The Role of Patents in Biotechnology Drug Development

Patent protection for drugs developed in the biotechnology sector serves as a legal safeguard and framework for innovation and the advancement of the domestic pharmaceutical industry. Patents provide legal protection for innovation, granting inventors or companies exclusive rights to utilize their innovations for a specific period.

In an era of rapid technological development, innovation in biotechnology drug development has become a key driver of progress in healthcare, pharmaceuticals, and medicine. Biotechnology in healthcare has led to the creation of life-saving drugs and treatments. Patent protection for biotechnology innovation plays a crucial role in encouraging the research and development of new biotechnology-based drugs.

Patents provide legal protection for innovations, allowing inventors or companies to exclusively utilize, manufacture, and commercialize their inventions for a specified period. Biotechnology drug development has significantly contributed to the development of new treatments, diagnostic methods, vaccines, and pharmaceutical products.

A patented drug is one that receives patent protection under the applicable laws in Indonesia, as stipulated in Article 1, Paragraph (42) of the Indonesian Food and Drug Authority Regulation No. 13 of 2021 concerning the Third Amendment to the Head of the Food and Drug Authority Regulation No. 24 of 2017 on Drug Registration Criteria and Procedures (“PerBPOM 13/2021”). A patented drug refers to a newly developed pharmaceutical product manufactured and marketed by a pharmaceutical company holding patent rights.

Pharmaceutical companies that hold patents are granted protection for 20 years. During this period, they have exclusive rights as stipulated in Article 19, Paragraph (1) of Law No. 65 of 2024 on the Third Amendment to Law No. 13 of 2016 on Patents (“Patent Law”):

Patent holders have exclusive rights to exercise their patents, grant licenses for their patents to other parties, and prohibit others from, without their consent:

For product patents: manufacturing, using, selling, importing, leasing, transferring, or offering for sale, lease, or transfer of patented products;

For process patents: using patented production processes to manufacture goods or perform other related activities as stated in point (a); and

For method, system, and usage patents: using patented methods, systems, and applications to manufacture goods or perform other related activities as stated in point (a).

Specifically, patents for biotechnology drugs involve protection of discoveries related to biological molecules, production procedures, or novel methods of drug use. During the patent application process, inventors must provide detailed and comprehensive information about their discoveries, including production methods, molecular characteristics, and evidence of therapeutic efficacy. Patent protection not only promotes innovation but also provides inventors with financial opportunities.

However, Article 109, Paragraph (1) of the Patent Law states that the government may implement patents in Indonesia under considerations related to national defense and security or urgent public interest. This article grants the government the authority to exercise patents by overriding or suspending the exclusive rights of patent holders in emergencies or matters of national interest. This is aimed at protecting public welfare and ensuring affordable drug availability.

Government patent implementation was observed during the COVID-19 pandemic, where the government applied patent execution for certain drugs used in COVID-19 treatment, including Remdesivir and Favipiravir. Through Presidential Regulation No. 100 of 2021 on Government Patent Implementation for Remdesivir (“Perpres 100/2021”), the government took measures to ensure sufficient and affordable drug availability for the public. In this implementation, the government designated pharmaceutical industries to manufacture patented drugs on behalf of the government.

The government’s patent execution for Remdesivir lasted three years from the enactment of the regulation. If the pandemic persisted beyond this period, the government extended the execution until the COVID-19 pandemic was officially declared over, as stipulated in Article 1, Paragraph (4) of Perpres 100/2021. To ensure that the rights of patent holders remain respected, the government is obligated to provide fair compensation for the use of such patents.

The benefits of patent rights for pharmaceutical inventors cannot be overstated. With patent protection, biotechnology drug inventors are legally assured of the commercialization of their innovations. This is also crucial for fostering innovation and progress in the pharmaceutical sector. Consequently, biotechnology drug development and innovation, particularly in healthcare, pharmaceuticals, and medicine, can continue to advance and make meaningful contributions to public health and well-being.***

Legal References:

Indonesian Food and Drug Authority Regulation No. 13 of 2021 concerning the Third Amendment to the Head of the Food and Drug Authority Regulation No. 24 of 2017 on Drug Registration Criteria and Procedures (“PerBPOM 13/2021”).

https://peraturan.bpk.go.id/Details/181753/peraturan-bpom-no-13-tahun-2021