Patent rights and the race to find a cure for the COVID-19 pandemic in Europe
Several pharmaceutical companies all around the world, including in the European Union (EU), have been racing to find a treatment for the virus. Since these may be subject to patent rights, government intervention may be needed.
Patent law confers a monopoly right to the patent holder. A new vaccine, or a new use of existing life-saving medicines, or medical equipment such as diagnostic kits for testing the virus, can be subject matter to a patent right. Such monopoly right, however, enables the right holder to determine if and where the life-saving technology will be made available, and at what cost. In the context of a global pandemics, this may be problematic as the right holder would be able to prevent easy access to these medicines and equipment at an affordable price. According to the statement by Dainius Pūras, the United Nation Human Rights’ expert on the right to health, “everyone, without exception, has the right to life-saving interventions and this responsibility lies with the national authorities”.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides for ‘compulsory licences’ for patents, which is one of the most important tools for increasing access to medicines at an affordable price. Many Members of the World Trade Organization (WTO) have specific laws to facilitate these arrangements.
How can compulsory licensing ensure public access to patented drugs or necessary medical equipment?
In case a WTO Member finds that a patent owner does not or cannot produce or import the relevant patented COVID-19 treatments in sufficient amounts or at an affordable price, the TRIPS Agreement provides for limited exceptions to the exclusive rights conferred to a patent owner. A compulsory license may be granted by a Member upon the request of a third party. Such a license usually mandates that a specific company or public body manufacture or sell the patented invention without the permission of the patent holder. Though controversial, the aim of a compulsory license is to protect the interest of the public from any potential abuses by the patent holder. Nevertheless, the latter retains the right to be compensated, and the amount of compensation is determined according to the circumstances of each case. Countries such as India and Thailand have made use of compulsory licenses in the past.
Given the seriousness of the current health crisis and mounting economic pressures, it does not come as a surprise that the prospect of compulsory licensing has been proposed in a number of countries in recent weeks. For instance, on 19th March, Israel issued compulsory licenses related to lopinavir/ ritonavir, which is an HIV medicine currently being tested for effectiveness in the treatment of Covid-19, including in combination with other products.
Compulsory Licenses in EU Member States
In the European Union, a compulsory license can be granted to secure access to medicines at times of national emergency, and for use in least-developed and developing countries. In fact, countries such as Germany and France, have adopted extraordinary measures to lessen the conditions governing the use of compulsory licenses. In Germany, §13 of the German Patent Act (GPA) allows the restriction of patent rights by means of an administrative order issued by state authorities. The recently enacted so-called Epidemic Protection Act, among others, authorizes state authorities to use a patent for reasons of public welfare in accordance with §13 of the GPA. This essentially means that the effect of a patent (and its scope of protection) can be limited when such patent is related to specific products that need to be used for public welfare (including public health). These include pharmaceuticals, medical devices, and laboratory diagnostics, as well as items of personal protective equipment and products for disinfection.
In France, broader measures have been adopted (i.e. the emergency law no. 2020-290) to deal with the COVID-19 epidemic. A new article L.3131-15 was introduced in the public health code. This article allows the Prime Minister, when a state of health emergency is declared, and for the sole purpose of guaranteeing public health, to (1) order the requisition of all goods and services necessary to fight against a sanitary disaster, (2) temporarily control the prices of products; and (3) to take all measures necessary to make available to patients the appropriate medicines for the eradication of the health disaster. The question remains as to whether this can include medicines under patent protection.
The race to find a cure for the COVID-19 has involved universities, publicly funded research institutes and biotechnology companies. Most experts agree that vaccines are the world’s best hope for bringing this pandemic to an end. Once COVID-19 vaccines have been found and patented, and are not made widely available at an affordable price, it is likely that governments will consider compulsory licensing. However, companies such as Johnson & Johnson are active in thwarting the event of a compulsory license being issued, and are already promising to bring themselves “an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.”