Vitalii Savchuk: Access of More Patients to Medicines May Be a Consequence, Not a Reason for Invalidation of the Patent

Comment of Vitalii Savchuk, Senior Associate of Legal Alliance Company for RBC-Ukraine

The law is indifferent to the good intention of patent invalidation, but attentive to the reasons therefor. This means that the court cannot be guided only by ideas of situational public interest - it must apply the norms of the law. The law in its turn (ideally) is designed to take into account the public interest all the time.

In most countries, patent law works in a similar way. For investments, efforts, and risks associated with the development of new technologies, the patent holder receives a reward - a 20-year monopoly on its use in the market. Any invention must meet a number of criteria (novelty, inventive step and industrial applicability). If at least one of them is not observed, the patent may be declared invalid. If this happens, the monopoly stops and a patient (if it's the pharmaceutical industry) can obtain earlier access to a more affordable generic drug. That is, access of a larger number of patients to medicines can only be a consequence, not a reason for patent invalidation.

If the cause is confused with the consequence, we can ignore the majority of patents - as a rule, it is easy to put a more affordable product on the market a few years after the publication of the patent. In the short term, it may seem that consumers will benefit from this. Producers of the same drugs lose the motivation to invest time and money in the development of new technologies. Thus, in the long term, patients are at risk of experiencing a slowdown in the industry, and therefore to remain without even better drugs.

The problem is not in Ukraine only. It is also not limited to the pharmaceutical industry exclusively. In the world there really is a problem of "evergreen patents" - the applicant receives a new patent for a known technology making minor changes in it. In this case, there is no other way to determine the validity of a patent than checking in a court of each individual invention for compliance with the criteria.

Thus, it cannot be unequivocally said that patent protection restricts patients' access to affordable medicines. The law makes it possible to verify this statement in each case in court. Obviously, the balance of interests of business and the consumer is important and, probably, unreachable. This does not mean that you do not need to try to achieve it. However, such cases when a compromise is impossible, still happen. Compulsory licensing exists specifically for such cases.

International law (article 31 of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights) and the current national legislation (in Article 30 of the Law of Ukraine on the Protection of Rights to Inventions and Utility Models and the Procedure for Granting Permission to Use the Patented Invention set by Resolution No. 8 of the Cabinet of Ministers of Ukraine as of January 14^th, 2004).

The world practice knows the cases of compulsory licensing (for example, TriAvir for HIV treatment in Rwanda, Kaleta (also for HIV / AIDS), Plavix in Thailand, Nexavar in India, Stocrin in Brazil).

Meanwhile, it is necessary to pay attention to the decision of the European Commission of November 29^th, 2017 on measures to ensure that intellectual property rights are well protected, thereby encouraging European companies, in particular small and medium-size enterprises and new companies to invest in innovation and creativity.