Measures for Implementing Early Dispute Resolution Mechanism for Drug Patents (Trial)

(Draft for Comments)

Article 1 [Legislative Purpose]

To protect the legitimate rights and interests of drug patentees, encourage new drug research and promote the development of quality generic drugs, and establish an early dispute resolution mechanism for drug patent.

Article 2 [Patent Information Registration]

The drug regulatory and administrative department under the State Council shall establish Patent Information Registration Platform of Marketed Drugs in China, for drug Marketing Authorization Holders (“MAHs”) to register patent information related to drugs registered and approved in China, and make said platform public to the general public.

This Measure does not apply to patent information that is not registered on the Patent Information Registration Platform for Listed Drugs in China (“PIRPAD”).

Article 3 [Platform Management]

The national drug evaluation institution is responsible for establishing and maintaining the Patent Information Registration Platform for Marketed Drugs in China.

When applying for drug marketing, the applicant shall register the drug name, relevant patent number, patent type, patent status, patentee, Marketing Authorization Holder, expiration date of patent protection, correspondence address, contact person, contact information and other contents by itself. For the patent related to the approved drug, the MAH may submit additional relevant patent information for supplement.

The applicant or the MAH shall be responsible for the authenticity, accuracy and completeness of the patent information submitted by the applicant or the MAH.

Article 4 [Information Management]

During the period of drug evaluation, the applicant who has obtained the patent right may, within 30 days after the announcement of the grant of the patent right, register the patent information on the PIRPAD, and submit the patent information to the national drug evaluation institution for supplementary submission. In the event of any change in the registered drug patent information, the applicant or the MAH shall, within 30 days after the change takes effect, register the change on the PIRPAD.

Article 5 [Patent Type of Registration on the Platform]

When an applicant for chemical drug registration submits an application for a drug marketing approval, said applicant may register patents for pharmaceutical active ingredient compounds, patents for pharmaceutical composition containing active ingredient(s), and pharmaceutical use patents on the PIRPAD.

Article 6 [Patent Statement]

When an applicant for a chemical generic drug submits an application for a drug marketing approval, said applicant shall, based on the patent information that has been listed on the PIRPAD, make a declaration on each drug patent related to the generic drug and provide the basis for said declaration. The declarations are divided into four categories:

Category I Declaration: There is no patent information related to the generic drug on the PIRPAD;

Category II Declaration: The patents related to the originator drug recorded on the PIRPAD have been terminated or declared invalid;

Category III Declaration: For patent(s) of the originator drug in the PIRPAD , the generic drug applicant promises not to put the generic drug until the expiration of the patent term.

Category IV Declaration: The patent rights recorded on the PIRPAD related to the generic drug shall be declared invalid, or the generic drug does not fall within the protection scope of the patent right related to the generic drug.

Generic drug applications and the corresponding declarations will be made public on the information platform of the national drug evaluation institution.

Article 7 [Objection]

The patentee or any interested party who have objections to the patent declaration(s) and the declaration basis may, within 45 days from the date when the national drug evaluation institution makes public the application for the drug marketing approval, file a lawsuit before People’s court or apply to the patent administration department under the State Council for an administrative ruling, regarding whether the relevant technical solutions of the drug applied for market approval fall within the protection scope of the patent rights.

If the patentee or an interested party files a lawsuit or applies for an administrative ruling within the prescribed time limit, the patentee or the interested party shall, within 10 days from the date when the case is instituted or accepted by the people’s court or the patent administration department under the State Council, submit a copy of the notification of acceptance to the national drug evaluation institution.

Where the patentee or an interested party fails to file a lawsuit or apply for an administrative ruling within the prescribed time limit, the drug regulatory and administrative department under the State Council may, on the basis of the conclusion of the technical review and the declaration submitted by the generic drug applicant, directly make a decision on whether to approve the application or not.

Article 8 [Stay Period]

From the date when the case is filed or accepted by the people’s court or the patent administration department under the State Council, the drug regulatory and administrative department under the State Council shall set up a 9-month stay period for the registration of chemical generic drugs. During the waiting period, the national drug evaluation institution shall not stop the technical review.

Article 9 [Examination and Approval by Categories]

For generic applications of chemical drugs with Category I and category II declarations, the drug regulatory and administrative department under the State Council shall make decisions on approval or not based on the conclusion of technical review; for generic applications of chemical drugs with Category III declarations, decisions of approval can be made after passing technical review and should include notes of market authorization after expiration of the patent term.

Article 10 [Examination and Approval by Categories]

With regard to the generic applications for chemical drugs with Category IV declaration, if the patentee or any interested party, within 45 days from the date when the national drug evaluation institution announces the generic application, files a lawsuit before a people’s court or apply to the patent administration department under the State Council for an administrative ruling regarding whether the relevant technical solutions of the generic drug fall within the protection scope of the patent rights or not, the patentee or the interested party shall, within 10 days upon receiving a judgment or decision, submit the judgment or the decision to the national drug evaluation institute.

With regard to the generic application for chemical drugs that has passed technical review, the national drug evaluation institution shall handle the applications in view of the judgment of the people’s court or the administrative ruling of the patent administration department under the State Council, as follows:

(I) If the relevant technical solutions are determined to fall within the protection scope of the relevant patent rights, the generic application for the chemical drug shall be transferred to the administrative examination and approval process 20 work days before the expiration of the patent right;

(II) If the relevant technical solutions are determined to be outside of the protection scope of the relevant patent rights, or both parties reach a settlement, the generic application for the chemical drugs shall be transferred to the administrative examination and approval process in accordance with the procedures;

(III) If the relevant patent right is declared invalid, the generic application for the chemical drugs shall be transferred to the administrative examination and approval process in accordance with the procedures;

(IV) If the people’s court or the patent administration department under the State Council has not made an effective judgment or administrative ruling, or has not issued a conciliation statement, the application for the chemical generic drugs shall be transferred to the administrative examination and approval process in accordance with the procedures.

(V) Where, during the period of administrative examination and approval, the drug regulatory and administrative department under the State Council receives a judgment of a people’s court or an administrative ruling of the patent administration department under the State Council, confirming that the chemical generic drugs fall within the scope of the relevant patent right protection, the drug regulatory and administrative department under the State Council shall submit the generic application for chemical drugs to the national drug evaluation institution for handling the application in accordance with the provisions of Paragraph I of this Article.

If, after the drug regulatory and administrative department under the State Council decides to suspend the approval in accordance with the judgment of the people’s court or the administrative ruling of the patent administration department under the State Council, the people’s court in its judgment of final instance overturns the original decision, then the generic applicants may apply for approval of the generic application to the drug regulatory and administrative department under the State Council, which will make a decision on whether to approve according to the technical review conclusions and the people’s court’s final judgment.

Article 11 [Encouragement Policy]

A market exclusivity period shall be granted to the first chemical generic drug that successfully challenged the drug patent and obtained market approval. The drug regulatory and administrative department under the State Council shall not approve generic applications of the same drug within 12 months from the date of approval of the drug, and the market exclusive period shall not exceed the patent term of the challenged drug. During the exclusive period of the market, the national drug evaluation institution will not stop the technical review. For the generic applications of chemical drug that has passed technical review, the relevant chemical generic drug application shall be transferred to the administrative examination and approval process 20 working days before the expiration of the market exclusive period.

Article 12 [Treatment by Categories]

Applicants for marketing approval of biological products and traditional Chinese medicines shall comply with Articles 2, 3, 4, 6, and 7 of this Measure for registering relevant patent information, making declarations, etc. For biological products, patents concerning sequence structure can be registered, and for traditional Chinese medicines, patents concerning Chinese medicine composition, Chinese medicine extract, and pharmaceutical use can be registered.

Article 13 [Treatment by Categories]

Concerning marketing approval application of biosimilar or Chinese medicine with the same name and formulation, the drug regulatory and administrative department under the State Council shall, on the basis of the conclusion of the technical review, directly decide on whether to approve the registration of biosimilar drugs and Chinese medicine with the same name and formulation or not. If the patentee or interested party file a lawsuit on whether the relevant technical solutions of the follow-on drug fall within the protection scope of the relevant patent rights before people’s court or apply to the patent administration department under the State Council for an administrative ruling within 45 days from the date when the national drug evaluation institution announces the application for the drug marketing license, and the people’s court or the patent administration department under the State Council determines that the relevant technical solutions fall within the protection scope before the conclusion of the administrative examination and approval process, the drug regulatory and administrative department under the State Council shall approve the application for marketing of the and the follow-on drug that passes technical review with note that marketing and sales are only allowed after the patent rights expire.

Article 14 [Means of Relief]

After a generic drug is approved, if the patentee believes that the generic drug infringes its patent rights and causes a dispute, the dispute shall be resolved in accordance with the provisions of the Patent Law and other laws and regulations. A decision on the marketing approval of a drug according to laws and regulations shall not be revoked, and its effectiveness shall not be affected.

Article 15 [Principal Responsibility]

Applicants and their agents who intentionally submit false statements or intentionally include other unrelated patents into the PIRPAD shall be subject to joint disciplinary punishment for dishonesty in accordance with the laws, and the applicants shall not apply for registration of the same drug again within one year; those who violate laws and regulations shall be handled according to the laws; and those who infringe the relevant patent rights of the patentee shall bear corresponding legal liabilities.

Article 16 [Implementation Time]

The instant measures shall come into force as of XX.