26 / 05 / 2021

Opinion column by Eduardo Molina, partner of Villaseca Abogados, leader of the patent area, originally published on El Mercurio Legal.

After a year under the effects of the coronavirus pandemic, the debate over the release of patents related to the cure or prevention of this disease has been growing.

Already in the middle of last year, the Chilean Chamber of Deputies entered a bill to regulate the access to non-voluntary licenses regarding patents and utility models, medicines, vaccines and medical technologies necessary for the prevention, diagnosis and treatment of diseases, establishing a special procedure to that effect, in the context of a health alert, epidemic or pandemic.

That project is in its first legislative step, with an official notification issued by the Supreme Court that, among other things, states: “recognizing that this legal initiative addresses a problem that has exposed the Covid-19 pandemic (… ) there are some procedural legal aspects in the initiative that can be improved.”

Among these aspects, it seems advisable, for example, to expressly define in the law the concept of “health alert context, pandemic or epidemic” and what would be the time limits it covers.

In this sense, it should be noted that the Chilean IP Law No. 19,039 on Industrial Property already includes provisions to declare these licenses, which is regulated in its article 51 and following.

At the international level, there are many laws that include compulsory licenses. In fact, according to the World Intellectual Property Organization (WIPO), 156 countries have incorporated, in their national patent laws, articles on compulsory licenses as a limitation to the right of the owner of an invention.

Similarly, the Paris Convention of 1883, the first international treaty on intellectual property, states in its article 5, section 2, that “each of the countries of the Union will have the power to take legislative measures that provide for the granting of compulsory licenses, to prevent the abuses that could result from the exercise of the exclusive right conferred by the patent, for example, lack of exploitation.”

For its part, the World Trade Organization provides in Article 31.b, of Annex 1C on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), “other uses without authorization of the rights holder.”

However, in general all the legations and international treaties are quite uniform in requiring very clear and precise conditions to grant a non-voluntary license. For example, article 51 of our law establishes the origin of non-voluntary licenses when: (a) the patent owner has engaged in practices or conducts declared contrary to free competition; (b) for reasons of public health, national security, non-commercial public use, or national emergency or other extreme urgency, declared by the competent authority, the granting of said licenses is justified; (c) is aimed at exploring a later patent that cannot be exploited without infringing an earlier patent.

From the foregoing, we can conclude that, without prejudice to the fact that most patent laws include articles that refer to and order the granting of non-voluntary licenses, all of them are based on a basic premise: the existence of already granted rights, dully constituted and in force. Without granted rights, on what can a license be required?

This, which seems obvious to anyone, looks to have been forgotten by our Chamber of Deputies that even before an application on the matter has been even filed, it initiates legislation that would have no effect on the premise that would justify this exception to the rights of inventors. The foregoing without prejudice to the fact that patents are in force from their filing date, provided they are granted.

Thus, article 1 that defines the purpose of this project states: the present law is intended to protect, through the flexibility of the rules on industrial property allowed by international legislation on this matter, access to medicines, vaccines, supplies and other technologies needed in a context of health alert, epidemic or pandemic declared by the national health authority.

It is known that the preliminary research for the filing of a patent application can easily last between 5 to 10 years from the first idea, especially in the field of pharmaceutical laboratories, and, once the applications have been submitted, the processing of these can easily take another 5 years to be granted, which makes legislation like this totally ineffective, which seeks to release patents on new diseases and, therefore, where there are no rights that could affect the distribution or prices of related drugs.

Finally, it is important to consider that the rapid response of the pharmaceutical industry has been largely due to the incentive to patent. If this award for research did not exist, we would hardly have had the response that we had from the pharmaceutical industry.