CORONAVIRUS: Between intellectual property rights enforcement and public health

Up so far, the most noticeable effects of Corona are the economical, fiscal and criminal ones. However, there are implications from the perspective of industrial property rights, some of which will be analysed in the following paragraphs.

A start-up in Italy decided a couple of weeks ago, due to the lack of ventilation equipment in hospitals to manufacture with the help of a 3D printer a replacement of the valves used for the production and operation of these devices. The news has spread around the world, the initiative being welcomed by people in the areas affected by the epidemic and the start-up praised for its efforts.

However, another news concerning the 3D printing of the valve replacement draws attention to an important problem in the current context: the balance between the protection of industrial property rights (“IPRs”) and the production of equipment, medical equipment and drugs needed to combat the coronavirus pandemic.

When the start-up contacted the manufacturer of the original valves for blueprints it could use for 3D printing, the company in question rejected the request and threatened to sue for infringement of patent rights. Faced with this, the start-up team decided to measure the respective valves and proceed to 3D printing three versions to test them together with the ventilator [1]. The manufacturer denied information about a potential dispute with the Italian start-up.

This type of profiteering on the advantages conferred by the legislation is not singular. In the United States, the pharmaceutical manufacturer Gilead initially requested the Food and Drug Agency (FDA) to grant the title of “orphan drug” to the experimental drug Remdesivir considered to be one of the most promising potential treatments for coronavirus. Under US law, the “orphan drug” status offers an exclusive market period of seven years, as well as tax incentives and facilities for drug companies developing treatments for rare diseases. Following pressure from public opinion, Gilead withdrew this request.

At the end of March 2020, Médecins Sans Frontières (MSF) [2] addressed the conflict between industrial property rights and the coronavirus pandemic, calling for patents not to be granted for drugs, tests or vaccines used for the COVID-19 pandemic, suggesting governments to take measures regarding a possible suspension of patent rights and / or their requisition, as well as other measures such as control and / or price reductions to ensure the availability of medicine.

Currently, Canada, Chile, Ecuador and Germany are among the states that have implemented measures to facilitate the issuance of compulsory licenses for COVID-19 treatment, drugs, vaccines and other medical instruments (equipment, tests). Also, the Government of Israel has established a compulsory license for the development of the generic version of Kaletra, a drug that is part of the treatment scheme for COVID-19 and is produced by AbbVie [3].

At the opposite end, in an attempt to combat the shortage of medical equipment needed to save lives, the ventilator manufacturer Smiths Group [4] has announced that it will provide access to the know-how and industrial property rights regarding one of its ventilators to other manufacturers in order for them to adapt and expand their production to meet hospitals’ needs.

Also, the drug manufacturer AbbVie has announced that it is giving free access to its patents on Kaletra (Lopinavir / Ritonavir) for research and development purposes in the treatment of COVID19 [5] declaring that scientists and competitors will not be sued for IPRs infringement.

Recently, the World Health Organization (WHO) welcomed Costa Rica’s proposal [6] to create a database of technology and industrial property rights much needed in the development of tests, medical devices, vaccines and treatments. Given the rapidity and aggressiveness coronavirus spreads, the creation of such a database will accelerate the development of technology and the adaptation of existing products. Such an initiative has taken place in the past on the development of drugs to combat HIV, tuberculosis and hepatitis C. Clearly, in such a context, the protection of industrial property rights should not impede or delay the development of treatments. and medical devices.

The situation should be assessed by looking at the purpose of granting patents, specifically the need to stimulate innovation and reward the researchers engaged in the fight against coronavirus. A balance must be struck. A solution in this regard would be the financing from the states through funds allocated for research and development and the granting of fiscal facilities. States may also implement compulsory licensing measures for COVID19 treatment.

Compulsory licensees are authorizations issued in certain conditions (such as health emergencies) by a national authority to a person for the use and exploitation of a patent without the consent of the patent holder.

In this respect, the provisions of article 30 TRIPS states that “Members may provide for limited exceptions to the exclusive rights conferred by a patent, provided that they do not unduly prejudice the normal exploitation of the patent nor cause undue harm to the legitimate interests of the patent holder, with taking into account the legitimate interests of third parties.”

According to the provisions of art. 46 paragraph (4) of Law no. 64/1991 on patents, “a compulsory license can be authorized by the Bucharest Court in situations of national emergency“. In such cases, for the purpose of granting a compulsory license, it is not necessary for the interested person applying for the compulsory license to prove that an attempt was made to obtain a contractual license. These provisions are applicable to patents for which 4 years have elapsed since the filing date or 3 years from the date of grant of the patent, taking into account the term that expires the last.

Recent news [7] shows that in Romania, protective equipment is being developed and manufactured using 3D printers and also vaccines are being tested, so it remains to be seen whether such situations requesting for compulsory licenses will arise.

Given the fact that the development of medical treatments and devices for coronavirus involves not only a global effort but also requires rapidity, it is justified to lift the barriers imposed by protection through know-how and industrial property rights, barriers that would delay the emergence of medicines and medical devices for years to come, delay which at this moment the whole society cannot afford.

According to a study carried out by the American Chemical Society [8] which was published in March 2020, there are currently over 500 patents that reveal methodologies and active substances with the potential for treating and preventing coronavirus infections and which may be applicable to COVID-19 (these being developed in the effective treatment of other RNA viruses, including SARS-CoV and MERS-CoV). This study counts the existing patents in the pharmaceutical field without including the patents developed for the manufacture and sale of medical devices for treating and testing these diseases (ventilators, detection test kits, masks etc.).

The idea of ​​creating a common database of industrial property rights (known as “patent pool“) to accelerate the innovation and development of new technologies is not new, over time different sectors making available to different competitors in certain conditions their technologies. Patent pools are formed when the holders of complementary patents (patents required for the development of new complementary technologies which are included in the end product – standard essential patents included in the 3G technology which subsequently developed into 4G and, recently, 5G are an example [9]) decide to share the results of their research in order to develop new and rapid answers to current problems. By participating in the patent pool, patent holders grant licenses to third parties on fair, reasonable and non-discriminatory terms (such as FRAND terms [10] to allow the manufacture and development of products that comply with the standard in question.

A couple of scientists have taken steps towards an agreement tackling COVID-19, agreement which is focused on accessibility – Open COVID Pledge [11] an initiative which guides itself by the fact that “immediate action is required to halt the COVID-19 Pandemic and treat those it has affected. It is a practical and moral imperative that every tool we have at our disposal be applied to develop and deploy technologies on a massive scale without impediment.” The Open COVID Pledge envisages the following basic terms:

“The Pledger grants to every person and entity that wishes to accept it, a non-exclusive, royalty-free, worldwide, fully paid-up license (without the right to sublicense) to make, have made, use, sell, import, reproduce, adapt, translate, distribute, perform, display, modify, create derivative works of and otherwise exploit all patent, copyright and other intellectual and industrial property rights (other than trademarks and trade secrets) in products, services, compositions of matter, machines, articles of manufacture, processes, and works of authorship that we have the right to license under these terms (the “Licensed IP”), for the sole purpose of ending the “COVID-19 Pandemic” (as defined by the World Health Organization, “WHO”) and minimizing the impact of the disease, including without limitation the diagnosis, prevention, containment, and treatment of the COVID-19 Pandemic.”

Furthermore, Medicines Patent Pool (MPP) [12] a health organisation endorsed by United Nations which is active in the development and access to life-saving medicines in developing countries has declared that the organisation stands ready to offer its support in access to treatment for the coronavirus, emphasizing that the organization works with a wide range of treatments and holds licences for HIV antiretroviral that may be effective in the treatment of COVID19.

Irrespective of the manner in which an agreement for the development and manufacturing of COVID19 related technology will be reached by the interested parties, the rational solution that is required in the present context is that of a global agreement that establishes not only the conditions of access to the development of new medical technologies and medicines, but also an adequate and equitable remuneration granted to the researchers, as well as the conditions of licensing and subsequent commercialization of medicines and devices at an affordable price.

Author: Cristina Neagu – See LinkedIn Profile