Only "Global New" can get patent term compensation?

• The "Regulations for the Implementation of the Patent Law" and the "Patent Examination Guidelines" have defined the meaning of "new drugs" as "global new"

• The "Regulations for the Implementation of the Patent Law" and the "Patent Examination Guidelines" have defined the meaning of "new drugs" as "global new"

• If 5.

• The patent term compensation system refers to the "global new" concept in the "new drug application" that has been abolished in the drug law system.

According to the concept of "global new" in the current "Regulations for the Implementation of the Patent Law" and the "Patent Examination Guidelines" draft, the "new drugs" applicable to the drug patent term compensation system only include Category 1 innovative drugs and some Category 2 improved new drugs.

"From the perspective of the legislative purpose of the patent law, the relationship between the patent law and the drug law, and the international practical experience of the system, it is still debatable whether defining a 'new drug' as a 'global new' can truly achieve the purpose of encouraging innovation

The "Implementation Rules of the Patent Law" and "Patent Examination Guidelines" are soliciting opinions.

Is "global new" justified?

Is "global new" justified?

At present, the "Regulations for the Implementation of the Patent Law" and the "Patent Examination Guidelines" have defined the meaning of "new drug" as "global new", which is the "new drug application" that appeared in the "Administrative Measures for Drug Registration".

In the view of Director Cheng Yongshun, the rationality of the patent term compensation system directly applying the definition of "global new" in "new drug application" should be viewed from the relationship between the patent law and the drug law and the legislative purpose set by the system

Cheng Yongshun, Director of Beijing Pragmatic Intellectual Property Development Center

Cheng Yongshun, Director of Beijing Pragmatic Intellectual Property Development Center

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According to the previous explanations by the legislators of the "Patent Law", the legislative purpose of introducing the drug patent term compensation system is to use it as a Bolar exception (the Bolar exception clause stipulates that generic drug companies can make an advance payment before the patent of the patented drug expires Carry out corresponding production and preparation, provide the information required for administrative approval, so that the original drug can enter the market immediately after the patent expires), achieve a balance with imitation, and promote foreign new drugs to be launched in China as soon as possible.

According to the previous explanations by the legislators of the "Patent Law", the legislative purpose of introducing the drug patent term compensation system is to use it as a Bolar exception (the Bolar exception clause stipulates that generic drug companies can make an advance payment before the patent of the patented drug expires Carry out corresponding production and preparation, provide the information required for administrative approval, so that the original drug can enter the market immediately after the patent expires), achieve a balance with imitation, and promote foreign new drugs to be launched in China as soon as possible.

In my opinion, the fundamental purpose of patent law should be to encourage drug innovation, and all inventions and creations that conform to novelty, creativity and practicality can be protected by patent law

Improving the accessibility of medicines to the people is an issue that should be considered in the Drug Law, and should not be directly used as the institutional goal of the patent protection term compensation system, nor should it be used as the legislative purpose of the Patent Law.

On the other hand, although the drug patent term compensation system involves both the Drug Law and the Patent Law, in fact, the nature and legislative purpose of these two laws are quite different, and the legal relationship they adjust is quite different.

The drug law belongs to the field of public law, requiring regulatory authorities to strengthen the management of drugs, to ensure the safety and effectiveness of drugs, and to be responsible for the health of the people; while the patent law belongs to the field of private law, dealing with the legal relationship between patent rights as private rights , whose legislative purpose is to protect the legitimate rights and interests of patentees, and to encourage and promote the invention and innovation of drugs

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From the perspective of improving the availability of drugs and meeting unmet clinical needs in China, Category 5.

From the perspective of improving the availability of drugs and meeting unmet clinical needs in China, Category 5.
1 imported drugs that are first marketed abroad and then applied for listing in China, as well as drugs developed under the license-in mode of domestic companies, will be excluded from compensation.
In addition to the system, it may also dampen the enthusiasm of some enterprises, which will not help increase the diversity of domestically available medicines
.
In addition, referring to the practical experience of foreign countries and regions that have implemented this system, there is almost no clear distinction between "global new" or "regional new" for new drugs in relevant regulations, and the applicable objects are all "regional new"
.

Is it "China New" or "Global New"?

Is it "China New" or "Global New"?

In the draft of the "Implementation Regulations of the Patent Law" and the "Guidelines for Patent Examination", the legislative department has followed the definition of "new drug" in "new drug application" that appeared in the "Administrative Measures for Drug Registration"
.
The "Measures for the Administration of Drug Registration" is a departmental administrative regulation in the system of the Drug Law.
Its superior laws and administrative regulations include fundamental laws such as the "Drug Administration Law", and administrative regulations such as the "Regulations on the Implementation of the Drug Administration Law"
.

After the revision of the Drug Administration Law in 2001, only the definition of "drug" was retained in its supplementary section, and the definition of "new drug" was deleted.
Article 83 of "New Drugs" stipulates the meaning of "new drugs": new drugs refer to drugs that have not been marketed in China
.

The "Implementation Regulations of the Drug Administration Law" was revised twice in 2016 and 2019.
The definition of "new drug" in Article 77 uses the above meaning without any further adjustment
.
The "Implementation Regulations of the Drug Administration Law" revised on March 2, 2019 is the currently effective administrative regulation
.

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In fact, looking at the changes in the Drug Administration Law and the Regulations for the Implementation of the Drug Administration Law over the past few decades, there has been no controversy about whether it is "new in China" or "new in the world"
.
Looking at it now, if you need to define it, from "new drugs refers to drugs that have not been produced in China" in the "Drug Administration Law" in 1985 to "drugs that have not been produced in China" in the "Implementation Regulations of the Drug Administration Law" in 2019.
"Marketed drugs", the geographical scope included in "new" should always be understood as "China's new"
.
Therefore, even if the drug law is to be compared, the definition of "new drug" should be "new in China"
.

In fact, looking at the changes in the Drug Administration Law and the Regulations for the Implementation of the Drug Administration Law over the past few decades, there has been no controversy about whether it is "new in China" or "new in the world"
.
Looking at it now, if you need to define it, from "new drugs refers to drugs that have not been produced in China" in the "Drug Administration Law" in 1985 to "drugs that have not been produced in China" in the "Implementation Regulations of the Drug Administration Law" in 2019.
"Marketed drugs", the geographical scope included in "new" should always be understood as "China's new"
.
Therefore, even if the drug law is to be compared, the definition of "new drug" should be "new in China"
.

A "new drug application" should not affect the definition of a new drug

A "new drug application" should not affect the definition of a new drug

In fact, a series of legal terms and concepts such as "new drug application", "global new" and "improved new" all appear in the relevant system rules surrounding the drug registration review and approval process in the "Administrative Measures for Drug Registration"
.
The origin of the concept of "global new" can be traced by sorting out the changes in the definition of "new drug application" in the "Administrative Measures for Drug Registration"
.

The concept of "new drug application" first appeared in the "Administrative Measures for Drug Registration (Trial)" which was implemented on December 1, 2002.
At that time, the domestic drug application methods were distinguished according to the personal method
.
Article 7 stipulates that drug registration applications shall include new drug applications, applications for existing national standard drugs, and applications for imported drugs and their supplementary applications
.
Domestic applicants shall follow the application for new drug applications and existing national standard drugs, and overseas applicants shall follow the application for imported drugs
.
Article 8 stipulates that "new drug application" refers to the registration application for a drug that has not been marketed in China.
If a drug that has already been marketed changes its dosage form or route of administration, it shall be managed as a "new drug"
.

According to the regulations at the time, registration applications that need to follow the "new drug application" procedure are not necessarily "new drugs"
.
For drugs that have not been marketed in China, as well as those that have been marketed with changed dosage forms and routes of administration, the new drug application process applies as long as the domestic applicant applies for registration
.

Subsequently, the "Administrative Measures for Drug Registration" were revised twice in 2005 and 2007 respectively, and some adjustments were made to the definition of "new drug application".
In accordance with the management of new drug applications, it was revised in 2007 to "the registration of drugs that have been marketed with changes in dosage form, route of administration, and new indications should be submitted in accordance with the procedures for new drug applications"
.

Looking at the three versions of the "Drug Registration Management Measures" in 2002, 2005, and 2007, the relationship between "marketed drugs that change the dosage form, change the route of administration, and add new indications" and "new drugs" is gradually weakening.
The definition of "new drug" is always "drugs that have not been marketed in China"
.

The change in the definition of "new drug" occurred in 2015.
In order to cope with the backlog of drug review and approval in China at that time, improve the quality of generic drugs, and encourage the listing of innovative drugs with independent intellectual property rights, the State Council issued the "Reform on the Review and Approval System for Drugs and Medical Devices".
Opinions" (hereinafter referred to as "Opinions"), the reform of China's pharmaceutical review and approval has begun
.

This "Opinion" adjusts the concept of "new drugs" from the original "drugs that have not been marketed in China" to "drugs that have not been marketed in China or abroad", that is, from "new in China" to "new in the world"
.

Since then, on March 4, 2016, CDE released the "Work Plan for the Reform of Chemical Drug Registration Classification", which adjusted the chemical drug registration classification categories, that is, there are five categories of chemical drugs that we are familiar with later under the new registration classification
.
When interpreting the "Opinions", CDE pointed out that new drugs refer to drugs that have not been marketed both inside and outside China, and are classified into innovative drugs under new registration category 1 and improved new drugs under category 2
.
The new review technical standards emphasize that innovative drugs should have a "global new" material structure and should also have clinical value
.

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It is worth noting that in the Implementation Regulations of the Drug Administration Law, which came into effect in 2019, the definition of "new drug" is still "new in China".
The concept of "global new" is inconsistent with the definition of "new drug" in the "Regulations for the Implementation of the Drug Administration Law" of the higher-level law.
Therefore, the definition of "new drug application" has been deleted from the "Administrative Measures for Drug Registration" which will be finally issued in 2020
.

It is worth noting that in the Implementation Regulations of the Drug Administration Law, which came into effect in 2019, the definition of "new drug" is still "new in China".
The concept of "global new" is inconsistent with the definition of "new drug" in the "Regulations for the Implementation of the Drug Administration Law" of the higher-level law.
Therefore, the definition of "new drug application" has been deleted from the "Administrative Measures for Drug Registration" which will be finally issued in 2020
.

Through the changes in the definition of "new drug application" in the Drug Law, it can be seen that the legislators of the Drug Law are deliberately distinguishing the definitions of "new drug" and "new drug application", and this distinction is reasonable
.
"New drug" is more inclined to the concept of substantive law, that is, what kind of drug and what conditions can be recognized as "new drug"
.
According to the definition still retained in the current law, "China New" should all belong to "New Drugs"
.
The "new drug application" is more inclined to the procedural method, and is closely related to the drug registration review and approval process.
In this process, the drug regulatory department pays more attention to the review of drug safety, efficacy and quality controllability
.

Through the changes in the definition of "new drug application" in the Drug Law, it can be seen that the legislators of the Drug Law are deliberately distinguishing the definitions of "new drug" and "new drug application", and this distinction is reasonable
.
"New drug" is more inclined to the concept of substantive law, that is, what kind of drug and what conditions can be recognized as "new drug"
.
According to the definition still retained in the current law, "China New" should all belong to "New Drugs"
.
The "new drug application" is more inclined to the procedural method, and is closely related to the drug registration review and approval process.
In this process, the drug regulatory department pays more attention to the review of drug safety, efficacy and quality controllability
.

For new drugs that have not been marketed in China, they may include innovative drugs, improved new drugs, and imported drugs that have been marketed overseas and seek to be marketed in China.
The registration application process is scientific, reasonable and practical
.
However, this distinction in the registration review and approval process has never been and should not affect the definition of "new drug" in the future, nor should it become the target of the definition of "new drug" in the patent term compensation system
.

For new drugs that have not been marketed in China, they may include innovative drugs, improved new drugs, and imported drugs that have been marketed overseas and seek to be marketed in China.
The registration application process is scientific, reasonable and practical
.
However, this distinction in the registration review and approval process has never been and should not affect the definition of "new drug" in the future, nor should it become the target of the definition of "new drug" in the patent term compensation system
.