Is the 1-year market exclusivity period of Zhengda Tianqing's "lenvatinib" stable?

On July 4, the State Food and Drug Administration issued a notice (No.

On the same day, China's listed drug patent information registration platform was officially launched

The "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" For listed drugs and unmarketed drugs, the requirements for registration on the listed drug patent information registration platform are different.

Chemical generic drugs, Chinese medicines with the same name and same prescription, and biological analogues are classified into the following four categories for related patent claims

The types of patents related to the registration of different types of original patent drugs are different, as shown in the following table

The important crystal forms, preparation methods and other patents of chemical drugs are not included, which will not affect the submission of marketing applications for generic drugs.

The "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" released this time did not consider the combination of biological products.

For the registration application of Chinese medicines with the same name and the same prescription and biosimilars, the State Council's drug regulatory authority directly makes a decision on whether to approve the listing based on the conclusion of the technical review

Before the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" is issued, generic drugs can be accepted and reviewed by CDE without a declaration when they submit their marketing applications, and technical review and administrative approval can be initiated

After the "Implementation Measures for the Early Resolution of Drug Patent Disputes (Trial)" is promulgated, generic drug companies need to make preparations in advance

At present, the patent information registration platform for listed drugs is initially established.

For the original research of registered patent information, there are four corresponding marketing strategies for generic drugs:

1.

2.

3.

4.

As for the four types of declarations, the possibility that the generic drugs fall within the scope of the relevant patent protection is extremely low, because under the current requirements for BE, the generic drugs need to maintain extreme consistency with the original research

The "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" focuses on chemical generic drugs, and uniquely empowers chemical generic drugs that take offensive methods
.

Empowerment A: Those who succeed in the patent challenge will receive a one-year market exclusivity period, but the remaining validity period of the original research patent shall not exceed the usual period of time.
For example, the original research patent expires in 2025, and now the challenge is successful, it will receive a one-year market exclusivity period.
The patent expires in December 2021, and the market exclusivity period for the patent challenger ends in December 2021
.

The one-year market exclusivity period maintains the principle of whoever challenges those who benefit.
Take Chia Tai Tianqing’s challenge to the patent of Eisai lunvatinib pharmaceutical composition as an example
.

Currently, Eisai has registered lenvatinib's patent information on the "China Listed Drug Patent Information Registration Platform", including compound patents (ZL 01819710.
8) and composition patents (ZL 201080030508.
6)
.

The corresponding relationship between the drug in the lenvatinib compound patent (ZL 01819710.
8) and the relevant patent claims is shown in the following table
.

The corresponding relationship between the medicines in the lenvatinib composition patent (ZL 201080030508.
6) and related patent claims is shown in the following table
.

On May 25, the State Intellectual Property Office declared the lenvatinib composition patent (ZL 201080030508.
6) invalid, and the requester for the patent invalidation was Nanjing Zhengda Tianqing
.

If, in the end, Eisai gives up the appeal or fails in the final appeal, then Nanjing Chia Tai Tianqing's generic drugs will be marketed without problems
.
After the lenvatinib compound patent expires on October 18, 2021, the China Food and Drug Administration can initiate the administrative examination and approval of Nanjing Chia Tai Tianqing lenvatinib, and according to the fourth statement, approve the listing of Chia Tai Tianqing lenvatinib
.

Although there are currently as many as 11 manufacturers of lenvatinib generics carrying out BE trials, and many of them have been successful in BE trials, some even earlier than Chia Tai Tianqing, and they have even completed the technical review according to the previous policy.
However, after the expiration of the lenvatinib compound patent, the China Food and Drug Administration can initiate an administrative review in accordance with the four types of declarations, and approve the listing of the patent challenger-Chia Tai Tianqing’s lenvatinib generic drug, while the products of other companies are in the current policy The next thing is more embarrassing.
Even if it is approved for listing in the second or third category, it will not be marketed until the exclusive period of lenvatinib is 1 year.
Chia Tai Tianqing will undoubtedly be called the first challenged patent and the first successful patent.
Approved chemical generic drugs for marketing
.

As the only challenger to the patent of lenvatinib composition, CP Tianqing cannot take a share of the pie
.
If there are other generic drug companies participating in the patent challenge at the same time, the companies participating in the patent challenge can enjoy a one-year market exclusivity period with CP Tianqing
.

Empowerment B: The technical review will not be stopped during the 9-month waiting period, and there will be one and only one time, which saves the time for the technical review of chemical generic drugs
.

Within 10 working days after an application for a generic drug is accepted, the National Drug Evaluation Agency shall disclose the application information and corresponding statement on the information platform; the applicant for a generic drug shall notify the marketing authorization holder of the corresponding statement and the basis for the statement
.

If the patentee or interested parties have objections to the four types of patent declarations, they may, within 45 days from the date when the national drug review agency publishes the drug marketing authorization application, whether the relevant technical solutions of the applied for marketing drugs fall within the protection scope of the relevant patent rights File a lawsuit with the people's court or request an administrative ruling from the patent administration department of the State Council
.
If a party is dissatisfied with the administrative ruling made by the Patent Administration Department of the State Council, he may file a suit in a people's court in accordance with the law after receiving the administrative ruling
.

If the patentee or interested party initiates a lawsuit or requests an administrative ruling within the prescribed time limit, it shall submit a copy of the case registration or acceptance notice to the National Drug Review within 15 working days from the date of acceptance by the People’s Court or the Patent Administration Department of the State Council.
Evaluation agency, and notify the generic drug applicant
.

After receiving a copy of the acceptance notice from the People's Court or the Patent Administration Department of the State Council, the drug regulatory department of the State Council sets a 9-month waiting period for the application for registration of chemical generic drugs
.
The waiting period shall only be set once from the date when the people's court filed the case or the patent administration department of the State Council accepted it
.
The National Drug Evaluation Agency will not stop the technical review during the waiting period
.

In summary, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" provides a systematic solution for future generic drug applications to market, eliminating most of the problems of first approving the listing of generic drugs before resolving patent disputes
.
It is even more empowering for chemical generics that take offensive methods
.
Chia Tai Tianqing has a high probability of obtaining a one-year market exclusivity for lenvatinib, and the time to market should be in October or November, that is, after the patent of lenvatinib expires
.