Full opinion text
Opinion & Order BARBARA S. JONES, District Judge. TABLE OF CONTENTS INTRODUCTION. CO CO o I. The Parties. CO CO o II. The Patents-In-Suit. 03 05 CO A. Patent Ownership. CO CO III. The Pleadings. CO CO A. Complaint Against Mylan/Esteve. CO 05 CO B. Complaints Against Lek. CO CO C. Complaint Against Apotex. 00 05 CO D. Complaints Against Impax. CO CO 00 DISCUSSION. CO CO CO I. Daubert Motions. 05 05 CO A. Choice of Law. CO CO CO B. Legal Requirements Under Daubert and Rule 702. o o C. Expert Qualifications . 1. Plaintiffs’ Expert Witnesses . o o to to D. Daubert Analysis Applies to Weight and Credibility. II. Infringement . A. General Principles. CO B. Infringement Analysis. tH '■ñP 1. Claim Construction.. to t — 1 ^ a. Statement of the Law. 10 r-H b. Construed Claims of the '505 and '230 Patents . oo rH ^ 2. Applying The Claims To The Allegedly Infringing Product. 03 CQ '■ñP a. Literal Infringement. 03 Cv! b. Infringement Under The Doctrine Of Equivalents. co 03 ^ C. Mylan/Esteve’s Product. to ^ 1. Mylan/Esteve’s Formulation and Manufacturing Process . to C7i a. Bulk Omeprazole From Esteve. to -q 2. Claim 1(a): An Effective Amount of an Alkaline Reacting Compound (ARC) . .fv to *vl a. Presence of an ARC . .IV to *<1 i. Tale. .IV to CO ii. HPMC. .IV CO i — iii. TEA. IIV CO CO iv. Combination of Carbonates/Bicarbonates in Talc and HPMC and TEA in Omeprazole. tO CO TP b. Effective Amount of an ARC in Mylan/Esteve’s Final Product LO CO i. Carbonates in Talc and HPMC. CO CO ^ ii. TEA in Omeprazole. 05 CO c. Micro-pH of the Omeprazole in Mylan/Esteve’s Product. O ^ d. Doctrine of Equivalents .442 e. Alkaline Omeprazole Salt Equivalent.443 Claim 1(b): An Inert Subcoating That is Soluble or Rapidly Disintegrating in Water.443 a. Presence of A Subcoating.443 b. Inert.444 c. Water Soluble or Rapidly Disintegrating in Water.444 Claim 1(c): Enteric Coating and Enhanced Stability.447 Conclusion.447 D. Lek s Product.448 1. Lek’s Formulation and Manufacturing Process.448 a. Bulk Omeprazole Used in Lek’s Product.449 b. Lek’s Product Manufacturing Process.449 2. Claim 1(a) of the '505 Patent: An Effective Amount of an Alkaline Reacting Compound (ARC).450 a. Micro-pH of the Omeprazole in Lek’s Product.450 i. Microenvironment of Lek’s Omeprazole.451 ii. pH of the Omeprazole Used in Lek’s Formulation .453 b. Presence of an ARC .455 i. Presence of MA in Lek’s Bulk Omeprazole.456 ii. Presence of TEA and MA in Lek’s Final Formulation.457 (a) Mass Spectrometry Testing of Lek’s Final Product.457 c. Effective Amount of TEA and MA.462 d. Doctrine of Equivalents .464 e. Alkaline Omeprazole Salt Equivalent.464 3. Claim 1(b): An Inert Subcoating That is Soluble or Rapidly Disintegrating in Water.465 4. Claim 1(c): Enteric Coating and Enhanced Stability.470 5. Conclusion.471 E. Apotex s Product.. ~q h* 1. Apotex’s Formulation and Manufacturing Process . -q i-* 2. Claim 1(a): An Effective Amount of an Alkaline Reacting Compound (ARC) . -q to 3. Claim 1(b): An Inert Subcoating That is Soluble or Rapidly Disintegrating in Water. a. Presence of A Continuous b. " c.Water Soluble or Rapidly Disintegrating in Water Claim 1(c): Enteric Coating and Enhanced Stability. Claim 5 of the '505 Patent and Claim 6 of the '230 Patent.. lO Claim 6 of the '505 Patent and Claim 7 of the '230 Patent.. CO Claim 10 of the '505 Patent and Claim 13 of the '230 Patent l> Conclusion. OO F. Impax’s Product.. co ^ 1. Impax’s Objections to Plaintiffs’ Exhibits. t- 2. Impax’s Formulation and Manufacturing Process. t> ^ 3. Claim 1 of the '505 and '230 Patents. co TP a. Claim 1(a): An Effective Amount of an Alkaline Reacting Compound (ARC). OO OO b. Claim 1(b): An Inert Subcoating That is Soluble or Rapidly Disintegrating in Water. OO co i. Presence of A Continuous Subcoating. ^ CO o ii. Inert.■. ÍO co iii. Water Soluble or Rapidly Disintegrating in Water ^ CO Co iv. Representativeness. ^ CO ^ c. Claim 1(c): Enteric Coating and Enhanced Stability. .. ^ iO -q £ > £ A. Presumption of Validity .499 B. 35 U.S.C. § 112. m o o 1. The Written Description and Enablement Requirements or o o 2. Best Mode. or o j_i C. Public Use. LO o LO 1. Ready for Patenting. 1C o LO 2. In Public Use. o LO a. Public Accessibility. Co LO b. Commercial Exploitation. Oi o LO D. Anticipation Under 35 U.S.C. § 102(b). o t — 1 lO 1. Applicable Law . o T — 1 kO 2. The Construed Claims as Compared to the Allegedly Anticipating Prior Art. a. The '495 Patent. H 1 — ! T — 1 IDU5 b. The '226 Patent. 03 T — 1 10 e.The '219 Patent. CO T — 1 10 d. The '815 Application. ^ 1 — 1 10 e. The '980 Patent. Th T — 1 10 E. Obviousness Under 35 U.S.C. § 103. t — 1 1. Applicable Law . t — I 2. The Level of Ordinary Skill in the Art. t — 1 3. Asserted Prior Art . t-H a. Plaintiffs’ Objections to Certain Prior Art References . t — H i. The Tsuda Writing. t — 1 ii. The Up-to-Date Writing. tH iii. The Pharmacoat 1969 Writing. t-H iv. The TC-5 Writing. t — 1 v. The H-22 and H-17 Writings. CvJ vi. The Eastman Brochures. 03 b. The Remaining Asserted Prior Art References. 03 4. Comparison of the Prior Art and the '505 and '230 Patents . 03 a. The '495 Patent and Pilbrant & Cederberg..... 03 b. Tsuda, Up-to-Date, and Other Subeoating References. 03 e. The '226 Patent. 03 d. The 03 e. The '980 Patent. 03 f. The “Cornucopia of Prior Art” and Other Prior Art References CO g. The Multiple Paths Facing a Person of Ordinary Skill in the t-¡ CC h. Market Pressures .534 i. Dependent and Process Claims.535 5. Secondary Considerations of Non-Obviousness.535 F. Conclusion.535 CONCLUSION 535 Claim 5 of the '505 Patent and Claim 6 of the '230 Patent.498 'Ü Claim 6 of the '505 Patent and Claim 7 of the '230 Patent.498 Claim 8 of the '505 Patent and Claim 10 of the '230 Patent.498 Claim 10 of the '505 Patent and Claim 13 of the '230 Patent.499 Conclusion.•.499 ¿3 INTRODUCTION These patent eases relate to the drug Prilosec®, one of the most widely prescribed medicines in history. Plaintiffs AstraZeneca AB, Aktiebolaget Hassle, KBI-E, Inc., KBI Inc., and AstraZeneca, LP (collectively “Plaintiffs”) assert certain claims of two patents which cover the Pri-losec® formulation, U.S. Patent Numbers 4,786,505 and 4,853,230 (the “'505 Patent” and the “'230 Patent”), as being infringed by the following defendant pharmaceutical corporations: Mylan Laboratories Inc. and Mylan Pharmaceuticals Inc. (together “Mylan”), Esteve Quimica, S.A. and Labo-ratorios Dr. Esteve, S.A. (together “Es-teve”), Apotex Corp., Apotex Inc., and Torpharm Inc. (together “Apotex”), Lek Pharmaceutical and Chemical Company D.D. and Lek USA, Inc. (together “Lek”), and Impax Laboratories, Inc. (“Impax”) (collectively “Second Wave Defendants”). Pursuant to 28 U.S.C. § 1407 (2000), the Judicial Panel on Multidistrict Litigation consolidated the patent infringement suits for pre-trial purposes before this court. The actions against Apotex and Impax were remanded to their original courts upon completion of pre-trial matters, and were subsequently transferred back to this Court for a consolidated trial with the other Second Wave Defendants. The case was tried to the Court sitting without a jury for 42 trial days, starting April 3, 2006 and ending June 14, 2006. The court has considered weeks of trial testimony, volumes of depositions, thousands of exhibits, pre-trial briefings, and post-trial findings of fact and conclusions of law submitted by all parties. The Court has made determinations as to the relevance and materiality of the evidence and assessed the credibility of each witness. Upon the record before the Court, pursuant to Federal Rule of Civil Procedure 52(a), the Court finds the following facts to have been proven and sets forth its conclusions of law. For the reasons stated below, the Court finds the following: Defendants Mylan and Esteve do not infringe the asserted claims of the '505 and '230 Patents. Defendant Lek does not infringe the asserted claims of the '505 and '230 Patents. Defendant Apotex literally infringes claims 1, 5, 6, and 10 of the '505 Patent, and claims 1, 6, 7, and 13 of the '230 Patent. Defendant Impax literally infringes claims 1, 5, 6, 8, and 10 of the '505 Patent, and claims 1, 6, 7, 10, and 13 of the '230 Patent. The asserted claims of the '505 and '230 Patents are valid. I. The Parties Plaintiff AstraZeneca AB (“Astra”) is a company organized and existing under the laws of Sweden, having its principal place of business at Sodertalje, Sweden. Plaintiff Aktiebolaget Hassle (“Hassle”) is a company organized and existing under the laws of Sweden, having its principal place of business at Molndal, Sweden. Plaintiff KBI-E Inc. (“KBI-E”) is a Delaware corporation, having its principal place of business at Wilmington, Delaware. Plaintiff KBI Inc. (“KBI”) is a Delaware corporation having its principal place of business at Whitehouse Station, New Jersey. KBI and KBI-E have exclusive rights in the United States under the patents-in-suit. Plaintiff Astra Pharmaceuticals, L.P. is a limited partnership organized under the laws of Delaware, having its principal place of business at Wayne, Pennsylvania. Plaintiff AstraZeneca, LP is a limited partnership organized under the laws of Delaware having its principal place of business at Wayne Pennsylvania. AstraZeneca, LP holds an approved New Drug Application from the United States Food and Drug Administration (“FDA”) for an omeprazole formulation which it sells under the name Prilosec®. (Second Am. Compl. Against Mylan ¶¶2-7; Compl. Against Esteve ¶¶ 2-7; Second Am. Compl. Against Lek ¶¶ 2-7; Second Am. Compl. Against Apo-tex ¶¶ 2-7; Second Am. Compl. Against Impax ¶¶2-6.) Plaintiffs are referred to collectively as “Astra.” Defendant Mylan Laboratories Inc. is a corporation organized under the laws of Pennsylvania having its principal place of business at Pittsburgh, Pennsylvania. Defendant Mylan Pharmaceuticals Inc. is a corporation organized under the laws of West Virginia having its principal place of business in Morgantown, West Virginia, and is registered as a foreign business in the State of New York. Mylan Pharmaceuticals is a wholly-owned subsidiary of My-lan Laboratories. (Second Am. Compl. Against Mylan ¶¶ 8-11; Mylan’s Answer, Affirmative Defenses, and Countercls. to Pis.’ Second Am. Compl. (“Mylan’s Answer & Countercls. to Second Am. Compl.”) ¶¶ 8-11.) Defendant Esteve Quimica, S.A. is a company existing under the laws of Spain, with its principal place of business in Barcelona, Spain. Defendant Laboratorios Dr. Esteve, S.A. is a company existing under the laws of Spain, with its principal place of business at Barcelona, Spain. Esteve Quimica and Laboratorios Dr. Esteve have entered into agreements, collaborated, and engaged in activities with Mylan Pharmaceuticals relating to the product that is the subject of Mylan Pharmaceuticals’ ANDA No. 75-876. (Compl. Against Esteve ¶¶ 8, 10, 15; Defendants’ Answer, Affirmative Defenses, and Countercls. to Pis.’ Compl. (“Esteve’s Answer & Coun-tercls. to Compl.”) ¶¶ 8,10,15.) Defendant Lek Pharmaceuticals d.d., formerly known as Lek Pharmaceutical and Chemical Company d.d., is a corporation organized under the laws of Slovenia, having its principal place of business at Ljubljana, Verovskova, Slovenia. Defendant Lek Services, Inc., formerly known as Lek USA, is a corporation organized under the laws of Delaware, having its principal place of business at Wilmington, North Carolina. (Second Am. Compl. Against Lek ¶¶ 8-9; Lek’s Am. Answer to Second Am. Compl. and Countercls. (“Lek Answer & Countercls. to Second Am. Compl.”) ¶¶ 8-9.) Defendant Apotex Corp. is a Delaware corporation with a place of business in Vernon Hills, Illinois. Defendant Apotex, Inc. is a Canadian corporation with a place of business in Weston, Ontario, Canada. Apotex Corp. is a wholly-owned subsidiary of Apotex, Inc. Defendant TorPharm, Inc. is a Canadian corporation with its principal place of business in Etobicoke, Ontario, Canada. (Second Am. Compl Against Apotex ¶¶ 8-11; Apotex’s Answer, Affirmative Defenses and Countercls. to Pls.’ Second Am. Compl. (“Apotex Answer & Countercls. to Second Am. Compl.”) ¶¶ 8-11.) Together they comprise Defendant “Apotex”. Defendant Impax Laboratories, Inc. is a Delaware corporation, having its principal place of business in Hayward, California. (Second Am. Compl. Against Impax ¶ 7; Impax’s Answer and Countercls. to Second Am. Compl. ¶ 7.) II. The Patents-In-Suit Omeprazole is a compound that inhibits gastric acid secretion and can be used for the treatment of gastric and duodenal ulcers. (PSWTX 1A 1:17-1:20.) It belongs to a class of medicines called “proton pump inhibitors.” (Langer Tr. 6969:1.) Ome-prazole is very difficult to formulate. In particular, it is exceptionally acid labile, which means it is susceptible to degradation and/or transformation in acid-reacting and neutral media. (PSWTX 1A 1:21-1:24.) It is also sensitive to heat, moisture, organic solvents, and light. (Langer Tr. 6970:19-25; PSWTX 2821-4.) An oral dosage form of omeprazole must be protected from contact with the acid reacting gastric juice in the stomach, in order to reach the proximal part of the small intestine, where it is effective, without degradation. (PSWTX 11:35-1:39.) Due to the stability properties of omeprazole, developing a formula or dosage form that would remain stable both in the body and on the shelf, and deliver the compound to the proper site of the body, proved to be formidable. A group of Astra scientists set out to develop an oral dosage form of omeprazole and its related compounds, and their work ultimately culminated in the patents at issue in this case. (PSWTX 1A; PSWTX 2A.) Drs. Ake Pilbrant and Kurt Lovgren were a part of that team, and they are two of the named inventors on Astra’s '505 and '230 Patents. (PSWTX 1A; PSWTX 2A.) Astra made and tested many different formulations before creating an oral formulation that included omeprazole with an alkaline reacting compound (“ARC”) in the core, a water soluble subcoat, and an en-teric coating. (Langer Tr. 6971:1-6975:4; PSWTX 2821-4.) After clinical trials of this formulation, Plaintiffs filed patent applications for their omeprazole formulation. On April 20, 1987, Plaintiffs filed the patent application that led to the '505 Patent with the United States Patent and Trademark Office (“USPTO”). This application claims priority on a U.K. patent application filed April 30, 1986. (PSWTX 1A.) The '505 Patent discloses particular oral pharmaceutical formulations for the ome-prazole compound, processes for making those formulations, and methods of treating gastrointestinal disease using those formulations. (PSWTX 1A 1:5-11.) The '505 Patent also describes some of the previously mentioned difficulties with making an oral omeprazole formulation. (PSWTX 1A 1:21-34.) For example, ome-prazole degrades rapidly in the stomach, unless it is protected from contact with the acidic gastric juice. (PSWTX 1A 1:17-56.) The omeprazole compound is also sensitive to moisture and organic solvents. (PSWTX 1A 1:33-34.) Despite this sensitivity, omeprazole is not very soluble in the water found in bodily fluids. Consequently, the drug is difficult to handle and formulate. (Langer Tr. 6970:19-25; PSWTX 2821-4.) Thus, the '505 Patent inventors were faced with the problems of developing an oral pharmaceutical formulation of omeprazole that had “good resistance towards gastric juice as well as good stability during long-term storage.” (PSWTX 1A 1:40-2:13; 14:64-16:40.) The '505 Patent claims a new formulation that, among other things, permits the omeprazole drug molecule to pass unharmed through the stomach’s acidic environment and to dissolve rapidly in the upper portion of the small intestine. (PSWTX 1A 3:14-18; 5:19-58.) The inventors’ solution to omeprazole’s multiple stability problems was a formulation that comprises (1) a core region containing omeprazole and an alkaline reacting compound (“ARC”) or an alkaline salt of ome-prazole optionally mixed with an ARC; (2) an inert subcoating that is water soluble or rapidly disintegrating in water and disposed on the core region; and (3) an outer enteric layer disposed on the subcoating. (See, e.g., PSWTX 1A 3:42-54.) As a result, the omeprazole in the patented formulation is available for absorption into the bloodstream, while possessing superior stability. (PSWTX 1A 3:14-20.) Claim 1 of the '505 Patent specifies a pharmaceutical product that includes three elements: 1. An oral pharmaceutical preparation comprising (a) a core region comprising an effective amount of a material selected from the group consisting of omeprazole plus an alkaline reacting compound, an alkaline omeprazole salt plus an alkaline reacting compound and an alkaline omeprazole salt alone; (b) an inert subcoating which is soluble or rapidly disintegrating in water disposed on said core region, said subcoat-ing comprising one or more layers of materials selected from among tablet ex-cipients and polymeric film-forming compounds; and (c)an outer layer disposed on said sub-coating comprising an enteric coating. (PSWTX 1A 16:42-54.) Claims 2 through 9, and 11 through 13, are product claims that depend on claim 1, but then add other features, such as the reference to microenvironment and pH in claim 5: 5. A preparation according to claim 1 wherein the alkaline core comprises omeprazole and pH-buffering alkaline compound rendering to the micro-environment of omeprazole a pH of 7-12. (PSWTX 1A 16:65-68.) In contrast to product claims like claim 1, claim 14 is a process claim. Claim 14 specifies: 14. A process for the preparation of an oral pharmaceutical preparation containing omeprazole, comprising (a) preparing a core comprising an effective amount of a material selected from the group consisting of omeprazole plus an alkaline reacting compound, an alkaline omeprazole salt plus an alkaline reacting compound and an alkaline ome-prazole salt alone; (b) coating the core with one or more layers of an inert subcoating material selected from among tablet excipients and polymeric film-forming compounds to form a subcoated core; and (c) coating the subcoated core with an enteric coating. (PSWTX 1A 18:13-25.) Like the '505 Patent, the '230 Patent relates to particular oral pharmaceutical formulations of omeprazole, processes for making formulations, and methods of treating gastrointestinal disease using those formulations. (PSWTX 2A 1:5-12.) The '230 Patent differs from the '505 Patent in that the '230 Patent covers not just omeprazole but acid-labile pharmaceutically active substances such as a certain class of benzimidazole compounds including omeprazole, and their salts. (PSWTX 2A 1:28-2:33.) The '230 Patent also includes claims directed to products and claims directed to processes. Claim 1, a product claim, specifies: “1. A pharmaceutical preparation comprising: (a) an alkaline reacting core comprising an acid-labile pharmaceutically active substance and an alkaline reacting compound different from said active substance, an alkaline salt of an acid labile pharmaceutically active substance, or an alkaline salt of an acid labile pharmaceu-tically active substance and an alkaline reacting compound different from said active substance; (b) an inert subcoating which rapidly dissolves or disintegrates in water disposed on said core region, said subcoat-ing comprising one or more layers comprising materials selected from the group consisting of tablet excipients, film-forming compounds and alkaline compounds; and (c) an enteric coating layer surrounding said subcoating layer, wherein the sub-coating layer isolates the alkaline reacting core from the enteric coating layer such that the stability of the preparation is enhanced” (PSWTX 2A 13:1-20.) Dependent product claims add features to claim 1. For example, claim 6 refers to a pH-buffering alkaline reacting compound which renders the microenvironment a specified pH. 6. A preparation according to claim 1, wherein an alkaline core comprises the acid labile compound and a pH-buffering alkaline reacting compound which renders to the micro-environment of the acid labile compound a pH of 7-12. (PSWTX 2A 14:4-8.) Claim 12 of '230 Patent, an independent process claim, provides: 12. Process for the preparation of an oral pharmaceutical formulation containing an acid labile compound in which cores containing the acid labile compound mixed with an alkaline reacting compound or compounds or an alkaline salt of the acid labile compound optionally mixed with an alkaline reacting compound or compounds are coated with one or more inert reacting subcoating layers where after the subcoated cores are further coated with an enteric coating layer. (PSWTX 2A 14:33^1.) A. Patent Ownership In the First Wave litigation, the Court found that Astra owns both the '505 and the '230 Patents. Astra v. Andrx, 222 F.Supp.2d at 514. Astra has again established ownership in the patents-in-suit. Astra is the owner of the '505 and '230 Patents by virtue of assignment from the inventors. The inventors, Kurt Lovgren, Áke Pilbrant, Mitsuru Yasumura, Satoshi Morigaki, Minoru Oda, and Naohiro Ohishi, assigned all their rights in the '505 and '230 Patents to Aktiebolaget Hassle. The assignments were executed between March 19, 1987 and April 2, 1987, before the filing of the U.S. applications leading to the patents-in-suit. (PSWTX 1266.) The '505 and '230 Patents were issued to Aktiebolaget Hassle as the assignee (PSWTX 1A; PSWTX 2A), and “[t]he issuance of [a] patent by the Patent Office to the plaintiff established] prima facie ownership,” Electric Auto-Lite Co. v. P. & D. Mfg. Co., 78 F.2d 700, 704 (2d Cir.1935) (citation omitted). Plaintiffs also own the '505 and '230 Patents as a result of agreements between Aktiebolaget Hassle and Fujisawa Pharmaceutical Co., Ltd. and Mitsubishi Phar-ma Corporation, successor to Yoshitomi Pharmaceutical Co., Ltd., that grant Astra all of Fujisawa and Yoshitomi’s interest in omeprazole-related patents outside of Japan. Aktiebolaget Hassle’s ownership of the '505 and '230 Patents was affirmed by Fujisawa Pharmaceutical Co., Ltd. and by Mitsubishi Pharma Corporation in October of 2003. Fujisawa and Mitsubishi confirmed that all rights they had in the '505 and '230 Patents through their employees, Mitsuru Yasumura, Satoshi Morigaki, Minoru Oda, and Naohiro Ohishi, were assigned to Aktiebolaget Hassle pursuant to an agreement between Fujisawa, Mitsubishi, and Aktiebolaget Hassle. (PSWTX 1266.) III. The Pleadings These infringement actions initially arose out of Abbreviated New Drug Applications (“ANDAs”) filed by Defendants. The Drug Price Competition and Patent Term Restoration Act, Pub.L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 21 U.S.C. § 355 and 35 U.S.C. § 271(e) (1994)), also known as the Hatch-Waxman Act, amended the Federal Food, Drug, and Cosmetic Act (“FDCA”), Pub.L. No. 52-675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-397 (1994)), to permit filing of an ANDA to expedite FDA approval of a generic version of a drug previously approved by the FDA. See Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1244 (Fed.Cir.2000), cert. denied, 531 U.S. 993, 121 S.Ct. 484, 148 L.Ed.2d 457 (2000). Under the Hatch-Waxman Act, an applicant may file an ANDA with the FDA requesting approval to market a generic drug without undergoing the same expensive and time-consuming FDA approval process as the maker of the branded version of the drug, often called the pioneer drug, by (1) demonstrating that the generic drug is the bioequiva-lent of the branded drug and (2) certifying that manufacturing, marketing and selling the drug will not infringe the patent rights held by the patentee of the pioneer drug. Id. The statute prescribes a precise four-step procedure for litigating patent disputes between the innovator drug company and the generic applicant. See 21 U.S.C. § 355(j)(2)(A)-(B). The holder of the New Drug Application for the pioneer drug lists all of its patents that claim the drug or a use of the drug in the book entitled New Drug Products with Therapeutic Equivalence Evaluations (referred to as the “Orange Book”) published by the FDA. See 21 U.S.C. § 355(b)(1). In its ANDA, a generic applicant must certify one of the following four statements with respect to the patents listed under the pioneer drug in the Orange Book: no patent information has been filed (“Paragraph I” certification), the patent has expired (“Paragraph II” certification), the patent soon will expire on a specified date (“Paragraph III” certification), or the patent “is invalid or will not be infringed by the manufacture, use, or sale of the new drug” covered by the ANDA (“Paragraph IV” certification). 21 U.S.C. § 355(j)(2)(A)(vii) (I)-(IV). Only one type of certification is pertinent here: a “Paragraph IV” certification. In a Paragraph IV certification, the generic manufacturer seeks to obtain FDA approval before a listed patent expires and asserts that the patent listed in the Orange Book is either not infringed or invalid. Following the issuance of a Paragraph IV certification, the Hatch-Waxman Act requires the generic company to give notice of the Paragraph IV certification to the innovator who listed the patent with the FDA. 21 U.S.C. § 356(j)(2)(B). The FDA can approve an ANDA containing a Paragraph IV certification unless the patent holder files suit within forty-five days of receiving notice of a Paragraph IV certification. 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2) (2006). If a patent infringement action is timely brought, final marketing approval of the ANDA cannot occur before expiration of thirty months or a decision of a court. See 21 U.S.C. § 355(j)(5)(B)(iii). Section 271(e) (2)(A) “define[s] a new (and somewhat artificial) act of infringement for a very limited and technical purpose that relates only to certain drug applications.” Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). Section 271(e)(2)(A) provides a patentee with a cause of action for patent infringement based solely upon the filing of an ANDA containing a Paragraph IV certification implicating a Plaintiffs’ patent rights. The artificial infringement arising by operation of law is an integral part of a statutory scheme designed to allow pharmaceutical manufacturers to market, and the public to purchase, generic drugs as soon as possible after the expiration of patents covering the pioneer drug. The infringement suit under section 271(e)(2) permits the patentee “to challenge the certification — i.e. to assert inter alia that the commercial manufacture, use or sale of the new drug would infringe its patent.” Glaxo, Inc. v. Boehringer Ingelheim Corp., 954 F.Supp. 469, 473 (D.Conn.1996) (emphasis added). The patentee’s challenge to the certification provides the court with a justiciable controversy, permitting it to efficiently resolve patent issues in advance of the generic drug’s release. See Warner-Lambert Co. v. Apotex Corp., No. 98 Civ. 4293, 1999 WL 259946, at *2 (N.D.Ill. Apr.8, 1999). Defendants have each issued Paragraph IV certifications against the patents-in-suit. (PSWTX 433; PSWTX 1126; PSWTX 1127A; PSWTX 1128; PSWTX 1129.) Defendants certified in their ANDA submissions for generic omeprazole that the patents-in-suit are “invalid or will not be infringed by the manufacture, use, or sale” of their generic products. (PSWTX 433; PSWTX 1126; PSWTX 1127A; PSWTX 1128; PSWTX 1129.) Based on those ANDA filings, Plaintiffs filed a patent infringement suit pursuant to 35 U.S.C. § 271(e)(2)(A), alleging that the generic omeprazole formulations for which Defendants seek approval will infringe or induce infringement of the asserted claims. In addition, Defendants started selling their respective products in the United States during the pendency of this litigation. For this reason, Plaintiffs have amended the complaints to include infringement pursuant to 35 U.S.C. § 271(a), (b) and (c). (Second Am. Compl. Against Mylan, Dec. 12, 2003; Compl. Against Esteve, Aug. 8, 2003; Second Am. Compl. Against Lek, Dec. 12, 2003; Second Am. Compl. Against Apotex, Apr. 6, 2005; Second Am. Compl. Against Impax, Mar. 2, 2005.) The issue of whether Defendants willfully infringe is not being addressed here. A. Complaint Against Mylan/Esteve Plaintiffs assert that Mylan committed an act of infringement under 35 U.S.C. § 271(e)(2) with respect to the '505 Patent and the '230 Patent by filing an ANDA seeking FDA approval to engage in the commercial manufacture, use or sale of Mylan’s product prior to the expiration of the patents-in-suit (Second Am. Compl. Against Mylan ¶¶ 21, 32); that Mylan has directly infringed the patents-in-suit under 35 U.S.C. § 271(a) by selling and offering for sale Mylan’s FDA-approved 10-mg and 20-mg generic omeprazole product (Id. ¶¶ 24c, 35c); and that under 35 U.S.C. § 271(b)-(c) Mylan has induced and contributed to infringement by others who administer or use Mylaris product (Id. ¶¶ 23, 24, 34, 35). Plaintiffs further assert that Mylan had knowledge of the '505 Patent before the infringement referred to above, and such infringement has been and will continue to be willful and deliberate. (Id. ¶ 24d.) Mylaris answer to the Second Amended Complaint denies infringement and asserts additional affirmative defenses of patent invalidity for failure to comply with the U.S. patent laws, including 35 U.S.C. §§ 101, 102, 103, and/or 112, and unen-forceability. Mylan asserts counterclaims for treble damages under the antitrust laws and declarations of patent invalidity and unenforceability, and requests attorneys’ fees and costs. (Mylaris Answer & Countercls. to Second Am. Compl.) My-lan’s antitrust counterclaims have been severed and stayed pending resolution of the allegations of the complaint. Plaintiffs assert that Laboratorios Dr. Esteve has directly infringed the patents-in-suit by offering for sale and selling within the United States, and importing into the United States the pellets used in My-laris product in contravention of 35 U.S.C. § 271(a). (Compl. Against Esteve ¶¶ 28, 53). In addition, Plaintiffs assert that both Laboratorios Dr. Esteve and Esteve Quí-mica have induced infringement of the '505 and '230 Patents under 35 U.S.C. § 271(b) by inducing infringing sales of the Mylan omeprazole products (Id. ¶¶35, 60), and inducing infringement by others who administer or use Mylan’s product (Id. ¶¶ 36, 61). Plaintiffs assert that Esteve Química has further induced infringement under 35 U.S.C. § 271(b) by Laboratorios Dr. Es-teve by inducing the import, .sale, and offer for sale in the U.S. of the pellets used in Mylaris product (Id. ¶¶ 38, 63); and Laboratorios Dr. Esteve has contributorily infringed the patents-in-suit under 35 U.S.C. § 271(c) by supplying to Mylan the pellets used in Mylaris product (Id. ¶¶46, 71). Plaintiffs also assert that Laboratorios Dr. Esteve had knowledge of the '505 Patent before the infringement referred to above, and such infringement has been and will continue to be willful and deliberate. (Id. ¶ 29.) Esteve’s Answer to the Complaint denies infringement and asserts additional affirmative defenses of patent invalidity for failure to comply with the U.S. patent laws, including 35 U.S.C. §§ 101, 102, 103, and/or 112, and unenforceability. Mylan also asserts counterclaims for declarations of patent invalidity and unenforceability, and requests attorneys’ fees and costs. (Esteve’s Answer and Countercls. to Compl.) B. Complaints Against Lek Plaintiffs assert that Lek committed acts of infringement under 35 U.S.C. § 271(e)(2) with respect to the '505 Patent and the '230 Patent by filing ANDAs seeking FDA approval to engage in the commercial manufacture, use, or sale of Lek’s products prior to the expiration of the patents-in-suit (Second Am. Compl. Against Lek ¶¶ 21-23, 32-35; Compl. Against Lek ¶¶ 19-21, 28-30); that Lek has directly infringed the patents-in-suit under 35 U.S.C. § 271(a) by manufacturing, selling, and offering for sale Lek’s FDA-approved 10-mg and 20-mg generic omeprazole products (Second Am. Compl. Against Lek ¶¶ 24a, 24b, 24c, 35a, 35b, 35c); and that Lek has induced and contributed to infringement by others who administer or use Lek’s products under 35 U.S.C. § 271(b)-(c) (Id. ¶¶ 23, 24, 34, 35). Lek’s Answers to the Second Amended Complaint and Complaint deny infringement by their products. Lek also sues for an award of attorneys’ fees and costs under 35 U.S.C. § 285, and asserts counterclaims for treble damages under the antitrust laws. (Lek’s Answer & Countercls. to Second Am. Compl.; Lek’s Answer and Countercls. to Compl.) Lek’s counterclaims have been severed and stayed pending resolution of the allegations of the complaints. C. Complaint Against Apotex Plaintiffs assert under 35 U.S.C. § 271(e)(2) with respect to the '505 Patent and the '230 Patent by filing an ANDA seeking FDA approval to engage in the commercial manufacture, use or sale of Apotex’s product prior to the expiration that Apotex committed an act of infringement of the patents-in-suit (Second Am. Compl. Against Apotex ¶¶ 21, 32); that Apotex directly infringed the patents-in-suit under 35 U.S.C. § 271(a) by selling and offering for sale Apotex’s FDA-approved 10-mg and 20-mg generic omepra-zole products (Id. ¶¶ 24c, 36c, 36d); that Apotex’s act was willful and deliberate (Id. ¶¶ 24e, 36e); and that Apotex has induced and contributed to infringement by others who administer or use Apotex’s products under 35 U.S.C. § 271(b)-(c) (Id. ¶¶ 23, 35). In addition, Plaintiffs claim that this case is exceptional under 35 U.S.C. § 285 based on Apotex’s lack of a meritorious defense and Apotex’s litigation misconduct. (Id. ¶¶ 24e, 37.) Apotex’s Answer to the Second Amended Complaint denies infringement and asserts additional affirmative defenses of patent invalidity and unenforceability. Apotex also sues for attorneys’ fees and costs and asserts counterclaims, including claims for treble damages under the antitrust laws and for declarations of patent invalidity and unenforceability. (Apotex’s Answer & Countercls. to Second Am. Compl.) Apotex’s antitrust counterclaims have been severed and stayed pending resolution of the allegations of the complaints. D. Complaints Against Impax Plaintiffs assert that Impax committed an act of infringement under 35 U.S.C. § 271(e)(2) with respect to the '505 Patent and the '230 Patent by filing an ANDA seeking FDA approval to engage in the commercial manufacture, use or sale of Impax’s products prior to the expiration of the patents-in-suit (Am. Compl. Against Impax ¶¶ 16, 28; Second Am. Compl. Against Impax ¶¶ 16, 28); that Impax has directly infringed the patents-in-suit under 35 U.S.C. § 271(a) by selling and offering for sale Impax’s FDA-approved “Omepra-zole Delayed Release Capsules, 10 and 20 mg” (Second Am. Compl. Against Impax ¶¶ 19c, 31c); and that Impax has induced and contributed to infringement by others who administer or use Impax’s products under 35 U.S.C. § 271(b)-(c) (Id. ¶¶ 18, 19, 30, 31). Plaintiffs further assert that Impax had knowledge of the '505 and '230 Patents before the infringement referred to above, and therefore such infringement has been willful and deliberate. (Id. ¶¶ 19d, 31d.) Additionally, Plaintiffs claim this case is exceptional under 35 U.S.C. § 285 (2000) based on Impax’s litigation misconduct and lack of a meritorious defense. (Id. ¶¶ 20, 32.) Impax’s answers to the Amended Complaint and Second Amended Complaint deny infringement and assert additional affirmative defenses of patent invalidity for failure to comply with the U.S. patent laws, including 35 U.S.C. §§ 102, 103, and/or 112, and unenforceability for patent misuse and inequitable conduct. Impax also sues for attorneys’ fees and asserts counterclaims for treble damages under the antitrust laws and declarations of patent invalidity and unenforceability. (Impax’s Answer & Counterels. to Am. Compl.; Impax’s Answer & Counterels. to Second Am. Compl.) Impax’s antitrust counterclaims have been severed and stayed pending resolution of the allegations of the complaints. DISCUSSION I. Daubert Motions All parties made timely motions, pursuant to Federal Rules of Evidence 104, 402, 702, and 703, to exclude certain challenged testimony under Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). Plaintiffs initially moved to exclude Mylan and Esteve’s expert witness Dr. Richard Durst, Apotex’s expert witness Dr. Michael Cima, Lek’s expert witnesses Dr. John Coates, Dr. John White, Dr. Brian Herman, and Dr. Yuval Garini, and Im-pax’s expert witnesses Mr. Andrew Hirt and Dr. David Piston, but withdrew all of their Daubert motions during trial. (Tr. 5226:23-25; 5227:1-6.) All Defendants moved to exclude various portions of the testimony of Dr. Martyn Davies, one of Plaintiffs’ expert witnesses who testified at the trial. In addition, Impax moved to exclude the testimony of Plaintiffs’ expert witness Dr. Robert Lan-ger, and Mylan and Esteve moved to preclude Plaintiffs’ expert witness Dr. Alexander Klibanov. Although the Court had initially scheduled Daubert hearings to be held in advance of trial, upon consideration of Plaintiffs’ motion for reconsideration of that scheduling decision, the Court elected to hear the Daubert proof during the trial itself. See Colon v. BIC USA, Inc., 199 F.Supp.2d 53, 71 (S.D.N.Y.2001). (“[N]othing in Daubert, or any other Supreme Court or Second Circuit case, mandates that the district court hold a Daubent hearing before ruling on the admissibility of expert testimony.”); see also Astra v. Andrx, 222 F.Supp.2d at 486. The Court has now thoroughly considered all submissions and arguments relating to the motions of all Defendants. The Court has considered all of the testimony of the experts, as well as the other evidence offered at trial. For the following reasons, Defendants’ motions to exclude or strike portions of the testimony of Dr. Davies, Dr. Langer, and Dr. Klibanov, as well as the exhibits offered through those three witnesses, are denied in their entirety. A. Choice of Law When deciding issues in a patent case, a district court applies the law of the circuit in which it sits to nonpatent issues and the law of the Federal Circuit to issues of substantive patent law. Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1378-79 (Fed.Cir.2005). An “issue that is not itself a substantive patent law issue is nonetheless governed by Federal Circuit law if the issue pertains to patent law, if it bears an essential relationship to matters committed to [the] exclusive control [of the Federal Circuit] by statute, or if it clearly implicates the jurisprudential responsibilities of [the Federal Circuit] in a field within its exclusive jurisdiction.” Midwest Indus., Inc. v. Karavan Trailers, Inc., 175 F.3d 1356, 1359 (Fed.Cir.1999) (en banc in relevant part) (internal citations and quotations omitted). Under these rules, evidentiary rulings concerning the admissibility of expert testimony are generally governed by regional circuit law. Odetics, Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1276 (Fed.Cir.1999) (“Because these evidentiary rulings raise procedural issues not unique to patent law, this court applies the law of the regional circuit where appeals from the district court would normally lie.”). However, the determination of whether material is relevant in a patent case is governed by Federal Circuit law when the material relates to an issue of substantive patent law. See Midwest Indus., Inc., 175 F.3d at 1359 (citing Truswal Sys. Corp. v. Hydro-Air Eng’g, Inc., 813 F.2d 1207, 1212 (Fed.Cir.1987)). Thus, this Court is governed by the law of the Federal Circuit as to relevance and the law of the Second Circuit as to the other issues raised by Defendants’ challenges to the testimony of Dr. Davies and Dr. Langer. B. Legal Requirements Under Dau-bert and Rule 702 The admissibility of expert testimony is governed by Federal Rule of Evidence 702, which has been amended to codify the holdings of Daubert and its progeny. See Micro Chem., Inc. v. Textron, Inc., 317 F.3d 1387, 1391-92 (Fed.Cir.2003.) Rule 702 provides: If, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case. Fed. R.E. 702. The admissibility of all expert testimony under Rule 702 is a preliminary question of law for the district court to determine pursuant to Federal Rule of Evidence 104(a), see Daubert, 509 U.S. at 592, 113 S.Ct. 2786, and district courts have broad discretion when determining whether or not to admit expert testimony, United States v. Feliciano, 223 F.3d 102, 120 (2d Cir.2000). The proponent of the evidence, in this case Astra, must establish admissibility under Rule 104(a) by a preponderance of the evidence. See Bourjaily v. United States, 483 U.S. 171, 175-76, 107 S.Ct. 2775, 97 L.Ed.2d 144 (1987); see also Colon, 199 F.Supp.2d at 69. However, when interpreting the requirements under Daubert and its progeny, the Second Circuit has noted that: [although expert testimony should be excluded if it is speculative or conjectural, or if it is based on assumptions that are so unrealistic and contradictory as to suggest bad faith or to be in essence an apples and oranges comparison, other contentions that the assumptions are unfounded go to the weight, not the admissibility, of the testimony. Boucher v. United States Suzuki Motor Corp., 73 F.3d 18, 21 (2d Cir.1996) (internal quotations and citations omitted). In determining admissibility under Dau-bert, trial judges are charged with a gate-keeping function pursuant to Rule 702 whereby they must determine (1) whether the theory or methodology underlying the testimony is reliable and (2) whether the expert’s theory or methodology is relevant in that it “fits” the facts of the case. See Daubert, 509 U.S. at 590-91, 113 S.Ct. 2786; Kumho Tire Co. v. Carmichael, 526 U.S. 137, 149-50, 119 S.Ct. 1167, 143 L.Ed.2d 238, (1999); Campbell v. Metro. Prop. & Cas. Ins. Co., 239 F.3d 179, 184-85 (2d Cir.2001). For consideration by district courts in determining the reliability of expert testimony, the Supreme Court set forth the following non-dispositive, non-exclusive factors as “flexible” guidelines in Daubert: (1) whether the theory or technique can be or has been tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) the known or potential rate of error associated with the technique along with the existence and maintenance of standards controlling the technique’s operation; and (4) whether the technique or theory has been generally accepted in the scientific community. Daubert, 509 U.S. at 592-95, 113 S.Ct. 2786. In addition to the five factors explicitly discussed in Daubert, district courts in the Second Circuit have considered a variety of other factors when determining the admissibility of expert testimony. Some of the more commonly used factors include consideration of the foundation for the opinion, Nimely v. City of New York, 414 F.3d 381, 396-97 (2d Cir.2005) (stating that “when an expert opinion is based on data, methodology, or studies that are simply inadequate to support conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony” (internal quotations and citations omitted)), its subjectivity, Highland Capital Mgmt, L.P. v. Schneider, 379 F.Supp.2d 461, 473 (S.D.N.Y.2005) (“Expert testimony that is speculative” or e. (internal quotations and citations omitted)), and any failure to test, Brooks v. Outboard Marine Corp., 234 F.3d 89, 91-92 (2d Cir.2000) (“[F]ailure to test theory can justify a trial court’s exclusion of the expert’s testimony.”). The “fit” or relevance requirement enunciated in Daubert has been interpreted to encompass several concepts. For scientific evidence to be admissible, it must be relevant, which means the evidence must have the “tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence.” Fed.R.Evid. 401; Daubert, 509 U.S. at 587, 113 S.Ct. 2786. Thus, even if the methodology used by the expert is considered to be reliable, the expert’s testimony will nevertheless fail to meet the “fit” requirement and should be excluded if the data relied upon by the expert is materially different from the data relevant to the facts of the case. See Raskin v. Wyatt Co., 125 F.3d 55, 67-68 (2d Cir.1997). If the expert has failed to consider the necessary factors, or if the analysis is premised upon a faulty assumption, his testimony may be excluded for lack of probative value. See Amorgianos v. Amtrak, 303 F.3d 256, 268-69 (2d Cir.2002). Likewise, where the proffered testimony is based on a methodology transposed from one area to a completely different context and there is no independent research supporting the transposition, the “fit” requirement may not be satisfied. Therefore, to the extent that any witness has based their opinions on studies, models, or experiments, it is their burden to connect those analyses to the facts of this case. See Gen. Elec. Co. v. Joiner, 522 U.S. 136, 144, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). Even if an expert’s methodologies satisfy the Daubert standard for admissibility, the court must still determine whether that evidence actually supports the expert’s conclusions. Joiner, 522 U.S. at 146, 118 S.Ct. 512. The court must reject expert testimony where “there is simply too great an analytical gap between the data and the opinion proffered.” Id.; Graham v. Playtex Prods., 993 F.Supp. 127, 132 (N.D.N.Y.1998) (noting that Joiner applies Daubert gate-keeping to conclusions as well as methodology). Failure to test for alternative causes or to use control experiments may provide a basis for exclusion. See In re Executive Telecard Ltd., Sec. Litig., 979 F.Supp. 1021, 1026 (S.D.N.Y.1997); Valentine v. Pioneer Chlor Alkali Co., 921 F.Supp. 666, 676-77 (D.Nev.1996). It is not required, however, that an expert categorically excludes each and every possible alternative cause in order to render the proffered testimony admissible. See, e.g., Zuchowicz v. United States, 140 F.3d 381, 385-87 (2d Cir.1998). C. Expert Qualiftcations Before determining whether the testimony and evidence offered by the expert witnesses in this case meet the Daubert standards, the Court must first determine whether each expert is qualified to testify. See In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 741 (3d Cir.1994); Mancuso v. Consol. Edison, 56 F.Supp.2d 391 (S.D.N.Y.1999), aff'd in relevant part, vacated in part, 216 F.3d 1072, 2000 WL 730417 (2d Cir.2000). The ultimate issue for the court to determine is whether the witness has “specialized knowledge” through “experience, training or education” as to the contents of his proposed expert testimony. Fed.R.Evid. 702. The Court considered each expert’s background and experience in order to determine whether each witness was qualified to render the opinion testimony he offered at trial. See McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1043 (2d Cir.1995). Pursuant to those standards, the Court evaluated the background and experience of each expert witness offered, as described below. 1. Plaintiffs’ Expert Witnesses Plaintiffs presented three expert witnesses, Dr. Martyn Davies, Dr. Robert Langer, and Dr. Alexander Klibanov. Dr. Davies was accepted by the Court an expert in the testing, analysis, and characterization of drug formulations (Tr. 145:15-19), and Dr. Langer was accepted by the Court as an expert in drug delivery and pharmaceutical dosage forms (Tr. 1124:3— 10). The Court accepted Dr. Klibanov as an expert in pharmaceutical chemistry and pharmaceutical formulation chemistry. (Tr. 5241:20-25.) a. Martyn Davies Dr. Martyn Davies is an expert in testing, analysis, and characterization of drug formulations. (PSWTX 804A; Davies Tr. 145:15-19.) Dr. Davies has over twenty years’ experience in the area of characterization of pharmaceutical dosage forms, and conducts his research in that area. Dr. Davies has a pharmacy degree from University of Brighton, and attended the University College Hospital at the University of London, for six months. He then spent six months at Welsh Pharmaceuticals, where he focused on characterizing drugs, preparing dosage forms, and preparing samples for clinical trials. He also spent time in the production plant, operating production facilities, and in the marketing and development departments. Dr. Davies obtained a Ph.D. from the University of London. (Davies Tr. 123:22-125:11; PSWTX 804A.) Dr. Davies has been a professor of biomedical surface chemistry in the school of pharmacy at the University of Nottingham since 1985. He has primarily taught in the areas of pharmaceutical technology, physical formulation, and advanced drug delivery. (Davies Tr. 123:9-13; 125:7-127:6; PSWTX 804A.) He was the Head of the School of Pharmaceutical Sciences and the Pharmacy School from 2000 until 2003. (PSWTX 804A.) Dr. Davies is the chair of the research committee at the school. Part of his responsibilities include teaching analytical techniques, including how to characterize drugs using vibrational spectroscopy, infrared, nuclear magnetic resonance (“NMR”), mass spectrometry, pH measurements, and fluorescence. He also performs independent research. (Davies Tr. 127:7-128:11; PSWTX 804A.) Dr. Davies is the founder and chairman of Molecular Profiles Ltd., a company which assists pharmaceutical companies with developing better formulations and conducts research for the pharmaceutical industry in that same area. (Davies Tr. 128:20-130:2; PSWTX 804A.) Molecular Profiles has consulted for over seventy different pharmaceutical companies and over 250 different projects since its creation. (Davies Tr. 133:22-134:18; PSWTX 804A.) In his role as chairman, Dr. Davies also oversees the management of the company and research conducted by the company. He designs experiments, ensures experiments are performed properly, and reviews and collates the data. (Davies Tr. 128:20-130:2; PSWTX 804A.) Dr. Davies has been published in over 300 publications for his research on characterization of pharmaceutical dosage forms. He has published articles on the fluorescence techniques used in this litigation. (Davies Tr. 136:16-137:2; PSWTX 804A.) Dr. Davies is involved in pharmaceutical scientific societies. He is a fellow of the Royal Pharmaceutical Society of Great Britain. He was also the science chairman of the millennium meeting of the British Pharmaceutical Conference. Dr. Davies served on the Royal Pharmaceutical Society’s science committee, helping the society develop their research activities. He is also a fellow of the Royal Society of Chemistry and has run several conferences for this society. Dr. Davies was also elected to serve as the scientific secretary of the Controlled Release Society, which has over 4,000 members and is the main international society for drug delivery. His responsibilities include serving on the board of the Controlled Release Society, coordinating the science activity, and overseeing all the science aspects of the society, including its publications. (Davies Tr. 142:6-143:24; PSWTX 804A.) Dr. Davies has received awards for his work in characterizing pharmaceutical systems. He received the Pharmatech Award in recognition for his work on the characterization of pharmaceutical dosage forms. He received the Pfizer award, which is given annually in the United Kingdom across all sciences within the pharmaceutical sector. He was also awarded the young investigator award by the Controlled Release Society; this award is given once a year to an individual who has shown outstanding research activity in the field of drug delivery. Recently, Dr. Davies and the researchers at Molecular Profiles were given the GlaxoSmithKline international achievement award for their work in academic research and for implementing that research in the industrial sector. (Davies Tr. 144:2-18; PSWTX 804A.) b. Dr. Robert Langer Dr. Robert Langer is an expert in the fields of drug delivery and pharmaceutical dosage forms. (Langer Tr. 1124:3-10; PSWTX 964A.) Dr. Langer received a B.S. in Chemical Engineering from Cornell University and a Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology (“M.I.T.”). Dr. Langer also did post-doctoral work at Harvard Medical School. He is currently an institute professor at M.I.T. (Langer Tr. 1120:7-12; PSWTX 964A.) Dr. Langer teaches courses in biotechnology, chemical engineering, and drug delivery systems. In addition to teaching, Dr. Langer conducts research in the area of biomedical engineering, drug delivery systems, and pharmaceutical dosage forms. Dr. Langer holds appointments at Boston Children’s Hospital and Harvard Medical School. (Langer Tr. 1119:12-1120:6; 1121:10-16; PSWTX 964A.) Dr. Langer also provides consulting in the area of drug delivery for over 150 companies. (Langer Tr. 1122:19-1123:5, 6967:9-18.) Dr. Langer has published about 870 papers and 650 abstracts, and edited thirteen books. Dr. Langer has over 540 issued or pending patents worldwide in the area of drug delivery systems, pharmaceutical dosage forms, and biomedical engineering. (Langer Tr. 1120:13-24; PSWTX 964A.) Dr. Langer has also received about 140 awards and honors, including the Charles Stark Draper prize, the General Motors prize, the Albany medical prize, and the Lemelson prize for invention. He was elected to the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine of the National Academy of Sciences, and has been inducted into the National Inventor’s Hall of Fame. (Langer Tr. 1121:22-1122:18, 6966:20-6967:5; PSWTX 964A.) c. Dr. Alexander Klibanov Dr. Alexander Klibanov is an expert in chemistry, including pharmaceutical and pharmaceutical formulation chemistry. (Klibanov Tr. 5238:24-25, 5239:1-2; PSWTX 961.) He received both his master’s and doctoral degrees in chemistry from Moscow University in Russia. He previously consulted for a state-owned pharmaceutical institute in the areas of medicinal chemistry, formulations, and drug delivery. (Klibanov Tr. 5239:3-16; PSWTX 961.) Dr. Klibanov is currently a researcher and a professor of chemistry and bioengineering at M.I.T. Dr. Klibanov has taught undergraduate and graduate courses in general chemistry, organic chemistry, biological chemistry, and analytical chemistry. (Klibanov Tr. 5238:13-5239:2; PSWTX 961.) He has also consulted for about two dozen pharmaceutical companies, started three biopharmaceutical companies, and served as a scientific advisor and member of the board of directors of several other biopharmaceutical companies. (Klibanov Tr. 5240:6-18; PSWTX 961.) Dr. Klibanov has published over 250 articles dealing with various aspects of chemistry in peer-reviewed journals. He has fifteen United States patents and several foreign patents. (Klibanov Tr. 5239:17-5240:5; PSWTX 961.) Dr. Klibanov has served on the editorial board of more than a dozen scientific journals, including Proceedings of the National Academy of Sciences. (Klibanov Tr. 5240:19-25; PSWTX 961.) Dr. Klibanov has also received several awards for his work and research, including election to the United States National Academy of Sciences and to the United States National Academy of Engineering. (Klibanov Tr. 5241:1-14; PSWTX 961.) 2. Mylan/Esteve’s Expert Witnesses Mylan’s Dr. Richard Durst was accepted by the Court as an expert in electrochem-istry and pH measurement (Durst Tr. 1758:4-9), and Dr. John Swenton was accepted by the Court as an expert in organic chemistry (Swenton Tr. 2263:12-15). a. Dr. Richard Durst Dr. Richard Durst is an expert in the field of electrochemistry and pH measurement. (Durst Tr. 1757:17-22, 1758:8-9.) Dr. Durst received his Bachelor’s Degree in chemistry from the University of Rhode Island in 1960 and his Ph.D. in analytical chemistry from M.I.T. in 1963, specializing in electroanalytical chemistry. Electroa-nalytical chemistry includes the measurement of pH. After graduating from M.I.T., Dr. Durst was a post-doctoral fellow at the National Bureau of Standards. (Durst Tr. 1750:13-1751:5.) Dr. Durst recently retired from the faculty of Cornell University, where he was hired to run the Cornell analytical laboratories and served as a full tenured professor for 15 years. (Durst Tr. 1756:14-20.) Before joining the Cornell University faculty, Dr. Durst spent about 25 years at the National Bureau of Standards. (Durst Tr. 1751:6-17.) During his 25 years at the National Bureau of Standards, Dr. Durst specialized in pH measurement and held the positions of research scientist in the analytical chemistry division, assistant director of the analytical division, and chief of the electrochemical analysis section. (Durst Tr. 1751:18-1752:8.) Dr. Durst’s responsibilities included maintaining the national pH scale, certifying pH calibration standards, developing new techniques for obtaining precise and accurate pH measurements, and representing the United States in the field of pH measurements before various national and international standard setting bodies, including the National Committee for Clinical Laboratory Standards, the Association of Official Analytical Chemists, the International Federation of Clinical Chemistry, and the International Union of Pure and Applied Chemistry (IUPAC). (Durst Tr. 1752:9-1753:25.) Dr. Durst has received numerous awards and honors for his work in the field of pH measurement, and has served in numerous professional associations and on scientific editorial boards. He has authored more than 200 peer-reviewed publications and presented scores of invited lectures at government and academic institutions, national and international sympo-sia, and elsewhere on the subject of elec-troanalytical chemistry. (Durst Tr. 1754:1-1756:13; M/EX 155.) b. Dr. John Swenton Dr. John Swenton is an expert in organic chemistry. (Swenton Tr. 2258:10-13, 2259:24-25.) Dr. Swenton graduated from the University of Kansas in 1962 with a degree in chemistry, and received his Ph.D. from the University of Wisconsin in 1965. He spent a year at Harvard University as a post-doctoral fellow. (Swenton Tr. 2254:19-2255:13.) He has been a chemistry professor at the Ohio State University since 1966, where his curriculum and research has been focused on organic chemistry and laboratory organic chemistry. (Swenton Tr. 2254:25-2255:2, 2255:14-2256:12.) Dr. Swenton has received numerous awards and honors for his work in the field of organic chemistry, has been involved in various professional associations and scientific editorial boards, and has authored well over 100 peer-reviewed articles on the subject of synthetic organic chemistry. (Swenton Tr. 2256:13-2258:9.) 3. Lek’s Expert Witnesses Lek presented the following expert witnesses: Dr. Gary Christian, Dr. Phillip E. Russell, Dr. John Coates, Dr. Brian Herman, Dr. Yuval Garini, Dr. Albert Padwa, and Dr. Calvin Quate. The Court accepted Dr. Christian as an expert in the field of analytical chemistry. (Christian Tr. 3752:16-20.) Dr. Russell was accepted by the Court as an expert in the fields of microscopy and microanalysis (Russell Tr. 4356:2-14), Dr. Coates was accepted as an expert in infrared spectroscopy, attenuated total reflectance Fourier spectr