Issues related to intellectual property in the medical and pharmaceutical sectors

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Issues related to intellectual property in the medical and pharmaceutical sectors

Intellectual property in the fields of healthcare and pharmaceuticals is a broad and diverse topic. It encompasses many important aspects such as copyrights, manufacturing and marketing licenses, distribution and preservation, protection of health data, production and use of fake drugs, and production and use of trial drugs.

In the field of healthcare and pharmaceuticals, copyrights and intellectual property are applied to many products, including new patents, drugs, academic materials, and health data. Companies must obtain licenses from regulatory agencies, such as the FDA, to produce and market medical and pharmaceutical products. The distribution and preservation of medical and pharmaceutical products play an important role in the healthcare industry due to special preservation requirements and appropriate temperature.

Protecting health data is crucial to ensure the privacy and safety of patients, and companies must comply with legal regulations related to the protection of patient health information, in which not disclosing patient medical information is one of the most important requirements.

In addition, the issue of counterfeit drugs is becoming increasingly serious in the healthcare industry, as the production and use of counterfeit drugs can harm the health of patients and make victims feel deceived, losing trust in the healthcare industry. However, from the perspective of intellectual property, the act of producing counterfeit drugs can also infringe on intellectual property rights such as patents for copying the patented formula for commercial purposes, or labeling the products with the trademark of a large pharmaceutical company.

Data security in trials

Because the healthcare and pharmaceutical industry is relatively specific in Vietnam, in terms of legal aspects, Vietnam has provisions in Article 128 of the Vietnam Intellectual Property Law amended in 2022 on test data security as follows:

  1. In cases where the law stipulates that the applicant for a license to circulate pharmaceuticals or agrochemicals must provide trial results or any other data that are business secrets obtained from significant investment, and the applicant requests to keep these information confidential, the competent authority issuing the license has the obligation to take necessary measures to prevent the data from being used for non-healthy commercial purposes and not being disclosed, except in cases where disclosure is necessary to protect the public.
  2. With regard to pharmaceuticals, from the time the confidential data in the application for a license is submitted to the competent authority stipulated in clause 1 of this Article until the end of the five-year period counting from the date the applicant is granted the license, the authority shall not grant a license to any applicant who submits an application later and uses the above-mentioned confidential data without the consent of the person who submitted the data, except as provided in point d Clause 3 of this Law.
  3. In the case where the competent authority for granting marketing authorization for a pharmaceutical allows a subsequent applicant to rely on the fact that a pharmaceutical has been granted marketing authorization or on data demonstrating the safety and efficacy of a pharmaceutical that has been granted marketing authorization to apply for marketing authorization for another pharmaceutical, the competent authority for granting marketing authorization must publish on the electronic information portal or the electronic information page of that competent authority information about the subsequent applicant within a period of one year before the pharmaceutical in the subsequent application is granted marketing authorization, except where the granting of marketing authorization needs to be carried out earlier in accordance with other relevant laws.
  4. With regard to plant protection products, from the time the confidential data in the application for a license is submitted to the competent authority stipulated in clause 1 of this Article until the end of the ten-year period counting from the date the applicant is granted the license, the authority shall not grant a license to any applicant who submits an application later and uses the above-mentioned confidential data or relies on the fact that the person who submitted the above-mentioned confidential data has been granted marketing authorization without the consent of the person who submitted the data, except as provided in point d Clause 3 of this Law or where the granting of the license is necessary to ensure national defense, security, nutrition for the people or to meet other urgent social needs.

In summary, intellectual property in the field of healthcare and pharmaceuticals is crucial to ensure the development and safety of the healthcare industry, and it is also very complex. Therefore, if readers need further advice for their intellectual property assets related to healthcare and pharmaceuticals, they can contact ASL LAW firm for more detailed advice.

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