Introduction

On 4 July 2021, the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly released the “Measures for the Implementation of Early Resolution Mechanism for Pharmaceutical Patent Disputes” (for Trial Implementation), ironing out the operational details of pharmaceutical patent linkage regime.

The Measures, which predates the China Supreme Court’s “Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases involving Patent Disputes Related to the Application for the Registration of Pharmaceuticals”, is the first legal document exclusively dedicated to pharmaceutical patent linkage system in China. This article is a brief introduction of the Measures' key takeaways.

Establishment of patent information registration platform for marketed drugs

The NMPA is tasked with coordinating the creation of a Patent Information Registration Platform for Marketed Drugs, whose creation and operation falls within the remit of the agency’s affiliate Centre for Drug Evaluation (CDE) (Rules 2 and 3). This platform is already accessible at https://zldj.cde.org.cn/home.

Rule 4 enumerates the information to be registered with the platform and the time limit to register the information and record any changes. The registered particulars shall be consistent with the patent information recorded in Patent Register. Marketing authorization holder (MAH) will answer for the truthfulness, accuracy and integrity of the registered information and shall verify and handle any dissent received thereabout.

Registration scope for pharmaceutical patent information

When seeking regulatory approval for chemical drugs, applicants may register with the platform patent information on active ingredients, pharmaceutical composition and pharmaceutical uses (Rule 5).

Applicants for biological products may register patent information on sequence structures and pharmaceutical uses, while applicants for traditional Chinese medicines (TCM) may register patent information regarding composition, extract and pharmaceutical uses (Rule 12).

Generic drug applicant must file patent status statement

When filing for regulatory approval, chemical generic drug applicants must make a statement with reference to each drug patent whose information has already been registered with the Patent Information Registration Platform for Marketed Drugs in China (Rule 6). Such statement is categorised as follows:

• Type I: There is no existing patent relating to the generic drug application.
• Type II: The patent to be exploited by the generic drug has expired or has been declared invalid, or the generic drug applicant has obtained a license from the patentee to exploit the patent.
• Type III: There is an existing patent relating to the generic drug application and the generic drug applicant agrees to seek regulatory approval upon the expiration of such patent.
• Type IV: The patent to be exploited by the generic drug should be declared invalid or the generic drug does not fall into the patent's protection scope.

The CDE shall publish the application particulars and the statement of a chemical generic application within 10 working days from the receipt of such application (Rule 6).

Generic drug applicants shall inform MAH of the patent status statement

The generic drug applicants shall inform MAH of the patent status statement and the grounds on which such statement is made. Apart from hard copies, the generic drug applicants shall also provide the MAH with foresaid information via email (the MAH’s email address is available in the Patent Information Registration Platform for Marketed Drugs) (Rule 6).

In case that the MAH is not the patentee, the MAH is responsible to inform the patentee of the statement and grounds of the generic drug applicants (Rule 6).

Patentee or interested party may raise objection within a time limit

The patentee or an interested party contesting a statement of Type IV may file a lawsuit before the court or request an administrative adjudication before the CNIPA within 45 days from the publication date of the generic drug application (Rule 7).

The administrative adjudication made by the CNIPA may be appealed before the court (Rule 7).

If the patentee or an interested party does not file a lawsuit before the court or request an administrative adjudication before the CNIPA within foresaid period, the generic drug applicant may file a lawsuit or request an administrative adjudication requesting affirmation that the technical solution of the generic drug does not fall within the protection scope of pertinent patent (Rule 8).

Delays in generic drug approvals

Rule 8 provides a nine-month one-off stay for chemical generic drug applications, should a patent dispute arise in the approval process; however, technical evaluation will not be suspended during the nine-month stay.

Granting of regulatory approval varies

The granting of regulatory approval for chemical generic drugs hinges on the technical assessment outcome should a Type I or Type II statement is filed. Regulatory approval upon the expiration of the pertinent patent and the expiration of market exclusivity could be granted to a chemical generic drug that has passed technical assessment in case of a Type III statement (Rule 10).

In the context of a Type IV statement, if the patentee or interested party does not raise any objection against this statement, the granting of regulatory approval hinges on the technical assessment outcome and the statement of the generic drug applicant. In case that such objection is filed and a stay period is triggered, the granting of regulatory approval hinges on an array of factors including, the outcome of both the technical assessment and the court or administrative decision, and is thus premised on the affirmation of patent invalidity, the determination of non-infringement, the reconciliation between two parties or the expiration of the stay period in absence of a decision, or otherwise shall be postponed until the expiration of the pertinent patent (Rules 8 and 9).

Similarly, the granting of regulatory approval for biosimilars and TCM with identical names and formula hinges on the technical assessment outcome. Apart from the technical assessment decision, the marketing of biosimilars and TCM with identical names and formula shall be postponed until the expiration of the pertinent patent if the technical solution of such drug is found to fall within the protection scope of the pertinent patent by a court decision or an administrative adjudication decision (Rule 13).

Encouraging generic drug patent to challenge the validity of patent

Rule 11 grants a 12-month exclusivity to the first generic drug applicant that succeeds in challenging the validity of a chemical pharmaceutical patent and acquiring the first regulatory approval. This only applies when a generic drug applicant files a statement of Type IV and had the pertinent patent invalidated through an invalidity proceeding. Said market exclusivity shall not exceed the original duration of the patent right being challenged.

Post-approval pharmaceutical patent dispute resolution

After the regulatory approval and actual marketing of chemical generic drug, biosimilars, TCM with identical names and formula, the patentee or interested party which deems such a drug infringes the pertinent patent right, shall cite the Patent Law or other laws to resolve the disputes. The arising of the disputes shall have no bearings on the efficacy of the regulatory approval, which will not be withdrawn (Rule 14).

Authored by Zhao Jie