Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.

• Decision Date: 11 February 2013
• Docket Number: Civil Action No. 10–805–CJB.
• Citation: 923 F.Supp.2d 602
• Parties: BRISTOL–MYERS SQUIBB COMPANY, Plaintiff, v. TEVA PHARMACEUTICALS USA, INC., Defendant.
• Court: U.S. District Court — District of Delaware

923 F.Supp.2d 602

BRISTOL–MYERS SQUIBB COMPANY, Plaintiff,

v.TEVA PHARMACEUTICALS USA, INC., Defendant.

Civil Action No. 10–805–CJB.

United States District Court, D. Delaware.

Feb. 11, 2013.

Jeffrey B. Bove, Esquire and Chad S.C. Stover, Esquire of Novak Druce Connolly Bove + Quigg LLP, Wilmington, DE, of Counsel: Paul H. Berghoff, Esquire, Joshua R. Rich, Esquire, Jeremy E. Noe, Esquire, and Alison J. Baldwin, Esquire of McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL, for Plaintiff.

John C. Phillips, Jr., Esquire and Megan C. Haney, Esquire, of Phillips, Goldman & Spence, P.A., Wilmington, DE, of Counsel: George C. Lombardi, Esquire, Lynn MacDonald Ulrich, Esquire, Ivan M. Poullaos, Esquire, Julia Mano Johnson, Esquire, John R. McNair, Esquire, and Elizabeth J. Thompson, Esquire of Winston & Strawn LLP, Chicago, IL, for Defendant.

MEMORANDUM OPINION

BURKE, United States Magistrate Judge.

INTRODUCTION

Plaintiff, Bristol–Myers Squibb Company (“BMS”), markets a medication under the trade name Baraclude® for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication, and either evidence of persistent elevations in serum aminotransferases or histologically active disease. (D.I. 135, ex 1 (hereinafter “Uncontested Facts”) at ¶¶ 21–23) The medication contains 0.5 mg and 1 mg of the compound entecavir in tablet form. ( Id. at ¶ 22) The United States Food and Drug Administration's (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) lists United States Patent No. 5,206,244 (the “ '244 Patent”) in connection with BMS's Baraclude product. ( Id. at ¶ 9)

Defendant Teva Pharmaceuticals USA, Inc. (“Teva”) filed an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Baraclude for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication, and either evidence of persistent elevations in serum aminotransferases or histologically active disease. ( Id. at ¶¶ 2425) On September 22, 2010, BMS initiated this litigation against Teva in connection with the Paragraph IV certification contained in Teva's ANDA. ( Id. at ¶ 34)

On August 8, 2012, the parties jointly consented to the Court's authority to conduct all proceedings in this case, including trial, the entry of final judgment, and all post-trial proceedings. (D.I. 132) The Court held a bench trial from October 15, 2012 to October 18, 2012. (D.I. 142; D.I. 143; D.I. 144; D.I. 145 (collectively, “Tr.”)) At trial, Teva contended that claim 8 of the '244 Patent is invalid as obvious under 35 U.S.C. § 103 (“Section 103”). (D.I. 151 at ¶ 8) Teva also asserted that the '244 Patent is unenforceable based on inequitable conduct committed by certain former BMS employees before the U.S. Patent and Trademark Office (“PTO”). (Uncontested Facts at ¶ 37; D.I. 151 at ¶ 8) The parties completed post-trial briefing on December 17, 2012. (D.I. 150; D.I. 151; D.I. 156; D.I. 157) The 30–month stay imposed by 21 U.S.C. § 355(j)(5)(B)(iii) on the FDA in relation to granting final approval of Teva's ANDA expires on or around February 12, 2013. (Uncontested Facts at ¶ 30)

As explained below, the Court finds in favor of Teva as to invalidity, finding that Teva has demonstrated by clear and convincing evidence that Claim 8 of the '244 Patent is invalid as obvious under Section 103. The Court finds in favor of BMS with respect to inequitable conduct, finding that Teva has not met its burden to prove that certain then-BMS employees committed inequitable conduct before the PTO regarding the application that led to the issuance of the '244 Patent.

Pursuant to Federal Rule of Civil Procedure 52(a), the Court hereby presents its findings of fact and conclusions of law.

FINDINGS OF FACT

I. BACKGROUND

A. Nature and Stage of Proceedings

1. BMS is the holder of New Drug Application (“NDA”) No. 21–797 for a medication in tablet form containing 0.5 mg and 1 mg of entecavir. (Uncontested Facts at ¶ 21)

2. On March 29, 2005, the FDA approved the marketing of the medication described in NDA No. 21–797 for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication, and either evidence of persistent elevations in serum aminotransferases or histologically active disease. ( Id. at ¶ 22)

3. BMS sells the medication described in NDA No. 21–797 in the United States under the trade name Baraclude. ( Id. at ¶ 23)

4. Teva has filed ANDA No. 202122 seeking approval to market a generic version of Baraclude. ( Id. at ¶ 24) Teva's ANDA application, containing a Paragraph IV certification, constituted an act of infringement of claim 8 of the '244 Patent under 25 U.S.C. § 271(e)(2), to the extent that claim was found to be valid and enforceable. ( Id. at ¶ 39)

5. The thirty-month stay barring Teva from marketing its drug expires on or around February 12, 2013. ( Id. at ¶ 30; 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(b)(3))

B. Key Players

6. Dr. Robert Zahler is one of two named inventors on the '244 Patent. (JTX 1) ¹ Dr. Zahler received a Ph.D. in organic chemistry from the University of California, Berkeley in 1977. He then completed four years of post-doctoral research in the areas of physical organic chemistry and synthetic methodologies and total synthesis of natural products at University College London and the California Institute of Technology. (JTX 51; Tr. 757:15–758:3) Dr. Zahler was hired by BMS's predecessor, E.R. Squibb and Sons, Inc. (“Squibb”) in 1981, and worked there and at BMS until 2007, when he was laid off by BMS.² (JTX 51; Tr. at 513:20–514:4) Dr. Zahler currently operates a consulting business. (JTX 51; Tr. 514:5–12)

7. Dr. William A. Slusarchyk is the other named inventor on the '244 Patent. (JTX 1) Dr. Slusarchyk received a Ph.D. in organic chemistry from Penn State in 1965. (Tr. 903:14–904:5) He was employed at Squibb, and then BMS following the merger, for approximately 37 years. (Tr. 904:13–23)

8. Stephen Venetianer was a patent prosecuting attorney at BMS from 1980 until December 1990. (Tr. 977:6–15) Mr. Venetianer filed U.S. Patent Application No. 07/599,568 (the “ '568 Application”) on October 18, 1990 on behalf of Drs. Zahler and Slusarchyk; that application was the first application for the ' 244 Patent. (JTX 2.0004–107)

9. Stephen Davis was a patent prosecuting attorney at BMS from 1973 until his retirement in 2005. (Tr. 674:18–20) Mr. Davis was Mr. Venetianer's successor in prosecuting the '568 Application. (Tr. 675:16–23) On September 20, 1991, Mr. Davis filed U.S. Patent Application 07/763,033 (the “ '033 Application”) as a continuation-in-part of the '568 Application, which led to the issuance of the '244 Patent. (Tr. 677:12–16; JTX 1.0001; JTX 3.0001, .0244)

10. Dr. Clayton Heathcock is an expert witness proffered by Teva in the field of organic and medicinal chemistry. (Tr. 120:5–7) Dr. Heathcock received a Ph.D. in organic chemistry from the University of Colorado in 1963 and completed one year of post-doctoral study at Columbia University. (JTX 149.0002; Tr. 100:4–11) He is an Emeritus Professor of Chemistry at the University of California, Berkeley, where he was hired as assistant professor in 1964. (JTX 149.0002; Tr. 98:20–23; 101:1–6) During the course of his career, the primary area of Dr. Heathcock's scientific research was synthetic organic chemistry, which is a field involving the making of complicated compounds. (Tr. 102:19–103:9; 109:6–7) Dr. Heathcock also completed projects in the field of medicinal chemistry and published in the area of physical organic chemistry. (Tr. 103:9–13) He has experience training medicinal chemists who went on to work for pharmaceutical companies. (Tr. 109:7–15) Since the 1960s, Dr. Heathcock has worked as a consultant for various pharmaceutical companies in regards to their medicinal chemistry programs. (Tr. 110:16–115:12) From approximately 1986–1991, Dr. Heathcock consulted with Abbott Laboratories concerning an antiviral nucleoside analog program. (Tr. 114:7–117:9) However, Dr. Heathcock has not otherwise focused his research or work on nucleoside analogs. (Tr. 243:17–23; 244:9–11; 244:18–20; 245:7–13) Although Dr. Heathcock has frequently testified about medicinal chemistry, this is the first case involving nucleoside analogs in which he has testified. (Tr. 247:11–19)

11. Dr. Chloe L. Thio is an expert witness proffered by Teva in the area of hepatitis B infection and its treatment. (Tr. 394:18–20) Dr. Thio is a physician and Associate Professor of Medicine at John Hopkins University. (JTX 148; Tr. 384:11–14) She received an M.D. from Yale University in 1992. (Tr. 385:18–20) Dr. Thio predominantly treats patients with infectious diseases, specializing in the treatment of hepatitis and HIV infections. (Tr. 387:13–18) Her research focuses mainly on hepatitis B and HIV-hepatitis B co-infection. (Tr. 389:7–8)

12. Dr. Bud C. Tennant is an expert witness proffered by BMS in the areas of woodchuck hepatitis virus, woodchuck research, and the testing of antiviral drugs on woodchucks. (Tr. 988:13–17) Dr. Tennant received a Ph.D. in veterinary medicine from the University of California in 1959. (JTX 147; Tr. 983:14–18) He is currently the James Law Professor of Comparative Medicine at Cornell University. (JTX 147; Tr. 985:3–9) For the past thirty years, Dr. Tennant's primary research work has been done on the woodchuck model of hepatitis B infection. (Tr. 985:20–24)

13. Dr. Stewart Schneller is an expert witness proffered by BMS in the area of nucleoside analog research. (Tr. 1052:24–1053:3) Dr. Schneller received a Ph.D. in organic chemistry from Indiana University in 1968. (JTX 145; Tr. 1045:23–1046:7) He then completed three years of post-doctoral work in organometallic chemistry. (JTX 145; Tr. 1045:24–1046:12) Dr. Schneller is currently a Professor of Chemistry and Biochemistry at Auburn University. (JTX 145; Tr....