Bristol Myers Squibb Holdings Ireland Unlimited v Norton (Waterford) Ltd T/A Teva Pharmaceuticals Ireland

JurisdictionIreland
JudgeMr Justice Max Barrett
Judgment Date08 December 2023
Neutral Citation[2023] IEHC 744
CourtHigh Court
Docket Number[2021 No. 1 PAP] [2021 No. 4758 P] [2021 No. 4759 P]

In the Matter of Irish Patent Number European Patent (IE) 1 427 415 “Lactam-Containing Compounds and Derivatives thereof As Factor XA Inhibitors” and Registered in the Name of Bristol-Myers Squibb Holdings Ireland Unlimited Company

and

In the Matter of the Patents Act 1992 to 2019

Between
Bristol Myers Squibb Holdings Ireland Unlimited
Petitioner
and
Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland
Respondent

[2023] IEHC 744

[2021 No. 1 PAP]

[2021 No. 3 PAP]

[2021 No. 4758 P]

[2021 No. 4759 P]

THE HIGH COURT

Summary

In this judgment I explain (i) why Irish Patent Number EP (IE) 1 427 415 is not valid, but (ii) how, by virtue of Delaware law, if it was valid (and it is not) it would enjoy its presently claimed priority date.

TABLE OF CONTENTS

VOLUME 1

I. SOME PREFATORY OBSERVATIONS

1. Introduction/Some Key Points

II. THE OPENING SUBMISSIONS

2. The Opening Submissions for Teva and BMS

III. THE IN-HOUSE EVIDENCE

3. Some Prefatory Remarks

4. Viva Voce Examination of Mr Brown

5. The Evidence of Ms Leung

6. The Evidence of Mr Golian

7. Some Conclusions

IV. THE EVIDENCE OF MESSRS RASSER AND GRANWELL

8. Some Prefatory Observations

9. The Evidence of Dr Rasser

10. The Evidence of Mr Granwell

V. THE EPC-RELATED EVIDENCE

11. Some Prefatory Observations

12. The Evidence of Dr Kinkeldey

13. The Evidence of Mr Rennie-Smith

14. Some Conclusions

VI. THE EVIDENCE AS TO UNITED STATES FEDERAL LAW

15. Some Prefatory Observations

16. The Evidence of Professor Thomas

17. The Evidence of Professor Chisum

18. Some Conclusions

VII. THE EVIDENCE AS TO DELAWARE LAW

19. The Evidence of Mr Steele

20. The Evidence of Mr Chandler

21. Some Conclusions

VIII. THE SCIENTIFIC EVIDENCE

22. Some Prefatory Observations

IX. THE PHARMACOLOGY EVIDENCE

23. The Evidence of Dr Gallagher

24. The Evidence of Professor Morrissey

X. THE PHARMACOKINETIC EVIDENCE

25. The Evidence of Dr Wargin

26. The Evidence of Professor Taft

XI. THE MEDICINAL CHEMISTRY EVIDENCE

27. The Evidence of Dr Edwards

28. The Evidence of Dr Young

29. Some Conclusions and Criticisms

XII. SOME FURTHER MATTERS CONSIDERED

30. Judicial Comity

31. The Expert Evidence

XIII. CONSOLIDATED CASES G1/22 AND G2/22

32. Consolidated Cases G1/22 and G2/22

XIV. FINAL CONCLUSIONS

33. Final Conclusions

VOLUME 2

APPENDICES

Appendix 1: Written Evidence of Mr CHANDLER.

Appendix 2: Written Evidence of Prof. CHISUM.

Appendix 3: Written Evidence of Dr EDWARDS.

Appendix 4: Written Evidence of Dr GALLAGHER.

Appendix 5: Written Evidence of Mr GOLIAN.

Appendix 6: Written Evidence of Mr GRANWELL.

Appendix 7: Written Evidence of Dr KINKELDEY.

Appendix 8: Written Evidence of Ms LEUNG.

Appendix 9: Written Evidence of Prof. MORRISSEY.

Appendix 10: Written Evidence of Dr RASSER.

Appendix 11: Written Evidence of Mr RENNIE-SMITH.

Appendix 12: Written Evidence of Mr STEELE.

Appendix 13: Written Evidence of Prof. TAFT.

Appendix 14: Written Evidence of Prof. THOMAS.

Appendix 15: Written Evidence of Dr WARGIN.

Appendix 16: Written Evidence of Dr YOUNG.

Appendix 17: Translated text of judgment in SAS Teva Santé v. BMS Holdings Ireland Unlimited Co.

(Judicial Court of Paris, 8 th June 2023).

Appendix 18: Translated text of judgment in Teva Norway AS v. BMS Holdings Ireland Unlimited Co.,

(Oslo District Court, 22 nd May 2023).

Appendix 19: Translated text of judgment in Teva Sweden AB v. BMS Holdings Ireland Unlimited Co.

(Stockholm, 2 nd November 2022).

Appendix 20: Professor Morrissey's Oral Testimony in London

Appendix 21: Translated text of judgment in

BMS Holdings Ireland Unlimited Co v. Sandoz BV,

(Court of Appeal of The Hague, 15 th August 2023).

CASES REFERRED TO IN THIS JUDGMENT

To avoid repeated case citations in the main body of this judgment and so to conserve space, the citations of various cases that are repeatedly referred to and/or considered in the main body of this judgment (not the appendices) are referred to below.

European Patent Office

Case G-0005/83 (Second medical indication) (ECLI:EP:BA:1984:G000583.19841205)

Case J-0019/87 Assignee (ECLI:EP:BA:1988:J001987.19880321)

Case G-0004/88 Transfer of opposition (ECLI:EP:BA:1989:G000488.19890424)

Case T-0939/92 Triazoles/AGREVO (ECLI:EP:BA:1995:T093992.19950912)

Case T-0590/98 Radiopharmaceuticals/AMERSHAM PLC (ECLI:EP:BA:2003:T059098.20030430)

Case T-1329/04 (Factor-9/JOHN HOPKINS) (ECLI:EP:BA:2005:T132904.20050628)

Case T-578/06 Pancreatic cells/IPSEN (ECLI:EP:BA:2011:T057806.20110629)

Case T-1642/07 (Viral enhancement of cell killing/Arch Development Corporation) (ECLI:EP:BA:2010:T164207.20101202)

Case T-0577/11 (Entitlement to priority) (ECLI:EP:BA:2016:T057711.20160414)

Case T-0205/14 Ibandronate sodium, Form QQ/Teva (ECLI:EP:BA:2015:T020514.20150618)

Case T-1201/14 (Transfer of right of priority) (ECLI:EP:BA:2017:T120114.20170209)

Case T-1103/15 University of Alabama (ECLI:EP:BA:2018:T110315.20180222)

Case T-1786/15 (BMP Antagonists/General Hospital Corporation) (ECLI:EP:BA:2020:T178615.20201015)

Case T-0488/16 Dasatinib/BMS (ECLI:EP:BA:2017:T048816.20170201)

Case T-1322/17 Ibandronate/ATNAHS (ECLI:EP:BA:2019:T132217.20190319)

Case G-0002/21 (Insecticide compositions/Sumitomo) (ECLI:EP:BA:2023:G000221.20230323)

France

Teva Santé v. BMS Holdings Ireland Unlimited Company, Judicial Court of Paris, 8 th June 2023.

Ireland

( Banco Ambrosiano. SPA v. Ansbacher & Co. Ltd Unreported, Supreme Court, 8th April 1987) [ 1987 ILRM 669].

Data Protection Commissioner v. Facebook Ireland Ltd [2019] IESC 46 [2019] 3 IR 255

Doyle v. Banville [2012] IESC 25 [2018] 1 IR 505.

Duffy v. McGee [2022] IECA 254

Glaxo Group Ltd & Patents Act 1992 [2009] IEHC 277

Keneally v. De Puy International Ltd [2016] IEHC 728 [2017] 2 IR 487.

Kutchera v. Buckingham International Holdings Ltd [1988] I.R. 61.

Lehane v. Dunne [2018] IECA 7.

MacNamara v. Owners of the SS “Hatteras” (No. 2) [1933] IR 675.

McC v. McC [1994] 1 IR 293.

McCaughey v. IBRC [2013] IESC 17.

Norton (Waterford) Ltd t/a Teva Pharmaceuticals Ltd v. Boehringer Ingelheim Pharma GmbH & Co. KG [2022] IECA 58.

O'Brien v. Clerk of Dáil Eireann [2016] 3 IR 384.

O'Callaghan v. O'Sullivan [1925] 1 IR 90.

O'Leary v. Mercy University Hospital Cork [2019] IESC 48.

Ranbaxy Laboratories Ltd v. Warner-Lambert Co [2007] IEHC 256.

Re Boehringer Ingelheim Pharma GmbH [2017] IEHC 495.

Unicredit Global Leasing Export GmbH v. Business Aviation Limited [2019] IEHC 139 [2019] 3 IR 689.

Walsh v. National Irish Bank Ltd [2013] IESC 2 [2013] 1 IR 294.

The Netherlands

BMS Holdings Ireland Unlimited Co v. Sandoz BV and ors, Court of Appeal of The Hague, 15 th August 2023.

Norway

Teva Norway AS and Anor v. BMS Holdings Ireland Unlimited Company, Oslo District Court, 22 nd May 2023

Sweden

Teva Sweden Aktiebolag v. BMS Holdings Ireland Unlimited Company, 2 nd November 2022.

United Kingdom

Accord Healthcare Ltd v. Research Corporation Technologies [2017] EWHC 2711 (Ch).

Actavis Group PTC v. ICOS Corporation [2019] UKSC 15

Advanced Bionics v. Med-El Elektromedizinische Geräte GmbH [2023] EWCA Civ 637.

Arrow Generics Ltd v. Merck & Co. Inc [2007] EWHC 1900 (Pat.).

Baron de Bode's Case (1845) 8 Q.B. 208, 115 E.R. 854.

Biogen Inc. v. Medeva plc [1997] RPC 1.

E. Mishan & Sons Inc. v. Hozelock Ltd [2020] EWCA Civ. 871.

Earl Nelson v. Lord Bridport 50 ER 207 (1845) 8 Beav. 527 (Rolls Court).

FibroGen Inc. v. Akebia Therapeutics Inc. [2021] EWCA Civ. 1279.

Fisher & Paykel Healthcare Limited v. Flexicare Medical Limited [2020] EWHC 3282 (Pat.).

Fujifilm Kyowa Biologics Company Ltd v. Abbvie Biotechnology Ltd [2017] EWHC 395 (Pat.).

HTC Corp v. Gemalto SA [2013] EWHC 1876 (Pat.).

Idenix Pharmaceuticals Inc. v. Gilead Sciences Inc. [2016] EWCA Civ. 1089.

KCI Licensing Inc. v. Smith & Nephew Plc [2010] EWHC 1487 (Pat.).

Kirin-Amgen Inc v. Hoechst Marion Roussel Ltd. [2005] RPC 9.

Medimmune v. Novartis [2011] EWHC 1669 (Pat.).

Mills & Rockley (Electronics) Ltd v. Technograph Printed Circuits Ltd [1971] FSR 188.

Pharmacia v. Merck [2001] EWCA Civ. 1610.

Regeneron Pharmaceuticals v. Genentech Inc [2013] EWCA Civ. 93.

Sandoz Ltd v. BMS Holdings Ireland Unlimited Co. [2022] EWHC 822 (Pat.).

Sussex Peerage Case (1844) 11 Cl & F 85.

National Justice Compania Naviera SA v. Prudential Assurance Co Ltd. (The Ikarian Reefer) (No. 1) [1993] 2 Lloyd's Rep. 68.

Virgin Atlantic Airways Ltd v. Premium Aircraft Interiors UK Ltd [2009] EWCA Civ. 1062.

Warner-Lambert Co LLC v. Generics (UK) Ltd [2018] UKSC 56.

United States

Abraxis Bioscience Inc v. Navinta LLC 625 F.3d 1359 (2010).

Ager v. Murray 105 U.S. 126 (1881).

Akazawa v. Link New Technology International Inc., 520 F.3d 1354 (2008).

Anadarko Petrol. Corp. v. Panhandle E. Corp., 545 A.2d 117 1 (Del. 1988).

Anderson v. C.I.R., 164 F.2d 870 (7th Cir 1947).

Arachnid, Inc. v. Merit Indus., Inc., 939 F.2d 1574, 1578–80 & n3. (Fed. Cir. 1991).

Aronson. v. Lewis, 473 A.2d 805 (Del.Supr.1984).

Baltimore & Ohio R. Co. v. Baugh, 149 U. S. 368,

Bausch & Lomb, Inc. v. Commissioner, 92 T.C. 525 (1989).

Beam Laser Systems, Inc. v. Cox Communications, Inc., 117 F.Supp.2d 515 (E.D. Va. 2000).

Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc, 583 F.3d 832 (Fed. Cir. 2009).

Buechner v. Farbenfabriken Bayer AG, 38 Del Ch 490 154 A.2d 684, 686–87 (Del. 1959).

Cartanza v. Lynn, 2002 WL 31007802 (Del. Ch. Aug. 8, 2002).

CME Group Inc. v. Chi. Bd. Options Exch., 2009 WL 1856693 (Del. Ch. June 25, 2009).

Dalzell v. Dueber Watch-Case Mfg. Co. 149 U.S. 315, 320 (1893).

Danvir Corp. v. Wahl, 1987 WL 16507 (Del. Ch. Sept. 8, 1987).

DDB Techs LLC v. MLB Advanced Media LP 517 F.3d 1284 (Fed. Cir. 2008).

DePuy Inc. v. Zimmer Holdings Inc. 384 F. Supp. 2d 1237 (ND III. 2005).

Dickman v. Volmer 303 Wis. 2d 241, 736 N.W.2d 202 (Wis. Ct. App. 2007).

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2 cases
  • Bristol Myers Squibb Holdings Ireland Unlimited Company v Norton (Waterford) Ltd
    • Ireland
    • Court of Appeal (Ireland)
    • March 1, 2024
    ...In the meantime, the invalidity action has been heard and determined by Barrett J. In a reserved judgment delivered on 8 December 2023 ( [2023] IEHC 744) he held that the underlying patent was 15 . BMS has lodged an appeal against this decision and sought a stay on the order and an injuncti......
  • Bristol-Myers Squibb Holdings Ireland Company v Norton (Waterford) Ltd Trading as TEVA
    • Ireland
    • Court of Appeal (Ireland)
    • June 13, 2024
    ...on the 13 th day of June, 2024 Introduction 1 . By a judgment delivered on 8 December 2023 in the patent proceedings (2021 No.1 PAP), ( [2023] IEHC 744) the High Court held that Irish Patent No. EP (IE) 1 427 415 (“the patent”) is invalid. As a consequence, the Supplementary Protection Cert......

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