Full opinion text
OPINION AND ORDER DONALD M. MIDDLEBROOKS, District Judge. THIS CAUSE comes before the Court for final disposition of the issues presented during a bench trial held from July 29, 2013, through July 31, 2013. Apotex asserts that UCB infringes Claims 8, 9, 10, 11, and 12 of United States Patent No. 6,767,556 (the “'556 Patent”) by manufacturing and selling their Univasc and Uniretic products, as well as generic versions thereof. UCB contends that it does not infringe the '556 Patent and that the patent is invalid. UCB also contends that: (1) Apotex disclaimed the Univasc process from the scope of the claims during prosecution of the '556 Patent; (2) Apotex’s infringement claims are barred by judicial estoppel; (3) the '556 Patent is unenforceable due to inequitable conduct; and (4) Apotex is barred by the laches doctrine from collecting pre-filing damages. This case involves an orchestrated scheme to deceptively obtain a patent with respect to a competitor’s product. It is illustrative of inventive litigation, as opposed to the scientific discovery that the patent laws were designed to promote. The claimed “invention” is the addition of an unspecified amount of water in a wet granulation process for an unspecified amount of time in a controlled but unspecified manner. The Patent issued because the inventor: (1) misrepresented the nature of an existing drug already on the market for years prior to his filing, as well as the prior art (pursuant to which that drug had been licensed); (2) concealed his knowledge of the Univasc process from the PTO; and (3) gave the United States Patent and Trademark Office (the “PTO”) Examiner results of experiments that he never conducted. Now, nearly 8 years after the inventor and founder of Apotex, Dr. Bernard Charles Sherman (“Dr. Sherman”), explicitly told the PTO that the existing drug’s manufacturing process was different, Apotex brings this suit alleging infringement by that same drug. Not only should the Patent never have issued, but this lawsuit should never have been brought, certainly not at this late date. For the reasons stated in greater detail below, judgment is due to be entered in favor of UCB and against Apotex. I. Procedural Background Apotex initiated this action for patent infringement on April 20, 2012. On July 24, 2012, I consolidated this case for pretrial purposes with another case before me, as the same plaintiffs alleged infringement of the same patent, but against different defendants. This separate case, No. 12-CV-60707-MIDDLE-BROOKS/TORRES, was later dismissed upon the submission of a Rule 41 joint stipulation of dismissal. In the Complaint, Plaintiffs allege that UCB infringes '556 Patent, which is owned by Apotex Inc. The '556 Patent is entitled “Pharmaceutical Compositions Comprising Moexipril Magnesium,” and was issued on July 27, 2004, naming Dr. Sherman as the sole inventor and assignee. Dr. Sherman subsequently executed a nunc pro tunc assignment of the '556 Patent to Apotex, Inc., effective as of July 2004. The '556 Patent claims a process for the manufacture of stable moexipril magnesium tablets for the treatment of high blood pressure. Specifically, the Complaint alleges that UCB’s processes for the manufacture of their “Univasc” and “Uniretic” products infringe the '556 Patent’s claims. UCB has manufactured and sold Univasc and Uniretic in the United States for the treatment of hypertension since the 1990s. Apotex is alleging infringement of Claims 8, 9, 10, 11, and 12 of the '556 Patent against UCB. Dependent Claims 9-12 are being asserted based on their dependency from Claim 8 only. In response to the Complaint, UCB filed its Amended Answer, Affirmative Defenses, and Counterclaims (“Answer”) (DE 88) on February 20, 2013. Defendants counterclaimed for the following: (1) a declaratory judgment of non-infringement of the '556 Patent (Count I); (2) a declaratory judgment of invalidity of the '556 Patent (Count II); and (3) a declaratory judgment of unenforceability of the '556 Patent (Count III). The parties filed cross Motions for Summary Judgment. In Apotex’s Motion, Apotex sought summary judgment on UCB’s unenforceability, invalidity, and non-infringement defenses and counterclaims. In UCB’s Motion, UCB sought summary judgment based on disclaimer, judicial estoppel, invalidity, unenforceability based on inequitable conduct, and laches. After conducting a Status Conference held on July 11, 2013, during which I listened to the parties’ arguments on the Motions, I determined that the best course action was to deny the motions and proceed to trial, given the specialized knowledge and understanding required. (See DE 188). Because of my suspicion based upon the argument and written submissions that the issues to be decided by the Court would predominate over matters entrusted to a jury, I decided to bifurcate the trial to spare jurors the inconvenience of a lengthy trial which might be unnecessary. The Court held a three-day bench trial to address the issues suited to be resolved by the Court, with a jury trial scheduled to follow for the remaining issues. After hearing the evidence and testimony presented by both parties, I found it appropriate to first rule on the bench issues before calling in prospective jurors. As stipulated by the parties, (see DE 209), the bench trial issues included claim construction issues (including UCB’s disclaimer defense and indefiniteness invalidity defense) and UCB’s equitable defenses (ie., inequitable conduct, laches, and judicial estoppel). Had a jury been selected, they would have considered infringement, damages, and UCB’s other invalidity defenses (including anticipation, obviousness, and lack of written description and enablement). This Opinion constitutes the Court’s findings of fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52(a). The parties filed post-trial proposed findings of fact and conclusions of law on August 7, 2018. II. Factual Background The issues in this case involve processes for making stable moexipril tablets, used to treat high blood pressure. The stability of a drug is important, as both the efficacy and safety of the drug can be negatively affected if the drug degrades over time. For example, moexipril must be stable because it will degrade over time into another chemical compound (diketopiperazine) that is not effective for treating high blood pressure. Mpexipril’s instability has been a known problem for pharmaceutical- formulators for quite some time— long before the issuance of the patent-in-suit. A. Univasc and Uniretic UCB has continuously marketed . and sold stable moexipril tablets — Univasc and Uniretic — in the United States since 1995 and 1997, respectively. The Univasc and Uniretic manufacturing processes are the same with respect to the moexipril component in each; they both involve the wet granulation of moexipril hydrochloride, lactose monohydrate, and magnesium oxide. The ingredients, master formulation, and manufacturing processes for the Univasc and Uniretic products have not materially changed since both drugs’ introduction to the market. The exact processes for manufacturing Univasc and Uniretic were never explicitly disclosed by UCB. While Apotex tried to argue that UCB took steps to retain the processes as a trade secret, the testimony from UCB’s witness, Jeffrey Seifert, indicated that the processes were merely never publicly disclosed. However, several factors lend'themselves to allow an experienced pharmaceutical formulator to determine UCB’s processes. First, the Univasc and Uniretic products were sold in the United States and able to be examined. Second, all of the ingredients used to manufacture Univasc tablets were publicly disclosed at least as' early as' 1998 in the “Product Monograph for Univasc” (JTX 2E). Third, the Food and Drug Administration’s (the “FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) associated Univasc and Uniretic with the '450 Patent, indicating that these products were made in accordance with the '450 Patent’s teachings. In sum, Univasc and Uniretic had been on the market for several years by 2001. This, combined with the publicly available information, allowed for a skilled pharmaceutical formulator to easily discover and practice UCB’s processes. As it turns out, Univasc’s process, which reacts moexipril hydrochloride with magnesium oxide to get the more stable moexipril compound, moexipril magnesium, is nearly the same process that was later claimed by one such skilled formulator. B. Dr. Bernard Sherman Enter Dr. Bernard Sherman, a distinguished engineer by education and accomplished pharmaceutical formulator and businessman by trade. Dr. Sherman is the founder and chairman of Apotex, Inc. and Apotex Corp. Apotex, Inc. is a pharmaceutical manufacturer of generic drugs, and the largest pharmaceutical company in Canada. In all, Dr. Sherman has about 10,000 employees under his direction. To say that Dr. Sherman is experienced in pharmaceutical formulations would be an understatement. He testified that he has supervised or conducted “tens of thousands” of - formulations, “many hundreds” of which have become marketable. In creating the generic formulations, Dr. Sherman testified that doing so is sometimes obvious, “but in other cases, you have got technical problems and you have got patent problems, intellectual property problems that you have to analyze to determine what are the barriers of getting a product of this type to market, both technically and in terms of the intellectual property.” (Trial Tr. Day 2 at 70:21 to 71:4 (Sherman)). Being the formulator that he is, it follows that Dr. Sherman is no stranger to patent applications. He testified that he has personally written 100 patent applications. Dr. Sherman is also highly familiar to patent prosecution and patent enforcement litigation, notwithstanding the fact that he is neither a lawyer nor a patent agent. Dr. Sherman directs all litigation for Apotex and has “been involved in litigation for [his] entire career.” (Id. at 73:17-18). Beginning in 1999, Dr. Sherman and Apotex were involved in one case that is of particular relevance to the case at hand. In that case, Apotex sued brand pharmaceutical developer Merck & Co., Inc. (“Merck”) alleging infringement of two patents issued to Dr. Sherman (which, as in the instant case, were assigned to Apotex prior to filing suit). See Apotex Corp. v. Merck & Co., Inc., No. 96-C-7375, 2000 WL 97582 (N.D.Ill. Jan. 25, 2000) [hereinafter Merck Litigation ]. The patents at issue in the Merck Litigation claimed a process for the manufacture of a pharmaceutical composition comprising enalapril sodium. The district court granted summary judgment against Apotex, finding Dr. Sherman’s patents to be invalid because Merck invented the process claimed in Dr. Sherman’s patents within the United States before Sherman, and did not abandon, suppress, or conceal that invention within the meaning of § 102(g). Contributing to the district court’s conclusion was the fact that “anyone with a fundamental knowledge of chemistry” would be able to figure out Merck’s manufacturing process once he or she knew the ingredients and knew that the process involved “adding water to the mix.” Merck Litigation, 2000 WL 97582, at *8. On June 8, 2001, the Federal Circuit affirmed the district court’s summary judgment ruling that Dr. Sherman’s patents were invalid in light of Merck’s prior invention of the process. See Apotex USA, Inc, v. Merck & Co., Inc., 254 F.3d 1031 (Fed.Cir.2001).- In its opinion, the Federal Circuit found that “Merck’s various disclosures [including the disclosure of the-ingredients used, distribution of the product monograph, and' description of the process through testimony given during a Canadian trial], in conjunction with Apdtex’s admissions [that the process was obvious after learning of the starting ingredients], therefore clearly and convincingly prove that Merck made the knowledge of its invention available to the public .... ” Id. at 1040. C. The '556 Patent The road to the '556 Patent began on March 16, 2001, when Dr. Sherman filed United States Patent Application No. 09/809,173 (the “'173 Application”).. The '173 Application was written entirely by Dr. Sherman, (Trial Tr. Day 2 at 73:10-15, 77:9-10 (Sherman)), and filed while the Merck Litigation was still pending. After a prosecution that lasted several years, the '556 Patent issued on July 27, 2004, naming Bernard Charles Sherman as the sole inventor. 1) The Claims and Asserted Utility of the '556-Patent The stated purpose of the invention claimed in the '556 Patent is to eliminate unstable moexipril, or an acid addition salt thereof, and replace it with stable moexipril magnesium. According to the Patent, this is accomplished “by reacting the moexipril or acid addition salt' with an alkaline magnesium compound, fed as to convert most or all (i.e.[J more than half) of the moexipril or'acid addition salt to moexipril magnesium.” (JTX-1, col. 2, 11. 47-65). The utility' of the claimed process is increased stability of moexipril. Claim 1 of the '556 Patent, the only independent claim, is as follows: A process of making a solid pharmaceutical composition comprising moexipril magnesium, said process comprising the step of reacting moexipril or an acid addition salt thereof with an alkaline magnesium compound in a controlled manner in the presence of a sufficient amount of solvent for a predetermined amount of time so as to convert greater then [sic] 80% of the moexipril or'moexipril acid addition salt to moexipril magnesium. (JTX 1, col. 6, 11. 24-31). The reaction claimed in Claim 1 of the '556 patent is an acid-base reaction in which “moexipril or an acid addition salt thereof’ is the acid and the “alkaline magnesium compound” is the base. (JTX-1, col. 3,11. 1-15, col. 6,11. 23-31.) Claim 8 of the '556 Patent, which depends from Claim 1, is as follows: The process of claim 1 comprising the steps of: • ■ ■’ 1) mixing the moexipril or acid addition salt thereof and alkaline magnesium compound with- one or more excipients; ii) adding a solvent and mixing to obtain a wet mass; iii) drying the wet mass to obtain a dry ■ mass; and iv) further processing the dried mass into the solid pharmaceutical composition. (JTX 1, col. 7,11. 4-12). The steps recited in Claim 8 describe the well-known wet granulation method of manufacturing tablets. (JTX-1, col. 7, 11. 4-12; Trial Tr. Day 1 at 68:22 to 69:3 (Cima)). Claims 9-12 depend from Claim 8, and so also depend from Claim 1, adding further limitations including the use of specific solvents, the use of moexipril hydrochloride, and the use of specific alkaline magnesium compounds. (JTX-1, col. 7, 1. 13 to col. 8, 1. 8; Trial Tr. Day 1 at 68:11 to 69:3 (Cima)). As discussed in more detail below, there are three terms in Claim 1 that are disputed: (1) “sufficient amount of solvent”; (2) “predetermined amount of time”; and (3) “controlled manner.” 2) Examples and Data in the '556 Patent Dr. Sherman included four Examples in the '556 Patent purporting to demonstrate his claimed process. Each Example is written in the past tense, as if the experiments had been conducted, and includes very specific results. (JTX-1 at cols. 5-6; Trial Tr. Day 1 at 200:22-201:11 (Chyall)). However, as made clear by the testimony elicited from Dr. Sherman, these Examples were never conducted, and the results were made up in Dr. Sherman’s head. Examples 2 through 4 disclose using 20% water (by weight) for wet granulation. (JTX-1, col. 5,11. 53-64; Trial Tr. Day 2 at 21:10-13 (Chyall)). However, neither the Examples nor the specification provide stability or conversion data of any kind. (JTX-1, cols. 5-6; Trial Tr. Day 1 at 202:20-203:6 (Chyall)). This is so despite Claim l’s limitation of “greater than 80%.” The only disclosure in the '556 Patent that relates to amounts of conversion is that “the amount converted will preferably be more than 70%, more preferably more than 80%, even more preferably more than 90%, and most preferably 100%, or virtually 100%.” (JTX-1, col. 2, 11. 62-65). Further, the only data in the patent that supports any conversion is in the fictitious Examples, which disclose 100% conversion. (JTX-1, col. 2,11. 62-65, cols. 5-6; Trial Tr. Day 1 at 202:20-203:6 (Chyall)). While it is possible to figure out whether a product has achieved 100%, there are no tests readily available to determine whether, for example, a reaction has resulted in 79% conversion or 81% conversion. Given that the Examples show 100% conversion, and that there is no test described in the '556 Patent or readily available for one skilled in the art to determine the exact percentage of conversion from moexipril hydrochloride to moexipril magnesium, one cannot deduce how to achieve 70% or 80% conversion, as there are too many variables in organic chemistry reactions, such as an acid-base reaction, to predict in advance which parameters to adjust. (Trial Tr. Day 1 at 203:7-12 (Chyall)). 3) The Prior Art Before the Examiner The following prior art references were considered by the Examiner before the '556 Patent issued and are relevant to the issues in this case. i) The '450 Patent On May 10th, 1988, United States Patent No. 4,743,450 (the “'450 Patent”) issued, describing a pharmaceutical manufacturing process that purports to solve the moexipril instability problem. The inventors of the '450 Patent were employees of Warner-Lambert, a major American pharmaceutical company. The '450 Patent discloses how to stabilize an ACE inhibitor drug (i.e., moexipril) using alkaline stabilizers and saccharides. According to the '450 Patent, “[mjagnesium is most preferred” to be used as the alkaline stabilizer in the invention. The '450 Patent also teaches that wet granulation is the “preferred” technique or process for manufacturing the '450 Patent’s invention. Each of the '450 Patent’s Examples A through D are of wet granulations. Examples A and B in the '450 Patent involve wet granulations of quinapril with magnesium carbonate, lactose, and gelatin. (Trial Tr. Day 1 at 174:21-175:8 (Chyall)). Except for Example C of the '450 Patent, which uses about 2% water, the Examples do not disclose how much water to use in the wet granulations. (Trial Tr. Day 2 at 19:2-20:13 (Chyall)). Example E of the '450 Patent provides stability data for tablets made pursuant to Examples A, B, and D, and indicates that the resulting tablets are more stable than tablets made without the use of an alkaline stabilizer (Example C), as measured by the amount of certain degradation products. (JTX-5, col. 5, 11. 42-55; Trial Tr. Day 1 at 175:4-176:14 (Chyall)). The '450 Patent is completely silent as to whether the disclosed processes are intended to cause or prevent a reaction. (JTX-5; Trial Tr. Day 2 at 21:5-9 (Chyall)). Further, the '450 Patent is silent as to acid-base reactions, and it does not indicate that the process disclosed therein is difficult to control or that it results in “variable” products. (JTX-5; Trial Tr. Day 1 at 180:18-181:23 (Chyall)). This patent was disclosed during the '556 Patent prosecution. But what was not disclosed, however, was that if one just adds water to the mix, he or she would get what Dr. Sherman invented. “Adding water to the mix” was exactly what Dr. Sherman was found to have done in the Merck Litigation. ii) The Gu Article In 1990, after the '450 Patent issued, an article was published by Leo Gu et al., entitled “Drug-Excipient Incompatibility Studies of the Dipeptide Angiotensin-Converting Enzyme Inhibitor, Moexipril Hydrochloride: Dry Powder vs Wet Granulation” (the “Gu Article”). (JTX 2F). The Gu Article teaches several things. First, Gu teaches that alkalizing agents, such as sodium carbonate, sodium bicarbonate, and calcium carbonate, were found to be effective in stabilizing moexipril hydrochloride via wet granulation. UCB’s expert, Dr. Chyall, testified that “Gu [] combined moexipril hydrochloride with the metal— alkalide metal excipients in one of two ways. One way was to dry powder blend them. This would be a dry granulation or what is called a dry powder mix. And then the second way was to combine moexipril hydrochloride and sodium bicarbonate in a wet granulation process.... What Gu identified from [his] research results is that wet granulation is key in getting a stable formulation.” (Trial Day 1 Tr. at 187:21 to 188:13 (Chyall)) (emphasis added). Second, based on research results that were conducted, Gu teaches that a neutralization reaction may be useful in stabilizing moexipril. (JTX-2F at 383; Trial Tr. Day 1 at 183:18-184:4 (Chyall)). Specifically, the Gu Article postulated that the stabilization resulted “from the neutralization of the acidic drug by basic excipients at the outer surface of the granulated material.” (JTX 2F at 383). The term “neutralization of the acidic drug by the basic excipients” in Gu refers to the reaction of a basic excipient with the moexipril hydrochloride to remove the proton on the nitrogen, thereby preventing the material from cyclizing to the DKP byproduct. (Trial Tr. Day 1 at 183:18-188:21; 192:2-9 (Chyall)). Gu also identifies an alternative hypothesis for the mechanism of stability. In the “Conclusion” section of the article, Gu states that “[i]t is also possible that a portion of the moexipril hydrochloride was converted to the cation salts via granulation and these cation salts degraded much slower in the solid state.” (JTX-2F at 383.) In other words, the moexipril hydrochloride could not only be neutralized, but could also be converted to a cation salt such as moexipril magnesium. (Trial Tr. Day 1 at 192:19-193:10 (Chyall)). This hypothesis directly correlates with Dr. Sherman’s claimed invention. From Gu it is clear that wet granulation is important for making stable formulations of moexipril. Moreover, a person of ordinary skill looking at the science disclosed in Gu would understand that stabilization can come from chemical reactions that convert moexipril hydrochloride to either the neutral species or the cation salt, or from some combination of these reactions. (Trial Tr. Day 1 at 194:6-14, 195:12-21 (Chyall)). However, one cannot determine from the disclosure in Gu how much of the moexipril hydrochloride converts to the cation salt. (Trial Tr. Day 1 at 194:15-18 (Chyall)). Further, there is no analytical method disclosed in Gu, and there was no technique available at the time or in existence today, as discussed further below, that could differentiate between the amounts moexipril hydrochloride and a neutralized form of moexipril in a final product. (Trial Tr. Day 1 at 195:2-7 (Chyall)). 4) The '556 Patent Prosecution When Dr. Sherman filed the '173 Application, he executed a declaration in connection with his inventorship of the '173 application, attesting that he had reviewed and understood the contents of the application and acknowledging his duty to disclose any information material to patentability as defined in 37 C.F.R. § 1.56. He also averred: I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and the like so made are punishable by fíne or imprisonment or both under 18 U.S.C. 1001 and that such willful false statements may jeopardize the validity of the application or any patent issued thereon. (JTX-2 at AI-MOEX0000334-5). Throughout the prosecution of the '173 Application, Dr. Sherman was represented by his patent agent, Mr. Neil Hughes. Dr. Sherman would have the Court believe that his only involvement of the prosecution was that he was “aware the prosecution was going on,” and that Mr. Hughes handled everything. This claim appears to be a mechanism by Dr. Sherman to impute the blame for any omissions or misrepresentations to the Examiner to Mr. Hughes. However, as discussed further below, the evidence demonstrates that Dr. Sherman has a hand in every aspect of his business, including the prosecutions of his patents, and that he was indeed aware of and involved in decisions made regarding the '173 Application’s prosecution. i) The September 18, 2002, Office Action Response Initially, Claim 1 of the Dr. Sherman’s patent application read as follows: A process of making a solid pharmaceutical composition comprising moexipril magnesium, said process comprising the step of reacting moexipril or an acid addition salt thereof with an alkaline magnesium compound in the presence of a solvent so as to convert most or all of the moexipril or moexipril acid addition salt to moexipril magnesium. (JTX-2 at AI-MOEX0000337) (emphasis added). On March 21, 2002, the PTO Examiner rejected the then-pending claims on the grounds that the term “most or all” rendered claim 1 indefinite, and that the claims were otherwise invalid as obvious over the '450 Patent alone or in view of the '949 Patent. (JTX-2C at AIMOEX0000413-417). The Examiner stated: “it would have been obvious to one of ordinary skill in the art at the time the invention was made to use any ACE inhibitor, particularly moexipril, in combination with alkalizing agents, to obtain a highly stable and effective drug composition for use in the treatment of hypertension.” (Id.). In response to the September 18, 2002, Office Action, Dr. Sherman, through his agent Mr. Hughes, attempted to distinguish his invention from the '450 Patent. As part of his argument, he submitted the Product Monograph for Univasc, which, inter alia, discloses the ingredients used to make the drug. Dr. Sherman told the PTO that the Product Monograph describes the actual contents of Univasc tablets, that moexipril and magnesium oxide were “unreacted but combined” in the tablets, and he linked Univasc to the '450 Patent: Applicant herewith submits the Product Monograph for Univasc® (Moexipril Hydrochloride Tablets) wherein the tablets marketed by Schwarz Pharma (as listed in the FDA Orange Book as per the teachings of United States Patent No. 4,743,450) include magnesium oxide; unreacted but combined and functioning as a stabilizer (see first page). The Examiner is referred to those pages. Full reconsideration is respectfully requested. (JTX-2D at AI-MOEX0000429) (emphasis added). Dr. Sherman also represented that the Gu Article “discusses that the stabilization is a result from the neutralization of the acid drug by basic excipients at the outer surface of the granulated material. However, primarily the product is moexipril hydrochloride as the active.” (Id.) (emphasis in original). This statement omits important aspects of Gu’s teachings. Dr. Sherman also amended Claim 1 to recite conversion of “at least 70%” in order to overcome the Examiner’s rejection based on indefiniteness. (JTX-2D at AIMOEX0000420; Trial Tr. Day 1 at 202:14-19 (Chyall)). ii) The June 11, 2003, Office Action Response On December 18, 2002, the PTO Examiner rejected the claims of the '173 Application as obvious over the Gu Article in view of the '450 Patent. (JTX-2G at AIMOEX0000469-474; Trial Tr. Day 1 at 205:12-20 (Chyall)). Dr. Sherman responded by further amending the claims to add the limitation “sufficient amount” in reference to the term “solvent” in the claim. (JTX-2H at AI-MOEX0000477; Trial Tr. Day 1 at 205:21-206:2 (Chyall)). Dr. Sherman’s response also again repeated his representation that the ingredients in Univasc are “unreacted but combined,” this time underscoring the phrase for added emphasis: Applicant previously submitted the Product Monograph for Univasc® (Moexipril Hydrochloride Tablets) hereby incorporated by reference wherein the tablets marketed by Schwarz Pharma (as listed in the FDA Orange Book as per the teachings of United States Patent No. 4,743,450) also hereby incorporated by reference include magnesium oxide; unreacted but combined and functioning as a stabilizer (see first page). The Examiner is again referred to those pages. Full reconsideration is respectfully requested. (JTX-2H at AI-MOEX0000481) (emphasis in original). Sherman also argued that “Gu et at [sic] teaches that only a portion (if any) of the drug, and only that portion at the outer surface of the granules, may be converted to the alkaline salt, and that the stable product thus results entirely or primarily not from conversion to alkaline salts, but from stabilization of the moexipril hydrochloride by the presence of the alkaline stabilizing compound in the final product:’ (JTX-2H at AIMOEX0000480) (emphasis in original). He then went on to distinguish the prior art Gu Article and '450 Patent from his invention on the grounds that those references taught combining the ingredients, whereas his invention was reacting them. Dr. Sherman again described Univasc as an example of a product made in accordance with the teachings of Gu and the '450 Patent, wherein the ingredients are combined but not reacted: Even if one skilled in the art were to combine Gu et al with [the '450 Patent] they would arrive at moexipril hydrochloride which is stabilized by an alkaline agent and preferably magnesium oxide as per the product monograph of the moexipril hydrochloride tablets manufactured by [Schwarz] attached in the prior Information Disclosure Statement provided. Applicant is not “combining” but is “reacting” the active and the agents to result in the moexipril magnesium. (JTX-2H at AI-MOEX0000480, AIMOEX0000486) (emphasis added). iii) The February 12, 200k, Office Action Response On August 22, 2003, the PTO Examiner issued a Final Rejection, once again rejecting the claims of the '173 Application as obvious over Gu in view of the '450 Patent. (JTX-2I at AI-MOEX0000493-502.) In his response to this Final Rejection, Dr. Sherman amended Claim 1 yet again, this time to include the terms “in a controlled manner” and “for a predetermined amount of time.” (JTX-2J at AIMOEX0000521). There is no discussion in the Patent or in the prosecution history as to what these newly added claim terms mean, although they appear from the amendment to be tied to the 70% conversion limitation. (JTX-2J at AIMOEX0000505-525; Trial Tr. Day 1 at 207:2-22 (Chyall)). Dr. Sherman again identified Univasc as an example of a product made in accordance with the prior art processes and again underscored the phrase “unreacted but combined.” (JTX-2J at AIMOEX0000508). And, once again, Dr. Sherman distinguished Gu and the '450 Patent as processes for stabilization in which moexipril and magnesium oxide are combined but not reacted and that Univasc is stabilized according to that prior art process: A reaction is not disclosed, inferred, suggested or discussed in [the '450 Patent] whatsoever. In fact only the stabilizing activity of the magnesium compound is discussed and the importance of avoiding excipients and saccharides which might interfere with that stabilizing function. Gu et al postulates that a minor insignificant portion may react but the stabilization is a result of the combination of the moexipril hydrochloride with the alkaline stabilizer as evidenced by the Product Monograph previously provided. No other conclusion can be reached. (JTX-2J at AI-MOEX0000513-514) (emphasis added). Relying on the Univasc example, Dr. Sherman also argued (again) that Gu teaches that a stable moexipril product results from the combination of ingredients and not a reaction: It thus appears clear that Gu et at [sic] teaches that only a portion (if any) of the drug, and only that portion at the outer surface of the granules, may be converted to the alkaline salt, and that the stable product thus results entirely or primarily not from conversion to alkaline salts, but from stabilization of the moexipril hydrochloride by the presence of the alkaline stabilizing compound in the final product. (JTX-2 at AI-MÜEX0000507) (emphasis in original). iv) The Lipp Declaration Near the time of the response to the final rejection, Dr. Sherman, through Hughes, hired Dr. Michael Lipp to submit a sworn declaration to the PTO, dated February 9, 2004, reinforcing Dr. Sherman’s arguments that Univasc was made by the prior art '450 Patent’s process. Dr. Lipp declared: Thus, as would be understood by persons skilled in the area of pharmaceutical chemistry, stabilizers used in standard pharmaceutical practice are molecules that inhibit or prevent reactions between active ingredients and other chemical species in pharmaceutical formulations.... An additional example particularly relevant to the matter at hand is the UN-FASC ® [sic] moexipril hydrochloride formulation.... The product monograph for the UNVASC® [sic] moexipril hydrochloride formulation lists moexipril hydrochloride as being present in the final formulation in addition to magnesium oxide as an alkaline stabilizer, as per the teachings of the '450 patent which is listed in the FDA Orange Book for this formulation. As a result, in my opinion, a skilled formulator reading Harris et al [the '450 Patent] would not expect a reaction to occur between an alkaline or saccharide stabilizer and an ACE inhibitor drug in the formulations disclosed therein. (JTX-2K at AI-MOEX0000545-546, ¶37) (emphasis added). At trial, Dr. Sherman testified he could not recall whether he instructed Hughes to have an expert declaration prepared in order to respond to the final office action. (Trial Tr. Day 2 at 156:3-17 (Sherman)). When presented with a letter from Hughes to Sherman enclosing the final office action and previous response, (DTX-535), Dr. Sherman testified that he did not recall whether he was informed about the prosecution on every occasion. (Trial Tr. Day 2 at 156:18-157:13 (Sherman)). Then, when presented with an e-mail from Hughes to Dr. Lipp stating that “Dr. Sherman has advised us to file further arguments with affidavit evidence,” (DTX-82), Dr. Sherman did not have a strong recollection of any such conversation, but presumed that it took place. (Trial Tr. Day 2 at 157:19-159:10 (Sherman)). v) The Examiner’s Acceptance It was only after Dr. Sherman amended Claim 1 to require “greater than 80%” conversion to moexipril magnesium that, on April 7, 2004, the PTO Examiner finally approved the claims of the '556 Patent. (JTX-2Q at AI-MOEX0000650-651; JTX 2S at AI-MOEX0000654-657; Trial Tr. Day 1 at 146:21-148:7 (Cima)). In the statement allowing the claims, the PTO Examiner accepted Dr. Sherman’s previous representations, stating that: The primary reason for allowance is that the prior art does not disclose nor fairly suggest a process of making a pharmaceutical composition comprising moexipril magnesium, comprising the step of reacting moexipril or an acid addition salt thereof with an alkaline magnesium compound so as to convert greater than 80% of the moexipril or moexipril acid addition salt to moexipril magnesium. Rather, the prior art teaches that only a portion of drug (if any) may be converted to the alkaline salt and that the stable product results entirely or primarily not from conversion to alkaline salts, but from stabilization of the moexipril hydrochloride by the presence of the alkaline stabilizing compound in the final product. (JTX-2 at AI-MOEX0000656; Trial Tr. Day 1 at 199:21-200:17 (Chyall)). These are basically the same opinions that were offered in the Lipp Declaration and by Dr. Sherman’s several Office Action responses. In each response to each rejection, Dr. Sherman referred the PTO to the “Product Monograph for Univasc,” stating that “tablets marketed by [Schwarz] (as listed in the Orange Book as per the teachings of United States Patent No. 4,743,450) [...] include magnesium oxide; unreacted but combined and functioning as a stabilizer.” (JTX-2 at AI-MOEX0000429 (emphasis added); JTX-2 at AI-MOEX0000481 (emphasis in original); JTX-2 at AIMOEX0000508) (emphasis in original). He repeatedly represented to the PTO that Univasc was made by the process disclosed in the '450 Patent and Gu, and that Univasc contained moexipril hydrochloride and magnesium oxide “unreacted but combined.” (JTX-2 at AIMOEX0000343, 429, 481, 486, 508, 513-14, 516-17, 545). Accordingly, Dr. Sherman argued, the prior art was outside the scope of what he was claiming. The phrase “unreacted but combined” does not appear in the prior art, including in the '450 Patent and Gu. Dr. Sherman distinguished the claimed invention from the prior art processes by stating that the prior art teaches “combining” moexipril and an alkaline magnesium compound as evidenced by Univasc, rather than “reacting” the ingredients so as to convert the moexipril or acid addition salt thereof to moexipril magnesium. (JTX-2 at AIMOEX0000426, AI-MOEX0000429; Trial Tr. Day 2 at 141:22-144:2 (S.herman).) But in the midst of all Dr. Sherman’s arguments and representations to the PTO, he never once mentioned that the process used to make Univasc was secret, or that he did not know the actual process used to make Univasc. In fact, the evidence before this Court indicates otherwise. 5) Misrepresentations or Omissions i) Knowledge of Univasc’s Process At trial, Dr. Sherman admitted everything but knowledge of the fact that Univasc was made according to his claimed process. He even ventured to say that, even before he filed his application, he had a “strong suspicion” and a “belief’ that Schwarz was utilizing his process. (Trial Tr. Day 2 at 95:6-10, 104:13 to 105:7 (Sherman)). Dr. Sherman was not a credible witness at trial, and, given the evidence presented, including his own testimony, I find that he indeed knew that Univasc was made according to his claimed process. On March 16, 2001, the same day Dr. Sherman filed the '173 Application, Dr. Sherman prepared a handwritten memorandum addressed to a Mr. Murthy, recording the results of stability tests comparing Apotex # 1002 to Univasc. (See DTX-51). These tests showed that Univasc was significantly more stable than moexipril hydrochloride alone, as measured by the DKP impurity content. (DTX-51; Trial Tr. Day 2 at 91:5-92:8, 95:6-10, 104:13-105:7 (Sherman)). In his own handwriting, Dr. Sherman commented, “Hence it appears that the moexipril hcl itself is much less stable than the magnesium salt.” (DTX-51 (emphasis in original); Trial Tr. Day 2 at 92:2-8 (Sherman)). In this memorandum, Apotex # 1002 and Univasc are the only two substances identified. Since “Apotex # 1002” was the “moexipril hcl itself,” Univasc must have been the “moexipril salt” identified by Sherman. (DTX-51). This demonstrates that Dr. Sherman knew Univasc was moexipril magnesium on the date that he filed his patent application. At trial, Dr. Sherman refuted this conclusion, arguing that he was not referring to Univasc as the magnesium salt. However, I did not find this testimony to be credible. On April 30, 2001, during the pendency of the '173 Application, two scientists at Apotex produced a detailed report entitled “Interim Report for Study of Moexipril Magnesium Salt” (the “2001 Study”). (DTX-94). The 2001 Study describes mass spectrometry (“MS”) tests Apotex had conducted to determine whether moexipril magnesium was present in Univasc tablets. (DTX-94; Trial Tr. Day 2 at 102:24-104:12 (Sherman)). Based on the observations from the 2001 Study, the researchers suggested (and, in my opinion, concluded) that the moexipril in Univasc is “mainly present in the form of magnesium complex” and that the moexipril in Univasc “could exist as moexipril magnesium complex.” (DTX-94 at 2-3; Trial Tr. Day 2 at 104:13-22 (Sherman)). Moexipril magnesium complex is the same compound that supposedly results from the process claimed in the '556 Patent. (JTX-1, col. 6, 11. 24-31; Trial Tr. Day 2 76:7-77:4 (Sherman)). The 2001 Study further states that “NMR studies of Moexipril raw material, prepared MO-Magnesium sample and brand product [i.e., Univasc] will be conducted for further confirmation” of the “extensive MO-Magnesium complex” detected. (DTX-94 at 3) (emphasis added). However, such NMR tests apparently were not performed on Univasc until 2012, shortly before Apotex filed suit. (Trial Tr. Day 2 at 81:21-83:23, 106:7-20 (Sherman)). The conclusion of Apotex’s 2001 Study — that moexipril is mainly present in Univasc as moexipril magnesium, (DTX-94 at 2-3) — directly refutes Dr. Sherman’s repeated representations to the PTO that the moexipril hydrochloride in Univasc was not reacted but was merely combined with an alkaline magnesium compound. (JTX-2 at AI-MOEX0000483, AIMOEX0000511; Trial Tr. Day 2 at 145:1-146:16 (Sherman)). Dr. Sherman claims that he does not remember this study being done, and that he does not recall having knowledge about it. However, given Dr. Sherman’s hands-on approach to his business, including litigation and formulation, as well as the fact that he was very much involved with Univasc stability testing, even doing tests himself and handwriting notes to his employees regarding Univasc’s stability, I find that Dr. Sherman was aware of this 2001 Study, and certainly would have been told of the study’s results. But despite the 2001 Study’s findings, Dr. Sherman continued to represent to the PTO that Univasc was made by a prior art process in which there was no conversion to moexipril magnesium. (JTX-2; Trial Tr. Day 2 at 143:25-144:10 (Sherman)). Nor did Dr. Sherman disclose the results of the 2001 Study, or the results of any testing on Univasc, to the PTO at any time during the three subsequent years of prosecution of the '173 Application. Further, Dr. Sherman testified that in January 2002 he was of the view that Univasc was probably not made according to the '450 Patent. Dr. Sherman claims he believed at the time that if one followed the teachings of the '450 Patent, it would be impossible to have a product suitable for regulatory approval. (Trial Tr. Day 2 at 110:25-111:14 (Sherman)). Keeping in mind that the '556 Patent did not issue until July 2004, Dr. Sherman went at least over two years without disclosing to the PTO his belief that Univasc was not created in accordance with the teachings of the '450 Patent. Based on these facts, I find that Dr. Sherman’s arguments to the Examiner regarding the nature of Univasc were knowingly false. ii) The Second Moexipril Patent Application Additional evidence of Dr. Sherman’s knowledge of the Univasc process is found in the disclosures of a second moexipril patent application filed by Dr. Sherman. On February 1, 2002, Dr. Sherman filed a second patent application directed toward processes of stabilizing moexipril, and published a PCT patent application, WO 03/063867 (the “'867 PCT”). (DTX-84; Trial Tr. Day 2 at 112:11-25 (Sherman)). Dr. Sherman prepared the specification of the '867 PCT application (DTX-84) himself and had it filed in the USPTO on February 1, 2002, less than one year after filing the '173 Application. (Trial Tr. Day 2 at 112:11-113:22 (Sherman)). First mention of this second moexipril application was in a January 12, 2002, Apotex Project Initiation Form (DTX-85), wherein Dr. Sherman referred to the second patent application (in addition to the '173 Application) that was about to be filed, which Teva (another pharmaceutical company) would probably infringe. (DTX-85; Trial Tr. Day 2 at 111:18 to 112:16 (Sherman)). Teva’s process was not publicly disclosed at the time, yet Dr. Sherman was still able to make this assertion. At trial, Dr. Sherman acknowledged that this second application (the '867 PCT) cites to the '949 Patent, (JTX-3), and that the '949 Patent discloses and claims moexipril. (Trial Tr. Day 2 at 113:17 to 114:15 (Sherman)). The '867 PCT further discloses that the Examples of the '450 Patent disclose the use of gelatin as a binder. (DTX-84 at 2; Trial Tr. Day 2 at 114:16-115:4 (Sherman)). Dr. Sherman testified that when gelatin is used as a binder for a tablet, it is used in wet granulation. (Trial Tr. Day 2 at 115:2-24 (Sherman)). The '867 PCT also discusses the Gu Article and its teaching that the stabilization of moexipril is accomplished only when the compositions are made by a wet granulation process. Sherman testified that he agreed with that statement and that the Gu Article teaches that a dry mix does not work in 2002. (DTX-84 at 2-3; Trial Tr. Day 2 at 115:21-116:18 (Sherman)). The '867 PCT then discloses that quinapril is sold in the United States under the tradename “Accupril,” and that the labeling indicates the formulation contains gelatin. (DTX-84 at 3; Trial Tr. Day 2 at 116:15-23 (Sherman)). The '867 PCT next discloses Univasc and states that its labeling indicates that it contains moexipril hydrochloride, magnesium oxide, lactose, gelatin, crospovidone, and magnesium stearate. (Trial Tr. Day 2 at 116:24 to 117:5 (Sherman)). The '867 PCT then concludes that the labeling of both products, Univasc and Accupril, “thus indicates that both products are made in accordance with the teaching[s]” of the '450 Patent and the Gu Article. (DTX-84 at 3; Trial Tr. Day 2 at 117:6-9 (Sherman)). I previously found that Dr. Sherman had knowledge of the Univasc process as of the date he filed the '173 Application. However, given the disclosures in the '867 PCT, and noting that Dr. Sherman wrote this PCT application, I now make the additional finding that, by no later than February 1, 2002 (the filing date of the '867 PCT), Dr. Sherman knew Univasc to be made by a wet granulation process and that, therefore, some reaction and conversion was certain to take place during that process. Notwithstanding, Dr. Sherman continued to make his consistent — yet deceptive— representations regarding Univasc, the '450 Patent, and the Gu Article to the PTO in the '173 Application prosecution, iii) The '560 PCT The prior art WO 99/62560, entitled “Stabilization of Quinapril Using Magnesium Oxide” (the “'560 PCT”), was published on December 9,1999. The abstract of the '560 PCT reads as follows: The present invention is directed to ACE inhibitor-containing compositions stabilized by the presence of magnesium oxide. Preferably, the ACE inhibitor, quinapril, is protected from certain forms of degradation when prepared in a pharmaceutical composition consisting essentially of magnesium oxide as the stabilizing agent. The presence of magnesium oxide also lends itself to favorable processing conditions during the manufacture of ACE inhibitor-containing compositions, especially processing by wet granulation. (JTX 10). This PCT application is an improvement over the '450 Patent because it recognizes magnesium oxide as a better stabilizing agent, as show in Example 5, than magnesium carbonate as preferred in the '450 Patent. (Trial Tr. Day 1 at 209:22 to 210:3, 211:24 to 212:19 (Chyall); JTX-10 at 17-18). Magnesium oxide is the same stabilizer used to make Univasc. (Trial Tr. Day 1 at 212:7-9 (Chyall); JTX-10 at 8, 11. 25-26). The '560 PCT describes advantages of the claimed process over the prior art, including the '450 patent. (JTX-10 at 1-2; Trial Tr. Day 2 at 211:24-212:6 (Chyall)). Example 4 of the '560 PCT contains data demonstrating that compositions that are wet granulated using magnesium oxide (Example 1) are stable. (JTX-10 at 16; Trial Tr. Day 1 at 214:13-18 (Chyall)). The '560 PCT also provides details of prior art wet granulation methods of making ACE inhibitors that are not disclosed in the '450 Patent. (Trial Tr. Day 1 at 210:8-13 (Chyall); JTX-10 at 2-3). Specifically, the '560 PCT (1) describes the steps of wet granulation, including “form[ing] a moist mass,” (JTX-10 at 14, line 6); (2) discloses specific amounts of time for mixing and drying (JTX-10 at 17-18); and (3) offers an example using granulation times of 4.5 to 5 minutes when using magnesium oxide as a stabilizer, (JTX-10 at 17, Il. 12-14). (Trial Tr. Day 1 at 214:19 to 215:12 (Chyall)). The '560 PCT discloses that the wet granulations were done using a gelatin solution. (Trial Tr. Day 1 at 213:18 to 214:6; JTX-10 at 5, 10, 15-17). It also indicates that in prior art wet granulation processes for ACE inhibitor drugs such as quinapril, at least 23 to 29% solvent was removed on drying, and thus the wet mass contained 23 to 29% water. (JTX-10 at 3; Trial Tr. Day 2 at 32:5-34:15 (Chyall)). The amount of water in the wet mass after wet granulation in the '560 PCT is equivalent to the 20% water for wet granulation used in the '556 Patent. This teaches that adding a relatively large amount of water to wet granulation would allow for a much more stable product. The granulation times of 37 minutes disclosed in the '560 PCT and the hold times of 30 minutes (after an unspecified granulation time) disclosed in Examples 2-4 of the '556 Patent are similar. (Trial Tr. Day 1 at 216:11-25 (Chyall)). The '560 PCT demonstrates the many variables involved in using wet granulation to prepare a stable ACE inhibitor tablet, and that these variables affect the amount of solvent and time necessary to complete the process. This lends itself to the conclusion that a person of ordinary skill in the art would not know in advance how to set up conditions to achieve greater than 80% conversion, or less than 80% conversion if one wanted to work outside the claims of the '556 Patent. (Trial Tr. Day 1 at 217:1-22 (Chyall)). Moreover, the four basic steps of wet granulation are disclosed in the '560 PCT. They are the same steps claimed in Claim 8 of the '556 Patent. (JTX-1 col. 7, 11. 4-12; JTX-10 at 14; Trial Tr. Day 1 at 217:23-218:6 (Chyall)). Given such, Dr. Chyall testified that the '556 Patent’s Claims are therefore not patentable over the '560 PCT publication. Dr. Chyall also testified that the '560 PCT is “not at all” cumulative of the '450 Patent’s disclosure. (Trial Tr. Day 1 at 218:7-13 (Chyall)). Further, given that the '560 PCT taught the use of large amounts of water in wet granulation to improve stability, one could easily apply this teaching to the '450 Patent’s examples and arrive at exactly what Dr. Sherman is claiming. Dr. Sherman never provided the '560 PCT to the PTO as part of the '173 Application. (1) Dr. Sherman’s Knowledge of the '560 PCT United States Patent Application No. 10/060,191 (the “'191 Application”) is the United States counterpart of the '867 PCT. (DTX-534). The '191 Application’s claims were directed to stable saccharidefree tablets containing quinapril or moexipril, an alkaline stabilizer, and an excipient that stabilizes against hydrolysis. (DTX-534). To prosecute this application, Dr. Sherman hired the Nixon & Vanderhyde firm, not Hughes’s firm. (Trial Tr. Day 2 at 128:2-4 (Sherman)). The purported invention of the '191 Application encompassed having an excess of alkaline magnesium compound in the final composition to stabilize moexipril, even when the moexipril had been converted to moexipril magnesium. (DTX-534; Trial Tr. Day 2 at 121:8-18 (Sherman)). The similarities between the '191 and '173 Applications are readily apparent. In the sole office action in the '191 Application, dated August 26, 2003, the claims were rejected as anticipated under 35 U.S.C. § 102(b) by the '560 PCT and also as obvious in view of the combination of the '560 PCT and the Gu Article. (Trial Tr. Day 2 at 127:8 to 129:12 (Sherman)). The PTO Examiner stated that: As discussed above, [the '560 PCT] disclose[s] a tablet formulation comprising quinapril, alkaline compounds, and excipients. The formulation however discloses the hydrochloride salt of quinapril. However a product of the process described in [the '560 PCT] is the magnesium salt of quinapril. The [salt] is produced from a reaction of the hydrochloride salt and the alkaline base. (DTX-534 at Office Action, page 3) (emphasis added). Given that the Examiner cited the '560 PCT as the basis for the rejection, Dr. Sherman certainly would have known about the '560 PCT during prosecution of the '556 Patent and, given his experience, he would have understood its relevance and materiality. Nevertheless, he never disclosed it to the PTO Examiner working on the '173 Application, nor was it considered by the PTO Examiner during the '173 Application prosecution. Immediately after receiving a notice of allowance in the '173 Application, Dr. Sherman abandoned the '191 Application. (DTX-534; JTX-2; Trial Tr. Day 2 at 130:4-24 (Sherman)). D. Dr. Sherman’s Intent As delineated below, the evidence demonstrates that Dr. Sherman engaged in a pattern of deceptive practices with the purpose of misleading the PTO into allowing the '556 Patent. 1) Past Tense in the Examples As noted above, Dr. Sherman repeatedly used the past tense in describing Examples 1 through 4, even though he had never performed the experiments described in the Examples. (Trial Tr. Day 1 at 200:19 to 201:17 (Chyall); Trial Tr. Day 2 at 77:11-20 (Sherman)). As explained by Dr. Chyall, a person of ordinary skill in the art reading the Examples of the '556 Patent would have believed the experiments were actually conducted. (Trial Tr. Day 1 at 200:22 to 201:11 Chyall)). In addition to describing the steps of the experiments entirely in the past tense, he also reported specific results of the experiments, even out to the hundredths-of-a-gram. (JTX-1, cols. 5-6). At trial, Dr. Sherman admitted that he had not performed the experiments described in Examples 1 through 4, but that he “really did them in [his] mind and on paper” based on his previous work with quinapril. (Trial Tr. Day 2 at 77:11-20 (Sherman)). Sherman also testified that he is not a lawyer, and that he was told that paper or “prophetic” examples are acceptable. (Trial Tr. Day 2 at 73:16-24, 79:14-80:2 (Sherman)). But the language used by Dr. Sherman in his- Examples disallows a description of “prophetic” as the word is commonly understood. See Random House Dictionary 1550 (2d ed.1983) (defining “prophetic” as “predictive”). 2) Mischaracterization of the %50 Patent and the Gu Article. In the '173 Application and throughout prosecution of the '556 Patent, Dr. Sherman repeatedly mischaracterized the contents of the prior art Gu Article and the '450 Patent. In the '556 Patent, Dr. Sherman stated that “Gu, et al teaches that only a portion (if any) of the drug, and only that portion at the outer surface of the granules, may be converted to the alkaline salt, and that the stable product thus results entirely or primarily not from conversion to alkaline salts, but from stabilization of the moexipril hydrochloride by the presence of the alkaline stabilizing compound in the final product.” (JTX-1 at col. 2, II. 5-11). Contrary to this assertion, Gu offered two hypotheses for the stabilization results he achieved: (1) neutralization of the acidic drug by the basic excipients at the outer surface of the granulated material (i.e., conversion to the free form of moexipril); and (2) “that a portion of the moexipril hydrochloride was converted to the cation salt by wet granulation.” (Trial Tr. Day 1 at 191:11 to 193:10 (Chyall)). This second conversion is not limited to the “outer surface of the granules,” as Dr. Sherman represented. Nor does Gu suggest that no reaction had occurred, which is contrary to Dr. Sherman’s statement, “if any”. (Trial Tr. Day 1 at 197:13 to 198:11 (Chyall)). Also, Dr. Chyall testified that he disagreed with the description of the Gu Article at column 2 of the '556 Patent to the extent that it states that Gu teaches the stabilization of moexipril is due to the presence of the basic material and not the result of a neutralization reaction and that the neutralization is limited to the outer surface of the granules. (Trial Tr. Day 1 at 195:25 to 197:9 (Chyall)). As explained by Dr. Chyall, “[t]he stabilization can’t be due to the mere presence of the material because when you mix these powders in dry granulations, they don’t work.” (Id.). Additionally, during prosecution, Dr. Sherman represented that Gu “postulates that a minor insignificant portion may react but the stabilization is a result of the combination of the moexipril hydrochloride with the alkaline stabilizer as evidenced by the Product Monograph previously provided. No other conclusion can be reached.” (JTX-2 at AIMOEX0000484) (emphasis added). However, Gu says nothing at all about the amount of reaction and conversion taking place in his experiments, and Gu does not state or suggest that the stabilization is the result of combining, rather than reacting, the ingredients. Nor does Gu use the words “minor insignificant” with respect to a reaction. (JTX-2F; Trial Tr. Day 1 at 197:19-198:11 (Chyall)). Moreover, Gu specifically found that combining the ingredients in a dry mix did not result in a stable composition. (JTX-2F at 383; Trial Tr. Day 1 at 196:14-17 (Chyall)). This contradicts the representations made to the PTO. The Gu Article was also mischaracterized in the Lipp Declaration. Paragraph 21 of the Lipp Declaration states that Gu does not teach significant conversion of moexipril hydrochloride into a cation salt formation such as moexipril sodium. (JTX-2 at AI-MOEX0000536; Trial Tr. Day 1 at 198:18-199:20 (Chyall)). This again mischaracterizes Gu because, as Dr. Chyall testified, Gu teaches that a reaction does occur and it may indeed be responsible for achieving stability. (Trial Tr. Day 1 at 199:4-6 (Chyall)). The Lipp Declaration also states that Gu teaches that the increased stability is due to an increase in the “microenvironmental pH on the outer surface of the granules.” (JTX-2 at AI-MOEX0000536; Trial Tr. Day 1 at 199:7-12 (Chyall)). There is no discussion or disclosure in Gu of an increase in the “microenvironmental pH,” and Gu clearly connects the resulting stability to a chemical reaction. (DTX-2F; Trial Tr. Day 1 at 198:18 to 199:20 (Chyall)). Importantly, the PTO Examiner’s notice of allowance repeats verbatim the arguments Dr. Sherman made about the prior art in favor of patentability — i.e., repeated misrepresentations that Univasc is an example of a product made by a prior art process wherein the ingredients were “combined but unreacted.” (JTX-2 at AIMOEX0000656; Trial Tr. Day 2 at 42:1-18, 43:18-44:1 (Chyall)). 3)“Unreacted but Combined” At trial, Dr. Sherman testified that he did not think his statements to the PTO about Univasc being “unreacted but combined” were false. According to Dr. Sherman, he was merely explaining what the prior art taught about Univasc, not commenting about Univasc itself. (Trial Tr. Day 2 at 141:20 to 143:24 (Sherman)). But Dr. Sherman did not tell the PTO that, in fact, he believed that Univasc contained moexipril magnesium, claiming he did not believe such information was relevant. (Trial Tr. Day 2 at 143:25 to 144:10 (Sherman)). Dr. Sherman admitted that, at the time the “unreacted but combined” statement was made to the PTO, he had information that the statement was not true, and that he had a “strong suspicion” or “belief’ that, in fact, UCB was following the process that he was attempting to patent. According to Dr. Sherman, that information was not relevant because, in his view, his statements about Univasc accurately characterized what the prior art and publicly available information taught about Univasc. (Trial Tr. Day 2 at 145:13-146:3 (Sherman)). Dr. Sherman acknowledges that UCB invented the process first, but asserts that he has prior rights because UCB kept its process secret. He claims “[t]hey told the world information that led away from what I had discovered and patented.” (Trial Tr. Day 2 at 146:25-147:12 (Sherman)). But in reality, he knew exactly what was going on. 4) The Lipp Declaration Dr. Lipp, who had worked as an expert witness on approximately 10 other matters for Apotex by the time of this request, submitted a declaration to the PTO, under oath, in which he essentially repeated Dr. Sherman’s arguments. (JTX-2K). In the declaration, dated February 2004, Dr. Lipp described Univasc as a “particularly relevant” example of a product made by the prior art processes ove