Patents & Trademarks
The low-down on the situation regarding patents and trademarks in Chile pharma. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
Any invention that has novelty, inventiveness and industrial application may be subject to patentability.
In general terms, the basic requirements to obtain patent protection are the following:
- To complete a form with information regarding the applicant and the inventor, if applicable, or regarding the PCT Patent Application.
- A Spanish translation of the title, abstract, specification claims and drawings of the invention; if the application is filed under the PCT, it is necessary to submit the Performed Search Report and any modifications or declarations performed during the international phase.
- To file an original or certified copy of the assignment of the inventor/s to the applicant/s. In case of PCT applications, it is not necessary to file this document if the corresponding declarations where performed during the international phase.
- In case the applicant is foreign, it will be necessary to appoint a local representative and submit a hard copy of a Power of Attorney.
- In case a priority is cited, a certified copy must be filed, along with its translation into Spanish in a period of 90 days as of the filing of the application. In case of PCT applications, in which the priority has been properly submitted during the international phase, it will be required to file the same during the Chilean procedure only if requested by the Chilean Industrial Property Institute – Instituto Nacional de Propiedad Industrial (INAPI).
- Pay the corresponding official fees, publication fees and expert fees for the examination of the application.
Any sign that is able to be graphically represented and capable to distinguish products and/or services may be subject to trademark protection.
To achieve trademark protection the interested party must file an application before INAPI and comply with the following basic requirements:
- Provide a graphic representation of the sign applied for registration, indicating its specific wording, figurative elements, and a description of the label or sound, if applicable.
- Indicate the products and/or services that the sign distinguishes.
- If the applicant is foreign, he must appoint a local representative and submit a hard copy of a Power of Attorney.
- Pay the corresponding official and publication fees.
2. What agencies or bodies regulate patents and trademarks?
Patent and trademark prosecution and cancellations are covered by the Instituto Nacional de Propiedad Industrial (INAPI) and by the Industrial Property Court. INAPI acts as a registrar entity and also as a first instance resolving authority. The Industrial Property Court is the second instance collegiate court in patent and trademark disputes, official rejections and cancellation actions. The Chilean Supreme Court may act on these proceedings in case a nullity remedy against a resolution issued by the Industrial Property Court is filed. Patent and Trademark infringement is under the jurisdiction of general civil courts.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
Any solution to a technical or art problem which originates an industrial task can be patented, provided it has novelty, inventiveness and industrial application.
Local regulations do not consider as an invention susceptible of patentability the following:
- Discoveries, scientific theories, and mathematical methods.
- Plants and animals, except microorganisms that comply with general conditions for patentability. Processes for the production of plants and animals which are essentially biological, cannot be patented, with exception of microbiological procedures.
- Easily verified and controlled economic, financial and commercial systems, methods, principles or economic plans and those referring to purely mental or intellectual activities or games.
- Surgical or therapeutic treatment methods for the human body or animals, as well as diagnostic methods applied to the human body or animals, except products used to implement one of these methods.
- The new use, change of form, dimensions, proportions or materials, objects or elements already known and employed for determined purposes. However, the new use of goods, objects or elements can be patent protected, provided that in addition to complying with the general patentability requirements, said new use solves a technical problem which did not have an equivalent solution, and that to obtain the new solution, changes in the objects or elements` dimensions, proportions or materials is required. The claimed new use must be proven by means of experimental evidence in the patent application.
- Parts of living beings as they are found in nature, natural biological procedures, biological material existing in nature or material that can be isolated, including genome or germoplasm. Nevertheless, procedures using one or more of the biological materials mentioned above and the products directly obtained by those procedures shall be patentable, provided they comply with the general patentability requirements, that the biological material is adequately described and that the industrial application of the same is explicitly outlined in the patent application.
- Inventions contrary to law, public order, national security, morality and good habits.
Any sign that is subject of graphic representation and that is able to distinguish products, services and commercial or industrial establishments in the market may be registered as a trademark. Those signs can consist of words including names, letters, numbers, and figures such as images, graphics, symbols, color combinations, sounds, and any combinations of the same. Also, propaganda or publicity slogans can be registered, provided that they are added to a trademark registration.
In general terms, the following cannot be registered as a trademark:
- Any sign that is generic or descriptive of the products or services requested to registration.
- Any sign that can induce consumers to an error or confusion about any of the qualities or place of origin of the products or services that it distinguishes.
- The shape or color of the packaging of a product or a color itself.
- Scientific or technical denominations, Plant Varieties, Indication of Origin or Geographical Indications, and any denomination recommended by the World Health Organization as a therapeutic action.
- Expressions against the morality and public order.
- The name or acronym of a state, international organization or public service, along with their symbols, such as their flag or emblems.
- Signs that reproduce or imitate official signs, seals or hallmarks indicating control or warranty, except if their registration is applied by the competent body.
- The name, pseudonym, portrait of a person unless such person or its legal representative gives its consent, or it has been more than fifty years since that person’s death and does not affect its honor.
- Signs identical or similar to trademarks registered in Chile.
- Signs identical or similar to trademarks registered aboard if these trademarks are famous and notorious.
- Any sign that may affect any third party’s legal right.
- Nontraditional signs such as tridimensional symbols, holograms, animated or multimedia material, smells, tastes and textures.
4. How can patents and trademarks be revoked?
A patent may be revoked by means of a cancelation action filed before INAPI. The grounds for cancelling a patent according to the Chilean legislation may be any of the followings: the patent (i) was granted to a person who is not the true inventor or assignee, (ii) was granted over the basis of erroneous or evidently deficient examiner’s reports, and (iii) was granted in contravention of the rules of patentability (e.g. lack of inventive step or novelty).
The applicable statute of limitation is five years as of the date of the patent registration.
A trademark may be revoked by means of a cancelation action filed before INAPI. The grounds for cancelling a trademark according to the Chilean legislation are any of the legal registration prohibitions (mentioned above). Currently, Chilean legislation does not recognize a cancelation action based on the non-use of a trademark. However, a new bill is being discussed by the Congress that includes use requirements for trademarks which might allow cancellation on these grounds.
The applicable status of limitation is five years as of the date of the trademark registration. However, no status of limitation applies in case of trademarks obtained in bad faith.
5. Are foreign patents and trademarks recognized and under what circumstances?
A patent must be registered in Chile to be recognized. However, if a patent has been previously requested abroad, the applicant has a one-year priority period to request the same in Chile.
Also, Patent Prosecution Highway (PPH), to speed up the national patent prosecution procedure is available due to international agreements with nine other jurisdictions, including Colombia, Mexico, Peru, Canada, Brazil and Japan, among others. The PPH conditions for each jurisdiction are regulated by specific guidelines.
PPH is available in both, Mottainai (in which the PPH request can be based on a favorable resolution obtained from a previous examination office) and PCT versions (in which the PPH can be requested based on a favorable result of the international phase examination).
A trademark must be registered in Chile to be recognized. However, if a trademark has been previously requested abroad, the applicant has a six months priority period to request the same in Chile.
In addition, famous and notorious trademarks registered abroad can claim rights in Chile over an identical or similar trademark registered, or filed for registration, for the same products, services and commercial or industrial establishments, by filing a cancellation action or by opposing a pending application.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Yes, Chile recognizes Regulatory Data Protection for Pharmaceutical products for both chemcically synthesized products and biotechnological products. Articles 89 to 91 of Law No. 19.039 “Industrial Property Law” regulate the protection of undisclosed data regarding safety and efficacy of a pharmaceutical product submitted to the authority to obtain sanitary registrations or authorizations for a new chemical entity.
Such legislation entered into force in December of 2005, through the publication of its regulations contained in Supreme Decree No. 153 of the MOH, later replaced by Supreme Decree No. 107/08, which entered into force in December of 2010.
The data protected under our current legislation is undisclosed data of a new chemical entity. Article 2.1 of S.D. 107/08 defines this concept stating that “Test data and other information of undisclosed nature is the background information concerning the safety and efficacy of a pharmaceutical product comprising a new chemical entity, such information consisting in complete studies with sufficiently developed information on the basis of clinical and pre-clinical trials. This will cover preclinical and clinical study data, whether in phase I, II or III.
RDP lasts 5 years since the sanitary registration of the pharmaceutical product containing the new chemical entity.
In this regard, the ISP shall:
(i) Maintain confidential all information with RDP.
(ii) Not use the protected data for granting a sanitary registration, unless authorized by the holder of the protected data.
Furthermore, article 53 (b) of S.D. 03/10, states that the simplified procedure (which corresponds to the generic pathway) is not available when “The pharmaceutical product for which registration is sought comprises the same active ingredient as another registered product, when the information regarding such product is protected under the provisions of section 2, title VIII of law No. 19,039 , granted in accordance to the specific regulations governing the matter, or when it is based in the data having such protection”. Article 53.b thus provides that a generic application for a generic pharmaceutical product may not be filed during Regulatory Data Protection period.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Yes. Dosages, Surgical or therapeutic treatment methods for the human body or animals, including administration routes and administration regimes, as well as diagnostic methods applied to the human body or animals, are not patentable in Chile.
Second medical use is accepted in Chile but only under a very strict evaluation criterion. In this sense, claims must be drafted using the Swiss format, and the same must be well supported with experimental evidence in the description.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
No, license agreements are not subject to the approval of any entity, nor is their registration required before the INAPI or any other official body. However, for a license to be enforceable against third parties it must be duly recorded before the INAPI.