NEWS

AbbVie's Ibrotinib VS Baiji Shenzhou's Zebrotinib-Patent First Battle

Release time:

2023-06-21 13:46

 

2023Year6Month15Day, under AbbVie'sofPharmacyclicsLLCCompanyAccusing Baekje Shenzhouof Bruton's tyrosine kinase (BTK)inhibitors“Brukinsa"(The trade name of Zerb in the United States)violated the company.of“Imbruvica”（Irulinbtrade name in the United States) of the United StatesPatent“US11672803”, and has been filed in the United States District Court for the District of Delaware. This is AbbVie'sBTKinhibitors“Brukinsa”(Zerbutinibtrade name in the United States)The first patent infringement lawsuit filed.Patent“US11672803”Is a use patent, its name is“BTKUse of inhibitors”, Authorized day is2023Year6Month13This shows that AbbVie was ready for litigation before the patent was granted.At present, Baiji Shenzhou has responded that it will take all necessary measures to protect its rights and interests.

Irulinb( )It is the world's first listedBTKinhibitors, by the United StatesPharmacyclicsCo-developed with Johnson & Johnson, at the earliest2013Year11Month13It was first listed in the United States on the dayImbruvica;2017Year08Month24Japan was approved for listing in China, the commodity name is Yike..As a highly efficient and selective small molecule inhibitor, ibitinib is suitable for chronic lymphocytic leukemia that has received at least one treatment in the past (CLL)/Small lymphocytic lymphoma, mantle cell lymphoma (MCL) treatment of patients. In2020YearCSCOIn the lymphoma guidelines, iBritinib is the only available first-line treatment.1Grade Specialist recommend for the Treatment of Fahrenheit's MacroglobulinemiaBTKinhibitors.The names of drugs approved in China are"Ibitinib Capsules" (140mg)Its currently registered patents are2The registered patent information is detailed in the following table.1shown.

Table1

Serial Number

Application Number

Authorization Number

Expiry date

The type of patent for the chemical corresponding to the right.

Status

1

200680056438.5

CN101610676B

2026-12-27

Compound Patents (Corresponding Rights1,3,5,10), Drug Combination Patents (Corresponding Rights6), patents for medical use (corresponding rights7-9,11)

effective

2

201210217024.3

CN102887900B

2026-12-27

Drug combination patents (corresponding rights3), patents for medical use (corresponding rights4-5)

effective

Zebulitinib ( )It belongs to the second generation.BTKinhibitors, independently developed by Baiji Shenzhou, for the treatment of Fahrenheit macroglobulinemia (WM) Adult patients,In2019Year11Month14Day by the United StatesFDAApproved, trade name“Brukinsa"(Its patent family in the United States has"US14/723417,US15/359871,US15/969864,US16/739447andUS14/951494"and"US16/325447,US17/146855,US17/740877,US17/740882,US17/858826,US17/858827andUS17/901951"and so on), its and in.2023Year1Month20The fourth indication was approved in the United States."Approved for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Adult patients". itsIn2020Year6Month3Approved in China, approved trade name."Baiyueze®”The drug is named"Zebutinib Capsules" (80mg), whose currently registered patents are2The registered patent information is detailed in the following table.2shown.

Table2

Serial Number

Application Number

Authorization Number

Expiry date

The type of patent for the chemical corresponding to the right.

Status

1

201480003692.3

CN104884458B

2034-04-21

Compound Patents (Corresponding Rights1-10,13,15), Drug Combination Patents (Corresponding Rights16,17), patents for medical use (corresponding rights18,19)

effective

2

201780049930.8

CN109563099B

2037-08-14

Patents for combinations of chemicals containing active ingredients (corresponding rights19-23), patents for pharmaceutical uses of chemical drugs (corresponding rights24-30)

effective

   After comparing the technical schemes one by one, the insiders preliminarily gave that zebutinib fell on ibrutinib.US11672803Within the technical scheme claimed.Right.This, Baiji Shenzhou can considerResponseProgramsThere areThe defense of the prior art or the invalidity of the patent.In addition, considering that the market competition for the above two commodities is global, China as aBTKinhibitorsThe main market for drugs in question, the author believes that the two (there may be moreBTKinhibitorscompetitors) will also set off a patent war in China.   

 

 

    

Patent, Correspondence, US, Inhibitor, btk, Treatment, us17, Shenzhou, Baiji