8-10.
In this case, which is not one in which a patentee in- vokes invalidity considerations to support a narrowing construction, Bayer seeks a broad construction of its own patent, and the alleged infringer Dow has raised invalidi- ty problems with that construction. A record regarding those problems was extensively developed at the same time as the record for claim construction. In these cir- cumstances, it is both possible and sensible to find that such grave doubts reinforce the textual objections to Bayer’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. Id. at 1327- 28.3
Bayer’s proposed construction broadly covers a class of enzymes defined by their function of causing cleaving of the side chain of 2,4-D, while its written description structurally identifies just one gene sequence and the enzyme it encodes. We have not articulated a comprehen- sive and precise formulation for identifying when such a combination runs afoul of Section 112(a)’s written- description requirement; indeed, we have counseled against “bright-line rules” in this area. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). But we have indicated the primacy of structural identification for inventions in certain areas like the one at issue here, and when we have adverted to the possibil- ity of other means of identification, we have focused on whether such alternative means sufficiently correlate with structure. See, e.g., Novozymes A/S v. DuPont Nutrition Biosciences APS, No. 2012-1433, 2013 WL 3779376, at *14 (Fed. Cir. July 22, 2013); Ariad, 598 F.3d at 1350; 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) (“functional descriptions of genetic mate- rial can, in some cases, meet the written description requirement if those functional characteristics are ‘cou- pled with a known or disclosed correlation between func- tion and structure, or some combination of such characteristics’”) (quoting Enzo Biochem, Inc. v. Gen- Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002));
AND
skilled artisans would readily understand the expla- nation here, namely, Bayer’s initial mistaken belief about its enzyme’s properties and then its insistence on retain- ing claim language reflecting that belief even after it was known to be false.
Lamb-Weston is cited (Ohio's wheelbarrow is not):
Moreover, 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 draft- ing. See, e.g., Chef Am., Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004); Elekta Instrument S.A. v. O.U.R. Scientific Int’l, Inc., 214 F.3d 1302, 1308-09 (Fed. Cir. 2000).
posted by Lawrence B. Ebert at 3:32 AM
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