Bristol-Myers Squibb Co. v. Andrx Pharmaceuticals, Inc. (343 F. Supp. 2d 1124, 2004)

FINDINGS OF FACT AND CONCLUSIONS OF LAW

HUCK, District Judge.

THIS MATTER is before the Court for a ruling on the issues presented during a bench trial held from April 26 to 30, 2004. In this patent infringement action, the crux of the Plaintiffs’ case relies on their suggestion that one of the ingredients, mi-crocrystalline cellulose, in the Defendants’ proposed medicinal tablet formulations can be divided into two portions, one portion of which functions actively as a binder and disintegrant and a second portion of which acts passively as a filler. The Court finds, largely on the ground that this is an artificial division of a single ingredient into two components that is neither based on scientifically sound principles nor satisfies the Court’s construction of the patent claims, that the Defendants’ products do not infringe Plaintiffs’ patent.

Background and Procedural History

On April 10, 2003, Plaintiffs Bristol-Myers Squibb and its wholly owned subsidiary E.R. Squibb & Sons, L.L.C. (collectively referred to as “Bristol”), Delaware corporations located in New York, New York, filed this claim for infringement of one of its pharmaceutical patents against Andrx Pharmaceuticals, Inc., and its wholly owned subsidiary, Andrx Pharmaceuticals, L.L.C. (collectively referred to as “Andrx”), Florida corporations located in Davie, Florida, under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2). The Hatch-Waxman Act establishes rules for patent infringement in pharmaceutical product cases which create a statutory act of infringement before a potentially infringing company actually brings its product to the market. See Glaxo Wellcome Inc. v. Andrx Pharm., Inc., 344 F.3d 1226, 1228 (Fed.Cir.2003); Yamanouchi Pharm. Co. v. Danbury Pharmacol, Inc., 231 F.3d 1339, 1347 (Fed.Cir.2000). Under the Hatch-Waxman Act, the producer of a generic pharmaceutical product does not have to provide the extensive safety and efficacy data required in a New Drug Application (“NDA”) that must be submitted to the Food and Drug Administration (“FDA”) before a new brand name drug can be put on the market. Rather, the generic company may submit an Abbreviated New Drug Application (“ANDA”) which must merely provide sufficient technical data to demonstrate that the generic drug is bioequivalent to the brand name drug, meaning that it provides equivalent blood plasma levels of the active ingredient over time as the brand name product. The names of all new drugs for which patents have been issued are recorded in an FDA publication called “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is more commonly referred to as the “Orange Book.”

The generic drug manufacturer must also explain to the FDA why its product does not infringe any patent listed in the Orange Book by certifying that (1) the brand name manufacturer has not filed a patent with the FDA, (2) the patent has expired (a “Paragraph II certification”), (3) the patent will expire before the generic product enters the market, or (4) the patent for the brand name drug is invalid or will not be infringed by production, use, or sale of the generic product, (a “Paragraph IV certification”). 21 U.S.C. § 355(j)(2)(A)(viii). If an ANDA applicant completes a Paragraph IV certification, the applicant must also submit a detailed notice to the patent owner explaining the factual and legal basis for the opinion that the patent is invalid or that the generic product will not infringe the patent. Id. at § 355(j)(2)(B). Upon receipt of a Paragraph IV notification letter, the patent owner may file a suit for patent infringement within forty-five days of receipt of that letter, in which case the FDA may not approve the ANDA for thirty months or until a United States court finds for the defendant based on non-infringement, patent invalidity, or patent unenforceability. 21 U.S.C. § 355(j)(5)(B)(iii). The patent holder can thus establish infringement by showing that the generic company’s certification “is in error as to whether commercial manufacture, .use, or sale of the new drug (none of which, of course, has actually occurred) violates the relevant patent.” Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990).

On December 27' and 30, 2002, Andrx filed two AND As, Nos. 76-608 and 76-620, with the FDA seeking approval to sell different dosage levels of generic versions of Bristol’s antihypertensive drug products containing fosinopril sodium which are sold under the brand .name Monopril® and Monopril® HCT (a fosinopril product that also contains a second active ingredient, the diuretic hydrochlorothiazide (“HCT”)). Although the Orange Book lists two patents for Monopril® and Monopril® HCT, the parties agree that the issues in this case all relate only to whether Andrx infringed United States Patent No. 5,006,344 (“ the ’344 patent”), issued April 9, 1991, and owned by Bristol’s subsidiary, E.R. Squibb & Sons, Inc. The ’344 patent, which does not expire until July 10, 2009, describes a stable tablet containing fosino-pril sodium or fosinopril sodium and HCT in combination with other inert pharmaceutical ingredients, known in the field as excipients. With respect to the. ’344 patent, on December 23, 2002, Andrx representative Ted Whitlock signed Paragraph IV certifications as to each fosinopril product Andrx intends to manufacture and sell, and, on February 21 and 24, 2003, signed two Notices of Certification of Invalidity or Noninfringement of a Patent, which were sent to Bristol Meyers Squibb Company. On April 10, 2003, within forty-five days of receipt of the Paragraph IV notice letters, Bristol timely filed identical complaints in both the United States District Court for the Southern District of Florida and the United States District Court for the Southern District of New -York. Andrx filed an answer in this case on May 13, 2003. After some initial discovery and motions directed to determining the proper venue for this action, the New York case was transferred. to the Southern District of Florida, and this case proceeded on the merits.

On December 15, 2003, Andrx moved this Court to conduct a separate claim construction hearing under Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.Cir.1995), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). After full briefing and oral argument, the Court concluded that a separate Markman hearing was not necessary because the case was being tried only to the Court and because there was a significant overlap between the evidence of infringement and evidence that would be presented in a claim construction hearing. Therefore, the Court held that conducting two separate proceedings would be inefficient and more costly and, on January 15, 2004, denied Andrx’s motion for a separate Markman hearing. On January 5, 2004, Bristol moved to amend its complaint to include a claim for willful infringement. The Court granted that motion on January 15, 2004. However, on February 6, 2004, the Court also granted Andrx’s cross-motion to bifurcate the trial on willfulness, deciding that, if necessary, an additional trial on willfulness related primarily to Andrx’s reliance on opinion of counsel, if Andrx chose to use such evidence, would be convened shortly after the first trial, allowing a brief period for additional discovery on that issue.

On February 6, 2004, the Court also denied as premature Andrx’s motion in limine to exclude evidence regarding an experiment conducted by UPM Pharmaceuticals, a company utilized by Bristol. The Court noted that, because that motion relied heavily on concerns over the scientific validity and relevance of the experiment which would need to be resolved in a Dau-bert hearing, the Court would allow the parties, at trial, to present evidence and argument regarding that experiment and would decide at that time whether that evidence should be excluded. On March 9, 2004, with the consent of both parties, the Court specially set the trial on infringement for April 26, 2004. Prior to trial, Bristol filed a motion in limine to exclude evidence of patent invalidity on the ground that Andrx had not provided an expert opinion on invalidity due to indefiniteness, arguing that Andrx would not be able to prove indefiniteness due to double inclusion without expert testimony. The Court denied that motion on April 15, 2004.

The Court commenced a five day non-jury trial on April 26, 2004. Bristol presented evidence in the form of lay testimony from Dr. Nemichand Jain, one of the inventor’s named in Bristol’s ’344 patent, from Stephen Davis, the patent lawyer who prepared the ’344 patent application for Bristol, and from Ted Whitlock, Andrx’s in-house legal counsel who prepared the Paragraph IV certifications and notice letters. Bristol also presented expert testimony, both in its case-in-chief and in its rebuttal case, from Dr. Alexander Klibanov, a Professor of Chemistry and Bioengineering at the Massachusetts Institute of Technology. Andrx presented lay testimony from Dr. Guohua Zhang, the Andrx formulator responsible for overseeing the development of Andrx’s generic fosinopril products, and expert testimony from Dr. Reza Fassihi, a Professor of Bio-pharmaceutics and Industrial Pharmacy at the Temple University School of Pharmacy. The Court considers both experts to be well-qualified to testify both as to the scientific principles of tablet formulation as well as to how one of ordinary skill in the art of pharmaceutical formulation would read the ’344 patent. In addition to this live testimony, the parties submitted deposition testimony from Jain, Whitlock, Zhang, and the following eight other witnesses: Dr. Ajit B. Thakur, Dr. Robert L. Jerzewski, Mr. Lewis Gryziewicz, and Dr. Thomas M. Wong, who were all Bristol employees who were involved in the development of the patented tablet formulations; Dr. DaCheng Tian and Dr. Xiu Xiu Cheng, Andrx employees who were involved in the formulation of the Andrx generic fosinopril products; Dr. Tony Yu, an employee of UPM Pharmaceuticals who conducted a model study for Bristol in connection with this litigation; and Larry Rosenthal, Executive Vice President of Sales and Marketing at Andrx. The parties also entered in evidence seventy-three Joint Trial Exhibits, thirty Plaintiffs’ Trial Exhibits, and twenty Defendants’ Trial Exhibits. During trial, the parties made or renewed several motions, on which the Court deferred ruling and will consider herein. The parties filed post-trial proposed findings of fact and conclusions of law on May 10, 2004. After careful consideration of the pleadings, motions, trial and deposition testimony, exhibits, and other submissions, the Court finds as follows.

Pending Motions

Both sides raised or renewed motions during and at the close of trial. Andrx moved under Rule 52 for judgment as a matter of law both on Bristol’s entire ease and specifically on the claim for willful infringement. The motion as to the entire case is denied on the ground that this Court’s decision on both the claim interpretation and infringement is based on factual and legal findings as to disputes of material fact, particularly with respect to how one of ordinary skill in the art of pharmaceutical formulation would interpret the patent claims. Therefore, judgment solely as a matter of law is inappropriate. As to Andrx’s motion for judgment as a matter of law on willful infringement, that motion is denied as moot given the Court’s finding of non-infringement.

Bristol moved during the trial to convert its previously denied in limine motion regarding excluding evidence of patent invalidity due to double inclusion to a motion to dismiss that claim on the ground that no expert opinion was provided on this theory and that, without such an opinion, Andrx had not met its burden of proving by clear and convincing evidence that the patent is invalid for indefiniteness. In closing arguments, Defendant conceded that its double inclusion argument would only be relevant if the Court agreed with Bristol’s claim interpretation by finding that an excipient can function as both a single agent that is binder and disintegrant and as a filler, despite the separate listings in Claim 1 for these ingredients. Due to the Court’s claim interpretation, there is no risk of double inclusion, and the patent cannot be held invalid on that ground. Therefore, the Plaintiffs motion is denied as moot.

Finally, Andrx renewed its motion in limine to exclude testimony and related evidence concerning a model study conducted by an outside laboratory, UPM Pharmaceuticals, on three batches of tablets containing different amounts of extra-granular microcrystalline cellulose (“MCC”). Andrx argues that the study should not be admitted because it does not meet the federal standard for scientific admissibility. See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Determinations of admissibility must be based on a finding that the evidence is sufficiently reliable to be admitted and that it is relevant to the issues in the case. See id. at 589, 113 S.Ct. 2786; see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999); Allison v. McGhan Med. Corp., 184 F.3d 1300, 1310 (11th Cir.1999). The cases make clear that a primary rational for the exclusion of evidence that does not meet the Daubert standard is its “inability to assist in factual determinations, its potential to create confusion, and its lack of probative value.” Allison, 184 F.3d at 1311-12. Judges are to act as gatekeepers to assure that only evidence that will assist the fact-finder is admitted. Daubert, 509 U.S. at 592, 113 S.Ct. 2786.

Andrx claims that evidence related to the UPM study should not be admitted because the test was not conducted in such a way as to render it reliable and that the test is not relevant because the tablets that were tested are not sufficiently similar to the Andrx formulations that the Court can draw any inferences related to the Andrx products from the results of those tests. Bristol contends that all of the concerns that Andrx raises regarding the UPM study, even if accepted, would only affect the weight this Court should afford the evidence, not its admissibility.

Having read the parties’ memoranda on the issue and having heard testimony from both experts, the Court agrees with Bristol that Andrx has not shown that the evidence is sufficiently unreliable and irrelevant that this Court should not consider it at all. Dr. Klibanov testified that the experiment was a model study that was conducted in accordance with a standard and accepted disintegration test procedure. He acknowledged that model studies are not as reliable as would be studies that use product formulations that more closely mimic the behavior of the actual accused infringing product. However, he testified that model studies are used quite commonly in science and noted that even Andrx’s expert had conducted a model study in this case. The Court agrees that the question of reliability and relevance in this case is merely one of degree, and cannot agree with Andrx that the evidence is not useful or probative in deciding the issues in this case. This is especially true since this is a bench trial, where the Court must evaluate the evidence regardless of whether it ultimately decides to exclude it. See Seaboard Lumber Co. v. United States, 308 F.3d 1283, 1302 (Fed.Cir.2002) (holding that, while issues of prejudice are “of lesser import in bench trials, where no screening of the factfinder can take place, the Daubert standards of relevance and reliability must still be met”); see also Multi-Medical Convalescent & Nursing Center, 550 F.2d 974, 977 (4th Cir.1977) (“In a non-jury trial ... little harm can result from the reception of evidence that could perhaps be excluded .... because the judge ... is presumably competent to disregard what he thinks he should not have heard, or to discount it for practical and sensible reasons.”). Thus, some courts have held that, in cases where the judge is the fact-finder, the criteria for finding evidence admissible can be applied less strictly. See SmithKline Beecham Corp. v. Apotex Corp., 247 F.Supp.2d 1011, 1042 (N.D.Ill.2003) (holding that, while Seaboard Lumber held that Daubert must be applied even in bench trials, “it did not say it must be followed rigidly,” and, therefore, “[i]n a bench trial, it is an acceptable alternative to admit evidence of borderline admissibility and give it the (slight) weight to which it is entitled”), aff'd, 365 F.3d 1306 (7th Cir.2004); see also Goodman v. Highlands Ins. Co., 607 F.2d 665, 668 (5th Cir.1977) (after noting that an evidentiary ruling-should not be disturbed on appeal absent a showing of manifest error, holding that “a trial judge sitting without a jury is entitled to even greater latitude concerning the admission of evidence”). Therefore, the Court will consider Andrx’s substantive objections to the UPM study when addressing the merits of the case, but denies Andrx’s motion to wholly exclude the evidence.

Legal Standards

A. Claim Construction

To prevail on a claim of infringement, the plaintiff must establish by a preponderance of the evidence that the accused product infringes the properly construed claims of the patent, either literally or under the doctrine of equivalents. Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 261 F.3d 1329, 1336 (Fed.Cir.2001). A determination of infringement involves a two-step analysis. First, the court must properly construe the asserted claims. Second, the court must determine whether the accused product infringes the properly construed claim. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed.Cir.1995), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). The function and purpose of a patent claim is to define the scope of the invention and the extent of the patentee’s rights. Markman, 517 U.S. at 373-74, 116 S.Ct. 1384. It has been said that patent claims define the metes and bounds of the invention. Markman, 52 F.3d at 1000. In this respect, the patent, similar to a deed, serves an important public notice function, informing the public as to what is claimed and what is not claimed. See PSC Computer Prods., Inc. v. Foxconn Int’l Inc., 355 F.3d 1353, 1358-59 (Fed.Cir.2004).

Claim construction is a matter of law exclusively for the court, and entails determining the meaning and scope of the patent claims asserted to be infringed. Markman, 52 F.3d at 976-978. It begins with the language of the claim itself. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996). A court need only construe the claim terms actually in controversy, and only to the extent necessary to resolve that controversy. Vivid Tech., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed.Cir.1999). A patent is written for and directed to persons of ordinary skill in the art to which the subject matter of the patent pertains. Id. at 804; In re Hayes Microcomputer Prods., Inc. Patent Litig., 982 F.2d 1527, 1533-34 (Fed.Cir.1992). Thus, claim terms must be construed as they would be understood by a person of ordinary skill in the art at the time the invention was made. Vivid Tech., 200 F.3d at 804; Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1332 (Fed.Cir.2001) (“It is important to bear in mind that the viewing glass through which the claims are construed is that of a person skilled in the art.”). Such persons are presumed, as a matter of law, to be aware of all pertinent prior art published or known in the United States prior to that date. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed.Cir.1986).

In construing a claim, the first step is to analyze the claim language itself. Markman, 52 F.3d at 979. The second step i's to examine the specification. It is well established that, because “[t]he specification contains a'written description of the invention that must enable one skilled in the art to make and use the invention,” claims must be read in .view of the specification of which they are a 'part. Markman, 52 F.3d at 979. While claim terms generally are to "be given their plain and ordinary meaning, that is not the case where the patent specification clearly indicates that the inventor intended a different meaning. National Recovery Techs., Inc. v. Magnetic Separation Sys., 166 F.3d 1190, 1195 (Fed.Cir.1999). Thus, the specification may, and often does, limit the claimed invention. SciMed, 242 F.3d at 1340-41; see also Watts v. XL Sys., Inc., 232 F.3d 877, 882 (Fed.Cir.2000). Finally, the third step is to examine the patent prosecution history. The prosecution history constitutes an undisputed public record of proceedings in the United States Patent and Trademark Office and is of primary significance in understanding the claims. Markman, 52 F.3d at 980.

In addition to the intrinsic evidence, in interpreting the claims, the court also may consider extrinsic evidence, including expert and inventor testimony, prior art, dictionaries and treatises, where necessary. See, e.g., Tanabe Seiyaku Co. v. United States Int'l Tr. Comm’n, 109 F.3d 726, 732 (Fed.Cir.1997); Vitronics, 90 F.3d at 1582; Interactive Gift, 256 F.3d at 1332 (“Consultation of extrinsic evidence -is particularly appropriate to ensure that [a judge’s] understanding of the technical aspects of the patent is not entirely at variance with the understanding of one skilled in the art.”) (internal citation omitted). Extrinsic evidence is also permissible to explain general scientific principles and the meaning of technical terms of art that appear in the intrinsic evidence when, after consulting the intrinsic evidence, the disputed claim terms are still unclear. Markman, 52 F.3d at 980-81; Vitronics, 90 F.3d at 1583. Extrinsic evidence, however, cannot contradict the- interpretation of the claims based on the intrinsic evidence. See Aqua-Aerobic Sys., Inc. v. Aerators Inc., 211 F.3d 1241, 1245 (Fed.Cir.2000); Bell & Howell Document Mgmt. Prods. Co. v. Altek Sys., 132 F.3d 701, 706 (Fed.Cir.1997). Rather, extrinsic evidence, including expert testimony, may be received, at the court’s discretion, to assist the court in arriving at the correct conclusion as to the true meaning of the language employed in the patent. Markman, 52 F.3d at 980-81.

B. Infringement

In order to infringe a patent, the accused product must meet each and every claim limitation, either literally or under the doctrine of equivalents. Cortland Line Co, v. Orvis Co., 203 F.3d 1351, 1356 (Fed.Cir.2000). In accordance with the public notice function of patent claims, the infringement inquiry requires attention to each claim element rather than the invention as a whole. See Pennwalt Corp. v. Durand-Wayland, Inc., 833 F.2d 931, 934 (Fed.Cir.1987). In order for a product to literally infringe a patent claim, the paten-tee must prove by a preponderance of the evidence that the accused product includes elements that are literally identical to each and every limitation of the patent claim. See Biovail Corp. Int’l v. Andrx Pharms., Inc., 239 F.3d 1297, 1302 (Fed.Cir.2001); Abbey v. Bill Ussery Motors, Inc., 74 F.Supp.2d 1217, 1221 (S.D.Fla.), affd sub nom. Abbey v. Robert Bosch GMBH, 217 F.3d 853 (Fed.Cir.1999). If an express claim limitation is absent from an accused product, there can be no literal infringement as a matter of law. Wolverine World Wide, Inc. v. Nike, Inc., 38 F.3d 1192, 1199 (Fed.Cir.1994).

Where no literal infringement is found, doctrine of equivalents infringement may sometimes be found where the accused product is insubstantially different from the claimed element, that is, where it performs substantially the same function in substantially the same way to obtain substantially the same result. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 23-25, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997). Like literal infringement, infringement under the doctrine of equivalents cannot be established unless every limitation of a claim is satisfied, either exactly or by a substantial equivalent. Carroll Touch, Inc. v. Electro Mech. Sys., Inc., 15 F.3d 1573, 1576 (Fed.Cir.1993). Any infringement analysis under the doctrine of equivalents must deal with each claimed element, rather than a less focused consideration of the invention as a whole. See Pennwalt, 833 F.2d at 935. Proof of equivalency can be made “through testimony of experts or others versed in the technology; by documents, including texts and treatises; and, of course, by the disclosures of the prior art.” Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 609, 70 S.Ct. 854, 94 L.Ed. 1097 (1950). The Federal Circuit, however, gives little weight to conclusory statements on equivalence offered by expert witnesses; factual evidence of equivalence is required. See Lemelson v. United States, 752 F.2d 1538, 1551 (Fed.Cir.1985); Tronzo v. Biomet, Inc., 156 F.3d 1154, 1160 (Fed.Cir.1998).

Findings of Fact and Conclusions of Law

I. Claim Construction

A. Factual Background

Fosinopril sodium is an angiotensin-con-verting enzyme inhibitor that is used for the treatment of essential hypertension. It functions by inhibiting the ability of the enzyme that catalyzes conversion of an-giotensin I, a protein found naturally in the body, to angiotensin II. The drug is primarily prescribed for lowering blood pressure. It is undisputed that Bristol, which developed fosinopril as an active pharmaceutical ingredient, held a patent on that active substance which expired near the end of 2002. However, in the process of conducting long-term shelf stability studies of their first formulation of the commercial tablet products, Bristol’s scientists discovered that one of the nonactive ingredients, or excipients, specifically the lubricant magnesium stearate, interacted poorly with the fosinopril, leading to reduced shelf stability. In response to this problem, Bristol’s researchers began searching for alternative formulations that would meet the FDA’s requirements for long-term shelf stability. They discovered that use of the alternative lubricants sodium stearyl fumarate (“SSF”) or hydrogenated vegetable oil (“HVO”) alleviated the shelf-life stability problem that resulted from the interaction of fosinopril and magnesium stearate, .and found that SSF was preferable. That discovery was clearly identified as the point of novelty that justified Bristol’s application for a patent on their tablet formulation.

Nonetheless, the ’344 patent claims a specific formulation that includes ingredients in addition to the active ingredient and the lubricant, which results in additional claim limitations. The parties are in agreement that the Andrx products must satisfy each of those claim limitations in order to be infringing. Bristol has asserted against the Andrx product only infringement of Claim 1 of the patent, which describes:

A stable tablet comprising on a weight percentage basis from about 1% to about 25% fosinopril sodium, up to about 25% of a diuretic, [1] from about 30% to 90% of a filler, [2] from about 2% to 10% of a disintegrant, [3] from about 1% to about 5% of a binder, or [4] from about 5% to about 15% of a single agent which is both binder and disintegrant, and from about 1.3% to about 4% of a lubricant selected from the group consisting of sodium stearyl fumarate and hydrogenated vegetable oil.

The parties have stipulated that the Andrx formulations meet each of the claim limitations of Claim 1 except for [1] and [4], and that the alternative claim limitations [2] and [3] are not being asserted by Bristol against the proposed tablet formulations. The dispute as to claim limitations [1] and [4] relates to the inclusion of about 30% of total tablet weight of MCC in the Andrx products. Andrx claims that the 30% MCC was included in its formulations as a filler, and that its tablets do not contain a disintegrant, a binder, or a single agent that acts as a binder and disintegrant, and, therefore, do not infringe Bristol’s patent. Bristol, on the other hand, claims that a portion of the MCC in the Andrx formulation functions as a “single agent which is both binder and disintegrant,” and the remainder of the MCC acts as a filler in combination with lactose. The only disputed claim terms are thus “filler,” “disinteg-rant,”. “binder,” and “single agent which is both binder and disintegrant.”

The ’344 patent was issued pursuant to an application filed with the patent office with the Serial No. 543,639 (“ ’639 application”). That application was a continuation-in-part (“c-i-p”) application of a prior parent application assigned the Serial No. 377,683 (“’683 application”), which was abandoned. A c-i-p application is an application that can rely on the earlier filed parent application for priority as to subject matter that is common to both applications, but cannot rely on the earlier filing date as to subject matter that is newly added in the c-i-p application. The testimony at trial established that the additional material disclosed in the c-i-p application included a new alternate claim limitation of “from about 5% to about 15% of a single agent which is both binder and disintegrant,” raised the upper limit of the lubricant in the formulation from 3% to 4%, and provided some new examples and identified preferred ingredients for certain claim terms.

B. Proposed Claim Constructions

At the close of the trial, the Court asked both parties to submit their proposed claim constructions. The essential point of difference is that Andrx argues that a person of ordinary skill in the art of pharmaceutical formulation would have read the claim as requiring a filler which is separate from the excipient or excipients which act as binder and disintegrant or as a single agent that is both binder and disintegrant. Specifically, Andrx proposes the following claim construction as to the relevant portion of Claim 1:

... [1] from about 30 to about 90% of a first excipient which is a filler, including but not limited to, lactose or a combination of lactose and microcrystalline cellulose; and [2] from about 2% to 10% of a second excipient which is a disin-tegrant, including but not limited to, sodium carboxymethyl starch, cross linked sodium carboxymethyl starch, crospovidone, cross linked sodium car-boxymethylcellulose, sodium starch gly-colate, and mixtures thereof; and [3] from about 1% to about 5% of a third excipient which is a binder, including but not limited to, povidone, hydroxy-propyl cellulose, and mixtures thereof, or [4] from about 5% to 15% of a second excipient that is a single agent which is both binder and disintegrant, including but not limited to pregelatinized starch; and ...

Andrx would also read the “is” in the clause “which is both binder and disinteg-rant” as connoting “equality” or “consists of,” such that the single agent would be limited to those two functionalities. Andrx further argues that, based on dependent patent claims, the patent specification, and the prosecution history, a person of ordinary skill in the art would understand the patent to define MCC as a filler in the ’344 patent and not as a single agent that is both binder and disintegrant. Finally, Andrx argues that, if the Court finds it necessary to resort to extrinsic evidence, then the expert testimony shows that a person of ordinary skill would classify an excipient based on its primary function in a formulation and that, in the Bristol patent and Andrx formulations, such a person would classify MCC as a filler and not additionally as a single agent that is both binder and disintegrant.

Bristol’s claim construction would read the claim simply as stated in the patent without any modifiers being inserted, adding only parenthetical notations containing Bristol’s understanding of the ordinary and customary meanings of the terms “filler,” “disintegrant,” “binder,” and “single agent which is both binder and disinteg-rant.” Nonetheless, Bristol represented at trial they would not object to Andrx’s claim construction with regard to the “including, but not limited to” clauses in italics above, but do object to the clauses in bold which modify the binder, disintegrant, and single agent limitation to require a “second” or “third” excipient that is separate from the filler. Bristol contends that importing such a requirement into the claim language is not warranted because the claim language does not use any terms which would require different or separate excipients for the filler and single agent which is both binder and disintegrant and that the intrinsic evidence does not show any intent by the inventors to require different and separate excipients. Moreover, Bristol would not read “is” in the “single agent” clause as limiting the functionality that the single agent can serve to only binder and disintegrant. Bristol also rejects Andrx’s claim that the patent “defines” MCC as filler, arguing that it merely designates MCC as a preferred filler without limiting it to performing only that function in other, conceivable formulations. Finally, Bristol submits that the extrinsic evidence supports that a person of ordinary skill in the art of pharmaceutical formulation would have understood that multifunctional excipients such as MCC can serve more than one role in a pharmaceutical formulation and that such a person would not have understood the patent to preclude a formulation that would have utilized a single agent that serves as filler, binder, and disintegrant. Because both Bristol and Andrx employ a wet granulation process, Bristol states that the Court need not consider how the claim terms of the ’344 patent might be interpreted in contexts other than the wet granulation process.

C. Analysis

Both parties submitted various learned treatises and testimony of experts who can be regarded as possessing at least “ordinary skill in the art of pharmaceutical formulation,” as well as testimony from the inventor of the Bristol product, the formulator of the Andrx product, and patent lawyers from each company. Consistent with the Markman directive, the Court will start with the plain language of the patent claim, and then evaluate the other intrinsic evidence. Although not necessary to complete the claim construction, the Court will then discuss the relevant extrinsic evidence.

1. The Single Agent Limitation

Looking at the plain language of Claim 1 of the ’344 patent, it appears that a person skilled in the art would see a list of ingredients, each of which describes a separate agent. There is an active ingredient, a diuretic, a lubricant, a filler, a disintegrant, and a binder, or, in lieu of the final two items, a single agent that is both. There is no express limitation in the patent for a single agent that is both a filler and a binder, nor an express limitation for a single agent that is both a filler and a disintegrant. This is true even though the 1990 edition of the United States Pharmacopeia iNational Formulary (“USP/NF ”), which is one of the primary reference materials relied on by skilled pharmaceutical formulators (and which is relied on by both Bristol and Andrx in this case), demonstrates that there were fillers that were known in 1990 to also act as a binder (starch) or as a disintegrant (dextrin). (JTX 40 at 1858). Most importantly, there is no express limitation in the patent claim for a single agent that is binder, filler, and disintegrant, even though there are two excipients that are listed in the USP/NF under all three functionalities, MCC and pregelatinized starch. Bristol’s argument that there is no requirement of separateness would be better supported if the single agent limitation for the binder and disintegrant had never been added to the patent claim, because Bristol’s argument in the presence of that single agent limitation would, as Andrx has asserted, render that single agent limitation superfluous. Since a term is included in Claim 1 for a single agent that is both binder and disin-tegrant, it does suggest that the claim is designating the filler as a different product from the binder, the disintegrant, or the single agent that is both. Otherwise, the patent claim should have designated additional alternatives of single agents that are both filler and binder, filler and disinteg-rant, or filler, binder, and disintegrant. Bristol does not dispute that at least a portion of the MCC is acting as a filler in the Andrx formulations.

Bristol argues, however, that adding the term “separate” or “first” and “second” excipient into the patent claim constitutes importing language unsupported by the plain meaning of the claim, in violation of the concept that a patent claim should be interpreted in the broadest manner supported by the intrinsic evidence. See CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir.2002) (holding that, where a claim term is expressed in a general manner, it is error to narrow the term without clear and unambiguous support from the intrinsic evidence); Teleflex Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed.Cir.2002) (imparting a “heavy presumption” that a claim term carries its broadest ordinary and customary meaning); Texas Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1203 (Fed.Cir.2002) (where more than one definition is consistent with the intrinsic evidence, “the claim terms may be construed to encompass all such consistent meanings”), cert. denied, 538 U.S. 1058, 123 S.Ct. 2230, 155 L.Ed.2d 1108 (2003). Nonetheless, while the Court uses the term “separate” to explain its construction, there is no need to import any additional words into the claim. Rather, the Court finds that the use of the alternative “single agent” limitation merely shows that the language was defining single excipients, each one of which must be different, unless one of them is both a binder and a disintegrant. The language of the claim need not be altered at all to understand that the patent provides an alternative, and that the use of the alternative term would alert a skilled practitioner to the fact that every other term describes an ingredient that is separate from the others.

As to the meaning of the word “is” in the single agent limitation, Andrx claims the term should mean “equal and limited to,” whereas Bristol submits it should mean “equal but not limited to.” Both parties have cited examples of more open-ended (“comprising”) or more closed (“consisting of’) terms that have been given specific meanings in patent claims, but none of which would make sense grammatically in place of “is” in the phrase “a single agent which is both binder and disintegrant.” Thus, there is no reason to believe that, in that claim limitation, any word more precise than “is” could or should have been used, and the meaning of 's” must be viewed in the context of the phrase and the claim. See Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1300 (Fed.Cir.2003) (holding that “the correct meaning of a word or phrase is informed only by considering the surrounding text .... [R]esort must always be made to the surrounding text of the claims in question, the other claims, the written description and the prosecution history.”). In that light, the Court agrees that the “is” in that phrase is meant to limit the single agent to an excipient that is only a binder and a disintegrant. Otherwise, again, the phrase would be redundant and superfluous, since, absent the single agent limitation, a multi-functional excipient already would have been covered by reading the binder and disintegrant limitations as allowing one excipient to satisfy both functions. Regardless of whether the inventors intended for “is” to limit the functionalities of the single agent to binder and disintegrant, the Court believes that a skilled formulator would have read this limitation as doing so.

Andrx argues that the prosecution history also supports its “separate” argument, claiming that the addition of the “single agent” limitation in the c-i-p application demonstrates that Bristol did not believe that its original phrasing of Claim 1 covered multi-functional excipients that perform more than one role. Andrx notes that the parent ’683 application does not describe a single agent that is both a disin-tegrant and binder. Andrx claims that the addition of the limitation describing and claiming “from about 6% to about 15% of a single agent which is both binder and disintegrant” as an alternative to “from about 2% to about 10% of a disintegrant” and “from about 1% to about 5% of a binder” constituted newly added matter. Bristol, however, presented testimony from Stephen Davis, who prepared the patent application for Bristol, explaining that the “single agent which is both a binder and disintegrant” was included in the ’639 application as new matter because, as Claim 1 was previously written, if one simply added up the percentages of “from about 2% to 10% of a binder” and “from about 1% to 5% of a disintegrant,” the apparent operative range for a product that served both functions would be from about 3% to about 15%. Thus, Bristol suggests, one would have concluded that a single agent used in a concentration of only 3% would properly function in the formulation. However, as Davis testified, Bristol had determined that concentrations as low as 3% are insufficient to provide both disintegrant and binder functionalities when a single agent such as pregela-tinized starch is used for both functions. Therefore, he felt Bristol needed to disclose the lower range limitation as “from about 5%” so that the patent would not be found invalid due to an inoperative term if concentrations of under 5% of a single agent would not produce a stable tablet. Nevertheless, Davis and Dr. Klibanov both testified that a person of ordinary skill in the art of pharmaceutical formulation would have understood, even under the original patent application that did not include the “single agent” limitation, that the patent claims would have covered a formulation using a single agent which functioned both as a binder and a disintegrant.

The Court finds this argument unpersuasive for three reasons. First, even if the subjective intent of the inventors were to add the single agent limitation only to increase the lower range limit, the objective reading of the patent claim, the specification, and the prosecution history by a person of ordinary skill in the art is the appropriate standard for deciphering claim terms that are not clearly defined in the patent itself. See Markman v. Westview Instruments, 52 F.3d 967, 985-86 (Fed.Cir.1996) (holding that the inventor’s subjective intent is entitled to little or no probative weight except as documented in the prosecution history and that “the focus in construing disputed terms in claim language is not the subjective intent of the parties to the patent contract when they used a particular term [but] rather is on the objective test of what one of ordinary skill in the art at the time of the invention would have understood the term to mean”), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). In this case, the prosecution history does not record that the subjective intent of disclosing the new matter was to increase the lower range limit. Based on the objective standard, the Court agrees with Andrx that the addition of the single agent limitation in the c-i-p application would be read by someone of ordinary skill as an indication that multifunctional excipients that served more than one function under the ’344 patent claim were not covered by the scope of the original Claim 1. Further, the fact that additional limitations for single agents providing all three functionalities was not added to the patent at the same time would have indicated to a person of ordinary skill either that no excipient could provide all three functionalities in the formulation or that such a formulation would not infringe.

Second, Plaintiffs argument that the c-i-p disclosure of the single agent was needed to raise the lower limit of the concentration of binder and disintegrant if a single agent were used does not appear to be a necessary, reason for such a disclosure. It is undisputed that the total concentrations of disintegrant and binder — reached by adding the concentrations at the lower and upper limit of each — under the original Claim 1 would have been from 3% to 15%, whereas the c-i-p disclosed that a single agent could be used in concentrations from 5% to 15%, a smaller range within the 3%' to 15% range. Bristol’s witnesses testified that their research found that concentrations higher than 3% had to be used when a single agent that was both binder and disintegrant was used, and that there was a danger that the binder and disintegrant terms would be found to be inoperative if a single agent was unable to function properly at the 3% level. However, from the .testimony of both Bristol and Andrx’s witnesses, it is clear that, when used separately, some binders and some disintegrants are more efficient than others, and thus the more efficient excipients will function at lower concentrations in a formulation than the less efficient excipients. Thus, the inclusion of a range of concentrations for the binder (l%-5%) and .disintegrant (2%-10%) in the original application was partially necessary to account for-the different efficiencies of various binders and disinteg-rants. Therefore, some of these less efficient excipients may not function at the lower end of the range for whichever function they are intended to fulfill. Yet, according to Bristol’s theory, if carried a bit further, the'binder range limitation would then be inoperative due to the fact that, for example, some non-preferred binders probably will not function at concentrations of as low as 1% but must be included at a higher percentage, as high as 5%, of tablet weight in order to impart their binding function. Clearly, the fact that all excipients will not function at all concentrations in a range limitation does not render that limitation inoperative, so the fact that a single agent which is both binder and disintegrant would be required in concentrations of more than 3% would similarly not make the binder and disintegrant terms inoperative. Thus, it was not necessary to include that additional limitation in Claim 1 for the sole purpose of raising the lower range limitation to 5%. As a result, a person skilled in the art would have looked for another reason for the addition of the single agent in the c-i-p application, and would have concluded that the prior claim language meant that each of the excipients listed in the claim were to be different. That skilled person would then reasonably conclude that the claim language should be read as listing a filler that is a separate excipient from the binder, disintegrant, or single agent that is both.

Third, Bristol’s suggestion that it needed to include the single agent limitation to raise the lower limit of the range suggests it should have been equally concerned about filing as new matter another single agent limitation for an excipient that provides all three functionalities in order to raise the upper range limit for a tri-func-tioning agent. The MCC in Andrx’s formulation is included in ranges of about 30%, and is thus outside the 5% to 15% range for a single agent which is both binder and disintegrant. According to Bristol’s own definition and expert trial testimony, the filler constitutes the bulk of most solid tablets. Nonetheless, no trifunctioning agent with higher range limitations was added; rather, Bristol argues that a skilled formulator would have been able to determine which percentage of a tri-functioning agent was performing the role of “single agent which is both binder and disintegrant” and which was acting as filler. If Bristol intended for an excipient to be able to perform all three functions, it should have added this as new material at this time in order to avoid the possibility that the patent would be found invalid for lack of enablement, as discussed further below.

2. MCC as a Filler in the ’3Ü Patent

Andrx also argues that MCC is “defined” as a filler in the ’344 patent. Andrx notes that three of the dependent ’344 patent claims, Claims 3, 12, and 18, contain the recitation “wherein said filler is a mixture of lactose and microcrys-talline cellulose.” Moreover, the ’344 patent specification states in two places that “[t]he preferred filler is lactose or lactose and microcrystalline cellulose” and that the patented product includes a filler that is “preferably lactose or lactose combined with microcrystalline cellulose.” Andrx further observes that MCC is described as a filler in the parent ’683 application, noting that it mentions MCC ten times, but never as a single agent. While Bristol does not dispute these observations, it contends that MCC is never “defined” as a filler in Claim 1, in the patent specification, or in the prosecution history, but is merely listed as a preferred filler.

The Court agrees with Bristol that the patent does not define MCC as a filler. The Court recognizes that not every conceivable and possible future embodiment of the invention must be disclosed in the patent specification. See SRI Int’l Inc. v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121-22 (Fed.Cir.1985); Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 1344 (Fed.Cir.2001). A court must not import limitations from the specification, including examples and preferred embodiments, or from the prosecution history, into the claims. Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1186-87 (Fed.Cir.1998) (stating that the Federal Circuit has repeatedly held that limitations from the specification are not to be read into the claims); Minnesota Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1566 (Fed.Cir.1992) (reading a claim in light of the specification must not be confused with reading into the claim a limitation that is in the specification but is not in the claim). The law recognizes that, because patent specifications are directed to those skilled in the relevant art, they require only a description of the inventor’s known “best mode.” See 35 U.S.C. § 112; SRI v. Matsushita, 775 F.2d at 1121 (quoting Autogiro Co. of America v. U.S., 181 Ct.Cl. 55, 384 F.2d 391, 398 (1967)) (“Claim interpretation must not make use of ‘best mode’ terms.”). Moreover, under the doctrine of claim differentiation, dependent claims are presumed to be narrower in scope than the independent claims on which they depend. AK Steel v. Sollac & Ugine, 344 F.3d 1234, 1242 (Fed.Cir.2003). Therefore, limitations stated in dependent claims cannot be read into independent claims. Wenger Mfg., Inc. v. Coating Mach. Sys. Inc., 239 F.3d 1225, 1234 (Fed.Cir.2001); SRI v. Matsushita, 775 F.2d at 1122 (it is error as a matter of law to read into a claim limitations from other claims). Each claim in a patent is presumed to be different in meaning and scope. Wenger, 239 F.3d at 1234. Because the absence of such a difference in meaning and scope would make a claim superfluous, the doctrine of claim differentiation states that this presumption is significant. Comark, 156 F.3d at 1187; SRI v. Matsushita, 775 F.2d at 1122 (a limitation from a second claim not contained in a first claim cannot be read into the first claim for purposes of determining either validity or infringement — to do so would render the second claim superfluous). Because MCC is never identified as anything other than a “preferred filler” in the specification and is only defined as the filler in dependent claims not at issue in this case, it would be error for the Court to construe Claim 1 as “defining” MCC as the filler.

Andrx’s argument that the patent defines MCC as a filler also relies on extrinsic expert testimony that an excipient’s function in a patent is determined by its primary function. Although the parties have provided slightly different formulations for the disputed terms, in the patent, the key difference is that Andrx states that binders and disintegrants are excipi-ents whose primary function is to facilitate, respectively, cohesion of powdered materials or breakdown of a dosage form when placed in an aqueous solution, whereas Bristol would not qualify their definitions by referring to the excipient’s primary function. The Court sees no justification for importing the qualifying-term “primarily” into the ordinary meaning of the excipients defined in Claim 1 of the ’344 patent. While it is conceded that the Bristol patent examples and specification do not assign a primary role of disin-tegrant or binder to MCC due to the presence of a strong binder and strong disintegrant in each dependent claim and example, the Court does not agree that a skilled formulator would necessarily discount the possibility that MCC in another formulation could have a different primary purpose or purposes. Therefore, the modification of the definitioh of the excipi-ents with the term “primary function” is unnecessary where a listed or preferred excipient could play a different role in an alternative formulation. Thus, although Andrx refers to various extrinsic evidence suggesting that the inventors had experimented with MCC and considered it to be a filler, such extrinsic evidence cannot be used to overcome the clear language of the patent claim, specification, and prosecution history, none of which refer to MCC as anything other than a preferred filler.

Nonetheless, while the patent does not “define” MCC as a filler, the Court believes that the patent language and knowledge of a.person of ordinary skill would have led such a person to the conclusion that MCC was acting only as a filler in the Andrx formulations. First, Dr. Fassihi testified that, in determining the function of a multi-functional excipient in a product, the skilled formulator would look at the total percentage by weight of that excipi-ent in the product. Learned treatises support that products appearing in higher percentages are likely to be fillers, since fillers make up the bulk of most tablets. Moreover, the suggested ranges for MCC when used for purposes other than filler are consistently lower: one treatise, the 1990 edition of Modern Pharmaceutics, suggests percentages of 0-8% if used to “improve adhesion of film coat to core” and 5-15% if used as a disintegrant, whereas the range when used as a binder/filler goes all the way from 5-95%. (PTX 8 at 363).

Further, the repeated references to MCC in the patent is something that a skilled formulator would take into account in determining whether Claim I precluded use of a single agent that functions as filler, binder, and disintegrant. It is undisputed that MCC is mentioned several times throughout that patent claims, the specification, and the prosecution history as a filler without ever being designated as a single agent that can act as a binder and disintegrant. Moreover, although the example of pregelatinized starch was given as an excipient that acts as a binder and disintegrant in one formulation, there are no examples and no claims that would indicate that any single agent, including pregelatinized starch, can act as binder, disintegrant, and filler. The 1990 USP/NF supports that pregelatinized starch and MCC are the only two excipi-ents that were recognized at that time to have the ability to perform all three functions. However, nothing in the patent would have notified a person of ordinary skill that the MCC and pregelatinized starch could act at one time in all three capacities under the claims of this patent. As noted, the only “single agent” limitation is of a binder and disintegrant, and this limitation was added at the same time as the examples which use pregelatinized starch as such a single agent.

Nonetheless, Bristol contends that the addition as new matter in the c-i-p application that a single agent “such as pregela-tinized starch” could be used should have clued a skilled pharmaceutical formulator to the fact that multi-functional excipients were available and might satisfy multiple claim limitations. Bristol argues that one skilled in the art would have known that pregelatinized starch has three functionalities, not just two, and that MCC is an excipient “such as pregelatinized starch” which also can exhibit those three func-tionalities. The Court finds that the teachings of this “new matter” is quite different. The Court believes that the facts that the multi-functional excipient pregelatinized starch was added to the specification and examples, that the patent claim was changed to add the single agent limitation without anywhere in the specification, examples, or prosecution history identifying the fact that pregelatinized starch can also serve as a filler in the formulation, and that no claim limitation for a single agent that is binder, disinteg-rant and filler was added to the patent claim would all lead a skilled formulator to reasonably conclude that the filler must be a separate excipient. Further, the fact that MCC is repeatedly referenced in the patent, yet was never identified even as a binder/filler, much less a single agent that is binder and disintegrant, would only further suggest to a skilled formulator that neither of the two products that the USP/NF lists as providing three function-alities can be used to satisfy both the filler and single agent limitation in this particular patent. This is particularly true since Andrx has submitted substantial extrinsic evidence in the form of learned treatises showing that a skilled pharmaceutical formulator in 1990 would have regarded MCC as a binder/filler which provides binding ability when tablets are compacted, but would not have regarded it as a wet granulation binder. Thus, the skilled formulator would have been unlikely to consider MCC to be serving three functions in the Andrx formulations which were produced through a wet granulation process.

3. Range Limitation

In its Paragraph IV notice letter to Bristol, Andrx clearly stated its argument which, at the end of the day, is the most persuasive argument that its product does not infringe:

Even if MCC were considered to have multiple functions for purposes of claim construction in the Listed - Patent, the Andrx Proposed Products use at least 28% MCC. This amount greatly exceeds the maximum amount of disintegrant, binder, or single agent which functions as both a disintegrant and binder recited in the claims of the Listed Patent. Thus, MCC in the Andrx Proposed Products cannot be considered as an equivalent of any one of a disintegrant (2-10%), a binder (1-5%) or both a binder and a disintegrant (5-15%) as required by the claims of the Listed Patent.

Even if the Court rejected all of. Andrx’s other arguments, it would still find that there is no infringement in this case because, as a matter of claim interpretation, the Court finds insufficient basis for Bristol’s argument that a skilled formulator would have not only known that a single excipient could have fulfilled more than one role in Claim 1 of the patent, but would also have known .that such an excipi-ent could and should be broken down by percentage to determine which portion contributes to which functionality. Rather, the Court agrees with the evidence presented by Andrx, including the testimony of Dr. Fassihi, that a skilled formulator would consider all 30% of the MCC to be contributing to any and all of the functions it is serving in the formulation, and percentage would still fall far outside of the range of from about 5% to about 15% of a single agent which is both binder- and disintegrant. As discussed below, the artificial division of MCC into percentage components is not scientifically well grounded an