[Ip-health] Ecuador grants compulsory license over HIV drug raltegravir

Luis Gil Abinader luis.gil.abinader at keionline.org
Fri Mar 5 04:30:39 PST 2021

Link: https://www.keionline.org/35509

Posted on March 4, 2021 by Luis Gil Abinader

On February 25, 2021, the intellectual property office in Ecuador granted a
compulsory license over a patent directed to the raltegravir active
ingredient. Raltegravir, commonly marketed under the brand name Isentress,
is used to treat HIV infections. The licensed patent is PI-2016-2142,
assigned to MSD Italia s.r.l. The compulsory license was granted for
non-commercial public use to import the active ingredient from
manufacturers in India.

The resolution is available here:

KEI translated the operative part, available here:

This request was filed on November 5, 2020, by SOULPHARMA. The license
extends to the remaining life of the patent, which expires on October 21,
2022. Daniel Díaz Reza, an intellectual property lawyer based in Ecuador,
represented SOULPHARMA in this case.

One of the key arguments made by the patent holder is that SOULPHARMA
lacked an authorization from the health authorities to market raltegravir
in Ecuador. SOULPHARMA argued that the status of the sanitary
authorizations is not among the grounds under which a compulsory license
request should be decided. The intellectual property office sided with
SOULPHARMA, explaining that whether the company had an authorization to
market the drug in the country was irrelevant to decide a compulsory
license request.

"[…] Public agencies are governed by the principle of legality and have to
act based on the scope of their jurisdictions. It would not be appropriate
if the [health regulatory agency] ARCSA require that an applicant
demonstrate ownership or license to use a patent, whether voluntary or
compulsory, in order to grant a sanitary authorization; therefore, it is
not appropriate for [the intellectual property office] SENADI to require
evidence of a granted sanitary authorization in order to issue a compulsory
license […]"

To determine the reasonable royalties, the intellectual property office
took into consideration the price of a raltegravir tablet in Italy, the
dollar amount to be paid for a royalty base of 5% over the price of each
tablet in Italy, and the average income in Ecuador according to the most
recent World Bank GDP per capita indicator. Based on those factors, the
intellectual property office determined a reasonable royalty of 0.17 USD
per tablet to be paid annually by SOULPHARMA to MSD.

Raltegravir is considered a “priority for public health,” according to
exhibits filed during the proceedings. The license allows SOULPHARMA to
market this drug in procurement processes carried out by any of the
entities of the public health sector in Ecuador.

Note: the Royalty methodology is the WHO/UNDP Tiered Royalty Method. See
Section 8.3.4, Remuneration Guidelines for Non-Voluntary Use of a Patent on
Medical Technologies, WHO/TCM/2005.1 Link:

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