[의약품]Novartis Pharmaceuticals Corporation 대 BPI LABS, LLC 간의 의약품 관련 특허 분쟁

발생일자 2015.02.05

사건번호 2:15-cv-00950

법원국가 UNITED STATES OF AMERICA

관할법원명 D.C.NewJersey(지방법원)

침해권리 특허

원고명 Novartis Pharmaceuticals Corporation ( 스위스 / 외국기업 ) 

피고명 BPI LABS, LLC ( 미국 / 외국기업 ) 

소송유형 침해금지

분쟁내용
[Novartis Pharmaceuticals Corporation v. BPI LABS, LLC] 사건번호 2:15-cv-00950에 따르면 원고 Novartis Pharmaceuticals Corporation는 피고 BPI LABS, LLC을 상대로 특허 US8324189 을 침해하였다는 이유로 미국 뉴저지 지방법원에 소를 제기하였다.

분쟁결과 분쟁중

산업분류 화학∙바이오 > 의약품

계쟁제품 4 mg / 5 mL vials of zoledronic acid concentrate, generic version of Zometa

지재권번호/명칭
US8324189   Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases

Use of zolendronate for the manufacture of a medicament for the treatment of bone metabolism diseases

Abstract

A method of intravenously administering a bisphosphonate to a patient in need of bisphosphonate treatment comprising intravenously administering 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid (zoledronic acid) or a pharmaceutically acceptable salt thereof over a period of 15 minutes to a patient in need of said treatment.

Claims

We claim:

 1. A method of treatment of bone metabolism diseases, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein said intravenous administration improves renal safety.

 2. The method according to claim 1, wherein said bone metabolism disease is tumour induced hypercalcemia.

 3. The method according to claim 1, wherein said infusion volume is from about 50 to about 100 ml.

 4. The method according to claim 1, wherein said infusion volume is about 100 ml.

 5. The method according to claim 1, wherein the 2(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

 6. The method according to claim 5, wherein said pharmaceutically acceptable cation is sodium.

 7. A method of treatment of bone metastases, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein said intravenous administration improves renal safety.

 8. The method according to claim 7, wherein said infusion volume is from about 50 to about 100 ml.

 9. The method according to claim 7, wherein said infusion volume is about 100 ml.

 10. The method according to claim 7, wherein the 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

 11. The method according to claim 10, wherein said pharmaceutically acceptable cation is sodium.

 12. A method of treatment of multiple myeloma, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein the intravenous administration improves renal safety.

 13. The method according to claim 12, wherein said infusion volume is from about 50 to abut 100 ml.

 14. The method according to claim 12, wherein said infusion volume is about 100 ml.

 15. The method according to claim 12, wherein the 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

 16. The method according to claim 15, wherein said pharmaceutically acceptable cation is sodium.

 17. A method of treatment of bone metabolism diseases, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein said intravenous administration reduces incidence of renal toxicity.

 18. The method according to claim 17, wherein said bone metabolism disease is tumour induced hypercalcemia.

 19. The method according to claim 17, wherein said infusion volume is from about 50 to about 100 ml.

 20. The method according to claim 17, wherein said infusion volume is about 100 ml.

 21. The method according to claim 17, wherein the 2(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

 22. The method according to claim 21, wherein said pharmaceutically acceptable cation is sodium.

 23. A method of treatment of bone metastases, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein said intravenous administration reduces incidence of renal toxicity.

 24. The method according to claim 23, wherein said infusion volume is from about 50 to about 100 ml.

 25. The method according to claim 23, wherein said infusion volume is about 100 ml.

 26. The method according to claim 23, wherein the 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

 27. The method according to claim 26, wherein said pharmaceutically acceptable cation is sodium.

 28. A method of treatment of multiple myeloma, said method comprising intravenous administration of 4 mg of 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid or a pharmaceutically acceptable salt thereof in an infusion solution volume of from about 5 up to about 200 ml over a period of 15 minutes to a patient in need of said treatment, wherein the intravenous administration reduces incidence of renal toxicity.

 29. The method according to claim 28 wherein said infusion volume is from about 50 to about 100 ml.

 30. The method according to claim 28, wherein said infusion volume is about 100 ml.

 31. The method according to claim 28, wherein the 2-(imidazol-1yl)-1-hydroxyethane-1,1-diphosphonic acid is in the form of a pharmaceutically acceptable salt having one acidic hydrogen and one pharmaceutically acceptable cation in each of the phosphonic acid groups.

 32. The method according to claim 31, wherein said pharmaceutically acceptable cation is sodium.

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