[의약품]Galderma Laboratories LP/ Galderma SA/ Galderma Research & Development SNC 대 Glenmark Generics, Inc. USA 간의 의약품 관련 특허 분쟁 

발생일자 2015.05.06 

사건번호 3:15-cv-01416 

법원국가 UNITED STATES OF AMERICA 

관할법원명 D.C.N.D.Texas(지방법원) 

침해권리 특허 

원고명 Galderma Laboratories LP/ Galderma SA/ Galderma Research & Development SNC ( 미국 / 외국기업 )  

피고명 Glenmark Generics, Inc. USA ( 미국 / 외국기업 )  

소송유형 침해금지 

분쟁내용

[Galderma Laboratories LP et al v. Glenmark Generics, Inc. USA] 사건번호 3:15-cv-01416에 따르면 원고 Galderma Laboratories LP/ Galderma SA/ Galderma Research & Development SNC는 피고 Glenmark Generics, Inc. USA을 상대로 특허 US8071644|US8080537|US8129362|US8445543|US8809305을 침해하였다는 이유로 미국 텍사스 북부 지방법원에 소를 제기하였다. 

분쟁결과 분쟁중 

산업분류 화학∙바이오 > 의약품 

계쟁제품 Generic Adapalene and Benzoyl Peroxide Gel, 0.1% / 2.5% 

지재권번호/명칭

US8071644  Combinations of adapalene and benzoyl peroxide for treating acne lesions 

 US8080537  Combinations of adapalene and benzoyl peroxide for treating acne lesions 

 US8129362  Combination/association of adapalene and benzoyl peroxide for treating acne lesions 

 US8445543  Combinations of adapalene and benzoyl peroxide for treating acne lesions 

 US8809305  Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris 

Combinations of adapalene and benzoyl peroxide for treating acne lesions 

Abstract

Adapalene or a pharmaceutically acceptable salt thereof formulated into a pharmaceutical composition is useful for reducing the number of acne lesions, via daily topical application, in combination or in association with benzoyl peroxide (BPO); such treatment may be via administration of a pharmaceutical composition combining adapalene and BPO or by a concomitant application of two pharmaceutical compositions, one containing adapalene and the other containing BPO. 

Claims

What is claimed is: 

 1. A method for potentiating the action of benzoyl peroxide, comprising administering therewith adapalene or a pharmaceutically acceptable salt thereof, wherein the benzoyl peroxide and adapalene or pharmaceutically acceptable salt thereof are topically administered together, as active ingredients, combined at fixed doses of 0.1% adapalene and 2.5% benzoyl peroxide in a single formula that delivers said active ingredients together in synergistically, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula. 

 2. The method according to claim 1, wherein the single formula is a gel. 

 3. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, adapalene or a pharmaceutically acceptable salt thereof and benzoyl peroxide, combined at fixed doses of 0.1% adapalene and 2.5% benzoyl peroxide in a single formula that delivers said active ingredients together synergistically, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, wherein said single formula is applied once daily for a period of 12 weeks, and wherein the net clinical benefit, expressed as at least one of success rate and reduction in total lesion counts in a group of such subjects, at least one of weeks 1, 2, 4, 8 and 12 is numerically superior to the sum of the net clinical benefits achieved by 0.1% adapalene alone and 2.5% benzoyl peroxide alone at least one of the corresponding time points. 

 4. The regimen according to claim 3, wherein the single formula is a gel. 

Combinations of adapalene and benzoyl peroxide for treating acne lesions 

Abstract

Adapalene or a pharmaceutically acceptable salt thereof formulated into a pharmaceutical composition is useful for reducing the number of acne lesions, via daily topical application, in combination or in association with benzoyl peroxide (BPO); such treatment may be via administration of a pharmaceutical composition combining adapalene and BPO or by a concomitant application of two pharmaceutical compositions, one containing adapalene and the other containing BPO. 

Claims

What is claimed is: 

 1. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, adapalene or a pharmaceutically acceptable salt thereof and benzoyl peroxide, combined at fixed doses of 0.1% adapalene and 2.5% benzoyl peroxide in a single formula that delivers said active ingredients together, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, wherein said single formula is applied once daily for a period of 12 weeks, and wherein the net clinical benefit, expressed as success rate or reduction in total lesion counts in a group of such subjects, achieved by the single formula at week 8 is synergistic and numerically superior to the net clinical benefit achieved by 0.1% adapalene alone or 2.5% benzoyl peroxide alone at week 12. 

 2. The regimen of claim 1, wherein the single formula is a gel. 

 3. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, adapalene or a pharmaceutically acceptable salt thereof and benzoyl peroxide, combined at fixed doses of 0.1% adapalene and 2.5% benzoyl peroxide in a single formula that delivers said active ingredients together wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, wherein said single formula is applied once daily for a period of 12 weeks, and wherein the net clinical benefit, expressed as success rate or reduction in total lesion counts in a group of such subjects, achieved by the single formula at week 1, 4 or 8 is synergistic and numerically superior to the net clinical benefit achieved by 0.1% adapalene alone or 2.5% benzoyl peroxide alone at week 4, 8 or 12, respectively. 

 4. The regimen of claim 3, wherein the single formula is a gel. 

 5. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% adapalene or a pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of non-inflammatory acne lesions by at least 40%, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, and wherein said single formula is applied once daily for a period of 12 weeks. 

 6. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% adapalene or a pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of inflammatory acne lesions by at least 50%, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, and wherein said single formula is applied once daily for a period of 12 weeks. 

 7. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% adapalene or a pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of total acne lesions by at least 40%, to reduce the number of non-inflammatory acne lesions by at least 40%, to reduce the number of inflammatory lesions by at least 50%, and to achieve, in a group of such subjects, a degree of success of at least 20%, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, and wherein said single formula is applied once daily for a period of 12 weeks. 

 8. The regimen of claim 7, wherein the single formula is a gel. 

Combination/association of adapalene and benzoyl peroxide for treating acne lesions 

Abstract

Acne lesions, whether of inflammatory and/or non-inflammatory type, are simultaneously or sequentially treated and their number reduced, via daily topical regimen, with the combination or association of adapalene or pharmaceutically acceptable salt thereof and benzoyl peroxide (BPO). 

Claims

What is claimed is: 

 1. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, adapalene or a pharmaceutically acceptable salt thereof and benzoyl peroxide, combined at fixed doses of 0.1% adapalene and 2.5% benzoyl peroxide in a single formula that delivers said active ingredients together, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, wherein said single formula is applied once daily for a period of 12 weeks, and wherein the net clinical benefit, expressed as success rate or reduction in total lesion counts in a group of such subjects, achieved by the single formula at week 8 is synergistic and numerically superior to the net clinical benefit achieved by 0.1% adapalene alone or 2.5% benzoyl peroxide alone at week 12. 

 2. The regimen of claim 1, wherein the single formula is a gel. 

 3. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, adapalene or a pharmaceutically acceptable salt thereof and benzoyl peroxide, combined at fixed doses of 0.1% adapalene and 2.5% benzoyl peroxide in a single formula that delivers said active ingredients together wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, wherein said single formula is applied once daily for a period of 12 weeks, and wherein the net clinical benefit, expressed as success rate or reduction in total lesion counts in a group of such subjects, achieved by the single formula at week 1, 4 or 8 is synergistic and numerically superior to the net clinical benefit achieved by 0.1% adapalene alone or 2.5% benzoyl peroxide alone at week 4, 8 or 12, respectively. 

 4. The regimen of claim 3, wherein the single formula is a gel. 

 5. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% adapalene or a pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of non-inflammatory acne lesions by at least 40%, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, and wherein said single formula is applied once daily for a period of 12 weeks. 

 6. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% adapalene or a pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of inflammatory acne lesions by at least 50%, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, and wherein said single formula is applied once daily for a period of 12 weeks. 

 7. A regimen for the therapeutic treatment of acne lesions, the regimen comprising topically applying to the skin of a subject in need of said treatment, as active ingredients, 0.1% adapalene or a pharmaceutically acceptable salt thereof and 2.5% benzoyl peroxide, combined at fixed doses in a single formula that delivers said active ingredients together synergistically to reduce the number of total acne lesions by at least 40%, to reduce the number of non-inflammatory acne lesions by at least 40%, to reduce the number of inflammatory lesions by at least 50%, and to achieve, in a group of such subjects, a degree of success of at least 20%, wherein the adapalene or pharmaceutically acceptable salt thereof and the benzoyl peroxide are the only anti-acne active ingredients in said single formula, and wherein said single formula is applied once daily for a period of 12 weeks. 

 8. The regimen of claim 7, wherein the single formula is a gel. 

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