Patents in times of pandemics

Author: Javier Fernández-Lasquetty, partner at ELZABURU S.L.P. and professor of Intellectual Property at IE Law School

In this strange and unsettling time we are living through, with a sense of drama that some equate to war, there’s no human activity that hasn’t been affected. Patents are no exception and, as we will see, they are playing, and will continue to play, a key role in this matter.

When the international alert was first announced, the need for immediate and large-scale production of all types of medical supplies (gloves, masks, etc.) was identified. This led the EU authorities to facilitate free access to the manufacturing standards created by CEN-CENELEC, which are usually only accessible through the payment of royalties.

While the fees to be paid to access the standards are fairly reasonable, it was interpreted as a gesture of solidarity and a demonstration of how intellectual property rights should be put aside in exceptional circumstances in which human rights, such as health, are involved. This is set out in Article 25 of the Universal Declaration of Human Rights.

Several public-private partnerships have launched initiatives, capitalizing on 3D technology to produce certain devices and parts.

Yet there has been tension regarding the manufacturing of devices that are protected by patent rights, either in their entirety, or for some of their essential parts. We have already seen how some organizations have attempted to assert their patents in Italy, against those who reproduced certain parts using 3D printers.

The preparation of COVID-19 tests has also been threatened by potential patent-based claims.

All this has given rise to heated criticism and has caused some complaints to be taken back. But what is clear is that those manufacturing these goods face a certain risk.

This is not a new phenomenon. In the mid-1980s, the IBSA (India, Brazil, and South Africa) trilateral alliance was formed to fight three endemic diseases, namely AIDS, malaria, and tuberculosis. This generated ample tensions with the pharmaceutical industry.

South Africa was badly affected by AIDS, and in 1997 the government under Nelson Mandela authorized parallel imports of medicines from India in order to make treatment available to the affected population, which peaked at 11 percent. The pharmaceutical industry filed a legal claim that was eventually resolved amicably in 2001.

Brazil was also involved in a similar dispute, within the WTO, although the conflict with the pharmaceutical industry had been ongoing. Once again, the matter was resolved amicably in 2001, ensuring an effective and reasonably priced supply of medicines for the affected population.

The creation of the WTO included an agreement called TRIPS, regarding intellectual property rights, which all members of the organization are committed to respecting.

As a result of the aforementioned conflicts, during the WTO Doha Conference, various agreements were approved regarding the balance between patent and human rights.  Thus, Article 5b states that “Each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.” Meanwhile, Article 5c states that “Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.” By doing so, a balance-of-interests framework was established, although there are still conflicting views on the issue.

Like in many other countries, successive Spanish patent laws have established mechanisms that can be used by the state to balance public and private interests in this matter.

Expropriation and compulsory licensing are mechanisms provided by law for situations like this. However, the truth is that they are complex and slow routes since they involve compensating the expropriated entity, or the one forced to grant the license. This leads to contradictory administrative procedures that can be delayed for long periods of time.

However, the rules of the state of alarm offer another swift and actionable alternative for conflict resolution. As we’ve seen some in the press, these laws allow for the requisition of goods. But they also allow for some lesser-known measures such as mandatory personal services actions being taken on those who must contribute to solving the vast array of problems that the pandemic poses—especially to guarantee the supply of medical materials or medicine. These mandatory personal services would therefore be legally binding.

Moreover, the patent law includes some limitations when it comes to infringement by third parties. There are general reasons, such as wrongful use, as well as temporary or indefinite restrictions or limitations which are or will be established according to statutory regulations^[1].

Moving on to another topic, it seems that treatment for COVID-19 offers different alternatives which vary depending on the patient.

As medical progress is made, it seems increasingly clear that the value of patents associated with certain drugs will increase markedly, although the price may not. Here it should also be noted that the pharmaceutical industry has already donated medicine and medical supplies.

It goes without saying that the value of the vaccine will be very high if it is patented, which is perfectly possible; but it is still too early to say what will happen. The rules on patents establish a time between the patent application and its publication. But that time has not yet passed, so it will take several months.

Meanwhile, the number of papers on different aspects of the virus is increasing exponentially. This reveals not only an eagerness to investigate, but also the interest of some to reveal aspects that serve to question the novelty of a patent application.

We do not yet know what conflicts will arise around this, but they will undoubtedly be significant. The background information cited tells us that a debate on limits will be very possible, exacerbated by the fact that we are facing a global pandemic that has generated great concern across the planet.

This hasty chronicle may therefore be continued once the unknowns highlighted here are cleared up, and we are in a position to offer a more detailed analysis.

Javier Fernández-Lasquetty is Partner at ELZABURU, specialising in Intellectual Property and Information Technology. He was Legal Counsel and General Legal Counsel in several IT and consultancy companies and IP/IT partner at a multinational law firm. He is panelist of WIPO Arbitration and Mediation Center and Professor of the WIPO Academy. He also is an active member of professional associations as AIPPI, ALAI and INTA and member of the Board in LES Spain & Portugal and DENAE (Spanish Entertainment Law Association).

Note: The views expressed by the author of this paper are completely personal and do not represent the position of any affiliated institution.

[1] ”The exploitation of the object of a patent may not be carried out in an abusive way or contrary to the law, morals, public order or public health, and will be subject, in all cases, to any temporary or indefinite restrictions or limitations already established or that may be established in the future according to law.” Article 66 of Spain’s Ley de Patente (patent law)

Bibliography

Thomsen, P R., Wright, G., Hoxie, T.: Patents for chemicals, pharmaceuticals and biotechnology: fundamentals of global law, practice and strategy. 6th ed. [S.l.]: Oxford University Press, 2016
Vidal-Quadras, M. y Ginés, N.: Patentes e industria farmacéutica. Barcelona: Bosch, 2006
García Vidal, Á. et al.: Patentes farmacéuticas y derecho de la competencia. Cizur Menor (Navarra): Aranzadi, 2015
Lema Devesa, C.: Patentes farmacéuticas y el acuerdo ADPIC. Granada: Comares, 2008
Sung, L.: Medical device patents. Thomson West, 2016
Love, J. y Potoslski, D.: IP strategies for medical device technologies: be your own incubator. ABA Book Publishing, 2018
Flear, M.:European law and new health technologies. Oxford University Press, 2013.
Correa, C.: Repercusiones de la Declaración de Doha relativa al Acuerdo sobre los ADPIC y la Salud Publica, Economía de la Salud y Medicamentos. Serie EDM nº 12 June 2002. World Health Organization