IP exploitation andCompulsory Licenses
during COVID-19 inColombia
Carlos A. ParraPartner
Head of Asia OfficeContext and Law and Regulations• Decision 486 Art. 65: grant a Compulsory License based on “…
public Interest, emergency or national security” declaration. Thesearticle is based on Articles 30 and 31 of TRIPS Agreement.
• Issue: has Colombia ever issued a Compulsory License for patents
based on said article of D. 486?
• Response: No. But…

© 11 March 2022 Olarte Moure & Asociados Ltda.

Previous attempts for a CL in CO• Governmet of Colombia had at east 2 previous non-successful requests where Compulsory
Licenses (CL) were considered:• LOPINAVIR and RITONAVIR-KALETRA® (antiretroviral medication for the treatment andprevention of HIV/AIDS) and• IMATINIB-GLEEVEC® (treatment of Philadelphia chromosome positive chronic myeloid
leukemia- a blood type of cancer).
• Declaration of public interest for both medicines issued in both cases based on Colombia´s publichealth interest. Request by NGOs and local pharma companies to grant CL based on said
Decalaration.

• No Compulsory License proceeding initiated at the Colombia IPO. Instead, the Declaration wasused to issue a Price Control Decree by Minstry of Health for said medicines.
• Based on said cases and experiences, a detailed regulation was requested and issued toestablsh a detailed procedure for granting a CL based on a Public Interest declaration: Decree N°
4302 of 2008.
© 11 March 2022 Olarte Moure & Asociados Ltda.

The Andean Tribunal of Justice provided a guidance for a CL inthe Andean Community countries (CO, PE, EC, and BO)
Andean Tribunal of Justice (Andean Community court for IP) issued ajudicial decisión on 2019 (“Interpretación Prejudicial 144-IP-2019”)
saying any public health emergency, such as a pandemic, is a valid
reason to grant CL only if it is a reasonble, necessary, and a valid
measure to:(i) effectvely control the health emergency;(ii) there is no other alternative less restrictive or burdensome to
the IP owners, and(iii) the benefits outweights the negative effects.
© 11 March 2022 Olarte Moure & Asociados Ltda.

¿Needed CO a CL based on a Health Public Interest
Declaration to control the COVID-19 pandemic?
• Issue: May the access, importation, use, and/or availability of COVID-19 related
medicines, treatments, and/or medical devices be blocked, become more
expensive, or affect the effectiveness of the government to control the publichealth crisis created by the pandemic because of the patents granted to theabove?
• Colombian Congress requested publicly to the President to declare a CL on
patents and trademarks related to COVID-19• The President of Colombia declared the “State of Emergency” in Colombia whichallows him to legislate instead of Congress.
• He issued Decree 476 de 2020 (Article 1.7): Ministry of Health was given
authorization to issue a Declaration of Public Interest for the protection of thepublich health and take measures to secure the access and use of “medicines,medical devices, vaccines and any other health related technology for diagnostic,prevention and treatment of COVID-19”.
© 11 March 2022 Olarte Moure & Asociados Ltda.

¿Is necessary a CL based on the Decalaration of
Public Interest due to COVID-19?
• Issue: Does this declaration meant Compulsory Licenses (CL) would be granted by the Colombian IPO onpatents granted over “medicines, medical devices, vaccines and any other health related technology for
diagnostic, prevention and treatment of COVID19”?
• No CL has been issued or initiated until today.
• Instead:• Between March 17 to June 15, 2020 exempt of annuity payment for patents or renovation oficial
fees for trademarks for any Colombian patents or trademarks related to COVID-19• PROSUR (BR, AR, CO, EC, PE, and UR) published a report with the list of patents amd
technology publicly available in each country(See: https://prosur.org/wpcontent/uploads/2020/04/Boletin-PROSUR-COVID19-1.pdf)• Declaration and Decree 476 was used to ease regulatory market and importation authorzation by
INVIMA (Colombian PMDA or FDA) for importation and commercialization of medicines,treatments, technologies, medical devices, etc.
• Ministry of Science and Technology created a public program to finance (USD 10.5M in 2020/21
and USD 3M aid for patent protection) and promote R&D in medicines, treatments, medicaldevices, epidemiology studies and software, AI, IoT and Big Data to fight, control, or treat
COVID-19 and support Start Ups that bring to market resulting medicines, treatments or medical
devices based on local R&D.
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THANK YOU
どうもありがとうございました。

Asia Office