Full opinion text
OPINION GREENAWAY, District Judge. This matter comes before the Court on the application for a preliminary injunction by Plaintiffs Aventis Pharmaceuticals, Inc., Merrell Pharmaceuticals Inc., Carderm Capital L.P., and AMR Technology, Inc. (collectively “Plaintiffs”), seeking to enjoin Defendants Barr Laboratories, Inc. (“Barr”), Teva Pharmaceuticals USA, Inc. (“Teva”), Ranbaxy Laboratories Limited and Ranbaxy Pharmaceuticals, Inc. (collectively “Ranbaxy”), and Amino Chemicals, Ltd. (“Amino”) (collectively “Defendants”), from patent infringement, or inducing patent infringement, by marketing, making, using, or selling generic fexofenadine. For the reasons set forth below, the application for a preliminary injunction is denied. BACKGROUND This dispute concerns patents owned by, or licensed to, Aventis Pharmaceuticals, Inc., Merrell Pharmaceuticals Inc., Carderm Capital L.P., and AMR Technology, Inc. relating to fexofenadine formulations sold in the United States by Aventis under the tradename ALLEGRA®. This antihistamine allergy medication product has achieved substantial commercial success in the United States. Between May 2001 and June 2002, Defendants Barr and Teva each filed Abbreviated New Drug Applications (“ANDA”) seeking the Federal Drug Administration’s (“FDA”) approval to market generic drug products containing the same active ingredient, fexofenadine hydrochloride (“fexofenadine”), as ALLEGRA®. In response, Plaintiffs filed a series of suits for infringement of a larger group of patents than is at issue in this motion for a preliminary injunction; litigation in these suits is ongoing. On August 31, 2005, the FDA approved Barr’s ANDA no. 076191. On September 1, 2005, the FDA approved Teva’s ANDA no. 076447. On September 6, 2005, Barr and Teva announced an agreement to market generic fexofenadine jointly. Ranbaxy has manufactured fexofenadine for Barr. Amino has manufactured fexofenadine for Teva. On September 20, 2005, Plaintiffs asked this Court to order Defendants to show cause why a preliminary injunction against Defendants should not issue. Plaintiffs sought for this Court to enjoin Defendants Teva and Barr from marketing generic fexofenadine, thereby actively inducing infringement of U.S. Patent No. 6,037,353 (filed Mar. 2, 1995) (the “’353 patent”), U.S. Patent No. 6,187,791 (filed Jan. 12, 2000) (the “ ’791 patent”), and U.S. Patent No. 6,399,632 (filed Sept. 15, 2000) (the “’632 patent”) (collectively “the method patents”), and to enjoin Defendants Barr, Teva, Ranbaxy and Amino from making, using, or selling generic fexofenadine, thereby infringing claim 7 of U.S. Patent No. 5,750,703 (filed Feb. 2, 1995) (the “’703 patent” or “process patent”). On September 29, 2005, this Court granted the application and ordered Defendants to show cause why the preliminary injunction should not issue. Subsequent to the filing of the application for the preliminary injunction, Plaintiffs stated that Barr has not put any fexofenadine manufactured by Ranbaxy on the market, beyond having made a token sale. Plaintiffs have not, however, withdrawn their application for a preliminary injunction against Barr or Ranbaxy. APPLICABLE LEGAL STANDARDS I.Preliminary Injunction As the moving party, a plaintiff “is entitled to a preliminary injunction if it shows: (1) a reasonable likelihood of success on the merits of its claims; (2) irreparable harm if an injunction is not granted; (3) a balance of hardships tipping in its favor; and (4) the injunction’s favorable impact on the public interest.” Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1370 (Fed.Cir.2005). In order to demonstrate a likelihood of success on the merits on a particular claim of patent infringement, Plaintiffs must show that, in light of the presumptions and burdens that will inhere at a trial on the merits, (1) Defendants likely infringe the patent, and (2) the claims of the patent will likely withstand Defendants’ challenges to validity. Id. If Defendants “raise[ ] a substantial question concerning either infringement or validity, i.e., assert[] an infringement or invalidity defense that the patentee cannot prove ‘lacks substantial merit,’ the preliminary injunction should not issue.” Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350-1351 (Fed.Cir.2001). Thus, once the non-movant has raised a substantial question as to infringement or validity, for the preliminary injunction to issue, the movant must prove that this question lacks substantial merit. “[I]nfringement and validity analyses must be performed on a claim-by-claim basis.” Id. at 1351. “[I]n cases involving multiple patent claims, to demonstrate a likelihood of success on the merits, the patentee must demonstrate that it will likely prove infringement of one or more claims of the patents-in-suit, and that at least one of those same allegedly infringed claims will also likely withstand the validity challenges presented by the accused infringer.” Id. II. Infringement The test for patent infringement requires a two step analysis: “the claim scope is first determined, and then the properly construed claim is compared with the accused device to determine whether all of the claim limitations are present either literally or by a substantial equivalent.” Id. “To prove direct infringement, the plaintiff must establish by a preponderance of the evidence that one or more claims of the patent read on the accused device literally or under the doctrine of equivalents. Literal infringement requires that each and every limitation set forth in a claim appear in an accused product.” Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1310 (Fed.Cir.2005) (internal citations omitted). Although claim construction is an issue of law, the determination of infringement is a question of fact. Pause Tech. LLC v. TiVo Inc., 419 F.3d 1326, 1329 (Fed.Cir.2005). III. Validity In Amazon, the Federal Circuit stated the standard for a validity challenge in the context of an application for a preliminary injunction: Validity challenges during preliminary injunction proceedings can be successful, that is, they may raise substantial questions of invalidity, on evidence that would not suffice to support a judgment of invalidity at trial. The test for invalidity at trial is by evidence that is clear and convincing.... In resisting a preliminary injunction ... one need not make out a ease of actual invalidity. Vulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial. The showing of a substantial question as to invalidity thus requires less proof than the clear and convincing showing necessary to establish invalidity itself.... When moving for the extraordinary relief of a preliminary injunction, a patentee need not establish the validity of a patent beyond question. The patentee must, however, present a clear case supporting the validity of the patent in suit. Amazon, 239 F.3d at 1358-1359 (citations omitted). ANALYSIS I. Plaintiffs have not demonstrated a likelihood of success in establishing that Barr has infringed the process patent. For purposes of the motion for a preliminary injunction, Plaintiffs assert only claim 7 of the ’703 manufacturing process patent. There is no dispute that Ranbaxy has manufactured fexofenadine for Barr. Plaintiffs contend that Ranbaxy has infringed claim 7 of the ’703 patent. Under 35 U.S.C. § 271(g), if Ranbaxy has infringed, Barr is liable as an infringer for importing Ranbaxy’s product. The parties agree that determination of Barr’s and Ranbaxy’s alleged infringement of claim 7 of the process patent turns on the Court’s construction of the phrase “substantially pure regioisomer” in claim 1, the independent claim on which claim 6 and, in turn, claim 7 depend. At issue is the question of the scope of “substantially pure” in regard to the regioisomer p-CPK (i.e., the para regioisomer of cyclopropylketone), an intermediate in the manufacturing process: how pure is “substantially pure?” A. Tentative claim construction of “substantially pure regioisomer” in the process patent At the preliminary injunction stage, the district court has the discretion to base its resolution on a tentative claim construction. Guttman, Inc. v. Kopykake Enters., 302 F.3d 1352, 1361 (Fed.Cir.2002). “District courts may engage in a rolling claim construction, in which the court revisits and alters its interpretation of the claim terms as its understanding of the technology evolves.” Id. The Court decides claim construction as a matter of law: “the construction of a patent, including terms of art within its claim, is exclusively within the province of the court.” Markman v. Westview Instruments, 517 U.S. 370, 372, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). “To ascertain the meaning of claims, we consider three sources: the claims, the specification, and the prosecution history.” Markman v. Westview Instruments, 52 F.3d 967, 979 (Fed.Cir.1995), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996) (citations omitted). 1. Ascertaining the meaning based on the claims The Court first looks to the language of the claims themselves to ascertain the meaning and scope of the phrase “substantially pure regioisomer.” Claim 1 recites “a process of preparing a piperidine derivative compound” of a formula which includes both fexofenadine and fexofenadone, “said process comprising: providing a substantially pure regioisomer” p-CPK and “converting the substantially pure regioisomer to the piperidine derivative compound” using the compound azacyclonol (“AZA”). ’703 Patent col. 23 1. 45—col. 24 1. 34. Claim 6 adds onto this process a step in which the piperidine derivative compound is transformed into an end product in the fexofenadine family. Id. col. 25 1. 63—col. 26 1. 16. Claim 7 recites the process of claim 6, with the end product being fexofenadine. Id. col. 26 11. 17-32. Thus, in claim 7, the patented process begins with the “substantially pure regioisomer” p-CPK, often referred to as an intermediate, and finishes with the end product fexofenadine. The parties agree that there is nothing express or implicit in the words of claims 1, 6, or 7 that delimits the purity of the p-CPK intermediate that the process begins with. They agree as well that “substantially pure” has no ordinary or customary meaning to one of ordinary skill in the art. (Def.’s Opp. Br. 44.) Claim 2 provides information relevant to construction of the phrase at issue. Nonasserted dependent claims may be helpful in construing a term in an independent claim, because the claims must be interpreted consistently. See Wright Med. Tech., Inc. v. Osteonics Corp., 122 F.3d 1440, 1445 (Fed.Cir.1997) • (“[W]e must not interpret an independent claim in a way that is inconsistent with a claim which depends from it”); accord Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1317 (Fed.Cir.2005). Claim 2 depends from claim 1 and recites steps comprising the “providing a substantially pure regioisomer” of the previous claim. Id. col. 24 1. 35—col. 25 1. 22. These steps comprise, in brief, producing a first mixture of regioisomers, which is hydrolyzed to form a second mixture of regioisomers, and then “recovering from the second mixture of regioisomers the substantially pure regioisomer” p-CPK. Id. col. 25 11. 12-13. The parties do not dispute that “mixture” in claim 2 refers to a mixture of meta regioisomers and para regioisomers. The claim language thus establishes that a “substantially pure regioisomer” is something that is recovered from, and therefore, not the same as, a “mixture of regioisomers.” This must mean that a “substantially pure regioisomer” is not a “mixture” of regioisomers. This supports an initial construction of “substantially pure regioisomer” as meaning “the regioisomer substantially different from a mixture.” Moreover, if the mixture consists only of para and meta regioisomers, and a non-mixture is recovered, then this non-mixture must logically substantially consist of only the para regioisomer or the meta regioisomer. Because the parties agree that, as a general rule, the meta regioisomers of fexofenadine are unwanted impurities that should be eliminated, and they do not dispute that one of ordinary skill in the art would have understood this at the time of application, it is reasonable to infer that “substantially pure regioisomer” in claim 2 means “the para regioisomer substantially not mixed with meta regioisomer.” Because claims must be interpreted consistently, this analysis provides the initial construction of “substantially pure regioisomer,” as used in claim 1. Drawings in a patent may be a source of information in claim construction. Ferguson Beauregard/Logic Controls v. Mega Sys., LLC, 350 F.3d 1327, 1338 (Fed. Cir.2003); Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1324 (Fed.Cir.2002). In the chemical drawings used in the claims, benzene rings are drawn as hexagons with a circle inside. Each circle is labeled with a letter that corresponds to the substituent of the ring. Defendants observed, and Plaintiffs did not dispute, that the diagrams themselves indicate whether a chemical is or is not a mixture: the drawings of chemicals identified as mixtures in the claims all show a bond line connecting the hexagon to the circle, whereas the drawings of chemicals identified as substantially pure have no such connecting bond line. This aspect to the drawings appears meaningful in examining claim 2. Thus, in claim 2, a diagram with a connecting line depicts “a first mixture of regioisomers” and “a second mixture of regioisomers.” ’703 Patent, col. 24 1. 58—col. 25 1. 9. After stating the step of “recovering from the second mixture of regioisomers the substantially pure regioisomer,” claim 2 shows a diagram without a connecting line. Id. col. 25 11. 11-22. This provides additional support for the inference that the “substantially pure regioisomer” of claim 2 is not a “mixture.” In addition, the diagram for the piperidine derivative of claim 7, depicting the end product fexofenadine, has no connecting line. Id. col. 26 11. 17-32. This supports the inference that the end product is also not a mixture. While this does not establish that the substantially pure intermediate and the end product have the same purity level, here is a place that the inventor could have expressly differentiated the purity of the substantially pure intermediate from the purity of the end product, but chose not to do so. Because the inventor may be his own lexicographer, however, one cannot know from the claims alone exactly where to draw the line that distinguishes, in terms of purity level, between the “substantially pure regioisomer” and the “mixture.” 2. Ascertaining the meaning based on the specification The Court next looks to the patent specification as a source of information for claim construction. Federal Circuit law is clear that courts must exercise great care when using the patent specification to limit the scope of claims: [T]his court recognizes that it must interpret the claims in light of the specification, yet avoid impermissibly importing limitations from the specification. That balance turns on how the specification characterizes the claimed invention. In this respect, this court looks to whether the specification refers to a limitation only as a part of less than all possible embodiments or whether the specification read as a whole suggests that the very character of the invention requires the limitation be a part of every embodiment. For example, it is impermissible to read the one and only disclosed embodiment into a claim without other indicia that the patentee so intended to limit the invention. On the other hand, where the specification makes clear at various points that the claimed invention is narrower than the claim language might imply, it is entirely permissible and proper to limit the claims. Alloc, Inc. v. Int’l Trade Comm., 342 F.3d 1361, 1370 (Fed.Cir.2003) (citations omitted). The test for limiting claim scope from the specification is a stringent one: “the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using ‘words or expressions of manifest exclusion or restriction.’ ” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed.Cir.2004) (quoting Tele flex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed.Cir.2002)). Of particular interest to the parties are the last two paragraphs in the “Background of the Invention” section: The above second mixture of regioisomers can be converted to a third mixture of regioisomers of formula: [diagram of fexofenadine] Although the second mixture of regioisomers and the third mixture of regioisomers can be analyzed by HPLC experiments, a practical separation to obtain gram quantities of substantially pure regioisomers has not been achieved. Each mixture (including the first), would be expected to contain 33% of the para isomer and 67% of the meta isomer. Since these components are inseparable, it has not been possible to obtain either of the regioisomers in each mixture in substantially pure form. ’703 Patent col. 31. 66—col. 41. 24. Plaintiffs argue that the only clear disavowal of claim scope in the specification appears in the second paragraph above: because it states that a mixture is not in substantially pure form, and also that a mixture may contain one of the regioisomers at a level of 67%, a “substantially pure regioisomer” must contain one of the regioisomers at a level greater than 67%. This, Plaintiffs argue, draws the line between “substantially pure” and “mixture” that one cannot discern from the claims themselves. Defendants argue that the analysis of the specification need not stop here, and this argument has merit. The parties do not dispute that this quoted section refers to the prior art Carr process, that the first mixture refers to the intermediate straight-chain PK, the “second mixture of regioisomers” refers to fexofenadone, and the “third mixture of regioisomers” refers to fexofenadine. The second paragraph states that, because the para isomer and meta isomer of fexofenadone or fexofenadine cannot be separated, it has not been possible to obtain these regioisomers in substantially pure form. This establishes that 1) “substantially pure regioisomers” is a term that the inventor applied not only to p-CPK, as in claim 1, but also to fexofenadone and fexofenadine; and 2) that “regioisomers in substantially pure form” are not mixtures, but are either the para or the meta isomer only, formed by separating mixtures. This second inference confirms the initial construction derived from the claims discussed supra. The parties dispute how the cited paragraphs in the specification should be construed to limit the claims. Defendants argue that they establish that the para and meta regioisomers of fexofenadone and fexofenadine are inseparable. Because mixtures of these products are inseparable, Defendants argue, any separation needed to purify the end product must occur at an early stage, prior to the reaction producing fexofenadone. This issue will be discussed in detail infra. Other parts of the specification provide information relevant to the construction of “substantially pure regioisomer.” i. Both the end product and the p-CPK intermediate are described in the specification as “substantially pure.” Although “substantially pure” describes only intermediates in the claims, it describes the end product at a number of points in the specification: in the abstract (“The present invention relates to a process for preparation of substantially pure piperidine derivative compounds” followed by generic formulae for fexofenadone and fexofenadine), ’703 Patent at [57], in the summary of the invention (“The present invention relates to substantially pure piperidine derivative compounds” followed by the same formulae), Id. col. 4 11. 27-28, in the detailed description of the invention (repeating the statement just quoted in the summary), Id. col. 6 11. 19-20, and in two examples of processes for converting the substantially pure regioisomer to the substantially pure piperidine derivative, Id. col. 16 11. 31—col. 19 1. 35. In the background of the invention, in one sentence, the patent groups together intermediates and end products as “substantially pure.” Id. col. 411.18-19. Thus, the inventor describes the invention as involving substantially pure piperidine derivative compounds at three key, prominent points in the specification. While there are two additional points where this phrasing is used in the context of preferred embodiments, the first sentences of the abstract, summary, and detailed description do not refer to particular embodiments but to the invention as a whole. This clearly establishes a limitation of the invention to processes producing substantially pure piperidine derivative compounds. As will be seen infra, this conclusion is well-supported by the prosecution history. Moreover, the inventor does not in any way differentiate the meaning of “substantially pure” as it describes the end product from the meaning of “substantially pure” as it describes the intermediate. ii. Both the end product and the p-CPK intermediate are described in the specification as “regioisomers.” Although only intermediates are described as “regioisomers” in the claims, the specification refers 'to fexofenadone and fexofenadine regioisomers. In the background of the invention, regarding prior art mixtures of fexofenadine and fexofenadone, the patent states:' “a practical separation to obtain gram quantities of substantially pure regioisomers has not been achieved.” Id. col. 4 11. 18-19. The patent then teaches that each mixture contaihs both meta' isomer and para isomer, and that “[s]ince these components are inseparable, it has not been possible to obtain either of the regioisomers in each mixture in substantially pure form.” Id. col. 4 11. 22-24. This expands the scope of “regioisomers” to include not only the intermediate p:CPK, as mentioned in the claims, but also fexofenadone and fexofenadine. The import of this reading of the specification is that, because both the end product, and the p-CPK intermediate are described in the specification as “substantially pure,” and both the end product and the p-CPK intermediate are described in the specification as “regioisomers,” the specification does not support two definitions of “substantially pure,” one for the intermediate and one for the end product, nor can “regioisomer” be read to connote or distinguish purity. iii. The piperidine derivative compounds have pharmaceutical uses. “Statements that describe the invention as a whole, rather than statements that describe only preferred embodiments, are more likely to support a limiting definition of a claim term.” C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 864 (Fed. Cir.2004). The specification describes pharmaceutical uses of the substantially pure piperidine, derivative compounds. The summary of the invention states: “These compounds are useful in pharmaceutical compositions, particularly as antihistamines, antiallergy agents, and bronchodilators.” ’703 Patent col. 5 11. 6-8. The detailed description of the invention describes pharmaceutical uses of the end products at some length, beginning by stating: “The piperidine derivative compounds of the present invention can be utilized as the biologically active components in pharmaceutical compositions.” Id. col. 11 11. 34-36. The parties do not dispute that only the para regioisomer piperidine derivative compounds are biologically active; the meta regioisomer end product is not. Because only para regioisomer piperidine derivative compounds are biologically active, only these compounds can be utilized for the described use. This could suggest a limitation of the invention to a process producing para regioisomer piperidine derivative compounds. Yet this does not rise to the level of establishing a clear intention to limit claim scope through “words of manifest exclusion or restriction.” The detailed description teaches how to use the “compounds of the present invention” to “treat” humans. Id. col. 12 1. 27. It discloses treatment methods using the compounds and makes no mention of further purification before such methods as intravenous administration. Id. col. 11 1. 44. While these statements appear to describe the invention as a whole, rather than preferred embodiments, again, one cannot characterize them as establishing a clear intention to limit claim scope through words of manifest exclusion or restriction. One is not led to the “inescapable conclusion,” based only on these specification statements, that the end product of every embodiment must be ready for pharmaceutical use or must be at a particular level of purity. See Microsoft Corp. v. Multi-Tech-Sys., 357 F.3d 1340, 1348 (Fed.Cir. 2004) (employing the “inescapable conclusion” standard in determining whether to find claim limitations in the specification). Moreover, Plaintiffs argue that, while it would be incorrect to limit the patent to processes producing end products pure enough for pharmaceutical use, such a limitation would not defeat their argument that Ranbaxy has infringed. If this Court construed “substantially pure regioisomer” as to the intermediate to mean “purity sufficient to obtain a pharmaceutical grade piperidine derivative compound,” Plaintiffs argue, Ranbaxy would literally infringe, since it necessarily uses p-CPK intermediate at a purity level sufficient to obtain a pharmaceutical grade piperidine derivative compound. Thus, even if this Court found a manifest restriction in the specification to processes producing end product pure enough for pharmaceutical use, this would not shield Ranbaxy from a finding of infringement. iv. The specification does not support two standards of substantial purity. The language of the specification does not support two definitions of “substantially pure,” one for the intermediate and one for the end .product. The inventor applies the phrases “substantially pure” and “substantially pure regioisomers” indiscriminately to intermediate and to end product; there is no evidence that he intended anything other than one common definition. The specification does not, however, establish a clear scope for “substantially pure.” Viewed as a whole, the language within the patent strongly suggests that “substantially pure” is a very high level of purity. While it is clear from the patent that a line separates what is “substantially pure” from what is a mixture, neither the claims nor the specification place that line with more clarity or certainty than the 67% line Plaintiffs point to. Because the inventor may act as his own lexicographer, he may define “mixture” and “substantially pure” in idiosyncratic ways. As such, the language of the patent, without more, does not justify limiting “substantially pure” beyond the 67% level Plaintiffs advocate; the language suggesting higher purity does not meet the standard of explicit restriction that the Federal Circuit requires in order to limit claim scope. Plaintiffs argue that one of ordinary skill in the art would understand that purity standards for intermediates are “often different” from purity standards for end products. (Pis.’ Reply Br. 101.) This statement, however, works against them. If one of ordinary skill in the art would understand that such purity standards are often different, one would sometimes understand that they are the same. This supports the conclusion from the specification that this is one of those times, and that “substantially pure” has one uniform meaning in the patent as a whole. : Plaintiffs state that there is nothing in the patent that expressly states that the purity standards are the same. (Id. at 101 n. 38.) But, for this to get them to their conclusion, Plaintiffs require a default rule that makes no sense: the reader of the patent should assume that one phrase has different meanings in different contexts unless told otherwise. In reality, the default rule is opposite: the reader assumes that one phrase has a uniform meaning unless told otherwise. As such, in the absence of any express differentiation of the two standards in the patent or prosecution history, Plaintiffs have in effect admitted that one of ordinary skill in the art might understand that the “substantially pure” purity standard for the regioisomer intermediate is the same as that for the “substantially pure” regioisomer end product. Further support for this interpretation comes from the deposition of the inventor, D’Ambra. Questioned specifically about this issue—whether “substantially pure” means one thing as applied to the end product and another thing as applied to the intermediate—D’Ambra admitted that this distinction does not appear in the patent: “Q: And where do I find that understanding in your patent? A: I don’t believe it’s clarified in there.” (James Decl. Ex. 12 137:10-13.) Of course, Plaintiffs have failed similarly to provide any support for such an understanding either. 3. Ascertaining the meaning based on the ’70S prosecution history The Federal Circuit restated the basic principles guiding the use of the prosecution history in claim construction in Seachange Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1372-73 (Fed.Cir.2005): [I]n construing the claim, we consider the prosecution history to determine whether the patentee disclaimed or disavowed subject matter, narrowing the scope of the claim terms. In doing so, we examine the entire prosecution history, which includes amendments to claims and all arguments to overcome and distinguish references. Where an applicant argues that a claim possesses a feature that the prior art does not possess in order to overcome a prior art rejection, the argument may serve to narrow the scope of otherwise broad claim language.. A disclaimer must be clear and unambiguous. Id. (citations omitted). On March 3, 1994, in response to the first office action on the parent application, serial no. 08/083,102, the applicant submitted an amendment to the application in which he asked the examiner to amend claim 1, and argued that the rejection of claims 1—6 and 13—19 under 35 U.S.C. § 103 should be withdrawn. (James Deck Ex. 67 at 10.) To support this argument, he distinguished the prior art Carr patents on two bases. One concerned the presence of substituent Z in the piperidine derivative, and the other was based on the purity of the end product. In describing the process in the Carr patents, D’Ambra stated that they: suggest a recrystallization treatment .... In attempting to reproduce the synthetic procedures of the Carr patents, applicant has discovered that, even with such recrystallization, the yield of the desired para isomer is about 2%. In addition, the meta isomer is present in an amount of up to 5% in admixture with the desired para product. Accordingly ... although the recrystallization steps in the Carr terfenadine metabolite patents are effective in removing some of the theoretically-present meta isomer, there remains a quantity of that impurity in the desired para-containing product stream which is inseparable. The present invention is directed to a process capable of producing substantially pure piperidine derivative compounds of the formula set forth above in claim 1. (Id. at 9.) As explained by Defendants, and not disputed by Plaintiffs, this states that the Carr process produced a yield of 2%; of that 2%, 5% was an impurity, the meta regioisomer, that could not be removed. It is only this remaining 5% that is inseparable. The applicant proceeded to distinguish the Carr process: [T]he Carr terfenadine metabolite patents use a substantially different process than that claimed by the applicant. More particularly, the Carr terfenadine metabolite patents’ product is prepared by the above-described prior art process which requires removal of a significant quantity of an impurity by recrystallization and, even after such treatment, it still contains that impurity at a level of up to 5%. (Id. at 11.) The applicant then described the process of the present invention, asserting that it “achieves substantial benefits over the prior art process.” (Id.) He explained that, by using the substantially pure regioisomer as starting material, the AZA coupling reaction: yields the piperidine derivative compound of applicant’s claimed invention with the desired para configuration. Unlike the prior art process, no separation step is required after that reaction and, even more interestingly, the product of the present process can be prepared in a substantially pure form suitable for pharmaceutical use. (Id. at 11.) The use of the words “substantially pure” in the last sentence clearly expresses the inventor’s understanding that the purity level he is defining is to be associated with these words. The applicant concluded: Even if a prima facie case of obviousness could be established from the combination of Carr, Sheehan, and Morrison (which it cannot), that combination is clearly rebutted by the advantageous results achieved with the process of the present invention. Here, as noted above, the prior art process for making the piperidine derivatives of the present invention produces an impure mixture which can only be partially purified to an impurity level of up to 5%. By contrast, as noted supra, the process of the present invention does not yield a product with such an impurity level and, as a result, is able to produce the desired piperidine derivative compounds at a purity level suitable for pharmaceutical use. {Id. at 13.) D’Ambra here expressly used the purity of the end product to distinguish the prior art and overcome an obviousness rejection. This is a clear statement that the process of the invention does not yield a product with a 5% impurity level; this sets a minimum purity level for the end product of 95%. Moreover, it explicitly associates that purity level with the words “substantially pure.” This operates as an unambiguous surrender of claim scope for claim 1: it does not cover processes which result in piperidine derivative compounds with an impurity level greater than or equal to 5%. It also establishes an unambiguous definition for “substantially pure” as “greater than 95% pure.” Here the inventor, acting as his own lexicographer, unambiguously defines that phrase. These statements clearly disavow processes which result in an impurity level greater than or equal to 5%. Because the language of the patent itself limits it to processes producing a “substantially pure piperidine derivative compound” end product, the prosecution history requires that “substantially pure” in this context be narrowed to the definition “having an impurity level less than 5%.” Because, as discussed above, the patent does not support different definitions for “substantially pure,” as applied to the intermediate, and “substantially pure,” as applied to the end product, the prosecution history narrows the scope of “substantially pure” in claim 1 to “having an impurity level less than 5%.” The case of Hockerson-Halberstadt, Inc. v. Avia Group Int’l, 222 F.3d 951 (Fed.Cir. 2000) is instructive on this point. In that case, the prosecution history contained a statement in which the inventor distinguished the prior art by claiming that the invention had a narrower groove. The Court found this statement to be limiting, concluding: “[fjlowing from this statement is the inventor’s clear disavowal of footwear having a groove width greater than that disclosed in the prior art.” Id. at 956. The Court explained that it could not disregard this statement, since to do so would: erase from the prosecution history the inventor’s disavowal of a particular aspect of a claim term’s meaning. Such an argument is inimical to the public notice function provided by the prosecution history. The prosecution history constitutes a public record of the patentee’s representations concerning the scope and meaning of the claims, and competitors are entitled to rely on those representations when ascertaining the degree of lawful conduct, such as designing around the claimed invention. In the present case, the inventor’s statements about groove width are part of the prosecution history and form the totality of the public record upon which competitors rely. Were we to accept HHI’s position, we would undercut the public’s reliance on a statement that was in the public record and upon which reasonable competitors formed their business strategies. Id. at 957 (citations omitted). The instant case presents similar facts. In the prosecution history, the inventor distinguished the prior art as a process producing an end product with an impurity level as high as 5%. Flowing from this is a clear disavowal of processes producing an end product impurity level as high as 5%, as well as a manifest restriction of “substantially pure” end product to piperidine derivative compounds that are greater than 95% pure. These are statements in a public record on which Defendants were entitled to rely in forming their business strategies. Plaintiffs argue that the “up to 5%” statement is ambiguous; it lacks sufficient clarity to operate as a disavowal. Plaintiffs contend that the statement “the process of the present invention does not yield a product with such an impurity level” is open to differing interpretations, as the antecedent to “such an impurity level” is “an impurity level of up to 5%.” Plaintiffs propose, for example, that “an impurity level of up to 5%” literally includes all impurity levels between 0% and 5%, and thus could be read as characterizing the prior art as having a purity level of greater than 95%. This is an illogical reading, because it means 1) that the inventor argued to the patent office that his invention produced results inferior to the prior art; and 2) that the inventor distinguished the prior art by arguing that his process achieved the same result. Because the inventor asserted that the invention “achieves substantial benefits over the pri- or art process,” the only reasonable interpretation is that the invention produces end product purer than the 95% pure end product of the prior art. (James Decl. Ex. 67 at 11.) The amendment from the ’703 prosecution history also supports the conclusion that the end product is limited to substantially pure piperidine derivative compounds. As noted above, D’Ambra stated, “The present invention is directed to a process capable of producing substantially pure piperidine derivative compounds of the formula set forth above in claim 1.” Id. at 9. This could not be more clear as a statement that the inventor intended “substantially pure” to characterize the end product of the invention as a whole. k- Ascertaining the meaning based on the ’610 prosecution history Both the ’703 patent and patent number 5,578,610 (the “ ’610 patent”) derive from the same parent application, serial no. 08/083,102. The ’610 patent issued on November 26, 1996. In September of 1997, an interference was declared; the examiner submitted two rejections, one based on 35 U.S.C. § 102 and one based on 35 U.S.C. § 103, requiring the applicant, D’Ambra, to demonstrate that claim 1 of the ’610 patent was not unpatentable over the prior art. The parties do not dispute that the interference is within the prosecution history of the ’610 patent. (PI. Reply. Br. 93.) The examiner’s first rejection focused on the definition of “purity” in relation to the piperidine derivative compound in claim 1 of the ’610 patent, cited prior art references that produced such compounds at higher levels of purity than that produced by the previously considered Carr ’129 patent, and stated: “The term ‘substantially pure’ broadly reads on the prior art compound----” (James Deck Ex. 49 at ALB006157.) “[T]he prosecution history of one patent is relevant to an understanding of the scope of a common term in a second patent stemming from the same parent application.” Microsoft, 357 F.3d at 1349. See also Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 980 (Fed.Cir.1999) (“When multiple patents derive from the same initial application, the prosecution history regarding a claim limitation in any patent that has issued applies with equal force to subsequently issued patents that contain the same claim limitation”). In Microsoft, a statement in the prosecution history of an earlier issued patent was applied to the interpretation of a related, subsequently issued patent. Microsoft, 357 F.3d at 1350. In the present case, the ’70S patent issued on May 12, 1998, and so Defendants seek to apply a statement from the prosecution history of the earlier issued patent to the interpretation of a related, subsequently issued patent. Defendants point to several statements made in D’Ambra’s October 17, 1997 response (the “D’Ambra response”) to the interference submitted to the Board of Patent Appeals and Interferences. (James Decl. Ex. 41.) This response distinguishes at length the ’610 patent from the prior art in terms of the purity of the fexofenadine end product. In particular, it states that the patent’s “entire thrust as well as that of the subject invention is to produce the desired para product at a higher level of purity than the Carr patents could achieve. As demonstrated by the Wille letter, the purity of the para product prepared according to the Carr patents was no greater than 96.3%.” (Id. at ALB005582.) The response also states: When read in light of the specification, one skilled in the art would have understood [ ] the phrase ‘substantially pure’ ... to mean that the subject compound has pharmaceutical grade purity and is in a form purer than that attained by the prior art [Carr patents] .... As demonstrated, infra, those skilled in the art recognized that the pharmaceutical grade purity requires an impurity level no greater than 2%, and the Carr Patents were unable to achieve such purity. (Id. at ALB005574.) Defendants argue that the Board of Patent Appeals and Interferences accepted this definition, as reflected in its final opinion, which states as a finding: “27. A person having ordinary skill in the art would interpret the phrase ‘substantially pure’ in the context of the D’Ambra [’610] patent to mean no more than 2.0% impurities.” (James Deck Ex. 40 at ALB006988.) Thus, Defendants argue, this Court should construe “substantially pure” in the context of the ’703 patent accordingly. Plaintiffs, however, counter that, in the context of the interference, this construction applied to the purity of the fexofenadine end product, not to the purity of the p-CPK intermediate. This appears to be correct. Dr. D’Ambra’s response distinguishes the prior art in terms of the purity of the final product, not the intermediate. The January 16,1998 Opinion of the Board of Patent Appeals and Interferences examines claim 1 of the ’610 patent, which refers only to the “substantially pure piperidine derivative compound” that is the end product of the ’703 patent; there is no express reference to CPK intermediates either in ’610 claim 1, the D’Ambra response, or the Opinion. In the last paragraph in the Board’s discussion of claim construction, the opinion of the Board applies “substantially pure” only to “pharmaceutical products.” (James Deck Ex. 40 at ALB006991.) There is no basis to infer that the Board intended this construction to apply to intermediates. Defendants argue that D’Ambra’s response implicitly applies the 98% definition to the intermediates, as the response applies the discussion to claims 1-17, and claims 12-17 use “substantially pure” in reference to only the intermediate, not the end product. While this supports Defendants’ argument, it does not satisfy the “clear and unambiguous” standard. The prosecution history of the ’610 patent shows a clear and unambiguous disclaimer of fexofenadine and fexofenadone end products that are less than 98% pure para isomer. These statements were made to overcome the prior art and thus limit the scope of “substantially pure,” as applied to the end product of the ’610 patent, and thus, the end product of the ’703 patent. They do not, however, show a clear and unambiguous disclaimer of p-CPK intermediates that are less than 98% pure. This Court agrees with Plaintiffs that the cited ’610 prosecution history was directed to interpretation of only the “substantially pure piperidine derivative compound” end products of the ’610 patent. But this does not render the ’610 prosecution history irrelevant to claim construction of “substantially pure regioisomer” in claim 1 of the ’703 patent. To the contrary, it supports Defendants’ proposed construction: because the ’703 patent does not distinguish between “substantially pure” as applied to the intermediate and as applied to the end product, a definition of either applies to both. Absent a contrary indication, a descriptive phrase has one uniform meaning in a patent. As established above, the ’703 patent does not distinguish between “substantially pure” as applied to end products and as applied to p-CPK. There is nothing within the patent that creates more than one uniform meaning for “substantially pure.” The prosecution history of the ’610 patent defines “substantially pure” as “at least 98% pure” in regard to the piperidine derivative end product, and this further supports this Court’s construction of “substantially pure regioisomers” in claim 1 of the ’703 patent as “of greater than 95% purity.” To decide this application for a preliminary injunction, this Court need not reach the question of whether the scope of “substantially pure regioisomer” should be further limited to mean “of purity greater than or equal to 98%.” Thus, this Court finds that the cited ’610 prosecution history provides additional support for its claim construction and, further, that the question of whether it requires a narrower construction need not be reached. 5. Claim construction based on “what the inventor invented” Defendants argue that Plaintiffs’ proposed claim construction attempts to expand the scope of the claim beyond what the inventor actually invented. Defendants rely on the following quote from Phillips: “Ultimately, the interpretation to be given a term can only be determined and confirmed with a full understanding of what the inventors actually invented and intended to envelop with the claim.” Phillips, 415 F.3d at 1316 (quoting Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed.Cir.1998)). Defendants argue that the specification, supported by extrinsic evidence, shows that the inventor did not invent a process for producing fexofenadine that used late stage purification, i.e., a process with a purification step occurring after the AZA reaction. This, Defendants contend, operates to limit the construction of “substantially pure regioisomers” to purity levels which will produce an end product of pharmaceutical purity without late stage purification. This argument asks this Court to depart from Federal Circuit guidance on the role of the specification and extrinsic evidence in claim construction. It does not appear that, in Phillips, the Federal Circuit intended to create a new, additional branch of claim construction analysis based on construing “what the inventors actually invented.” Rather, the quote is offered as support for the general principle that claims are construed in the context of the specification. Id. In the two sentences following Defendants’ quote from Phillips, the Federal Circuit identifies two ways in which the specification may be used in claim construction: it may “reveal a special definition given to a claim term by the patentee,” and it may “may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor.” Id. Defendants here appear to contend that the specification reveals an intentional disclaimer of claim scope. Yet, as discussed supra, for such an argument to succeed, the Federal Circuit requires that the disclaimer be explicit in the specification. See Gillette, 405 F.3d at 1374 (“words or expressions of manifest exclusion or explicit disclaimers in the specification are necessary to disavow claim scope”) (citations omitted). Defendants here attempt again to use the ’703 patent’s “Background of the Invention” statements about the prior art described supra, (e.g., “these components are inseparable”), to limit claim scope; but these statements are not explicit disclaimers, and their meaning is not clear. It is difficult to understand how to reconcile “a practical separation ... has not been achieved” (suggesting separation is possible but impractical) with “these components are inseparable” one sentence later (suggesting separation is impossible). ’70S Patent col. 4 11.18-22. Nor does the extrinsic evidence presented clarify what these statements mean. For example, the D’Ambra response describes separation in the prior art to a level of 96.3%, and points to the recrystallization step in example 5 of the Carr patent. (James Decl. Ex. 41 at ALB005581-2.) The ’703 amendment submission also points to the use of late-stage crystallization for purification of the end product. (James Decl. Ex. 67 at 11.) These pieces of extrinsic evidence contradict the statement that separation is impossible. It may be that D’Ambra meant “inseparable” to mean “not 100% separable,” but the meaning is ambiguous. Moreover, Defendants agreed that these statements in the specification were directed to describing the prior art, not the present invention. (Hr’g Tr. 157, Oct. 28, 2005.) Thus, in any case, they are not statements about what the inventor actually invented. In sum, Defendants’ argument based on “what the inventor invented” does not convincingly point to any clear disclaimer of claim scope. 6. Conclusion as to tentative claim construction For the purposes of determining likelihood of success in showing infringement, it is sufficient for this Court to construe tentatively “substantially pure regioisomer,” as used in claim 1 of the ’703 patent, to mean “of greater than 95% purity.” This construction is derived from the ’703 patent’s claims, specification, and prosecution history, with confirming support from the ’610 prosecution history. The parties also disputed how purity should be understood. Plaintiffs argued that it means regioisomeric purity, that is, purity relative only to meta regioisomers. Defendants argued that it means chemical purity, that is, purity relative to all other impurities. The parties do not dispute that Plaintiffs’ construction of purity results in Ranbaxy’s p-CPK measuring higher levels of purity, while Defendants’ construction results in lower numbers. Because, as will be discussed infra, the highest number for Ranbaxy’s p-CPK that Plaintiffs allege, and have evidence to support, does not reach the level needed to literally infringe, the Court need not reach the question of which concept of purity “substantially pure regioisomer” entails. B. Infringement of the process patent Having construed the disputed language of claim 1, in the second step of the infringement analysis, the properly construed claim 7 is compared “with the accused device to determine whether all of the claim limitations are present either literally or by a substantial equivalent.” Amazon, 239 F.3d at 1351. While the parties dispute the level of purity of Ranbaxy’s p-CPK, the highest value that Plaintiffs have alleged is 92%, which would not literally infringe under this Court’s construction. Plaintiffs argued different numbers at different points. Initially, at oral argument, Plaintiffs selected 90% as their statement of the purity of Ranbaxy’s p-CPK. (Hr’g Tr. 140, Oct. 28, 2005.) At a different point, Plaintiffs asserted that a note on a Ranbaxy document stated a purity level of 92%. (Hr’g Tr. 479, Nov. 3, 2005.) Defendants responded that this was an erroneous calculation, and that the Ranbaxy scientist who made the error testified that it was a mistake. (Hr’g Tr. 489, Nov. 3, 2005.) Even if the 92% figure is accurate, that is not pure enough to literally infringe a claim limitation construed to require greater than 95% purity. Plaintiffs argued that Ranbaxy’s production of p-CPK has a variance of plus or minus 4%, which turns the 92% into 96%, putting Ranbaxy over the 95% line. This argument relies on a distortion of the deposition testimony of Ranbaxy’s 30(b)(6) witness, Dr. Khanduri, and actually conflicts with that testimony. On the subject of the regioisomeric purity of the p-CPK Ranbaxy produced, Dr. Khanduri was asked, “So in certain cases, there could be as little as eight percent or as much as 22 percent; would that be correct?” (Pis.’ Supp. Letter Ex. D 409:12-15.) Dr. Khanduri answered, “Yeah, you can consider that.” {Id. at 409:16.) Thus, even setting aside the fact that this interchange concerned rough approximation rather than clear limits, the highest level of regioisomeric purity that Dr. Khanduri agreed to was 92%. The deposition testimony provides no basis for an inference that the purity level has ever reached 96%. In their Reply Brief, Plaintiffs devoted two paragraphs to arguing infringement under the doctrine of equivalents. (Pis.’ Reply Br. 111-12.) At oral argument, given an opportunity to expand on this, Plaintiffs declined to do so and rested on the briefs. (Hr’g Tr. 125, Oct 27, 2005.) The argument presented is insufficient to show a likelihood of success in proving infringement under the doctrine of equivalents. Because, under the tentative claim construction described, Defendants have raised a substantial question as to infringement, and Plaintiffs have not shown that this question lacks substantial merit, Plaintiffs have not shown a likelihood of success in proving that Barr and Ranbaxy have infringed the process patent. II. Plaintiffs have not demonstrated a likelihood of success in establishing that Teva has infringed the process patent. To show likelihood of success in establishing that Amino and, under 35 U.S.C. § 271(g), Teva, have infringed the process patent, Plaintiffs seek to invoke the burden-shifting effect of 35 U.S.C. § 295: In actions alleging infringement of a process patent based on the importation, sale, offer for sale, or use of a product which is made from a process patented in the United States, if the court finds— (1) that a substantial likelihood exists that the product was made by the patented process, and (2) that the plaintiff has made a reasonable effort to determine the process actually used in the production of the product and was unable to so determine, the product shall be presumed to have been so made, and the burden of establishing that the product was not made by the process shall be on the party asserting that it was not so made. Plaintiffs present an array of arguments directed toward proving that Amino did not manufacture its fexofenadine by the process claimed in its Drug Master File (“DMF”). Plaintiffs also contend that their experts have detected the chemical CPKEE in Amino’s fexofenadine samples, and that this is both inconsistent with the DMF process Amino has asserted and consistent with the ’703 process. Together, Plaintiffs argue, these establish a substantial likelihood that Amino’s product was made by the patented process, meeting the requirement of § 295(1). Defendants contend that Plaintiffs’ experts’ conclusions and analyses regarding the presence of CPKEE are faulty, presenting expert rebuttal to Plaintiffs’ experts’ analyses. (Matthews Decl. 18.) Defendants offered their own analyses of Amino’s fexofenadine, which did not detect CPKEE. (Allegrini Deck ¶ 7.) The conflicting evidence on whether CPKEE is present in the Amino fexofenadine samples creates a factual dispute which is not material at the preliminary injunction stage and need not be resolved. Even if it is true that traces of CPKEE are present in Amino’s product, Plaintiffs have not satisfied the requirements of the first prong of § 295. Moreover, even adjusting the § 295(1) substantial likelihood standard in accordance with the preliminary injunction reasonable likelihood standard, Plaintiffs still have not shown a likelihood of being able to establish a substantial likelihood at trial. The parties agree that only one published case addresses the test for “substantial likelihood” under § 295(1), and both turn to the legislative history of the provision for help in understanding what the statute requires. At oral argument, Plaintiffs quoted the legislative history of the Process Patents Amendments Act of 1987, as contained in Report 100-60 of the House Committee on the Judiciary and Report 100-83 of the Senate Committee on the Judiciary. Plaintiffs offered this quote from the Senate Report: “To establish a substantial likelihood, for example, a patentee might show that ... physical evidence, such as the exact chemical composition of the product, indicates the use of the patented process.” S. REP. No. 100-83, at 45 (1987). Plaintiffs edited this quotation so as to leave out unfavorable language. Where Plaintiffs left marks of ellipsis, the report reads: “a patentee might show that the patented process was the only known method, or the only commercially practical method, for producing the product, or that physical evidence ...” S. REP. No. 100-83, at 45. Viewing the Senate Committee’s examples in their entirety, it appears that the Committee contemplated a much more persuasive showing of substantial likelihood than Plaintiffs have offered. Plaintiffs offered this quote from the House Report: “Adequate circumstantial evidence for example, could include telltale signs of the use of the patented process which could be found in the product itself. When chemical processes are used, unique trace impurities or a characteristic pattern of impurities may be present which fingerprint the process of manufacture.” H.R. REP. No. 100-60, at 17 (1987). This quote is incomplete as well. The section continues: “Circumstantial evidence also could include a showing that the patented and process [sic] represent a substantial improvement in effeiciency [sic] over prior processes and that no alternative, economically feasible process exists. This could be demonstrated by showing that the sales price of the product would have to be considerably higher if the product was made by any known process other than the patented one.” H.R. REP. No. 100-60, at 17. The House Report also cautions the Court as to the standard for establishing a substantial likelihood: “This rebuttable presumption, however, cannot be casually established.... [T]he plaintiff is expected to set forth facts ... which form the basis for a reasonable belief that the product was made using the patented process.” Id. at 16-17. Even if every allegation made about Amino’s manufacturing process were accepted as true, Plaintiffs have not set forth facts sufficient to establish a substantial likelihood that Amino’s fexofenadine was made using the patented process, given the insight into that standard provided by the full legislative history. Plaintiffs’ argument rests on the evidence provided by the declarations of two experts, Drs. Atwood and Baldwin, in support of their claim that “[t]he only reasonable conclusion is that Amino is using the ’703 process instead of its reported DMF process.” (Hr’g Pis.’ Slide 8, Nov. 3, 2005.) This greatly overstates the opinions of the experts. In his declaration, Dr. Baldwin stated: 24. The presence of CPKEE in Amino’s fexofenadine samples is consistent with the use of the process of the ’703 patent. In my opinion, it is possible that Amino has utilized the D’Ambra process in synthesizing the fexofenadine samples provided to [Plaintiffs] in this lawsuit and therefore that Amino has in