[의약품]Sanofi-Aventis U.S., LLC/ Aventis Pharma SA/ Sanofi 대 Fresenius Kabi USA, LLC 간의 의약품 관련 특허 분쟁

발생일자 2015.04.13

사건번호 3:15-cv-02631

법원국가 UNITED STATES OF AMERICA

관할법원명 D.C.NewJersey(지방법원)

침해권리 특허

원고명 Sanofi-Aventis U.S., LLC/ Aventis Pharma SA/ Sanofi ( 미국 / 외국기업 )

피고명 Fresenius Kabi USA, LLC ( 미국 / 외국기업 )

소송유형 침해금지

분쟁내용

[Sanofi-Aventis U.S., LLC et al v. Fresenius Kabi USA, LLC] 사건번호 3:15-cv-02631에 따르면 원고 Sanofi-Aventis U.S., LLC/ Aventis Pharma SA/ Sanofi는 피고 Fresenius Kabi USA, LLC을 상대로 특허 US8927592을 침해하였다는 이유로 미국 뉴저지 지방법원에 소를 제기하였다.

분쟁결과 분쟁중

산업분류 화학∙바이오 > 의약품

계쟁제품 Cabazitaxel injection, 60 mg/ 1.5 mL (40 mg/mL), generic version of JEVTANA

지재권번호/명칭

US8927592 Antitumoral use of cabazitaxel

Antitumoral use of cabazitaxel

Abstract

The invention relates to a compound of formula: ##STR00001## which may be in base form or in the form of a hydrate or a solvate, in combination with prednisone or prednisolone, for its use as a medicament in the treatment of prostate cancer, particularly metastatic prostate cancer, especially for patients who are not catered for by a taxane-based treatment.

Claims

What is claimed is:

1. A method for treating a patient with prostate cancer that has progressed during or after treatment with docetaxel, comprising administering to said patient a dose of 20 to 25 mg/m.sup.2 of cabazitaxel, or a hydrate or solvate thereof, in combination with a corticoid.

2. The method according to claim 1, where the prostate cancer is an advanced metastatic disease.

3. The method according to claim 1, where the cabazitaxel is in the form of an acetone solvate.

4. The method according to claim 3, in which the acetone solvate contains between 5% and 8% by weight of acetone.

5. The method according to claim 1, comprising repeating the administration of cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

6. The method according to claim 1, wherein the cabazitaxel is in base form.

7. The method according to claim 1, wherein said cabazitaxel, or hydrate or solvate thereof, is administered in an amount to provide an AUC of about 991 ngh/mL (CV 34%).

8. The method according to claim 1, wherein said cabazitaxel, or hydrate or solvate thereof, is administered in an amount to provide an C.sub.max of about 226 ngh/mL (CV 107%).

9. The method according to claim 1 wherein said cabazitaxel, or hydrate or solvate thereof, is administered in an amount to provide a plasma clearance of 48.5 L/h (CV 39%).

10. The method according to claim 1, further comprising monitoring blood counts and measuring neutrophil levels in the patient.

11. The method according to claim 10, further comprising discontinuing cabazitaxel treatment in a patient with a neutrophil count of .ltoreq.1,500 cells/mm.sup.3.

12. The method according to claim 1, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

13. The method according to claim 1, wherein the corticoid is selected from the group consisting of prednisone and prednisolone.

14. The method according to claim 13, where the prednisone or prednisolone is administered at a dose of 10 mg/day.

15. The method according to claim 14, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m.sup.2.

16. The method according to claim 14, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

17. The method according to claim 1, where the prostate cancer is a castration resistant or hormone-refractory prostate cancer.

18. The method according to claim 17, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

19. The method according to claim 17, comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

20. The method according to claim 1, wherein the prostate cancer is a castration resistant or hormone-refractory, metastatic prostate cancer.

21. The method according to claim 20, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m.sup.2.

22. The method according to claim 20, where cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

23. The method according to claim 20, comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

24. The method according to claim 1, wherein the prostate cancer is a castration resistant or hormone-refractory, metastatic prostate cancer, and wherein the corticoid is selected from the group consisting of prednisone and prednisolone, and wherein the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

25. The method according to claim 24, comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

26. The method according to claim 1, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m.sup.2.

27. A method of increasing the survival of a patient with a castration resistant or hormone refractory, metastatic prostate cancer that has progressed during or after treatment with docetaxel, comprising administering a dose of 20 to 25 mg/m.sup.2 of cabazitaxel, or hydrate or solvate thereof, to the patient in combination with prednisone or prednisolone.

28. The method according to claim 27, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 25 mg/m.sup.2.

29. The method according to claim 27, comprising repeating the administration of said cabazitaxel, or hydrate or solvate thereof, as a new cycle every 3 weeks.

30. The method according to claim 27, where the cabazitaxel, or hydrate or solvate thereof, is administered at a dose of 20 mg/m.sup.2.

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