Theory and practice of intellectual property
№ 2 / 2021

ISSN (Print) 2308-0361
ISSN (Online) 2519-2744

PDF (Ukrainian)

DOI: https://doi.org/10.33731/22021.236528

Published      2021-05-14

Experience of EU countries on ethical aspects of patenting biotechnologies in the field of medicine and pharmacy

Olena Ponomarova
Ukraine
https://orcid.org/0000-0002-8232-3748

Abstract
The progress of modern biotechnological achievements poses new ethical and social challenges to society. Research using biotechnology in medicine and pharmacy leads to more in-depth knowledge of diseases. With the help of biotechnology, it becomes possible to treat previously incurable diseases. It is worth noting that today with the possibility of using biotechnological developments, the scientific community in a very short time was able to successfully invent vaccines against COVID-19.

During clinical trials, the safety of study subjects should be unneglected for the rapid introduction of the product to the market. Ethics and innovation in modern society always go hand in hand, especially in the field of health care. The worldwide spread of COVID-19 underscores the importance of maintaining a balance between ethics and intellectual property rights when human lives are in mortal danger.

Society is concerned about the ethics of patenting life, namely, the possibility of patenting genes, cell lines and human tissues. The Directive states that the human body cannot be invented at certain stages of its formation and development, including germ cells, as well as the simple discovery of one of its components, including the sequence or partial sequence of a gene.

Patents that relate to the human gene are particularly critically examined ethically.

Ethics, morality, and law are interrelated components and are extremely important for society to accept the invention. EU patent law is based on ethical principles. Thus, the adoption of the Directive was envisaged for the development of the EU economy, the ability to regulate controversial issues regarding the patenting of biotechnological inventions by criteria of ethics and morality and to harmonize EU legislation.

Owners who run biotechnology institutions (organizations) must protect the results of research, and obtaining patents is the most effective way. After all, long-term research and development of new products or processes require significant financial costs. The intellectual property product must be protected by a patent, including biotechnological inventions.

Keywords: patenting, ethics, biotechnological inventions, medicine, pharmaceuticals, health

References

European Patent Office.
https://www.epo.org/news-events/in-focus/biotechnology-patents.html

Директиви 98/44/ЄС Європейського парламенту та Ради від 6 липня 1998 року про правовий захист біотехнологічних винаходів.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31998L0044

Healthcare technologies in the age of coronavirus.
https://www.epo.org/about-us/annual-reports-statistics/statistics/2020/healthcare-and-life-sciences.html

Що таке цукровий діабет та як він виникає?
https://mcplus.com.ua/shho-take-czukrovyj-diabet-ta-yak-vin-vynykaye/

The German Patent and Trade Mark Office (DPMA).
https://www.dpma.de/english/patents/patent_protection/protection_requirements/biotechnology_and_patents/index.html

Patentgesetz.
https://dejure.org/gesetze/PatG/1a.html

The Ethics of Patenting Coronavirus Cures.
https://ip.com/blog/the-ethics-of-patenting-coronavirus-cures/