THE REGULARISATION OF THE MEDICINAL PRODUCT AGAINST COVID-19: Is generic medicine possible? Will the vaccine be available for all?

Industrial Property

Ownership is recognised in our legal system as a fundamental right. Intellectual property arises in two ways: on the one hand, to recognise the sphere of control over creations and inventions and, on the other hand, to promote artistic and industrial development through the legal incentive for their economic exploitation and defence against third parties.

However, Article 90 of Law 24/2015 of 24 June 1968 on Patents (‘the Law on Patents’), with the ultimate aim of ensuring that such industrial development takes place in the interests of society as a whole, requires the proprietor of a patent to operate a patent in such a way that it is sufficient to supply the market.

 

How does this affect the health emergency caused by SARS-CoV-2?

As a result of the global pandemic, caused by the SARS-CoV-2 virus (also known as ‘coronavirus’ or ‘Covid-19’), States and private companies around the globe have joined the race for the discovery and patent of the medication to combat this disease. In this context, the reality is that only 30 % of these investigations are financed by public funds, compared with 70 % of private investment1. This leads to the following conclusions:

  • The legal incentive for economic exploitation and defence is effective for the development of industry, science and R & D & I.

  • Faced with high demand, once the medication is discovered, there is a risk of abuse of the patent by its owner, for exemple by charging exorbitant prices, among other possible anti-competitive practices.

This balance of interests between the public and private spheres means that, on the one hand, the mass declaration of a compulsory license without restriction would lead to a disincentive in the investigation; on the other hand, failing to intervene the patent at the relevant time, by the públic administration, could jeopardise equal access to the vaccine or the Coronavirus medication, afforable for the population.

 

What is the solution of the Law on Patents in order to overcome this balance of interests?

Article 91 of the Law on Patents lists the five possible grounds on which a compulsory licence may be granted, that is to say: Liberalise a patent or turning a patented medication into a generic medicine before that pharmaceutical patent expires. Of all these, from MES Advocats, we believe that the most in line with the current situation is that which is based on reasons of public interest.

A compulsory license for reasons of public interest (Article 95 of the Law on Patents) is granted by the approval of a Royal Decree aimed at regularising the grant of licences in respect of a particular pharmaceutical patent. The merits of this system are:

  • It is faster than the rest of the scenarios;

  • It is applicable not only to a patent, but also to the application for a patent (i.e., even if not yet granted);

  • May, where appropriate, cover a supplementary protection certificate relating to an existing patent (that is to say, where a previously patented medication is found to be effective in combating the coronavirus and that new use is patented); and

  • It serves to regulate the conditions for granting the patent, the scope, the fee payable and the duration of the license, among others.

In particular, the latter characteristic of compulsory licenses for reasons of public interest is the key to combating the deterrence of private undertakings, as a result of the legal certainty that this solution offers in comparison with the other types of compulsory licences.

 

Will the Royal Decree liberalise the patent of the coronavirus?

Since the start of the crisis caused by Covid-19, the Government has amended Organic Law 3/1986 on Special Measures in Public Health Matters, so that the executive administration is now empowered to implement a centralised supply of medicinal products and medical devices; Royal Legislative Decree 1/2015 amending the Law on guarantees and rational use of medicines and health products to enable the government to regulate the pricing mechanism for medicinal products and medical devices not subject to medical prescription and, in addition, to set the maximum amount for retail prices; and has issued Order SND/276/2020 laying down obligations to supply information, supply and manufacture of certain medications in the health crisis caused by the Covid-19; along with other measures.

All these preliminary steps lead us to believe that, if necessary, a compulsory patent may be triggered on public health grounds which ensures the same supply of the medication, under economically reasonable conditions, to the entire population.

However, as of today, there is no example of a compulsory licence in Spain, as all petitions have so far been refused or archived. However, we find the case of Israel, which on 19 March saw the mandatory licensing of Kaletra, an HIV medication which is currently used, along with other treatments, to treat patients infected with the coronavirus.

 

1Source:OEPM — Spanish Patents and Trademarks Office