LEONIE M. BRINKEMA, District Judge.
Plaintiff/Counterclaim-Defendant UCB, Inc. ("UCB") brought this declaratory judgment action seeking a declaration that its Cimzia® product, a humanized monoclonal antibody approved by the Food and Drug Administration ("FDA") for the treatment of rheumatoid arthritis, psoriatic arthritis, active ankylosing spondylitis, and Crohn's disease, does not infringe defendant's patent and that the patent is invalid. Specifically, UCB argues that the defendant's patent does not cover humanized monoclonal antibodies like Cimzia®, Defendant/Counterclaim-Plaintiff Yeda Research and Development Co., Ltd. ("Yeda") owns United States Patent No. 6,090,923, titled "Murine Monoclonal Antibody Binding TNFa" (the "`923 Patent"). In its answer and counterclaim, Yeda alleges that the `923 Patent is valid and that UCB infringes claims 1, 5, and 9 of the `923 Patent by producing Cimzia®.
Before the Court are Yeda's Motion for Partial Summary Judgment, [Dkt. No. 83],
Humans and animals have immune systems which produce specialized cells called "antibodies" to attack viruses, bacteria, and other foreign invaders (also referred to as "antigens"). Plaintiffs Opening Brief in Support of Summary Judgment [Dkt. No. 81] ("UCB's MSJ Br.") at 3; Defendant Yeda's Opening Claim Construction Brief [Dkt. No. 88] ("Yeda's CC Br.") at 9. An antibody contains a "constant region" and a "variable region," also referred to as a "variable domain." Yeda's CC Br. at 9. An antibody genus consists of all antibodies with the same constant region. Id. Species within that genus have identical constant regions, but different variable regions. Id. The antibody genus relevant to the present civil action is the immunoglobulin ("IgG") antibody, as shown below:
Yeda's CC Br. Ex. 4 at 4. All antibodies in a given species have identical constant and variable regions. In addition, each antibody species is produced by a specialized immune cell called a "B-cell." Declaration of Dr. Scott A. Siegel [Dkt. No. 166] Ex. 1 ("Siegel Opening Report") ¶ 16. Each B-cell is only capable of making a single antibody species. Id
An antibody attacks an antigen by binding its variable region to the antigen. Yeda's CC Br. at 3. Multiple species of antibodies can bind to the same antigen, but each antibody will bind to the antigen in a different way. Id. at 8. For example, different species of antibodies may bind to different parts of the same antigen, to the same part of the antigen but in a different orientation, or bind more or less strongly to the antigen. Id. Binding location, binding orientation, and binding strength all contribute to how successfully an antibody can neutralize an antigen. Id. The variable region not only determines which antigen the antibody attacks, but also how effectively the antibody attacks that antigen. Id
To develop antibodies useful for treating human illnesses, scientists had to be able to produce large quantities of the particular antibody they sought to study. In 1975, two scientists developed a method which allowed researchers to study populations of homogenous antibodies. By fusing the B-cell for a particular antibody with benign tumor cells, researchers could create a single, hybrid cell, referred to as a "hybridoma,"
Initially, the cells used to make the hybridoma which created monoclonal antibodies came from mice.
During the 1980s, researchers began to use genetic engineering to create antibodies less likely to induce immune responses. Instead of being produced by a hybridoma, genetic engineering involved isolating the gene responsible for producing the antibody, altering the gene, and introducing that gene into a host cell capable of producing large amounts of the antibody. Id. ¶ 26. "Chimeric"
Yeda's Supplemental Brief [Dkt. No. 217] ("Yeda's Supp. Br.") at 29.
In 1975, scientists discovered that some animals, including humans, produced a
High levels of TNF were also found to lead to serious medical conditions such as "sepsis, rheumatoid arthritis, and Crohn's disease." Marasco Report ¶ 64. As research continued into the late 1980s, scientists discovered that in addition to being used to purify TNF, "the antibodies themselves could serve as therapeutic agents." Yeda's CC Br. Ex. 5 at 4. Specifically, the antibodies could be used to reduce the levels of TNF in a person's body, thereby reducing the debilitating effects of those disorders. This realization, and subsequent research, eventually led to the development of Cimzia®, a humanized monoclonal antibody that functions by binding (and therefore neutralizing) TNF.
The application which would become the `923 Patent was filed on December 12, 1985, claiming priority to an Israeli patent application filed on December 20, 1984. The `923 Patent did not issue until July 18, 2000. The nearly fifteen-year pendency of that application led Yeda's own attorney to describe the `923 Patent as a "`submarine' patent"
The claims of the `923 Patent are directed to a monoclonal antibody which binds to a cytotoxin
Independent claims 5
Although claim 1 is directed to a monoclonal antibody, much of the patent's written description addresses a process to purify the cytotoxin to which the monoclonal antibody binds. For example, the "Background of the Invention" is directed to describing "[p]roteins which exert a toxic effect on cells," and the history of "cytotoxic proteins." `923 Patent Col. 1 lines 24-56. The "Summary of the Invention" describes a "purified cytotoxic protein referred to as cytotoxin (CT)," "a procedure for effectively inducing this protein," and "a process for preparing . . . purified, essentially homogeneous CT." Id. col. 1 lines 59-65. The summary also describes CT in more detail, and provides a method to deliver CT in "a pharmaceutically acceptable carrier" to treat "virus infected cells and tumor target cells." Id. Col. 2 lines 10-17. Monoclonal antibodies are discussed as a method for isolating and purifying CT. Of significance to this litigation, the monoclonal antibodies are described as being produced by hybridoma, see id. at col. 1 line 66-col. 2 line 52, and consistent with the title of the patent, "Murine Monoclonal Antibody Binding TNFα," the hybridomas are described as being "derived from . . . mice." Id. col. 2 lines 63-65.
The preferred embodiment of the invention is also focused on purification of CT. The major steps of the preferred embodiment are "Induction of CT," "Quantitation of CT," and "Chromatographic Enrichment of CT." Id. col. 3 line 52-col. 4 line 49. Monoclonal antibodies are only referenced for their ability to screen for and purify CT, and those antibodies again are
Regarding claim construction, UCB argues that the term "monoclonal antibody" in claims 1, 5, and 9 only includes antibodies made via mouse-derived hybridoma because the technology at the relevant period had not reached the point where the term "monoclonal antibody" included chimeric or humanized antibodies. UCB's Opening Claim Construction Brief [Dkt. No. 86] ("UCB's CC Br.") at 6-9. Yeda responds that the ordinary meaning of "monoclonal antibody" does not encompass the method through which the antibody was made. Yeda's Responsive Claim Construction Brief [Dkt. No. 161] ("Yeda's CC Opp'n") at 3-13.
Regarding infringement, UCB argues that under its claim construction Cimzia® does not literally infringe the `923 Patent because Cimzia® is a humanized antibody. UCB's MSJ Br. at 20. UCB further argues that Yeda is estopped from arguing that Cimzia® infringes under the doctrine of equivalents because Yeda cancelled claims to chimeric and humanized antibodies during prosecution of the `923 Patent. Id. at 9-14; UCB's Responsive Supplemental Brief [Dkt. No. 218] ("UCB's Supp. Br.") at 8-17. Yeda responds that Cimzia® does literally infringe, given the broad scope of the ordinary meaning of the term "monoclonal antibody," Yeda's Memorandum of Law in Opposition to UCB's Motion for Summary Judgment [Dkt. No. 162] ("Yeda's MSJ Opp'n") at 20-27, and even if Cimzia® does not literally infringe, Yeda is not estopped from asserting a doctrine of equivalents argument that a humanized antibody like Cimzia® is equivalent to an antibody made via hybridoma.
Summary judgment is appropriate where the record demonstrates "that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed. R.Civ.P. 56(c). A genuine issue of material fact exists "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
The Court must view the record in the light most favorable to the nonmoving party, see Bryant v. Bell Atl. Md., Inc., 288 F.3d 124, 132 (4th Cir.2002); however, the "mere existence of a scintilla of evidence in support of the [nonmovant's] position will be insufficient; there must be evidence on which the jury could reasonably find for the [nonmovant]." Anderson, 477 U.S. at 252, 106 S.Ct. 2505; see also Othentec Ltd. v. Phelan, 526 F.3d 135, 140 (4th Cir.2008); TecSec, Inc. v. Int'l Bus. Machines Corp., 763 F.Supp.2d 800, 804-05 (E.D.Va.2011) aff'd, 466 Fed.Appx. 882 (Fed.Cir.2012). When relying on expert testimony, "[a] party does not manufacture more than a merely colorable dispute by submitting an expert declaration that something is black when the moving party's expert says it is while; there must be some foundation or basis for the opinion." Invitrogen Corp. v. Clontech Labs., 429 F.3d 1052, 1080 (Fed.Cir.2005).
"The first step of the infringement analysis is claim construction," Nazomi Comm'ns, Inc. v. Nokia Corp., 739 F.3d 1339, 1343 (Fed.Cir.2014), an issue of law for determination by the Court. Markman v. Westview Instruments, Inc., 517 U.S. 370, 387, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). In claim construction, the words of the claim are "given their
Because the meaning of words may change over time, it is important that claim construction be tied to the appropriate timeframe, "[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips, 415 F.3d at 1312-13. That means that when "a claim term understood to have a narrow meaning when the application is filed later acquires a broader definition, the literal scope of the term is limited to what it was understood to mean at the time of filing." Mass. Inst. of Tech. and Elecs. For Imaging, Inc. v. Abacus Software, 462 F.3d 1344, 1353 n. 3 (Fed.Cir.2006) (quoting Kopykake Enters., Inc. v. Lucks Co., 264 F.3d 1377 (Fed.Cir.2001)).
In construing a claim term, the Court begins with the language of the claims themselves. Phillips, 415 F.3d at 1314. "[T]he context in which a term is used in the asserted claim can be highly instructive," and "claim terms are normally used consistently throughout the patent." Id. Specifically, under the doctrine of claim differentiation there is a presumption "that an independent claim should not be construed as requiring a limitation added by a dependent claim" Curtiss-Wright Flow Control Corp. v. Velan, Inc., 438 F.3d 1374, 1380 (Fed.Cir.2006); however, claim differentiation is merely a presumption, "not a rigid rule and it cannot overcome a construction required by the prosecution history." TecSec, Inc. v. Intern. Bus. Mach. Corp., 731 F.3d 1336, 1345 (Fed.Cir.2013) (citing Regents of Univ. of Cal. v. Dakocytomation Cal., Inc., 517 F.3d 1364, 1375 (Fed.Cir.2008)). In particular, claim differentiation "cannot enlarge the meaning of a claim beyond that which is supported by the patent documents, or relieve any claim of limitations imposed by the prosecution history." Fenner Investments, Ltd. v. Cellco P'ship, 778 F.3d 1320, 1327 (Fed.Cir.2015). Claim differentiation also may not "serve to broaden claims beyond their meaning in light of the specification." Id. (quoting Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1302 (Fed.Cir.1999)).
In addition to the language of the claim, the specification must also be considered. Indeed, "claims must be read in view of the specification, of which they are a part." Phillips, 415 F.3d at 1315 (internal quotations marks and citation omitted). "[T]he specification `is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.'" Phillips, 415 F.3d at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996)). Although claims are generally not limited to the preferred embodiment disclosed in the specification, id. at 1323, "[t]he written description and other parts of the specification. . . may shed contextual light on the plain and ordinary meaning [of a claim term.]" Aventis Pharms., Inc. v. Amino
The history of prosecution before the United States Patent and Trademark Office ("USPTO") must also be considered. "Any explanation, elaboration, or qualification presented by the inventor during patent examination is relevant, for the role of claim construction is to capture the scope of the actual invention that is disclosed, described, and patented." Fenner Investments, 778 F.3d at 1323 (internal quotation marks omitted). The relevant determination is how "persons in the field of the invention" would have understood the prosecution history. Id. Accordingly, the inventor's subjective intent to claim certain subject matter "is of little or no probative weight in determining the scope of a claim." Howmedica Osteonics Corp. v. Wright Medical Tech., Inc., 540 F.3d 1337, 1346 (Fed.Cir.2008).
Evidence extrinsic to the patent, including "expert and inventor testimony, dictionaries, and learned treatises" may also be considered, Phillips, 415 F.3d at 1317; however, the Federal Circuit has expressed a preference for intrinsic evidence over extrinsic evidence. "Intrinsic evidence . . . is a more reliable guide to the meaning of a claim term than are extrinsic sources like technical dictionaries, treatises, and expert testimony." Chamberlain Grp., Inc. v. Lear Corp., 516 F.3d 1331, 1335 (Fed.Cir.2008). "Although definitions based on dictionaries, treatises, industry practice, and the like are often important aids in interpreting claims, they may not be `used to contradict claim meaning that is unambiguous in light of the intrinsic evidence.'" ArcelorMittal France v. AK Steel Corp., 700 F.3d 1314, 1320 (Fed.Cir.2012) (quoting Phillips, 415 F.3d at 1312-17).
One of "only two exceptions" to the general rule that the meaning of the words in a claim should be based on what one of ordinary skill in the art when the patent application was effectively filed would have understood the term to mean, is "when a patentee sets out a definition and acts as his own lexicographer." Thorner, 669 F.3d at 1365. "To act as its own lexicographer, a patentee must `clearly set forth a definition of the disputed claim term' other than its plain and ordinary meaning." Id. (quoting CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir.2002)).
The second exception to the general rule is "when a patentee disavows the full scope of a claim term either in the specification or during prosecution." Thorner, 669 F.3d at 1365. Accordingly, "when a patentee unequivocally and unambiguously disavows a certain meaning to obtain a patent, the doctrine of prosecution history disclaimer narrows the meaning of the claim consistent with the claim scope surrendered." Biogen Idec, Inc. v. GlaxoSmithKline LLC, 713 F.3d 1090, 1095 (Fed.Cir.2013).
The parties dispute the meaning of several claim terms; however, because the construction of "monoclonal antibody" leads to resolution of the present action, only that term will be construed.
Claims 1, 5, and 9 do not provide any detail regarding the meaning of "monoclonal antibody," instead defining the claimed antibody through the specific, single human cytotoxin to which the antibody binds. Therefore, the asserted claims themselves are not helpful in determining what "monoclonal antibody" would have meant to a person of ordinary skill in the art in 1984.
Unasserted claims may also be relevant to claim interpretation. Curtiss-Wright, 438 F.3d at 1380. Each of claims 1, 5, and 9 have associated dependent claims (claims 3, 7, and 11) which add, among other things, that the monoclonal antibody of the independent claim "is produced by a hybridoma formed by a fusion of myeloma cells with spleen cells from a mammal previously immunized with a pure or impure preparation of said cytotoxin." Yeda argues that because dependent claims must be narrower than the independent claims on which they depend, the presence of "produced by a hybridoma" in dependent claims 3, 7, and 11 means that independent claims 1, 5, and 9 are not so limited. Yeda's CC Br. at 15. Because claims 3, 7, and 11 were filed more than 14 years after the effective filing date of the `973 Patent, that argument has less force. Moreover, the remainder of the intrinsic evidence defeats Yeda's argument by showing that when the `923 Patent was filed, the term "monoclonal antibodies" was not understood to include chimeric or humanized antibodies.
The specification, which went unchanged through the course of prosecution, provides better evidence of how a person of ordinary skill in the art would have understood the term "monoclonal antibody" in 1984. The way that the written description and other parts of the specification use the term "monoclonal antibody" may be considered in determining the plain and ordinary meaning of the term, Aventis Pharms., Inc., 715 F.3d at 1373, and that use supports the conclusion that "monoclonal
There is no description of chimeric or humanized monoclonal antibodies anywhere in the `923 Patent. The drawings and written description do not contain the terms "chimera," "chimeric," "humanized," or any derivatives of those words. There is also no description of an antibody with a human constant region and a mouse variable region (a chimeric monoclonal antibody), or an antibody with a chimeric variable region (a humanized monoclonal antibody). Indeed, the words "constant," "variable," "domain," and "region" are also completely absent from the patent. The `923 Patent does not even address the possibility that monoclonal antibodies would be made through genetic engineering in general, and the words "genetic" and "engineering" do not appear. By contrast, the word "hybridoma" appears in the specification sixteen times.
In response, Yeda does not argue that the specification of the `923 Patent describes monoclonal antibodies produced by genetic engineering. See Yeda's CC Opp'n at 4-5. Instead, Yeda cites the patent law truism that "the fact that the specification describes only a single embodiment, standing alone, is insufficient to limit otherwise broad claim language." Id. at 4 (quoting Howmedica, 540 F.3d at 1345). Because the claims appear to sweep broadly enough to include more than just monoclonal antibodies made via hybridoma, Yeda asserts that the scope of "monoclonal antibody" should not be limited to the only described embodiment.
Yeda's argument misses the mark. UCB's argument is that there were no other methods for making monoclonal antibodies in December of 1984 at all. If the embodiment disclosed in the specification is the only embodiment which could have been understood to fall within the claim terms at the time of filing, then interpreting the claims to be coextensive with that single embodiment is simply giving the claims their correct meaning. In other words, Yeda's argument that the claims cannot be limited only to disclosed embodiments
Accordingly, the use of the term "monoclonal antibody" in the written description and other parts of the specification of the `923 Patent supports the conclusion that the term is limited to an antibody made through hybridoma and did not extend to chimeric or humanized monoclonal antibodies.
The prosecution history of the `923 Patent, as part of the intrinsic evidence, must also be considered in determining the meaning of claim terms. The evidence in the prosecution history supports the conclusion that "monoclonal antibody" in 1984 only meant an antibody made through hybridoma.
As they were filed closest to the effective filing date of the `923 Patent, the original claims provide additional evidence regarding the meaning of "monoclonal antibody" during the relevant period. Those original claims only describe production of monoclonal antibodies through hybridoma. For example, original claim 11 was directed to a method "by which multiple hybridoma cultures can be screened for the production of antibodies." Prosecution History at 13. Similarly, original claim 16 was directed to "a process for preparing monoclonal antibodies" including "detecting hybridomas which produce such antibodies." Id. The originally-filed drawings, consistent with the final drawings, also only describe production of monoclonal antibodies through hybridoma. Id. at 161, 163.
On July 21, 1988, Yeda added claim 31 which described a monoclonal antibody secreted by a hybridoma "or a hybridoma derived therefrom,"
That argument fails. Yeda's argument to the examiner in 1996, which was rejected by the examiner and was made regarding language that was eventually removed,
Yeda also argues that the prosecution history supports a construction including chimeric and humanized antibodies because at various times beginning on March 10, 1999, Yeda attempted to define "monoclonal antibody" as including chimeric and humanized antibodies. Specifically, Yeda refers to its March 20, 1999 response to an office action in which Yeda quoted a 1992 "Dictionary of Biochemistry" for a broader definition of "monoclonal antibody." Yeda's CC Br. at 16-17; Prosecution History at 509, 511.
Although providing a broad definition of monoclonal antibody in 1999 might be evidence of a subjective intent to claim chimeric and humanized antibodies, the subjective intent to claim certain subject matter "is of little or no probative weight in determining the scope of a claim." Howmedica, 540 F.3d at 1346. The focus in claim construction is on "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips, 415 F.3d at 1312-13. The expanded scope of protection that Yeda sought in 1999 or even a definition given in a technical dictionary in 1992 is of little weight when determining the meaning of that claim term in 1984.
On June 2, 1999, Yeda also submitted the Declaration of Hartmut Engelmann, an assistant professor at the Munich University Institute of Immunology. Prosecution History at 527-31. Dr. Engelmann claimed that the first description of the generation of mouse-human antibody chimeras was published in an article by S.L. Morrison et al. in November of 1984 ("Morrison Article"), and therefore that a person of ordinary skill in the art could make mouse-human chimeras in December 1984 without undue experimentation. Id. at 529-30. Dr. Engelmann did not make any conclusions regarding what the term "monoclonal antibody" meant or whether the term "monoclonal antibody" would have been understood in 1984 to include chimeric antibodies. See id.
Examination of the prosecution history reveals that for the first ten years of prosecution, neither Yeda nor the examiner understood the term "monoclonal antibodies" to include chimeric or humanized antibodies. Like the evidence in the specification, the prosecution history weighs towards a construction of "monoclonal antibodies" which does not include chimeric or humanized antibodies. As the specification was created at the time of filing, and the prosecution history developed beginning at that time, those pieces of intrinsic evidence are given great weight.
To the extent that it does not conflict with the intrinsic evidence, extrinsic evidence may also be relevant to claim construction. Phillips, 415 F.3d at 1318. The Federal Circuit has cautioned, however,
Yeda produces several pieces of extrinsic evidence which it claims establish that a person of ordinary skill in the art in 1984 would have understood "monoclonal antibody" to include chimeric and humanized antibodies. For the reasons that follow, the extrinsic evidence does not establish that the term "monoclonal antibody" included chimeric or humanized antibodies in 1984.
Yeda first argues that because UCB scientists referred to Cimzia® as a "monoclonal antibody," the term "monoclonal antibody" should be construed to include chimeric and humanized antibodies. Yeda's CC Br. at 17. The statements at issue do not help Yeda because they were published in 2006 and 2010, more than twenty years after the relevant period. The statements of UCB's scientists only provide evidence of what the term "monoclonal antibody" meant in the mid-to-late 2000s, but have no relevance to what the term meant in 1984.
Yeda also cites to United States Patent No. 4,816,567 (the "`567 Patent"), which is assigned to Genentech, Inc. The application for that patent was filed in 1983, and the patent issued in 1989. Yeda argues that the `567 Patent is evidence that the term "monoclonal antibody" included chimeric antibodies. Specifically, Yeda points to the patent's statement that chimeric antibodies "can be readily prepared in pure `monoclonal' form. They can be manipulated at the genomic level to produce chimeras of variants . . . from species which differ from each other." `567 Patent col. 4 lines 59-63.
This argument fails because each time that the `567 Patent uses the term "monoclonal antibodies," it explicitly uses the term to refer to antibodies made via hybridoma.
Even if Yeda were right about the meaning of "monoclonal antibody" in the `567 Patent, that understanding of "monoclonal
Yeda also provides a number of expert declarations claiming that, in December 1984, the term "monoclonal antibody" included chimeric and humanized antibodies. Huston Opening Report ¶¶ 26, 28, 29, 31-33, 36, 46; Siegel Opening Report ¶¶ 20, 52-53. These declarations have limited value because they are not adequately supported. For example, none of Yeda's experts address the specification of the `923 Patent in the context of claim construction, and none address whether and how the patent's description of only the hybridoma method of production affects their conclusions. See Huston Opening Report ¶¶ 28-37; Siegel Opening Report ¶¶ 52-53. Instead, Yeda's experts skip straight to extrinsic evidence to reach their claim construction. Even then, across Yeda's expert reports, only two pieces of objective evidence are offered to support the conclusion that in December 1984 the term "monoclonal antibody" was understood by those of ordinary skill in the art to include chimeric and humanized antibodies. The two references are the November 1984 Morrison Article, see Siegel Opening Report ¶¶ 20, 52; Huston Opening Report ¶¶ 26, 32, and a December 8, 1984 Nobel Prize speech by Cesar Milsten, see Huston Opening Report 33 ("Milsten Speech").
At best, these references establish that scientists knew of chimeric antibodies in November 1984. Establishing that chimeric antibodies existed in 1984, however, is different from establishing that a person of ordinary skill in the art would have understood chimeric antibodies to be monoclonal antibodies in 1984. See Abacus Software, 462 F.3d at 1353 n. 3 (citing Kopykake Enters., Inc. v. Lucks Co., 264 F.3d 1377 (Fed.Cir.2001)). For example, although the title of the Morrison Article uses the phrase "[c]himeric human antibody molecules," it does not use the term "monoclonal" or "monoclonal antibodies." Huston Opening Report ¶ 26 n. 5. Moreover, the cited excerpt of the Milsten Speech, although it does appear to describe what is now known to be chimeric antibodies, does not use the terms "chimeric" or "monoclonal." Accordingly, the extrinsic evidence relied upon by Yeda's experts does not support the conclusion that the understanding of "monoclonal antibodies" in 1984 included either chimeric or humanized antibodies.
Moreover, the expert opinions regarding "monoclonal antibody" are artfully worded to create the impression that the experts concluded that humanized antibodies were within the literal meaning of "monoclonal antibodies" in 1984. See Huston Opening Report ¶ 46 ("[I]t is my opinion that in 1984, a person of ordinary skill in the art would have understood the term `monoclonal antibody' to include antibodies produced by a genetically engineered cell");
Yeda's admission that humanized antibodies were not developed until 1986 is independently dispositive of the issue of whether in December 1984 the term "monoclonal antibody" was understood to include humanized antibodies. If humanized antibodies were not recognized until May of 1986, there is clearly no way that a person of ordinary skill in the art would have understood them to be included in the term "monoclonal antibody" in December of 1984.
Lastly, Federal Circuit precedent confirms the conclusion that in 1984 the understanding of "monoclonal antibody" did not include chimeric and humanized antibodies. In Chiron Corp. v. Genentech, Inc., the Federal Circuit was also confronted with construing the term "monoclonal antibody." 363 F.3d 1247, 1250 (Fed.Cir.2004). In that case, the Federal Circuit found that "the first publication to disclose humanized antibodies appeared in May 1986," id. at 1251, and that "the tenn `monoclonal antibody' in 1984 apparently referred to antibodies made with hybridoma and was not broad enough to encompass chimeric antibodies." Id. at 1257. In that opinion, the Federal Circuit also referred to a 1983 treatise which defined "monoclonal antibody" as only including hybridoma, and another 1984 article which differentiated monoclonal antibodies from chimeric antibodies. Id.
Although the parties center their dispute on whether "monoclonal antibody" would have only included the hybridoma method of production, there are other differences between the parties' proposed definitions. Specifically, Yeda's proposed definition includes "a homogenous (essentially identical) population of a single species of an immunoglobulin protein capable of specifically binding to an antigen," while UCB's proposed definition includes "an antibody that binds to a single antigen." Yeda's CC Br. at 14. Yeda observes that the experts in the present action appear to agree that "monoclonal antibody" descriptively refers, and referred in December 1984, to "a homogenous population of a single type of antibody." See Yeda's CC Br. at 14. Accordingly, that aspect of Yeda's proposed
Accordingly, in December 1984 the term "monoclonal antibody" would not have included chimeric or humanized antibodies. Therefore, the term "monoclonal antibody" in claims 1, 5, and 9 is construed to mean "a homogenous population of a single type of antibody produced via hybridoma and not including chimeric or humanized antibodies."
"To establish literal infringement, all of the elements of the claim, as correctly construed, must be present in the accused [product]." TechSearch, L.L.C. v. Intel Corp., 286 F.3d 1360, 1371 (Fed.Cir.2002). Under the Court's construction of "monoclonal antibody" as "a homogenous population of a single type of antibody produced via hybridoma and not including chimeric or humanized antibodies," Cimzia®, which is a humanized antibody, cannot literally infringe claims 1, 5, and 9 of the `923 Patent. See, e.g., Yeda's Supp. Br. at 27; UCB's MSJ Br. at 10. For this reason, UCB's Motion for Summary Judgment will be granted as to its claim that Cimzia® does not literally infringe the `923 Patent.
Yeda argues that even if Cimzia® does not literally infringe claims 1, 5, and 9 of the `923 Patent, Cimzia® infringes under the doctrine of equivalents because a humanized antibody is equivalent to an antibody made via hybridoma. "Even without literal infringement of a certain claim limitation, a patentee may establish infringement under the doctrine of equivalents if an element of the accused device `performs substantially the same function in substantially the same way to obtain the same result as the claim limitation.'" EMD Millipore Corp. v. AllPure Techs., Inc., 768 F.3d 1196, 1202 (Fed.Cir.2014) (quoting AquaTex Indus., Inc. v. Techniche Solutions, 419 F.3d 1374, 1382 (Fed.Cir.2005)). The purpose of the doctrine of equivalents is to "allow[] the patentee to claim those insubstantial alterations that were not captured in drafting the original patent claim but which could be created through trivial changes." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 733, 122 S.Ct. 1831, 152 L.Ed.2d 944 (2002) ("Festo I"). "Thus the doctrine of equivalents is invoked to prevent a `fraud on the patent,' when an accused infringer is `stealing the benefit of the invention' by making insubstantial changes that avoid the literal scope of the claims." EMI Grp. North America, Inc. v. Intel Corp., 157 F.3d 887, 898 (Fed.Cir.1998).
UCB responds that Yeda is estopped from asserting that humanized or chimeric antibodies are equivalent to antibodies made via hybridoma by its actions during prosecution of the `923 Patent. The doctrine of prosecution history estoppel is a "legal limitation" on the range of equivalents available to a patentee, Warner-Jenkinson Co., Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 30, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997), which "requires that the claims of a patent be interpreted in light of the proceedings in the PTO during the application process."
Prosecution history estoppel analysis proceeds in four steps. First, the accused infringer must establish that an amendment filed before the USPTO narrowed the literal scope of a claim. Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 344 F.3d 1359, 1366 (Fed.Cir.2003) (en banc) ("Festo II"). Although prosecution history estoppel arises most often when a claim is narrowed to avoid the prior art, "a narrowing amendment made to satisfy any requirement of the Patent Act may give rise to an estoppel." Festo I, 535 U.S. at 736, 122 S.Ct. 1831.
If the accused infringer establishes a narrowing amendment, then the reason for the amendment must be assessed. If the prosecution history does not reveal the reason for the amendment, then the amendment is presumed to be substantially related to patentability and a presumption of prosecution history estoppel arises. Festo II, 344 F.3d at 1366-67. The patentee may then attempt to rebut the presumption that the amendment was related to patentability. Id. at 1367.
At the third step, the scope of the surrendered subject matter must be determined. The presumption is that the patentee surrendered all subject matter between the original claim and the narrowed claim. Id. The scope of surrender is evaluated through reference to the intrinsic evidence in the patent. See Abbott Labs. v. Novopharm Ltd., 323 F.3d 1324, 1331 (Fed.Cir.2003).
Finally, "the patentee may rebut the presumption of total surrender by demonstrating that it did not surrender the particular equivalent in question." Festo II, 344 F.3d at 1368. The patentee may rebut the presumption of total surrender by showing that "an alleged equivalent would have been `unforeseeable at the time of the amendment and thus beyond a fair interpretation of what was surrendered,'" id. at 1369 (quoting Festo I, 535 U.S. at 738, 122 S.Ct. 1831), that "the rationale underlying the narrowing amendment [bore] no more than a tangential relation to the equivalent in question," id. (quoting Festo I, 535 U.S. at 740, 122 S.Ct. 1831), or that there was "some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question." Id. at 1370 (quoting Festo I, 535 U.S. at 741, 122 S.Ct. 1831). If the patentee fails to rebut the presumption of total surrender, prosecution history estoppel bars the patentee
The application and scope of prosecution history estoppel is an issue of law. Biagro Western Sales, Inc. v. Grow More, Inc., 423 F.3d 1296, 1301-02 (Fed.Cir.2005). Although rebuttal of the surrender presumption may rely on factual determinations, those factual issues may be decided by the Court. Id. at 1302.
The prosecution history of the `923 Patent establishes that Yeda attempted to claim chimeric and humanized antibodies, that the attempt was rebuffed by the USPTO, and that Yeda then cancelled any claim to that subject matter rather than appealing the examiner's rejection.
Specifically, the prosecution history shows that Yeda added claim 41, the claim which would become claim 1 of the `923 Patent, on June 30, 1998.
Yeda argues that its cancellations did not narrow the scope of the claims for several reasons. First, Yeda argues that the cancellation of dependent claims does not narrow the scope of a broader independent claim that was not amended. Yeda's Supp. Br. at 16. As authority, Yeda cites Smith v. Snow, in which the Supreme Court stated that "[i]t is of no moment that in the course of the proceedings in the Patent Office the rejection of narrow claims was followed by the allowance of the broader claim 1." 294 U.S. 1, 16, 55 S.Ct. 279, 79 L.Ed. 721 (1935).
In Smith, "[f]our groups of method claims were successively presented to the Patent Office, and three were successively rejected." Id. at 15, 55 S.Ct. 279. The final group of method claims ultimately matured into the asserted claims of the patent. Id. The accused infringer argued that a limitation introduced in one of the previous three groups of method claims should be read into issued claim 1. Id. at 8-9, 55 S.Ct. 279. In that context, the quotation simply means that limitations introduced when attempting to claim one embodiment of the invention do not cause prosecution history estoppel if that embodiment is not encompassed by the claims which ultimately issue. By contrast, the cancelled claims at issue in the present action are directed to Yeda's attempts to claim humanized and chimeric antibodies, the specific subject matter that Yeda is now seeking as equivalent. Accordingly, Smith does not apply.
Moreover, the Supreme Court has held that narrower claims cancelled during prosecution may limit the scope of the independent claims on which they were intended to depend. In Schriber-Schroth Co. v. Cleveland Trust Co., the Supreme Court stated that "[i]t is a rule of patent construction consistently observed that a claim in a patent as allowed must be read and interpreted with reference to claims that have been cancelled or rejected and the claims allowed cannot by construction be read to cover what was thus eliminated from the patent." 311 U.S. 211, 220-21, 61 S.Ct. 235, 85 L.Ed. 132 (1940). Accordingly, "[t]he patentee may not, by resort to the doctrine of equivalents, give to an allowed claim a scope which it might have had without the amendments, the cancellation of which amounts to a disclaimer." Id. at 221, 61 S.Ct. 235. Although the Supreme Court recognized that "the rule is most frequently invoked when the original and cancelled claim is broader than that allowed," it also found that "the rule and the reason for it are the same if the cancelled or rejected claim be narrower," Id. Using that rationale, the Supreme Court found that by "having acquiesced" to the rejection of the narrow claims, the patentee was "no longer free to gain the supposed advantage of the rejected claims by a construction of the allowed claims as equivalent to them." Id. at 221-22, 61 S.Ct. 235. Schriber-Schroth was cited with approval by the Supreme Court in Festo I for the proposition that "claims are interpreted by reference to `those that have been cancelled or rejected,'" Festo I, 535 U.S. at 733, 122 S.Ct. 1831 (quoting Schriber-Schroth, 311 U.S. at 220-21, 61 S.Ct. 235). Yeda does not address, or even cite, Schriber-Schroth in its briefing. Given this line of cases, it is clear that cancelled claims can operate to narrow the issued claims.
Yeda further argues that cancelling the dependent claims did not narrow the scope of claim 41 because claim 41 independently covered chimeric and humanized antibodies, again invoking the
Yeda argues that when it agreed to cancel the dependent claims, it did not have the purpose of renouncing coverage of chimeric and humanized antibodies, but instead was merely acknowledging that it was not entitled to dependent claims directed to those types of antibodies. Yeda's Supp. Br., at 17. Under Festo however, the analysis is not whether the patentee intended to renounce claim scope through its actions, but instead whether the narrowing amendment was made "for a `substantial reason related to patentability.'" Festo II, 344 F.3d at 1366 (quoting Warner-Jenkinson, 520 U.S. at 33, 117 S.Ct. 1040). Yeda's admission that the claims were cancelled because they did not meet the written description requirement of 35 U.S.C. § 112-1 establishes that the dependent claims were cancelled for reasons substantially related to patentability, and the allowance of the `923 Patent shortly after that cancellation, without Yeda adding claims of scope similar to the cancelled claims, is compelling further evidence that the cancellation of the claims was substantially related to patentability.
Because the dependent claims to chimeric and humanized antibodies were cancelled for reasons substantially related to patentability, the "presumption that the patentee has surrendered all territory between the original claim limitation and the amended claim limitation" applies. Festo II, 344 F.3d at 1367. Yeda argues that the scope of surrender does not extend to humanized antibodies because the word "humanized" does not specifically appear in the cancelled claims. Yeda's Supp. Br. at 25.
The evidence does not support Yeda's argument. When Yeda introduced claim 41, it defined the term "chimeric" as being "intended to encompass both mouse variable/human constant chimeras, and those with chimeric variable domains (mouse hypervariable/human framework) and human constant domains." Prosecution History at 509 n. 1. Yeda therefore specifically defined "chimeric" as including humanized antibodies, and later introduced claims to chimeras. Id. at 507-09. By later cancelling those claims, Yeda surrendered both chimeric and humanized antibodies.
The presumption of prosecution history estoppel may be rebutted if the patentee can demonstrate that the alleged equivalent was not foreseeable at the time that the narrowing amendment was made. Festo II, 344 F.3d at 1365 n. 2. Yeda argues that allowing prosecution history estoppel here would strip the doctrine of equivalents of its ability to claim after-arising technology because humanized antibodies are an after-arising technology that Yeda could not have foreseen at the time of invention. Yeda's Supp. Br. at 23-24, 26. This argument fails because "the time when the narrowing amendment was made, and not when the application was filed, is the relevant time for evaluating unforeseeability." Festo II, 344 F.3d at 1365 n. 2. When the dependent claims were cancelled in 1999, chimeric and humanized antibodies were not unforeseeable. To the contrary, Yeda was specifically attempting to claim chimeric and humanized antibodies when it introduced the relevant dependent claims. Accordingly, Yeda has not overcome the estoppel presumption, and Yeda cannot now assert Cimzia®, a humanized antibody, infringes under the doctrine of equivalents.
When the USPTO rejected Yeda's efforts to claim chimeric and humanized antibodies and Yeda acquiesced to those rejections, Yeda's competitors and interested members of the public were entitled to rely on Yeda's actions. Having conceded the correctness of the rejections made by the USPTO, Yeda cannot now complain that it is estopped from re-capturing that subject matter as an equivalent. Accordingly, UCB's motion for summary judgment of no infringement under the doctrine of equivalents will be granted.
Because Cimzia® does not infringe the `923 Patent either literally or under the doctrine of equivalents, the issues of the validity of the `923 Patent