The term of invention patents is twenty years, counted from the date of application. The newly revised Patent Law, specifically in the second and third paragraphs of Article 42, introduces provisions for extending the patent term through compensation mechanisms. These provisions include the following two specific types of compensation:
compensation for the patent term due to the delay in the authorization process of invention patent applications, namely, compensation for patent authorization term.
compensation for the patent term given to account for the time required for the approval of new drugs for marketing, namely, compensation for pharmaceutical patent term.
A detailed explanation of compensation for patent authorization delays has been provided previously. This article will focus on the provisions related to compensation for pharmaceutical patent terms.
1. Conditions that must be met to request compensation for the term of a pharmaceutical patent (1)The date of the patent authorization announcement for which compensation is requested must precede the date of approval for the drug marketing authorization application (2)At the time the claim for compensation is filed, the patent right must be in force;
(3)The patent has not previously received any compensation for the duration of the drug patent right;
(4) The claims of the patent for which compensation is requested include the technical solutions related to the new drug that has obtained marketing approval;
(5)If a drug is covered by multiple patents, the patentee may only request compensation for the patent term of the drug under one of the patents;
(6)If a patent covers multiple drugs, a request for compensation for the patent term can only be made for one of the drugs.
2. Submission of request The patent holder should submit a request for compensation for the patent term of a drug to the Patent Office within three months from the date the drug obtains marketing authorization in China, along with a request fee of RMB 200.
For drugs that have obtained conditional marketing authorization, a request should be submitted to the Patent Office within three months from the date of obtaining formal marketing authorization in China. However, the compensation period will be calculated based on the date of obtaining the conditional marketing authorization.
3. Supporting Documents When requesting for compensation for the term of a pharmaceutical patent, the applicant shall also submit the following materials:
(1) If the patentee is not the same as the marketing authorization holder, the written consent of the marketing authorization holder, along with other materials, shall be submitted;
(2) Relevant technical information used to determine the scope of patent protection during the compensation period for the pharmaceutical patent must be submitted. For example, if a request is made for term compensation for a preparation method patent, the pharmaceutical production process information approved by the drug supervision and administration department of the State Council shall be provided;
(3) Other supporting documents required by the Patent Office.
The applicant shall include in the request the name of the drug, the drug registration classification, the approved indications and the patent number for which term compensation is requested. The request shall specify the claims related to the new drug that has obtained marketing authorization, and, along with the supporting materials, provide a detailed explanation of why the designated claims include technical solutions related to the new drug, the basis for calculating the requested compensation period, and the technical solutions protected during the compensation period of the drug patent.
4. Scope of application Medicines refer to medicines intended for humans use, excluding those used for animals, such as veterinary medicines and pesticides.
The scope of application covers innovative drugs approved for marketing by the drug supervision and administration department of the State Council, as well as improved new drugs that comply with the Guidelines. Compensation for the patent term of the drug may be granted for product invention patents of active pharmaceutical ingredients, preparation method invention patents, or medical use invention patents The definitions of innovative drugs and improved new drugs are determined in accordance with relevant laws and regulations, and the relevant provisions set forth by the State Council's drug supervision and administration department. The "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" issued by the State Council in 2015 provides the definitions of the new drugs.
Time limit compensation can only be granted for improved new drugs that are classified under the following categories in the drug registration certificate issued by the drug supervision and administration department of the State Council:
(1) Chemical drugs in category 2.1 that are esters or salts of known active ingredients;
(2) Chemical drugs in Category 2.4, i.e., drugs with new indications containing known active ingredients;
(3) Vaccines that are improvements upon vaccine bacteria and viruses in Category 2.2 of preventive biological products;
(4) Biological products with new indications added to Category 2.2 of therapeutic biological products;
(5) Chinese medicine in Category 2.3, i.e. Chinese medicine with additional functions and indications.
5. Review to determine whether the specified claims include technical solutions related to the new drug The technical solutions related to new drugs shall be based on the structure, composition and content of new drugs approved by the drug supervision and administration department of the State Council, as well as the approved production process and indications. If the designated claims do not include the technical solutions related to new drugs that have obtained marketing authorization, no term compensation will be granted.
6. Determination of compensation period If compensation is granted for the patent term of a drug, the compensation period shall be the number of days between the patent application date and the date the new drug obtains marketing authorization in China, minus 5 years.
The compensation period shall not exceed 5 years, and the total effective patent term after the approval of the drug marketing authorization application shall not exceed 14 years.
7. Approval of Request for Term Compensation If, after examination, it is determined that a request for compensation of the term of a pharmaceutical patent right does not meet the conditions for such compensation, the Patent Office shall provide the applicant with at least one opportunity to present his/her opinion and/or supplement the required documents. If the conditions for term compensation are still not met thereafter, a decision will be made to deny the compensation of the term.
If, upon examination, it is determined that compensation for the patent term of a drug should be granted, and if the patent holder has already filed a request for compensation for the patent term but the Patent Office has not yet made a decision, the examiner shall wait for the approval decision on the request for compensation for the patent term before determining the period for granting compensation for the drug patent term.
If the patent owner has not yet filed a request for compensation of the patent term and the three-month period from the date of the patent authorization announcement has not expired, the examiner shall wait until the deadline for requesting compensation of the patent term has passed before determining the period for granting compensation for the patent term of the drug, unless the patent owner explicitly waives the request for compensation of the patent term.
If, after examination, it is determined that the request for compensation of the term of a pharmaceutical patent meets the conditions for term compensation, the Patent Office shall issue a decision to grant term compensation and notify the number of days for which compensation is granted.
8. Registration and announcement After the Patent Office makes a decision to grant compensation for the patent term of a drug, it shall register the relevant details in the patent register and publish the announcement in the Patent Gazette.
9. Expenses of current compensation during the drug patent period If the compensation period exceeds one year, the annual fee will be RMB 8,000 per year; if the compensation period is less than one year, no annual fee is required.
