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RANBAXY LABORATORIES LTD. v. ABBOTT LABORATORIES

November 10, 2005.

RANBAXY LABORATORIES LTD., and RANBAXY PHARMACEUTICALS, INC., Plaintiffs/Counterdefendants,
v.
ABBOTT LABORATORIES, Defendant/Counterclaimant. ABBOTT LABORATORIES, Plaintiff, v. ANDRX PHARMACEUTICALS, INC., TEVA PHARMACEUTICALS USA, INC. and ROXANE LABORATORIES, INC., Defendants.



The opinion of the court was delivered by: DAVID COAR, District Judge

MEMORANDUM OPINION AND ORDER

This matter comes before the court on plaintiff Abbott Laboratories, Inc.'s ("Abbott") motion for a preliminary injunction against defendant Andrx Pharmaceuticals, Inc. ("Andrx") (No. 05-1490); and on defendant Abbott Laboratories, Inc.'s motion for a preliminary injunction against plaintiffs Ranbaxy Laboratories, Ltd. and Ranbaxy Pharmaceuticals, Inc. (collectively "Ranbaxy") (No. 04-8078). Abbott seeks to enjoin Andrx and Ranbaxy from marketing generic versions of the antibiotic drug, clarithromycin, in extended release formulation. Abbott is the patent holder on a series of patents relating to clarithromycin, which Abbott markets under the brand name "BIAXIN" and, in its extended release formulation, "BIAXIN XL." Abbott alleges that Andrx's and Ranbaxy's generic products will infringe Abbott's U.S. Patent No. 6,010,718 ("the '718 patent"); No. 6,551,616 ("the '616 patent"); and No. 6,872,407 ("the '407 patent"), relating to its BIAXIN XL product. This opinion addresses the specific infringement and invalidity issues as to Ranbaxy, followed by the specific infringement and invalidity issues as to Andrx, and then considers the common issues relating to the remainder of the preliminary injunction analysis.

I. BACKGROUND

  Ranbaxy Pharmaceuticals, Inc. is a wholly-owned American subsidiary of Ranbaxy Laboratories, Ltd., an Indian corporation. Ranbaxy develops and markets pharmaceuticals, including generics. In 2003, Ranbaxy filed Abbreviated New Drug Applications ("ANDAs") with the Food and Drug Administration ("FDA"), seeking approval to market generic extended-release clarithromycin products. On December 14, 2004, Ranbaxy filed a complaint in this court, requesting a declaratory judgment of noninfringement of several of Abbott's patents relating to clarithromycin. Abbott now seeks to preliminarily enjoin Ranbaxy from producing and marketing its 1000 mg clarithromycin extended release product.*fn1 Abbott contends that Ranbaxy's 1000 mg clarithromycin extended release product infringes its U.S. Patent No. 6,010,718 ("the '718 patent"); No. 6,551,616 ("the '616 patent"); and No. 6,872,407 ("the '407 patent"). Each of these patents relates to Abbott's extended release clarithromycin product, BIAXIN XL.

  Abbott also seeks a preliminary injunction against Defendant Andrx Pharmaceuticals, Inc. ("Andrx") for alleged imminent infringement of Abbott's extended release clarithromycin patents. Andrx Pharmaceuticals, a division of Andrx Corporation, is a Florida-based corporation that manufactures generic versions of branded pharmaceuticals. The Food and Drug Administration ("FDA") granted Andrx's ANDA for generic extended release clarithromycin. In response, Abbott brought the current infringement suit. This Court held a preliminary injunction hearing and now has reviewed the extensive record on this matter.*fn2 Abbott alleges that Andrx's generic extended release product will infringe claims 1, 2, and 4 of Abbott's United States Patent No. 6,010,718 ("the '718 patent"); claim 2 of United States Patent No. 6,551,616 ("the '616 patent"); and claims 8, 9, 10, 12, and 16 of United States Patent No. 6,872,407 ("the '407 patent").*fn3

  Clarithromycin, an erythromycin derivative, 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 clarithromycin, 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 clarithromycin. Abbott began marketing this extended release formulation under the name BIAXIN XL in 2000. On March 29, 2005, the United States Patent and Trademark Office ("US PTO") issued the '407 patent to Abbott, which also relates to extended release clarithromycin. The '407 patent is described as a continuation of the '616 patent, which is itself described as a continuation-in-part of the '718 patent. 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 or about May 24, 2005.

  Ranbaxy asserts that Abbott engaged in inequitable conduct in prosecuting its patents and is therefore foreclosed from preliminary relief under the unclean hands doctrine. In addition, Ranbaxy contends that its product does not infringe the '718 or the '407 patents. Finally, even if it was found to be infringing, Ranbaxy argues that all of Abbott's asserted patents are invalid as anticipated or obvious under the prior art.

  Andrx contends that it does not infringe any of the asserted patents either literally or under the doctrine of equivalents. In addition, it asserts that Abbott's patents are invalid for indefiniteness, obviousness, and in light of prior art.

  This Court held hearings on Abbott's motions for preliminary injunction on September 12 and 13, 2005 (Ranbaxy), and September 21, 2005 (Andrx). II. PRELIMINARY INJUNCTION STANDARD

  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. ANALYSIS OF CLAIMS AGAINST RANBAXY

  A. Likelihood of Success on the Merits

  To demonstrate likelihood of success on the merits, the movant must show that the nonmovant infringes the patents in suit, and also that the movant's infringement claim likely will survive the alleged infringer's defenses of patent invalidity and unenforceability. Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997). A patent is presumed to be valid, 35 U.S.C. § 282 (2001), and a challenger must show invalidity by clear and convincing evidence. 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 Pharms., Inc., 274 F. Supp. 2d 597, 601 (N.D. Ill. 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 patentee 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 it will prove infringement at trial of one or more of the claims of the patents-in-suit. Abbott also contends that it likely will demonstrate that Ranbaxy's challenges to the validity of the patents in suit lack substantial merit. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1351 (Fed. Cir. 2001).

  B. Inequitable Conduct

  This Court will analyze Ranbaxy's claim that Abbott engaged in inequitable conduct before addressing the issues of claim construction and infringement. A finding of inequitable conduct would invalidate one or more of the patents at issue, thereby rendering the dispute moot to the extent of the invalidity.

  1. Standard for Inequitable Conduct

  Inequitable conduct occurs when a patent applicant violates his or her "duty of candor and good faith" to the US PTO. 37 C.F.R. § 1.56(a) (2001); Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs., Ltd., 394 F.3d 1348, 1351 (Fed. Cir. 2005). A court determines inequitable conduct based on "failure to disclose" by a three-step analysis. First, the court examines whether the accused conduct concerns information that was material to patentability. Second, the court determines whether the inventors or their attorney knew of the information and knew that it was material. After finding materiality, the court then queries whether the conduct demonstrates that the patentee had an intent to deceive the US PTO. FMC Corp. v. Manitowoc Co., Inc., 835 F.2d 1411, 1415 (Fed. Cir. 1987). The challenger bears the burden of establishing materiality and intent by clear and convincing evidence. Once materiality and intent to deceive have been established, the court applies a balancing test to determine whether, in light of all the circumstances, a finding of inequitable conduct is warranted. Purdue Pharma L.P. v. Boehringer Ingelheim GMBH, 237 F.3d 1359, 1366 (Fed. Cir. 2001). The Federal Circuit has stated that "when balanced against high materiality, the showing of intent can be proportionally less." Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1234 (Fed. Cir. 2003) (citation omitted). A finding of inequitable conduct with respect to any one claim of the patent will render the entire patent unenforceable. Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d 1326, 1336 (Fed. Cir. 1998).

  2. Ranbaxy's Allegations

  Ranbaxy contends that during the prosecution of the '718, the '616, and the '407 patents, Abbott selectively withheld information from two large clinical studies it conducted on BIAXIN XL from the US PTO. Specifically, Abbott claimed in its patent prosecutions that its extended release formulation provided reduced taste perversion*fn4 compared to its immediate release formulation. Ranbaxy alleges that Abbott failed to disclose relevant data from two of its own studies that cast doubt on this assertion: the double-blind Acute Bacterial Exacerbation of Chronic Bronchitis ("the bronchitis study") and the Acute Maxillary Sinusitis studies ("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 three-fold 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 clarithromycin (ER) and immediate-release clarithromycin (IR)." See, e.g., U.S. Pat. No. 6,872,407, at 11:27-30.*fn5 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. But only the gastrointestinal side effects data was reported to the US PTO. Ranbaxy avers that the taste perversion data from the clinical studies at best failed to support Abbott's contention that extended release clarithromycin had improved taste perversion over immediate release. Further, Ranbaxy 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.

  According to Ranbaxy, the Abbott inventors involved in prosecuting the '718 and the '407 patents knew about the taste perversion results from the two clinical studies but failed to report them to the prosecuting attorney or to the PTO. Instead, they chose to disclose only favorable data relating to gastrointestinal side effects. Ranbaxy further asserts that the clinical studies were completed and the results reported at least eight months before the '718 patent issued, thus providing ample time for Abbott to amend the claims of the '718. Abbott did not do so. Ranbaxy contends, however, that two of the inventors, Linda Gustavson and Susan Semla, of the '718 patent presented the results of the clinical studies at a scientific conference in San Francisco in September 1999. In October 1999, Abbott filed the continuation-in-part application that ultimately issued as the '616 patent; Susan Semla is listed as an inventor. By December 7, 1999, Abbott submits reports on the two clinical studies to the FDA for approval. In January 2001, a scientific journal article co-authored by Gustavson, Jie Zhang, an inventor on both the '616 and the '407 patents, Karen Devcich, also an inventor on the '616 and the '407 patents, reviewing the gastrointestinal and taste perversion results of the clinical studies, was accepted for publication. David R.P. Guay et al., Pharmacokinetics and Tolerability of Extended-Release Clarithromycin, Clinical Therapeutics 566-77 (2001). The article stated that "abnormal taste" was one of the "most commonly reported" side effects of both immediate release and extended release clarithromycin; significantly, the percent of study populations reporting abnormal taste was identical between the immediate release and extended release groups (six percent vs. six percent). Id. at 576. In the following paragraph, however, the article stated that "the incidence of premature discontinuation from treatment due to GI events was significantly less with the ER formulation . . ., as was treatment discontinuation due to GI or abnormal taste events. No patient prematurely discontinued treatment with clarithromycin ER tablets because of abnormal taste." Id.

  On November 22, 2002, Abbott filed a continuation application (the '166 application) to the '616 patent, using the same information in the specification as the '616 patent (which was, itself, virtually the same information as the specification as the '718 patent). This continuation application, which issued as the '407 patent, included a claim for reduced taste perversion but did not include the taste perversion results from the clinical studies.*fn6 The '407 patent lists three inventors who also signed off on the two clinical studies: Jie Zhang, Richard Hom, and Robert Palmer.

  The '407 patent includes a claim for "improved taste perversion compared to an immediate release formulation," (claim 2) and a claim for "providing a 3-4 fold reduction in incidence rates for taste perversion as compared to the immediate release formulation" (claim 4), which Abbott initially asserted against Ranbaxy. Over the course of this litigation, Abbott withdrew that claim and now maintains that it is engaged in internal investigation to determine whether the '407 patent has "an inventorship problem." It is apparently Abbott's position that it inadvertently neglected to include the inventor of the taste perversion claim on its application for what was issued as the '407 patent; Abbott asserts that it will correct this oversight with the US PTO once it determines who the appropriate inventor is. Ranbaxy argues that an "inventorship problem" does not overcome the presence of claim 2 in the patent as issued, and instead, supports Ranbaxy's assertions that Abbott knowingly withheld material information from the PTO.

  For these reasons, Ranbaxy contends that the facts warrant an inference of an intent to deceive the PTO.

  3. Abbott's Response

  Abbott asserts that it has not committed inequitable conduct and that Ranbaxy is unable to demonstrate otherwise by clear and convincing evidence. At most, according to Abbott, Ranbaxy's alleged evidence establishes that Abbott acted negligently, but engaged in no intentional deception. In particular, Abbott contends that Ranbaxy fails to demonstrate that material information to the patentability of Abbott's claimed invention existed, that the inventors or their attorney knew of such information and that it was material information; and that the inventors or their attorney failed to disclose the information with the intent to mislead the PTO. In support of this position, Abbott submits declarations from the attorney who prosecuted the '718 patent, Mona Anand; the Assistant Director of Clinical Research named as an inventor on the '616 and the '407 patents, Robert Palmer; a formulator named as an inventor on the '718 patent, Nelly Milman; a named inventor on the '407 patent who also managed the clinical study reports on the two studies, Karen Devcich; a Medical Director for Macrolide Venture, Anti-Infective Franchise, and the Anti-Infective Global Project Team and a named inventor on the '616 and the '407 patents, Gerard Notario; a formulation team leader and named inventor on the 718 patent, Ho-Wah Hui; and former senior counsel in Abbott's Patent and Trademark Division who oversaw the '407 patent prosecution, Nicholas Poulos. The declarations state that the declarants were ignorant of the taste perversion results of the studies, of the taste perversion claims of the patent, or both. Those who admit knowledge of the taste perversion results of the studies contend that they did not know the results were relevant or material to any Abbott patent because they did not know that any of the patents included claims relating to taste perversion.

  During the prosecution of the '718 patent, Abbott contends that neither the prosecuting attorney nor the inventors were aware of the taste perversion data from the bronchitis and sinusitis studies. 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 pharmacokinetic analyses; in clinical studies, she only interpreted blood concentration data and 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.

  With respect to the '616 patent, Abbott again contends that it did not withhold taste perversion data. Abbott emphasizes that the '616 patent was a continuation-in-part of the '718 patent, directed to side effects of the invention that were not claimed in the '718 patent. According to Abbott, sometime after the '718 patent had been allowed, Semla saw a poster announcing results from the clinical studies and learned that BIAXIN XL reduced gastrointestinal adverse side effects compared to the immediate release formulation. Semla thought these results were significant for the patent application and put the clinician who prepared the poster, Devcich, in contact with the prosecuting attorney, Anand, who reviewed a summary of conclusions relating to gastrointestinal side effects from the studies. Anand then incorporated that summary into the '616 patent. Anand did not know of and did not inquire about taste perversion data. Abbott asserts that Anand had no duty to investigate other possible data. Because Devcich was not an inventor on or otherwise involved in the '718 patent, she was unaware that the taste perversion data might be relevant to Anand, the prosecuting attorney. Finally, Abbott contends that Ranbaxy's other arguments are unavailing. Specifically, Abbott argues that none of the presentations at the September 1999 Interscience Conference on Antimicrobial Agents and Chemotherapy ("ICAAC") in San Francisco related to the taste perversion findings of the studies. See Pharmacokinetics of a New Extended-Release Clarithromycin Tablet as Doses of 500 and 1000 mg Daily, Abbott Labs ICAAC Poster #1191 (Sept. 1999) (reporting bioavailability studies comparing multiple dose pharmacokinetics of extended release clarithromycin with immediate release clarithromycin, but reporting no taste perversion data); Gastrointestinal Adverse Event Severity Comparisons with Extended-Release Clarithromycin and Immediate-Release Clarithromycin, Abbott Labs ICAAC Poster #1758 (Sept. 1999) (reporting "the extended-release formulation of clarithromycin is better tolerated, is less likely to cause gastrointestinal adverse events" but reporting no taste perversion data). The 2001 article in Clinical Therapeutics was completed over a year after the '718 patent issued; Gustavson's role in preparing the article was limited to the pharmacokinetics discussion. Abbott then asserts that the timing of submission of clinical studies to the FDA is irrelevant because the patent inventors were not involved with the studies' submission.

  With respect to Ranbaxy's argument that the '616 patent inventors must have known that Abbott was pursuing taste perversion claims, Abbott contends that Ranbaxy overstates the evidence. The '616 patent, as originally filed, did include a taste perversion claim. But Abbott asserts that the claim was simply carried over from the '718 patent, which had already been allowed, and therefore could not be granted again. Although the inventors of the '616 patent completed a new oath, Abbott contends that was because of new matter in the patent which related solely to gastrointestinal side effects and had no bearing on their awareness of taste perversion claims in the '616 patent. In any event, Abbott avers that the declaration and power of attorney forms on the '616 patent were executed "long after" the taste perversion claim was withdrawn and "several months before" the application that became the '407 patent was filed. As for the '407 patent, Abbott contends that the inventors were unaware that the prosecuting attorneys were pursuing claims for improved taste perversion. Although five of the six named inventors knew of the two clinical studies, a "lack of communication with Abbott's patent department" meant that none knew of the taste perversion claims in the patent application. In addition, the '407 patent attorney was "unaware" that the study reports identified in the '616 patent might have any relevance to the taste perversion claims in the '407 patent. But, Abbott opines, it is not necessary to submit new inventor declarations or power of attorney forms when filing a continuation application, such as the '407 patent, because a continuation pertains to the same invention as the parent (in this case, the '718 patent). Thus, patent attorneys can prosecute continuation patents without consulting with the inventors. Finally, Abbott argues that if the inventors had intended to deceive the PTO, they had results from yet another study that would have even more strongly supported their taste perversion claim and could have submitted those results; the fact that they did not do so demonstrates that they had no intent to deceive.*fn7

  4. Analysis

  In evaluating materiality, this Court refers to the definition provided in 37 C.F.R. § 1.56 (2001). 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 unpatentability relied on by the Office, or
(ii) Asserting an argument of patentability.*fn8
37 C.F.R. § 1.56(b) (2001). It is beyond dispute that the results of the two clinical studies were material to the patentability of the '407 patent. The results directly refute Abbott's claims that extended release clarithromycin results in reduced taste perversion. 37 C.F.R. § 1.56(b)(2)(ii). 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. 37 C.F.R. § 1.56(b). For these same reasons, the results were also material to the prosecution of the '718 patent, which contained a claim for improved taste perversion over immediate release clarithromycin. The '616 patent, as originally filed, also included a claim for taste perversion. The results of the two clinical studies were therefore material to the patentability of that claim. 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").*fn9 "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 nondisclosed 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 patents at issue. Moreover, the results were Abbott's own proprietary information, at least until Abbott began to publish the results more broadly. Abbott contends that it had no duty to investigate the existence of possible taste perversion data. Not so. A patent applicant may not selectively disclose only certain portions of material information. See, e.g., Semiconductor Energy, 204 F.3d at 1374. The Federal Circuit has stated that "[a]s a general rule, there is no duty to conduct a prior art search, and thus there is no duty to disclose art of which an applicant could have been aware." FMC Corp. v. Hennessy Indus., Inc., 836 F.2d 521, 526 n. 6 (Fed. Cir. 1987) (quoted in Frazier v. Roessel Cine Photo Tech, Inc., 417 F.3d 1230, 1238 (Fed. Cir. 2005)); see also Bruno Indep. Living Aids., Inc., 394 F.3d at 1351 n. 4; Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1362 (Fed. Cir. 1984). The difficulty for Abbott is that each of the cases cited dealt with prior art from a source other than the patent applicant. It may be that Abbott's patent prosecuting attorneys had no duty to investigate the prior art, but it does not follow that there was no duty to disclose information that Abbott itself had generated, espeically where Abbott selectively disclosed other information from the same study. If accepted, Abbott's argument would permit a company to conduct sweeping studies of an invention, compartmentalize the results in separate divisions, and then submit only discrete portions to the PTO in support of specific claims while claiming ignorance of other, potentially highly material information, because that information was in a different compartment.

  Abbott argues that the facts of the instant suit "stand in stark contrast" to Semiconductor Energy because in Semiconductor, the "applicant submitted a partial translation of a Japanese prior art reference that failed to include a portion that the inventor, a native Japanese speaker, knew would decrease the likelihood of the patent being granted." Abbott's Reply Br. to Ranbaxy, at 25 n. 26. This Court finds the facts of this case and the facts of Semiconductor to be less easily distinguished. Abbott argues that its inventors and patent attorneys either had no knowledge of the results of the clinical studies or did not know the results were relevant to any of Abbott's patents or both. But the inventor in Semiconductor also argued that he did not believe that the undisclosed portion of the Japanese prior art reference was relevant to his patent application. The district court and the Federal Circuit found otherwise.

  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. Abbott's explanation of the difference between its submissions to the FDA and the PTO is that the "submission of studies to the FDA is 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." But the '718 inventors are not the most important for this determination. Three of the named inventors on the '616 and '407 patent, Hom, 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 and '407 patent 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 Ranbaxy has raised a substantial likelihood that it can show intent to deceive as to the '407 and the '616 patents.

  Next, the Court must engage in a balancing of the evidence to determine whether the scales tilt towards finding inequitable conduct. Based on the evidence presented at this juncture, Abbott's argument appears to be that it is a very large corporation with many employees performing disparate tasks in separate facilities who cannot all be required to know what each of the others is doing. In short, Abbott appears to be arguing that because it has many employees who do not all communicate with each other as well as they might, this Court should find no more than negligence on Abbott's part in its failure to disclose the material results of the clinical studies. With respect to the '718 patent, such an argument may have merit. The prosecution of the patent and the clinical studies occurred contemporaneously. Ranbaxy has not yet demonstrated a substantial question that it can show intent to deceive the PTO in the prosecution of the '718 patent. After balancing the evidence, this Court declines to find inequitable conduct in the prosecution of the '718 patent. With respect to the '616 and the '407 patents, however, this Court preliminarily finds that Abbott fails to provide a credible explanation for the failure to disclose the taste perversion results to the PTO. The results were highly material, but Abbott selectively disclosed only the gastrointestinal results despite claiming reduced taste perversion in both the '616 and '407 patents. For that reason, this Court preliminarily finds both the '616 and the '407 patents invalid over Abbott's inequitable conduct in intentionally failing to disclose highly material information to the US PTO.

  C. Infringement

  To determine infringement, a court must first determine the scope and meaning of the patent claims asserted and then compare the properly-construed claims to the allegedly infringing device. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed. Cir. 1998) (en banc). When comparing the claim to the device, a court will only find infringement if each and every limitation of the claim is met in the accused device, either literally or under the doctrine of equivalents. The analysis must be performed on a limitation-by-limitation basis, not by comparing the claimed and accused devices "as a whole." See, e.g., Biagro Western Sales, Inc. v. Grow More, Inc., 423 F.3d 1296 (Fed. Cir. 2005).

  1. Claim Interpretation

  Claim terms are presumed to carry their ordinary meanings unless the patentees "clearly set forth a definition of the disputed claim term in either the specification or prosecution history." CCS Fitness v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002); see also Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The "ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips v. AWH Corp., 415 F.3d 1303, 1013 (Fed. Cir. 2005). The court gives "primary consideration" to the specification and prosecution history and may also consider prior art, technical treatises, and dictionaries. If expert testimony would be relevant and helpful, it may also be considered. Glaxo Wellcome, Inc. v. Andrx Pharmaceuticals, Inc., 344 F.3d 1226, 1229 (Fed. Cir. 2003); see also Phillips, 415 F.3d 1303.

  As a threshold matter, the court must determine what constitutes a person of ordinary skill in the art for the purposes of the patent. Abbott argues for a less stringent standard, while Ranbaxy contends for a more demanding one. After reviewing the expert declarations submitted by all parties, this Court finds no compelling reason to alter its determination of the person of ordinary skill as found in Abbott Labs v. Teva Pharmaceuticals, No. 05-1490, slip op., 2005 WL 1323435, *1 (N.D. Ill. Jun. 3, 2005). Thus, this Court will define 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.

  Abbott asserts that Ranbaxy infringes claims 4, 6, and 7 of the '718 patent. Those claims state:
4. 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 upon oral ingestion, maximum peak concentrations of the erythromycin derivative are lower than those produced by an immediate release pharmaceutical composition, and area under the concentration-time curve and the minimum plasma concentration are substantially equivalent to that of the immediate release pharmaceutical composition.
6. An extended release pharmaceutical composition comprising an erythromycin derivative and a pharmaceutically acceptable polymer, the composition having an improved taste profile as compared to the immediate release formulation. 7. The extended release pharmaceutical composition according to claim 3,*fn10 wherein the polymer is hydroxypropylmethyl cellulose.
a. Claims 4 and 7 of the '718 patent
  Abbott and ...

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