WARNER CHILCOTT COMPANY, LLC et al v. AMNEAL PHARMACEUTICALS, LLC, et al, No. 2:2011cv05989 - Document 201 (D.N.J. 2013)

Court Description: OPINION. Signed by Magistrate Judge James B. Clark on 11/19/2013. (nr, )

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NOT FOR PUBLICATION UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY WARNER CHILCOTT CO., LLC, et al., Civil Action No. 11-5989 (FSH) Plaintiffs, v. AMNEAL PHARMACEUTICALS, LLC, et al., Defendants. WARNER CHILCOTT CO., LLC, et al., Civil Action No. 11-6936 (FSH) Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC., Defendant. WARNER CHILCOTT CO., LLC, et al., Civil Action No. 12-2474 (FSH) Plaintiffs, v. RANBAXY INC. et al., OPINION DENYING MOTION TO AMEND Defendants. PRESENTLY BEFORE THE COURT are joint motions to amend Defendants' Answers and Counterclaims, made in three actions consolidated for pretrial purposes. Defendants Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals ofNew York, LLC (hereinafter "Amneal") in Civil Action No. 11-5989 filed the motion at Docket Entry No. 131. 1 1 This motion was originally brought by Watson Laboratories, Inc.,- Florida. Plaintiffs filed the action against Watson after Watson filed its Abbreviated New drug Application ("AND A'') No. 203090. Prior to the Court's Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 2 of 17 PageiD: 4297 Defendant Teva Pharmaceuticals USA, Inc., in Civil Action No. 11-6936 filed the motion at Docket Entry No. 135. Defendants Ranbaxy Inc., and Ranbaxy Laboratories Limited (hereinafter "Ranbaxy"), in Civil Action No. 12-2474, filed the motion at Docket Entry No. 95. Amneal, Teva, and Ranbaxy, ("Defendants") seek to add a claim for inequitable conduct before the Patent and Trademark Office ("PTO") relating to the applications of the patents-in-suit. See Amneal' s Motion to Amend/Correct Answer and Counter Claims to the Amended Complaint, Docket Entry No. 139 on Docket 11-5989. 2 Plaintiffs, Warner Chilcott Co., LLC, and Warner Chilcott (US), LLC, ("Plaintiffs") oppose the motion, arguing that Defendants fail to plead the elements of inequitable conduct. See Plaintiffs' Opposition Brief at Docket Entry No. 134 ("Pis.' Opp."). For the reasons stated below, Defendants' Motions to Amend are denied. I. Procedural History The underlying actions are patent infringement suits triggered by the filing of Defendants' ANDAs with the United States Food and Drug Administration ("FDA") for the sale of generic versions of Plaintiffs' osteoporosis drug, A telvia. Atelvia is a delayed-release formulation of the drug risedronate. See Amended Complaint~ 13 at Docket Entry No. 71 ("Am. Compl."). A telvia encompasses the three patents-in-suit: 7,645,459 ('" 459"), entitled "Dosage Forms ofBisphosphonates," 7,645,460 ('"460"), entitled "Dosage forms of Risedronate," and 8,246,989 ("989"), entitled "Dosage Forms ofRisedronate." See Am. Compl. ~~ 14-16 & Exhibits A-C. The '459 and '460 patents were prosecuted by The Proctor & Gamble decision on the motion, Watson sold certain assets, including ANDA No. 203090, to Amneal. Amneal filed an Order of Substitution as the real party in interest, which was so ordered by the Hon. FaithS. Hochberg, U.S.D.J. See Docket Entry No. 172. 2 As Defendants' motions are identical, the Court will refer to the motion papers filed on Docket 11-5989, Warner Chilcott, eta!. v. Amneal Pharmaceuticals, eta!. For reference, the corresponding papers may be found at the following locations: for 11-5989, Defendants' Motion is at Docket Entry No. 131, and brief in support at No. 132; Plaintiffs' Opposition at Docket Entry No. 134; and Defendants' Reply at No. 139. For Docket 11-6936, Motion papers are at Docket Entry No. 135, and brief in support at No. 137; Opposition is at No. 138; Reply is at No. 143. For Docket 12-2474, Defendants' Motion papers are at Docket Entry No. 95, and brief in support at No. 96; Opposition is at No. 98, and Reply is at No. 103. 2 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 3 of 17 PageiD: 4298 Company ("P&G" or the "Applicants"), from whom Plaintiffs acquired their pharmaceutical business and intellectual property. Pis.' Opp. at 7, n.2. 3 The '989 patent is a continuation in part of the '459 patent. See Exhibit C, Am. Compl.. On October 12, 2011, November 22, 2011, and April26, 2012, Plaintiffs initiated patent infringement actions against Defendants for the infringement of the '459 and '460 patents as triggered by Defendants' ANDAs. Plaintiffs filed an Amended Complaint with the later-granted '989 patent in September 2012. On September 28, 2012 and October 2, 2012, Defendants filed their respective Answers and Counterclaims, including claims for non-infringement and invalidity of the patents-at-issue. The three actions were consolidated for pretrial purposes. See Docket Entry No. 64. On March 8, 2013, Defendants filed their respective motions to amend to add inequitable conduct. See Docket Entry Nos. 122 & 123. As the motions included information designated confidential, Defendants filed their papers under seal, including the proposed Amended Answers and Counterclaims. See Docket Entry No. 126. Judge Shwartz, the then-assigned magistrate judge, terminated the motions and directed the parties to confer on pleadings that could be fully made public. See Docket Entry No. 127. Judge Shwartz also encouraged the parties to consent to the amendments without prejudice to Plaintiffs' right to move to dismiss. /d. Defendants renewed their motions on publically accessible pleadings on April12, 2013. See Docket Entry No. 131. Plaintiffs, however, chose to challenge the motion on substantive grounds and refused to consent to the amendments. Thus, to address any substantive arguments made, the parties argue the motion on the publically accessible pleadings and confidential 3 Due to inconsistencies between the pagination of the parties briefs and the Court's electronic filing system ("ECF"), the Court will refer to the pagination ofECF. 3 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 4 of 17 PageiD: 4299 information, and their motion papers are filed under seal. See Defendants' Brief in Support of the Motions to Amend ("Defs.' Br. ") at 8-9. II. Standard A. Motion to Amend Pursuant to Fed.R.Civ.P. 15(a)(2), leave to amend the pleadings is generally freely granted. See Foman v. Davis, 371 U.S. 178, 182 (1962); Alvin v. Suzuki, 227 F.3d 107, 121 (3d Cir. 2000). Nevertheless, the Court may deny a motion to amend where there is "undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice to the opposing party by virtue of allowance of the amendment, [or] futility of the amendment." Foman, 371 U.S. at 182. An amendment is futile if it "is frivolous or advances a claim or defense that is legally insufficient on its face." Harrison Beverage Co. v. Dribeck Imp., Inc., 133 F.R.D. 463,468 (D.N.J. 1990) (internal quotation marks and citations omitted). The court uses "the same standard oflegal sufficiency" as a motion to dismiss under Rule 12(b)(6). Shane v. Fauver, 213 F.3d 113, 115 (3d Cir. 2000). When faced with a motion to dismiss for failure to state a claim, the court conducts a two-step analysis. Fowler v. UPMC Shadyside, 578 F.3d 203,210 (3d Cir. 2009). First, the court separates the factual elements from the legal elements of the claim. !d. at 210-11. The court must accept the factual elements alleged in the well-pleaded complaint as true, but may disregard any legal conclusions. Id. Second, the court must decide if the facts alleged are sufficient to show a "plausible claim for relief." Fowler, 578 F.3d at 210 (quoting Ashcroft v. Iqbal, 129 S.Ct. 1937, 1955 (2009)). A plausible claim is one which "allows the court to draw the reasonable inference that the 4 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 5 of 17 PageiD: 4300 defendant is liable for the misconduct alleged." Id. (quoting Iqbal, 129 S.Ct. at 1948). "Ultimately, this two-part analysis is 'context specific' and requires the court to draw on 'its judicial experience and common sense' to determine if the facts pled in the complaint have 'nudged [plaintiffs] claims' over the line from '[merely] conceivable or [possible] to plausible."' Hobson v St. Luke's Hospital and Health Network, 735 F. Supp. 2d 206,211 (E.D. Pa. 2010) (quoting Fowler, 578 F.3d at 211). B. Inequitable Conduct A patent applicant has a duty of good faith and candor in dealing with the PTO, "which includes a duty to disclose to the [PTO] all information known to that individual to be material to patentability." McKesson Info. Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897, 913 (Fed. Cir. 2007); 37 C.P.R.§ 1.56. A breach of this duty gives rise to the defense of inequitable conduct, an equitable remedy that may nullify the patent at issue. See Sepracor Inc. v. Teva Pharmaceuticals USA, Inc., 2010 WL 2326262 at *3 (D.N.J. Jun. 7, 2010). A party may plead the defense by alleging "affirmative misrepresentation of material fact, failure to disclose material information, or submission of false information, coupled with an intent to deceive." Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed. Cir. 1995). Where a party alleges misrepresentations, courts look to distinguish between misrepresentations of material facts and permissible attorney argument. See Young v. Lumen is, Inc., 492 F.3d 1336, 1349 (Fed. Cir. 2007). Attorney argument is a permissible method for applicants to distinguish or present their interpretations of the prior art. !d. Often where the examiner is provided the prior art, courts fmd an applicant's statements is only argument. Id.; WesternGeco LLC v. ION Geophysical Corp., 2012 WL 567430 at *19 (S.D. Tex. Feb. 21, 2012). Misrepresentations are found where applicants exceed the boundaries of argument, by 5 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 6 of 17 PageiD: 4301 presenting false information or withholding information necessary to understand other references before the PTO. See, e.g., Wyeth Holdings Corp. v. Sandoz, Inc., 2012 WL 600715 at *12 (D. Del. Feb 3. 2005) (fmding misrepresentations where the applicant failed to accurately describe industry knowledge, internal testing and protocol and failed to provide significant error rates); Therasense, Inc. v. Becton, Dickinson and Co., 864 F. Supp. 2d 856 (N.D. Cal. 2012) (fmding inequitable conduct where the applicant withheld briefs submitted to foreign patent office that contradicted the applicant's main point being made to the PTO). Inequitable conduct is subject to the higher pleading standards ofFed.R.Civ.P. 9(b). See Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1326 (Fed. Cir. 2009). A party alleging inequitable conduct must plead "the specific who, what, when, where, and how of the material misrepresentation or omission committed before the PTO." !d. at 1327. To prove inequitable conduct, the alleging party must establish by clear and convincing evidence that the applicant "misrepresented or omitted material information with the specific intent to deceive the PTO." Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276, 1287 (Fed. Cir. 2011). At the pleading stage, the moving party must provide sufficient facts for the court to "reasonably infer that a specific individual both knew of invalidating information that was withheld from the PTO and withheld that information with specific intent to deceive the PTO." Delano Farms Co., v. Cal. Table Grape Comm 'n, 655 F.3d 1337, 1350 (Fed. Cir. 2011). Materiality and intent are independent factors. Therasense, 649 F.3d at 1287. Materiality is a "but-for" standard. Id. Information is material if the examiner would not have allowed a claim had it been aware of the undisclosed prior art. Id. at 1291. Intent cannot be merely inferred from the materiality of the reference. See Therasense at 1290 (citing Star Scientific Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1366 (Fed. Cir. 6 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 7 of 17 PageiD: 4302 2008)) ("Proving that the applicant knew of a reference, should have known of its materiality, and decided not to submit it to the PTO does not prove specific intent to deceive."). Since deceit is rarely explicit, courts may infer intent from indirect and circumstantial evidence. Id. "[T]o meet the clear and convincing evidence standard, the specific intent to deceive must be 'the single most reasonable inference able to be drawn from the evidence."' Therasense, 649 F.3d at 1290 (quoting Star, 537 F.3d at 1366). While conditions of the mind may be averred generally, the pleadings must contain "sufficient underlying facts from which a court may reasonably infer that a party acted with the requisite state of mind." Exergen, 575 F.3d at 1327. III. Background 4 A. Atelvia and the Patents-in-Suit Atelvia is a member of the bisphosphonate class of drugs for the treatment of osteoporosis. See Pis.' Opp. at 7. Prior to Atelvia, bisphosphonate products on the market were immediate release formulations. !d. Eating too soon after taking the drug or at the same time as taking the drug resulted in reduced absorption of the medication, an event called "food effect." Id. Patients had to take the medication in a fasted state to maintain efficacy. Id. This restriction, however, "posed a major inconvenience to patients, resulting in a high degree of noncompliance." /d. at 7. P&G developed Atelvia to overcome the problem through a delayed release formulation that allowed patients to take the drug with or without food without compromising the medication's efficacy. See id. at 8. The patents-in-suit "cover the use of Atelvia in accordance with the labeling approved by the FDA." Am. Compl. ,-r 18. Each patent shares three features: a delayed release mechanism, the active ingredient risedronate, and an additive ingredient ethylenediaminetetraacetic acid, 4 The facts and history have been taken from the proposed First Amended Answer and Counterclaims as well as the parties' motion papers. 7 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 8 of 17 PageiD: 4303 commonly referred to as EDTA. In Atelvia, EDTA is added to "chelate metal ions such as calcium" and has the effect of preventing calcium and other metals in food ingested by patients from interacting with the risedronate, which would otherwise cause a decreased absorption, or "food effect." Defs.' Br. at 6. Each of the asserted claims of the patents is "directed to an oral dosage form and includes a limitation to an amount of EDT A, with amounts in different claims ranging from 1 mg to 500 mg." See Defendants' proposed First Amended Answer ("FAA"), Fourth Affirmative Defense,~ 2, Docket Entry No. 131 at 39. B. Statements to regulatory agencies In 2005, P&G raised its proposed Atelvia drug with the regulatory agencies. Confidential FAA~ 4. 5 In particular, P&G sought guidance on the use of EDTA prior to seeking permission to pursue clinical trials. See Defs.' Br. at 12. Defendants allege that during these discussions, P&G "told regulatory authorities that the prior art established the safety of disodium EDTA in humans in the claimed amounts." FAA~ 4. In particular, P&G cited references which established an acceptable daily intake amount ("ADI") of EDTA at 2.5 mg per kg body weight per day. P&G then used that figure to argue for the safety of EDTA in its proposed drug because the amounts it intended on using were below the ADI. FAA~ 5; Confidential FAA~ 7. While the FDA accepted P&G's claims of the safety of the limited doses of EDTA, it further questioned P&G about EDTA's effect on the absorption rates of other drugs and cited to prior art references Ezra and Janner. Confidential FAA~ 9. P &G distinguished Ezra and Janner, arguing the references involved instances of substantially higher doses ofEDTA than P&G intended to use. Confidential FAA at ~10. P&G believed the "increase in absorption was due at 5 The Court has included certain information only found in the Defendants' original First Amended Answers and Counterclaims which were filed under seal. Docket Entry No. 123-1. References to the confidential and sealed First Amended Answer and Counterclaims will be cited as "Confidential FAA." 8 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 9 of 17 PageiD: 4304 least in part to known effects high doses of edetate [EDTA] on mucosal permeability," which P&G believed would not occur with the lower doses. Confidential FAA,~ 10. C. Prosecution of the Patents In 2005, P&G submitted the '459 and '460 patent applications to the PTO. See Pis.' Opp. at 8. As part of the applications, P&G listed various prior art references, including the three at issue here: Lin, Janner, and Ezra. /d. The patent examiner rejected the claims for obviousness based on several existing United States patents and other prior art, including Lin. FAA ~ 9; Pis.' Opp. at 9. The examiner reasoned, "[t]he person of ordinary skill in the art would have been motivated to make those modifications, because the disodium EDTA would increase the absorption of bisphosphonate drugs, and reasonably would have expected success because all references dealt with drug absorptions." FAA~ 9. In response, P&G argued that "the prior art 'taught away' from the clinical use of EDTA in humans" due to its effect on mucosal integrity. FAA ~1 0. In particular, P &G used Lin, Janner and Ezra to demonstrate the teachings of the prior art: Lin reports that EDTA results in a 12-fold increase in alendronate absorptions (see Lin, p. 1745) ... Notably, Lin actually teaches away from the use ofEDTA by stating that "clinical use ofEDTA is limited" (see Lin, p. 1745, last paragraph). Of importance in this context, in addition to Lin, other references in the art teach away from EDT A used with bisphosphonates, for example: --Ezra et al., (2000), p. 185: "the applicability of this agent [EDTA] in human pharmacology is impossible" in light of damaging effects on mucosal integrity ... "absorption still remains variable and occurs at EDTA concentrations that make this chelator unsuitable for clinical use." --Janner et al., Calif. Tissue Int. (1991), p. 280: "EDTA can ... increase the intestinal absorption ofbisphosphonates. The mechanism might involve an increase in available 9 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 10 of 17 PageiD: 4305 bisphosphonate ... The amount ofEDTA required is, however, too high for use clinically." FAA ,-r 10 (emphasis in original). In further support, Dr. David Burgio, a named inventor, submitted a sworn declaration in which he argued that the prior art taught away from using EDTA with bisphosphonates "because its effect on the gastrointestinal tract caused too large an increase in absorption of bisphosphonates when taken with food." FAA ,-r,-r 11-12. He claimed in contrast to Lin, which reported a 12-fold increase in alendronate absorption, results from his study showed only a 1.4 times greater absorption rate from the delayed release with EDT A and immediate release without EDTA formulations. FAA ,-r 11. Dr. Burgio argued that "[in his] opinion, Lin teaches away from the unexpected results demonstrated in this Study." FAA ,-r 11. The examiner found these arguments persuasive and cited them in his statement that withdrew his objections and allowed the '459 and '460 patents: Applicants' argument that the use of EDTA has been taught away by the prior art is persuasive. Note, the ZAKELJ et al reference (published in 2005) cited in the IDA filed on 03/06/09 also disclosed "the implementations of ... EDTA in any kind of clinical study on humans would be inappropriate." FAA ,-r 14. He made similar comments in the statement allowing the '989 patent. FAA ,-r 15. D. Defendants' Inequitable Conduct Defense Based on P&G's Inconsistent Statements and Omission of a Foreign Patent Application Defendants allege "[t]he '459, '460, and '989 patents are unenforceable due to inequitable conduct because the Applicants, through at least the named inventors David E. Burgio and Richard Dansereau, intentionally deceived the United States Patent and Trademark Office ("PTO") during patent prosecution by misrepresenting and failing to disclose information regarding the safety ofusing EDTA in humans." FAA ,-r 1. Defendants allege that 10 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 11 of 17 PageiD: 4306 misrepresentations were made via statements to the PTO that were inconsistent with the positions P&G took with other regulatory agencies and that P&G withheld a foreign patent application that demonstrated other scientists' knowledge of the safety ofEDTA. FAA~~ 3, 7-8, 13, 18-19, & 24. In regard to the statements made to the PTO, Defendants allege that the contrast between P&G's statements before the regulatory agencies and the PTO demonstrate "that the applicants misrepresented to the examiner how a person or ordinary skill in the art would have understood the teachings of Lin, Janner, and Ezra in light of the other prior art concerning the use of EDTA in human pharmacotherapy." FAA ~ 18. Furthermore, "[h]ad the applicant been candid with the PTO, it would have informed the examiner that, far from teaching away, the prior art would have led a person or ordinary skill in the art to use the claimed amounts of EDTA in combination with delayed-release bisphosphonates because the prior art taught those amounts were safe for use in human pharmacotherapy." FAA~ 19. In making such statements, Defendants allege that P&G "intentionally deceived the PTO [as] is evident from the statements [P&G] previously made concerning the safety of EDTA." FAA ~ 17. Defendants specifically name Dr. Burgio and Dr. Dansereau as having violated their duty of candor to the PTO. See FAA~~ 1, 8, 11, 12, 13, & 21-24; Defs.' Reply at 9. Defendants allege that both individuals participated in the regulatory discussions regarding the safety of EDTA. FAA~ 21. Dr. Burgio, despite his knowledge of the regulatory discussions, signed a declaration arguing contradictory terms "to overcome a rejection from the PTO." FAA~ 22. Dr. Dansereau "was responsible for formulating these statements regarding the safety of EDTA (citations omitted), but knew of and allowed the misleading statements regarding the teachings in Lin, Janner, and Ezra to be filed with the PTO." FAA~ 11 23. Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 12 of 17 PageiD: 4307 In terms of the foreign patent application, Defendants allege that P&G, including at least Dr. Burgio and Dr. Dansereau, knew of a foreign patent application that "disclosed the same pharmaceutical compositions" and not only failed to disclose it to the PTO, but "actively concealed it during the prosecution of the claims." FAA ~8. Defendants claim that ifP&G had disclosed the application, "it would have had to abandon its argument that a person of ordinary skill would have understood from the prior art that EDTA was unsafe for human clinical use." FAA~ 8. In support, Defendants cite to emails filed under seal that discuss the foreign patent and also show that P&G was involved in the withdrawal of the foreign patent. !d., citing exhibits at Docket Entry No. 133. Some of the emails are to or from Dr. Burgio and Dr. Dansereau. !d. Additionally, Defendants allege that "Dr. Burgio's and Dr. Dansereau's specific intent to deceive the PTO is further evidenced by their knowledge that other formulation scientists, including the inventors of the foreign patent application, were not dissuaded by Lin, Janner, or Ezra from using EDTA in pharmaceutical compositions." IV. FAA~ 24. Analysis A. Inconsistent Statements to the PTO Plaintiffs oppose the motion on the grounds of futility. Plaintiffs argue that no misrepresentation occurred because the examiner had the Lin, Janner, and Ezra references. See Pls.' Opp. at 18-19. P&G only summarized, quoted, or cited the prior art references, and thus its statements were only attorney arguments, not misrepresentations. See id., citing Young at 1349. Furthermore, Plaintiffs argue that Defendants' motions must be denied because Defendants fail to "point out anything incorrect in what the Applicants actually told the PTO." !d. at 15-18. Defendants counter that Plaintiffs overstate the law. Under 37 C.F.R. § 1.56, all applicants owe a duty of candor to the examiner regardless of what is submitted, including any 12 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 13 of 17 PageiD: 4308 argument made. See Defendants' Reply ("Defs.' Reply") at 12. Providing references does not give the applicant license to make whatever representations he or she may like under the guise of "attorney argument." !d. at 12-13. Here, the applicants did just that by "mischaracterize[ing] Lin, Janner, and Ezra as teaching that any amount of EDTA was unsuitable for clinical use in humans, instead of being candid with the examiner and explaining- as it did to the FDA- that those references did not teach away from, or even address, use of the claimed amounts of EDTA." !d. at 8. Accordingly, the threshold question before the Court is whether the statements made to the PTO by the Applicants are misrepresentations or attorney argument. The Federal Circuit delineated the two concepts in Young. There, the lower court found misrepresentations in the applicant's statements about the teachings of a certain prior art reference, the Fossum Reference, regarding where to make an incision in a patent application for a method of declawing cats. !d. The Federal Circuit overturned the finding, stating, Those statements are attorney argument, attempting to distinguish the claims from the prior art, not gross mischaracterizations or unreasonable interpretation of the Fossum Reference. They describe Young's interpretation of what the Fossum Reference teaches and why the incision disclosed in that reference is different from the claimed incision .... Based on [the figure in the reference], that statement does not appear to be demonstrably false and, instead, represents Young's interpretation ofwhat the Fossum Reference teaches. The examiner had the Fossum reference to refer to during the reexamination proceeding and initially rejected claim 1 based on that reference. Young argued against the rejection, and the examiner was free to reach his own conclusions and accept or reject Young's arguments. Young, 492 F.3d 1336, 1349. 13 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 14 of 17 PageiD: 4309 Two important points arise from the Federal Circuit's fmding. First, the Federal Circuit drew a line between a reasonable attempt to distinguish the art and statements that evidence a certain level of culpability: statements that are demonstrably false, gross mischaracterization, or unreasonable interpretations. Second, where the examiner has the prior art references, he is free to reject the statements made by an applicant as argument. These points can be found in several of the cases cited by the parties. See, e.g., Wyeth, 2012 WL 600715. In Wyeth, the defendant argued that the applicant's conduct "'was not just zealous advocacy; it was a misleading characterization of a key reference'" and that the applicant withheld information material to data before the examiner. !d. at *11. The court found that the defendants had sufficiently pled misrepresentations to survive the motion to dismiss. Specifically, the court found that the applicant's statements about industry-specific information and internal procedures was information that the applicant "uniquely qualified to characterize and explain, which is what allegedly allowed him to 'deceive' the Examiner by failing to do so accurately." !d. at *12. Furthermore, the same individual withheld material information "which would have required the Examiner to rely even more significantly on [the applicant]'s representations." !d. This Court notes that these cases provide a focus for examination: whether a party made statements or withheld information that would have prevented the examiner from accurately judging the prior art provided. Here, Defendants have not alleged Plaintiffs thwarted the examiner in any way. Defendants recite the right words, that the Applicants "incorrectly asserted that the prior art 'taught away'" and that "the applicant misrepresented the prior art," but these phrases alone are conclusory. See FAA~ 10. Defendants do not support the allegations with facts that 14 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 15 of 17 PageiD: 4310 demonstrate that misstatements were made. The examiner had the Lin, Janner, and Ezra references, and Plaintiffs listed them in the original patent application. The examiner rejected the claims, in part based on Lin. P&G responded by summarizing and quoting Lin, Ezra, and Janner and cited specific pages. Missing are allegations that the Applicants withheld information relating to the references, submitted false information, or misrepresented material facts that would hamper the examiner's ability to accept or reject the Applicants' arguments. In fact, Defendants allege only that "a person of ordinary skill in the art would not have interpreted the prior art in the way the applicants portrayed it to the examiner." FAA~ 13. This fits squarely within the type of statements recognized by Young: an attempt to distinguish the prior art. Without more, P&G's statements rise only to the level of attorney argument and are not misrepresentations that evoke the defense of inequitable conduct. Consequently, the Court denies Defendants' motions to amend to add inequitable conduct claims relating to misrepresentations of the prior art references Lin, Janner, and Ezra. B. Foreign Patent Application Plaintiffs also contest Defendants' allegations relating to the foreign patent application as futile. Both parties argue the materiality of the application. Plaintiffs argue the application does not include EDT A safety data or examples of EDT A based formulations, and thus is not material. Pls.' Opp. at 23. Defendants claims the application reveals the primary components of the formulation: delayed release, using a chelating agent, and EDT A, and thus is material. Defs.' Reply at 14. The Court, however, will not reach the contents of the application as Defendants fail to allege several of the factors required by Therasense, Exergen, and Rule 9(b) for pleading inequitable conduct. As set forth in Exergen, allegations cannot be directed towards an organization as the duty of candor to the PTO lies with individuals. /d. at 1329. Allegations of 15 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 16 of 17 PageiD: 4311 "who" must "name the specific individual associated with the filing or prosecution of the application ... , who both knew of the material information and deliberately withheld or misrepresented it." !d. Dr. Dansereau and Dr. Burgio are the only named individuals in the FAA. Defendants allege Dr. Dansereau only knew of the application and allowed others to make statements to the PTO. FAA~ 23-24. Defendants do not allege facts pertaining to his role in the application, how his duty arises, when or how he made any misrepresentations or omissions. Additionally, Defendants allege no facts that establish he any deliberate intent to do anything. Merely being aware of a potentially material reference is insufficient to allege inequitable conduct. See, e.g., Exergen, 575 F.3d at 1327 (fmding the relevant conditions of the mind include "knowledge of the withheld material information" and the "specific intent to deceive the PTO.") Dr. Burgio is named in six paragraphs of the FAA. See~~ 8, 11-13,22-24. Of those paragraphs, only~ 8 and~ 24 relate to the foreign patent application. 6 In~ 8, Defendants allege Dr. Burgio and Dr. Dansereau knew of the foreign patent and did not disclose it. Paragraph 24 draws Dr. Burgio's intent from his "knowledge of other formulation scientists, including the inventors of the foreign patent application, were not dissuaded by Lin, Janner or Ezra from using EDTA in pharmaceutical composition." !d. at~ 24. This allegation of intent, however, falls short as it is based only on the alleged materiality of the patent application. The Federal Circuit cautions against using the knowledge of materiality to impose intent. See Star at 1366 ("Proving that the applicant knew of a reference, should have known of its materiality, and decided not to submit it to the PTO does not prove specific intent to deceive.") Instead, intent is a separate factor. Therasense at 1290. The 6 The Court has also reviewed the pleadings filed under seal. While the sealed pleadings provide more detail, the allegations suffer from the same defects. Therefore, while the Court here references the publically accessible pleadings, the analysis equally applies to the pleadings filed under seal. 16 Case 2:11-cv-06936-FSH-JBC Document 186 Filed 12/13/13 Page 17 of 17 PageiD: 4312 moving party must allege facts from which the court may reasonably infer the party acted with the requisite state of mind. Exergen, 575 F.3d at 1327. Defendants allege sufficient facts to show that Dr. Burgio had a duty to the PTO arising from his certification on the Lin prior art. Defendants also allege sufficient facts to show that Dr. Burgio knew of the foreign patent application. However, Defendants do not allege facts from which the Court may infer that Dr. Burgio was aware of the patent application's materiality or that he had the opportunity to disclose it and deliberately decided against it. Considering the draconian nature of an inequitable conduct claim, the Court is hesitant to permit the requested amendment where Defendants themselves fall silent on the relationship between knowing of the application and any intent to hide it from the PTO. Therefore, as Defendants have failed to sufficiently allege the necessary factors under Exergen and R. 9(b), the Court denies Defendants' motions to amend to add an inequitable conduct claim relating to the foreign patent application. V. Conclusion For the reasons stated above, Defendants' Motions to Amend are DENIED. A separate order will follow. s/ James B. Clark. III JAMES B. CLARK, III United States Magistrate Judge Date: November 19, 2013 17

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