Full opinion text
FINDINGS, RULINGS, AND ORDER YOUNG, Chief Judge. In this jury waived declaratory judgment action, Amgen, Inc. (“Amgen”) seeks a declaration that certain of the patents protecting its best selling drug EPOGEN ® are infringed by the conduct of the defendants, Hoechst Marion Roussel, Inc. and Transkaryotic Therapies, Inc. (collectively “TKT”). TKT denies infringement and, in turn, counterclaims that Amgen’s patents are invalid on a number of grounds. Amgen, the first to discover and manufacture a recombinant DNA product similar to natural erythropoietin (“EPO”) and useful in various medical treatments, has reaped significant commercial rewards from its discoveries, see Patricia Van Arnum, Active Pharmaceutical Ingredients: The Opportunities in the Branded Prescription Market, Chemical Market Rep., Oct. 30, 2000, WL 10/30/00 CHEMMKT REP FR 14 (noting that Amgen’s Epogen had sales of $1.76 billion in 1999); Vicki Brower, Amgen Comes Out on Top in Blood Drug Patent Tussle, Biotechnology Newswatch, Jan. 4, 1999, WL 1/4/99 BIO-TECHNW 1 (noting that EPO was then the “biggest-selling biotechnology drug ever developed” and that Amgen’s EPO sales accounted for over fifty percent of its 1997 $2.4 billion revenue). As one would expect, Amgen has sought to preserve its commercial success through a cluster of related patents that it has defended with skill and perseverance. In conjunction with Hoechst Marion Roussel, Inc., now known as Aventis Pharmaceuticals, Inc., TKT, a smaller company, seeks to capitalize upon apparent advances in genetic engineering by targeting the most lucrative commercial recombinant DNA products and designing around them. See Trial Tr. at 1772:21 to 1773:2,1786:5 to 1787:7. It, too, as one might expect, is no stranger to litigation. The present litigation, in fact, has been brewing for some time, see Amgen, Inc. v. Hoechst Marion Roussel, Inc., 3 F.Supp.2d 104 (D.Mass.1998), and when it ultimately erupted in June of 1999, the parties were ready. As an aside, it is only just to note that this case has been presented with high integrity, an unswerving fidelity to court rules and procedures, and a consummate excellence in trial practice that makes it a model not only for the intellectual property bar, but for lawyers everywhere. Any failings in understanding are mine, and mine alone. The course of the litigation may be briefly sketched. Early on, the parties agreed on a list of experts upon whom the Court might call for technical assistance. The Court chose Professor Chris Kaiser of the Massachusetts Institute of Technology from this list, and has met privately with him for background tutorial assistance. Towards the close of discovery, Amgen moved for summary judgment on the issue of infringement. This motion necessitated construction of the patent claims, and the Court held a Markman hearing on March 27, March 28, and April 10, 2000. Thereafter, the Court granted summary judgment to Amgen on a particular claim in one of the five patents in issue. The motion for summary judgment was otherwise denied. Trial commenced on May 15, 2000 and continued for twenty-three days spread over four months. At the close of Am-gen’s case in chief, the Court held, pursuant to Fed.R.Civ.P. 52(c), that TKT had not infringed the process claims of Amgen’s U.S. Patent No. 5,618,698 (issued Apr. 8, 1997). Trial concluded on September 8, 2000, and the matter was taken under advisement. I. THE PATENTS AT ISSUE There are five patents at issue in this case: U.S. Patent No. 5,547,933 (issued Aug. 20, 1996) (“ ’933 patent”), Trial Ex. 2; U.S. Patent No. 5,618,698 (issued Apr. 8, 1997) (“’698 patent”), Trial Ex. 4; U.S. Patent No. 5,621,080 (issued Apr. 15, 1997) (“’080 patent”), Trial Ex. 3; U.S. Patent No. 5,756,349 (issued May 26, 1998) (“ ’349 patent”), Trial Ex. 5; and U.S. Patent No. 5,955,422 (issued Sept. 21, 1999) (“’422 patent”), Trial Ex. 6. All of these patents share a common disclosure and identical specifications. Trial Exs. 2-6. Only the claims differ. Each of the patents claim priority from the following common applications: U.S. Patent Application Serial No. 675,298 (Nov. 30, 1984), which is a continuation-in-part of U.S. Patent Application Serial No. 655,841 (Sept. 28, 1984), which is a continuation-in-part of U.S. Patent Application Serial No. 582,185 (Feb. 21, 1984), which is a continuation-in-part of U.S. Patent Application Serial No. 561,024 (Dec. 13, 1983). Trial Exs. 2-6. Interactive Charting for Amgen, Inc., at http://www.marketwatch.com (last visited Apr. 26, 2000). Amgen's NASDAQ Quote, at http://www.quicken.com (last visited May 18, 2000). II. “THE NAME OF THE GAME IS THE CLAIM”: CLAIM CONSTRUCTION It is appropriate to pause for a moment to emphasize the particular procedural approach that this Court used in conducting the Markman hearing. District courts have differed significantly in the timing and procedure for Markman hearings— some engaging in claim construction prior to trial and others after hearing all of the evidence at trial. See William F. Lee & Anita K. Krug, Still Adjusting to Markman: A Prescription for the Timing of Claim Construction Hearings, 13 Harv. J.L. & Tech. 55, 73 (1999). I have consistently taken the procedural approach of conducting the Markman hearing at the summary judgment stage of litigation or at the point when discovery has closed and trial is approaching. See, e.g., MacNeill Eng’g Co. v. Trisport, Ltd., No. 98-12019, 2001 WL 46970, slip op. at 7 (D.Mass. Jan. 10, 2001); MediaCom, 4 F.Supp.2d at 22-23. I have taken care to note that the benefits of so doing range from constitutional concerns arising from conducting such a hearing too soon to efficiency concerns arising from conducting the hearing too late. See MediaCom, 4 F.Supp.2d at 22; Lee & Krug, supra at 82-85. Here, however, I want more specifically to emphasize that when the Mark-man hearing is conducted at the summary judgment stage, it is also important to conduct the two hearings independently of each other — the Markman hearing being held prior to and entirely independently of the summary judgment hearing. This is exactly the procedure that the Court followed in the case at hand, although other courts have chosen to address the issues raised with respect to claim construction in the context of the motion for summary judgment and hence conduct the Mark-man hearing in conjunction with the hearings on summary judgment, see, e.g., Biogen v. Berlex Labs., Inc., 113 F.Supp.2d 77, 81 (D.Mass.2000) (conducting the Mark-man hearing “in connection with” the summary judgment hearings). This Court’s Markman procedure turns on what this Court sees as the crucial distinction between construing patent claims in the context of considering motions for summary judgment as opposed to construing the patent claims without regard to the alleged infringement issue presented in the summary judgment motion. With this distinction in mind, this Court scrupulously kept the issues separate in order to avoid conflating the legal explication required by Markman with the fact finding that the Seventh Amendment ultimately reserves for the American jury. See Ciulla v. Rigny, 89 F.Supp.2d 97, 101, 102 & n. 7 (D.Mass.2000) (discussing the constitutional and communitarian values strengthened by jury fact finding) Although, under current law, both approaches are permitted in the wake of Markman, just as the Federal Circuit has spoken to the question of what evidence a court should consider in a Markman hearing, Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582-83 (Fed.Cir.1996), perhaps it ought similarly fashion flexible procedural boundaries within which to conduct such a hearing. Failure to do so not only deprives litigants of the benefit of consistent treatment among districts (or even among specific judges), but also risks descending a slippery slope toward the erosion of the role of the fact finder in patent litigation. This latter fear is the central concern of this Court with the procedural approach to Markman hearings that mixes issues of claim construction with that of infringement by simultaneously considering factual evidence of each. I concede that, analytically, such mixing ought not affect the outcome of claim construction. Nonetheless, I fear that such mixing cuts against the spirit of both Markman itself and its recognition of the importance of the fundamental divide between fact and law (and consequently, fact finder and law definer) upon which our legal system is based because it openly invites the risk that issues of fact and law will be conflated. Indeed, to limit proeedurally the consideration of factual issues at the Markman hearing is analogous to the Federal Circuit’s own warning against the consideration of extrinsic evidence where intrinsic evidence alone will adequately allow for definition of the disputed claim term. See Vitronics Corp., 90 F.3d at 1583. Judges are expected to be objective and analytic in their role as law definer, and I daily seek to meet this standard. Moreover, I do not even mean to suggest that the outcome of this case would have somehow been different had this Court followed the approach that other courts apply and mixed the questions of claim construction into the hearing on summary judgment. But the risk that this procedure creates of conflating issues of fact and law is simply too high in my eyes. Let us not forget that the Seventh Amendment requires that infringement cases be tried to a jury. Markman v. Westview Instruments, Inc., 517 U.S. 370, 377, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). The judiciary has recently mandated other procedural hurdles that seem to fly in the face of efficiency in the sole effort to preserve the role of the American jury. See Apprendi v. New Jersey, 530 U.S. 466, 120 S.Ct. 2348, 147 L.Ed.2d 435 (2000). Believing in the benefits of such a simple prophylactic measure — considering claim construction without regard to infringement — I made careful efforts to follow this procedure consistently. The result is an honest effort to give meaning to the true spirit of Markman and the due consideration that it gave to the role of the jury in patent litigation. During the three-day Markman hearing, the Court entertained oral argument from counsel for each party with respect to ten claim terms that were pre-selected due to their relationship to disputed issues arising in Amgen’s pending summary judgment motion. Counsel referred the Court to relevant portions of the specification as well as the prosecution history. Demonstrative exhibits were utilized, but evidence was neither offered nor admitted. After hearing each party’s presentation, the Court announced its constructions. During the course of the Markman hearing, the positions of each party remained generally consistent. On the one hand, Amgen consistently advocated what the Court referred to as the “ordinary meaning” of a particular claim term. On the other hand, TKT often sought to insert a limitation by arguing that without such limitation, the claim would be invalid for lack of adequate description or enablement. Their positions, of course, were not surprising. As the patent holder, Amgen had every incentive to persuade the Court to adopt the broadest possible interpretation in order to sweep within its patents’ span the greatest possible amount of its competitors’ activities. TKT meanwhile proffered limiting interpretations with an eye toward distinguishing its products and process from the scope of the patents’ language. This dance is well known. Both parties cite Federal Circuit case law that appears to support their conflicting views, thus creating the impression that the case law itself is contradictory. A close examination of this case law, however, reveals that TKT’s approach—though accepted in some limited circumstances—is inappropriate here. In many instances, Amgen relied primarily on the familiar notion that “[f]irst, and most importantly, the language of the claim defines the scope of the protected invention.” Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 619 (Fed.Cir.1995); see also Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed.Cir.1998) (“[T]he claim construction inquiry, therefore, begins and ends in all cases with the actual words of the claim. [T]he resulting claim interpretation must, in the end, accord with the words chosen by the patentee to stake out the boundary of the claimed property.”); Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed.Cir.1997) (“[T]he language of the claim frames and ultimately resolves all issues of claim interpretation”). Relatedly, absent a clear and specific statement in the patent specification giving a claim term a special definition, the Court must adopt the plain and ordinary meaning given by persons experienced in the field of the invention. See Renishaw, 158 F.3d at 1249; Hoechst Celanese Corp. v. BP Chems. Ltd., 78 F.3d 1575, 1578 (Fed.Cir.1996); see also Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1344 (Fed.Cir.1998) (patentee may be her own. lexicographer). Adhering to these cardinal principles of claim construction, this Court discharges its duty of claim construction by interpreting the claim terms pursuant to the plain and ordinary meaning ascribed to them by one skilled in the art. Derived from these core principles is the additional canon of claim construction that a court may not read a limitation into a claim from the written description, but may look to the written description to define a term already in a claim limitation, for a claim must be read in light of the- specification. Vitronics Corp., 90 F.3d at 1582. Thus, even when the Court looks at intrinsic evidence to assist it in identifying the meaning of a claim term, the words of the claim should still be given their preeminence. This canon creates a fine but important line for the Court to walk: “It is entirely proper to use the specification to interpret what the pat-entee meant by a word or a phrase in the claim. But this is not to be confused with adding an extraneous limitation appearing in the specification, which is improper.” E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1433 (Fed.Cir.1988) (citation omitted); see generally David C. Radulescu, The Federal Circuit’s Narrowing of the Literal Scope of Patent Claims by Focusing on Embodiments Disclosed in the Specification, 82 J. Pat. & Trademark Off. Soc’y 59 (2000). To ensure that a litigant does not improperly cross this line, a party wishing to use statements in the written description to confine a patent’s scope must first point to a term in the claim with which to incorporate those statements. Renishaw, 158 F.3d at 1248. “Without any [such] claim term that is susceptible of clarification by the written description, there is no legitimate way to narrow the property right.” Id. Under such circumstances, use of the specifications to “define” the claim term would impermissibly cross over the line by using the specifications to add extraneous limits on the patent. In contrast, TKT relies most heavily upon a number of Federal Circuit cases standing for the proposition that claims ought be construed so as to sustain their validity. See, e.g., Wang Labs. v. Am. Online, Inc., 197 F.3d 1377, 1383 (Fed.Cir. 1999). During the claim construction phase of the case, counsel for TKT implored the Court to reject Amgen’s proffered interpretations because such broad interpretations were not adequately disclosed in the patents’ specification. In short, TKT argued that while Amgen taught the production of EPO using a precise process and specific cells, Amgen went on to claim far beyond its teachings. Thus, if the Court adopted a claim construction commensurate with the plain and ordinary meaning of the overbroad claim terms, its construction would run counter to the Federal Circuit’s command that claims be construed so as to sustain their validity. Indeed, incorporating validity concerns during claim construction may apply “where there are several common meanings for a claim term” and thus “the patent disclosure serves to point away from the improper meanings and toward the proper meaning.” Renishaw, 158 F.3d at 1250. In this sense, the canon that claim terms ought be construed to sustain their validity is simply an interpretation tool to aid courts in determining what a reasonably disputed claim term means in light of the specifications. The Federal Circuit has warned, however, that the canon that claims ought be interpreted to sustain their validity is not without limits: The [Supreme] Court has consistently limited the axiom [that claims should be interpreted to preserve their validity] to cases where the construction is “practicable” and does not conflict with the explicit language of the claim. [The Federal Circuit also has] consistently employed the caveat, “if possible,” to our instruction that claims should be construed to sustain their validity. We have also admonished against judicial rewriting of claims to preserve validity Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed.Cir.1999) (citations omitted). With this limitation in mind, the claim term being construed must first be reasonably capable of the interpretation that is purportedly favored by the arguments for invalidity. Thus, in employing this doctrine, the Court is not permitted to construe a term that has a plain and ordinary meaning in a manner contrary to that meaning. This, of course, would constitute the type of “judicial rewriting” about which the Federal Circuit has warned. See id. Nor does it grant courts the authority to somehow jump to the conclusion that a claim term is reasonably susceptible of competing interpretations. Simply put, the doctrine does not grant courts the power to employ validity arguments to limit claim terms where such claim terms, even considering all alternative definitions, could not reasonably be construed to incorporate such limits. In such circumstances, validity concerns must lie in the province of the fact finder. There is good reason, of course, to avoid conflating invalidity concerns with claim construction. First, the Court is mindful that determining whether a patent is invalid because it lacks a sufficient written description is an issue of fact. See Union Oil Co. of Cal. v. Atl. Richfield Co., 208 F.3d 989, 996 (Fed.Cir.2000). As a result, in a jury case, the members of the jury should determine whether the patent adequately describes each element of the claimed invention. If the Court were to conflate invalidity concerns involving the written description requirement with claim construction, then a function reserved for the jury would be usurped by the trial judge. At the same time, the Supreme Court has made clear that construing the claims of a patent is an issue of law and, as such, claim construction is within the province of the trial judge. See Markman, 517 U.S. at 386, 116 S.Ct. 1384. The conflict, then, becomes clear. If the Court were to select a construction that it believed was more consistent with the written description of the patent but contorted the language of the claim terms in order to do so, the jury, in effect, would be preempted from making the invalidity determination, which is within its province. This the Court cannot do. Second, one must be cognizant that Congress has determined that “[a] patent shall be presumed valid.” 35 U.S.C. § 282. This eongressionally-mandated presumption of validity not only places the burden of proving invalidity on the defendant, but also requires the defendant to prove the point by clear and convincing evidence. SIBIA Neurosciences, Inc. v. Cadus Pharm. Corp., 225 F.3d 1349, 1355 (Fed.Cir.2000). In order to give congressional will the deference it deserves, courts ought not permit defendants to shirk this responsibility by arguing that concerns regarding validity should be accounted for during claim construction. Instead, it strikes the Court that the proper way to proceed, where it is possible, is to interpret the claim terms consistent with their plain and ordinary meaning and hold the defendant to its burden to prove invalidity by clear and convincing evidence. Any other approach would neglect the congressional mandate. In this case, the Court ruled during the Markman hearing that TKT’s claim construction theory extends the canon that claims ought be construed in favor of their validity far beyond its intended reach. Instead, as explained below, because the terms to be construed simply are not reasonably capable of the interpretation proffered by TKT, it became apparent that TKT was actually attempting to add limitations to claim terms rather than merely attempting to define the disputed terms. At the end of the day, the canon that claims ought be construed so as to sustain their validity simply does not include under its umbrella TKT’s arguments as they apply in this matter. With these concerns in mind, the Court conducted the Markman hearing and interpreted ten words and phrases central to the patents-in-suit and the dispute between the parties. Each term, the arguments relevant to it, and the Court’s construction are reproduced below seriatim. A. Vertebrate Cells The term “vertebrate cells” is contained in Claims 4, 6, and dependent Claim 7 of the ’698 patent and Claims 1, 4, and dependent Claims 3, 6, and 7 of the ’349 patent. There is no contention by either party that the term should have a different meaning in the various claims. Aside from that agreement, however, the parties (not surprisingly) proffered quite different constructions. Amgen contended that “vertebrate cells” means “cells originating from an animal having a backbone,” Pl.’s Mark-man Hr’g (Mar. 27, 2000) Demonstrative Ex. 12, whereas TKT argued that the term means “non-human cells that originate from an animal having a backbone,” Defs.’ Markman Hr’g Demonstrative Ex. 1. Thus, while Amgen proffered the broad, albeit ordinary meaning of the term, TKT sought to have the Court add a limitation to the claim by including the word “nonhuman.” The reason for the particular distinction between the parties’ proffered constructions is, not surprisingly, fueled by the related infringement and validity analysis. In order to make EPO, TKT activates the native human EPO gene in a human cell. As a result, there is little wonder why TKT offered, and Amgen vehemently opposed, a construction of the term “vertebrate” that excluded human cells. Had the Court adopted TKT’s version, it would have been bound to issue, upon proper motion, summary judgment of non-infringement — at least as to literal infringement. That, of course, is no reason to reject TKT’s proffer, but merely explains the importance of construing the term appropriately. While counsel for TKT admitted that its construction was contrary to the ordinary meaning of the term “vertebrate,” TKT argued that “the terms of a claim cannot be construed in a vacuum.” Tr. of Mark-man Hr’g, Vol. I at 7:17-18. Instead, implored TKT, the Court must interpret the claims in accordance with the specification and the prosecution history and, set in this context, “vertebrate cells” were not meant to encompass human cells even though humans are admittedly a subset of vertebrates. Id. at 7:22-25. For the reasons expressed above, however, TKT’s contention is untenable. Even if significant intrinsic evidence pointed toward a more limited definition of “vertebrate,” “the claim construction inquiry ... begins and ends in all cases with the actual words of the claim.... [T]he resulting claim interpretation must, in the end, accord with the words chosen by the patentee to stake out the boundary of the claimed property.” Renishaw, 158 F.3d at 1248 (citations omitted). There simply is no hook in the claim term that allows for TKT’s alternate construction. The term “vertebrate” is a widely known and understood word which has a precise scientific meaning. A vertebrate is a member of the subphylum Vertebrata, which is a primary division of the phylum Chordata, which in turn is a division of the Animal Kingdom. A vertebrate is uniquely characterized by a segmented bony or cartilaginous spinal cord. Therefore, the plain and ordinary meaning of the term “vertebrate cells,” i.e., cells that originate from an animal having a backbone, accords with the words chosen by the pat-entee to identify the scope of the claimed invention. Because humans are vertebrates, TKT’s construction betrays the plain and ordinary meaning of the claim term. Thus, the Court construed the term “vertebrate cells” to mean “cells from an animal having a backbone.” Tr. of Markman Hr’g, Vol. I at 67:8-9. B. Mammalian Cells The term “mammalian cells” is contained in Claim 1 of the ’422 patent and dependent Claim 9 of the ’698 patent. Consistent with its approach to vertebrate cells, TKT proffered a construction of the term “mammalian cells” that excluded human cells. Specifically, TKT contended that “mammalian cells” are “[cjells from warm-blooded non-human vertebrate animals whose young are fed by milk secreted from the mammary glands.” Defs.’ Markman Hr’g Demonstrative Ex. 1. Again, with an eye toward literal infringement, Amgen opposed this construction and instead argued that “mammalian cells” are “cells from a warm-blooded animal that has a backbone and whose young are fed by milk secreted from mammary glands.” Pl.’s Markman Hr’g (Mar. 27, 2000) Demonstrative Ex. 14. For the same reasons explained above, the Court could not remain faithful to the widely known and specific meaning of the word “mammalian” if it were to add the non-human limitation. Simply put, the claim term was not reasonably susceptible to TKT’s construction. As a result, the Court determined that “mammalian cells” are “cells from a warmblooded animal, whose young are fed by milk secreted from mammary glands.” Tr. of Markman Hr’g, Vol. I at 67:9-11. C. Mature Erythropoietin Amino Acid Sequence of Fig. 6 This phrase is contained in Claims 4 and 6 of the ’698 patent and Claims 2 and 8 of the ’080 patent. Although the phrase sits in different contexts — and thus modifies different subjects- — the parties agree that the phrase should have the same meaning in both settings. Focusing on the ordinary meaning of the term “mature,” Amgen contended that the phrase means “the fully processed form of the protein secreted by a cell ... when it transcribes and translates the DNA in Figure 6.” Id. at 70:24 to 71:4. In contrast, relying on a portion of the specification that explains that “Fig. 6 thus serves to identify the primary structural conformation (amino acid sequence) of mature human EPO as including 166 specified amino acid residues,” Trial Ex. 1 at 21:3-6, TKT contended that the phrase means “the 166 amino acid sequence of human EPO shown in Fig. 6,” see Tr. of Markman Hr’g, Vol. I at 90:9 to 102:15. The dispute focused on the amino acid located in the 166th position, arginine. Unknown to Dr. Lin at the time of the invention, arginine is cleaved off at some point during protein synthesis prior to secretion from the cell. Thus, the protein that is actually secreted from the cell contains only 165 amino acids. Figure 6, however, depicts the arginine. By proffering the language “fully processed,” Amgen hoped to obtain an interpretation encompassing the secreted version of the protein, regardless of the specific number of amino acids. Meanwhile, TKT, whose process produces secreted proteins containing only 165 amino acids, sought an interpretation of Figure 6 that specifically required 166 amino acids. The Court agreed that the term “mature” implied the fully processed form of EPO secreted by the cell, but whether “mature” included the 165 amino acid sequence as well as the 166 amino acid sequence was ambiguous. The patent specification used “mature” to describe an EPO polypeptide that has been secreted by a cell: the first residue designated for the amino acid sequence of the mature protein is indicative of the likelihood that EPO is initially expressed in the cytoplasm in a precursor form including a 27 amino acid “leader” region which is excised prior to entry of mature EPO into circulation. Trial Ex. 1 at 19:86-41. By identifying the EPO that enters circulation as “mature,” Dr. Lin essentially defined the term “mature” to mean “the fully processed form of the protein that is secreted by the cell.” Consequently, on the one hand, the Court agreed with Amgen’s contention that “fully processed” or “fully realized” ought be incorporated into the Court’s construction of the phrase “mature erythropoietin amino acid sequence of Fig. 6.” On the other hand, the Court was not further persuaded by Amgen that reference to Figure 6 did not limit the meaning of the claim terms to the 166 amino acid sequence disclosed in that figure. Yet neither was TKT able to .persuade the Court at the Markman hearing that the term was necessarily limited to a 166 amino acid construction. Consequently, the Court chose to abstain for the time being from deciding the “165-166 dispute” and concluded only that the phrase “the mature erythropoietin amino acid sequence of Figure 6” means “the fully realized form of amino acid sequence of Figure 6.” Tr. of Markman Hr’g, Vol. II at 23:14-18. D. Non-human DNA Sequences That Control Transcription and Transcription Control DNA Sequences As background, transcription is the process whereby RNA polymerase copies genetic information contained in a DNA nucleotide sequence into a complementary RNA sequence. As the patent explains, “the programming function of DNA is generally effected through a process wherein specific DNA nucleotide sequences (genes) are ‘transcribed’ into relatively unstable messenger RNA (mRNA) polymers.” Trial Ex. 1 at 1:52-55. Transcription is a critical step in the expression of proteins like erythropoietin and is itself controlled by its own DNA sequences. These “transcription control DNA sequences” “precede a selected gene (or series of genes) in a functional DNA polymer [and] cooperate to determine whether the transcription (and eventual expression) of a gene will occur.” Id. at 2:10-13. According to the patent, “transcription control sequences” is the collective term for DNA sequences that not only “provide a site for initiation of transcription into mRNA,” but also are capable of binding proteins that determine “the frequency (or rate) of transcriptional initiation.” Id. at 2:3-12. Claims referring to these transcription control sequences were the subject of the following disputes between the parties. The phrase “non-human DNA sequences that control transcription” is contained in Claim 1 of the ’349 patent. Amgen contended that this phrase means “[n]on-human DNA sequences that are able to initiate or regulate RNA synthesis from EPO DNA.” Pl.’s Markman Hr’g (Mar. 27, 2000) Demonstrative Ex. 69. In contrast, TKT argued that the phrase means “DNA sequences which did not originate in the human genome, which initiate and regulate RNA synthesis of adjacent DNA, and which replace the human EPO transcription control sequences.” Defs.’ Markman Hr’g (Mar. 27-28, 2000) Demonstrative Ex. 1. The dispute centered around a few crucial terms. First, TKT contended that in order to “control” transcription, the DNA sequences must both initiate and regulate the transcription of a gene. Amgen objected to the use of “and,” preferring a construction that required DNA sequences either to initiate or regulate transcription. Second, the parties disputed the importance of location. By including the term “adjacent DNA” in its construction, TKT sought to require the DNA sequences that control transcription to be located in a position adjacent to the gene segment intended to be expressed. Third, the parties disagreed as to the meaning of “non-human.” Amgen argued that “non-human” means “not part of the human genome,” whereas TKT contended that it means “not originating in the human genome.” Because it is scientifically arguable that viral DNA originates in the human genome, the viral promoter DNA that TKT employs thus might not fall within the meaning of the claim. The Court first determined that “nonhuman” DNA sequences are DNA sequences that are “not part of the human genome.” Tr. of Markman Hr’g, Vol. II at 56:25 to 57:1. The Court rejected TKT’s construction, ruling that Amgen meant simply to exclude the human DNA sequences that control transcription from the reach of its claim, sequences which, of course, are part of the human genome. By construing the term “non-human” to mean “not part of the human genome,” then, the Court settled on a construction that best effectuated Amgen’s intent. Second, the Court rejected TKT’s “adjacent” language because no claim term could reasonably be construed to be limiting the transcription control DNA sequences by their location. Consequently, the Court adopted a construction that was in no way limited by the location of the transcription control sequences relative to the gene to be expressed. Third, the Court held that “DNA sequences that control transcription are DNA sequences that initiate and may regulate the processes of transcription.” Id. at 57:1-4. When it announced its construction of this phrase, the Court used the term “may,” which signifies that while the DNA sequence must initiate transcription, it need not regulate transcription. The Court then considered the phrase “transcription control DNA sequences,” which is contained in Claim 4 of the ’349 patent. Borrowing extensively from the patent specification, the Court explained that “transcription control sequences” are “collectively promoter DNA sequences that provide a site that is capable of initiating transcription ... and regulator DNA sequences that are capable of binding proteins that determine the frequency or rate ... of transcription initiation.” Id. at 57:16-23. At the time, the Court did not recognize the inconsistency between these two constructions. Although “DNA sequences that control transcription” and “transcription control DNA sequences” should have the same meaning, the Court’s constructions permitted regulator functions in one instance and required them in the other instance. As will be explained in the infringement portion of the decision, however, the parties tried the case with the latter construction in mind and thus no harm to the parties resulted. E. Purified from Mammalian Cells Grown in Culture The phrase “purified from mammalian cells grown in culture” is contained only in Claim 1 of the ’422 patent, for which the Court subsequently granted summary judgment on literal infringement grounds. The parties presented strikingly different constructions of this phrase during the Markman hearing. Amgen contended it means “[pjurified from the in vitro culture in which the mammalian cells have been grown,” Pl.’s Markman Hr’g (Apr. 10, 2000) Demonstrative Ex. Amgen’s ’422 Patent Claim 1, whereas TKT argued that it means “obtained in a substantially homogeneous state from the mammalian cells in which it was produced and not from the cell culture media,” Defs.’ Markman Hr’g (Apr. 10, 2000) Demonstrative Ex. 50. TKT admitted that the specification taught three different methods of obtaining EPO: extraction (1) from the cell cytoplasm; (2) from the cell membrane; and (3) from the cell culture medium. TKT nonetheless contended that the plain and ordinary meaning of the phrase meant that the EPO had to be purified from the cells. Thus, argued TKT, Amgen only claimed one of the three methods it taught in the patent. Because TKT obtains its EPO from the cell culture media and not directly from its cells, the parties’ positions are not surprising. The Court, however, disagreed with TKT’s interpretation of the claim with respect to both the plain and ordinary meaning of the terms and the consistency of its interpretation with the other claims. First, TKT’s construction would exclude the patent’s preferred embodiment: Example 10. Constructions that exclude the patent’s preferred embodiment should rarely be adopted. Modine Mfg. Co. v. United States Int’l Trade Comm’n, 75 F.3d 1545, 1550 (Fed.Cir.1996); Media-Com, 4 F.Supp.2d at 28. Example 10 extensively describes techniques for obtaining substantially purified erythropoietin from cell culture media. Trial Ex. 1 at 27:15-50, 28:29-32. TKT’s claim construction would exclude the method taught in the patent’s preferred embodiment and hence is suspect. Second, from the Court’s perspective, TKT’s construction ignored the language “grown in culture” and focused solely on the immediately preceding language, “purified from mammalian cells.” If the claim merely read “purified from mammalian cells,” then TKT’s argument that the human erythropoietin must be extracted from the cell itself would indeed have held more sway. Yet all of the terms of the claim must be given effect. Consequently, the Court read the phrase “mammalian cells grown in culture” as a whole and, therefore, as not specifying a particular method, but rather encompassing purification techniques from the cells or the cell culture medium. Thus, the Court held that “purified from mammalian cells grown in culture” means “obtained in substantially homogeneous form from the mammalian cells, using the word from in the sense that it originates in the mammalian cells, without limitation to it only taking it directly out of the interior of the cells, which have been grown in the in vitro culture.” Tr. of Markman Hr’g, Vol. III at 16:15-19. F. DNA Encoding Human Erythro-poietin The phrase “DNA encoding human er-ythropoietin” is contained in Claim 1 and related to dependent Claims 3 and 7 of the ’349 patent. Amgen, on the one hand, contended that the claim terms are so straightforward that interpretation of any of the terms was unnecessary. TKT, on the other hand, argued that the phrase means “[h]uman EPO DNA that is exogenous to the cell in which the EPO is produced, i.e., the human EPO DNA did not originate in the genome of the cell into which it is inserted,” Defs.’ Markman Hr’g (Apr. 10, 2000) Demonstrative Ex. 19— more succinctly, “exogenous DNA encoding human erythropoietin.” TKT argued that because the patent specification only taught using DNA that encoded for human erythropoietin that did not originate in the genome of the host cell (exogenous DNA), the claim term should not be interpreted to include both exogenous and endogenous human EPO DNA. Because TKT activates the human erythropoietin gene in the human host cell (the endogenous EPO gene), one can understand TKT’s motivation in proffering its construction. Yet, as the Court pointed out, TKT’s construction is merely “a variant of the argument that’s already been made here.” Tr. of Markman Hr’g, Vol. III at 23:2-3. TKT was once again employing invalidity contentions in an attempt to add limitations into claim terms that by their plain meaning were not amenable to such limitations. The plain meaning of the claim terms simply do not call for any such limitation. This portion of the claim language claims any and all DNAs that encode human erythropoietin regardless of such DNA’s relationship to the host cell in which it is expressed. Thus, the Court held that “DNA encoding human erythro-poietin” means “DNA which encodes human erythropoietin, not including the word exogenous DNA which encodes human erythropoietin.” Id. at 35:1-3. G. Operatively Linked “Operatively linked” is located in Claim 4 of the ’698 patent and related by dependency to Claims 5 and 9. In context, the phrase relates to the relationship between promoter DNA and the DNA that is transcribed downstream from the promoter DNA. Amgen contended that the phrase means “[positioned such that it provides for initiation of transcription of a gene.” Pl.'s Markman Hr’g (Apr. 10, 2000) Demontrative Ex. Amgen’s ’698 Patent Claim 4. TKT argued that the term means “[positioned adjacent] to the DNA encoding EPO in a way that maintains the capability to initiate transcription of EPO DNA.” Defs.’ Markman Hr’g (Apr 10, 2000) Demonstrative Ex. 69 (alteration in original). The parties disputed, once again, the issue of the location of the promoter relative to the gene to be expressed. Amgen argued that the words “operatively linked” imposed no locational restriction, whereas TKT contended that because the patent taught placing the promoter DNA immediately adjacent to the DNA encoding EPO, the term “operatively linked” ought be limited by location. The term “linked” could, if unmodified by “operatively,” imply a spatial relationship in that a link could fix the maximum distance between the two linked objects. Yet modification by the term “operatively” implies a functional rather than physical link between the two objects — in this instance one entity’s exertion of influence on another entity. More specifically, in this case, the link between the promoter DNA and DNA encoding EPO consists of the influence possessed by the promoter DNA to initiate the transcription from the DNA encoding EPO. As a result, the term “op-eratively linked” is not defined by the physical location of the promoter DNA relative to the DNA encoding erythro-poietin, but rather by the functional effect the promoter DNA has on the EPO DNA. Thus, contrary to TKT’s contentions, the term “operatively linked” could not reasonably be construed to impose a locational restriction, because the link is limited only in the sense that the promoter DNA must initiate transcription of the EPO DNA. Consequently, the Court determined that “operatively linked” means “the promoter DNA is linked to the EPO DNA in a way that maintains the capability of the promoter DNA to initiate transcription of the EPO DNA.” Tr. of Markman Hr’g, Vol. III at 43:8-10. H. Non-naturally Occurring The phrase “non-naturally occurring” modifies the erythropoietin glycoprotein product claimed in the ’933 patent, Claims 1 and 2 and dependent Claim 9, as well as Claim 3 and dependent Claim 4 of the ’080 patent. TKT argued that the phrase was meant to incorporate the exogenous DNA limitation that it had sought (unconvincingly) with respect to many of the prior construed claim terms. Thus, it proffered the following definition: “produced from an EPO DNA coding sequence which was not part of the native genome of the host cell in which the EPO protein is produced .... ” Defs.’ Markman Hr’g Demonstrative Ex. 36. Amgen, in contrast, contended that the term means “[ojbtained from a source that does not naturally produce or contain EPO.” Pl.’s Markman Hr’g (Apr. 10, 2000) Demonstrative Ex. Amgen’s ’933 Patent Claim 1 (emphasis omitted). The contentions conflicted in this manner because TKT activates an endogenous EPO gene in a human cell, as opposed to generating EPO from an exogenous gene transfected into a host cell. Unlike the prior instances in which TKT attempted to impose the exogenous DNA limitation into the construction of a claim term, there is a reasonable argument that the term “non-naturally occurring” has the meaning that TKT attempted to ascribe to it because, to put it simply, there is something a bit “non-natural” about an erythro-poietin glycoprotein being produced by transfecting host cells with exogenous EPO DNA. Yet TKT’s interpretation is deficient for various reasons. First, TKT’s ship runs aground on the claim construction axiom that a claim will not be construed as containing a limitation that is expressed in other claims. See Karlin Tech. Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971-72 (Fed.Cir.1999). Similarly, “[a]U the limitations of a claim must be considered meaningful,” Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1562 (Fed.Cir.1991) (citation omitted), and if two separate and distinct limitations are construed as synonymous, the claim recitation of both limitations is redundant and superfluous. See Beachcombers, Int'l v. WildeWood Creative Prods. Inc., 31 F.3d 1154, 1162 (Fed.Cir.1994); Tex. Instruments, Inc. v. United States Int’l Trade Comm’n, 988 F.2d 1165, 1171 (Fed.Cir.1993). Claim 3 of the ’933 patent, though not in suit, claims a “non-naturally occurring glycoprotein product of the expression in a mammalian host cell of an exogenous DNA sequence comprising a DNA sequence encoding human erythropoietin .... ” If the Court were to adopt TKT’s construction of “non-naturally occurring,” it would render the terms redundant in the context of the ’933 patent’s Claim 3. Thus, neither the paten-tee nor the examiner could have meant the term “non-naturally occurring” to refer to the use of exogenous EPO DNA. Second, the patent specification also explains that the recombinant-produced and synthetic products are both similar to and different from natural EPO. For example, one passage compares the biological activity of the synthetic products to that of “EPO isolates from natural sources” or “natural EPO isolates.” Trial Ex. 1 at 33:14, 33:24; see id. at 33:40-44. Thus, the specification indicates that Dr. Lin contemplated his polypeptide products visa-vis the unpatentable EPO polypeptide from natural sources. Furthermore, the Supreme Court has used the term “nonna-turally occurring” to distinguish a “product of human ingenuity” from the “natural phenomenon” that the non-natural version mimics. See Diamond v. Chakrabarty, 447 U.S. 303, 309-10, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980). In considering the terms “non-naturally occurring” here, the Court held that Dr. Lin intended a similar meaning. By including this limitation, Dr. Lin meant to stand clear of the unpatentable, naturally occurring products. He intended nothing more. In light of these considerations, after taking the matter under advisement on April 10, 2000, the Court informed the parties at the final pretrial conference on April 18, 2000 that “non-naturally occurring” means “not occurring in nature.” I. Glycosylation Which Differs The phrase “glycosylation which differs” is recited only in Claim 1 of the ’933 patent and relates to Claims 2 and 9 of the same patent by dependency. The parties essentially agreed that glycosylation refers to the carbohydrate side chains that are attached to a molecule, in this case erythro-poietin. Yet Amgen further contended that the phrase means that “[t]he attached carbohydrate groups differ when analyzed by standard prior art techniques known as of 1983-84.” Pl.’s Markman Hr’g (Apr. 10, 2000) Demonstrative Ex. Amgen’s ’933 Patent Claim 1 (emphasis omitted). TKT argued that it means “the carbohydrate groups attached to side chains of the er-ythropoietin polypeptide backbone differ by Western blot analysis and SDS/ PAGE and carbohydrate composition analysis from those of human urinary erythropoietin to at least the degree described in the patents-in-suit.” Defs.’ Markman Hr’g (Apr. 10, 2000) Demonstrative Ex. 89 (footnotes added). The primary discrepancy concerned which, if any, techniques would be specifically identified as methods encompassed under the meaning of the term “glycosylation which differs.” TKT contended that the specification describes two tests by which to prove differences in glycosylation: SDS-PAGE/Western Blot and carbohydrate composition analysis. Thus, TKT’s construction would require proof with respect to both types of tests and no others, whereas Amgen’s construction would not limit the manner by which differences in glycosylation are proven. Example 10 of the patent describes comparisons made between recombinant glyco-protein products and human urinary eryth-ropoietin using various techniques. See Trial Ex. 1 at 28:33-67. The specification not only reports data obtained from SDS-PAGE/Western blot analysis, but also by monosaccharide, or carbohydrate, analysis. See id. Yet the claim term “glycosylation which differs” is not further limited by the methods used to identify such differences in Example 10. A comparison of Claims 1 and 2 of the ’933 patent exposes the significance of the exclusion of such a limitation. Claim 2 of the ’933 patent requires the EPO glycoprotein product to have “a higher molecular weight than human urinary EPO as measured by SDS-PAGE.” Id. at 38:23-25 (emphasis added). Claim 1, however, merely states that the erythropoietin glycoprotein product must have “glycosylation which differs from that of human urinary erythropoietin.” Id. at 38:20-21. The inference is that the patentee knew how to limit claim terms regarding differences in glycosylation by specifying the method by which such differences are empirically tested. Taking this into account, the Court was loath to mandate that proof of glycosylation differences must be shown using the particular types of tests specifically identified in the patent. As a result, the Court avoided mandatory language, but nonetheless ruled that “glycosylation which differs” means: “Glycosylation as to which there is a detectable difference based upon what was known in 1983-1984 from that of human urinary erythropoietin, having in mind that the patent holder, Amgen, taught the use of this Western blot, SDS-PAGE and monosaccharide test.” Tr. of Markman Hr’g, Vol. III at 102:18-23. J. Human Urinary Erythropoietin The ’933 patent employs the phrase “human urinary erythropoietin” in Claims 1 and 2 and dependent Claim 9. Trial Ex. 2 at 38:21, 38:23, 39:3. Amgen contended that the term means “[h]uman EPO isolated from pooled urine of aplastic anemia patients isolated using any method used in the prior art,” Pl.’s Markman Hr’g (Apr. 10, 2000) Demonstrative Ex. Amgen’s ’933 Patent: The Parties Constructions (emphasis omitted), whereas TKT argued that it means “[a]ll EPO preparations that can be isolated or purified from human urine by any method,” Defs.’ Markman Hr’g (Apr. 10, 2000) Demonstrative Ex. 2. The dispute, then, is essentially one of scope: Does the claim term encompass all eryth-ropoietin preparations obtained from human urine or is it limited to only EPO obtained from the pooled urine of aplastic anemia patients? In order to support its construction, Am-gen relied on the specification and prosecution history. The specification, for instance, identifies and briefly describes the “Miyake procedure” for “purifying human erythropoietin from urine of patients with aplastic anemia.” Trial Ex. 1 at 7:10-17. The patent cites other prior art sources that describe the isolation of human urinary erythropoietin from the pooled urine of aplastic anemia patients. Id. at 8:13-16. The specification also reports the results relating to molecular weight comparisons of CHO-produced EPO, COS-produced EPO, and the “pooled source human urinary extract.” Id. at 28:33-41. Similarly, Amgen pointed to comparisons between its recombinant er-ythropoietin and human urinary erythro-poietin purified by the Miyake procedure as evidence of novelty. Trial Ex. 2 Tab 6 at 11. Though Amgen’s construction may be supported by these aspects of the specification and prosecution history, Amgen’s narrow interpretation of this claim limitation is not faithful to the plain and ordinary meaning of the claim language. The claim terms themselves do not specify which type of human urinary erythropoiet-in is contemplated. Instead, the plain and ordinary meaning of the phrase “human urinary erythropoietin” broadly encompasses all urinary EPOs. As a result, “on this one, in all candor, the shoe is on the other foot .... ” Tr. of Markman Hr’g, Vol. III at 106:11-12. Thus, adhering to the plain meaning of the terms, the Court concluded that “human urinary erythro-poietin” means “erythropoietin derived from human urine.” Id. at 112:23-24. III. SUMMARY JUDGMENT OF INFRINGEMENT ON CLAIM 1 OF THE ’422 PATENT Following the Markman hearing, the Court turned promptly- — albeit in an entirely separate hearing, see supra Part II — to considering the then pending motion for summary judgment. On April 26, 2000, the Court heard oral argument regarding whether TKT’s activities literally infringe Claim 1 of the ’422 patent and Claims 1, 3, 4, and 6 of the ’349 patent. Amgen argued that there were no genuine issues of material fact regarding the technologies of each party and that a plain reading of the claims of Amgen’s patents entitled Amgen to judgment as matter of law. Summary judgment is appropriate when there are no genuine issues of material fact and the movant is entitled to judgment as matter of law. Fed.R.Civ.P. 66. Nonetheless, the Court must view the evidence in the light most favorable to the non-movant and must draw all reasonable inferences and resolve all doubts regarding factual issues in favor of the party opposing summary judgment. Pfaff v. Wells Elecs., Inc., 5 F.3d 514, 517 (Fed.Cir.1993). In considering a motion for summary judgment, the Court relies upon any “ ‘pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits’” which, in toto, comprise the relevant record. Rotec Indus., Inc. v. Mitsubishi Corp., 215 F.3d 1246, 1250 (Fed.Cir.2000) (quoting Fed.R.Civ.P. 56[c]). As is required under controlling law, the Court considers only the documents in the summary judgment record as of April 26, 2000. As this Court has previously held, “if there are no genuine issues of material fact, summary judgment is appropriate in a patent infringement case as in any other.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 3 F.Supp.2d 104, 107 (D.Mass.1998). Infringement is a two-part inquiry requiring the construction of the claims, which is a question of law, and the application of the properly construed claims to the allegedly infringing article, which is a question of fact. Markman v. Westview Instruments, Inc., 517 U.S. 370, 391, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996); Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1247-48 (Fed.Cir.1998). When the parties do not dispute relevant facts regarding infringement, but merely disagree over claim construction, “the question of literal infringement collapses to one of claim construction and is thus amenable to summary judgment.” Athletic Alternatives, Inc. v. Prince Mfg., Inc., 73 F.3d 1573, 1578 (Fed.Cir.1996); see K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 52 U.S.P.Q.2d (BNA) 1001, 1004 (Fed.Cir.1999). In contrast, when the Court construes the claims in favor of the plaintiff, and a genuine issue of material fact regarding infringement nonetheless exists, summary judgment is not appropriate. See MacNeill Eng’g Co. v. Trisport, Ltd., 126 F.Supp.2d 51, 58 (D.Mass.2001). With these considerations in mind, the Court addressed the legal issue whether, upon the summary judgment record, TKT’s product, HMR4396, and TKT’s R223 cells literally infringe Claim 1 of the ’422 patent. Claim 1 of the ’422 patent claims a “pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.” Trial Ex. 6 at 38:36-40. As Federal Circuit precedent requires, the Court broke down Claim 1 into each of its limiting terms and compared those terms — and any meanings ascribed to them during the Markman hearing — with TKT’s HMR4396 and R223 cells. A. Pharmaceutical Composition Amgen submitted ample and uncontra-dicted evidence on the summary judgment record that TKT’s HMR4396 injection is a pharmaceutical composition. As explained in Section 3.6 of TKT’s Investigational New Drug Application (“IND”) for HMR4396, which is submitted to the Food and Drug Administration (“FDA”) in order to initiate and facilitate the agency’s clinical investigation of the product, “HMR4396 Injection is a sterile, nonpyro-genic, colorless aqueous solution in Water for Injection at 4000 U/ml or 10,000 U/ml concentrations.” Galvin Decl. (Nov. 4, 1999) Ex. 10 at IND000019. Furthermore, the fact that the product has been submitted for investigation by the FDA is clear evidence that HMR4396 is a pharmaceutical composition. Another IND document describes diluting the HMR4396 purified bulk “to obtain the desired drug product dosage strengths .... ” Id. Ex. 18 at IND501303; see id. Ex. 1 at 242:9 to 243:25, 282:8-21 (explaining that HMR4396 is an aqueous solution that is further formulated into a pharmaceutical composition). In light of this uncontra-dicted evidence, HMR4396 is a pharmaceutical composition as that term is used in Claim 1 of the ’422 patent. B. Therapeutically Effective Amount of Human Erythropoietin It cannot be disputed that HMR4396 is human erythropoietin. Section 3.3 of the IND for TKT’s “Gene-Activated Erythropoietin” directly states that “HMR4396 is human erythropoietin produced by TKT’s gene-activation technology.” Id. Ex. 10 at IND000019; see id. Ex. 14 at IND000335-37, 000385 (identifying HMR4396 as human erythropoietin). Furthermore, in response to the question whether HMR4396 is human erythropoiet-in, TKT’s Federal Rule of Civil Procedure 30(b)(6) designee, David S. Johnson, answered affirmatively. Id. Ex. 4 at 37:10-11. Another TKT Rule 30(b)(6) designee, Richard F. Selden, admitted that HMR4396 is human erythropoietin. Stretch Decl. (Apr. 20, 2000) Ex. 4 at 399:15-19; see Galvin Decl. (Nov. 4, 1999) Ex. 1 at 14:12 to 15:6. In the face of these significant admissions, TKT opted to take two tacks, but neither steadied its rocking boat because both were unsuccessful attempts at changing the Court’s claim construction rather than efforts to raise an issue of disputed material fact. First, in its initial response to Amgen’s summary judgment motion and during subsequent argument, TKT contended that HMR4396 was not human er-ythropoietin because as that term is used in the patent “human erythropoietin” means recombinant EPO produced in nonhuman cells transfected with cloned, exogenous human EPO DNA. Because HMR4396 is produced by activating the endogenous EPO gene in a human cell, such a construction would exclude TKT’s product. This contorted claim construction, however, was rejected by the Court. See supra Section II.F, at 33-34. Second, during oral argument following claim construction, TKT attempted to add a further limitation into the claim. Relying on language from the specification regarding Claim 1 of the ’422 patent that explained that the pharmaceutical composition was comprised of “effective amounts of polypeptide products of the invention,” Trial Ex. 6 at 12:6-7, TKT argued that “human erythropoietin”should be limited by this phrase. Thus, contended TKT, because the polypeptide products of the invention are defined in part by Figure 6, see id. 11:42-54, which erroneously specifies a 166 amino acid chain, see Trial Ex. 1 Fig.6, and TKT only isolates a 165 amino acid product, HMR4396 could not be human erythropoietin. TKT thus seeks to read a 166 amino acid limitation into the claim term “human erythropoietin.” This the Court cannot do. As with the previous tack, this argument drifted far astray from the language of the claim and was therefore unpersuasive. Rather than attack the Court’s claim construction, to forestall summary judgment, TKT needed to point to evidence that would demonstrate a genuine issue of material fact regarding infringement in the context of the Court’s construction. Because it failed to do so, and Amgen’s evidence on the same point was substantial, the Court determined that HMR4896 is human erythropoietin. Moreover, when asked by the Court whether HMR4396 contains a therapeutically effective amount of human erythro-poietin, counsel for TKT admitted that, “If it didn’t, believe me, we wouldn’t be standing here.” Tr. of Markman Hr’g, Vol. II at 130:19-20. As admissions on the record constitute evidence upon which reliance may be placed at the summary judgment stage, see Fed.R.Civ.P. 56(c), counsel’s direct answer is more than sufficient to warrant summary judgment of infringement with respect to this claim term. Counsel’s response also comports with the common sense con