Abbott Laboratories v. Sandoz, Inc. (500 F. Supp. 2d 807, 2007)

MEMORANDUM OPINION AND ORDER

COAR, District Judge.

This matter comes before this Court on the motion of the plaintiff, Abbott Laboratories (“Abbott”), for a preliminary injunction against defendant, Sandoz, Inc. (“San-doz”). Abbott seeks to enjoin Sandoz from marketing a generic extended release form of the antibiotic drug, clarithromycin, that allegedly infringes Abbott’s U.S. Patent Nos. 6,010,718 (the “'718 patent”), 6,551,616 (the “'616 patent”) and 6,872,407 (the “'Ji-07 patent”) relating to its Biaxin ® XL product. For purposes of this motion, however, only the '718 and '616 patents are at issue. For the reasons stated below, Abbott’s motion for a preliminary injunction is GRANTED.

I. BACKGROUND

Abbott filed a complaint against Sandoz alleging patent infringement. Sandoz manufactures and markets generic versions of branded pharmaceuticals in the United States. Abbott sought a declaratory judgment that Sandoz would infringe the '718, '616, and '407 patents. Each of these patents pertains to Abbott’s branded antibiotic product, BIAXIN ® XL, which is an extended release formulation of clari-thromycin, an erythromycin derivative.

Clarithromycin is a macrolide antibiotic used to treat bacterial infections, particularly those of the skin and upper respiratory system. Abbott held a patent on the immediate release version of clarithromy-cin, marketed as BIAXIN ®, until the patent expired on May 23, 2005. Abbott began marketing BIAXIN ® in the United States in approximately 1991. In 2000, Abbott was issued two formulation patents (the '616 and the '718 patents) on an extended release formulation of clarithromy-cin. Abbott began marketing this extended release formulation under the name BIAXIN ® XL in 2000. As of May 2005, Abbott estimated that BIAXIN ® XL accounted for approximately 70% of the sales in the BIAXIN ® market. Generic competitors entered the market for immediate release clarithromycin on May 24, 2005.

Abbott filed for separate preliminary injunctions against Andrx Pharmaceuticals, Inc. (“Andrx”) and Teva Pharmaceuticals USA, Inc. (“Teva”) in this Court. This Court held hearings and entered preliminary injunction orders against Teva and against Andrx. The Federal Circuit Court of Appeals, in an opinion authored by Circuit Judge Prost, vacated the preliminary injunction order against Teva on June 22, 2006. Teva and Abbott subsequently entered into a settlement agreement. Andrx also appealed the preliminary injunction order entered against it. The Federal Circuit, in an opinion again authored by Circuit Judge Prost, affirmed that preliminary injunction against Andrx on January 5, 2007.

Sandoz has brought to market a generic version of an extended release clarithro-mycin product that undoubtedly will cause Abbott some loss of market position. Thus, Abbott here seeks to stop Sandoz’s intrusion upon the market for extended release clarithromycin products. Abbott previously moved this Court for a temporary restraining order against Sandoz. This Court denied Abbott’s motion because of the practical effect of the Federal Circuit’s holding in the Teva case, this Court could not issue a temporary restraining order based on the limited record before it. Abbott Laboratories v. Sandoz, Inc., No. 05 C 5373, 2006 WL 3718025 (N.D.Ill. Dec. 15, 2006); see also Abbott Laboratories v. Andrx Pharmaceuticals, Inc., 452 F.3d 1331 (vacating Abbott Laboratories v. Andrx Pharmaceuticals, Inc., et. al., 2005 WL 1323435 (N.D.Ill. June 3, 2005)). Now, after having the benefit of a full hearing, this Court is able to better decide the merits of enjoining Sandoz from further selling or marketing its extended release formulation of clarithromycin.

II. STANDARD FOR PRELIMINARY INJUNCTION

A party seeking a preliminary injunction must make a four-part threshold showing that (1) the movant has some likelihood of success on the merits of the underlying litigation; (2) immediate irreparable harm will result if the relief is not granted; (3) the balance of hardships to the parties weighs in the movant’s favor; and (4) the public interest is best served by granting the injunctive relief. Polymer Techs., Inc. v. Bridwell, 103 F.3d 970, 973 (Fed.Cir.1996).

III. DISCUSSION

The '718 and '616 patents at issue here, have already been analyzed by both this Court and the Federal Circuit Court of Appeals, most recently in upholding this Court’s grant of a preliminary injunction in a separate but related case. In the Teva case, Abbott secured a preliminary injunction against another generic drug-maker, Teva, that was trying to come to market with its own extended release clar-ithromycin product. 452 F.3d at 1332. For purposes of the motion, Teva conceded that its generic extended release clarithro-mycin product infringed upon the '718 patent. Id. at 1333. However, Teva raised the defense that Abbott’s '718 patent claims 2, 4 and 6 were invalid for obviousness under 35 U.S.C. § 103. Id. This Court found that Teva had failed to raise a substantial question as to the validity of Abbott’s claims 2, 4 and 6. Id. On appeal, the Federal Circuit vacated the Order of this Court. Id. It held that this Court erred in assessing the content of prior art, which in the Federal Circuit’s view, supported Teva’s arguments and it held further that Teva had indeed demonstrated a substantial question regarding the validity of the '718 patent’s claims 2, 4 and 6. Id. at 1348.

In the Andrx case, Abbott also obtained a preliminary injunction against a generic drugmaker, Andrx, who was trying to come to market with yet another extended release clarithromycin product. Abbott Laboratories v. Andrx Pharmaceuticals, Inc., 473 F.3d 1196, 1198 (Fed.Cir. January 5, 2007). Andrx argued that its product did not infringe any claims of Abbott’s asserted patents, either literally or under the doctrine of equivalents. Id. at 1199. Furthermore, Andrx asserted that the '718, '616 and '407 patents were invalid because of indefiniteness under 35 U.S.C. § 112; and the '718 and '616 patents were invalid as anticipated under 35 U.S.C. § 102(b) and invalid for obviousness 35 U.S.C. § 103. Id. This Court held that Abbott had shown a likelihood of success on its claims that Andrx infringed claims 1, 4, and 6 of the 718 patent under the doctrine of equivalents; induced and contributed to infringement under the doctrine of equivalents of claim 2 of the '616 patent; and literally infringed claims 8 and 16 of the '407 patent. 473 F.3d at 1200. This Court also held that Andrx did not meet its burden of raising a substantial question of invalidity as to any of the patents in suit. Id. On appeal, the Federal Circuit affirmed the Order of this Court. Id. at 1213. However, it held that this Court erred in construing the claims of the '718 patent by narrowing the scope of the claim term “pharmaceutically acceptable polymer.” Id. Now Abbott seeks a preliminary injunction against Sandoz for manufacturing and selling a generic extended release product that infringes on its patents’ claims.

A. Likelihood of Success on the Merits

In order to demonstrate a likelihood of success on the merits, the movant (Abbott) must show, in light of the presumptions and burdens that will be present at any eventual trial on the merits, that it is likely to prove that the non-movant (Sandoz) infringed the patents in suit, and that any of the non-movant’s challenges to the validity and enforcement of its asserted patents lack substantial merit. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350-51 (Fed.Cir.2001). Patents are presumed to be valid, 35 U.S.C. § 282 (2002), and at trial, the party raising a validity challenge must prove invalidity by clear and convine-ing evidence. Gemmy Indus. Corp. v. Chrisha Creations Ltd., 452 F.3d 1353, 1358 (Fed.Cir.2006). This presumption does not relieve a patentee who moves for a preliminary injunction from carrying its normal burden of demonstrating a likelihood of success on all disputed liability issues at trial, including validity. See Canon Computer Sys., Inc. v. Nu-Kote Intern., Inc., 134 F.3d 1085, 1088 (Fed.Cir.1998).

A validity challenge at the preliminary injunction stage can succeed on evidence that would not support a judgment of validity at trial. 239 F.3d at 1359. “Vulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial.” Id. The alleged infringer must identify at least some persuasive evidence of invalidity at this early stage to overcome the presumption of validity. Pharmacia & Upjohn Co. v. Ranbaxy Pharmaceuticals, Inc., 274 F.Supp.2d 597, 601 (D.N.J.2003). The patentee also is held to a less stringent standard and must only present a “clear case supporting the validity of the patent in suit.” Id. A paten-tee can make such a case by showing, for example, that the patent in suit has withstood previous validity challenges in other proceedings or benefitted from a long period of industry acquiescence in its validity.

Abbott asserts that it is likely to succeed on the merits because at trial it will likely prove infringement of one or more of the claims of the '718 and '616 patents in suit. Abbott also contends that it likely will demonstrate that Sandoz’s challenges to the validity of the patents in suit lack substantial merit.

1. Inequitable Conduct

Sandoz alleges that Abbott engaged in inequitable conduct when prosecuting the '718 and '616 patents. This Court will analyze Sandoz’s claim that Abbott engaged in inequitable conduct before addressing the issues of infringement and validity. A finding of inequitable conduct that would warrant holding the patents at issue to be unenforceable would render this dispute moot. Kingsdown Med. Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867, 877 (Fed.Cir.1988).

a. Standard for Inequitable Conduct

Inequitable conduct occurs when a patent applicant violates his or her “duty of candor and good faith ..., which includes a duty to disclose to the Office all information known to that individual to be material to patentability....” 37 C.F.R. § 1.56(a) (2007); Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs., Ltd., 394 F.3d 1348, 1350-1 (Fed.Cir.2005). A court will hold a patent unenforceable due to inequitable conduct if there is clear and convincing evidence that the applicant while prosecuting the patent at issue, (1) made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information, and (2) intended to deceive the U.S. Patent and Trademark Office (“PTO”). Impax Labs., Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1374 (Fed.Cir.2006).

b. Sandoz’s Allegations

(1) '718 Patent

Sandoz contends that during the prosecution of the '718 and the '616 patents, Abbott failed to disclose material information, selectively withheld information that contradicted assertions made in its patent claims, and submitted information to the PTO that contained material misrepresentations of fact. In particular, Linda Gus-tavson submitted a declaration to the PTO in support of the '718 patent prosecution. In this declaration, Gustavson claimed a statistical test demonstrated the maximum plasma concentration (“C-max”) of the extended-release clarithromycin (the claimed composition) was statistically significantly lower than the C-max of the immediate-release clarithromycin (a prior art composition). Sandoz contends that Abbott breached its duty of candor by submitting the Gustavson declaration because (1) it did not assert what Gustavson declared it did and (2) the data on which the declaration was based was improper, and Abbott should have disclosed the nature of the data. Sandoz asserts that the data on which Gustavson relied did not in fact show a “statistically significant” difference in C-max for the extended-release and immediate-release formulations and that Gus-tavson did not perform any such statistical test nor did she even know how to perform one. Also, Sandoz claims that the data was derived from an improper cross-study involving different study participants instead of the same study participants.

Sandoz also claims Abbott withheld information from the PTO that contradicts Abbott’s claims that BIAXIN ® XL has a statistically significantly lower mean fluctuation index {“DFL”) in the plasma than an immediate release composition. Specifically, Abbott claimed that the mean DFL values for a modified release version of clarithromycin claimed by a prior patent, the '190 patent, were substantially equal to the mean DFL values for the immediate release version of clarithromycin. However, while the '718 patent was pending, Abbott and more specifically, Gustavson, became aware that the mean DFL values for a modified release version of clarithro-mycin claimed by '190 patent were actually statistically significantly lower than the immediate release composition. Thus, San-doz concludes, this evidence tends to show that BIAXIN ® XL has the same pharma-cokinetic (“PK”) properties as the modified release formulation covered by the prior art patent; a material fact according to Sandoz.

Abbott also claimed in its patent prosecutions that its extended release formulation provided reduced taste perversion compared to its immediate release formulation. Sandoz alleges that Abbott failed to disclose relevant data to the PTO from two of its own studies that cast doubt on this assertion: the double-blind Acute Bacterial Exacerbation of Chronic Bronchitis study (the “bronchitis study”) and the Acute Maxillary Sinusitis study (the “sinusitis study”). The prosecution history reveals that Abbott supported it assertions about improved taste perversion by citing the results of a 24-subject pilot study which allegedly showed a two- to threefold improvement in taste perversion of the extended release product over the immediate release formulation. The bronchitis and sinusitis studies, by contrast, involved 910 subjects and were described as “two well-controlled, double-blind clinical trials” “conducted to compare the safety and efficacy of extended release clarithro-mycin and immediate release clarithromy-cin.” See, e.g., U.S. Pat. No. 6,872,407, at 11:27-30. Generally, larger study samples produce statistically more reliable results. Abbott collected data about a wide range of reported side effects in the bronchitis and sinusitis studies, including both gastrointestinal side effects and taste perversion. Yet only the gastrointestinal side effects data was reported to the PTO. San-doz avers that the taste perversion data from the clinical studies failed to support Abbott’s contention that extended release clarithromycin had improved taste perversion over immediate release. Further, Sandoz states that Abbott was aware of the taste perversion results, that the results were material to Abbott’s patent application, and that Abbott intentionally withheld the results in order to receive the patent.

Sandoz states the final reports on the two clinical studies was completed in April 1999. Yet, according to Sandoz, the BIAXIN ® XL label submitted to the FDA in May of 1999 stated that three percent of patients taking immediate release BIAXIN ® reported incidences of taste perversion while six percent of patients taking extended release BIAXIN ® XL reported incidences of taste perversion. Thus Sandoz alleges that Abbott had evidence that its taste perversion claims of BIAXIN ® XL were incorrect and it intentionally withheld this information from the PTO.

(2) '616 Patent

Sandoz also alleges that the '616 patent is unenforceable because it is a continuation-in-part of the '718 patent. Sandoz contends that the unenforceability of a parent patent for inequitable conduct infects the later-issued descendants of that patent. However, unenforceability of a parent patent for inequitable conduct does not automatically render the later-issued descendants of that patent unenforceable. Cordis Corp. v. Boston Sci. Corp., 188 Fed.Appx. 984, 986 (Fed.Cir.2006). In fact, when determining whether later-issued descendants of a parent patent that has been found to be unenforceable are themselves unenforceable, a court must determine whether inequitable conduct occurred during the prosecution of the descendant patents or “whether the ‘inequitable conduct in prosecuting the [parent] patent had immediate and necessary relation to the ... enforcement of the [child] patents.’ ” Id. (quoting Consol. Aluminum Corp. v. Foseco Int’l Ltd., 910 F.2d 804, 810-811 (Fed.Cir.1990)). Sandoz does not address the '616 patent’s immediate and necessary relation to the '718 patent. Sandoz does, however, contend that the prosecution of the '616 patent was tainted by its own inequitable conduct.

Sandoz alleges that Abbott had data from its studies showing no reduction in the incidences of adverse gastrointestinal (“GI”) events after taking extended release clarithromycin, contrary to the claims of the '616 patent. Sandoz contends that Abbott withheld this information from the PTO, choosing only to present data on the reduced number of patients who dropped out of the studies due to incidences of adverse GI events. Use of such drop-out data instead of the data showing no reductions in the number of incidences of adverse GI events was improper and misleading.

Sandoz also alleges inequitable conduct on the part of Abbott in filing its '616 application with claims of improved taste profile even though it had evidence from its two clinical studies that allegedly contradicted those then-pending claims. A month before filing the '616 patent application, the same inventors who co-authored the clinical study reports attended a conference where they publicized only certain elements of their data, not the taste-perversion data that contradicted the then-pending claims.

c. Abbott’s Response

(1) '718 Patent

Abbott contends that its actions during the prosecution of the '718 and '616 patents did not amount to inequitable conduct. Abbott first states that Gustavson’s declaration of a “statistically significant” difference in C-max for the extended-release and immediate-release formulations and the admission that Gustavson did not perform any such statistical test nor did she even know how to perform one is immaterial. Abbott asserts that no claim of the '718 patent requires the ER formulation to have a statistically significant lower C-max than the IR formulation. Furthermore, Abbott argues that Sandoz has failed to allege any evidence that Gustavson made the statement with an intent to deceive, rather than out of a simple mistaken belief.

Regarding the propriety of the data Gustavson used to reach her conclusions that there was a “statistically significant” difference in C-max for the extended release and immediate release formulations, Abbott concedes that crossover comparisons are generally more reliable than cross-study comparisons. However, Abbott has provided evidence that such cross-study comparisons are fairly common and not indicative of fraud; especially in the instant case given that Gustavson declared that “pharmacokinetics studies were conducted in similar groups.” Thus, by declaring to the PTO that she used multiple studies, instead of a single study, using similar groups, as opposed to the same subjects, Abbott satisfied its duty of candor to the PTO.

Abbott also regards Sandoz’s argument that it withheld information that contradicted its claim that the extended release version of clarithromycin have a statistically significantly lower DFL than the immediate release version of clarithromycin to be specious. According to Abbott, its internal study W98-268 showed that the extended release version did in fact have a statistically significantly lower DFL than the immediate release version. The results from study W98-268 showed the modified release version’s DFL was lower than the DFL of immediate release version of clarithromycin (1.94 > 2.22). At that time Dr. Gustavson was aware of other studies that showed the modified release version did not have a statistically significantly lower DFL than the immediate release version. Thus, one showing of a lower DFL did not suggest to Gustavson that a statistically significantly lower DFL was a property of the modified release version of clarithromycin.

Abbott also claims that it satisfied its duty to candor with regard to its claims of reduced incidence of taste perversion. Abbott states that the information it presented to the PTO adequately supported its claim for reduced incidence of taste perversion and was found to be acceptable by the PTO. Next, Abbott contends that neither the prosecuting attorney nor the inventors were aware of the taste perversion data from the bronchitis and sinusitis studies during the prosecution of the '718 patent. Semla and Gustavson testified at deposition that they never saw the clinical study reports and did not know of the taste perversion results. Abbott asserts that Semla, who was the lead formulator on the '718, had no responsibilities for clinical studies and did not receive phase III clinical study reports such as these. Gustavson was a pharmacokineticist who performed PK analyses, but in clinical studies, her duties were limited to interpreting blood concentration data only; she had no involvement with clinical studies that measured side effects. Three of the remaining four inventors on the '718 patent also were formulators with no responsibilities for phase III clinical studies. Sheri Crampton, the final inventor, was the only one with any responsibilities for clinical trials, but she left Abbott on August 18, 1998, seven months before the reports on the sinusitis and bronchitis studies were completed.

Lastly, Abbott asserts that the Biaxin ® label, which states that the taste perversion incidence rate of the immediate-release formulation is 3% while that of the extended release formulation is 6%, is not actually relevant to its claims of reduced incidence of taste perversion. Abbott explains that the 3% rate was derived from a combination of 500 milligram {“mg”) and 1000 mg dosage studies whereas the 6% rate was based on studies utilizing 1000 mg dosages only. Furthermore, Gustav-son claims she never reviewed this part of the label as it dealt with side effects; not pharmacokinetics, her speciality.

(2) '616 Patent

With respect to the '616 patent, Abbott contends that it did’ not withhold taste perversion data with the requisite intent to deceive. Abbott emphasizes that the '616 patent was a continuation-in-part of the '718 patent, whose application originally included the taste perversion claim originally filed in the '718 application. According to Abbott, that claim was withdrawn contemporaneously with the submission of the signed inventor oaths with the '616 application. Thus, Abbott contends that for this Court to find inequitable conduct based upon the withdrawn claim would be inconsistent with Federal Circuit precedent that states that references that are material only to withdrawn claims cannot form the basis of a finding of inequitable conduct. Scripps Clinic & Research Found, v. Genentech, Inc., 927 F.2d 1565, 1583 (Fed.Cir.1991).

Abbott explains that the claims of the '616 patent refer to the clarithromycin formulation as producing a “method for reducing adverse gastrointestinal side effects.” According to Abbott, the side-effect improvements discussed in the '616 patent include both the most severe GI side effects and the patient discontinuations due to GI side effects, not the overall incidence rates of GI side effects. The incidence data provided in the patent specification actually shows the two formulations of clarithromycin to have similar overall GI side effect incidence rates. Thus, since the incidence data form the two studies merely corroborated data that was already present in the patent, the data was cumulative and not material. See 37 C.F.R. § 1.56(b).

In response to Sandoz’s argument that it improperly submitted data on the severity of the GI side effects, Abbott first states that this data has no relevance to the prosecution of the '616 patent claims. Second, Abbott asserts that the rating scale it used is not misleading and is commonly used in clinical studies.

d. Analysis

In evaluating materiality, this Court refers to the definition provided in 37 C.F.R. § 1.56. See, e.g., Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs., Ltd., 394 F.3d 1348, 1352 (Fed.Cir.2005) (citing Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253, 1257 (Fed.Cir.1997)). The rule defines information as material to patentability when:

[I]t is not cumulative to information already of record or being made of record in the application, and

(1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or

(2) It refutes, or is inconsistent with a position the applicant takes in:

(I) Opposing an argument of unpa-tentability relied on by the Office, or (ii) Asserting an argument of patenta-bility.

37 C.F.R. § 1.56(b).

(1) '718 Patent

Cmax data

Sandoz contends that Abbott breached its duty of candor when it submitted the Linda Gustavson declaration stating that the Cmax of the claimed extended release composition of clarithromy-cin was statistically significantly lower than the Cmax of a prior art composition (immediate release pediatric suspension formulation) of clarithromycin, when in fact it was not statistically significantly lower. Abbott asserts that the statement was immaterial because it had no bearing on any claim of the '718 patent. Claim 4 of the '718 patent claims in relevant part that “... maximum peak concentrations of the erythromycin derivative are lower than those produced by an immediate release pharmaceutical composition ...” This Court finds that the Gustavson declaration that the Cmax of the extended release clarithromycin was statistically significantly lower than the Cmax of the prior-art composition of clarithromycin was not material to patentability.

The PTO had rejected the claims of the '718 application and had issued Abbott a challenge to show that its product did not have the same PK properties of the prior art product. Abbott made clear that the purpose of the Gustavson declaration was to clarify to the PTO that the prior art of the '411 patent was different from the '718 patent. So, the statement obviously had relevance on the difference between the extended release formulation and the prior art formulation. However, neither party disputes that the extended release formulation was indeed pharmacokinetieally different from the prior art immediate release suspension formulation, just as Abbott had asserted to the PTO. Given the accuracy of the ultimate conclusion — that the extended release formulation was indeed different from the immediate release suspension formulation, Gustavsoris declaration of a “statistically significantly lower” Cmax is immaterial despite the fact that it satisfies the definition of “material” provided by 37 C.F.R. § 1.56(b). There still must be a showing of a substantial likelihood that a reasonable examiner would consider the statement important in deciding whether to allow the application to issue as a patent. See Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359, 1364 (Fed.Cir.2007).

Abbott has submitted evidence that the Cmax of the extended release formulation was in fact lower than the Cmax of the immediate release suspension formulation. Declaration of Linda Gustavson in Support of Abbott Laboratories’ Motion for a Preliminary Injunction, ¶ 31. Sandoz has not submitted any evidence to the contrary. Since 1) no claim of the '718 patent requires the extended release formulation to have a statistically significant lower Cmax than the immediate release formulation; 2) the data in fact shows the Cmax of the extended release formulation to be lower (albeit not statistically significantly lower) than the Cmax of the immediate release formulation; and 3) the extended release formulation was in fact pharmacok-inetically different from the immediate release suspension formulation, it is more likely than not that the PTO would not have found the “statistically significantly lower” statement to be important. Therefore, this Court declines to find that the statement was material to the PTO’s decision to issue the '718 patent.

Sandoz has failed to explain why a reasonable examiner would assign any importance to Gustavsoris statement in evaluating whether the Cmax of the extended release formulation was indeed lower than the Cmax of the immediate release formulation. Since this Court finds the Gustav-son statement to be immaterial, the specifics of how she arrived at the statement are also immaterial.

DFL Data

Sandoz takes issue with Gustav-soris use of a cross-study comparison instead of a crossover comparison study. Sandoz has presented evidence that generally, crossover comparisons yield more accurate results that cross-study comparisons. Abbott submitted evidence that Gustavson disclosed the nature of the cross-study data to the PTO, thus leaving the PTO to freely accept or reject her conclusions drawn from the data. This Court finds that Gustavson, and thus Abbott, did not breach the duty of disclosure here because Gustavsoris Rule 132 declaration explicitly stated that she drew her conclusions from data gathered from “pharmacokinetic studies” that were conducted “in similar groups of subjects.” Thus, Abbott had informed the PTO of the origin of the data even though it did not explicitly state: “This data was derived from a cross-study comparison.”

The final problem with Gustav-soris declaration regarding Cmax values is that she did not actually perform a statistical test to verify her assertion of statistical significance. While it is obviously troublesome that Gustavson made her assertion without having actually performed the statistical test, it does not amount to a material omission or misrepresentation for the same reasons outlined above. The extended release formulation is different from the immediate release suspension formulation. The data suggested to Gustavson that the Cmax of the former was actually lower than that of the latter. Simply put, the fact that Gustavson did not perform a statistical test was not material to the patentability of the '718 application.

Sandoz also claims Abbott intentionally withheld material information regarding the DFL of the extended release clarithro-mycin formulation from the PTO while the '718 patent was being prosecuted. Abbott responds that the information was not material. Claim 1 of the '718 patent states in relevant part that “the [extended release] composition induces statistically significantly lower mean fluctuation index in the plasma than an immediate release composition of the erythromycin derivative .... ” Abbott claimed that the mean DFL values for a modified release version of clarithro-mycin claimed by a prior patent, the '190 patent, were substantially equal to the mean DFL values for the immediate release version of clarithromycin. However, while the '718 patent was pending, Abbott and more specifically, Gustavson, became aware that the mean DFL values for a modified release version of clarithromycin claimed by '190 patent were actually statistically significantly lower than the immediate release composition through an internal Abbott study, Study W98-268.

The final report of Study W98-268 states that the modified release formulation exhibited a statistically significantly lower mean DFL than that for the immediate release formulation. Similarly the extended release formulation also exhibited a statistically significantly lower mean DFL than that for the immediate release formulation. The specification of the '718 patent states in relevant part that “[t]he mean DFL values for the controlled release formulation and for the IR are substantially equal in value ...” U.S. Patent No. 6,010,718 col. 11:1.18-19 (filed Apr. 11, 1997). Abbott knew of the report of Study W98-268 but did not disclose it to the PTO. Abbott basically treated the result of modified release being nearly equal to immediate release as an aberration since it chose to rely on the results of several other studies that showed differing mean DFL values. The situation can be summarized as follows:

Simply put, this Court fails to see the relevance of Sandoz’s argument. Sandoz claims that the results of Study W98-268 contradict the claim 1 requirement that the extended release formulation have a statistically significantly lower DFL than the immediate release formulation and that is why Abbott did not disclose it to the PTO. But claim 1 speaks of the PK relationship of extended release and immediate release formulations, not of modified release and immediate release formulations. Undisclosed information is material if it satisfies 37 C.F.R. § 1.56(b) and if there is a substantial likelihood that a reasonable examiner would have considered the undisclosed information important in deciding whether to allow the patent to issue. See Cargill, Inc., 476 F.3d at 1364. Abbott has submitted evidence demonstrating the Study W98-268 results differed from the results of three other studies. Furthermore, Abbott also submitted evidence showing a mean DFL value consistently lower than the mean DFL value for the IR formulation is not a static characteristic of the MR formulation. Abbott has also demonstrated that the totality of the evidence suggests the DFL of the MR formulation is not consistently lower than the DFL for the IR formulation. Yet there is no evidence showing the DFL of the ER formulation to be anything but consistently statistically significantly lower than the DFL of the IR formulation. Thus, contrary to Sandoz’s assertion, Study W98-268 does not demonstrate that the prior art MR formulation has the same broad PK properties as those claimed for the ER formulation. Therefore, Study W98-268 is not material to the patentability of the '718 patent.

Taste Perversion Data

Sandoz’s first argument regarding the taste perversion data found in Table VI of the '718 patent is without merit. Sandoz does not allege that the data is false or misleading, but rather that it simply does not demonstrate what Abbott purported. Specifically, Sandoz alleges Abbott committed inequitable conduct because it did not tell the PTO that there was no difference statistically in the adverse events of the extended and immediate release clarithromycin. Since this data was before the PTO, this Court presumes the PTO had every opportunity to review it when prosecuting claim 6. Claim 6 of the '718 patent states the extended release formulation has “an improved taste profile as compared to the immediate release formulation.” Sandoz submitted the declaration of an expert biostatistician, Dr. Paga-no, concluding that the data of Table VI does not provide any support for claim 6. Declaration of Dr. Marcello Pagano, ¶ 11. However, Dr. Pagano’s own analysis reveals that five out of twenty-three patients experienced taste perversion under the immediate release regimen only, while one patient out of twenty-four experienced taste perversion under the extended release regimen A only and one patient out of twenty-three experienced taste perversion under the extended release regimen B only, respectively. When comparing the ratio of 5/23 to the ratios of 1/24 and 1/23, it is readily apparent that some improvement is a justifiable conclusion. Abbott was not under any obligation to show a statistical difference to support claim 6, just some improvement.

Sandoz is correct in asserting that the results of the two clinical studies were material to the patentability of the '718 patent. First, the results directly refute Abbott’s claims that extended release clar-ithromycin results in reduced taste perversion. See 37 C.F.R. § 1.56(b)(2)(h) (2007). By contrast, they indicate that the extended release formulation offers no improvement over the immediate release formulation. The results were not cumulative of other evidence before the PTO; the only other evidence relating to taste perversion was the 24-subject pilot study discussed in the specification of the three patents. These results were material to the prosecution of the '718 patent because it contained a claim for improved taste perversion over immediate release clari-thromycin.

With respect to intent, this Court previously found that Ranbaxy had not demonstrated a substantial question that it could show intent to deceive the PTO in the prosecution of the '718 patent under the same facts as presented here. Ranbaxy Labs. Ltd. v. Abbott Labs., Abbott Labs. v. Andrx Pharms. Inc., Nos. 04 C 8078, 05 C 1490, 2005 WL 3050608 (N.D.Ill. Nov. 10, 2005) The prosecution of the patent and the clinical studies occurred contemporaneously. This Court accepted Abbott’s explanation that the difference between its submissions to the FDA and the PTO was that the “submission of studies to the FDA [was] of no moment, given that the '718 inventors’ roles with respect to the FDA submission, to the extent they were involved at all, had nothing to do with adverse event data.” Sandoz has not offered any new evidence supported an inference of intent to deceive. Abbott has submitted declarations of the '718 inventors and prosecuting attorney, each stating that she was unaware of the data at the relevant times. Since Sandoz has not yet demonstrated a substantial question that it can show intent to deceive the PTO in the prosecution of the '718 patent, this Court declines to find Abbott engaged in inequitable conduct by withholding the results of the two clinical studies.

Lastly, Sandoz argues that Abbott withheld material labeling data from the PTO. Sandoz contends that the label is material because it contains information that contradicts claim 6 of the '718 patent of an improved taste profile. The labels states that the taste perversion incidence rate of the immediate-release formulation is 3% while that of the extended-release formulation is 6%. Abbott claims the label is not material because these incidence rates came from different tests involving different dosages and that incidence of side effects is related to dosage. Sandoz retorts that there is no dosage limitation contained in claim 6.

Through Gustavson’s declaration and the supplemental declaration of Professor Stanley Davis, Abbott contends that given the differences in dosages, a person of ordinary skill in the art would find a comparison of the two percentages to be useless in determining whether the extended release formulation results in an improved taste profile over the immediate release formulation. Gustavson declares that the Biaxin ® IR was administered in dosages of 500mg and lOOOmg per day. Davis declares that the Biaxin ® IR was administered primarily in dosages of 250mg BID. Both declare that the Biaxin ® XL was administered in lOOOmg dosages per day. The labeling data is material under 37 C.F.R. § 1.56(b). It was not cumulative to information already of record or being made of record in the application, and it is (at least superficially) inconsistent with a position the applicant took in asserting an argument of patentability. Again, the relevant inquiry is whether a reasonable examiner would have found the data to be important in determining whether the patent should have issued.

Sandoz is correct that claim 6 contains no limitation on dosage. However, Abbott asserts (and Sandoz does not disagree) that the dosage of the drug affects the incidence of side effects. Taste perversion is a side effect. Thus, Abbott contends that because these incidence rates derive from studies based on different dosages of the two formulations, a person of ordinary skill would not have found a comparison of the two incidence rates important in the prosecution of the claim of an improved taste profile. Although this Court disagrees with Abbott’s use of a “person of ordinary skill”, it nonetheless finds that the labeling data was not material to pat-entability.

Materiality is determined from the point of view of the reasonable examiner, not the subjective view of the patentee. Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1238 (Fed. Cir.2003). Although the labeling information deals with the incidence rates of taste perversion, Abbott has submitted evidence that demonstrates that the data is not actually probative of whether or not the extended release formulation has an improved taste over the immediate release profile. While information may be material even if its disclosure would not have rendered the invention unpatentable, Digital Control, Inc. v. Charles Mach. Works, 437 F.3d 1309, 1318 (Fed.Cir.2006), information is not material if there is not a substantial likelihood that a reasonable examiner would consider the statement important in deciding whether to allow the application to issue as a patent. See Car-gill, Inc., 476 F.3d at 1364. Therefore, this Court finds that the information regarding the incidence rates on the label submitted to the FDA was not material to patentability.

After considering the evidence, this Court declines to find persuasive evidence of inequitable conduct in the prosecution of the '718 patent.

(2) The '616 Patent

Taste Perversion Data

The '616 patent, as originally filed, included a claim for taste perversion. The results of the two clinical studies were therefore material to the patentability of that claim at the time of filing. The fact that the taste perversion claim was deleted shortly after filing, as Abbott asserts, does nothing to diminish the materiality of these results to the patent application at the time of filing. The abstract and specification for all three patents contain references to improved taste perversion and/or taste profile (a term Abbott uses synonymously with “taste perversion”). However, Abbott argues that a finding of materiality is not warranted where claims have been withdrawn. See Scripps Clinic & Research Fund. v. Genentech, Inc., 927 F.2d 1565, 1583 (Fed.Cir.1991) (citing Kimberly-Clark Corp. v. Johnson & Johnson Co., 745 F.2d 1437, 1457 (Fed.Cir.1984)). Despite the fact that it withdrew the claim, Abbott filed the '616 application with knowledge of the results of the two studies. Those results were highly material to the claim at issue. These actions are enough to support an inference of an intent to deceive.

“Intent need not be proved by direct evidence; it is most often proven by a showing of acts, the natural consequence of which are presumably intended by the actor.” Molins PLC v. Textron, Inc., 48 F.3d 1172, 1180 (Fed.Cir.1995). Proof that non-disclosed information was highly material and that the patent applicant knew or should have known of that materiality makes it “difficult to show good faith to overcome an inference of intent to mislead.” Semiconductor Energy Lab. Co., Ltd. v. Samsung Elecs. Co., Ltd., 204 F.3d 1368, 1375 (Fed.Cir.2000) (citing Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253, 1257 (Fed.Cir.1997)). The clinical study results were highly material to the patent at issue. Moreover, the results were Abbott’s own proprietary information, at least until Abbott began to publish the results more broadly. Further complicating Abbott’s position is the fact that it submitted the complete results of the two clinical studies to the FDA in May 1999. Three of the named inventors on the '616 and '407 patent, Horn, Zhang, and Palmer, approved the reports of the two clinical studies, signing their names under a statement that they had read the reports and that the reports accurately stated the results of the studies. Two of the '616 inventors, Devcich and Zhang, were named authors on a 2001 journal article reciting the taste perversion results of the studies.

This Court finds, as a preliminary matter, that Sandoz has raised a substantial likelihood that it can show intent to deceive as to the '616 patent based upon the withholding of the results of the two studies. But this is not the end of the analysis; Sandoz has asserted other grounds for finding the '616 patent unenforceable.

GI Incidence Rates

Sandoz alleges that Abbott had data from its studies showing no actual reduction in the incidences of adverse GI events after taking extended-release clari-thromycin. The '616 patent claims a method of reduction of “gastrointestinal adverse side effects”. Sandoz contends that Abbott withheld this information from the PTO, choosing only to present data on the reduced number of patients who dropped out of the studies due to incidences of adverse GI events. According to Abbott, the improvements in “gastrointestinal adverse side effects” discussed in the '616 patent referred to 1) the most severe GI side effects and 2) the patient discontinuations due to GI side effects, not the overall incidence rates of GI side effects. The incidence data provided in the patent specification actually shows the two formulations of clarithromycin to have similar overall GI side effect incidence rates. See U.S. Patent No. 6,551,616 col. 11:1. 55-col. 12:1. 36 (filed Oct. 13, 1999). Thus, since the incidence data form the two studies merely corroborated data that was already present in the patent, the data was cumulative and not material. See 37 C.F.R. § 1.56(b).

Abbott claims that the '616 patent invention provides a “method of reducing gastrointestinal adverse side effects”. In a memorandum filed by Abbott on March 20, 2006, Abbott took the following position regarding construction of claim 1 of the '616 patent:

“[RJeducing gastrointestinal adverse side effects,” as used in claim 1 of the '616 patent, should be construed to mean a reduced incidence of gastrointestinal adverse side effects following ingestion of the ER clarithromycin formulation compared to an immediate release formulation, including reduced incidence of severe gastrointestinal adverse side effects and/or a reduced incidence of gastrointestinal side effects severe enough to cause patient or subject discontinuance of treatment. “Gastrointestinal adverse side effects” means those physiological effects to the gastrointestinal system which cause pain and discomfort to the individual subject.

The parties do not dispute the meaning of “gastrointestinal adverse side effects.” As Ranbaxy, Teva, Andrx, and Sandoz all note, examples of such effects include abdominal pain, constipation, diarrhea, dyspepsia, flatulence and nausea, all of which are listed in Table VI of the '616 patent.

Abbott Laboratories’ Memorandum in Support of Its Proposed Claim Construction, p. 26 (emphasis added). Sandoz’s own proposed construction did not differ very much from Abbott’s.

One of ordinary skill in the art would understand the term “gastrointestinal adverse side effects” to include adverse events in the digestive system, abdominal pain, constipation, diarrhea, dyspepsia, flatulence and nausea. (Ex. D at ¶ 15.) These are the adverse side effects listed in Table VI of the patent specification.

Memorandum of Law in Support of Defendant Sandoz, Inc.’s Construction of Claim Terms of the Patents In Suit, p. 10-11.

This Court declines to find that the term “reducing gastrointestinal adverse side effects” only refers to the most severe GI side effects and the patient discontinuations due to GI side effects. However, it is clear from both Table VI and Table VIII that some data demonstrating no change in the subcategories of GI adverse side effects of abdominal pain, constipation, diarrhea, dyspepsia, flatulence and nausea were in fact disclosed to the PTO. The data Sandoz claims was withheld demonstrates the exact same conclusion as the data that was disclosed. Therefore, such data was cumulative under 37 C.F.R. § 1.56, Abbott was not under a duty to disclose it and Sandoz’s argument fails.

Severity Data

Sandoz alleges that Abbott used a rating system that mischaracterized the severity of the adverse GI side effects. Sandoz states that while Abbott did disclose data from the two clinical studies and an Integrated Summary of Safety to the FDA, it did not disclose this data to the PTO. Pagano’s Declaration, ¶ 48-50. Despite the fact that this data was not submitted to the PTO, Sandoz nonetheless complains that Abbott engaged in inequitable conduct by categorizing the data in a deceitful manner. Given that Sandoz concedes this data was not submitted to the PTO, it is difficult to understand how the manipulation of the data was an act of fraud upon the patent examiner. Sandoz does state that Abbott was improper to “report the number of discontinuations due to gastrointestinal adverse side effects to the PTO.” Pagano’s Declaration, ¶ 49.

Submitting the number of discontinuations due to gastrointestinal adverse side effects to the PTO was not an act of inequitable conduct. The information was highly relevant to Abbott’s contention that use of the ER formulation reduced the number of patient discontinuations. San-doz has not submitted any evidence that the number is false or misleading while Abbott has produced evidence through the declaration of Dr. Daniel Weiner, (Supplemental Declaration of Weiner, Exhibits A and B.) that demonstrates the common usage of the disputed rating system in the pharmaceutical industry in measuring symptom severity. Therefore, even if this argument is relevant, this Court finds that it fails.

e. Conclusion

Having found that Sandoz has shown a substantial likelihood of materiality and intent to deceive only in regard to the '616 patent application on Abbott’s failure to disclose the taste perversion data at the time of filing, the Court must now engage in a balancing of the evidence to determine whether the scales tilt towards finding inequitable conduct.

Despite its previous ruling in the Ran-baxy case, this Court now declines to preliminary find the '616 patent unenforceable because of inequitable conduct. Although this Court found the taste perversion data to be material at the time of filing and Abbott probably had an intent to deceive the PTO at the time of filing, Abbott nonetheless on its own volition, abandoned the claim. According to Kimberly-Clark, it is inappropriate to find a patentee committed inequitable conduct based on a claim that was abandoned during prosecution where the PTO rejected the claim for reasons unrelated to the abandonment. 745 F.2d at 1457. Here, the PTO rejected the '616 application as non-conforming because it lacked signed inventor roles. Abbott then provided the signatures and that very same day withdrew the taste perversion claim. Redemption is one of the core principles of the American ethos. Thus in addition to being contrary to the spirit of Seribbs, Kimberly-Clark and the Code of Federal Regulation, it seems wholly inequitable to hold a patent to be invalid for fraudulent conduct in the prosecution of a claim that was withdrawn before actual prosecution had even begun. Based on the evidence presented at this juncture, this Court preliminarily finds both the '616 and the '718 patents are not invalid over Abbott’s alleged inequitable conduct in intentionally failing to disclose highly material information to the PTO.

2. Infringement Analysis

An infringement inquiry proceeds in two steps. MBO Laboratories, Inc. v. Becton, Dickinson & Co., 474 F.3d 1323, 1329 (Fed.Cir.2007). First, a court will determine, as a matter or law, the correct scope and meaning of the disputed claim term(s). Id. Then, the court will compare the properly construed claim to the accused device and ascertain whether that device contains every limitation of the claim or a substantial equivalent thereof. Id.

Despite upholding the preliminary injunction order against Andrx, the Court of Appeals for the Federal Circuit held that this Court’s claim construction was flawed. 473 F.3d at 1213. Therefore, this Court will again construe the relevant claims of the patents at issue.

a. '718 Patent

There is a “ ‘heavy presumption’ that a claim term carries its ordinary and customary meaning.” CCS Fitness Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir.2002). Claim terms should therefore be accorded their ordinary meaning unless the patentees “clearly set forth a definition of the disputed claim term in either the specification or prosecution history.” Id. The ordinary and customary meaning of a claim term refers to that meaning a person of ordinary skill in the art in question would attach to the term. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed.Cir.2005) (en banc). Even though a term may have a distinct ordinary meaning to a person of ordinary skill in the art, a patentee may still “expressly define terms used in the claims.” Phillips, 415 F.3d at 1321. When interpreting an asserted patent claim, the court should look first to the intrinsic evidence of record, which is the patent itself, including its claims, specification, and complete prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed.Cir.1995) (en banc). This intrinsic evidence is the primary and most significant source of the legally operative meaning of any claim language that is in dispute. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed.Cir.1996). The court may also consider extrinsic evidence such as expert declaration evidence provided for the parties. Pharmacia, 274 F.Supp.2d at 602.

As a threshold matter, the court must determine what constitutes a person of ordinary skill in the art for the purposes of the patent. Previously, this Court defined a person of ordinary skill in the art as someone with “a Ph.D. in pharmaceutical chemistry or a related field and at least two years experience in formulating drugs” or a skilled artisan with “a Bachelor’s or Master’s Degree in an appropriate field and substantially more practical experience in formulating drugs.” Teva, No. 05-1490, 2005 WL 1323435, at *7, n. 3. Neither party has suggested that the Court should modify its previous definition and therefore, that definition is hereby adopted and will be used in construing the claims below.

(1) Claim 1 Construction

First, “the claims themselves provide substantial guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d at 1314. Claim 1 reads as follows:

A pharmaceutical composition for extended release of an erythromycin derivative in the gastrointestinal environment, comprising an erythromycin derivative and from about 5 to about 50% by weight of a pharmaceutically acceptable polymer, so that when ingested orally, the composition induces statistically significantly lower mean fluctuation index in the plasma than an immediate release composition of the erythromycin derivative while maintaining bioavailability substantially equivalent to that of the immediate release composition of the erythromycin derivative.

U.S. Patent No. 6010718 col. 11 11.28-38 (filed Apr. 11, 1997).

None of the following elements are disputed and each term is assigned its plain and ordinary meaning as understood by a skilled artisan. The term “pharmaceutical composition” means an aggregated product formed from two or more substances for use as a drug in medical treatment. The term “gastrointestinal environment” means the organs that make up the GI tract, including the stomach, intestines, and to a lesser extent the mouth, pharynx, esophagus and the anus. The term “mean fluctuation index” means the average degree of fluctuation ((Cmax-Cmin)/Cavg) over a specified period of time (usually twenty-four hours) by which pharmacoki-neticists can distinguish rates of release into the plasma.

The term “bioavailability” in the context of the '718 patent means the total exposure of the erythromycin derivative in the bloodstream as measured by the logarithm-transformed area under the plasma concentration-time curve (“AUC”), which is a mathematical and visual representation of the aggregate amount of the drug reaching systemic circulation over a given period of time. Bioavailability does not encompass both the rate and effect of release because extended release and immediate release formulations have different rates of release by definition. That is also why the claim calls for a lower mean fluctuation index for the extended release formulation versus the immediate release formulation — to highlight the importance of changing the rate of release without changing the overall amount of erythromy-cin derivative in the plasma. Both parties agree that in claim 1, the term “substantially equivalent to that of the immediate release composition” means the extended release composition AUC values must be between 80% to 125% within a 90% confidence level as compared to the immediate release composition AUC values.

The parties do not dispute that clari-thromycin is an “erythromycin derivative.” The extended release composition at issue is designed for release in the gastrointestinal environment (e.g., oral administration). The patent specification defines “erythro-mycin derivative” as meaning “erythromy-cin having no substituent groups, or having conventional substituent groups, in organic synthesis, in place of a hydrogen atom of the hydroxy groups and/or a methyl group of the 3'-dimethylamino group, which is prepared according to the conventional manner.” U.S. Pat. No. 6,010,718, at col. 3:11. 34-39. The patent specification further states that the “pharmaceutically active compound” of the composition “is an erythromycin derivative.” Id., at 11. 58-61. It goes on, “[pjreferably, the erythromycin derivative is 6-O-methoxy erythromycin A, known as clarithromycin.” Id. The language of the claim is definite (“an erythro-mycin derivative”) but not closed. It does not specify that the pharmaceutically active compound “is a member selected from the group consisting of A, B, and C.” Thus, clarithromycin is an erythromycin derivative under this meaning.

Sandoz’s product uses clarithromycin as its pharmaceutically active compound. As noted in an earlier decision, Abbott defined “erythromycin derivative” in the '718 patent in such a way as to leave out azithro-mycin. Azithromycin is the name for 9a-aza-9a-methyl-9-deoxo-9a-homoerythro-mycin A. Pfizer, the patent holder on azi-thromycin, describes azithromycin as a “broad spectrum antimicrobial compound derived from erythromycin A.” WO 95/30422 (the “'1,22 patent”). It is likely that Abbott consciously defined “erythro-mycin derivative” as it did to avoid infringing Pfizer’s existing '422 patent.

The primary dispute in this matter is over the meaning of the term “pharmaceutically acceptable polymer.” The term is not defined in the claim. Even the claims of a patent that are not at issue in an infringement suit are nonetheless part of intrinsic evidence to be considered during claim construction. Claim 1 of the '718 patent requires a composition that includes a “pharmaceutically acceptable polymer.” col. 11:11. 31-32. Claim 2, not at issue here, depends from claim 1 and further requires that the pharmaceutically acceptable polymer “is a hydrophilic water-soluble polymer.” Id., col. 11 11. 39-40. Claim 3, also not asserted in this case, depends from claim 2 and more specifically requires that “the polymer is selected from the group consisting of polyvinylpyrroli-dine, hydroxypropyl cellulose, hydroxypro-pylmethyl cellulose, methyl cellulose, vinyl acetate/crotonic acid copolymers, metha-crylic acid copolymers, maleic anhy-dride/methyl vinyl ether copolymers and derivatives and mixtures thereof.” Id., col. 11 11. 42-47. “The presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim.” Phillips, 415 F.3d at 1315. Furthermore, independent claims are generally given broader scope so as to avoid rendering corresponding dependent claims redundant. Id. at 1324 (citing Dow Chem. Co. v. United States, 226 F.3d 1334, 1341 (Fed.C