발생일자 2015.05.07 

사건번호 2:15-cv-03217 

법원국가 UNITED STATES OF AMERICA 

관할법원명 D.C.NewJersey(지방법원) 

침해권리 특허 

원고명 Jazz Pharmaceuticals, Inc. ( 미국 / 외국기업 )  

피고명 Amneal Pharmaceuticals, LLC/ Par Pharmaceutical, Inc./ Ranbaxy, Inc./ Sun Pharmaceutical Industries LTD./ Ohm Laboratories, Inc. ( 미국 / 외국기업 )  

소송유형 침해금지 

[Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC et al] 사건번호 2:15-cv-03217에 따르면 원고 Jazz Pharmaceuticals, Inc.는 피고 Amneal Pharmaceuticals, LLC/ Par Pharmaceutical, Inc./ Ranbaxy, Inc./ Sun Pharmaceutical Industries LTD./ Ohm Laboratories, Inc.을 상대로 특허 US8952062을 침해하였다는 이유로 미국 뉴저지 지방법원에 소를 제기하였다. 

분쟁결과 분쟁중 

산업분류 화학∙바이오 > 기초재료화학기술 

계쟁제품 500 mg/mL sodium oxybate oral solution, generic version of XYREM� 

지재권번호/명칭

US8952062  Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy 

Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gamma-hydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient. 

 1. A method of treating a condition responsive to gamma-hydroxybutyrate comprising orally administering two doses to a patient afflicted with the condition: (i) an aqueous composition comprising a first dose of about 3 to about 10 grams of salt of gamma-hydroxybutyrate; and (ii) an aqueous composition comprising a second dose of about 3 to about 10 grams of a salt of gamma-hydroxybutyrate within 2.0 to 5 hours after the first dose; wherein two doses are administered to the patient for a total amount of between 6 to 20 grams per day wherein the aqueous composition of the first dose and the aqueous composition of the second dose each were prepared by diluting a solution of gamma-hydroxybutyrate of 350 to 750 mg/ml. 

 2. The method of claim 1, wherein the condition is selected from the group consisting of apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus. 

 3. The method of claim 1, wherein the aqueous composition of the first dose and the aqueous composition of the second dose each were prepared from a solution of gamma-hydroxybutyrate of 450 to 750 mg/ml. 

 4. The method of claim 3, wherein the solution of 450 to 750 mg/ml has a pH of about 7.0 to about 9.0, is chemically stable and resistant to microbial growth, and does not require preservatives. 

 5. The method of claim 1, wherein the salt is selected from the group consisting of sodium, ammonium, calcium and magnesium forms of gamma-hydroxybutyrate. 

 6. The method of claim 1, wherein the aqueous composition contains one or more of salts selected from the group consisting of lithium, potassium, sodium, calcium, ammonium, and magnesium. 

 7. The method of claim 1, wherein the second dose is administered within about 2.0, about 2.1, about 2.2, about 2.3, about 2.4, about 2.5, about 2.6, about 2.7, about 2.8, about 2.9, about 3.0, about 3.1, about 3.2, about 3.3, about 3.4, about 3.5, about 3.6, about 3.7, about 3.8, about 3.9, about 4.0, about 4.1, about 4.2, about 4.3, about 4.4, about 4.5, about 4.6, about 4.7, about 4.8, about 4.9, or about 5.0 hours after the first dose. 

 8. A method of treating a condition responsive to gamma-hydroxybutyrate comprising orally administering to a patient afflicted with the condition: (i) an aqueous composition comprising a first dose of about 1.0 to about 4.5 grams of a salt of gamma-hydroxybutyrate; and (ii) an aqueous composition comprising a second dose of about 1.0 to about 4.5 grams of a salt of gamma-hydroxybutyrate within 2.0 to 5 hours after the first dose; wherein the aqueous composition of the first dose and the aqueous composition of the second dose each were prepared from a solution of gamma-hydroxybutyrate of 350 to 750 mg/ml. 

 9. The method of claim 8, wherein the condition is selected from the group consisting of apnea, sleep time disturbances, narcolepsy, cataplexy, sleep paralysis, hypnagogic hallucination, sleep arousal, insomnia, and nocturnal myoclonus. 

 10. The method of claim 8, wherein the solution has a pH of about 7.0 to about 9.0, is chemically stable and resistant to microbial growth, and does not require preservatives. 

 11. The method of claim 8, wherein the salt is selected from the group consisting of sodium, ammonium, calcium and magnesium forms of gamma-hydroxybutyrate. 

 12. The method of claim 8, wherein the aqueous composition contains one or more salts selected from the group consisting of lithium, potassium, sodium, calcium, ammonium, and magnesium. 

 13. The method of claim 8, wherein the aqueous composition of the first dose and the aqueous composition of the second dose each comprises about 2.25 to about 4.5 grams of the salt of gamma-hydroxybutyrate. 

 14. The method of claim 8, wherein the aqueous composition of the first dose and the aqueous composition of the second dose each comprises about 1.0 to about 3.0 grams of the salt of gamma-hydroxybutyrate. 

 15. A method of treating a condition responsive to sodium gamma-hydroxybutyrate, comprising (i) diluting a solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a first dose of about 3 to about 4.5 grams of sodium gamma-hydroxybutyrate; (ii) diluting a solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a second dose of about 3 to about 4.5 grams of sodium gamma-hydroxybutyrate; (iii) orally administering to a patient afflicted with the condition the first dose; (iv) orally administering to a patient afflicted with the condition the second dose within 2.5 to 4 hours after the first dose; wherein the condition is cataplexy or daytime sleepiness in a patient with narcolepsy. 

 16. The method of claim 15 in which each dose of from about 3 to about 4.5 grams of sodium gamma-hydroxybutyrate is prepared by diluting a solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with about 60 mL of water. 

 17. The method of claim 15, wherein the first dose is orally administered to the patient immediately prior to bedtime. 

 18. A method of treating a condition responsive to sodium gamma-hydroxybutyrate, comprising (i) diluting a solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a first dose of about 3 to about 5 grams of sodium gamma-hydroxybutyrate; (ii) diluting a solution comprising about 500 mg/mL of sodium gamma-hydroxybutyrate with an aqueous medium to provide a second dose of about 3 to about 5 grams of sodium gamma-hydroxybutyrate; (iii) orally administering to a patient afflicted with the condition the first dose; (iv) orally administering to a patient afflicted with the condition the second dose within 2.5 to 4 hours after the first dose; wherein the condition is cataplexy or daytime sleepiness in a patient with narcolepsy. 

 19. The method of claim 18, wherein each diluted dose contains about 50 mg/mL to about 167 mg/mL sodium gamma-hydroxybutyrate. 

 20. The method of claim 18, wherein each dose is about 3 to about 4.5 grams of sodium gamma-hydroxybutyrate. 

 21. The method of claim 20, wherein each diluted dose contains about 50 mg/mL to about 75 mg/mL sodium gamma-hydroxybutyrate. 

 22. The method of claim 18, wherein the first dose is orally administered to the patient immediately prior to bedtime.