Patents & Trademarks
A structured legal guide about patents & trademarks in Ecuadorian Pharma. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75.
1. What are the basic requirements to obtain patent and trademark protection?
Any sign that is capable of distinguishing goods and services on the market shall constitute a mark. Signs that are capable of graphic representation shall be eligible for registration as a mark; in particular, the shape of a product, its packaging or wrapping may constitute a trademark.
Patents will be granted for inventions, whether for goods or processes, in all areas of technology, provided that they are new, involve an inventiveness, and are industrially applicable.
2. What agencies or bodies regulate patents and trademarks?
The local IP Office SENADI is the entity in charge of regulating patents and trademarks.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
For trademarks there are basically no restrictions; protection will be granted to all non-traditional marks including 3D marks.
The patentability exceptions are: a) discoveries, scientific theories, and mathematical methods; b) Any living thing, either complete or partial, as found in nature, natural biological processes, and biological material, as existing in nature, or able to be separated, including the genome or germ plasma of any living thing; c) literary and artistic works or any other aesthetic creation protected by copyright; d) plans, rules, and methods for the pursuit of intellectual activities, playing of games, or economic and business activities; e) computer programs and software, as such; f) methods for presenting information; g) therapeutic or surgical methods; and, h) second and novel uses.
4. How can patents and trademarks be revoked?
Cancellation: A mark becomes vulnerable to a cancellation action for lack of use (total or partial) if it has not been used by its registered owner (for all the protected goods/services in the case of a partial cancellation) within the past three years in at least one of the Andean Countries (Colombia, Ecuador, Peru and Bolivia). The burden of proof of use of the mark falls on the owner of the registration. A positive resolution in a cancellation action grants the plaintiff preferential rights to register the cancelled mark and this action may be also brought as a defense in an opposition proceeding.
A cancellation action for notoriety may be brought when notoriety existed in any country party to the Paris Convention and/or member of the Andean Community, at the time the challenged Ecuadorian mark was filed and continues at the time the action is brought.
Where the owner of the mark has caused or allowed that mark to become a common or generic sign to identify or denote one or several of the goods or services for which it was registered, the competent national office shall order, ex-officio or at the request of a party, the cancellation of the mark or the limitation of its scope.
Nullity: The authority shall either ex-officio or at the request of an interested party and at any time, declare the registration of a mark absolutely null and void when registration of such mark was granted against absolute grounds for refusal. The authority, shall either ex-officio or at the request of a third party with legitimate interest, declare the invalidation of a registration where granted in contravention of relative or absolute grounds for refusal or obtained in bad faith.
Andean Decision 486, which is the IP supra-national law applicable in Ecuador, determines that the competent national authority may, either ex-officio or at a request of a party, and at any time, declare a patent null and void, when the subject matter of the patent is not an invention (i.e., discoveries, scientific theories, mathematical methods, living things as found in nature, literary and artistic works, plans, rules, and methods for pursuing intellectual activities, playing of games, or economic and business activities, computer programs and software, as such, and methods for presenting information).
Other causes of nullity are the lack of fulfillment of the patentability requirements (novelty, inventiveness, industrial applicability), matter excluded from patentability (inventions whose commercial exploitation is necessary to protect public order, human or animal health and the environment, plants or animals and essential biological process for their production other than non-biological or microbiological processes, diagnostic, therapeutic, and surgical methods for the treatment of humans or animals), lack of proper disclosure of the invention or lack of deposit of biological material; claims not duly supported by the specification; a granted patent that is of broader scope than the original application; lack of the access contract of genetic resources in such inventions, or lack of a document certifying the existence of a license or authorization for use of traditional knowledge belonging to local communities.
The nullity of a patent can also be declared when there are grounds for absolute invalidation according to domestic law covering administrative acts and is applicable to the claims or parts thereof that are affected. The defects in administrative acts that have not brought about absolute invalidity shall result in relative invalidity. In such cases the competent national authority shall declare such invalidity within the following five years counted from the date of the grant of the patent, as provided for by the national law.
The patent, claim, or part of a claim that has been invalidated shall be deemed null and void as from the filing date of the patent application.
The competent national authority may cancel a patent where it has been granted to a person not entitled to such grant. The action for cancellation may only be brought by the person to whom the right to the patent belongs. Such an action shall not be possible after five years following the date of grant of the patent, or after two years following the date on which the person to whom that right belongs became aware of the exploitation of the invention in the country, whichever period expires first.
The competent national authority ruling on a case of invalidity shall inform the owner of the patent so that he may present such arguments and submit such evidence as he may consider fit. Where this is necessary for a ruling on the invalidity of a patent, the national authority may request the owner of the patent to submit documents referring to expert opinions or related patentability examinations performed by other patent authorities.
In addition, the local IP Law in force since December 2016 introduces sanctions for the falsehood, deliberate omission, deliberate obscurity or deliberate complication of the information in the application or in the description of the invention, hindering the national competent IP authority from examining the patent application, misleading it in the examination or not allowing it to be put into practice, which will be grounds for rejection of the application or absolute nullity of the granted patent, without prejudice to the claim for damages of any third party affected.
On the other hand, the local IP Law introduced limitations as to the patentability of several products, defining as non-inventions the new forms of a substance, including salts, esters, ethers, complexes, combinations and other derivatives; polymorphs, metabolites, pure forms, particle sizes and isomers. These restrictions would be against the Supranational Law, and therefore not applicable.
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
In general terms foreign trademarks and patents are not recognized. Ecuador is a first to file country for trademarks. The sole exception is for well-known trademarks.
6. Are there any non-patent/ trademark barriers to competition to protect medicines or devices?
There are no non-patent/trademark barriers to competition to protect medicines or devices.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
There are no restrictions.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
License agreements do not require approval; however, registration with the IP Office is advisable in order to be enforceable against third parties.