발생일자 2015.02.03 

사건번호 1:15-cv-00124 

법원국가 UNITED STATES OF AMERICA 

관할법원명 D.C.Delaware(지방법원) 

침해권리 특허 

원고명 Teva Pharmaceuticals USA, Inc./ Teva Pharmaceutical Industries Ltd./ Teva Neuroscience, Inc./ Yeda Research and Development Co Ltd. ( 이스라엘 / 외국기업 )  

피고명 Amneal Pharmaceuticals, LLC ( 미국 / 외국기업 )  

소송유형 침해금지 

[Teva Pharmaceuticals USA, Inc. et al v. Amneal Pharmaceuticals, LLC] 사건번호 1:15-cv-00124에 따르면 원고 Teva Pharmaceuticals USA, Inc./ Teva Pharmaceutical Industries Ltd./ Teva Neuroscience, Inc./ Yeda Research and Development Co Ltd.는 피고 Amneal Pharmaceuticals, LLC을 상대로 특허 US8232250, US8399413 을 침해하였다는 이유로 미국 델라웨어 지방법원에 소를 제기하였다. 

분쟁결과 분쟁중 

산업분류 화학∙바이오 > 의약품 

계쟁제품 Glatiramer acetate injection, 40 mg/mL, generic version of COPAXONE 40 mg/mL 

지재권번호/명칭

US8232250   Low frequency glatiramer acetate therapy  

US8399413   Low frequency glatiramer acetate therapy 

A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient. 

 1. A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient a therapeutically effective regimen of three subcutaneous injections of a 40 mg dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, the regimen being sufficient to alleviate the symptom of the patient. 

 2. The method of claim 1, wherein alleviating a symptom comprises reducing the frequency of relapses. 

 3. The method of claim wherein the 40 mg dose of glatiramer acetate is in a prefilled syringe for self administration by the human patient. 

 4. The method of claim 1, wherein alleviating a symptom comprises reducing the mean cumulative number of Gd-enhancing lesions, reducing the mean number of new T.sub.2 lesions, reducing the total volume of T.sub.2 lesions, or reducing the cumulative number of enhancing lesions on T.sub.1-weighted images in the brain of the patient. 

 5. The method of claim 1, wherein alleviating a symptom comprises reducing brain atrophy in the patient. 

 6. The method of claim 1, wherein alleviating a symptom comprises increasing the time to a confirmed relapse in the patient. 

 7. The method of claim 1, wherein alleviating a symptom comprises reducing the total number of confirmed relapses in the patient. 

 8. The method of claim 1, wherein alleviating a symptom comprises reducing the progression of MRI-monitored disease activity in the patient. 

 9. The method of claim 1, wherein alleviating a symptom comprises reducing the number of new hypointense lesions on enhanced T.sub.1 scans in the patient or reducing the total volume of hypointense lesions on enhanced T.sub.1 scans in the patient. 

 10. The method of claim 1, wherein alleviating a symptom comprises reducing a level of disability as measured by EDSS Score, by the work productivity and activities impairment-General Health (WPAI-GH) questionnaire, or by EuroQoL (EQ5D) questionnaire in the patient. 

 11. The method of claim 1, wherein alleviating a symptom comprises reducing a change in EDSS Score in the patient or reducing a change in Ambulation Index in the patient. 

 12. The method of claim 1, wherein the 40 mg dose of glatiramer acetate is in a prefilled syringe for self administration by the patient. 

 13. The method of claim 1, wherein the patient has not received glatiramer acetate therapy prior to initiation of the regimen. 

 14. The method of claim 1, wherein the frequency of an immediate post injection reaction or the frequency of an injection site reaction is reduced relative to daily subcutaneous administration of 20 mg glatiramer acetate. 

 15. A method of increasing the tolerability of GA treatment in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis which comprises reducing frequency of subcutaneous injections from daily subcutaneous injections of a pharmaceutical composition comprising a 20 mg dose of glatiramer acetate to a regimen of three subcutaneous injections of a 40 mg dose of glatiramer acetate over a period of seven days with at least one day between every injection, wherein the regimen is therapeutically effective, so as to thereby increase the tolerability of GA treatment in the patient. 

 16. The method of claim 15, wherein increasing the tolerability of glatiramer acetate treatment in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the frequency of an immediate post injection reaction. 

 17. The method of claim 15, wherein increasing the tolerability of glatiramer acetate treatment in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the frequency of an injection site reaction. 

 18. The method of claim 15, wherein the pharmaceutical composition is in a prefilled syringe for self administration by the patient. 

 19. A method of reducing frequency of relapses in a human patient suffering from relapsing-remitting multiple sclerosis comprising administering to the human patient a therapeutically effective regimen of three subcutaneous injections of a 40 mg dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, the regimen being sufficient to reduce frequency of relapses in the human patient. 

 20. The method of claim 19, wherein the 40 mg dose of glatiramer acetate is in a prefilled syringe for self administration by the human patient. 

A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient. 

 1. A method of reducing the frequency of relapses in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and has MRI features consistent with multiple sclerosis comprising administering to the human patient a therapeutically effective dosage regimen of three subcutaneous injections of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, the regimen being sufficient to reduce the frequency of relapses in the patient. 

 2. The method of claim 1, further comprising reducing the mean cumulative number of Gd-enhancing lesions in the brain of the patient. 

 3. The method of claim 1, further comprising reducing the mean number of new T.sub.2 lesions in the brain of the patient. 

 4. The method of claim 1, further comprising reducing the cumulative number of enhancing lesions on T.sub.1-weighted images. 

 5. The method of claim 1, wherein the pharmaceutical composition is in a prefilled syringe for self administration by the patient. 

 6. The method of claim 1, wherein the patient has not received glatiramer acetate therapy prior to initiation of the subcutaneous injections. 

 7. The method of claim 1, wherein the frequency of an immediate post injection reaction or the frequency of an injection site reaction is reduced relative to daily subcutaneous administration of 20 mg glatiramer acetate. 

 8. The method of claim 2, further comprising reducing the mean number of new T.sub.2 lesions in the brain of the patient. 

 9. The method of claim 2, further comprising reducing the cumulative number of enhancing lesions on T.sub.1-weighted images. 

 10. The method of claim 3, further comprising reducing the cumulative number of enhancing lesions on T.sub.1-weighted images. 

 11. The method of claim 8, further comprising reducing the cumulative number of enhancing lesions on T.sub.1-weighted images. 

 12. The method of claim 1, wherein the pharmaceutical composition has a pH in the range of 5.5 to 8.5. 

 13. The method of claim 12, wherein the pharmaceutical composition has a pH in the range of 5.5 to 7.0. 

 14. The method of claim 1, wherein the patient has at least 1 cerebral lesion detectable by an MRI scan and wherein the lesion is associated with brain tissue inflammation, myelin sheath damage or axonal damage. 

 15. The method of claim 14, wherein, the lesion is a demyelinating white matter lesion visible on brain MRI and wherein the white matter lesion is at least 3 mm in diameter. 

 16. The method of claim 1, wherein the patient has experienced a first clinical episode and wherein the first clinical episode includes a clinical episode of optic neuritis, blurring of vision, diplopia, involuntary rapid eye movement, blindness, loss of balance, tremors, ataxia, vertigo, clumsiness of a limb, lack of coordination, weakness of one or more extremity, altered muscle tone, muscle stiffness, spasms, tingling, paraesthesia, burning sensations, muscle pains, facial pain, trigeminal neuralgia, stabbing sharp pains, burning tingling pain, slowing of speech, slurring of words, changes in rhythm of speech, dysphagia, fatigue, bladder problems (including urgency, frequency, incomplete emptying and incontinence), bowel problems (including constipation and loss of bowel control), impotence, diminished sexual arousal, loss of sensation, sensitivity to heat, loss of short term memory, loss of concentration, or loss of judgment or reasoning. 

 17. The method of claim 16, wherein the patient has at least 1 cerebral lesion detectable by an MRI scan and wherein the lesion is associated with brain tissue inflammation, myelin sheath damage or axonal damage. 

 18. The method of claim 17, wherein, the lesion is a demyelinating white matter lesion visible on brain MRI and wherein the white matter lesion is at least 3 mm in diameter. 

 19. A method of reducing the frequency of relapses in a human patient suffering from relapsing-remitting multiple sclerosis comprising administering to the human patient a therapeutically effective dosage regimen of three subcutaneous injections of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe for self administration by the patient, wherein the pharmaceutical composition further comprises mannitol, and wherein the pharmaceutical composition has a pH in the range of 5.5 to 7.0, the regimen being sufficient to reduce the frequency of relapses in the patient. 

 20. A method of reducing the frequency of relapses in a human patient who has experienced a first clinical episode and has MRI features consistent with multiple sclerosis comprising administering to the human patient a therapeutically effective dosage regimen of three subcutaneous injections of 1 ml of a pharmaceutical composition comprising 40 mg of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, wherein the pharmaceutical composition is in a prefilled syringe for self administration by the patient, wherein the pharmaceutical composition further comprises mannitol, and wherein the pharmaceutical composition has a pH in the range of 5.5 to 7.0, the regimen being sufficient to reduce the frequency of relapses in the patient.