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From the Roche statement, explore issues related to the protection of intellectual property rights in medicines

 Last Update: 2022-10-31
 Source: Internet
 Author: User

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On October 18, 2022, Roche Pharmaceutical issued a statement on its official account saying [1] that the recently approved generic version of mabasavir by CSPC Ouyi fell within the scope of protection of the original drug patent, calling on all parties not to manufacture, sell or promise to sell related products, and has filed a patent link lawsuit
.
The incident sparked extensive discussions
in the industry on drug infringement and patent linkage systems.
This article will explore several key issues and further reflect on
the protection of intellectual property rights in pharmaceuticals.

。

First, problem analysis

CSPC submitted its marketing application 3 months after the approval of the original drug, and the patent of the original drug will not expire
until 2031.
So, is it allowed for CSPC to quickly submit a generic drug marketing application under such circumstances?

Whether it is allowed for CSPC to promptly submit a generic drug marketing application

The problem can be boiled down to whether there is a time limit
for the submission of a generic drug marketing application at the level of drug declaration.
In fact, the 2002 Regulations for the Implementation of the Drug Administration Law set a "new drug monitoring period" for new drugs of no more than five years, during which other enterprises could not be approved to produce and import.

However, there is currently no regulation that explicitly limits the time for generic drugs to submit marketing applications, and also allows the submission of generic drug marketing applications (such as Class 3 chemical drugs)
when the original drug is not listed in China.

Is there a time limit
for the submission of a generic drug marketing application at the drug application level?

At the patent level, it can be divided into two levels, how to judge drug infringement? Is the filing of a marketing application infringing during the patent period?

How to judge drug infringement at the patent level? Is the filing of a marketing application infringing during the patent period?

First, it needs to be clarified that our discussion should be based on the law
applicable to the marketing application of a generic drug of mabasavir.
In addition to technical judgments, it is also necessary to determine whether drugs are infringing (whether they are produced, sold and promised for sale for the purpose of production and operation), and whether these acts are excluded from the scope of infringement by the relevant provisions of the Patent Law[2].

Therefore, "the pharmaceutical technical solution falls within the scope of patent protection" does not necessarily mean infringement
.

First, it needs to be clarified that our discussion should be based on the law
applicable to the marketing application of a generic drug of mabasavir.

According to the Beijing Municipal Higher People's Court (2018) Jingmin Zhong No.
474 ruling [3], although the submission of a marketing application to the drug regulatory department during the patent period is for the purpose of production and operation, it does not belong to the act of enforcing the patent right as mentioned in Article 11 of the Patent Law; Although it is inevitable that the manufacture of relevant drugs will be necessary in this process, this behavior is excluded by the relevant provisions of the BOLAR exception of the Patent Law and is not actionable, so the 2018 Beijing High School ruling rejected the appeal request
of the original research company.

Although the submission of a marketing application to the drug regulatory department during the patent period is for the purpose of production and operation, it does not fall under the act of enforcing the patent right as mentioned in Article 11 of the Patent Law

Therefore, pharmaceutical technical solutions fall within the scope of patent protection and can be considered to be in the "middle ground" after approval, and whether they are infringing depends on whether to expand production and sales
.
Original drug companies cannot resolve potential disputes in advance based on generic drug companies' marketing applications, and can only continue to "monitor" the dynamics of generic drug companies in order to take corresponding measures
.
If both parties are caught in litigation in the future, the production of generic drugs is suspended or withdrawn from the market, which is also a huge threat
to drug access.

Second, the positive significance of the implementation of patent linkage

Since July 4, 2021, China has officially implemented the Implementation Measures for the Early Resolution Mechanism for Patent Disputes, which will advance possible future disputes between the original imitation parties to be resolved before the drug is marketed
.
Specifically, the patentee or interested party may request the people's court or the patent administration department under the State Council to confirm "whether the pharmaceutical technical solution falls within the scope of patent protection" within the specified time specified by the marketing authorization applicant for a generic drug to submit a marketing application; Within a certain period of time, the NMPA may make a decision
on whether to approve the marketing based on the ruling made by the court or the patent administration department under the State Council on whether to "fall within the scope of patent protection".

Patent linkage not only plays an early role in resolving disputes, but also plays a balancing effect
on both sides of imitation.
On the one hand, it protects the legitimate rights and interests of the original drug in the patent period, maintains a reasonable length of the drug life cycle, and enables the innovative drug to obtain sufficient returns to invest in new research and development
.
On the other hand, it also provides the opportunity for
generic drugs to challenge patents and be marketed before the patent expires.
The first generic drug that successfully challenges the patent can obtain a certain period of market exclusivity, so as to achieve effective replacement of the original drug, save medical insurance funds, and improve drug
accessibility.
In the recently concluded first patent-linked "confirmation lawsuit", the generic drug successfully "bypassed" the original drug patent and is expected to be marketed
about 3 years before the patent expires.

Third, further improve the thinking of the protection of intellectual property rights of drugs

Patent linking enables early resolution of
potential patent disputes.
But is it reasonable to file a generic drug for marketing so quickly?

This is partly due to the fact that our country has not yet established a data protection period system
.
According to this system (taking the United States as an example), the FDA does not accept any simplified marketing application (ANDA) 4 years after the launch of a chemical innovative drug, and it is only in the fifth year that it begins to accept ANDA, and the generic drug can be approved for marketing
in the sixth year.
This is equivalent to setting a 4-year "quiet period"
for the initiation of patent links.
On the one hand, the existence of the silent period provides sufficient market expectations for the original drug, and on the other hand, it potentially delays the approval time of the generic drug [4].

In May 2022, the implementation regulations deleted the "new drug monitoring period" and set a six-year data protection period
for drugs in Article 40.
The specific implementation rules for the future data protection period will be further clarified
in light of the current situation of the industry.

This is partly due to the fact that our country has not yet established a data protection period system
.

On the other hand, it is also due to the fact that innovative drugs have not yet carried out a perfect patent layout
.
On the one hand, enterprises need to formulate a thorough patent layout strategy according to the degree of material innovation and the progress of clinical trials; On the other hand, patent administration departments can establish an information communication mechanism with drug evaluation agencies to escort the life cycle layout of innovative drugs [5].

On the other hand, it is also due to the fact that innovative drugs have not yet carried out a perfect patent layout
.

The optimization and implementation of the patent linkage system and related systems have added an important link
to the realization of the "construction of a large intellectual property protection pattern" proposed in the 14th Five-Year Plan for Market Supervision Modernization.
The protection of pharmaceutical intellectual property rights runs through all links of the drug life cycle and industrial chain, and requires all institutions to work together to build a scientific, efficient and coherent protection system
.
In addition to the above-mentioned communication mechanism between the patent administration department and the drug evaluation agency at the patent application stage, for core patents with a high risk of infringement in patent disputes that have not been settled due to various reasons in the patent link, a communication mechanism between the drug supervision, medical insurance and CNIPA should also be established in the core links of drug market sales, such as medical insurance negotiations and volume procurement[6].

Policy Research Center, China Association for the Promotion of Pharmaceutical Innovation

Author: Sun Tanlin Researcher suntl@phirda.
com

Review and proofreader: Zhang Zhijuan, Liu Fapeng

Resources:

1.
Statement on the approval of the generic drug of mabaloxavir tablets of CSPC Ouyi Pharmaceutical Co.
, Ltd.
https://mp.
weixin.
qq.
com/s/iX3hxmDAdCXjareyhzoFvQ

2.
In-depth interpretation of the first judgment and ruling of "Drug Patent Link" and its procedural comparison source: Zhang Qiulin's lecture PPT

3.
The application for registration of generic drugs is https://mp.
weixin.
qq.
com/s/x4oHKPR4nUzR48tVKKvNoA with the "Bolar exception"| the dispute between Stone Medicine Enbip v.
Lizhulimin for infringement of invention patent rights

4.
Xu Feng | "Early Resolution Mechanism for Drug Patent Disputes Version 1.
0" End User Experience https://mp.
weixin.
qq.
com/s/9SbvQdJEJfNSJu3r9wVU3w

5.
Depth | Taking osimertinib as an example to discuss the opportunities and challenges of patent management under the situation of accelerated review and approval of new drugs, https://mp.
weixin.
qq.
com/s/pmDtZUL2a7YWO7Ys1S5gUA

6.
Anniversary | Controversy and prospect of China's pharmaceutical patent linkage system https://mp.
weixin.
qq.
com/s/k97DcmCKPKirjC6ffCh-TQ

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