[기초재료화학기술]Diabetic Care RX, LLC 대 Pentec Health, Inc. 간의 기초재료화학기술 관련 특허 분쟁

발생일자 2015.03.13

사건번호 0:15-cv-60532

법원국가 UNITED STATES OF AMERICA

관할법원명 D.C.S.D.Florida(지방법원)

침해권리 특허

원고명 Diabetic Care RX, LLC ( 미국 / 외국기업 )

피고명 Pentec Health, Inc. ( 미국 / 외국기업 )

소송유형 Declaratory Judgement

분쟁내용

[Diabetic Care RX, LLC v. Pentec Health, Inc.] 사건번호 0:15-cv-60532에 따르면 원고 Diabetic Care RX, LLC는 피고 Pentec Health, Inc.을 상대로 특허 US8927505을 침해하지 않았다는 이유로 미국 플로리다 남부 지방법원에 소를 제기하였다.

분쟁결과 분쟁중

산업분류 화학∙바이오 > 기초재료화학기술

계쟁제품 Intradialytic parenteral nutrition therapies (Declaratory Judgment)

지재권번호/명칭

US8927505 Nutritive compositions and methods of using same

Nutritive compositions and methods of using same

Abstract

The invention provides intradialytic parenteral nutrition (IDPN) compositions with low carbohydrate for the treatment of malnutrition in dialysis subjects. In some embodiments, the IDPN compositions are advantageous for the treatment of malnutrition in subjects who are diabetic or suffer from other glucose management related pathologies or subjects who benefit from strict fluid management.

Claims

What is claimed is:

1. A method, comprising administering a sterile aqueous intradialytic parenteral, nutrition (IDPN) solution to a human subject in need thereof, the IDPN solution comprising between 0.02 g/mL and 0.1 g/mL of dextrose and between 0.1 g/mL and 0.2 g/mL of amino acids, wherein the solution is lipid-free and the dextrose and the amino acids are both present in the same aqueous solution, and wherein the IDPN solution, when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.01 g/dL to about 1.0 g/dL.

2. A method, comprising administering a sterile aqueous IDPN solution to a human subject in need thereof, the IDPN solution comprising between 0.02 g/mL and 0.1 g/mL of dextrose, between 0.1 g/mL and 0.2 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids, wherein the dextrose, the amino acids, and the lipids are all present in the same aqueous solution, and wherein the IDPN solution , when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.01 g/dL to about 1.0 g/dL.

3. The method of claim 1 or 2, wherein the amino acids comprise seventeen amino acids.

4. The method of claim 3, wherein the seventeen amino acids are lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid, and tyrosine.

5. The method of claim 1 or 2, wherein the IDPN solution comprises between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.

6. The method of claim 1 or 2, wherein the IDPN solution comprises between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.

7. The method of claim 1 or 2, wherein the IDPN solution comprises between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.

8. The method of claim 1 or 2, wherein the IDPN solution comprises between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.

9. The method of claim 1 or 2, wherein the IDPN solution comprises between 0.12 g/mL and 0.18 g/mL of amino acids.

10. The method of claim 1 or 2, wherein the IDPN solution comprises between 0.15 g/mL and 0.17 g/mL of amino acids.

11. The method of claim 1 or 2, wherein the IDPN solution, when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.1 g/dL to about 0.6 g/dL.

12. The method of claim 1 or 2, wherein the IDPN solution, when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.2 g/dL to about 0.4 g/dL.

13. The method of claim 1 or 2, wherein the IDPN solution has a volume between about 100 mL and about 2 liters.

14. The method of claim 1 or 2, wherein the IDPN solution has a volume between about 350 mL and about 635 mL.

15. The method of claim 1 or 2, wherein the IDPN solution, when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen, does not induce hyperglycemia in the subject.

16. The method of claim 1 or 2, wherein the IDPN solution comprises vitamins and minerals.

17. A method, comprising administering a sterile aqueous intradialytic parenteral, nutrition (IDPN) solution a human subject in need thereof, the IDPN solution consisting essentially of between 0.02 g/mL and 0.1 g/mL of dextrose and between 0.1 g/mL and 0.2 g/mL of amino acids, wherein the solution is lipid-free and the dextrose and the amino acids are both present in the same aqueous solution, and wherein the IDPN solution, when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.01 g/dL to about 1.0 g/dL.

18. A method, comprising administering a sterile aqueous IDPN solution a human subject in need thereof, the IDPN solution consisting essentially of between 0.02 g/mL and 0.1 g/mL of dextrose, between 0.1 g/mL and 0.2 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids, wherein the dextrose, the amino acids, and the lipids are all present in the same aqueous solution, and wherein the IDPN solution, when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.01 g/dL to about 1.0 g/dL.

19. The method of claim 17, wherein the IDPN solution consists essentially of between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.

20. The method of claim 17, wherein the IDPN solution consists essentially of between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.

21. The method of claim 18, wherein the IDPN solution consists essentially of between 0.04 g/mL and 0.08 g/mL of dextrose, between 0.12 g/mL and 0.18 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids.

22. The method of claim 18, wherein the IDPN solution consists essentially of between 0.05 g/mL and 0.07 g/mL of dextrose, between 0.15 g/mL and 0.17 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids.

23. The method of claim 17 or 18, wherein the IDPN solution, when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.1 g/dL to about 0.6 g/dL.

24. The method of claim 17 or 18, wherein the IDPN solution, when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.2 g/dL to about 0.4 g/dL.

25. The method of claim 17 or 18, wherein the IDPN solution, when administered to the human subject as part of an intradialytic parenteral nutrition treatment regimen, does not induce hyperglycemia in the subject.

26. The method of claim 1 or 2, wherein the human subject is diabetic.

27. The method of claim 26, further comprising administering insulin to the subject.

28. The method of claim 26, further comprising monitoring glucose tolerance in the subject.

29. The method of claim 28, further comprising administering insulin to the subject.

30. The method of claim 26, wherein the IDPN solution comprises between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.

31. The method of claim 26, wherein the IDPN solution comprises between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.

32. The method of claim 26, wherein the IDPN solution comprises between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.

33. The method of claim 26, wherein the IDPN solution comprises between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.

34. The method of claim 26, wherein the IDPN solution comprises between 0.12 g/mL and 0.18 g/mL of amino acids.

35. The method of claim 26, wherein the IDPN solution comprises between 0.15 g/mL and 0.17 g/mL of amino acids.

36. The method of claim 26, wherein the IDPN solution, when administered to the diabetic human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.1 g/dL to about 0.6 g/dL.

37. The method of claim 26, wherein the IDPN solution, when administered to the diabetic human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.2 g/dL to about 0.4 g/dL.

38. The method of claim 17, wherein the human subject is diabetic.

39. The method of claim 38, further comprising administering insulin to the subject.

40. The method of claim 38 or 39, further comprising monitoring glucose tolerance in the subject.

41. The method of claim 38, wherein the IDPN solution consists essentially of between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.

42. The method of claim 38, wherein the IDPN solution consists essentially of between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.

43. The method of claim 38, wherein the IDPN solution, when administered to the diabetic human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.1 g/dL to about 0.6 g/dL.

44. The method of claim 38, wherein the IDPN solution, when administered to the diabetic human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.2 g/dL to about 0.4 g/dL.

45. The method of claim 18, wherein the human subject is diabetic.

46. The method of claim 45, further comprising administering insulin to the subject.

47. The method of claim 45 or 46, further comprising monitoring glucose tolerance in the subject.

48. The method of claim 45, wherein the IDPN solution consists essentially of between 0.04 g/mL and 0.08 g/mL of dextrose, between 0.12 g/mL and 0.18 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids.

49. The method of claim 45, wherein the IDPN solution consists essentially of between 0.05 g/mL and 0.07 g/mL of dextrose, between 0.15 g/mL and 0.17 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids.

50. The method of claim 45, wherein the IDPN solution, when administered to the diabetic human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.1 g/dL to about 0.6 g/dL.

51. The method of claim 45, wherein the IDPN solution, when administered to the diabetic human subject as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.2 g/dL to about 0.4 g/dL. 

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