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[속보] 의약품 관련 특허 분쟁 2015.04.24

Noven Pharmaceuticals, Inc./ Hisamitsu Pharmaceutical Co, Inc. 대 Mylan Technologies, Inc./ Mylan Pharmaceuticals, Inc./ Mylan, Inc.

[의약품]Noven Pharmaceuticals, Inc./ Hisamitsu Pharmaceutical Co, Inc. 대 Mylan Technologies, Inc./ Mylan Pharmaceuticals, Inc./ Mylan, Inc. 간의 의약품 관련 특허 분쟁 



발생일자 2015.04.24 

사건번호 1:15-cv-00069 

법원국가 UNITED STATES OF AMERICA 

관할법원명 D.C.N.D.WestVirginia(지방법원) 

침해권리 특허 

원고명 Noven Pharmaceuticals, Inc./ Hisamitsu Pharmaceutical Co, Inc. ( 미국 / 외국기업 )  

피고명 Mylan Technologies, Inc./ Mylan Pharmaceuticals, Inc./ Mylan, Inc. ( 미국 / 외국기업 )  

소송유형 침해금지 

분쟁내용
[Noven Pharmaceuticals, Inc. et al v. Mylan Technologies, Inc. et al] 사건번호 1:15-cv-00069에 따르면 원고 Noven Pharmaceuticals, Inc./ Hisamitsu Pharmaceutical Co, Inc.는 피고 Mylan Technologies, Inc./ Mylan Pharmaceuticals, Inc./ Mylan, Inc.을 상대로 특허 US6841716|US8231906을 침해하였다는 이유로 미국 웨스트버지니아 북부 지방법원에 소를 제기하였다. 

분쟁결과 분쟁중 

산업분류 화학∙바이오 > 의약품 

계쟁제품
Generic Estradiol Transdermal System, USP "Twice-Weekly" in 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day dosage strengths 

지재권번호/명칭
US6841716   Patch 

US8231906   Transdermal estrogen device and delivery 

Patch 

Abstract

According to the invention, a patch provided with a support 1, an adhesive layer 2 laminated on one side of the support, and a release film 4 attached in a releasable manner to the adhesive layer and having a slit 42 running from one edge to the opposite edge, is characterized in that the shape of the slit in the release film is a wave shape such that, by simply bending the support slightly along the slit while the exposed side of the adhesive layer which has been exposed by peeling off part of the release film along the slit is attached to the attachment site, the edge 44 of the slit of the remaining release film can promptly protrude outward from between the attachment site and the adhesive layer. 


Claims

What is claimed is: 

1. A patch provided with a support, an adhesive layer laminated on one side of said support, and a release film attached in a releasable manner to said adhesive layer and having a slit running from one edge to the opposite edge, the patch being characterized in that the shape of the slit in said release film is a wave shape such that, by simply bending said support slightly along said slit while the exposed side of said adhesive layer which has been exposed by peeling off part of said release film along said slit is attached to the attachment site, the edge of said slit of the remaining release film can promptly protrude outward from between the attachment site and said adhesive layer, the wave pitch of said wave-shaped slit of said release film is 6 mm to 12.5 mm, and the wave height of each said wave-shaped slit of said release film is 4 mm to 8 mm. 

2. The patch according to claim 1, wherein two said wave-shaped slits are provided in said release film, and the two said slits are substantially parallel to each other. 

3. The patch according to claim 2, wherein the spacing between the two wave-shaped slits of said release film is 20 mm to 30 mm. 

4. The patch according to claim 1, wherein the wave height of said wave-shaped slit of said release film is 6 mm to 7 mm. 

5. The patch according to claim 1, wherein said patch has corners, said corners are rounded so as to have a curvature radius of at least 5 mm. 

6. The patch according to claim 1, wherein said adhesive layer is from 10 .mu.m to 400 .mu.m thick. 

7. The patch according to claim 1, wherein said support is from 0.01 to 5 mm thick. 

8. The patch according to claim 1, wherein the spacing between the two wave-shaped slits of said release film is 20 mm to 30 mm, the wave height of said wave-shaped slit of said release film is 6 mm to 7 mm, said patch has corners, said corners are rounded so as to have a curvature radius of at least 5 mm, said adhesive layer is from 10 .mu.m to 400 .mu.m thick, and said support is from 0.01 to 5 mm thick. 

Transdermal estrogen device and delivery 

Abstract

Described are transdermal drug delivery systems for the transdermal administration of estrogen, comprising a polymer matrix and estrogen. Methods of making and using such systems also are described. 

Claims

What is claimed is: 

 1. A monolithic transdermal drug delivery system for estradiol, comprising a single polymer matrix layer defining an active surface area and comprising a polymer matrix comprising estradiol as the only drug, wherein the polymer matrix layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2, includes greater than 0.156 mg/cm.sup.2 estradiol, and achieves an estradiol flux that is greater than 0.01 mg/cm.sup.2/day, based on the active surface area. 

 2. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises a polymer blend comprising an acrylic adhesive, a silicone adhesive, and soluble polyvinylpyrrolidone (PVP). 

 3. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises about 2-25% by weight acrylic adhesive, about 45-70% by weight silicone adhesive, about 2-25% by weight soluble PVP, and about 5-15% penetration enhancer, all based on the total dry weight of the polymer matrix. 

 4. The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises oleyl alcohol. 

 5. The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises dipropylene glycol. 

 6. The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises oleyl alcohol and dipropylene glycol. 

 7. The transdermal drug delivery system of claim 3, wherein the acrylic adhesive and silicone adhesive are present in a ratio of from about 1:2 to about 1:6, based on the total weight of the acrylic and silicone adhesives. 

 8. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises an amount of estradiol effective to deliver a therapeutically effective amount of estradiol over a period of time selected from the group consisting of at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days and at least 7 days. 

 9. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises an amount of estradiol effective to deliver an amount of estradiol selected from the group consisting of about 0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day. 

 10. A monolithic transdermal drug delivery system for estradiol comprising a single polymer matrix layer comprising estradiol as the only drug, wherein the polymer matrix layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2, and the system has an active surface area that is about 60% of a size selected from the group consisting of 2.5, 3.75, 5.0, 7.5 and 10.0 cm.sup.2 and is effective to deliver an amount of estradiol per day of about 0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day, respectively. 

 11. A method for administering estradiol, con to the skin or mucosa of a subject in need thereof a monolithic transdermal drug delivery system comprising a single polymer matrix layer defining an active surface area and comprising a polymer matrix comprising estradiol as the only drug, wherein the polymer matrix layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2, includes greater than 0.156 mg/cm.sup.2 estradiol, and achieves an estradiol flux that is greater than 0.01 mg/cm.sup.2/day, based on the active surface area. 

 12. The method of claim 11, wherein the system has an active surface area that is about 60% of a size selected from the group consisting of 2.5, 3.75, 5.0, 7.5 and 10.0 cm.sup.2 and is effective to deliver an amount of estradiol per day of about 0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day, respectively. 

 13. A method of making a monolithic transdermal drug delivery system for administering estradiol, comprising forming a polymer matrix comprising estradiol as the only drug and a polymer blend comprising an acrylic adhesive, a silicone adhesive, and soluble PVP, and applying the polymer matrix to a support layer to form a single polymer matrix layer such that the polymer matrix layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2 and includes greater than 0.156 mg/cm.sup.2 estradiol. 

 14. The method of claim 13, wherein the system has an active surface area that is about 60% of a size selected from the group consisting of 2.5, 3.75, 5.0, 7.5 and 10.0 cm.sup.2. 



   출처 [US Patent & Trademark Office, Patent Full Text and Image Database]

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