21.11.2024

The Myriad Cause or when economic interest overwhelms the concept of humanity

From the very beginning of the decoding of the human genome, in the 1990-2000s, the thorny question of the commercialization of these discoveries has been raised. In order to solve this problem, it was first necessary to answer the following question: can the microscopic components of the human body, or information about these components used by scientists for research purposes, be included in the category of movable property, whether or not they are in the civil circulation? Obviously, in the first place, such a categorization would open the way to patenting discoveries and subsequently exploiting them in various forms.

The human body can be "viewed" or broken down into its molecular components, which can be isolated from their natural context (according to Art. 5(II) of Directive 1998/44/EC), preserved (Directive 2004/23/EC), labeled and transformed into traceable elements (Directive 2006/86/EC), but above all manipulated with the consequence of altering the natural processes they follow, obviously for good reasons, for example for scientific purposes.

There was an attempt to patent such components in the USA, giving rise to a famous case. Very briefly, in 1990, researchers at the University of California discovered the link between a particular chromosome and breast cancer, and the study was published before genome sequencing existed as a procedure. Based on this study, one researcher, Dr. Skolnik, discovered the DNA sequence responsible for breast cancer. Using patient databases held by the University of Utah, he developed research in this niche area and set up the company Myriad to commercialize the results of this research. Intensifying their efforts in this field, the company's researchers discovered two genes responsible for breast cancer, making them the absolute pioneers in this niche. Myriad has chosen not to license to third parties but to operate through its own laboratory. It has built up a complex network of relationships with diagnostic centers, requiring those linked to it to send DNA samples to its laboratory. Myriad has also threatened to prosecute any further laboratory tests performed on the BRCA 1 and 2 genes without its authorization.

Myriad gradually applied for and obtained patents on mutations in the genes it discovered. As a result, it acquired a monopoly for the analysis of BRCA 1 or BRCA 2 genes, their mutations and, above all, the use of tests for their discovery in patients. Clearly the commercial interest in discovery became more and more apparent as more and more patients wanted to be tested and clinics and medical institutions had to buy, in various forms, the right to use the test.

This created a groundswell of discontent among physicians, with the Association for Molecular Pathology in the United States campaigning to bring together in a joint action medical organizations and professionals who considered Myriad's (monopoly-like) exploitation to be abusive. In 2009, the case was brought before a federal court.

The plaintiffs pointed out that "Myriad patents" (representing patents on natural phenomena and laws and nature) have significant adverse effects, including privatization of genetic heritage in violation of fundamental principles of heritage, public domain and public trust.

The risk of manipulation (and infringement of genetic freedom) was also emphasized, which is obvious. On the contrary, it was pointed out that the sole motivation for Myriad's actions was solely its economic interest, rather than the welfare of mankind.

The Court showed sensitivity to this issue, stating that the proliferation of intellectual property rights related to genetic material was considered to contribute to a phenomenon called the "anti-goods tragedy". The plaintiffs said that isolated DNA is a natural product that is not patentable and also to allow a single lab to provide tests means that a single lab sets the standard for patient care. However, patient care is encouraged by using different methods when multiple labs provide specific genetic tests, as this can ensure the quality of the tests.

The Myriad case has revealed the problematic nature of patenting genetic material, questioning the assumption of the property rights paradigm and putting pressure on the definition of the notion of the commons in law.

This case reflects the need for specific legislation dedicated to the components of the human body in relation to exploitation resulting from scientific research, which, if it cannot be achieved at European or international level because of divergences, can certainly be adopted at national level, obviously in compliance with the legal institutions already adopted at European Union level.

An article written by Veronica Dobozi – Partner.