ECUADOR - DIRECTIVE FOR GRANTING OF COMPULSORY LICENSES FOR DRUG PATENTS. FIRST REQUESTS WERE ALREADY FILED!
Dr. Janet Hernandez.
ABREU & ASOCIADOS - Quito, Ecuador
On October 23, 2009 a Presidential Decree - Decree 118- entered into force in Ecuador to introduce the granting of compulsory licenses for patents related to human medicinal products.
Decree 118 declares of public interest the access to medicines used to treat diseases that affect the Ecuadorian population and that are a priority for public health.
On 15 January 2010 the Intellectual Property Ecuadorian Institute -IEPI-issued Resolution 10-04, which contains the Directive for the granting of such compulsory licenses for patented drugs, defining the guidelines that will govern the procedure applied in the handling of petitions for compulsory licensing of patented drugs.
The Directive determines that the compulsory licenses may be granted for public non-commercial use or for commercial use.
Both cases require the submission of an Affidavit stating that the drugs produced under this regime will be "mainly" intended for domestic supply. This condition leaves open the possibility of selling a part of the resulting product to other countries.
In the case of compulsory licenses for commercial use, it is also required to demonstrate that the applicant has attempted to obtain from the patent holder an authorization in “reasonable terms and conditions" and that such attempts failed in 45 days.
Regarding the proceedings, once the competent authority – IEPI- reviews the formal issues of the petition, duly corrected, clarified or widened by the applicant, when applicable, IEPI will notify the patent holder and request a report to be submitted by the Public Health Ministry to determine whether the object of the requested license is a drug used for treatment of diseases affecting the Ecuadorian population and a priority for public health. It is not stated a deadline for action of the patent holder - which is optional-, or to receive a response from the health authority, although in application of the local administrative rules it is considered that this term must be not longer than 60 days. A positive declaration from the Health Ministry regarding the condition of being "a priority for public health" is essential for granting the compulsory license.
There is no official fee established for the procedure. The resolution that settles up the granting of the compulsory license shall reach a decision on the extent, purpose and applicable terms, as well as the amount of royalties and corresponding payment provisions.
Minimum or maximum amounts are not set for royalties; it is only mentioned that royalties should be "appropriate to each case, taking into account the economic value of the authorization".
Against the decision to grant a compulsory license any available action to challenge administrative acts according to the national law can be used, but under no circumstance the exploitation of the granted license would be prevented.
Article 12 of the directive determines that "nobody else other than titleholders of patents and compulsory licenses may exploit a patent and offenders will be punished in accordance with the law". The statement is confusing about the legitimacy of the voluntary licenses’ beneficiaries.
Therefore, analyzing the new Directive it is reasserted that the Presidential Decree 118 established the legal basis allowing the Intellectual Property Ecuadorian Institute (IEPI) to issue compulsory licenses for drug patents in favour of third parties without the intervention of the licensed patents owner and even if they are being used in Ecuador. Additionally, IEPI will have the power to unilaterally decide the exploitation conditions and royalties to be paid to the patent holder.
However, when declaring that the guidelines are mandatory for compulsory licensing of patents on drugs - Chapter 1 - and subordinating the granting of such compulsory licenses to the positive declaration of the health authority asserting that the product is a priority for human health, the Directive would exclude the use of classic compulsory licenses, presided over by the Intellectual Property Law and the Andean Decision 486. It may then be understood that it is not possible to obtain compulsory licenses on medicines that are not a priority for human health - e.g. analgesics, anti-inflammatory drugs – as they will not receive the "a priority for human health" qualification, required as mandatory in the process.
We are aware that two requests for compulsory licenses under the provisions of Decree 118 and this new Directive have been already filed with the IEPI. So far the requests have not been notified to the interested patents owners as there are formal objections that should be amended by the applicants before the authority continues with the process. |
|
2008 Patent Statistics. The 98% of patent applications
filed in Ecuador are PCT entries into the national phase. The 96% of patent
Ecuadorian applications are in the pharmaceutical field. |
|
|
Decision 689. Ecuador has not enacted Andean Community Decision 689, and
therefore, it is not possible to reinstate lapsed priority rights, and the use
of a multiclass trademark registration system was not approved. |
|
|
First color registration -not delimited- in Ecuador. On December 4, 2008
Ecuador granted the first color mark registration, without an specific form, on
the grounds of the acquired distinctive capacity - secondary meaning- of the
mark “COLOR ROJO” (pantone 186C) to protect “Mobile communications and advanced
mobile services”, class 38 services. |
|
Legalization of documents. The Hague Convention Abolishing the
Requirement of Legalization for Foreign Public Documents entered into force in
Ecuador on April 2nd, 2005. Therefore, the legalization process before an
Ecuadorian consulate may be replaced by the issuance of an Apostille
Certificate.
Please, see
http://www.hcch.net/index_en.php?act=conventions.authorities&cid=41 to determine
the competent authority in your country to issue an Apostille Certificate. |
|
|
Patent annuities. Annual fees in Ecuador should be paid bearing in mind
the Ecuadorian filing date, up to the last day of the corresponding month. This
rule also applies for PCT applications in national phase. Industrial designs do
not pay annuities. |
|
 |
|
