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    Home > Medical News > Medical Science News > New drugs approved before May 31 will receive a patent-free compensation period!

    New drugs approved before May 31 will receive a patent-free compensation period!

    • Last Update: 2021-06-04
    • Source: Internet
    • Author: User
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    The Twenty-Second Meeting of the Standing Committee of the 13th National People's Congress voted to pass the revised Patent Law on October 17, 2020, and it will come into effect on June 1, 2021.


    For new drugs approved before May 31, whether there is a patent compensation period is a topic of concern to the industry.


    On May 27, the State Intellectual Property Office issued "Answers to Related Questions Concerning the Implementation of the Revised Patent Law".


    The State Intellectual Property Office gave a clear answer: For new drug-related invention patents that have obtained marketing authorization before May 31, 2021 (including that date), the drug patent right period compensation system is not retroactive.


    This means that new drugs approved for marketing before May 31 will lose up to 5 years of compensation for patent rights.


    Reply to the original text:

    6.


    Article 93 of my country’s Legislative Law stipulates: laws, administrative regulations, local regulations, autonomous regulations, separate regulations, and rules are not retroactive, but are required to better protect the rights and interests of citizens, legal persons, and other organizations.


    Article 42 Paragraph 3 of the revised Patent Law stipulates that, in order to compensate for the time taken by the new drug marketing review and approval, the State Intellectual Property Office shall grant a patent at the request of the patentee for the new drug-related invention patents that have been approved for marketing in China.


    As the implementation rules of the Patent Law are still in the process of revising, the relevant supporting electronic systems are under development.


    The amended patent law will come into effect on June 1, 2021, and the pharmaceutical industry will usher in heavy benefits.


    Medicines are special products that are closely related to the lives and health of the people.


    Song Jianhua said that this amendment to the Patent Law has added relevant provisions in strengthening the protection of pharmaceutical patents and encouraging innovation in the pharmaceutical field:

    A new provision on compensation for the term of pharmaceutical patents has been added.


    12.


    "In order to compensate for the time occupied by the review and approval of the new drug market, the patent administration department of the State Council shall, at the request of the patentee, grant compensation for the duration of the patent right for the new drug-related invention patents that have been approved for marketing in China.


    At this stage, with the development of my country's pharmaceutical industry, pharmaceutical companies have gradually increased their R&D investment and innovation capabilities for innovative drugs.


      Added an early resolution mechanism for drug patent disputes

      Modified content:

      27.


      "The drug regulatory department of the State Council, in conjunction with the patent administration department of the State Council, shall formulate specific measures for the connection of patent dispute resolution at the stage of drug marketing license approval and drug marketing license application stage, which shall be implemented after the approval of the State Council.
    "

      A new mechanism for early resolution of drug patent disputes has been added to resolve potential patent disputes as soon as possible before relevant drugs are launched on the market.
    Providing alternative dispute resolution channels for relevant parties can better balance the interests of patentees, generic drug companies and the public, improve the availability of drugs, and protect public health.
    It should be noted that even if the dispute is not resolved through this mechanism within the statutory time limit, another patent infringement lawsuit can still be filed.

      CDE launched the drug patent information registration platform, and the drug patent link system is coming

      On May 18, 2021, the National Drug Evaluation Center issued the "Notice on Public Testing of Patent Information Registration Platforms Related to the Early Resolution Mechanism for Drug Patent Disputes"; the Review Center officially released the "China Listed Drug Patent Information Registration Platform", The test time is until May 31.

      In order to implement the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" and the relevant provisions of the Patent Law, the State Food and Drug Administration has actively promoted the formulation and promulgation of implementation measures for the early resolution of drug patent disputes in conjunction with relevant departments.
    In order to cooperate with the implementation of the measures, in accordance with the overall work deployment of the State Food and Drug Administration, after internal discussions and consultation with experts and relevant departments, our center has established a patent information registration platform for listed drugs in China, with an explanation of the form and a template for the disclosure of patent declarations.
    The registration platform is now being tested publicly and opinions from all parties are solicited.
    Test address: https://zldj.
    cde.
    org.
    cn.

      Please actively participate in the registration test of relevant drug patent information for the marketing authorization holders of drugs that have been marketed in China.
    In order to facilitate work connection, after the implementation of the early resolution mechanism for drug patent disputes, relevant patent information that has been registered as required during the test period will be disclosed after confirmation by the drug marketing license holder, as chemical generic drugs, traditional Chinese medicines with the same name, and biosimilars Information on the basis of the patent statement made by the drug applicant.
    The drug marketing authorization holder is requested to ensure the authenticity, accuracy and completeness of the registered information.
    The test time is until May 31.
    At the same time, all sectors of the society are welcome to put forward valuable opinions and suggestions so that we can continue to improve.
    Please send your feedback to zhangxx@cde.
    org.
    cn, copy to yjjdc@nmpa.
    gov.
    cn, and indicate the subject "China Listed Drug Patent Information Registration Platform".

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