Project funded by NCN, carried out between 18 July 2017 and 17 July 2019
Modern medicine owes a great deal to biotechnology. It is the advancement of biotechnology that makes it possible to diagnose diseases before any symptoms occur, to treat previously incurable conditions, and to develop therapies and drugs tailored to the particular features of a particular body. The creation of such achievements requires research into the functioning of the human body: the structure and function of its individual components. It is not feasible to carry out such research without access to components of the human body such as blood, body fluids, and cells. The outcomes of such research are often patented. The holder of a patent obtains exclusive rights to their invention, and can therefore prevent anyone else from using it for professional or commercial profit.
Importantly, patents can now be granted for many things that were once outside the patent protection system. It is possible, for example, to obtain a patent which grants exclusive use of elements of the human body, e.g. fragments of the human DNA, human cells or tissues, as well as life-saving drugs.
The question also arises as to whether making access to medicines dependent on the decision of the patent holder does not infringe people’s right to the protection of health and life.
These and other questions emerge when one realises how controversial the interface between patent law and fundamental rights is in the area of patenting achievements related to the human body.
The goal of the project is to answer the question whether patenting such inventions concerning the human body does not infringe fundamental rights; whether granting such patents may violate human dignity; whether, for example, the effect of such a patent is not to limit a person’s right to decide about their own body, the way they use it, including their unique genetic information; whether granting a patent for such an invention should be dependent on the consent of the person whose biological material is used in it; and whether the patented biological material should not, however, be available to researchers for further research.
In view of the doubts that have emerged, it is first of all necessary to establish whether patent law can indeed affect fundamental rights, limit the scope of their protection, and if so, whether such an effect can be accepted, for instance as justified by the protection of other values or rights, or whether, on the contrary, the possibility of such limitations should be excluded. It is also legitimate to consider whether and how the fundamental rights of various individuals and groups should be balanced against the rights of the patent holder and the interests of society at large.
Although individual issues presented above are addressed in international literature, it is difficult to find a comprehensive overview of the topic in Poland. The list of countries selected for comparative research is also innovative. In the Polish literature, the issues in question are touched upon only briefly. As part of the research, we anticipate analysing national, EU and international law, court rulings and decisions of patent offices, as well as mainly international doctrine. This will help to identify legal regulations adopted in Poland, Germany, Great Britain, Italy and France, compare them and draw conclusions. The research will result in a publication with the findings and postulates addressed to the Polish as well as EU and international legislator.
Head: Prof. Helena Żakowska-Henzler