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The policy is clear! 1-year market exclusivity period for the first generic drug that challenges the patent and succeeds
2022-06-13 17:56:09    Access: 7  Author: spf4

  (Reporter Luo Nan from this newspaper)Recently,the State Drug Administration and the State Intellectual Property Office jointly issued the"Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes(Trial)"(hereinafter referred to as the"Measures").As a link between the approval of drug marketing authorization and the resolution of patent disputes at the application stage of drug marketing authorization,the"Measures"aim to protect the legitimate rights and interests of drug patentees,encourage new drug research,and promote the development of high-level generic drugs.The"Measures"put forward the relevant practice of establishing a drug patent link system,clarify the requirements for patent information registration and disclosure,generic drug patent declaration,etc.,and introduce systems such as approval waiting period,drug review and approval classification,and first generic drug market exclusivity period.The"Measures"stated that a 9-month waiting period will be set for the registration application of related chemical generic drugs according to the procedures,and a 12-month market exclusivity period will be given to the first chemical generic drug that successfully challenges the patent and is approved for marketing.

  The"Measures"propose that the drug regulatory department of the State Council organizes the establishment of a patent information registration platform for Chinese marketed drugs(hereinafter referred to as the information platform)for drug marketing license holders to register related patent information on drugs registered and marketed in China.The National Drug Evaluation Agency is responsible for establishing and maintaining an information platform to disclose relevant patent information of drugs that have been approved for marketing.The holder shall register the information as required and be responsible for the authenticity,accuracy and completeness of the relevant information registered.

  The"Measures"stipulate that when an applicant for a chemical generic drug submits an application for a drug marketing authorization,it shall make a statement for each related drug patent of the generic drug in accordance with the patent information that has been disclosed on the information platform.The declarations are divided into four categories,among which four categories of declarations are that the patent rights related to the generic drugs included in the information platform should be declared invalid,or that the generic drugs do not fall within the protection scope of the relevant patent rights.

  If the patentee or interested party has any objection to the four types of patent declarations,he or she may,within 45 days from the date when the national drug review agency publishes the application for drug marketing authorization,to check whether the relevant technical scheme of the drug applied for marketing falls within the scope of protection of the relevant patent rights.File a lawsuit in the people's court or request an administrative ruling from the patent administration department under the State Council.After the patentee or the interested party raises an objection within the prescribed time limit,the State Council's drug administration department shall set a waiting period of 9 months for the application for the registration of chemical generic drugs.The waiting period is set only once from the date when the case is filed by the people's court or accepted by the patent administration department under the State Council.The technical review will not be stopped during the waiting period.

  The application for registration of chemical generic drugs of different types of patent declarations shall be processed by classification.For the application for registration of Class I and Class II declarations,the drug regulatory department of the State Council makes a decision on whether to approve the listing based on the conclusion of the technical review.For the registration application of the three types of declarations,if the technical review is passed,a decision to approve the marketing will be made,and the relevant drugs will not be marketed until the expiration of the corresponding patent right and market exclusivity period.For chemical generic drug registration applications that trigger a waiting period,the national drug review agency shall deal with them in accordance with the technical review conclusion,the effective judgment of the people's court or the administrative ruling of the patent administration department of the State Council.

  According to the"Measures",chemical generic drug applicants submit four types of declarations,and according to their request for invalidation of patent rights,the relevant patent rights are declared invalid,so that generic drugs can be approved for marketing,then the patent challenge is successful.A market exclusivity period will be given to the first chemical generic drug that successfully challenges the patent and is approved for marketing.The drug regulatory department of the State Council will no longer approve the marketing of the same variety of generic drugs within 12 months from the date of approval of the drug,except for the successful joint challenge of the patent.The term of market exclusivity shall not exceed the term of the original patent of the challenged drug.

  It should be noted that there are differences between the types of registrable patents for traditional Chinese medicines and biological products and those for chemical drugs.For the registration application of Chinese medicines with the same name and the same formula and biosimilars,the drug regulatory department of the State Council directly makes a decision on whether to approve the listing based on the technical review conclusion.If the people's court or the patent administration department of the State Council confirms that the relevant technical solution falls within the scope of the relevant patent right,the relevant drug may not be marketed until the expiration of the corresponding patent right.

  [Article source:China Medical News]

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