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The newly revised "Patent Law of the People's Republic of China" came into force on June 1st.
It will give innovative drug and generic drug companies two-way opportunities and challenges
.
It will give innovative drug and generic drug companies two-way opportunities and challenges
.
In 2020, about 24 patents related to 18 multinational pharmaceutical companies' original drugs were challenged by Chinese pharmaceutical companies or individuals, involving 26 decision numbers
.
.
With the gradual advancement of domestic generic drug consistency evaluation and centralized drug procurement policies, the competitive pressure of generic drug companies has increased sharply
.
For most domestic pharmaceutical companies whose main business is the development of generic drugs, challenging the patents of original research drugs by multinational pharmaceutical companies can enable them to bring their approved or under-development generic drugs to the market earlier than expected
.
.
For most domestic pharmaceutical companies whose main business is the development of generic drugs, challenging the patents of original research drugs by multinational pharmaceutical companies can enable them to bring their approved or under-development generic drugs to the market earlier than expected
.
The author's preliminary search on the patent invalidation decision of the State Intellectual Property Office found that the number of invalidation decision numbers published by the State Intellectual Property Office in 2020 is basically the same as the previous two years (2018-2019) (29 and 27 respectively)
.
It is worth noting that in the past two years (2019-2020) of invalidation decisions, more than half of all invalidation decisions (59% and 54%, respectively)
.
.
It is worth noting that in the past two years (2019-2020) of invalidation decisions, more than half of all invalidation decisions (59% and 54%, respectively)
.
Of course, a successful challenge invalid patents also prompted some generics on the market in advance, many of whom are blockbuster drugs, some drugs belong to rare diseases (such as infants and young children hemangioma, idiopathic pulmonary fibrosis)
.
.
Sorafenib
Sorafenib is a targeted liver cancer drug developed by Bayer and was approved to enter China in 2006
.
.
Although the patent for sorafenib compound (ZL00802685.
8) expired in 2020, and the crystal form patent (ZL200580040775.
0) was declared invalid by the national intellectual property rights in the request for invalidation in Hangzhou, China and East China in 2018, the drug’s The preparation patent (ZL200680007187.
1) originally had to expire in 2026
.
Chongqing Yaoyou Pharmaceutical challenged the patent of this pharmaceutical preparation, and the State Intellectual Property Office made a complete invalidation decision on ZL200680007187.
1 in October 2020
.
8) expired in 2020, and the crystal form patent (ZL200580040775.
0) was declared invalid by the national intellectual property rights in the request for invalidation in Hangzhou, China and East China in 2018, the drug’s The preparation patent (ZL200680007187.
1) originally had to expire in 2026
.
Chongqing Yaoyou Pharmaceutical challenged the patent of this pharmaceutical preparation, and the State Intellectual Property Office made a complete invalidation decision on ZL200680007187.
1 in October 2020
.
At present, Chongqing Yaoyou and other two companies have obtained two approval document numbers for generic drugs of sorafenib tosylate tablets in China, and there are also four approval document numbers for the application for the listing of generic drugs of this variety
.
.
Rivaroxaban
Rivaroxaban is a blockbuster anticoagulant drug developed by Bayer and was approved to enter China in 2009
.
.
The original compound patent ZL00818966.
8 expired on December 11, 2020.
Three companies, Nanjing Zhengda Tianqing, Nanjing Hengsheng Pharmaceutical, and Nanjing Life Energy Technology, respectively filed patent invalidation applications for the patent.
The State Intellectual Property Office issued a patent application on August 8, 2020.
In September and September, the invalidation decision of partial invalidation of the patent right was made successively
.
In 2019, the patent for a rivaroxaban preparation 200480035106.
X was declared invalid.
Therefore, after the patent for the original compound expired, domestic generic drugs with approved document numbers flocked to the market
.
8 expired on December 11, 2020.
Three companies, Nanjing Zhengda Tianqing, Nanjing Hengsheng Pharmaceutical, and Nanjing Life Energy Technology, respectively filed patent invalidation applications for the patent.
The State Intellectual Property Office issued a patent application on August 8, 2020.
In September and September, the invalidation decision of partial invalidation of the patent right was made successively
.
In 2019, the patent for a rivaroxaban preparation 200480035106.
X was declared invalid.
Therefore, after the patent for the original compound expired, domestic generic drugs with approved document numbers flocked to the market
.
At present, 14 domestic companies, including Chia Tai Tianqing Pharmaceutical, have obtained 19 rivaroxaban generic drug approval document numbers, and the approval number of the generic drug listing application for this variety has also reached 41
.
.
Tenofovir Propofol Fumarate
Tenofovir propofol fumarate is a blockbuster hepatitis B drug developed by Gilead, which was approved for import in China in 2018
.
.
The original compound preparation method patent ZL200410097845.
3 was challenged by the patent invalidation of Fujian Guangshengtang Pharmaceutical Industry, and the State Intellectual Property Office made a partial invalidation decision in January 2020
.
However, tenofovir generics of propofol fumarate are also restricted by other patents of the original research, such as the authorized compound patent (ZL01813161.
1) of the drug and the salt-type patent under examination (application number 201280039891.
0, 201910647566.
6, etc.
)
.
3 was challenged by the patent invalidation of Fujian Guangshengtang Pharmaceutical Industry, and the State Intellectual Property Office made a partial invalidation decision in January 2020
.
However, tenofovir generics of propofol fumarate are also restricted by other patents of the original research, such as the authorized compound patent (ZL01813161.
1) of the drug and the salt-type patent under examination (application number 201280039891.
0, 201910647566.
6, etc.
)
.
At present, 6 companies including Chengdu Better Pharmaceuticals have obtained 5 approval numbers for propofol tenofovir fumarate tablets, and the number of application acceptance numbers for generic drugs for this variety has also reached 20
.
In the next few years, the probability of the original research patent being invalidated is extremely high
.
.
In the next few years, the probability of the original research patent being invalidated is extremely high
.
Ibrutinib
Ibrutinib is an oncology drug jointly developed by Pharmacyclics and Johnson & Johnson's Janssen Company .
It was approved to enter China in 2018
.
It was approved to enter China in 2018
.
The original core compound patents ZL201210217024.
3 and ZL200680056438.
5 of the drug will expire in 2026.
Nanjing Huaxun Intellectual Property Consulting Co.
, Ltd.
failed to challenge its patent invalidation.
The State Intellectual Property Office made a decision on the above two patents in June 2020.
Maintain effective decisions
.
3 and ZL200680056438.
5 of the drug will expire in 2026.
Nanjing Huaxun Intellectual Property Consulting Co.
, Ltd.
failed to challenge its patent invalidation.
The State Intellectual Property Office made a decision on the above two patents in June 2020.
Maintain effective decisions
.
At present, there is currently no generic drug of Ibrutinib capsules on the market in China, and Simcere has submitted an application for the generic drug of this category
.
.
Lurasidone
Lurasidone is a schizophrenia drug developed by Japan's Sumitomo Pharmaceuticals and was approved for import in China in 2018
.
.
Although the original compound patents are not protected in China, two formulation patents (ZL201010564784.
2, ZL200680018223.
4) will be protected until 2026.
After an individual request for invalidation, they were announced by the State Intellectual Property Office in November 2020.
All are invalid
.
2, ZL200680018223.
4) will be protected until 2026.
After an individual request for invalidation, they were announced by the State Intellectual Property Office in November 2020.
All are invalid
.
At present, there is no generic drug for lurasidone hydrochloride tablets on the market in China, and Zhejiang Hisun Pharmaceutical and other companies have submitted applications for the generic drug for this variety
.
.
Propranolol Oral Solution
Propranolol oral solution is a typical "old drug with new use", developed by the French pharmaceutical manufacturer Pierre Fabre Dermatologie Laboratories (Pierre Fabre Dermatologie Laboratories), for the treatment of infantile hemangioma, the original research drug has not Imported from China
.
The critical use patent (ZL200880111892.
5) of the drug was partially invalidated by the State Intellectual Property Office in September 2020 after Yabao Pharmaceutical filed a request for invalidation
.
.
The critical use patent (ZL200880111892.
5) of the drug was partially invalidated by the State Intellectual Property Office in September 2020 after Yabao Pharmaceutical filed a request for invalidation
.
At present, there is no generic drug for propranolol hydrochloride oral solution in the domestic market, and two companies including Yabao Pharmaceutical have submitted applications for the generic drug for the market
.
.
other
The patents related to original research drugs such as Enpagliflozin, nintedanib, vothiaxetine hydrobromide, and sofosbuvir have also encountered invalidation challenges
.
.
At the same time, with the improvement of China's pharmaceutical companies' innovation capabilities, more and more domestically-made innovative drugs have also been approved for listing in China
.
As the original domestically developed new drug, it has also begun to become a target for competitors to challenge patents
.
According to the ten major annual patent reexamination invalidation cases announced by the State Intellectual Property Office from 2017 to 2020, 2 to 3 drug patent cases are involved each year.
Among them, CSPC's domestic innovative drug butylphthalide encountered the challenge of patent invalidation last year.
.
.
As the original domestically developed new drug, it has also begun to become a target for competitors to challenge patents
.
According to the ten major annual patent reexamination invalidation cases announced by the State Intellectual Property Office from 2017 to 2020, 2 to 3 drug patent cases are involved each year.
Among them, CSPC's domestic innovative drug butylphthalide encountered the challenge of patent invalidation last year.
.
statement
From the perspective of drug patent protection, the original research company often lays out the patent network for drugs through compounds, salt forms, crystal forms, synthetic routes, preparations, uses, etc.
, and legal proceedings may be involved after a patent invalidation decision
.
This article only provides limited information that has been disclosed or as of press time.
Please do not use this as a basis for registration and declaration of non-infringement of intellectual property rights during the development of generic drugs
.
, and legal proceedings may be involved after a patent invalidation decision
.
This article only provides limited information that has been disclosed or as of press time.
Please do not use this as a basis for registration and declaration of non-infringement of intellectual property rights during the development of generic drugs
.
The newly revised "Patent Law of the People's Republic of China" came into force on June 1st.
It will give innovative drug and generic drug companies two-way opportunities and challenges
.
It will give innovative drug and generic drug companies two-way opportunities and challenges
.
In 2020, about 24 patents related to 18 multinational pharmaceutical companies' original drugs were challenged by Chinese pharmaceutical companies or individuals, involving 26 decision numbers
.
.
With the gradual advancement of domestic generic drug consistency evaluation and centralized drug procurement policies, the competitive pressure of generic drug companies has increased sharply
.
For most domestic pharmaceutical companies whose main business is the development of generic drugs, challenging the patents of original research drugs by multinational pharmaceutical companies can enable them to bring their approved or under-development generic drugs to the market earlier than expected
.
.
For most domestic pharmaceutical companies whose main business is the development of generic drugs, challenging the patents of original research drugs by multinational pharmaceutical companies can enable them to bring their approved or under-development generic drugs to the market earlier than expected
.
The author's preliminary search on the patent invalidation decision of the State Intellectual Property Office found that the number of invalidation decision numbers published by the State Intellectual Property Office in 2020 is basically the same as the previous two years (2018-2019) (29 and 27 respectively)
.
It is worth noting that in the past two years (2019-2020) of invalidation decisions, more than half of all invalidation decisions (59% and 54%, respectively)
.
.
It is worth noting that in the past two years (2019-2020) of invalidation decisions, more than half of all invalidation decisions (59% and 54%, respectively)
.
Of course, a successful challenge invalid patents also prompted some generics on the market in advance, many of whom are blockbuster drugs, some drugs belong to rare diseases (such as infants and young children hemangioma, idiopathic pulmonary fibrosis)
.
.
Sorafenib
Sorafenib is a targeted liver cancer drug developed by Bayer and was approved to enter China in 2006
.
.
Although the patent for sorafenib compound (ZL00802685.
8) expired in 2020, and the crystal form patent (ZL200580040775.
0) was declared invalid by the national intellectual property rights in the request for invalidation in Hangzhou, China and East China in 2018, the drug’s The preparation patent (ZL200680007187.
1) originally had to expire in 2026
.
Chongqing Yaoyou Pharmaceutical challenged the patent of this pharmaceutical preparation, and the State Intellectual Property Office made a complete invalidation decision on ZL200680007187.
1 in October 2020
.
8) expired in 2020, and the crystal form patent (ZL200580040775.
0) was declared invalid by the national intellectual property rights in the request for invalidation in Hangzhou, China and East China in 2018, the drug’s The preparation patent (ZL200680007187.
1) originally had to expire in 2026
.
Chongqing Yaoyou Pharmaceutical challenged the patent of this pharmaceutical preparation, and the State Intellectual Property Office made a complete invalidation decision on ZL200680007187.
1 in October 2020
.
At present, Chongqing Yaoyou and other two companies have obtained two approval document numbers for generic drugs of sorafenib tosylate tablets in China, and there are also four approval document numbers for the application for the listing of generic drugs of this variety
.
.
Rivaroxaban
Rivaroxaban is a blockbuster anticoagulant drug developed by Bayer and was approved to enter China in 2009
.
.
The original compound patent ZL00818966.
8 expired on December 11, 2020.
Three companies, Nanjing Zhengda Tianqing, Nanjing Hengsheng Pharmaceutical, and Nanjing Life Energy Technology, respectively filed patent invalidation applications for the patent.
The State Intellectual Property Office issued a patent application on August 8, 2020.
In September and September, the invalidation decision of partial invalidation of the patent right was made successively
.
In 2019, the patent for a rivaroxaban preparation 200480035106.
X was declared invalid.
Therefore, after the patent for the original compound expired, domestic generic drugs with approved document numbers flocked to the market
.
8 expired on December 11, 2020.
Three companies, Nanjing Zhengda Tianqing, Nanjing Hengsheng Pharmaceutical, and Nanjing Life Energy Technology, respectively filed patent invalidation applications for the patent.
The State Intellectual Property Office issued a patent application on August 8, 2020.
In September and September, the invalidation decision of partial invalidation of the patent right was made successively
.
In 2019, the patent for a rivaroxaban preparation 200480035106.
X was declared invalid.
Therefore, after the patent for the original compound expired, domestic generic drugs with approved document numbers flocked to the market
.
At present, 14 domestic companies, including Chia Tai Tianqing Pharmaceutical, have obtained 19 rivaroxaban generic drug approval document numbers, and the approval number of the generic drug listing application for this variety has also reached 41
.
.
Tenofovir Propofol Fumarate
Tenofovir propofol fumarate is a blockbuster hepatitis B drug developed by Gilead, which was approved for import in China in 2018
.
.
The original compound preparation method patent ZL200410097845.
3 was challenged by the patent invalidation of Fujian Guangshengtang Pharmaceutical Industry, and the State Intellectual Property Office made a partial invalidation decision in January 2020
.
However, tenofovir generics of propofol fumarate are also restricted by other patents of the original research, such as the authorized compound patent (ZL01813161.
1) of the drug and the salt-type patent under examination (application number 201280039891.
0, 201910647566.
6, etc.
)
.
3 was challenged by the patent invalidation of Fujian Guangshengtang Pharmaceutical Industry, and the State Intellectual Property Office made a partial invalidation decision in January 2020
.
However, tenofovir generics of propofol fumarate are also restricted by other patents of the original research, such as the authorized compound patent (ZL01813161.
1) of the drug and the salt-type patent under examination (application number 201280039891.
0, 201910647566.
6, etc.
)
.
At present, 6 companies including Chengdu Better Pharmaceuticals have obtained 5 approval numbers for propofol tenofovir fumarate tablets, and the number of application acceptance numbers for generic drugs for this variety has also reached 20
.
In the next few years, the probability of the original research patent being invalidated is extremely high
.
.
In the next few years, the probability of the original research patent being invalidated is extremely high
.
Ibrutinib
Ibrutinib is an oncology drug jointly developed by Pharmacyclics and Johnson & Johnson's Janssen Company .
It was approved to enter China in 2018
.
It was approved to enter China in 2018
.
The original core compound patents ZL201210217024.
3 and ZL200680056438.
5 of the drug will expire in 2026.
Nanjing Huaxun Intellectual Property Consulting Co.
, Ltd.
failed to challenge its patent invalidation.
The State Intellectual Property Office made a decision on the above two patents in June 2020.
Maintain effective decisions
.
3 and ZL200680056438.
5 of the drug will expire in 2026.
Nanjing Huaxun Intellectual Property Consulting Co.
, Ltd.
failed to challenge its patent invalidation.
The State Intellectual Property Office made a decision on the above two patents in June 2020.
Maintain effective decisions
.
At present, there is currently no generic drug of Ibrutinib capsules on the market in China, and Simcere has submitted an application for the generic drug of this category
.
.
Lurasidone
Lurasidone is a schizophrenia drug developed by Japan's Sumitomo Pharmaceuticals and was approved for import in China in 2018
.
.
Although the original compound patents are not protected in China, two formulation patents (ZL201010564784.
2, ZL200680018223.
4) will be protected until 2026.
After an individual request for invalidation, they were announced by the State Intellectual Property Office in November 2020.
All are invalid
.
2, ZL200680018223.
4) will be protected until 2026.
After an individual request for invalidation, they were announced by the State Intellectual Property Office in November 2020.
All are invalid
.
At present, there is no generic drug for lurasidone hydrochloride tablets on the market in China, and Zhejiang Hisun Pharmaceutical and other companies have submitted applications for the generic drug for this variety
.
.
Propranolol Oral Solution
Propranolol oral solution is a typical "old drug with new use", developed by the French pharmaceutical manufacturer Pierre Fabre Dermatologie Laboratories (Pierre Fabre Dermatologie Laboratories), for the treatment of infantile hemangioma, the original research drug has not Imported from China
.
The critical use patent (ZL200880111892.
5) of the drug was partially invalidated by the State Intellectual Property Office in September 2020 after Yabao Pharmaceutical filed a request for invalidation
.
.
The critical use patent (ZL200880111892.
5) of the drug was partially invalidated by the State Intellectual Property Office in September 2020 after Yabao Pharmaceutical filed a request for invalidation
.
At present, there is no generic drug for propranolol hydrochloride oral solution in the domestic market, and two companies including Yabao Pharmaceutical have submitted applications for the generic drug for the market
.
.
other
The patents related to original research drugs such as Enpagliflozin, nintedanib, vothiaxetine hydrobromide, and sofosbuvir have also encountered invalidation challenges
.
.
At the same time, with the improvement of China's pharmaceutical companies' innovation capabilities, more and more domestically-made innovative drugs have also been approved for listing in China
.
As the original domestically developed new drug, it has also begun to become a target for competitors to challenge patents
.
According to the ten major annual patent reexamination invalidation cases announced by the State Intellectual Property Office from 2017 to 2020, 2 to 3 drug patent cases are involved each year.
Among them, CSPC's domestic innovative drug butylphthalide encountered the challenge of patent invalidation last year.
.
.
As the original domestically developed new drug, it has also begun to become a target for competitors to challenge patents
.
According to the ten major annual patent reexamination invalidation cases announced by the State Intellectual Property Office from 2017 to 2020, 2 to 3 drug patent cases are involved each year.
Among them, CSPC's domestic innovative drug butylphthalide encountered the challenge of patent invalidation last year.
.
statement
From the perspective of drug patent protection, the original research company often lays out the patent network for drugs through compounds, salt forms, crystal forms, synthetic routes, preparations, uses, etc.
, and legal proceedings may be involved after a patent invalidation decision
.
This article only provides limited information that has been disclosed or as of press time.
Please do not use this as a basis for registration and declaration of non-infringement of intellectual property rights during the development of generic drugs
.
, and legal proceedings may be involved after a patent invalidation decision
.
This article only provides limited information that has been disclosed or as of press time.
Please do not use this as a basis for registration and declaration of non-infringement of intellectual property rights during the development of generic drugs
.
The newly revised "Patent Law of the People's Republic of China" came into force on June 1st.
It will give innovative drug and generic drug companies two-way opportunities and challenges
.
It will give innovative drug and generic drug companies two-way opportunities and challenges
.
In 2020, about 24 patents related to 18 multinational pharmaceutical companies' original drugs were challenged by Chinese pharmaceutical companies or individuals, involving 26 decision numbers
.
Enterprise business enterprise.
With the gradual advancement of domestic generic drug consistency evaluation and centralized drug procurement policies, the competitive pressure of generic drug companies has increased sharply
.
For most domestic pharmaceutical companies whose main business is the development of generic drugs, challenging the patents of original research drugs by multinational pharmaceutical companies can enable them to bring their approved or under-development generic drugs to the market earlier than expected
.
Procurement Procurement Procurement.
For most domestic pharmaceutical companies whose main business is the development of generic drugs, challenging the patents of original research drugs by multinational pharmaceutical companies can enable them to bring their approved or under-development generic drugs to the market earlier than expected
.
The author's preliminary search on the patent invalidation decision of the State Intellectual Property Office found that the number of invalidation decision numbers published by the State Intellectual Property Office in 2020 is basically the same as the previous two years (2018-2019) (29 and 27 respectively)
.
It is worth noting that in the past two years (2019-2020) of invalidation decisions, more than half of all invalidation decisions (59% and 54%, respectively)
.
.
It is worth noting that in the past two years (2019-2020) of invalidation decisions, more than half of all invalidation decisions (59% and 54%, respectively)
.
Of course, a successful challenge invalid patents also prompted some generics on the market in advance, many of whom are blockbuster drugs, some drugs belong to rare diseases (such as infants and young children hemangioma, idiopathic pulmonary fibrosis)
.
Toddler, toddler, toddler.
Sorafenib
Sorafenib Sorafenib is a targeted liver cancer drug developed by Bayer and was approved to enter China in 2006
.
.
Although the patent for sorafenib compound (ZL00802685.
8) expired in 2020, and the crystal form patent (ZL200580040775.
0) was declared invalid by the national intellectual property rights in the request for invalidation in Hangzhou, China and East China in 2018, the drug’s The preparation patent (ZL200680007187.
1) originally had to expire in 2026
.
Chongqing Yaoyou Pharmaceutical challenged the patent of this pharmaceutical preparation, and the State Intellectual Property Office made a complete invalidation decision on ZL200680007187.
1 in October 2020
.
8) expired in 2020, and the crystal form patent (ZL200580040775.
0) was declared invalid by the national intellectual property rights in the request for invalidation in Hangzhou, China and East China in 2018, the drug’s The preparation patent (ZL200680007187.
1) originally had to expire in 2026
.
Chongqing Yaoyou Pharmaceutical challenged the patent of this pharmaceutical preparation, and the State Intellectual Property Office made a complete invalidation decision on ZL200680007187.
1 in October 2020
.
At present, Chongqing Yaoyou and other two companies have obtained two approval document numbers for generic drugs of sorafenib tosylate tablets in China, and there are also four approval document numbers for the application for the listing of generic drugs of this variety
.
.
Rivaroxaban
Rivaroxaban Rivaroxaban is a blockbuster anticoagulant drug developed by Bayer and was approved to enter China in 2009
.
.
The original compound patent ZL00818966.
8 expired on December 11, 2020.
Three companies, Nanjing Zhengda Tianqing, Nanjing Hengsheng Pharmaceutical, and Nanjing Life Energy Technology, respectively filed patent invalidation applications for the patent.
The State Intellectual Property Office issued a patent application on August 8, 2020.
In September and September, the invalidation decision of partial invalidation of the patent right was made successively
.
In 2019, the patent for a rivaroxaban preparation 200480035106.
X was declared invalid.
Therefore, after the patent for the original compound expired, domestic generic drugs with approved document numbers flocked to the market
.
8 expired on December 11, 2020.
Three companies, Nanjing Zhengda Tianqing, Nanjing Hengsheng Pharmaceutical, and Nanjing Life Energy Technology, respectively filed patent invalidation applications for the patent.
The State Intellectual Property Office issued a patent application on August 8, 2020.
In September and September, the invalidation decision of partial invalidation of the patent right was made successively
.
In 2019, the patent for a rivaroxaban preparation 200480035106.
X was declared invalid.
Therefore, after the patent for the original compound expired, domestic generic drugs with approved document numbers flocked to the market
.
At present, 14 domestic companies, including Chia Tai Tianqing Pharmaceutical, have obtained 19 rivaroxaban generic drug approval document numbers, and the approval number of the generic drug listing application for this variety has also reached 41
.
.
Tenofovir Propofol Fumarate
Tenofovir Propofol Fumarate Tenofovir propofol fumarate is a blockbuster hepatitis B drug developed by Gilead, which was approved for import in China in 2018
.
.
The original compound preparation method patent ZL200410097845.
3 was challenged by the patent invalidation of Fujian Guangshengtang Pharmaceutical Industry, and the State Intellectual Property Office made a partial invalidation decision in January 2020
.
However, tenofovir generics of propofol fumarate are also restricted by other patents of the original research, such as the authorized compound patent (ZL01813161.
1) of the drug and the salt-type patent under examination (application number 201280039891.
0, 201910647566.
6, etc.
)
.
3 was challenged by the patent invalidation of Fujian Guangshengtang Pharmaceutical Industry, and the State Intellectual Property Office made a partial invalidation decision in January 2020
.
However, tenofovir generics of propofol fumarate are also restricted by other patents of the original research, such as the authorized compound patent (ZL01813161.
1) of the drug and the salt-type patent under examination (application number 201280039891.
0, 201910647566.
6, etc.
)
.
At present, 6 companies including Chengdu Better Pharmaceuticals have obtained 5 approval numbers for propofol tenofovir fumarate tablets, and the number of application acceptance numbers for generic drugs for this variety has also reached 20
.
In the next few years, the probability of the original research patent being invalidated is extremely high
.
.
In the next few years, the probability of the original research patent being invalidated is extremely high
.
Ibrutinib
Ibrutinib Ibrutinib is an oncology drug jointly developed by Pharmacyclics and Johnson & Johnson's Janssen Company .
It was approved to enter China in 2018
.
Tumor tumor tumorIt was approved to enter China in 2018
.
The original core compound patents ZL201210217024.
3 and ZL200680056438.
5 of the drug will expire in 2026.
Nanjing Huaxun Intellectual Property Consulting Co.
, Ltd.
failed to challenge its patent invalidation.
The State Intellectual Property Office made a decision on the above two patents in June 2020.
Maintain effective decisions
.
3 and ZL200680056438.
5 of the drug will expire in 2026.
Nanjing Huaxun Intellectual Property Consulting Co.
, Ltd.
failed to challenge its patent invalidation.
The State Intellectual Property Office made a decision on the above two patents in June 2020.
Maintain effective decisions
.
At present, there is currently no generic drug of Ibrutinib capsules on the market in China, and Simcere has submitted an application for the generic drug of this category
.
.
Lurasidone
Lurasidone Lurasidone is a schizophrenia drug developed by Japan's Sumitomo Pharmaceuticals and was approved for import in China in 2018
.
.
Although the original compound patents are not protected in China, two formulation patents (ZL201010564784.
2, ZL200680018223.
4) will be protected until 2026.
After an individual request for invalidation, they were announced by the State Intellectual Property Office in November 2020.
All are invalid
.
2, ZL200680018223.
4) will be protected until 2026.
After an individual request for invalidation, they were announced by the State Intellectual Property Office in November 2020.
All are invalid
.
At present, there is no generic drug for lurasidone hydrochloride tablets on the market in China, and Zhejiang Hisun Pharmaceutical and other companies have submitted applications for the generic drug for this variety
.
.
Propranolol Oral Solution
Propranolol Oral Solution Propranolol oral solution is a typical "old drug with new use", developed by the French pharmaceutical manufacturer Pierre Fabre Dermatologie Laboratories (Pierre Fabre Dermatologie Laboratories), for the treatment of infantile hemangioma, the original research drug has not Imported from China
.
The critical use patent (ZL200880111892.
5) of the drug was partially invalidated by the State Intellectual Property Office in September 2020 after Yabao Pharmaceutical filed a request for invalidation
.
.
The critical use patent (ZL200880111892.
5) of the drug was partially invalidated by the State Intellectual Property Office in September 2020 after Yabao Pharmaceutical filed a request for invalidation
.
At present, there is no generic drug for propranolol hydrochloride oral solution in the domestic market, and two companies including Yabao Pharmaceutical have submitted applications for the generic drug for the market
.
.
other
other The patents related to original research drugs such as Enpagliflozin, nintedanib, vothiaxetine hydrobromide, and sofosbuvir have also encountered invalidation challenges
.
.
At the same time, with the improvement of China's pharmaceutical companies' innovation capabilities, more and more domestically-made innovative drugs have also been approved for listing in China
.
As the original domestically developed new drug, it has also begun to become a target for competitors to challenge patents
.
According to the ten major annual patent reexamination invalidation cases announced by the State Intellectual Property Office from 2017 to 2020, 2 to 3 drug patent cases are involved each year.
Among them, CSPC's domestic innovative drug butylphthalide encountered the challenge of patent invalidation last year.
.
.
As the original domestically developed new drug, it has also begun to become a target for competitors to challenge patents
.
According to the ten major annual patent reexamination invalidation cases announced by the State Intellectual Property Office from 2017 to 2020, 2 to 3 drug patent cases are involved each year.
Among them, CSPC's domestic innovative drug butylphthalide encountered the challenge of patent invalidation last year.
.
statement
statement From the perspective of drug patent protection, the original research company often lays out the patent network for drugs through compounds, salt forms, crystal forms, synthetic routes, preparations, uses, etc.
, and legal proceedings may be involved after a patent invalidation decision
.
This article only provides limited information that has been disclosed or as of press time.
Please do not use this as a basis for registration and declaration of non-infringement of intellectual property rights during the development of generic drugs
.
Medicine, medicine, medicine , and legal proceedings may be involved after a patent invalidation decision
.
This article only provides limited information that has been disclosed or as of press time.
Please do not use this as a basis for registration and declaration of non-infringement of intellectual property rights during the development of generic drugs
.
