Full opinion text
MEMORANDUM GREGORY M. SLEET, Chief Judge. I. INTRODUCTION In this consolidated patent infringement action, plaintiffs Cephalon, Inc. and Cephalon France (collectively, “the plaintiffs” or “Cephalon”) allege that pharmaceutical products proposed by defendants Apotex, Inc., Lupin Limited, Sandoz, Inc., and Watson Laboratories, Inc. (collectively, “the defendants”), infringe the asserted claims of the patents-in-suit. (D.I. 1.) The court held a four-day bench trial in this matter on July 17 through July 20, 2012. (D.I. 304-307.) Presently before the court are the parties’ post-trial proposed findings of fact and conclusions of law concerning the validity of the patents-in-suit. (D.I. 314; D.I. 319.) Pursuant to Federal Rule of Civil Procedure 52(a), and after having considered the entire record in this case and the applicable law, the court concludes that: (1) the asserted claims of the patents-in-suit are not invalid as anticipated under 35 U.S.C. § 102(b); and (2) the asserted claims of the patents-in-suit are not invalid as obvious under 35 U.S.C. § 103. These findings of fact and conclusions of law are set forth in further detail below. II. FINDINGS OF FACT A. The Parties 1. Plaintiff Cephalon, Inc. (“Cephalon”) is a Delaware corporation having its corporate offices and principal place of business at 41 Moores Road, Frazer, Pennsylvania 19355. 2. Plaintiff Cephalon France (“Cephalon France”) is a societe par action simplifiee (“SAS”) under the laws of France, is a wholly-owned subsidiary of Cephalon, Inc., and is located at 20 Rue Charles Martigny, 94701 Maisons-Alfort Cedex, France. 3. Defendant ■ Watson Laboratories, Inc. (“Watson”) is a corporation organized and existing under the laws of Nevada, with a principal place of business at Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054. 4. Defendant Sandoz, Inc. (“Sandoz”) is a corporation organized and existing under the laws of Colorado, with a principal place of business at 506 Carnegie Center, Suite 400, Princeton, New Jersey 08540. 5. Defendant Lupin Limited (“Lupin”) is a corporation organized and existing under the laws of India, with a principal place of business at B/4 Laxmi Towers Bandra Kurla Complex, Bandra (E), Mumbai 400051, India. 6. Defendant Apotex, Inc. (“Apotex”) is a corporation organized and existing under the laws of Canada, with a principal place of business at 150 Signet Drive, Toronto, Ontario M9L 1T9, Canada. 7. Apotex, Lupin, Sandoz, and Watson will be collectively referred to as “defendants.” B. Background 8. Armodafinil is a chemical compound known as (-)-2-[R-(diphenylbenzhydryl-sulphinyl) ]acetamide and has the following chemical structure: 9. Armodafinil is also known by other names, including 2-[ (R)-(diphenylmethyl)sufínyl]acetamide, CRL 40982, (-)-benzhydrylsulfinylacetamide, (-)-modafinil, and the levorotatory or laevorotatory enantiomer of modafinil. 10. Armodafinil is also known as the Renantioer of modafinil. Modafinil is a racemic mixture containing equal amounts of both the R-enantiomer and S-enantiomer of modafinil. 11. Enantiomers have different three-dimensional spatial arrangements that make them non-superimposable mirror images of each other, much like a person’s right and left hand. 12. Enantiomers may have identical physical properties (such as melting point, weight, and density) and, therefore, cannot necessarily be distinguished from each other based on measurements of these properties. However, they may be differentiated by their biological properties, and can be differentiated by their optical activity. 13. Substances that can rotate polarized light are said to be optically active because they interact with light and can rotate polarized light. 14. Enantiomers that rotate plane-polarized light clockwise are said to be dextrorotatory (from the Latin dexter, “right”) or (+). Those that rotate plane-polarized light counterclockwise are called levorotatory or laevorotatory (from the Latin ¿news, “left”) or (-). 15. The R-enantiomer of modafinil (i.e., armodafinil) is also called (-)-modafinil because it rotates plane-polarized light counterclockwise. C. The Patent-in-Suit 16. United States Patent No. 7,132,570 (“the '570 Patent”), entitled “Methods for the Production of Crystalline Forms and Crystalline Forms of Optical Enantiomers of Modafinil,” naming Olivier Neckebrock and Pierre Leproust as inventors, was issued on November 7, 2006. 17. Cephalon holds approved New Drug Application (“NDA”) No. 21-875 for armodafinil tablets in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg dosage strengths. 18. Cephalon sells 50 mg, 100 mg, 150 mg, and 250 mg dosage strengths in the United States under the tradename Nuvigil®. 19. Nuvigil® is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work sleep disorder. 20. Polymorphic Form I armodafinil was chosen for Nuvigil® for its favorable aggregate of properties, including solubñity and stability. 21. Pursuant to 21 U.S.C. § 355 and attendant FDA regulations, the '570 Patent is listed in the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations (“the Orange Book”) for Nuvigil®. 1. The Asserted Claims 22. Cephalon originally asserted claims 1-9 of the '570 Patent against each of the defendants. i. '570 Patent, Claim 1 23. Claim 1 states: A laevorotatory enantiomer of modaflnil in a polymorphic form that produces a powder X-ray diffraction spectrum comprising intensity peaks at the interplanar spacings: 8.54, 4.27, 4.02, 3.98(A). ii. '570 Patent, Claim 2 24. Claim 2 states: The laevorotatory enantiomer of modafinil according to Claim 1, wherein the polymorphic form produces a powder X-ray diffraction spectrum further comprising intensity peaks at the interplanar spacings: 13.40, 6.34, 5.01, 4.68, 4.62, 4.44, 4.20, 4.15, 3.90, 3.80, 3.43(A). , ■ iii. '570 Patent, Claim 3 25. Claim 3 states: A laevorotatory enantiomer of modafinil in a polymorphic form that produces a powder X-ray diffraction spectrum comprising reflections at 15.4, 31.1, 33.1 and 33.4 degrees 29. iv. '570 Patent, Claim 4 26. Claim 4 states: The laevorotatory enantiomer of modaflnil according to Claim 3, wherein the polymorphic form produces a powder X-ráy diffraction spectrum comprising reflections at 9.8, 20.8, 26.4, 28.3, 28.7, 29.9, 31.6, 32, 34.1, 35.1 and 39 degrees 2G. v. '570 Patent, Claim 5 27. Claim 5 states: A pharmaceutical composition comprising a laevorotatory enantiomer of modafinil according to any one of Claims 1 to 4. vi. '570 Patent, Claim 6 28. Claim 6 states: A pharmaceutical composition consisting essentially of a laevorotatory enantiomer of modafinil according to any one of Claims 1 to 4. vii. '570 Patent, Claim 7 29. Claim 7 states: A Form 1 polymorph of (-)-modafinil. viii. '570 Patent, Claim 8 30. Claim 8 states: A pharmaceutical composition comprising a Form 1 poly-morph of (-)modafinil according to Claim 7. ix. '570 Patent, Claim 9 31. Claim 9 states: A pharmaceutical composition consisting essentially of a Form 1 polymorph of (-)-modafinil accords ing to Claim 7- 32. - The court held a Markman hearing on July 14, 2011 and, on July 25, 2011, 2011 WL 9158436, issued an Order construing the disputed terms. (D.I. 172.) 33. The court construed disputed term “A laevorotatory enantiomer of modafinil in a polymorphic form that produces a powder X-ray diffraction spectrum comprising ...” in Claims 1 and 3 to mean “A crystal form of Armodafinil having the claimed powder X-ray diffraction features.” (Id. at 1.) 34: The court construed disputed term “... intensity peaks at the interplanar spacings ...” in Claims 1 and 2 to mean: “Peaks in the powder x-ray diffraction pattern corresponding to the claimed crystal interplanar spacings with variances associated with X-ray diffraction spectroscopy.” (Id. at 2.) 35. The court construed disputed term “... reflections at ...” in Claims 3 and 4 to mean: “Peaks in the powder x-ray diffraction pattern, using chromium radiation, corresponding to the claimed value -with variances associated with X-ray diffraction spectroscopy, or corresponding values based on another radiation source.” (Id.) 36. The parties agreed prior to the Markman hearing that disputed term “A form I polymorph of (-)-modafinil” in Claims 5 and 8 means: “A composition comprising the specified pharmaceutically active component and optionally one or more pharmaceutically acceptable ingredients.” (Id. at 3.) 37. The parties decided prior to the Markman hearing that the disputed term “A pharmaceutical composition consisting essentially of ...” in Claims 6 and 9 means: “A composition consisting of the specified pharmaceutically active component and optionally unlisted pharmaceutically acceptable ingredients that do not materially affect the basic and novel properties of the specified pharmaceutically active component.” (Id.) 2. The Accused Products i. ANDA No. 200-156 Submitted by Watson 38. Under 21 U.S.C. § 355(j), Watson submitted to the FDA ANDA No. 200-156 to obtain approval for the commercial manufacture, use, marketing, and sale of generic armodafinil products in.the United States in 150 mg and 250 mg dosage strengths. 39. Watson amended its ANDA No. 200-156 to obtain approval for the commercial manufacture, use, marketing, and sale of generic armodafinil products in the United States in 50 mg, 100 .mg, and 200 mg dosage strengths (collectively, with respect to all five dosage strengths, “the Watson proposed generic armodafinil products”). 40. Watson filed ANDA No. 200-156 to obtain approval to manufacture, use, market, and sell the Watson proposed generic armodafinil products in the United States before the expiration of the '570 Patent. 41. Watson’s ANDA No. 200-156 contains a certification, pursuant to 21 U.S.C. § 355Q)(2)(A)(vii)(IV), alleging that the '570 Patent is invalid, unenforceable, and/or not infringed. 42. By letter dated November 24, 2009 (‘Watson’s Notice Letter”), Watson notified Cephalon that it had filed ANDA No. 200-156 seeking approval to market the Watson proposed generic armodafinil products, and that it was providing information to Cephalon pursuant to 21 U.S.C. § 355(j)(2)(B)(ii). ii. ANDA No. 200-511 Submitted by Sandoz 43. Under 21 U.S.C. § 355(j), Sandoz submitted to the FDA ANDA No. 200-511 to obtain approval for the commercial manufacture, use, marketing, and sale of generic armodafinil products in the United States in 50 mg, 150 mg, and 250 mg dosage strengths. 44. Sandoz amended its ANDA No. 200-511 to obtain approval for the commercial manufacture, use, marketing, and sale of generic armodafinil products in the United States in 100 mg and 200 mg dosage strengths (collectively, with respect to all five dosage strengths, “the Sandoz proposed generic armodafinil products”). 45. Sandoz filed ANDA No. 200-511 to obtain approval to manufacture, use, market, and sell the Sandoz proposed generic armodafinil products in the United States before the expiration of the '570 Patent. 46. Sandoz’s ANDA No. 200-511 contains a certification, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), alleging that the '570 Patent is invalid, unenforceable, and/or not infringed. 47. By letters dated December 15, 2009 and July 27, 2011 (collectively, “Sandoz’s Notice Letter”), Sandoz notified Cephalon that it had filed and amended ANDA No. 200-511 seeking approval to market the Sandoz proposed generic armodafinil products, and that it was providing information to Cephalon pursuant to 21 U.S.C. § 355(j)(2)(B)(ii). iii. ANDA No. 200-751 Submitted by Lupin 48. Under 21 U.S.C. § 355(j), Lupin submitted to the FDA ANDA No. 200-751 to-obtain approval for the commercial manufacture, use, marketing, and sale of generic armodafinil products in the United States in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg dosage strengths (collectively, “the Lu-pin proposed generic armodafinil products”). 49. Lupin filed ANDA No. 200-751 to obtain approval to manufacture, use, market, and sell the Lupin proposed generic armodafinil products in the United States before the expiration of the '570 Patent. 50. Lupin’s ANDA No. 200-751 contains a certification, pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), alleging that the '570 Patent is invalid, unenforceable, and/or not infringed. 51. By letter dated February 5, 2010 (“Lupin’s Notice Letter”), Lupin notified Cephalon that it had filed ANDA No. 200-751 seeking approval to market the Lupin proposed generic armodafinil products, and that it was providing information to Cephalon pursuant to 21 U.S.C. § 355(j)(2)(B)(ii). iv. ANDA No. 20-1514 Submitted by Apotex 52. Under 21 U.S.C. § 355(j), Apotex submitted to the FDA ANDA No. 20-1514 to obtain approval for the commercial manufacture, use, marketing, and sale of generic armodafinil products in the United States in 50 mg, 150 mg and 250 mg dosage strengths (collectively, “the Apotex proposed generic armodafinil products”). 53. Apotex filed ANDA No. 20-1514 to obtain approval to manufacture, use, market, and sell the Apotex proposed generic armodafinil products in the United States before the expiration of the '570 Patent. 54. Apotex’s ANDA No. 20-1514 contains a - certification; pursuant to 21 U.S.C. § 355(j) (2) (A) (vii) (IV), alleging that the '570 Patent is invalid, unenforceable, and/or not infringed. 55. By letter dated July 6, 2010 (“Apotex Notice Letter”), Apotex notified Cephalon that it had filed ANDA No. 20-1514 seeking approval to market the Apotex proposed generic armodafinil products, and that it was providing information to Cephalon pursuant to 21 U.S.C. § 355(j)(2)(B)(ii). D. Procedural History 56. Cephalon filed its Complaint for patent infringement against Watson on January 5, 2010, in what was labeled Civil Action No. lO-cv-0007 (GMS), alleging that Watson infringes the '570 Patent. (10-cv-0007 (GMS), D.I. 1.) 57. Cephalon filed its Complaint for patent infringement against Sandoz on January 22, 2010, in what was labeled Civil Action No. lO-cv-055 (GMS), alleging infringement of the '570 Patent and other Cephalon patents. (10-cv-055 (GMS), D.I. 1.) 58. Cephalon filed its Complaint for patent infringement against Sandoz on September 6, 2011, also alleging infringement of the '570 Patent in what was labeled Civil Action No.ll-ev-782 (GMS). (11-ev-782 (GMS), D.I. 1.) 59. Cephalon filed is Complaint for patent infringement against Lupin on March 16, 2012, alleging infringement of the '516 and '570 Patents, in what was labeled Civil Action No. 10-cv-210 (GMS). (10-cv210 (GMS), D.I. 1.) 60. Cephalon filed its Complaint for patent infringement against Apotex on August 18, 2010, alleging infringement of the '516 and '570 Patents, in what was labeled Civil Action No. 10-cv-695 (GMS), as well as on August 19, 2010, in what was labeled Civil Action No. 10-cv-1078 (GMS). (10-cv-695 (GMS) (D.I. 1); 10-cy-1078 (GMS) (D.I. 1).) 61. On December 18, 2010, these actions were centralized in the District of Delaware via the United States Judicial Panel on Multidistrict Litigation’s Transfer Order. (10-md-2200 (GMS) (D.I. 1).) 62. On November 23, 2011, the court granted the parties’ joint motion to consolidate case ll-cv-782 into the multidistrict litigation. (10-md-2200 (GMS) (D.I. 219).) 63. On March 31, 2012, the above-captioned defendants stipulated to infringement of the asserted claims of the patent-in-suit in the parties’ Pretrial Order. (D.I. 259 at ¶¶ 40-43; see also D.I. 258.) 64. On July 11, 2012, Cephalon informed the .court that, in an effort to streamline presentation of the evidence, it agreed that the defendants’ right to enter the market with respect to the '570 Patent with their proposed armodafinil ANDA products, “will stand or fall based upon the outcome of this litigation with respect to claim 6 (as it depends upon claim 2) and claim 9 of the '570 Patent.” (D.I. 295.) Thus, Cephalon limited its presentation of the evidence at trial to those claims. (Id.) 65. The court held a four-day bench trial in this matter on July 17, 2012 through July 20, 2012. (D.I. 304-307.) 66. On December 28, 2012, the plaintiffs filed a Motion to Amend the Caption (D.I. 322) to include Teva Sante SAS as a party-plaintiff, following Teva Pharmaceutical Industries Ltd.’s acquisition of Cephalon, Inc. (Id. at 2.) The court granted this motion on February 5, 2013. (D.I. 325.) III. DISCUSSION AND CONCLUSIONS OF LAW The court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 1331,1338(a), 2201, and 2202. The parties have consented to personal jurisdiction and venue in this court for the purpose of adjudicating the present dispute. (D.I. 259 at 11.) After having considered the entire record in this case, the substantial evidence in the record, the parties’ post-trial submissions, and the applicable law, the court concludes that: (1) the asserted claims of the patents-in-suit are not invalid as anticipated under 35 U.S.C. § 102(b); (2) the asserted claims of the patents-in-suit are not invalid as obvious under 35 U.S.C. § 103; and (3) the plaintiffs’ Rule 52(c) motion is granted and the defendants’ Rule 52(c) motion is denied. The court’s reasoning follows. A. Anticipation The defendants contend that the asserted claims of the '570 Patent are invalid as inherently anticipated by Preparation I of the '855 Patent. Specifically, the defendants assert that a person of ordinary skill in the art “will necessarily and inevitably obtain Form I armodafinil from following the prior art Preparation I process.” (D.I. 319 at 7.) 1. The Legal Standard “[Invalidity by anticipation requires that the four corners of a singlet] prior art document describe every element of the claimed invention, either expressly or inherently, such that a person of ordinary skill in the art could practice the invention without undue experimentation.” Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed.Cir.2000). The Federal Circuit recently discussed the standards for inherent disclosure in Verizon Services Corp. v. Cox Fibernet Virginia, Inc., 602 F.3d 1325 (Fed.Cir.2010): “[A] prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference.” However, a patent claim “cannot be anticipated by a prior art reference if the allegedly anticipatory disclosures cited as prior art are not enabled.” “The standard for what constitutes proper enablement of a prior art reference for purposes of anticipation under section 102, however, differs from the enablement standard under section 112.” It is well-settled that utility or efficacy need not be demonstrated for a reference.to serve as anticipatory prior art under section 102. Id. at 1337 (internal citations omitted). In sum, inherent anticipation “requires that the missing descriptive material is ‘necessarily present,’ not merely probably or possibly present, in the prior art.” Trintec Indus., Inc. v. Top-U.S.A Corp., 295 F.3d 1292, 1295 (Fed.Cir.2002) (quoting In re Robertson, 169 F.3d 743, 745 (Fed.Cir.1999)). “A reference includes an inherent characteristic if that characteristic is the ‘natural result’ flowing from the reference’s explicitly explicated limitations.” Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 970 (Fed.Cir.2001). The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Oelrich, 666 F.2d 578, 581 (1981) (quoting Hansgirg v. Kemmer, 26 C.C.P.A. 937, 102 F.2d 212, 214 (1939)). To be inherent, an undisclosed feature must “necessarily and inevitably” flow from practice of what is disclosed. Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1378 (Fed.Cir.2003). Therefore, if the teachings of the prior art can be practiced in a way that yields a product lacking the allegedly inherent property, the prior art in question does not inherently anticipate. See Glaxo Inc. v. Novopharm, Ltd., 52 F.3d 1043, 1047-48 (Fed.Cir.1995) (finding no inherent anticipation where testing evidence demonstrated that the prior art example could yield crystals of either the claimed polymorph or a different polymorph). Whether a prior art reference anticipates a patent claim is a question of fact and must be proven by clear and convincing evidence. See Advanced Display Sys., 212 F.3d at 1281. 2. The Parties’ Contentions and Discussion The defendants .maintain that the asserted claims of the '570 Patent are inherently anticipated because, as compared to claim 6 of the '855 Patent, the asserted claims recite only the interplanar spacings and 2-theta values intrinsic to Form I armodafinil. (D.I. 319 at 6.) Thus, the defendants contend that the only question at trial was “which polymorphic form of armodafinil inherently results from performing Preparation I of the '855 Patent.” (Id.) The defendants argue that their experts, Drs. Mark Hollingsworth and Albert Lee, performed Preparation I of the '855 Patent as persons of ordinary skill in the art in the late 1990s and early 2000s and obtained Form I armodafinil, thus proving anticipation by clear and convincing evidence. Specifically, the defendants detail that Dr. Hollingsworth completed two reproductions of Preparation I and many additional recrystallizations from ethanol, as set out in Preparation I in the '855 Patent, and then confirmed that his experiments produced Form I armodafinil each time using the “gold standard” XRPD analysis. (Id. at 7.) The defendants assert that Dr. Hollingsworth performed each step of the four step process outlined in Preparation T and, therefore, produced more credible results than the plaintiffs’ experts, who, the defendants allege, performed only three steps of the Preparation on Cephalon’s instructions. (Id. at 7-8.) The defendants highlight that Dr. Hollingsworth did not end his analysis after he completed two replications of Preparation I, but instead performed two additional recrystallizations from ethanol and obtained Form I' armodafinil both times. (Id. at 9 (citing Tr. at 111:20-21, 112:10-12, 112:22-113:3, 113:10-15 (Hollingsworth); DTX-163.9-.10; DTX-255A.487, .501; JTX-40.57).) He also performed an additional ethanol recrystallization after completing the second synthesis and, once more, obtained Form I armodafinil according to his XRPD examination. (Id. (citing Tr. at 113:19— 114:4 (Hollingsworth); DTX-163.16; DTX-255A.6, .380-.382, .625; JTX-41.67).) Thus, Dr. Hollingsworth performed, over the course of his two replications of Preparation I, five recrystallizations from ethanol and, per his analysis, obtained Form I armodafinil each of those five times. (Id.) The defendants further assert that Dr: Hollingsworth’s work demonstrates that Form I armodafinil results even before a person of ordinary skill in the art fully completes Preparation I. Specifically, the defendants detail that Dr. Hollingsworth’s testing and XRPD analysis demonstrates that he obtained Form I after the methanol evaporation part of step (d) in both reproductions of Preparation I, as well as after the ether wash part of step (d) in both preparations. (Id. at 10 (citing Tr. at 115:15-22, 116:7-14, 116:10-117:17 (Hollingsworth); DTX-163.3, .18; DTX-255A.1, .3, .4, .387-388, A23-A25, ,562-.563, .578-.580; JTX-40.23).) In sum, the defendants contend, with respect to Dr. Hollingsworth’s testing, that they have proven by clear and convincing evidence that Form I armodafinil necessarily flows from the replication of Preparation I. Moreover, the defendants note that Dr. Lee also replicated Preparation I twice following the laboratory work Cephalon’s experts, Drs. Smith and Seibo, prepared. The defendants assert, however, that Dr. Lee completed Preparation I beyond the plaintiffs’ truncated method, and obtained Form I armodafinil both times. (Id. at 10-12.) Specifically, the defendants contend that step (d) of Preparation I involves three parts: (1) dissolving the substance in methanol and treating with ammonia gas; (2) evaporating the methanol and washing with ether; and (3) recrystallizing from ethanol to obtain crystals. (Id. at 11 (citing JTX-103.3 col. 3,11. 43-57).) The defendants maintain that Drs. Smith and Seibo performed the first two parts of step (d), but failed to complete the ethanol recrystallization step on Cephalon’s instruction. (Id: (citing Tr. at 721:19-23 (Seibo)).) Dr. Lee, however, synthesized crystalline armodafinil twice using Drs. Smith and Selbo’s methods, including heating to 70-90 degrees Celsius in step (b) and then finished the Prepation by performing ethanol recrystallization as a person of ordinary skill in the art. (Id.- (citing Tr. at 277:3-8, 283:6-284:14, 286:1-287.3, 298:3-8(Lee); DTX-212).) Dr. Lee confirmed that his samples were armodafinil by sending-them to Dr. Robie, an expert in XRPD analysis, who searched two databases of known crystal materials for matches to the patterns of the samples and identified both as Form I. (Id. at 11-12.) This finding, the defendants argue, confirms,Dr. Hollingsworth’s conclusion that Form I armodafinil naturally and inevitably results from Preparation I. Finally, the defendants contend that their inherent anticipation position is supported by: (1) the Kofler hot bar analyses disclosed in the '855 Patent; (2) non-instantaneous melting point data listed at the end of Preparation I; and (3) three declarations submitted to the PTO during prosecution of the '570 Patent. (Id. at 12-16.) With regard to the first, the defendants maintain that Form I inevitably results from Preparation I when the melting point analysis disclosed in the '855 Patent, which would have been determined by using a Kofler hot bar, is performed. (Id. at 12-13 (citing Tr. at 142:16-20, 143:2-144:30 (Hollingsworth)).) The '855 Patent provided a 153-154 degrees Celsius instantaneous melting point range for the armodafinil produced by Preparation I. (Id. at 13 (citing JTX-103.3 col. 3, 1. 55).) According to Dr. Hollingsworth, if any form(s) of armodafinil resulted from Preparation I, it would necessarily convert to Form I during the instantaneous melting point measurement, such that the poly-morph would become Form I. (Id. (citing Tr. at 145:20-22 (Hollingsworth)).) The data Cephalon provided in the '570 Patent’s file history confirms this assertion, the defendants argue, because that information demonstrated that Forms II and IV converted to Form I at temperatures well within the Kofler hot bar’s operating range. (Id. (citing Tr. at 143:18-144:12 (Hollingsworth)).) Second, the defendants contend that the non-instantaneous melting point data confirms that Preparation I results in Form I armodafinil. Specifically, the defendants note that, during the prosecution of the '570 Patent, Cephalon provided the PTO with a comparison of the instantaneous melting point data at the end of Preparation I (153-154 degrees Celsius), to the instantaneous melting points observed with its own Form I armodafinil (156-164 degrees Celsius), to show that the product of Preparation I was not Form I armodafinil. (Id. at 14 (JTX-103.3 col. 3, 1. 55; JTX-38.28-.29, n. 7).) However, the defendants argue that Cephalon did not “disclose to the PTO that the Kofler hot bar used to measure the instantaneous melting point is an archaic ‘museum piece.’ ” (Id. (citing Tr. at 185:16-18 (Hollingsworth); Tr. at 337:18-21 (Lee)).) Dr. Hollingsworth observed the non-instantaneous melting points after the ethanol recrystallization steps from his first reproduction of Preparation I ranged from 150.4-153.8 degrees Celsius, which is in the same range as the non-instantaneous melting points of Cephalon’s data for Form I armodafinil. (Id. (citing Tr. at 139:15-24 (Hollingsworth); Tr. at 782:5-7, 782:14-783:12 (Myerson); JTX-40.63, .65; JTX-38.29 at n. 7; JTX-40.19, .63, .65, .67; JTX-41.69).) Dr. Lee found similar results. (Id. (citing Tr. at 304:17-21(Lee)).) Moreover, the defendants detail that the plaintiffs’ experts did not use the Kofler hot bar to analyze armodafinil’s melting point, and instead used more accurate equipment to test their samples. (Id. (citing Tr. at 185:16-18, 192:12-18 (Hollingsworth); Tr. at 303:16-18(Lee); JTX-48.20; Tr. at 777:18-23 (Myerson)).) Therefore, the defendants assert that, according to the most reliable melting point data available, the crystals that result from following Preparation I are Form I armodafinil and the PTO did not have this information available when considering the '570 Patent’s claims. (Id. at 14-15.) Finally, the defendants allege that the three declarations submitted to the PTO during the '570 Patent prosecution by Drs. Blomsma, Peterson, and Mallamo support the conclusion that Form I armodafinil naturally and inevitably results from Preparation I. In particular, the defendants note that of the thirty-four experiments described in these.declarations that resulted in crystals, thirty, or .nearly ninety-percent, unambiguously resulted in Form I armodafinil. (Id. at 15 (citing Tr. at 130:19-22 (Hollingsworth)).) While, as the defendants acknowledge, the experiments contained in these declarations were not faithful reproductions of Preparation I and, therefore, are not directly probative of the anticipation question, they do demonstrate that “even under conditions that in some instances differed markedly from Preparation I, Form I armodafinil resulted almost all of the time.” (Id. (citing Tr. at 131:2-7 (Hollingsworth); JTX-38.1-.45).) Moreover, the four experiments that did not result in Form I were sufficiently dissimilar from Preparation I and, therefore, “provide no useful evidence regarding what crystal form is made by following Preparation I.” (Id.) The defendants detail that Drs. Peterson and Mallamo’s declarations referenced experiments similarly demonstrating the ease with which Form I armodafinil is made and that those experiments that did not result in Form I were outside the scope of Preparation I, such that these declarations reinforce Dr. Hollingsworth’s conclusion. Conversely,- the plaintiffs argue that, in view of the relevant law and consistent with the evidence presented in Cephalon’s PTO declarations, testing did not show that Preparation I in the '855 Patent necessarily and inevitably'produces a pharmaceutical composition consisting of “the specified pharmaceutically active component” — Form I armodafinil — and other pharmaceutically acceptable ingredients, as required by the asserted claims. (D.I. 314 at 8.) Rather, the plaintiffs maintain that the defendants’ testing “showed that mixtures of polymorphic forms and' various uncharacterized impurities result” from- reproducing Preparation I and, further, that the defendants’ experiments were flawed and insufficient because they departed from the express method taught in the '855 Patent and are not representative of its full scope. Therefore, the plaintiffs argue, the defendants have not proven inherent anticipation by clear and convincing evidence. In consideration of the record and the relevant law, the court concludes that the defendants have not met their burden of demonstrating that Preparation I of the '855 Patent necessarily and inevitably results in Form I armodafinil or a composition consisting essentially thereof and, therefore, have not proved invalidity by inherent anticipation. The court reaches this conclusion for three reasons. First, the court finds that the defendants have not demonstrated clearly and convincingly through their experts’ experiments and testing that the performance of Preparation I necessarily and inevitably results in Form I armodafinil. Second, the court concludes that the defendants have failed to show by clear and convincing evidence that the result of performing Preparation I meets the requirements of the asserted claims of the patent-in-suit. Third, the court concludes that the defendants have not demonstrated clearly and convincingly that their reproductions of the '855 Patent’s Preparation I were consistent with how a person of ordinary, skill in the art would have performed the Preparation and, therefore, have not proven that their experts’ experiments accurately demonstrate that Form I armodafinil inevitably results from Preparation I. a. Whether Preparation I of the '855 Patent Inherently Produces Form I Armodafinil or a Composition Consisting Essentially Thereof The evidence presented at trial demonstrates that the Preparation of Form I and a “recrystallization from ethanol” can yield different forms, mixtures of forms, and unknown impurities, depending on the variables selected in conducting the Preparation. In fact, and as the court details below, the defendants’ experimental evidence yielded mixtures of forms that contained impurities. Based on the evidence before it, the court concludes that the defendants’ evidence fails to clearly and convincingly demonstrate that Form I armodafinil claimed in the '570 Patent necessarily results from Preparation I. As detailed above, Dr. Hollingsworth carried out two experiments, Run 1/2 and Run 3/4, to perform Preparation I and conducted XRPD testing on the armodafinil he produced. (Id. (citing Tr. at 91:2-4, 106:3-7 (Hollingsworth)).) Dr. Hollingsworth testified that Run 1/2 generated pure Form I armodafinil. (Id. (citing Tr. at 106:8-19 (Hollingsworth); Tr. at 748:25-749:19 (Myerson); PDX-5-14).) Dr. Hollingsworth’s second experiment, Run 3/4, was conducted after the first recrystallization from ethanol and produced Form I accompanied by some other unknown crystalline impurities and, after a second recrystallization from ethanol, produced a mixture of Form I and Form II. (Id. at 9-10 (citing Tr. at 195:16-200:7 (CDX-1 to 4), 249:23-251:13 (CDX-5, CDX-6) (Hollingsworth); Tr. at 748:25-749:19 (PDX-5-14)).) In addition, Dr. Hollingsworth testified that he performed XRPD testing on samples that were produced at two intermediate points along step (d) — after the methanol evaporation and after the ether wash— and concluded that both samples contained Form I. (Id. at 10 (citing Tr. at 114:23-117:17 (Hollingsworth)).) However, in his second Run 3/4 recrystallization, Dr. Hollingsworth used a slightly higher solute concentration of about 13.8% and obtained a mixture that was mostly Form II armodafinil, instead of Form I, which he obtained in other experiments using a 9.6% solution. (Id. (citing Tr. at 195:16-200:4, 208:4-7, 210:5-12 (Hollingsworth); Tr. at 748:25-749:19 (Myerson)).) Drs. Myerson and Bernstein credibly testified that Dr. Hollingsworth’s formation of Form II and unknown crystals confirms that small variations in procedure can yield very different polymorphic results. (Id. (citing Tr. at 730:17-731:4 (Myerson); Tr. at 535:17-537:2 (Bernstein)).) Dr. Hollingsworth also acknowledged that his mixture of Forms I and II is not a composition containing only one pharmaceutically active form of armodafinil, as is required by the asserted claims of the '570 Patent. (Id. (Tr. at 253:15-254:12 (Hollingsworth)).) Cephalon’s experts, Drs. Smith and Seibo, performed a synthesis of armodafinil up to the same points as Dr. Hollingsworth in step (d), using different, but reasonable experimental conditions that the court finds credible, and found their products to be amorphous, non-crystalline forms. (Id.) Therefore, while Dr. Hollingsworth found that the methanol evaporation and ether wash steps produced Form I, Drs. Smith and Seibo concluded that these steps do not necessarily and inevitably produce Form I. (Id. (citing Tr. at 716:14-19 (Seibo)).) Moreover, while the defendants’ expert, Dr. Lee, attempted to repro-. duce Drs. Smith and Selbo’s work and completed Preparation I through the final recrystallization step — at which point he found Form I with unknown impurities— Dr. Robie did not analyze Dr. Lee’s intermediate products after the methanol evaporation and ether wash. (Id. (citing Tr. at 277:3-8, 309:18-25, 317:8-25; 361:10-13, 361:23-362:12(Lee)).) Dr. Lee also stated on cross-examination that he did not follow Drs. Smith and Selbo’s procedures exactly, but instead made some “variations in heating rate, colling time[,] and the use of filter paper. (Id. (citing Tr. at 292:6-11(Lee)).) In view of the foregoing, the court concludes that the defendants have not demonstrated that the Form I armodafinil claimed in the '570 Patent inevitably results from performing Preparation I because it is clear from the evidence presented that variations in the Preparation I process — variations not detailed in that Preparation — lend to different outputs, some of which are inconsistent with the asserted claims. See Glaxo Inc. v. Novophann Ltd., 52 F.3d at 1047-48 (finding no inherent anticipation where the testing evidence demonstrated that the prior art in question could yield crystals of the claimed polymorph or a different poly-morph). The court finds that this conclusion is further reinforced by the declarations Drs. Mallamo, Peterson, and Blomsma submitted to the PTO in connection with the '570 Patent. Specifically, Dr. Mallamo’s declaration detailed various experiments demonstrating that, depending on the conditions used, a “recrystallization in ethanol” does not necessarily' produce Form I armodafinil. (Id. at 10 (citing Tr. at 633:9-14, 644:16-645:10, 655:4-9, 657:11-16, 660:21-661:22 (Mallamo); JTX-120-5 at ¶ 18).) In addition, other testing described in the declarations reported that the instantaneous melting point of the product in the '855 Patent was inconsistent with Form I armodafinil, which would indicate that, they result in different products. (Id. at 10-11 (citing JTX-120-6 at ¶20; see also Tr. at 738:18-739:16 (Myerson)).) In view of the foregoing, the court disagrees with the defendants’ assertion that, as Dr. Hollingsworth opined, the declarations are invalid and support a finding of anticipation. Rather, the court finds that Dr. Hollingsworth’s testimony regarding the Mallamo declaration are predicated on an overly narrow interpretation of “ethanol.” In addition, the court finds Dr. Hollingsworth’s argument that Drs. Peterson and Blomsma’s declarations are invalid to be unpersuasive. Specifically, these declarations detail that a wide variety of conditions for recrystallization from ethanol can result in multiple polymorphic forms, which, the court concludes, supports the plaintiffs’ assertion that there is lack of predictability for Form I over the '855 Patent. (Id. at n. 10 (citing JTX-120-5 at ¶¶ 16-18).) b. Whether the Product of Preparation I of the '855 Patent Meets the Requirements of the Asserted Claims of the '570 Patent Claims 6 and 9 must be considered with the limitations of the claims from which they depend' — Claims 1^4 and 7. The defendants claim that, rewritten to include these limitations, the asserted claims are: 6. A pharmaceutical composition consisting essentially of a laevorotatory en- , antiomer of modafinil in a polymorphic form that produces a powder X-ray diffraction spectrum comprising intensity-peaks at the interplanar spacings: 8.54, 4.27, 3.98, 13.40, 6.34, 5.01, 4.68, 4.62, 4.44, 4.20, 4.15, 3.90, 3.80, 3.43(1). 9. A pharmaceutical composition consisting essentially of a Form I poly-morph of (-)-modafinil. (D.I. 319 at 29.) Dr. Hollingsworth explained that, while the language of the claims appear to be different, they cover “essentially the same thing.” (Id.) Specifically, the XRPD data incorporated in Claim 6 is that of Form I armodafinil, which is expressly recited in Claim 9. (Id. (citing Tr. at 78:23-79:8, 79:19-24 (Hollingsworth); Tr. at 388:14-25 (Cima)).) According to the defendants, the elements of Claims 6 and 9 combine to require: (1) a pharmaceutical composition; (2) consisting essentially of; and (3) Form I armodafinil. The defendants also assert that Claims 6 and 9 allow for the presence of more than one pharmaceutically active component. (Id. at 29.) Specifically, the defendants maintain that the language “unlisted pharmaceutically acceptable ingredients” encompasses other ingredients, including other active components of armodafinil, so long as they “do not materially affect the basic and novel properties” of Form I. (Id. (citing Tr. at 155:7-12 (Hollingsworth)).) The defendants further, support this claim by noting that the '570 Patent states that the invention “relates to the use of’ armodafinil Forms II-IV “for the manufacture of a medication” and that “pharmaceutical compositions according to this invention may also contain another crystalline form of (-)-modafinil ... in particular [F]orm I and/or another active ingredient ... as a mixture with one or more other polymorphic forms of modafinil” such as Forms II through V. (Id. (citing JTX-1.24-.25 col. 12, 11. 64-col. 13, 11. 2, col. 13, II. 9-32).) Thus, the defendants argue, the '570 patent teaches that “unlisted pharmaceutically acceptable ingredients” encompasses a mixture of Form I with armodafinil’s other polymorphic forms. (Id. at 31-32 (citing Tr. at 151:3-9, 154:3-11, 155:7-12 (Hollingsworth)).) Conversely, the plaintiffs maintain that asserted Claims 6 arid 9, taken together, specify pharmaceutical compositions with an active component “consisting essentially of’ Form I armodafinil, riieaning that Form I must be the only pharmaceutically active crystal form of armodafinil present in the compositions, and that any additional ingredients be pharmaceutically acceptable. (D.I. 314- at 7 (citing Tr. at 256:5-14 (Hollingsworth); Tr. ‘ at 756:6-16 (Myerson)).) The plaintiffs also state that unasserted Claims 5 and 8 of the '570 Patent recite a composition “comprising” Form I armodafinil, which would allow for other active ingredients and forms of armodafinil. (Id. (citing JTX-1-38 at 40:33-35 & 40:38-39; see D.I. 172).) Finally, tl>e plaintiffs assert that, as it is “specified” in Claims 4 and 7, Claims 6 and 9 require that Form I armodafinil be “ ‘the,’ as in only, pharmaceutically active component present in the claimed compositions.” (Id. at 11 (citing Tr. at 255:11-19, 256:Í2-14 (Hollingsworth)).) Thus, because Form II is pharmaceutically active, its presence is excluded from Claims 6 and 9. (Id. (citing JTX-1-24; JTX-12-10).) With respect to both parties’ arguments, the court first notes that, contrary to each sides’ references to the “court’s construction” of the terms in question, it did not construe the terms “pharmaceutical composition comprising” or “pharmaceutical composition consisting essentially . of.” Rather, the parties informed the court via letter on July 13, 2011 that the parties had conferred and agreed on the meaning of these two disputed terms. (D.I. 143.) Therefore, the parties’ arguments — and particularly those of the defendants, who repeatedly reference' how the court construed “pharmaceutical composition consisting essentially of’ to allow for more than one pharmaceutically active form of armodafinil — strike the court as misleading. Because the parties reached agreement on the meaning of these terms before the Markman hearing, the court did not construe these terms and made note of this point in its July 25, 2011 Order construing the disputed terms of the '570 Patent. (D.I. 172 at 3.) The court also did not have the benefit of reviewing the record or the parties’ arguments in connection with these terms and the parties do not meaningfully present such support for their opposing positions in their Proposed Findings of Fact and Conclusions of Law. In consideration of the record before it, the court agrees with the plaintiffs that the term “pharmaceutical composition consisting essentially of,” requires, as specified in Claims 4 and 7, that Form I armodafinil be the only pharmaceutically active component present in the claimed composition. In reaching this conclusion, the court considers, as the plaintiffs suggest, that the definition of this term states “composition consisting of the specified pharmaceutically active component.” The court finds that the use of “the” in the parties’ construction indicates “only.” As noted above, unasserted Claims 5 and 8 of the '570 Patent recite a composition “comprising” Form I armodafinil, which, as compared to Claims 6 and 9, would allow for other active ingredients and forms of armodafinil. (D.I. 314 at 7 (citing JTX-1-38 at 40:33-35 & 40:38-39).) Notably, even the defendants’ expert, Dr. Hollingsworth, agreed that the term “pharmaceutical composition consisting essentially of’ refers to the “specified pharmaceutically active component,” which is Form I. The court concludes that the defendants’ experiments have failed to show that a composition “consisting essentially of’ Form I armodafinil is the necessary and inevitable result of Preparation I. Specifically, Dr. Hollingsworth’s Run 3/4 experiment showed either mixtures of Form I with other unknown crystalline material or, when using a higher concentration of solute, mostly Form II armodafinil. Thus, the defendants’ testing demonstrates that a reasonable “recrystallization from ethanol” does not inevitably and necessarily produce a product within the scope of the asserted claims. In addition to the foregoing arguments, the plaintiffs note that Claims 6 and 9 recite a “pharmaceutical composition.” (Id. at 12.) In light of this requirement, the plaintiffs assert that the defendants have failed to prove invalidity because they have not demonstrated that the product of Preparation I is suitable for pharmaceutical use. (Id. (citing Tr. at 541:5-542:8 (Bernstein); Tr. at 756:11-16 (Myerson); PTX-36-2 at ¶ 6).) The plaintiffs note that even the defendants’ expert, Dr. Cima, acknowledged that one would need to prove that the amount and type of any impurities in an armodafinil product intended for human use are safe. (Id. (citing Tr. at 457:15-18, 459:1-11 (Cima)).) Because the defendants “made no effort to determine the type or quantity of impurities in the samples from their experiments, or determine if they were pharmaceutically acceptable, the plaintiffs assert that the defendants have not proven by clear and convincing evidence that the result of Preparation I meets the “pharmaceutical composition” requirement of Claim 6. (Id.) In response, the defendants maintain that the plaintiffs’ argument is unfounded and “misses the point.” (D.I. 319 at 32.) Specifically, the defendants state that their experts made armodafinil according to the Preparation I and determined that it was Form I. (Id.) Therefore, according to the defendants, whether the particular crystals Drs. Hollingsworth and Lee made via Preparation I could be directly formulated into a pharmaceutical composition is irrelevant to the anticipation analysis because the '855 Patent expressly discloses that armodafinil produced by Preparation I was used in the tablets or capsules in human clinical trials and that it has therapeutic efficacy. (Id. at 5-6; at 33 (citing Tr. at 298:20-23(Lee)).) Therefore, the defendants maintain that because Form I armodafinil can be obtained with the purity level necessary for human consumption by performing Preparation I, the impurities contained in Drs. Hollingsworth and Lee’s experiment results do not need to be identified, as performance of Preparation I will result in a product that is a pharmaceutical composition. (Id. at 33 (citing Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268 (Fed.Cir.1991) (recognizing that a single reference may anticipate where the “common knowledge of technologists is not recorded in the reference”)).) Moreover, the defendants note that the “therapeutic” and “pharmaceutical” compositions claimed in the '855 Patent are presumed enabled. (Id. (citing 35 U.S.C. § 282).) The '855 Patent, according to the defendants, “does not describe any purification of armodafinil beyond step (d) of Preparation I” and, therefore, “Form I armodafinil made according to Preparation I is either pharmaceutically acceptable asís, or techniques to further purify the product of Preparation I were so well-known and routine that they need not be expressly described.” (Id. at 27 (citing Tr. at 383:16-21, 430:16-432:16, 458:7-20 (Cima)).) Specifically, and in support of the latter, the defendants note that the '855 Patent does not contain explicit instructions regarding purification or formulation techniques — yet still enables claims to pharmaceutical compositions “consisting essentially of’ armodafinil — demonstrates the routine nature of the purification process. (Id. (citing Tr. at 150:22-151:21 (Hollingsworth); JTX-103.5 col. 7, 11. 18-col. 8,11. 29, claims 1-6).) Thus, the defendants argue that the plaintiffs are incorrect in asserting that the '855 Patent does not anticipate the '570 Patent because the defendants did not prove that Preparation I is suitable for use in a pharmaceutical composition. (Id. at 33.) The court disagrees, and concludes that the defendants have not proven anticipation by clear and convincing evidence. As noted, the defendants contend that the claimed pharmaceutical compositions can contain additional components, such as impurities, that do not affect the basic and novel properties of Form I and that different solid state forms of armodafinil and chemical impurities would not affect those properties. (D.I. 314 at 12 (citing Tr. at 154:3-155:12 (Hollingsworth)).) However, Drs. Bernstein and Myerson’s testified credibly that different solid state forms and/or impurities can, in fact, affect the properties of Form I and the ultimate result of Preparation I. See Tr. at 539:22-540:19 (Bernstein). The defendants’ expert, Dr. Cima, agreed with Dr. Bernstein that the product of Preparation I will contain impurities, such as unreacted starting materials, reaction byproducts, or unreacted chemicals. (D.I. 314 at 12 (citing Tr. at 457:19-458:2 (Cima); Tr. at 540:20-541:1 (Bernstein)).) Here, as the plaintiffs note, Dr. Hollingsworth’s XRPD analysis from.Run 3/4 after the first ethanol recrystallization— the number of ethanol recrystallization required by the '855 Patent — showed the presence of three peaks that could not be attributed to the Form I fingerprint. (Id. (citing Tr. at 249:23-251:13 (Hollingsworth); PTX-411).) Dr. Hollingsworth testified that he believed those peaks to represent a chemical impurity, but that he did not know the amount or identity of the impurity. (Id. at 12-13 (citing Tr. at 251:9-24 (Hollingsworth); Tr. at 746:7-12 (Myerson)).) In addition, Dr. Lee did not test his experimental products, Samples 10 and 12S, for impurities and, instead, sent them to Dr. Robie for XRPD testing. This testing indicated that, for Samples 10 and 12S, there were five and nine XRPD peaks, respectively, and that the impurities did not match to Form I armodafinil’s fingerprint. (Id. at 13 (citing Tr. at 364:19-365:23 (Robie)).) Drs. Lee and Robie did not seek to identify these impurities, however, and did not test to determine the quantity of the impurities in the Preparation I product. (Id. (citing Tr. at 365:24-366:10, 366:15-18 (Robie)).) Dr. Robie did not know whether or how these impurities would impact the mixture, as he is not an expert in polymorph identification, and did not opine on whether the product was a pharmaceutical composition. (Id. (citing Tr. at 366:19-22, 366:23-367:5, 367:9-11 (Robie)).) In consideration of Dr. Bernstein and Dr. Myerson’s convincing and credible testimony — particularly their testimony related to the impact of impurities — the court finds, with respect to Drs. Hollingsworth and Lee’s experiments, that the defendants have not demonstrated clearly and convincingly that the product of Form I will inevitably and necessarily produce a “pharmaceutical composition” as required by the asserted claims, c. Whether the Defendants Demonstrated That Their Experiments Were Accurate and Obtained the Same Product Described in Preparation I of the '855 Patent As discussed above, the court finds that the evidence presented establishes that Preparation I and a recrystallization from ethanol can yield different forms, mixtures of forms, and unknown impurities, depending on how one performing the Preparation selects numerous variables not specified in the '855 Patent. The plaintiffs’ and defendants’ witnesses agreed that the '855 Patent does not mention or describe polymorphism, or any polymorphic form of armodafinil. (Id. at 8-9 (citing Tr. at 157:5-7, 234:9-17 (Hollingsworth); Tr. at 307:8-ll(Lee); Tr. at 537:3-6, 630:8-12 (Bernstein); Tr. at 648:6-8, 653:18-654:4 (Mallamo)).) Moreover, Preparation I does not disclose the crystallization conditions needed to make any particular polymorph, such as the solvent, the cooling rate, and the concentration — all factors which, according to Drs. Bernstein and Myerson’s credible testimony — can affect the result. (Id. at 9 (citing Tr. at 564:19-566:19 (Bernstein); Tr. at 745:3-7, 750:10-12, 764:2-7 (Myerson); Tr. at 157:14-158:11 (Hollingsworth); JTX-7-3 Tbl. 1).) Dr. Myerson also agreed with Dr. Bernstein that Preparation I of the '855 Patent did not specify such details as “reaction time, filtration temperature, the washing conditions, [or the] dry conditions,” all of which will impact the “impurity profile” of the resulting product. See Tr. at 731:5-734:25 (Myerson). Likewise, the defendants’ expert, Dr. Hollingsworth, agreed on cross-examination that “impurities in [a] system” “can matter.” (Id. at 12 (citing Tr. at 163:22-25 (Hollingsworth)).) In view of the foregoing, and for the reasons detailed below, the court concludes that the defendants have failed to prove anticipation by clear and convincing evidence because they have not established that their Preparation I experiments were accurate and produced the material intended by the '855 Patent’s Preparation. Therefore, the defendants have not shown that the Form I armodafinil claimed in the asserted claims of the '570 Patent is, in fact, the necessary and inevitable result of performing Preparation I. i. The Defendants’ Experts’ Performance of Preparation I The plaintiffs contend that the defendants’ inherent anticipation defense fails because their experts failed to follow Preparation I as written or consider the range of variables that would have been reasonably available to skilled artisans. In particular, the plaintiffs assert that defects in following Preparation I and/or selecting the method for performing Preparation I, render the results insufficient in establishing the necessary and inevitable result of that Preparation. First, the plaintiffs note that the defendants did not correctly follow step (b) of the '855 Patent which states that “the (-)- bezhydrylsulfinylacetate of (-)-a-methylbenzylamine (17 g) obtained in this way is dissolved in 800 ml of warm water (3(M0 degrees Celsius).” See JTX-103-3 at 3:22-24. The '855 Patent also states elsewhere that this step should be performed at 30-45 degrees Celsius. See id. at 2:31-32. However, Drs. Hollingsworth and Lee testified that they did not perform Preparation I as written and, instead, used higher temperatures of 70 and 90 degrees Celsius. See Tr. at 234:18-235:10 (Hollingsworth); Tr. at 312:24-313:6(Lee). Dr. Hollingsworth testified that, in his opinion, dissolution at the stated 30 to 40 degrees Celsius may be impossible, but that he had not fully tested his theory and the experiment forming the foundation for Preparation I could have used 30 to 40 degrees Celsius. See id. at 238:8-22, 236:1-9 (Hollingsworth). The plaintiffs contend that the defendants’ experts’ decision to use a different temperature is significant because, even using a melting point test method different from what is specified in the '855 Patent, Dr. Hollingsworth and the other experts obtained a product that had a “very wide range” of melting points inconsistent with the narrow melting point reported in the '855 Patent. (D.I. 314 at 18 (citing Tr. at 237:18-238:7 (Hollingsworth); Tr. at 780:7-19 (Myerson)).) Therefore, because they did not follow the stated procedure in step (b) and did not obtain the reported melting point, the defendants’ experiments, the plaintiffs argue, cannot be considered probative of whether Preparation I would inherently or naturally result in Form I armodafinil by the required clear and convincing standard. In view of the foregoing credible arguments, the court agrees. See Valeant Int’l (Barbados) SRL v. Watson Pharm., Inc., No. 10-20526-CIV, 2011 WL 6792653, at *5 (S.D.Fla. Nov. 8, 2011) (“Thus, because Dr. Adlington did not follow the explicit disclosure of Example I of the Mehta patent, his experiment is simply not probative of the issue of inherent anticipation”). Second, the plaintiffs assert that the defendants did not test a representative range of conditions in conducting their Preparation I experiments. ' Specifically, Preparation I has four major synthetic steps, but allows skilled artisans the selection of conditions used to carry out the many steps listed. See JTX-103-3 at 3:5-56. However, instead of testing a variety of conditions, the defendants’ experts chose to use a “narrow set of experimental conditions,” which, the plaintiffs allege, is legally insufficient to demonstrate inherency. (D.I. 314 at 19.) The court agrees and concludes that the defendants have not demonstrated that all reasonable ways to practice Preparation I would necessarily result in Form I armodafinil consistent with the limitations of the asserted claims. For instance, in step (a), the reaction time, reaction temperature, and recrystallization conditions are not specified; in step (b), the reaction time, filtration temperature, washing conditions, and drying conditions are not specified; and in ,step (c), the filtration conditions, washing conditions, and drying conditions are not specified. See Tr. at 307:25-308:4(Lee); Tr. at 731:5-732:6 (Myerson). Further, step (d) leaves entirely open the specific experimental conditions for “recrystallize[ation] from ethanol,” and does not specify the form of the crude product to be recrystallized, the identity, and quantity of the impurities in the crude product, the grade of ethanol, the amount of solvent, the starting temperature, the cooling rate, the final temperature, or the drying conditions. See Tr. at 566:20-567:9 (Bernstein); Tr. at 654:5-11 (Mallamo); Tr. at 308:5-19 (Lee); Tr. at 839:15-840:21 (Coquerel); JTX-120-3 at ¶ 9. ■ Thus, one reproducing Preparation I would need to make several decisions, unsupported by the '855 Patent, and, as the testimony at trial demonstrated, there are a variety of reasonable conditions that can be used for crystallization and the specific conditions of crystallization selected can affect the solid state ultimately formed. See Tr. at 542:17-543:2, 564:19-21 (Bernstein); . PTX-585-49; JTX-120-5 at ¶¶ 17, 18. Indeed, the plaintiffs’ and defendants’ experts agreed that, depending on the choices made, the resulting product will contain different kinds and/or amounts of impurities, which can affect whether and which final solid state form — crystals, solvates, or amorphous compound — will result. See Tr. at 157:14-158:11, 163:22-25 (Hollingsworth); Tr. at 732:7-23 (Myerson); 533:22-535:16 (Bernstein). Specifically, the plaintiffs contend that solvent composition, concentration, and cooling rate can impact the final solid state form. For the reasons detailed in the discussion below, the court agrees. With regard to the defendants’ experts’ selection of the concentration of armodafinil used in the recrystallization step, the plaintiffs persuasively argue that their selection was inconsistent with the prior art and affected the product they obtained. The defendants used only one concentration in all but one of their recrystallizations — a recrystallization that yielded a different result — such that their testing does not necessarily contemplate the full scope of Preparation I. As the testimony-presented made clear, standard textbooks indicate that the “MINIMUM AMOUNT©” of solvent,