[의약품]Bausch & Lomb Incorporated/ Bausch & Lomb Pharma Holdings Corp./ SENJU PHARMACEUTICAL CO, Ltd. 대 Micro Labs USA, Inc./ Micro Labs Limited 간의 의약품 관련 특허 분쟁

발생일자 2015.05.01

사건번호 1:15-cv-03113

법원국가 UNITED STATES OF AMERICA

관할법원명 D.C.NewJersey(지방법원)

침해권리 특허

원고명 Bausch & Lomb Incorporated/ Bausch & Lomb Pharma Holdings Corp./ SENJU PHARMACEUTICAL CO, Ltd. ( 미국 / 외국기업 )

피고명 Micro Labs USA, Inc./ Micro Labs Limited ( 미국 / 외국기업 )

소송유형 침해금지

분쟁내용

[Bausch & Lomb Incorporated et al v. Micro Labs USA, Inc. et al] 사건번호 1:15-cv-03113에 따르면 원고 Bausch & Lomb Incorporated/ Bausch & Lomb Pharma Holdings Corp./ SENJU PHARMACEUTICAL CO, Ltd.는 피고 Micro Labs USA, Inc./ Micro Labs Limited을 상대로 특허 US8877168을 침해하였다는 이유로 미국 뉴저지 지방법원에 소를 제기하였다.

분쟁결과 분쟁중

산업분류 화학∙바이오 > 의약품

계쟁제품 Generic bepotastine besilate ophthalmic solution, 1.5%

지재권번호/명칭

US8877168 Aqueous liquid preparations and light-stabilized aqueous liquid preparations

Aqueous liquid preparations and light-stabilized aqueous liquid preparations

Abstract

An aqueous liquid preparation containing (+)-(S)-4-[4-[(4-chlorophenyl) (2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof, which is stabilized with a water-soluble metal chloride, is provided.

Claims

The invention claimed is:

1. An aqueous liquid preparation consisting of, in an aqueous solution: (a) an active ingredient consisting of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof; (b) a water-soluble metal chloride in a light-stabilizing effective amount; (c) water; and (d) at least one material selected from the group consisting of a buffer, a preservative, a chelating agent, sodium hydroxide, and a flavor; wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt thereof has a concentration selected from the range of a lower limit concentration of 0.1 w/v % and an upper limit concentration of 2.0 w/v %; and wherein the metal chloride has a concentration selected from the range of a lower limit concentration of 0.15 w/v % and an upper limit concentration of 1.5 w/v %.

2. The aqueous liquid preparation according to claim 1, wherein the metal chloride is selected from the group consisting of sodium chloride, potassium chloride and calcium chloride.

3. The aqueous liquid preparation according to claim 1, wherein the acid addition salt is monobenzenesulfonate.

4. The aqueous liquid preparation according to claim 1, wherein the aqueous liquid preparation has a pH in the range of 4-8.5.

5. The aqueous liquid preparation according to claim 1, wherein the metal chloride has a concentration selected from the range of a lower limit concentration of 0.2 w/v % and an upper limit concentration of 1.2 w/v %.

6. The aqueous liquid preparation according to claim 1, wherein the metal chloride has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.2 w/v %.

7. The aqueous liquid preparation according to claim 1, wherein the metal chloride is sodium chloride and has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.0 w/v %.

8. The aqueous liquid preparation according to claim 1, wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt thereof has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 2.0 w/v %.

9. The aqueous liquid preparation according to claim 1, wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt thereof has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.5 w/v %.

10. The aqueous liquid preparation according to claim 1, wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt thereof has a concentration selected from the range of a lower limit concentration of 0.5 w/v % and an upper limit concentration of 1.5 w/v %.

11. The aqueous liquid preparation according to claim 1, which is an eye drop.

12. The aqueous liquid preparation according to claim 1, which is a nasal drop.

13. The aqueous liquid preparation according to claim 1, wherein: (a) the acid addition salt of the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid is monobenzenesulfonate salt, and the acid addition salt has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.5 w/v %; (b) the water-soluble metal chloride is selected from the group consisting of sodium chloride, potassium chloride, and calcium chloride, and the metal chloride has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.0 w/v %; and the aqueous liquid preparation has a pH min the range of 5-8.

14. The aqueous liquid preparation according to claim 13, wherein the metal chloride is sodium chloride.

15. The aqueous liquid preparation according to claim 13, wherein the metal chloride is potassium chloride.

16. An aqueous eye drop consisting of: (a) an active ingredient consisting of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof; (b) at least one water-soluble metal chloride selected from the group consisting of sodium chloride, potassium chloride, and calcium chloride; (c) sodium dihydrogenphosphate buffer; (d) a preservative; (e) water; and (f) sodium hydroxide; wherein the metal chloride has a concentration selected from the range of a lower limit concentration of 0.2 w/v % and an upper limit concentration of 1.2 w/v %; and wherein the pH is in the range of 5-8.

17. The aqueous liquid preparation according to claim 16, wherein the acid addition salt is monobenzenesulfonate.

18. The aqueous liquid preparation according to claim 16, wherein the metal chloride has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.2 w/v %.

19. The aqueous liquid preparation according to claim 16, wherein the metal chloride is sodium chloride and has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.0 w/v %.

20. The aqueous liquid preparation according to claim 16, wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt thereof has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 2.0 w/v %.

21. The aqueous liquid preparation according to claim 16, wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt thereof has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.5 w/v %.

22. The aqueous liquid preparation according to claim 16, wherein the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or the pharmacologically acceptable acid addition salt thereof has a concentration selected from the range of a lower limit concentration of 0.5 w/v % and an upper limit concentration of 1.5 w/v %.

23. An aqueous liquid preparation consisting of, in an aqueous solution: (a) an active ingredient consisting of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof; (b) a water-soluble metal chloride; (c) benzalkonium chloride; (d) sodium dihydrogenphosphate dihydrate; (e) sodium hydroxide; and (f) water; wherein the metal chloride is sodium chloride and has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.0 w/v %; and wherein the pH is in the range of 6-8.

24. The aqueous liquid preparation according to claim 23, wherein the active ingredient consists of (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid monobenzenesulfonate.

25. The aqueous liquid preparation according to claim 24, wherein the sodium chloride has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 0.8 w/v %.

26. The aqueous liquid preparation according to claim 25, wherein the active ingredient has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 2.0 w/v %.

27. The aqueous liquid preparation according to claim 26, wherein the active ingredient has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 1.5 w/v %.

28. The aqueous liquid preparation according to claim 26, wherein the active ingredient has a concentration selected from the range of a lower limit concentration of 0.5 w/v % and an upper limit concentration of 1.5 w/v %.

29. The aqueous liquid preparation according to claim 23, wherein (a) the acid addition salt of the (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid is monobenzenesulfonate salt, and the monobenzenesulfonate salt has a concentration selected from the range of a lower limit concentration of 0.5 w/v % and an upper limit concentration of 1.5 w/v %; and (b) the water-soluble metal chloride is sodium chloride, and the sodium chloride has a concentration selected from the range of a lower limit concentration of 0.3 w/v % and an upper limit concentration of 0.8 w/v %.

30. The aqueous liquid preparation according to claim 29, wherein the monobenzenesulfonate salt has a concentration of 1.5 w/v %. 

   출처