Working Competition and Biotechnology Patent Pools – Article from #1 2018

ABSTRACT

Patent pools have always been a subject of heated discussions due to their ambiguous position on the market as they bear both anti-competitive and pro-competitive characteristics. On the one hand, they create a common market for licensors and licensees, guarantee access to the industry standards (if any), as well as induce further innovation. On the other hand, they bear a certain risk of violating anti-trust laws.

Patent pools were introduced into life sciences quite recently. Biotechnology patent pools play an immensely important role in providing access to essential, up-to-date medicines for terminal diseases that affect a great number of population in certain countries. They make medicines affordable to the local generic producers in developing and least developed countries who bring the affordable new drug formulations to the market. Furthermore, since modern medicine is largely based on gene patents, pooling is suggested to resolve the patent thicket issue around genetic diagnostics. At this moment, the most successful and global example is the Medicine Patent Pool founded in 2010 by UNITAID.

Patent pools generally encompass patents that protect developed technology. However, for the pharmaceutical industry, it is of major importance that the patent pools facilitate further development of the drugs. This necessity stems from, among other factors, a) the ability of viruses to develop resistance to the treatment, b) scarcity of paediatric drug formulas, and c) the need in fixed dose drug combinations (FDCs) for the treatments requiring simultaneous consumption of several medicines such as antiretroviral drugs.

As patent pools gained more popularity, concern about their adverse impact on competition practices grew as well. Despite the recognized benefits of patent pooling, such as promotion of technical progress and dissemination of technology rights as a special type of goods allowing for an even further increase in manufacturing capacity, the technology transfer block exemption under Regulation 316/2014 is inapplicable to the pooling agreements.

As a result, an examination of the relationship between current EU competition law policy towards patent pools appears to be a particularly relevant and valuable subject for discussion. By establishing whether legal safeguards of the EU anti-trust framework help to reach a healthy balance between the protection of market competition and industrial development, we are able to identify the place of patent pooling in the context of legal solutions for distributing the benefits of health care biotechnologies.