발생일자 2015.06.30 

사건번호 1:15-cv-05021 

법원국가 UNITED STATES OF AMERICA 

관할법원명 D.C.NewJersey(지방법원) 

침해권리 특허 

원고명 Horizon Pharma Ireland Limited/ Horizon Pharma USA, Inc./ HZNP Limited ( 아일랜드 / 외국기업 )  

피고명 Taro Pharmaceuticals USA, Inc./ Taro Pharmaceutical Industries Ltd. ( 미국 / 외국기업 )  

소송유형 침해금지 

[Horizon Pharma Ireland Limited et al v. Taro Pharmaceuticals USA, Inc. et al] 사건번호 1:15-cv-05021에 따르면 원고 Horizon Pharma Ireland Limited/ Horizon Pharma USA, Inc./ HZNP Limited는 피고 Taro Pharmaceuticals USA, Inc./ Taro Pharmaceutical Industries Ltd.을(를) 상대로 특허 US9066913을(를) 침해하였다는 이유로 미국 뉴저지 지방법원에 소를 제기하였다. 

분쟁결과 분쟁중 

산업분류 화학∙바이오 > 의약품 

계쟁제품 Diclofenac sodium topical solution 2%, generic version of PENNSAID 2% 

지재권번호/명칭

US9066913   Diclofenac topical formulation 

The present invention provides a gel formulation comprising diclofenac sodium which has superior transdermal flux properties, which may be used for the topical treatment of pain, such as in osteoarthritis. 

 1. A topical formulation comprising: diclofenac sodium present at 2% w/w; DMSO present at about 40 to about 50% w/w; ethanol present at 23-29% w/w; propylene glycol present at 10-12% w/w; hydroxypropyl cellulose; and water to make 100% w/w, wherein the formulation has a viscosity of 500-5000 centipoise. 

 2. The topical formulation of claim 1, wherein the formulation has a pH of 6 to 10. 

 3. The topical formulation of claim 1, wherein the propylene glycol is present at 11.2% w/w. 

 4. The topical formulation of claim 1, wherein the topical formulation produces less than 0.1% impurity A after 6 months at 25.degree. C. and 60% humidity. 

 5. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof, said method comprising: administering to the knee a topical formulation of claim 1, wherein the administration of the formulation is twice daily. 

 6. The method of claim 5, wherein 2 mL of said topical formulation is administered to the knee twice daily. 

 7. The method of claim 5, wherein the amount of diclofenac sodium administered to the knee is 40 mg twice daily. 

 8. The topical formulation of claim 1, wherein the DMSO is present at 45.5% w/w. 

 9. The topical formulation of claim 8, wherein the hydroxypropyl cellulose is present at 2.5% w/w. 

 10. The topical formulation of claim 1, wherein the hydroxypropyl cellulose is present at 2.5% w/w. 

 11. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof, said method comprising: administering to the knee a topical formulation of claim 8, wherein the administration of the formulation is twice daily. 

 12. A method for treating pain due to osteoarthritis of a knee of a patient in need thereof, said method comprising: administering to the knee a topical formulation of claim 9, wherein the administration of the formulation is twice daily.