Theory and practice of intellectual property
№ 4 / 2020

ISSN (Print) 2308-0361
ISSN (Online) 2519-2744

PDF (Ukrainian)

DOI: https://doi.org/10.33731/42020.216948

Published      2020-11-23

Intellectual property on data of COVID-19 off-label treatment and data of compassionate use of medicines and access to treatment in a pandemic

Oksana Kashyntseva
Ukraine
https://orcid.org/0000-0002-2598-5614

Mykyta Trofymenko
юрист БО «100% Відсотків Життя»

Abstract
The article concerns the issues of legal protection of data obtained as a result of off-label drugs therapy of COVID-19 and of data obtained of the compassionate use of medicines in treatment of COVID-19. The authors argue that neither data on the use of off-label or on the basis of a compassionate use in the treatment of coronavirus (data obtained in solidarity clinical trials) are not determined as the information that should be protected from unfair commercial use. Regarding to the use of off-label for a new purpose of drag it is not be considered as a «new chemical substance», because the drug is already registered, and therefore known, and in the case of obtaining data in compassionate use, this information is removed from the trade secret regime by the WHO and EMA opinion. Such information is opened to use from the beginning. Therefore, in both of the above cases, it could not be considered as an «unfair use» in the meaning of Art. 39 TRIPS Agreements.

The WHO apply to the world community and informed about the «Solidarity» clinical trial for COVID-19 treatments». Solidified clinical trials of COVID-19 treatment compare four treatment options to evaluate their efficacy in COVID-19 therapy. Solidarity-based clinical trials aim to quickly identify which of the drugs tested slows disease progression or improves survival. New drugs can be added to solidarity studies based on new data.

On April 3, 2020, the Committee for Medicinal Products for Human Use of European Medicines Agency (EMA) issued recommendations for compassionate use for remdesivir as the most promising treatment for COVID-19. The EMA explicitly states that the compassionate use is not part of the clinical trial in its usual meanings.

IFLA (International Federation of Library Associations and Institutions) also wrote an open letter to WIPO urging WIPO to use all available flexible intellectual property mechanisms to maximize worldwide access to information (research data) on COVID-19 treatment.

Thus, the legal regime of «Solidarity clinical trials and the WHO and EMA declarations lead us to conclude that all data obtained in the Solidarity clinical trials should not be monopolized by intellectual property, either as objects of patenting for a new scope / new purpose of treatment, or like an object of data exclusivity protection.

Keywords: intellectual property, access to treatment, compassionate use of medicines, off-label treatment, access to treatment

References

«Solidarity» clinical trial for COVID-19 treatments.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments

EMA provides recommendations on compassionate use of remdesivir for COVID-19.
https://www.ema.europa.eu/en/news/ema-provides-recommendations-compassionate-use-remdesivir-covid-19

The Lancet.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30798-4/fulltext

Médecins Sans Frontières.
https://www.msf.org/no-profiteering-covid-19-drugs-and-vaccines-says-msf