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19 new drugs launched in the first quarter
Or regret losing the New Deal bonus
The industry generally believes that the normalization and institutionalization of mass procurement of drugs will continue to accelerate the differentiation of the pharmaceutical industry and force pharmaceutical companies to transform into innovation.
At the same time, medical insurance "vacation of cages for birds" is also accelerating the market for innovative drugs.
Guided by the innovation policy, my country's pharmaceutical innovation has ushered in a golden period of development.
Some analysts pointed out that my country's innovative drug industry has truly entered a period of rapid growth since 2015.
It is expected that the market segment will have a compound growth rate of more than 30% in the next ten years, and the prospects are broad.
At the same time, medical insurance "vacation of cages for birds" is also accelerating the market for innovative drugs.
Guided by the innovation policy, my country's pharmaceutical innovation has ushered in a golden period of development.
Some analysts pointed out that my country's innovative drug industry has truly entered a period of rapid growth since 2015.
It is expected that the market segment will have a compound growth rate of more than 30% in the next ten years, and the prospects are broad.
Thanks to the continuous deepening of the reform of the drug review and approval system by the drug regulatory authorities in recent years, the number of innovative drugs approved for marketing in my country has continued to rise, and the number of domestic new drugs approved in 2020 alone will reach 11, breaking through two for the first time number.
And 2021 is obviously more worth looking forward to.
According to incomplete statistics from reporters from the "Pharmaceutical Economic News", in the first quarter of this year, including pratinib capsules and avatinib from CStone Pharmaceuticals, and Youti from Chengdu Huahao Zhongtian Pharmaceuticals 19 new drugs including Delong Injection, Rongchang Biotech’s Tataceptin, Zai Lab’s Repetinib, and Beijing Kexing Zhongwei, Sinopharm Zhongsheng, Kangsino, and Zhifeilongkema's new crown vaccine were approved.
And 2021 is obviously more worth looking forward to.
According to incomplete statistics from reporters from the "Pharmaceutical Economic News", in the first quarter of this year, including pratinib capsules and avatinib from CStone Pharmaceuticals, and Youti from Chengdu Huahao Zhongtian Pharmaceuticals 19 new drugs including Delong Injection, Rongchang Biotech’s Tataceptin, Zai Lab’s Repetinib, and Beijing Kexing Zhongwei, Sinopharm Zhongsheng, Kangsino, and Zhifeilongkema's new crown vaccine were approved.
It is true that missing the dividends of the patent right period compensation system due to the approval of the market earlier than the implementation of the new law will be a huge loss that is irreversible for the companies that develop these new drugs .
However, from a long-term perspective, the implementation of the drug patent right term compensation system represents a solid step forward for my country to build a drug patent linkage system, which is of great significance to promoting the healthy development of the pharmaceutical industry.
At this stage, various regulatory agencies are stepping up the implementation of the compensation system for the duration of drug patent rights.
However, from a long-term perspective, the implementation of the drug patent right term compensation system represents a solid step forward for my country to build a drug patent linkage system, which is of great significance to promoting the healthy development of the pharmaceutical industry.
At this stage, various regulatory agencies are stepping up the implementation of the compensation system for the duration of drug patent rights.
Recently, CDE issued the "Notice on Public Testing of Patent Information Registration Platforms Related to Early Resolution Mechanisms for Drug Patent Disputes", and officially launched public testing of the "China Listed Drug Patent Information Registration Platform" established by it, and solicited all parties.
opinion.
According to requirements, holders of marketing authorizations of drugs that have been marketed in China need to actively participate in the registration and testing of relevant drug patent information.
CDE also clarified that, in order to facilitate work linkage, after the implementation of the early resolution mechanism for drug patent disputes, relevant patent information registered as required during the test period will be disclosed after confirmation by the drug marketing license holder, as a chemical generic drug and a traditional Chinese medicine with the same name.
Information on the basis of patent claims made by applicants for drugs and biosimilar drugs.
opinion.
According to requirements, holders of marketing authorizations of drugs that have been marketed in China need to actively participate in the registration and testing of relevant drug patent information.
CDE also clarified that, in order to facilitate work linkage, after the implementation of the early resolution mechanism for drug patent disputes, relevant patent information registered as required during the test period will be disclosed after confirmation by the drug marketing license holder, as a chemical generic drug and a traditional Chinese medicine with the same name.
Information on the basis of patent claims made by applicants for drugs and biosimilar drugs.
The State Intellectual Property Office also revealed in its Q&A that because the implementation rules of the Patent Law are still in the process of revising, and related supporting electronic systems are being developed, from June 1, 2021, patentees can follow the revised Patent Law 40 Article 2, Paragraph 3, within three months from the date when the new drug marketing authorization request is approved, temporarily submit a paper form to the State Intellectual Property Office for compensation for the patent right period, and then follow the payment notice issued by the office to pay the relevant requirements.
cost.
The office will review the above-mentioned applications after the implementation of the newly revised Patent Law Implementation Rules.
cost.
The office will review the above-mentioned applications after the implementation of the newly revised Patent Law Implementation Rules.
The new law creates a new pattern of drug patents
It is urgent to adjust the strategy of pharmaceutical companies
From the perspective of the industry, the amendment and implementation of the new "Patent Law" will create a new pattern of drug patent protection and litigation in my country.
The official introduction of the patent linkage system in the future will undoubtedly bring more selectivity to drug companies.
The patent layout of innovative drugs will be a key game between original research drug companies and generic drug companies, and it is urgent for companies to adjust related strategies.
The official introduction of the patent linkage system in the future will undoubtedly bring more selectivity to drug companies.
The patent layout of innovative drugs will be a key game between original research drug companies and generic drug companies, and it is urgent for companies to adjust related strategies.
Some experts suggest that innovative drug companies should make full use of basic patent strategies and follow-up patent strategies in the development of new drugs to extend the drug patent rights period after the drug is marketed.
This requires pharmaceutical companies not only to do a good job in planning for the marketing of new drugs, as well as to prepare for patent linking and patent compensation, but also to choose an appropriate patent compensation period for patent applications.
For multinational pharmaceutical companies, they also need to do a good job in unifying litigation resources, unifying litigation plans, and comprehensively formulating Chinese and foreign coordinated patent litigation strategies.
This requires pharmaceutical companies not only to do a good job in planning for the marketing of new drugs, as well as to prepare for patent linking and patent compensation, but also to choose an appropriate patent compensation period for patent applications.
For multinational pharmaceutical companies, they also need to do a good job in unifying litigation resources, unifying litigation plans, and comprehensively formulating Chinese and foreign coordinated patent litigation strategies.
For generic drug companies, the above-mentioned experts believe that they should first fully understand the original drug information, including the patent expiration date, the protection strength, whether the protected product is a compound, composition or pharmaceutical use, the scope of protection and patent stability, etc.
, combined with their own Advantages, reasonable selection of generic products; secondly, in-depth evaluation of the difficulty and risk of patent litigation in the process of listing of generic drugs; lastly, strengthening innovation and research and development, and maximizing the risk avoidance of generic drugs.
, combined with their own Advantages, reasonable selection of generic products; secondly, in-depth evaluation of the difficulty and risk of patent litigation in the process of listing of generic drugs; lastly, strengthening innovation and research and development, and maximizing the risk avoidance of generic drugs.
Answers to related questions about the revised patent law
1.
What is the protection period for design patents applied for before May 31, 2021 (including that date)?
What is the protection period for design patents applied for before May 31, 2021 (including that date)?
Article 93 of China’s Legislative Law stipulates that laws, administrative regulations , local regulations, autonomous regulations, separate regulations, and rules are not retroactive, but are required to better protect the rights and interests of citizens, legal persons, and other organizations.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, in accordance with the provisions of the patent law before the amendment, the protection period for design patent applications and patent rights granted before the entry into force of the new patent law is ten years.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, in accordance with the provisions of the patent law before the amendment, the protection period for design patent applications and patent rights granted before the entry into force of the new patent law is ten years.
2.
Starting from June 1, 2021, can an applicant submit a partial design patent application for the product requested for protection?
Starting from June 1, 2021, can an applicant submit a partial design patent application for the product requested for protection?
With the development of the industry, product design is becoming more refined, and it is more and more difficult to innovate the overall design of mature products.
Partial design gradually becomes an important manifestation of design innovation.
Innovative designers have an increasingly strong demand for protecting partial designs.
Therefore, in response to the demands of innovation entities, the revised Patent Law, Article 2, paragraph 4, clarifies that patent protection is granted to “partial” designs of products.
Starting from June 1, 2021, applicants can submit a design patent application for partial protection of the product to the State Intellectual Property Office.
However, since the implementation rules of the Patent Law are still in the process of revising and related supporting electronic systems are under development, starting from June 1, 2021, applicants can temporarily submit the above partial design patent applications in the form of paper or offline electronic applications.
Our office will review the above-mentioned applications after the implementation of the newly revised patent law implementation rules.
Partial design gradually becomes an important manifestation of design innovation.
Innovative designers have an increasingly strong demand for protecting partial designs.
Therefore, in response to the demands of innovation entities, the revised Patent Law, Article 2, paragraph 4, clarifies that patent protection is granted to “partial” designs of products.
Starting from June 1, 2021, applicants can submit a design patent application for partial protection of the product to the State Intellectual Property Office.
However, since the implementation rules of the Patent Law are still in the process of revising and related supporting electronic systems are under development, starting from June 1, 2021, applicants can temporarily submit the above partial design patent applications in the form of paper or offline electronic applications.
Our office will review the above-mentioned applications after the implementation of the newly revised patent law implementation rules.
3.
If the application date is after June 1, 2021 (including that date), can the applicant request the national priority of the design? Can the applicant submit a copy of the priority document in accordance with Article 30 of the revised Patent Law?
If the application date is after June 1, 2021 (including that date), can the applicant request the national priority of the design? Can the applicant submit a copy of the priority document in accordance with Article 30 of the revised Patent Law?
This revision of the Patent Law introduces a domestic design priority system, giving design applicants the opportunity to further improve the application and clarify the scope of protection.
Article 29 of the revised Patent Law stipulates that within six months from the date of filing the first patent application for a design in China, a patent application on the same subject is filed with the State Intellectual Property Office to enjoy the right of priority.
The filing date is a design patent application after June 1, 2021, and the applicant can submit a written statement to the State Intellectual Property Office requesting the national priority of the design.
However, since the implementation rules of the Patent Law are still in the process of revision, our office will examine the above-mentioned applications and the prior design patent applications that are the basis for the priority claim after the newly revised implementation rules of the Patent Law come into effect.
Article 29 of the revised Patent Law stipulates that within six months from the date of filing the first patent application for a design in China, a patent application on the same subject is filed with the State Intellectual Property Office to enjoy the right of priority.
The filing date is a design patent application after June 1, 2021, and the applicant can submit a written statement to the State Intellectual Property Office requesting the national priority of the design.
However, since the implementation rules of the Patent Law are still in the process of revision, our office will examine the above-mentioned applications and the prior design patent applications that are the basis for the priority claim after the newly revised implementation rules of the Patent Law come into effect.
In addition, in order to implement the reform of decentralization, regulation and service, and to further facilitate applicants, this revision of the Patent Law appropriately adjusted the relevant provisions of the deadline for submission of copies of priority documents.
Article 30 of the revised Patent Law stipulates that if an applicant claims priority for a patent for invention or utility model, it shall submit a written statement at the time of application, and within 16 months from the date of the first filing of the application, the first application shall be submitted.
A copy of the patent application file filed at one time; if the applicant claims priority for a design patent, he shall submit a written statement at the time of application and submit a copy of the patent application file filed for the first time within three months.
The filing date is a patent application after June 1, 2021, and the applicant can submit a copy of the priority document in accordance with Article 30 of the revised Patent Law.
Article 30 of the revised Patent Law stipulates that if an applicant claims priority for a patent for invention or utility model, it shall submit a written statement at the time of application, and within 16 months from the date of the first filing of the application, the first application shall be submitted.
A copy of the patent application file filed at one time; if the applicant claims priority for a design patent, he shall submit a written statement at the time of application and submit a copy of the patent application file filed for the first time within three months.
The filing date is a patent application after June 1, 2021, and the applicant can submit a copy of the priority document in accordance with Article 30 of the revised Patent Law.
4.
Starting from June 1, 2021, can an applicant submit a request for no loss of novelty grace period in accordance with Paragraph 1 of Article 24 of the revised Patent Law?
Starting from June 1, 2021, can an applicant submit a request for no loss of novelty grace period in accordance with Paragraph 1 of Article 24 of the revised Patent Law?
When a state of emergency or extraordinary situation occurs in the country (such as a major epidemic), some inventions and creations need to be put into use immediately in practice to protect the public interest, but this kind of disclosure does not fall under the pre-revision patent law without loss of novelty Exceptional circumstances may lead to the risk of not obtaining patent protection for related inventions and creations due to loss of novelty.
In order to meet the needs of extraordinary situations such as epidemic prevention and control, promote the timely application of these inventions and creations in disease treatment and other aspects, solve public health problems, respond to the needs of innovative entities to relax exceptions without loss of novelty, and better protect inventions and creations.
Article 24 of the later Patent Law adds an exception that does not lose novelty, that is, when a state of emergency or extraordinary situation occurs in the country, it is disclosed for the first time for the purpose of public interest.
For a patent application with an application date after June 1, 2021 (including that date), if the applicant believes that there are circumstances under Article 24, Paragraph 1 of the revised Patent Law, it may submit a request to the State Intellectual Property Office.
Request for loss of novelty grace period.
However, since the implementation rules of the Patent Law are still in the process of revising and the relevant supporting electronic systems are under development, starting from June 1, 2021, applicants can temporarily submit requests in paper form, and our office will implement the newly revised patent law.
The above application will be reviewed after the implementation of the rules.
In order to meet the needs of extraordinary situations such as epidemic prevention and control, promote the timely application of these inventions and creations in disease treatment and other aspects, solve public health problems, respond to the needs of innovative entities to relax exceptions without loss of novelty, and better protect inventions and creations.
Article 24 of the later Patent Law adds an exception that does not lose novelty, that is, when a state of emergency or extraordinary situation occurs in the country, it is disclosed for the first time for the purpose of public interest.
For a patent application with an application date after June 1, 2021 (including that date), if the applicant believes that there are circumstances under Article 24, Paragraph 1 of the revised Patent Law, it may submit a request to the State Intellectual Property Office.
Request for loss of novelty grace period.
However, since the implementation rules of the Patent Law are still in the process of revising and the relevant supporting electronic systems are under development, starting from June 1, 2021, applicants can temporarily submit requests in paper form, and our office will implement the newly revised patent law.
The above application will be reviewed after the implementation of the rules.
5.
For invention patents authorized from June 1, 2021, can the patentee file a request for compensation for the duration of the patent in accordance with the second paragraph of Article 42 of the revised Patent Law?
For invention patents authorized from June 1, 2021, can the patentee file a request for compensation for the duration of the patent in accordance with the second paragraph of Article 42 of the revised Patent Law?
Article 93 of my country’s Legislative Law stipulates: laws, administrative regulations, local regulations, autonomous regulations, separate regulations, and rules are not retroactive, but are required to better protect the rights and interests of citizens, legal persons, and other organizations.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, for invention patents that are announced and authorized before May 31, 2021 (including that date), the patent right period compensation system is not retroactive.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, for invention patents that are announced and authorized before May 31, 2021 (including that date), the patent right period compensation system is not retroactive.
As a supporting regulation of the Patent Law, the implementation rules of the Patent Law currently being revised have detailed provisions on the relevant content of the patent right period compensation system, including the request time and unreasonable delays caused by the applicant.
The draft amendments to the implementation rules of the Patent Law have been publicly solicited opinions from the public from November 27, 2020 to January 11, 2021.
Based on extensive solicitation of opinions and research and demonstration, the draft proposes that the patentee should submit the proposal to our office within three months from the date of the authorization announcement.
The draft amendments to the implementation rules of the Patent Law have been publicly solicited opinions from the public from November 27, 2020 to January 11, 2021.
Based on extensive solicitation of opinions and research and demonstration, the draft proposes that the patentee should submit the proposal to our office within three months from the date of the authorization announcement.
In addition, because the implementation rules of the Patent Law are still in the process of revising, and related supporting electronic systems are being developed, for invention patents authorized from June 1, 2021, the patentee can three months from the date of the announcement of the patent right authorization.
Within, temporarily submit a request for compensation for the term of patent right to the State Intellectual Property Office in paper form, and then pay the relevant fees in accordance with the payment notice issued by the Office.
Our Office will review the above-mentioned request after the implementation of the newly revised Patent Law Implementation Rules.
Within, temporarily submit a request for compensation for the term of patent right to the State Intellectual Property Office in paper form, and then pay the relevant fees in accordance with the payment notice issued by the Office.
Our Office will review the above-mentioned request after the implementation of the newly revised Patent Law Implementation Rules.
6.
If the application for the marketing license of a new drug is approved, from June 1, 2021, can the patentee make a request for compensation for the duration of the patent in accordance with Article 42 Paragraph 3 of the revised Patent Law?
If the application for the marketing license of a new drug is approved, from June 1, 2021, can the patentee make a request for compensation for the duration of the patent in accordance with Article 42 Paragraph 3 of the revised Patent Law?
Article 93 of my country’s Legislative Law stipulates: laws, administrative regulations, local regulations, autonomous regulations, separate regulations, and rules are not retroactive, but are required to better protect the rights and interests of citizens, legal persons, and other organizations.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, for new drug-related invention patents that have obtained marketing authorization before May 31, 2021 (including that date), the drug patent right period compensation system is not retroactive.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, for new drug-related invention patents that have obtained marketing authorization before May 31, 2021 (including that date), the drug patent right period compensation system is not retroactive.
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When a state of emergency or extraordinary situation occurs in the country (such as a major epidemic), some inventions and creations need to be put into use immediately in practice to protect the public interest, but this kind of disclosure does not fall under the pre-revision patent law without loss of novelty Exceptional circumstances may lead to the risk of not obtaining patent protection for related inventions and creations due to loss of novelty.
In order to meet the needs of extraordinary situations such as epidemic prevention and control, promote the timely application of these inventions and creations in disease treatment and other aspects, solve public health problems, respond to the needs of innovative entities to relax exceptions without loss of novelty, and better protect inventions and creations.
Article 24 of the later Patent Law adds an exception that does not lose novelty, that is, when a state of emergency or extraordinary situation occurs in the country, it is disclosed for the first time for the purpose of public interest.
For a patent application with an application date after June 1, 2021 (including that date), if the applicant believes that there are circumstances under Article 24, Paragraph 1 of the revised Patent Law, it may submit a request to the State Intellectual Property Office.
Request for loss of novelty grace period.
However, since the implementation rules of the Patent Law are still in the process of revising and the relevant supporting electronic systems are under development, starting from June 1, 2021, applicants can temporarily submit requests in paper form, and our office will implement the newly revised patent law.
The above application will be reviewed after the implementation of the rules.
Healthy, healthy, healthyIn order to meet the needs of extraordinary situations such as epidemic prevention and control, promote the timely application of these inventions and creations in disease treatment and other aspects, solve public health problems, respond to the needs of innovative entities to relax exceptions without loss of novelty, and better protect inventions and creations.
Article 24 of the later Patent Law adds an exception that does not lose novelty, that is, when a state of emergency or extraordinary situation occurs in the country, it is disclosed for the first time for the purpose of public interest.
For a patent application with an application date after June 1, 2021 (including that date), if the applicant believes that there are circumstances under Article 24, Paragraph 1 of the revised Patent Law, it may submit a request to the State Intellectual Property Office.
Request for loss of novelty grace period.
However, since the implementation rules of the Patent Law are still in the process of revising and the relevant supporting electronic systems are under development, starting from June 1, 2021, applicants can temporarily submit requests in paper form, and our office will implement the newly revised patent law.
The above application will be reviewed after the implementation of the rules.
5.
For invention patents authorized from June 1, 2021, can the patentee file a request for compensation for the duration of the patent in accordance with the second paragraph of Article 42 of the revised Patent Law?
For invention patents authorized from June 1, 2021, can the patentee file a request for compensation for the duration of the patent in accordance with the second paragraph of Article 42 of the revised Patent Law?
Article 93 of my country’s Legislative Law stipulates: laws, administrative regulations, local regulations, autonomous regulations, separate regulations, and rules are not retroactive, but are required to better protect the rights and interests of citizens, legal persons, and other organizations.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, for invention patents that are announced and authorized before May 31, 2021 (including that date), the patent right period compensation system is not retroactive.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, for invention patents that are announced and authorized before May 31, 2021 (including that date), the patent right period compensation system is not retroactive.
As a supporting regulation of the Patent Law, the implementation rules of the Patent Law currently being revised have detailed provisions on the relevant content of the patent right period compensation system, including the request time and unreasonable delays caused by the applicant.
The draft amendments to the implementation rules of the Patent Law have been publicly solicited opinions from the public from November 27, 2020 to January 11, 2021.
Based on extensive solicitation of opinions and research and demonstration, the draft proposes that the patentee should submit the proposal to our office within three months from the date of the authorization announcement.
The draft amendments to the implementation rules of the Patent Law have been publicly solicited opinions from the public from November 27, 2020 to January 11, 2021.
Based on extensive solicitation of opinions and research and demonstration, the draft proposes that the patentee should submit the proposal to our office within three months from the date of the authorization announcement.
In addition, because the implementation rules of the Patent Law are still in the process of revising, and related supporting electronic systems are being developed, for invention patents authorized from June 1, 2021, the patentee can three months from the date of the announcement of the patent right authorization.
Within, temporarily submit a request for compensation for the term of patent right to the State Intellectual Property Office in paper form, and then pay the relevant fees in accordance with the payment notice issued by the Office.
Our Office will review the above-mentioned request after the implementation of the newly revised Patent Law Implementation Rules.
Within, temporarily submit a request for compensation for the term of patent right to the State Intellectual Property Office in paper form, and then pay the relevant fees in accordance with the payment notice issued by the Office.
Our Office will review the above-mentioned request after the implementation of the newly revised Patent Law Implementation Rules.
6.
If the application for the marketing license of a new drug is approved, from June 1, 2021, can the patentee make a request for compensation for the duration of the patent in accordance with Article 42 Paragraph 3 of the revised Patent Law?
If the application for the marketing license of a new drug is approved, from June 1, 2021, can the patentee make a request for compensation for the duration of the patent in accordance with Article 42 Paragraph 3 of the revised Patent Law?
Article 93 of my country’s Legislative Law stipulates: laws, administrative regulations, local regulations, autonomous regulations, separate regulations, and rules are not retroactive, but are required to better protect the rights and interests of citizens, legal persons, and other organizations.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, for new drug-related invention patents that have obtained marketing authorization before May 31, 2021 (including that date), the drug patent right period compensation system is not retroactive.
Except for special regulations.
In October 2020, the Standing Committee of the National People's Congress voted to amend the "Patent Law".
The revised Patent Law did not make special provisions on the issue of retroactivity.
Therefore, for new drug-related invention patents that have obtained marketing authorization before May 31, 2021 (including that date), the drug patent right period compensation system is not retroactive.
Article 42 Paragraph 3 of the revised Patent Law stipulates that, in order to compensate for the time taken by the new drug marketing review and approval, the State Intellectual Property Office shall grant a patent at the request of the patentee for the new drug-related invention patents that have been approved for marketing in China.
Right period compensation.
The compensation period shall not exceed five years, and the total effective patent right period after the new drug is approved for marketing shall not exceed 14 years.
As a supporting regulation of the patent law, the implementation rules of the patent law currently being revised refine the relevant content of the drug patent right period compensation system, including the applicable drugs and patent scope, the calculation method of the compensation period, the scope of protection during the compensation period, and the compensation conditions.
Regulations.
The draft amendments to the implementation rules of the Patent Law have been publicly solicited opinions from the public from November 27, 2020 to January 11, 2021.
On the basis of extensive solicitation of opinions and research and demonstration, the draft proposes to provide compensation for the drug patent term for eligible new drug products, preparation methods, and medical use-related patents.
The compensation request shall be sent to me within three months from the date when the new drug is approved for marketing.
Bureau proposed.
Right period compensation.
The compensation period shall not exceed five years, and the total effective patent right period after the new drug is approved for marketing shall not exceed 14 years.
As a supporting regulation of the patent law, the implementation rules of the patent law currently being revised refine the relevant content of the drug patent right period compensation system, including the applicable drugs and patent scope, the calculation method of the compensation period, the scope of protection during the compensation period, and the compensation conditions.
Regulations.
The draft amendments to the implementation rules of the Patent Law have been publicly solicited opinions from the public from November 27, 2020 to January 11, 2021.
On the basis of extensive solicitation of opinions and research and demonstration, the draft proposes to provide compensation for the drug patent term for eligible new drug products, preparation methods, and medical use-related patents.
The compensation request shall be sent to me within three months from the date when the new drug is approved for marketing.
Bureau proposed.
As the implementation rules of the Patent Law are still in the process of revising, the relevant supporting electronic systems are under development.
Starting from June 1, 2021, the patentee can, in accordance with Article 42 Paragraph 3 of the revised Patent Law, obtain the approval for the marketing of new drugs.
Within three months from the date of approval of the request, temporarily submit a paper form to the State Intellectual Property Office for compensation for the duration of the patent right, and then pay the relevant fees in accordance with the payment notice issued by the Office.
Our office will review the above-mentioned applications after the implementation of the newly revised patent law implementation rules.
Starting from June 1, 2021, the patentee can, in accordance with Article 42 Paragraph 3 of the revised Patent Law, obtain the approval for the marketing of new drugs.
Within three months from the date of approval of the request, temporarily submit a paper form to the State Intellectual Property Office for compensation for the duration of the patent right, and then pay the relevant fees in accordance with the payment notice issued by the Office.
Our office will review the above-mentioned applications after the implementation of the newly revised patent law implementation rules.
7.
Starting from June 1, 2021, can the patentee voluntarily declare to implement an open license for his patent?
Starting from June 1, 2021, can the patentee voluntarily declare to implement an open license for his patent?
In order to promote the transformation and application of patents, and solve problems such as the asymmetry of supply and demand information in the patent market, this revision of the Patent Law introduced an open licensing system.
Article 50 Paragraph 1 of the revised Patent Law stipulates that if the patentee voluntarily declares in writing to the State Intellectual Property Office that he is willing to license any entity or individual to exploit his patent, and clarify the payment method and standard of the license fee, the state shall The Intellectual Property Office made an announcement and implemented an open license.
Starting from June 1, 2021, patentees can voluntarily declare to implement an open license for their patents in accordance with the provisions of Article 50, paragraph 1, of the Patent Law.
However, as the implementation rules of the Patent Law are still in the process of revising, and related supporting electronic systems are under development, starting from June 1, 2021, patentees can temporarily voluntarily declare open licenses for their patents in paper form.
Our Office will review the above statement after the implementation of the newly revised Patent Law Implementation Rules.
Article 50 Paragraph 1 of the revised Patent Law stipulates that if the patentee voluntarily declares in writing to the State Intellectual Property Office that he is willing to license any entity or individual to exploit his patent, and clarify the payment method and standard of the license fee, the state shall The Intellectual Property Office made an announcement and implemented an open license.
Starting from June 1, 2021, patentees can voluntarily declare to implement an open license for their patents in accordance with the provisions of Article 50, paragraph 1, of the Patent Law.
However, as the implementation rules of the Patent Law are still in the process of revising, and related supporting electronic systems are under development, starting from June 1, 2021, patentees can temporarily voluntarily declare open licenses for their patents in paper form.
Our Office will review the above statement after the implementation of the newly revised Patent Law Implementation Rules.
8.
From June 1, 2021, can the accused infringer request a patent right evaluation report?
From June 1, 2021, can the accused infringer request a patent right evaluation report?
The second paragraph of Article 66 of the revised Patent Law stipulates that if a patent infringement dispute involves a utility model patent or a design patent, the people’s court or the administrative department of patent work may require the patentee or interested parties to issue a certificate issued by the national intellectual property rights.
The patent right evaluation report made by the bureau after searching, analyzing and evaluating related utility models or designs is used as evidence for trial and handling of patent infringement disputes; patentees, interested parties or accused infringers can also proactively issue patent rights Evaluation report.
This amendment to the Patent Law expands the subjects who can request to issue a patent evaluation report to the accused infringer.
This amendment will help them fully assess the risk of infringement and take reasonable countermeasures, which will help both parties to form a reasonable expectation of the patent right.
Promote dispute resolution and reduce the cost of rights protection.
Therefore, from June 1, 2021, the accused infringer can request a patent evaluation report.
However, because the implementation rules of the Patent Law are still in the process of revising, and the relevant supporting electronic systems are under development, starting from June 1, 2021, the accused infringer can temporarily request our office to issue a patent evaluation report in paper form.
The patent right evaluation report made by the bureau after searching, analyzing and evaluating related utility models or designs is used as evidence for trial and handling of patent infringement disputes; patentees, interested parties or accused infringers can also proactively issue patent rights Evaluation report.
This amendment to the Patent Law expands the subjects who can request to issue a patent evaluation report to the accused infringer.
This amendment will help them fully assess the risk of infringement and take reasonable countermeasures, which will help both parties to form a reasonable expectation of the patent right.
Promote dispute resolution and reduce the cost of rights protection.
Therefore, from June 1, 2021, the accused infringer can request a patent evaluation report.
However, because the implementation rules of the Patent Law are still in the process of revising, and the relevant supporting electronic systems are under development, starting from June 1, 2021, the accused infringer can temporarily request our office to issue a patent evaluation report in paper form.
9.
Starting from June 1, 2021, can the State Intellectual Property Office examine patent applications in the preliminary examination, substantive examination and reexamination procedures in accordance with the principle of good faith?
Starting from June 1, 2021, can the State Intellectual Property Office examine patent applications in the preliminary examination, substantive examination and reexamination procedures in accordance with the principle of good faith?
The principle of good faith is one of the most important basic principles of our civil law.
As early as 1986, Article 4 of the General Principles of the Civil Law stipulates that civil activities should follow the principles of voluntariness, fairness, compensation for equal value, and good faith; January 1, 2021 Article 7 of the Civil Code that came into effect today stipulates that "Civil entities engaged in civil activities shall follow the principle of good faith, uphold honesty, and abide by their promises.
" Patent right is an important civil right.
Whether it is applying for a patent or exercising a right, it should follow the principle of good faith, cannot obtain patent right through plagiarism, forgery, etc.
, and cannot abuse the patent right in violation of the principle of good faith.
Therefore, Article 1 of the Patent Law clearly states the purpose of the legislation to encourage inventions and creations, promote the application of inventions and creations, and improve innovation capabilities; Article 5 stipulates that patents shall not be granted for inventions and creations that violate the law, social morality, or interfere with the public interest.
.
The irregular patent application behavior in patent application not only violates the legislative purpose of the patent law, but also violates the basic principle of good faith in the civil law.
As early as 1986, Article 4 of the General Principles of the Civil Law stipulates that civil activities should follow the principles of voluntariness, fairness, compensation for equal value, and good faith; January 1, 2021 Article 7 of the Civil Code that came into effect today stipulates that "Civil entities engaged in civil activities shall follow the principle of good faith, uphold honesty, and abide by their promises.
" Patent right is an important civil right.
Whether it is applying for a patent or exercising a right, it should follow the principle of good faith, cannot obtain patent right through plagiarism, forgery, etc.
, and cannot abuse the patent right in violation of the principle of good faith.
Therefore, Article 1 of the Patent Law clearly states the purpose of the legislation to encourage inventions and creations, promote the application of inventions and creations, and improve innovation capabilities; Article 5 stipulates that patents shall not be granted for inventions and creations that violate the law, social morality, or interfere with the public interest.
.
The irregular patent application behavior in patent application not only violates the legislative purpose of the patent law, but also violates the basic principle of good faith in the civil law.
The Party Central Committee and the State Council attach great importance to intellectual property work.
General Secretary Xi Jinping issued a series of important instructions on intellectual property work, emphasizing the need to strengthen intellectual property protection and improve the quality and efficiency of intellectual property review.
Especially during the 25th collective study session of the Political Bureau of the Central Committee in 2020, the general secretary clearly proposed to realize the "transition from a big country in introducing intellectual property rights to a big country in intellectual property creation, from pursuing quantity to improving quality".
General Secretary Xi Jinping issued a series of important instructions on intellectual property work, emphasizing the need to strengthen intellectual property protection and improve the quality and efficiency of intellectual property review.
Especially during the 25th collective study session of the Political Bureau of the Central Committee in 2020, the general secretary clearly proposed to realize the "transition from a big country in introducing intellectual property rights to a big country in intellectual property creation, from pursuing quantity to improving quality".
In order to severely crack down on irregular patent applications and promote the improvement of patent quality from the source, the State Intellectual Property Office has adopted a series of measures since 2007.
In 2007, the State Intellectual Property Office issued Bureau Order No.
45 "Regulations on the Regulation of Patent Application Behaviors", which regulated irregular patent applications and their handling measures; in 2017, it was revised and the No.
Bureau Order No.
75 added the identification of irregular patent applications and strengthened the handling.
According to Bureau Order No.
75, the State Intellectual Property Office conducted investigations and disposals of irregular patent applications from 2018 to 2020, and notified local authorities of irregular patent applications that were not intended to protect innovation.
This revision of the Patent Law adds the principle of good faith, which provides a clear and direct legal basis for regulating patent applications at the legal level, which is conducive to improving the quality of patents.
In 2007, the State Intellectual Property Office issued Bureau Order No.
45 "Regulations on the Regulation of Patent Application Behaviors", which regulated irregular patent applications and their handling measures; in 2017, it was revised and the No.
Bureau Order No.
75 added the identification of irregular patent applications and strengthened the handling.
According to Bureau Order No.
75, the State Intellectual Property Office conducted investigations and disposals of irregular patent applications from 2018 to 2020, and notified local authorities of irregular patent applications that were not intended to protect innovation.
This revision of the Patent Law adds the principle of good faith, which provides a clear and direct legal basis for regulating patent applications at the legal level, which is conducive to improving the quality of patents.
The State Intellectual Property Office resolutely implemented the important instructions of General Secretary Jin Ping on intellectual property work.
Since 2021, in order to further regulate the behavior of patent applications and intensify the crackdown on irregular patent applications, the State Intellectual Property Office has issued the "Notice on Further Strict Regulation of Patent Application Behaviors" to local intellectual property management departments on January 27, and At the end of February, the investigation of irregular patent applications was notified to all localities.
The State Intellectual Property Office will deal with the patent applications that have not been actively withdrawn in this and subsequent notifications in a timely manner.
Since 2021, in order to further regulate the behavior of patent applications and intensify the crackdown on irregular patent applications, the State Intellectual Property Office has issued the "Notice on Further Strict Regulation of Patent Application Behaviors" to local intellectual property management departments on January 27, and At the end of February, the investigation of irregular patent applications was notified to all localities.
The State Intellectual Property Office will deal with the patent applications that have not been actively withdrawn in this and subsequent notifications in a timely manner.
Therefore, starting from June 1, 2021, the State Intellectual Property Office will examine patent applications in the preliminary examination, substantive examination, and reexamination procedures in accordance with the first paragraph of Article 20 of the revised Patent Law.
