발생일자 2015.02.06 

사건번호 2:15-cv-01043 

법원국가 UNITED STATES OF AMERICA 

관할법원명 D.C.NewJersey(지방법원) 

침해권리 특허 

원고명 Jazz Pharmaceuticals, Inc./ JAZZ PHARMACEUTICALS IRELAND LIMITED ( 아일랜드 / 외국기업 )  

피고명 Amneal Pharmaceuticals, LLC ( 미국 / 외국기업 )  

소송유형 침해금지 

[Jazz Pharmaceuticals, Inc. et al v. Amneal Pharmaceuticals, LLC] 사건번호 2:15-cv-01043에 따르면 원고 Jazz Pharmaceuticals, Inc./ JAZZ PHARMACEUTICALS IRELAND LIMITED는 피고 Amneal Pharmaceuticals, LLC을 상대로 특허 US8731963, US8772306, US8859619 을 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� drug product 

지재권번호/명칭

US8731963   Sensitive drug distribution system and method 

US8772306   Method of administration of gamma hydroxybutyrate with monocarboxylate transporters 

US8859619   Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy 

A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in the database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients. Further verification is made that the physician is eligible to prescribe the drug by consulting a separate database, and optionally whether any actions are taken against the physician. Multiple controls beyond those for normal drugs are imposed on the distribution depending on the sensitivity of the drug. 

 1. A computer-implemented system for treatment of a narcoleptic patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising: one or more computer memories for storing a single computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields; said prescription fields, contained within the database schema, storing prescriptions for the prescription drug with the potential for abuse, misuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug; said patient fields, contained within the database schema, storing information sufficient to identify the narcoleptic patient for whom the company's prescription drug is prescribed; said prescriber fields, contained within the database schema, storing information sufficient to identify a physician or other prescriber of the company's prescription drug and information to show that the physician or other prescriber is authorized to prescribe the company's prescription drug; a data processor configured to: process a database query that operates over all data related to the prescription fields, prescriber fields, and patient fields for the prescription drug; and reconcile inventory of the prescription drug before the shipments for a day or other time period are sent by using said database query to identify information in the prescription fields and patient fields; wherein the data processor is configured to process a second database query that identifies that the narcoleptic patient is a cash payer and a physician that is interrelated with the narcoleptic patient through the schema of the single computer database; said identifying that the narcoleptic patient is a cash payer by said second database query being an indicator of a potential misuse, abuse or diversion by the narcoleptic patient and being used to notify the physician that is interrelated with the narcoleptic patient through the schema of the single computer database. 

 2. The system of claim 1, wherein the data processor selectively blocks shipment of the prescription drug to the patient based upon said identifying by the database query. 

 3. The system of claim 1, wherein the prescription drug is shipped to the narcoleptic patient if no potential misuse, abuse or diversion is found for the narcoleptic patient. 

 4. The system of claim 1, wherein the single computer database is an exclusive database that receives data associated with all patients being prescribed the prescription drug that is associated with the company. 

 5. The system of claim 1, wherein an exclusive central pharmacy controls the single computer database. 

 6. The system of claim 1 wherein the prescription drug comprises gamma hydroxyl butyrate (GHB). 

 7. The system of claim 1, wherein the single computer database comprises a relational database. 

 8. The system of claim 1, wherein the single computer database is distributed among multiple computers and the database query operates over all data relating to said prescription fields, prescriber fields, and patient fields for the prescription drug. 

 9. The system of claim 1, wherein the data processor is configured to initiate an inquiry to a prescriber when one or more prescription fields, patient fields, or prescriber fields are incomplete in the computer database. 

 10. The system of claim 1, wherein the data processor is configured to process a third database query that identifies an expected date for a refill of the prescription drug. 

 11. The system of claim 10, wherein the expected date is based on a prescription for the prescription drug and a date of a previous filling of the prescription. 

 12. The system of claim 11, wherein the prescription identifies an amount of the prescription drug to be provided and a schedule for consumption of the prescription drug. 

 13. The system of claim 1, wherein the database schema further contains and interrelates insurance fields, wherein the insurance fields, contained within the database schema, store information sufficient to identify an insurer to be contacted for payment for prescription drugs of an associated patient. 

 14. The system of claim 1, wherein the single computer database is used to identify a current pattern or an anticipated pattern of abuse of the prescription drug; wherein the current pattern or the anticipated pattern are identified using periodic reports generated from the single computer database. 

 15. The system of claim 14, wherein one or more controls for distribution of the prescription drug are selected based on the identified pattern. 

 16. The system of claim 15, wherein the one or more controls are submitted to an approval body for approval of distribution of the prescription drug. 

 17. The system of claim 1, wherein additional controls for distribution are selected in a negotiation with an approval body to garner the approval of distribution. 

 18. The system of claim 17, wherein the data processor is used to add further controls until approval is obtained. 

 19. The system of claim 18, wherein the approval body is the Food and Drug Administration (FDA) or the Drug Enforcement Agency (DEA). 

 20. The system of claim 1, wherein current inventory is cycle counted and reconciled with database quantities before shipments for a day or other time period are sent. 

 21. The system of claim 1, wherein the single computer database comprises an exclusive computer database of the company that obtained approval for distribution of the prescription drug, wherein all prescriptions for the company's prescription drug are stored only in the exclusive computer database of the company, and wherein the company's prescription drug is sold or distributed by the company using only the exclusive computer database of the company. 

 22. The system of claim 1, wherein the single computer database comprises a single computer database of the company that obtained approval for distribution of the prescription drug, wherein the prescription fields store all prescription requests, for all patients being prescribed the company's prescription drug, only in the single computer database of the company, from all physicians or other prescribers allowed to prescribe the company's prescription drug, such that all prescriptions for the company's prescription drug are processed using only the single computer database of the company. 

 23. A computer-implemented system for treatment of a narcoleptic patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising: one or more computer memories for storing a single computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields; said prescription fields, contained within the database schema, storing prescriptions for the prescription drug with the potential for abuse, misuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug; said patient fields, contained within the database schema, storing information sufficient to identify the narcoleptic patient for whom the company's prescription drug is prescribed; said prescriber fields, contained within the database schema, storing information sufficient to identify a physician or other prescriber of the company's prescription drug and information to show that the physician or other prescriber is authorized to prescribe the company's prescription drug; a data processor for processing a database query that operates over all data related to the prescription fields, prescriber fields, and patient fields for the prescription drug; said database query identifying information in the prescription fields and patient fields for reconciling inventory of the prescription drug before the shipments for a day or other time period are sent, wherein an inventory reconciliation is performed where current inventory is counted and reconciled with database quantities before shipments for a day or other time period are sent, and wherein the data processor is configured to selectively block shipment of the prescription drug based on the inventory reconciliation; wherein the data processor is configured to process a second database query that identifies that the narcoleptic patient is a cash payer and a physician that is interrelated with the narcoleptic patient through the schema of the single computer database; said identifying that the narcoleptic patient is a cash payer by said second database query being an indicator of a potential misuse, abuse or diversion by the narcoleptic patient and being used to notify the physician that is interrelated with the narcoleptic patient through the schema of the single computer database. 

 24. A computer-implemented system for treatment of a narcoleptic patient with a prescription drug that has a potential for misuse, abuse or diversion, wherein the prescription drug is sold or distributed by a company that obtained approval for distribution of the prescription drug, comprising: one or more computer memories for storing a central computer database of the company that obtained approval for distribution of the prescription drug, for receiving prescriptions from any and all patients being prescribed the company's prescription drug, said central computer database having a database schema that contains and interrelates prescription fields, patient fields, and prescriber fields; said central computer database being distributed over multiple computers; said prescription fields, contained within the database schema, storing prescriptions for the prescription drug with the potential for abuse, misuse or diversion; said patient fields, contained within the database schema, storing information sufficient to identify the narcoleptic patient for whom the company's prescription drug is prescribed; said prescriber fields, contained within the database schema, storing information sufficient to identify any and all physicians or other prescribers of the company's prescription drug and information to show that the physicians or other prescribers are authorized to prescribe the company's prescription drug; one or more data processors for processing one or more database queries that operate over data related to the prescription fields, prescriber fields, and patient fields for the prescription drug; said one or more database queries checking for abuse within the central computer database, wherein the filling of the prescriptions is authorized for the company's prescription drug only if there is no record of incidents that indicate abuse, misuse, or diversion by the narcoleptic patient and prescriber and if there is a record of such incidents, the central computer database indicates that such incidents have been investigated, and the central computer database indicates that such incidents do not involve abuse, misuse or diversion. 

 25. The system of claim 24, wherein the one or more database queries are processed by the one or more data processors for identifying: that the narcoleptic patient is a cash payer and a physician that is interrelated with the narcoleptic patient through the schema of the single computer database; said identifying that the narcoleptic patient is a cash payer by said second database query being an indicator of a potential misuse, abuse or diversion by the narcoleptic patient and being used to notify the physician that is interrelated with the narcoleptic patient through the schema of the single computer database. 

 26. The system of claim 24, where the central computer database is distributed among multiple computers, and where the one or more database queries operate over all data relating to said prescription fields, prescriber fields, and patient fields for the prescription drug. 

 27. The system of claim 24, wherein the central computer database is used to identify a current pattern or an anticipated pattern of abuse of the prescription drug; wherein the current pattern or the anticipated pattern are identified using periodic reports generated from the single computer database. 

 28. The system of claim 24, wherein current inventory is cycle counted and reconciled with database quantities before shipments for a day or other time period are sent. 

One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition. 

 1. A method for treating a patient who is suffering from excessive daytime sleepiness, cataplexy, sleep paralysis, apnea, narcolepsy, sleep time disturbances, hypnagogic hallucinations, sleep arousal, insomnia, or nocturnal myoclonus with gamma-hydroxybutyrate (GHB) or a salt thereof, said method comprising: orally administering to the patient in need of treatment at least 5% decrease in an effective dosage amount of the GHB or salt thereof when the patient is receiving a concomitant administration of valproate, an acid, salt, or mixture thereof. 

 2. The method in accordance with claim 1, wherein there is at least about a 15% reduction in the effective dosage amount of the GHB or salt thereof given to the patient and wherein the valproate, acid, salt or mixture thereof is divalproex sodium. 

 3. The method in accordance with claim 2, wherein the dose of the GHB or salt thereof given to the patient without concomitant administration of valproate, an acid, salt or mixture thereof is from 4.5 to 9 grams per day. 

 4. The method in accordance with claim 1, wherein the effective dosage amount is a reduction of about 5% to 10%, about 10% to 15%, about 15% to 20%, about 20% to 25%, about 25% to 30%, about 30% to 35%, about 35% to 40%, about 40% to 45%, or about 45% to 50%, relative to the dose of the GHB or salt thereof normally given to the patient. 

 5. The method in accordance with claim 1, wherein the patient is suffering from narcolepsy. 

 6. The method in accordance with claim 1, further comprising administering aspirin to the patient. 

 7. The method in accordance with claim 1, wherein the effective dosage amount of the GHB or a salt thereof is reduced from a range of 4.5 to 9 grams per day. 

 8. The method in accordance with claim 1, wherein the dose of the GHB or salt thereof without concomitant administration of valproate, an acid, salt or mixture thereof is from 4.5 to 9 grams per day. 

 9. The method in accordance with claim 1, wherein the effective dosage amount of the GHB or salt thereof is between 3 grams and 7 grams per day. 

 10. The method in accordance with claim 1, wherein the effective dosage amount of the GHB or salt thereof is between 3.5 grams and 4 grams per day. 

 11. A method of safely administering GHB or a salt thereof for excessive daytime sleepiness, cataplexy, sleep paralysis, apnea, narcolepsy, sleep time disturbances, hypnagogic hallucinations, sleep arousal, insomnia, or nocturnal myoclonus in a human patient who is being administered GHB, said method comprising: determining if the patient has taken, or will take, a concomitant dose of valproate, an acid, salt or mixture thereof; and orally administering a reduced amount of the GHB or salt thereof to the patient wherein the reduction is at least 5% compared to a dose without concomitant administration of valproate, an acid, salt or mixture thereof. 

 12. The method in accordance with claim 11, wherein the amount of GHB or salt thereof is reduced at least 10% to 30%. 

 13. The method in accordance with claim 11, wherein the amount of GHB or salt thereof is reduced at least 15% patient and wherein the valproate, acid, salt, or mixture thereof is divalproex sodium. 

 14. The method in accordance with claim 11, wherein the valproate, acid, salt or mixture thereof is administered within two weeks of administration of the GHB or salt thereof. 

 15. The method in accordance with claim 11, wherein the valproate, acid, salt or mixture thereof is administered within three days of administration of the GHB or salt thereof. 

 16. The method in accordance with claim 11, wherein the patient is suffering from narcolepsy. 

 17. The method in accordance with claim 11, further comprising administering aspirin to the patient. 

 18. The method in accordance with claim 11, further comprising recommending to decrease the dose of GHB or salt thereof by 20% patient and wherein the valproate, acid, salt, or mixture thereof is divalproex sodium. 

 19. A method for treating a patient who is suffering from narcolepsy, said method comprising: administering a therapeutically effective amount of a formulation containing a GHB salt to a patient starting at a concentration of between 350 and 750 mg/ml with a pH of between 6 and 10; determining if the patient is also being administered valproate, an acid, salt or mixture thereof; warning of a potential drug/drug interaction due to the combination of valproate, an acid, salt or mixture thereof and the GHB salt; and recommending reducing the dose of the GHB salt at least 15%. 

 20. The method in accordance with claim 19, wherein the valproate, acid, salt or mixture thereof is administered within two weeks of administration of the GHB salt. 

 21. The method in accordance with claim 19, wherein the valproate, acid, salt or mixture thereof is administered within three days of administration of the GHB salt. 

 22. The method in accordance with claim 19, wherein the GHB salt is administered starting at a concentration of between 450 to 550 mg/ml. 

 23. The method in accordance with claim 22, further comprising adding water to the GHB salt formulation. 

 24. The method in accordance with claim 19, wherein the GHB salt formulation has a pH between 6.5 and 8. 

 25. The method in accordance with claim 19, further comprising administering the reduced dose of the GHB salt to the patient. 

 26. The method in accordance with claim 19, wherein the GHB salt comprises a single salt or a mixture of salts of GHB selected from the group consisting of a sodium salt of hydroxybutyrate (Na.GHB), a potassium salt of gamma-hydroxybutyrate (K.GHB), a magnesium salt of gamma-hydroxybutyrate (Mg.(GHB).sub.2), and a calcium salt of gamma-hydroxybutyrate (Ca.(GHB).sub.2). 

 27. The method in accordance with claim 19, further comprising administering aspirin to the patient. 

 28. The method in accordance with claim 19, comprising recommending reducing a dose of GHB or salt thereof at least 20% patient and wherein the valproate, acid, salt, or mixture thereof is divalproex sodium. 

 29. The method in accordance with claim 19, further comprising adding water to the GHB salt formulation. 

 30. A method for treating a patient who is suffering from narcolepsy, said method comprising: administering a therapeutically effective amount of a formulation containing a GHB salt to a patient; determining if the patient is also being administered valproate, an acid, salt or mixture thereof; recommending a 20% decrease in the starting dose of the GHB salt such that a patient starts taking the GHB salt at an adjusted dosage amount between 3.5 grams and 4 grams the GHB salt per night administered orally. 

 31. The method in accordance with claim 30, wherein the starting adjusted dosage amount of the GHB salt is about 3.6 grams. 

 32. The method in accordance with claim 30, further comprising optionally diluting the GHB salt formulation from a starting concentration of between 350 and 750 mg/ml with a pH of between 6 and 10. 

 33. A method for treating a patient who is suffering from narcolepsy, said method comprising: orally administering a therapeutically effective amount of a formulation containing a GHB salt; determining if the patient is also being administered valproate, an acid, salt or mixture thereof; recommending a 20% decrease in the starting dose of the GHB salt such that the amount that the patient is administered is reduced to about 3.6 grams GHB per day. 

 34. The method in accordance with claim 33, further comprising optionally diluting the GHB salt formulation from a starting concentration of between 350 and 750 mg/ml with a pH of between 6 and 10.