Part 3
Intellectual property regulation in Mercosur Countries

Chapter 1
The case of Argentina

Protection modes

In Argentina, biotechnology investments can be protected legally by two systems: patent law, which grants so-called “inventions patents” and laws on seeds and plant genetic creations, which include granting “property rights for plant varieties” (CARULLO, 1997). This legislation was enhanced during 1996 with the enactment of Law No. 24,766, which governs the confidentiality of the information and products that are legally under a person’s control. This regulation establishes responsibilities for regulatory bodies and establishes a mechanism to address possible violations.

Regarding patents, Law No. 24,481, modified by a similar law, Law No. 24,572 on Patents for Inventions and Utility Models, and Decree No. 260/96, which provides the text specified by these laws and implements their regulatory basis, presents a more modern regulatory framework for addressing the problems of patenting of biotechnological processes and products, while strengthening the institutional structure of the industry by creating the National Industrial Property Institute (INPI) [Instituto Nacional de la Propiedad Industrial]44.

The new law allows the patenting of products developed from biotechnology processes, in the context of authorizing the patenting of any human creation that allows transforming matter or energy so that they may be used by man, provided that it is new, involves an inventive step and is capable of industrial application. In the case of microorganisms, the law authorizes their patenting and establishes the requirements for their storage and reproduction.

Argentina has established a system of protection of plant varieties, indicating crop plants or phytogenetic creations (new plant varieties) as the object being patented. The legislation is based on Law No. 20,247/73, on Seeds and Phytogenetic Creations, on Decree No. 2,183/91, which provides its regulatory basis, and Decree No. 2,817/91, which created Argentina’s National Seeds Institute (INASE) [Instituto Nacional de Semillas]45. In December 1994, Argentina joined the International Union for the Protection of New Varieties of Plants (UPOV 78)46. The application of the plant varieties protection system combines sanitary and quality aspects with breeder’s rights, and establishes a system for monitoring compliance with breeder’s rights. About 45 seed companies and national and international institutes, representing 80% of the breeders’ organizations of the country, are part of the Argentine Association for the Protection of New Varieties (ARPOV) [Asociación Argentina de Protección de las Obtenciones Vegetales].

The collective control exercised by plant breeders and public authority has been fully effective in reducing the black market in seeds, at least in some crops, demonstrating that the implementation of legislation to protect breeder’s rights requires the following attributes: sufficient quality control of the seed market; a good system of registration of varieties; qualified, impartial authority with adequate human resources; efficient processes; a transparent system of appropriate sanctions, and initiatives by breeders to protect their rights (JAFFE; WIJK, 1997).

Patent legislation (CARULLO, 1997)

Materials eligible for protection

The legislation for patents on inventions provides the principle that inventions can be protected in all genres and areas of production. Inventions of products or procedures shall be patentable provided that they are new, involve an inventive step and are capable of industrial application.

This law considers an “invention” to be any human creation that allows transforming matter or energy so that it can be used by man. There is an inventive step when the creative process or its results are not deduced from prior art, in a manner obvious to a person having ordinary skill in the art, and there is industrial application when the object of the invention leads to obtaining a result or a product of agriculture, forestry, livestock, fisheries, mining, processing industries and services.

Patent owner

The right to the patent belongs to the inventor, who shall have the right to assign or transfer it by any lawful means and to grant licensing agreements. Unless proved otherwise, the person or persons who declare themselves as the inventor in the patent application or utility model certificate shall be considered to be the inventor. The inventor or inventors are entitled to be mentioned in the corresponding patent.

Inventions developed during a working relationship have a detailed treatment under this law. Inventions made by the employee during the course of an employment contract or employment or service relationship with the employer, whose purpose, in whole or in part, is to carry out innovative activities, belong to the employer. The employer also has rights to an invention made by an employee of the company if this invention is related to the professional activity of the employee and if the inventor has been significantly influenced by knowledge acquired within the company, or has used resources provided by the company.

In the first case, the worker who created the invention shall be entitled to additional remuneration for their achievement, if the personal contribution to the invention and its importance to the company or the employer clearly exceed the explicit or implicit content of their contract or service relationship. In the second case, the right to fair economic compensation can reach up to 50% of the royalties.

Work inventions developed under circumstances not satisfying those mentioned above belong exclusively to the inventor. Also, any advance waiver of employee rights under this article shall be null and void.

Conditions for protection

The law requires that in order to be patentable, the invention must be new, meaning it must not be disclosed in prior art, i.e., in the set of technical skills that had become public before the filing date of the patent application or, in other cases, with priority recognized by an oral or written description, by commercial exploitation or by any other means of communication or information in the country or abroad.

The disclosure of an invention does not affect its novelty, if within one year prior to the date of filing the patent application or the recognized priority, the inventor has disclosed the invention by any means of communication or has displayed it in an exhibition at the national or international level. The condition of novelty does not exist in the case of reinstated patents, since the only requirement is that the foreign patent which is desired to be reinstated be valid within the country.

When a patent is being applied for after having been applied for in another country, for purposes of recognizing priority, the date when the first patent application was filed shall be used, provided no more than one year has elapsed since the original filing. Where several inventors have made the same invention independently, the patent right shall belong to the one who applied for it where the patent application filing date, or the recognition of priority, is the oldest. If the invention was made jointly by several persons, the patent right shall belong in common to them all.

For applications related to microorganisms, the product obtained by a patent claim directed to a process must be described in the application along with the process, and the strain of microorganism must be deposited at an authorized institution, according to the standards prescribed by regulations.

Requirement of deposit of biological material

When the object of a patent application is a microorganism, or when, for its execution, a microorganism is required which is not publicly known or available, the applicant shall deposit the strain of microorganism at an approved institution recognized by Argentina’s INPI, on or before the date when the application is filed.

Argentina’s INPI shall recognize, for the purposes of receiving microorganisms in deposits, the institutions recognized by the World Intellectual Property Organization (WIPO), or those which meet the following conditions: they must be permanent; they must not be dependent on control by the depositors; they must have staff and facilities appropriate to prove the relevance of the deposit and guarantee its storage and maintenance without risk of contamination; and, most importantly, they must provide the safety measures necessary to minimize the risk of loss of the material deposited.

At any time from the date of publication of the patent application, access to the strain of microorganisms in the depositing institution may be obtained, provided that the ordinary conditions governing this operation are complied with.

Rights conferred and limitations

A patent on an invention grants its owner the exclusive right of exploitation. The legislation applies sanctions against defrauding the patent owner’s rights as a crime of counterfeiting. Sanctions are also provided against any parties which, while being aware of the counterfeiting, cooperate with it, either by selling, displaying or introducing, or by communicating the protected invention.

The right conferred by a patent has no effect on individuals who manufacture or use a product or use a process which is the same as the patented one, in cases where such use is performed in the private or academic sphere for non-commercial purposes, associated with purely experimental R&D activities, for testing or teaching purposes. It also does not affect the preparation of medicines performed on a regular basis by qualified professionals and by entities pursuant to the execution of a prescription, nor acts related to medicines so prepared.

The right does not affect any person who purchases, uses, imports or otherwise sells the product patented or obtained by the patented process if the product has been lawfully placed into trade in any country, in accordance with the Agreement on Trade-Related Aspects of Intellectual Property Rights (GATT-TRIPS Agreement, Part III, Section IV).

Argentina’s INPI, in accordance with requirements established by the competent authority, may provide limited exceptions to the rights conferred by a patent. The guiding elements of the law are: anti-competitive conduct, lack of commercial exploitation and national health emergencies.

The right to commercial exploitation conferred by a patent shall be granted, without authorization of the patent owner, when the competent authority acknowledges that the patent owner has engaged in anti-competitive conduct, which is understood to include: setting prices which are excessive compared to the market average or which are discriminatory towards patented products; being unable to supply the local market on reasonable commercial terms; cessation of business or production activities; and any other act that fits the behavior considered punishable by Law No. 22,262.

Argentina’s INPI may allow other uses of a patent without authorization from the owner, when a potential user has attempted to obtain the granting of a license from a patent owner on reasonable commercial terms and such attempt has not been handled within a reasonable time, or to permit the commercial exploitation of a patent which cannot be exploited without infringing another patent, provided that the invention offers a significant technical advance of considerable economic importance. Under these conditions, the owner of the first patent shall be entitled to obtain a cross-license.

Three years after the granting of the patent, or four years after the filing of the application if the invention has not been commercially exploited (except in cases of force majeure) or if effective and serious preparations to use the invention have not been made, or when its commercial exploitation has been interrupted for more than one year, any person may request authorization to use the invention without permission of the patent owner. A product shall be considered to be properly exploited when there is distribution and commercialization sufficient to satisfy the demand of the domestic market on reasonable commercial terms.

In addition to reasons legally recognized as such, the following shall be considered force majeure: objective difficulties of a technical-legal nature, such as delays in obtaining permits from public bodies, beyond the control of the patent owner. Lack of economic resources and lack of economic feasibility of exploitation do not in themselves constitute justified circumstances.

The Executive branch may, for reasons of medical emergency or national security, provide for the use of certain patents, by granting the right of commercial exploitation. Its scope and duration shall be limited to the end of the concession, with the assistance of the Ministry of Economy and Public Works and Services, the Ministry of Defense and the Ministry of Health and Social Action, within the legal framework of the jurisdiction of the ministries.

If other uses are allowed without the authorization of the patent owner, the patent owner shall receive reasonable remuneration, according to the circumstances of each case, depending on the economic value of the authorization. If there is no agreement between the parties, the authorization application shall establish a reasonable remuneration to the patent owner, taking into account the average rates of return for the relevant sector, as found in contracts for commercial licenses.

Once the circumstances are no longer occurring and these concessions are void, the legitimate interests of the persons who received such authorization shall be taken into account. In the case of semiconductor technology, non-commercial public use or use for rectification of conduct declared to be anti-competitive shall be allowed only after legal or administrative proceedings.

The owner of a patent granted in Argentina shall have the right to prevent third parties from performing acts of making, using, offering for sale or importing into the country the patented product, provided said product has not been lawfully placed into trade of any country. A product shall be deemed lawfully placed into trade when the person authorized for marketing in the country proves permission for purchase from the patent owner in the country or from the third party authorized for marketing.

The defrauding of the rights of the inventor is considered counterfeiting and shall be punishable by 6 months to 3 years of imprisonment and a fine. The same penalty shall be imposed on those who knowingly: produce or cause to be produced one or more goods in violation of the rights of the owner of the patent or of the utility model; or who import, sell, offer to sell or market or exhibit or introduce into the territory of the Republic of Argentina one or more objects in violation of the rights of the owner of the patent or the utility model. The law provides for aggravating circumstances for persons directly linked to the inventor or the application office staff, who usurp or disclose an invention, even if not protected.

In addition to criminal prosecutions, the owner of the patent and his licensee may exercise civil actions to prohibit continued illegal exploitation and to obtain compensation for damages suffered. The plaintiff may apply for suspension of operation or request a security from the defendant so as to not interrupt him in the exploitation of the invention, if the latter wishes to continue with its commercial exploitation.

Duration

An invention patent is granted for 20 years with no extensions, counted from the date of filing. Additional patents (improvements to already patented inventions) shall be granted for the duration of the basic patent, and where there are several, the longer one shall apply. A utility model certificate shall have a term of 10 years with no extensions, counted from the date of filing.

Exploitation of patents: licenses

The patent and utility model shall be transferable and shall be eligible for a license in whole or in part, the granting of which must be recorded with Argentina’s INPI. Licensing agreements must not contain restrictive trade clauses that affect the production, marketing or technological development of the licensee, which restrict competition or which involve other conduct such as exclusive grant-back conditions, conditions which prevent challenging the validity, conditions which impose mandatory joint licenses, or any of the conducts specified by Law No. 22,262.

Unpatentable materials

For the purposes of the law, the following shall not be considered inventions, among others: discoveries, scientific theories and mathematical methods; scientific works, plans, rules and methods for pursuit of intellectual activities, as well as computer programs, methods of surgical, therapeutic or diagnostic treatments applied to the human body and those relating to animals and all kinds of living matter and substances preexisting in nature. Plants, animals and essentially biological procedures for their reproduction shall not be considered patentable.

The following are not patentable: inventions whose exploitation in the territory of Argentina would constitute an obstacle to protecting the health or life of persons or animals, preserving plants or preventing serious harm to the environment; all biological and genetic material existing in nature or its replica, in biological processes implicit in animal, plant and human reproduction, including processes related to genetic material capable of conducting its own replication in normal and free conditions, as occurs in nature. For such purposes, Argentina’s Executive branch may also prohibit the manufacture and commercialization of inventions.

Pharmaceutical patents

Pharmaceutical inventions began to be patentable in Argentina five years after publication of Law No. 24,572 in the Official Gazette [Boletín Oficial]. As of the current date, there are no provisions in effect pertaining to the patentability of pharmaceutical inventions, nor precepts directly pertaining to their patentability. However, applications may be filed for patents on pharmaceutical products, which have been granted since March 22, 2001.

The patent owner shall have exclusive rights over the invention from the date specified, unless those who are making use of the invention without the patent owner’s authorization ensure full supply of domestic markets at the same real prices. In this case, the patent owner shall only be entitled to receive a fair and reasonable compensation from those who are using it, from the granting of the patent until its expiration. If there is no agreement between the parties, Argentina’s INPI shall determine this compensation. The law provides that this situation can be modified to enforce decisions of the World Trade Organization adopted in accordance with the GATT-TRIPS agreement.

The law also states that patent applications filed abroad before the enactment of Law No. 24,572 may be presented, provided that the first application has been made within the year prior to the enactment of the law without exploitation or commercial scale import of the invention having been initiated. The term of validity of patents granted under these conditions is the same as the expiration date in the country where the first application was filed, provided this does not exceed 20 years.

Applications for patents on pharmaceutical products whose first applications in Argentina or abroad were filed before January 1, 1995 will not be accepted, except for cases where the applicants claim priority under the Paris Convention. In no case may the first application serving as the basis for the initiation of proceedings in Argentina have been made prior to January 1, 1994. The same criteria shall be applied in cases of applications to modify or convert patents on processes to patents on pharmaceutical products.

Publication and confidentiality

The patent application in process and its attachments are confidential until publication. The National Patent Administration (ANP) permits the publication of patent applications in process within 18 months, counted from the filing date. If requested by the applicant, the application may be published before this date.

All staff of ANP involved in the handling of applications are required to maintain confidentiality with respect to the content of patent application filings, with the exception of information of an official nature which may be requested by the judiciary. The administrative technical information contained in patent application filings is secret, and agents of the ANP and the Argentina’s INPI shall not allow it to be known, disclosed or used by uninvolved third parties.

Officials and employees who violate this secrecy shall be liable to the corresponding legal action, subject to penalty of dismissal and fines if they are direct dependents of Argentina’s INPI, ANP or any entity which is required to be involved for technical reasons.

Protection of new varieties of plants (CARULLO, 1997)

Materials eligible for protection

The Seeds Law protects “phytogenetic creations” (“novel plant varieties”) or “cultivars” under breeder’s rights, where the breeder is understood to be the person who creates or discovers and develops a variety. It does not authorize the granting of protection for first generation hybrid plant varieties, nor for phytogenetic creations which do not meet legal criteria47.

The Seeds Law considers a “seed” to be any plant organ, not only seeds in the strict botanical sense but also fruits, bulbs, tubers, buds, cuttings, cut flowers and any other structure, including nursery plants, which are intended or used for cultivation, planting or propagation. A “novel plant variety” means any plant variety or crop, whatever its genetic nature, obtained by discovery or by incorporation and/or application of scientific knowledge. The definition incorporates all types of biological material that can be reproduced and propagated, including all biotechnology applied for the micropropagation of plant species using asexual or vegetative reproduction.

A “variety” means the set of plants of the same botanical group of the smallest known standard which can be defined by the expression of the characteristics resulting from a given genotype or a certain combination of genotypes, and which can be distinguished from any other group of plants by the expression of at least one of these characteristics. A particular variety may be represented by one plant, various plants or parts of a plant, provided that such part or parts can be used to produce complete plants of that variety.

Patent owner

The right of ownership of a crop belongs to the person who obtained it. Unless expressly authorized by this person, the people involved in the work related to the new plant variety or discovery of the new crop shall not be entitled to exploit it privately. The request for a title of ownership for a foreign plant variety must be made by its breeder or his legal representative domiciled in Argentina. It shall be granted provided that the country where it originated recognizes rights for novel plant varieties similar to those recognized in Argentina.

Conditions for protection

The law establishes the following requirements for protection:

  1. Novelty: It must not been offered for sale or commercialized by the breeder or with his consent: in national territory, until the date of filing the application with the National Registry of Proprietary Plant Varieties (RNPC) [Registro Nacional de la Propiedad de Cultivares]; and in the territory of another State which is a party, together with Argentina, to a bilateral or multilateral agreement on the matter, for a period exceeding four years, or in the case of trees and vines, for a period longer than six years prior to the application for registration.
  2. Differentiation: It must be clearly differentiable it through one or more traits from any other variety whose existence is a matter of common knowledge at the time the application is filed.
  3. Uniformity: It must maintain it most important hereditary traits in a sufficiently uniform manner, subject to expected variations arising in the particular mechanisms of its propagation.
  4. Stability: Its hereditary most important traits must remain in conformance with their definition after repeated propagation or, in the case of a special cycle of propagation, at the end of each of said cycles.

Rights conferred and limitations

Ownership titles on plant varieties give their beneficiaries a property right on the plant obtained. The legislation does not specify the scope of this property right, though the note that accompanied the bill when presented for approval states that the title to a plant shall operate in such a way that no other person may reproduce or sell the plant without authorization.

The property title on a plant does not prevent others from using the plant to create a new one, as long as the first plant is not permanently used to produce the new plant. Persons who keep and plant seeds for their own use, or who use or sell the product of the plant as a raw material or food, do not infringe upon the property title on the plant.

The property title on a plant may be declared for “restricted public use,” with fair compensation to the owner, when it is determined that such declaration is necessary in order to ensure an adequate supply in the country of the product obtained from cultivating this plant and that the property rights holder is not supplying the public needs for the seeds of such plant variety in quantity and prices which are considered reasonable.

Duration

The title to a plant is granted for a period of between 10 and 20 years, namely: 12 years for annual species, biennial species for 15 years, and 20 years for perennial species. A property title obtained for a foreign plant shall have as duration the maximum time remaining for the validity of the corresponding right in the country of origin.

Law of confidentiality (KORS, 1998)

Argentine law on this matter is based on the provisions of Article 39 of the TRIPS Agreement. It recognizes “exclusive rights” and protects against unfair competition, that is, against dishonest or unfair commercial practices. Under competition law [US: antitrust law], unfair competition is a residual category of law, i.e., it protects what can not be protected in other areas of law. It is a growing area of law, since its modern theory incorporates all intellectual property rights – and in particular industrial rights – within the field of competition law, as a broader issue.

In order for this type of secret information to be able to protected in accordance with the provisions of Law No. 24,766, certain requirements must be met: (a) the information must first be really secret; (b) it must be commercially valuable because it is secret; (c) all necessary measures must have been taken to maintain it with a certain degree of confidentiality. In short, there are the following requirements: to keep the information secret, to be commercially valuable due to this situation, and, finally, to resolutely maintain the confidentiality.

In order for the secret information to be protected by law, it must have an economic value and must also be voluntarily protected, which means that the owner or the person or entity having lawful control over it must do everything necessary to keep it secret. Therefore, their neglect is a negative element to achieving protection. This information shall only be protected if the secret is kept. If it is obtained in a lawful manner, then nobody shall have the right to object to knowledge which was legitimately obtained.

The law only protects the secret if its disclosure has been illegal. This is in sharp opposition to patent law. Patent law is unique and exclusive, but trade secrets are not. Anyone else who comes by this knowledge in different ways can use it and dispose of it, if they can demonstrate that their access was lawful. Law No. 24,766 is very brief and very concrete: it consists of fifteen articles, of which the last one is purely formal. The Act is divided into three parts: a general part; a part on special protection in relation to chemicals or pesticides, which must be submitted to government agencies for authorization and registration for commercial sale; and a third part, relating to actions involving confidentiality.

Regulatory institutions

National Industrial Property Institute (INPI) (Felix, 1998)

Argentina’s National Industrial Property Institute (INPI) [Instituto Nacional de la Propiedad Industrial] is an autonomous body with legal personality and its own assets, and operates under the Ministry of Economy, Public Works and Services [Ministerio de Economía, Infraestructura y Servicios Públicos]. Its mission is the protection of industrial property rights, through the granting of titles and/or the implementation of registries established by national legislation for this purpose. In this sense, Argentina’s INPI is the enforcement agency for the following laws: No. 24,481 (Patents and Utility Models), No. 22,362 (Trademarks) and No. 22,426 (Technology Transfer), and Decree-Law No. 6,673/63 (Models and Industrial Designs).

Decrees 1,049/2001 and 1,115/2001 establish that Argentina’s INPI, similar to most organizations governing intellectual property throughout the world, shall be directed and administered by a president and a vice-president, who shall seek greater efficiency and speed in decision making. In case of temporary or permanent absence or unavailability of the president, his functions shall be performed by the vice president, who also exercises powers delegated by the president.

The management and administration of bureaucratic procedures, studies and resolution of patent grants and utility models is the duty of the National Patent Administration (ANP), which reports to Argentina’s INPI. It is directed by a commissioner and a deputy commissioner of patents, designated by the INPI Board. ANP performs a range of services that are geared towards guarding property rights on products of inventions activities. Its operations can be summarized as follows:

The main activity of ANP is to grant industrial property rights as the only authority for the enforcement of Law No. 24,481 (consolidated text 1996 [T.O. 1996]) and Regulatory Decree No. 260/96. The law provides for granting industrial property rights relating to invention patents and utility model certificates. ANP grants property rights in exchange for publication of inventions, disseminating material rich in technical and legal information, which is the basis for new developments, thereby contributing to the promotion of sustainable scientific and technological development in society.

Argentina’s INPI establishes a registry for invention patents and one for utility model certificates. The owner of a patent may, from the date of grant, request inclusion in the Registry of Patents Open to Voluntary Licensing, which may be consulted by interested parties. INPI publishes a Newsletter of Patents and Trademarks, and Books of Trademarks, Patents, Utility Models and Models and Industrial Designs.

Argentina’s INPI began operating in December 1995. Its budget comes from taxes collected on various procedures performed by the Institute and fees for additional services. Currently, its funds are allocated from the national budget.

The Trademark Director’s office manages enforcement of trademark law. The official function of this office is to record applications for trademarks which have been filed. The procedure is quite simple: an application is made for a trademark and the office performs a preliminary study. The Trademark Director’s office publishes a weekly newsletter, where filed applications can be tracked and objections can be raised. For example, a study conducted in 1996-1998 shows that the greatest number of trademark applications were from the United States, followed by Germany, France, UK, Brazil, Switzerland, Spain, Italy and Chile.

The Technology Transfer Director’s office is responsible for enforcing Technology Transfer law. The Technology Transfer Director’s office records international transfers of technology. While this process is not mandatory, it provides many advantages to businesses; i.e., it provides a legal guarantee, allowing a contract and related documentation to be recognized from a given date. Depending on the purpose of the contract, direct tax benefits can be obtained, and it is possible to participate in international agreements on double taxation, signed by the following countries: Germany, Australia, Canada, Brazil, Chile, Denmark, Spain, France, Italy, Belgium and Sweden. Because registration is voluntary, the statistics do not show a precise timeline of when technology was imported. The record is, however, valuable for general information purposes.

In 1993, the Department of Technology Information was created, which has a dual function. It is in charge of performing the search for prior patents for use by examiners from the National Patent Administration (ANP) office, and it provides information to the public conducting national and international searches on groups of patents. The Department provides information services for industry, researchers and inventors on the patent documents for products, devices and technology in general, performing searches on internal and external databases to provide information on specific technologies.

Simultaneously with the formation of Argentina’s INPI, the National Patent Administration (ANP) was created, which reports to INPI and is the enforcement authority of laws for invention patents and utility models. ANP is higher in the hierarchy than the other Director’s offices. ANP has an obligation to provide information for applications filed and on all resolved proceedings. This information is published weekly in the patents bulletin. INPI is responsible for publishing books of all patents, trademarks, industrial designs that have been granted, on an annual basis.

Patent applications filings have noticeably increased. In 1997, almost 6,500 applications for invention patents were filed, and 7,031 in 2000. This increase relates to applications for utility models and for pharmaceutical patents. The pharmaceutical sector accounted for 16% of patent applications filed since Patent Law No. 24,481 went into effect. In 2000, a total of 7,031 patent applications were filed, of which 397 were for utility models. Of these applications, 3,766 were resolved and 1,514 patents were granted. Of that number, 101 were for the area of biotechnology.

INPI recognizes deposits of microorganisms made at depositary authorities in countries that have joined the Budapest Treaty.

National Seeds Institute (INASE)

The enforcement agency for the Seeds Law is the National Seeds Institute (INASE) [Instituto Nacional de Semillas], an autonomous government agency of the Department of Agriculture, Livestock, Fisheries and Food. INASE is in charge of the National Registry of Plant Varieties (RNC) [Registro Nacional de Cultivares], which is an official list of plant varieties. Registration is compulsory for all seeds identified, in order to contribute to standardization and knowledge and to avoid duplication.

INASE grants titles for new plant varieties and administers the RNC and the National Registry of Proprietary Plant Varieties (RNPC) [Registro Nacional de la Propiedad de Cultivares]. INASE also deals with national and international certifications, according to OECD standards, for the varietal identity of every vegetatively propagated organism, and quality control for physiological, physical-botanical, sanitary and genetic aspects of seeds intended for internal and external marketing, according to rules of the International Seed Testing Association (ISTA), which sets standards in order to facilitate trade.

Since 1996, 732 applications for protection of plant varieties have been approved. The ratio of national versus foreign new varieties changed gradually from 67% versus 33% in 1994, to 37% versus 63% in 1999 (WENDT; IZQUIERDO, 2000).

Chapter 2
Intellectual property regulation in Brazil

Introduction

The evolution and development of new technologies are directly subordinated to industrial property rights of the different entities involved, including the state, academia and the private sector (MATTOS, 1998).

One of the problems currently faced by people engaged in this area involves adjusting the concept of ‘invention’ to their creations, which is an essential criterion in order for their creations to be eligible for patent privileges under Brazil’s Industrial Property Law No. 9,279/96. Undoubtedly, many issues are still unclear regarding which biotechnology products can be considered to be inventions. Under most national laws, including Brazilian law, a distinction is made between invention and discovery, the second being excluded from the privilege of a patent. Some countries, however, employ the two words as synonyms, leading to confusion in international jurisprudence. Currently, only inventions are protected, except in a minority of Asian countries, but questions remain about how to identify inventions.

According to Friedrich-Karl Beier and Joseph Straus (cited by WOLFF, 1997), in their book The Protection of Scientific Research Results [Der Schutz Wissenschaftlicher Forschungsergebnisse], there are three steps inherent in an inventive process:

  1. The research stage itself, which includes scientific advances.
  2. The development stage, which includes technical advances.
  3. The implementation phase of the research, which represents social and economic advances.

The development stage is where patented inventions are created, and it is often at this stage that patent applications are drawn up, even if the overall inventive context of the newly developed product or process has not yet been completed in detail. The implementation phase involves the commercial use of the product or process.

In the period 1980-1993, the number of patent applications filed in Brazil was around 8,500. In the shorter period 1993 to 2000, 20,000 applications were filed. The most prominent sectors included: chemical and pharmaceutical, electrical and electronics, and mechanical. This increase may reflect the current legislation on the subject since 1996, when patent application procedures became more flexible (CAVALCANTI, 2002).

Intellectual Property Rights (IPR) related to genetic resources

There are two ways to protect innovations: by technical and/or by legal means.

Intellectual Property Rights (IPR) are legal mechanisms to prevent unauthorized use of an innovation. They are an exclusive and temporary right, granted by the national authority. The objectives of Intellectual Property Rights include encouraging innovation and disseminating innovation.

Certain agreements affect intellectual property rights over genetic resources, including:

  1. the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), administered by the World Trade Organization (WTO).
  2. the International Union for the Protection of New Varieties of Plants (UPOV).
  3. the Convention on Biological Diversity (CBD).
  4. the FAO’s International Treaty on Plant Genetic Resources for Food and Agriculture (IT PGRFA).

Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), a framework for national legislation laying down minimum standards for IPR protection, administered by the World Trade Organization (WTO), was approved in April 1994 and ratified by 138 countries. Its purpose is the protection of IPR, promoting innovation and technology transfer and dissemination.

According to Article 27.3(b) of TRIPS, members may exclude from patentability “plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof....”

Plant Breeder’s Rights (PBR)

Plant breeder’s rights (PBR), also known as plant variety rights (PVR), are a form of sui generis (specially designed) system ensuring the rights of the breeder and preventing others from commercially selling reproductive material without a license. In order to be able to be protected under plant breeder’s rights, it is necessary for the plant materials in question to be distinct, uniform, stable and new.

What distinguishes plant breeder’s rights from patents are: the cost, the farmer’s privilege provided by PBR (allowing farmers to store their production for their own use as seed, without necessarily allowing sales of seed), and the breeder’s exception provided by PBR (allowing breeders to use protected varieties as sources of initial variation to create new varieties of plants, or for other experimental purposes).

Andean Community

According to Decision 391 on the Common Regime on Access to Genetic Resources [Régimen Común sobre Acceso a los Recursos Genéticos] of the Andean Community’s Treaties and Legislation [Normativa Andina], “the Member Countries shall not acknowledge rights, including intellectual property rights, over genetic resources, by-products or synthesized products and associated intangible components, that were obtained or developed through an access activity that does not comply with the provisions of this Decision.”

Patents and industrial property

Brazil’s “pipeline patent” is an instrument of transition between the patent protection regime and Industrial Property Code of 1971 – which had excluded protection for chemical substances, compositions and products, in particular for the chemical, pharmaceutical and food industry – and the new patent law, which extends protection to these areas.

Industrial property is the recognition of rights to a patent or a brand on the part of whoever developed it, subject to compliance with the provisions of Industrial Property Law No. 9,279/96, granted by Brazil’s National Industrial Property Institute (INPI).

The rules governing this issue are regulatory acts which are guidelines to help the person to meet the provisions of Law No. 9,279 and obtain the rights to the patent or the brand to which the claim is directed.

Patents have the following basic functions:

Patent legislation around the world

In Germany and Switzerland, there are only two situations:

  1. If the invention was developed during the employee’s employment contract, the employer is entitled to claim the invention, with the employee receiving royalties for the life of the patent.
  2. If the invention occurred outside the time of the employee’s employment contract, the employee retains all rights.

In Japan, the encouragement of inventions is so great that the inventor receives profits on three occasions if he was employed. First, when filing the application; second, when the patent is granted; and third, when it is sold. This causes the invention to be surrounded by many small patents in all its details.

The United States follows, in principle, the position of Germany and Switzerland, but at the same time, offers significant encouragement to researchers from universities and research centers. At the University of California, as well as at other universities, there is a technology transfer center that handles all intellectual property rights, including the searching for licensees, marketing the invention, requesting records and splitting the royalties earned with the researchers (50%).

Patents in Brazil

In Brazil, there has been progress in recent years in biotechnology legislation. The country has adopted a patent law and has biosafety legislation: the Biosafety Act of 1995, repealed by Draft Law PL No. 2,401-03, the Patent Act of 1996 and the Plant Variety Protection Act of 1997.

The following list shows the major changes in the legal context of intellectual property in Brazil:

These changes were advocated by several positive aspects of the TRIPS Agreement, namely:

Paris Convention for the Protection of Industrial Property

In turn, the Paris Convention for the Protection of Industrial Property, established in 1883, was the first multilateral treaty to address industrial property patents, trademarks and unfair competition. Its guidelines have already undergone six revisions, the last one in 1967 in Stockholm. There are 40 signatory countries, which form the Paris Union (exceptions: India and Taiwan).

The Paris Convention is administered by the World Intellectual Property Organization (WIPO), a specialized agency of the United Nations, based in Geneva, Switzerland.

The basic principles of the Paris Convention, which are mandatory for the signatory countries to comply with, are: national treatment, the “Convention priority right” (also called “Paris Convention priority right” or “Union priority right”) and independence of patents.

National treatment: Each signatory country must treat residents and non-residents in the country equally. No special legal treatment may be given in favor of residents, passing over non-residents.

Convention priority right: The Convention priority right aims to ensure that, based on a first patent application duly filed in one of the signatory countries, the applicant may, during a period of 12 months (for industrial patents and utility models) or 6 months (for industrial designs), seek protection for the same invention in any of the other signatory countries.

Independence of patents: Patent applications filed and granted in the signatory countries to the Union are independent of the corresponding patents obtained for the same invention in other countries, whether they are or not signatories to the Paris Convention. The granting of a patent in one signatory country does not require another signatory country to grant patents for the same invention.

Brazil’s National Institute of Industrial Property (INPI)

The INPI has the following responsibilities:

The INPI currently has a collection of some 25 million patent documents in its patent database.

Concepts that govern the granting of a patent

Certain prerequisites are stipulated to allow applying for a patent: novelty, inventive step, capability of industrial application and descriptive adequacy.

The definition of “novelty” is understood as anything that is not disclosed in prior art, which consists of everything made accessible to the public by any means, with an exact date of disclosure and sufficiently described so that it can be understood by a person having ordinary skill in the art.

In the case of biotechnology, Article 10, section IX of Law No. 9,279 clearly states its non-recognition of the novelty of materials found in nature that may be used industrially in their natural state.

In the area of biotechnology, there is a clear division between pure scientific creation and technological creation. Thus, only patenting of products with obvious industrial application is justified.

Likewise, the notion of “inventive step” recognizes that the product is not merely a result of the prior art. For this purpose, a distinction between discovery and invention must be made. The definition of “discovered” is understood to mean the identification of a natural phenomenon, without the exercise of man’s creative activity and, therefore, not capable of industrial application. The notion of “invention” consists of a new idea which results from the creative activity of man, which allows, in practice, a solution to a specific technical problem, and is therefore capable of industrial application.

The notion of “descriptive sufficiency” in biotechnology is unique, since it requires supplementation of the patent application with a deposit of biological material at an internationally recognized depositary authority. It is the duty of the depositary authority to receive, maintain and store samples of biological material and make them available to the technically qualified public.

According to the Budapest Treaty, adopted in 1977, in effect from 1980, it was agreed that a deposit made at a single international authority is sufficient for the purposes of patent procedure for all the other organs of the official patent signatories of the Treaty (single fee). This measure aims to eliminate or limit the multiplicity of culture deposits. Thus, it has the advantage of minimizing costs and providing greater security. All signatories of the Paris Convention may have access to the deposit.

Based on the Budapest Treaty, the status of International Depositary Authority (IDA) was recognized.

Thus, an International Depositary Authority (IDA) is a collection of cultures officially recognized by the industrial property office of the country. The culture collections are not universal, i.e., they are always limited to a certain type or types of microorganisms depending on the training of human resources and on the infrastructure available.

The requirements for the recognition of an IDA under the Budapest Treaty are: the institution must be located within the territory of a contracting country; its facilities and staff must be approved by the contracting country; it must exist continuously; it must have sufficient specialized staff and equipment; it must be impartial and objective; it must be accessible to any applicant on an equal basis; it must accept species of microorganisms; it must examine their viability and store them according to the criteria established in the Regulations under the Budapest Treaty; it must publish the declaration of receipt and viability of the biological material being submitted for filing; it must comply with the Confidentiality Agreement; and it must provide samples in accordance with the regulations of the Treaty.

An IDA is responsible for:

The scenario in Brazil: A brief history

Biotechnology patent law in Brazil

Articles eligible for protection in biotechnology are: biological material per se, a method or process of obtaining biological material, industrial products obtained by an industrial process that uses biological material, and industrial products that incorporate biological material.

The types of inventions encompassing organic products include: amino acids, peptides, proteins, enzymes, nucleotides (RNA and DNA), plasmids, vectors, monoclonal antibodies, transgenic microorganisms (bacteria, fungi, viruses, and yeasts), hybridomas, transgenic seeds, medicines, vaccines and cosmetics.

The Industrial Property Law (No. 9,279/96) brought the following changes:

In the case of patents on living matter, there are special rules. According to Article 10, Section IX of Law No. of 9,279, “all or part of natural living beings and biological materials found in nature or isolated therefrom, including the genome or germplasm, of any natural living being and the natural biological processes” are not considered an invention or utility model. Also, “all or part of living beings are not considered patentable, except those microorganisms meeting the three patentability requirements – novelty, inventive step and capability of industrial application – provided for in Article 8 and which are not mere discoveries” (Article 18, Section III). Article 18, Section III, also excludes from patentability those whose tissues are capable of forming tissues and therefore organs.

Examples

Animals

Plants

Germ cell lineage

Any part of a plant which can represent the indirect patenting of the whole

Egg cell (regeneration of the whole animal)

A cell or part of a plant with the capacity to generate a new plant

Animal organs

Germ cells (egg, egg cell, embryo, seed, embryo culture)

Article 24 of Law No. 9,279 (sole paragraph) deals with the clarity of the patent document: “In the case of biological material, which is essential for the practical application of the object to which the patent claim is being directed, and which can not be described in this article and which is not accessible to the public, the report shall be supplemented by a deposit of material in an institution authorized by INPI or indicated in an international agreement.”

According to subsection 16.1.1 of item 16 of Regulatory Act No. 127 dated May 3, 1997 for Law No. 9,279 (hereinafter the IPL), which provides for specific provisions in the area of biotechnology, “under the circumstances described in Article 24 of the IPL, the deposit of biological material must be made at institutions located in the country, duly authorized by INPI through accreditation.” Thus, only if such institution does not exist under these conditions, “the applicant may make the deposit at any of the international depositary authorities acknowledged by the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure.”

Also according to Regulatory Act No. 127, subsection 16.1.1.5, “where necessary for the assessment of the technical characteristics of the biological material, INPI may stipulate requirements based on technical analysis and verification of such material in situ.”

Item 16.2 (and its sub-items of Regulatory Act No. 127) concern the specification, providing that the description in the application, in addition to the specifications required in item 15 (which specifies the format of the document for the initial and final application), must contain “the essential properties of the living material necessary for its complete description, according to the technologies inherent in the subject matter considered relevant for its complete characterization.” Thus, certain common points must be specified for all organisms, such as states of growth in the appropriate media and physiological properties. In addition, certain more specific traits for each group must also be indicated. For example, in the case of yeast, it must be specified whether there is formation of ascospores and “assimilation of more than fifteen carbon sources.” For bacteria, it must be specified, among other traits, whether there are other properties required for being characterized as a new species, such as: “gluconic acid oxidation, decomposition of cellulose, decomposition of ethanol, hemolysis, coagulases or lipases.” For algae, the formation of stabilizing agents must be specified (alginates, agar, carrageenan). In protozoa, information regarding pathogenicity (life cycles, host range) must be specified. For viruses, the development of infections and pathogenicity must also be reported (DNA or RNA viral diseases).

Regulatory Act No. 127, item 16.3 further states: “every patent application that describes a sequence of nucleotides or amino acids must contain – in addition to the specification, the claims, the drawings and the abstract – a separate section named Sequence Listing, immediately after the claims.”

The biological sequence listing must contain:

The nucleotide sequences must be submitted in letter code for nucleotide bases, as specified in Table 3.

“The amino acids corresponding to the codons of the sequence must be presented immediately below the corresponding codon” (item 16.3.4.4).

“The amino acids in a sequence shall be listed in the direction from N-terminus to Cterminus, using the three letter code, with the first letter uppercase (item 16.3.4.5), as shown in Table 4.”

Table 3. Presentation of nucleotide sequences.

Code

Meaning

A

Adenine

C

Cytosine

G

Guanine

T

Thymine

U

Uracil

M

A or C

R

A or G

W

A or T/U

S

C or G

E

C or T/U

K

G or T/U

V

A or C or G, not T/U

H

A or C or T/U; not G

D

A or G or T/U; not C

B

C or G or T/U; not A

N

A or C or G or T/U or unknown

Table 4. Presentation of amino acid sequences.

Code

Amino Acid

Ala

Alanine

Arg

Arginine

Ars

Asparagine

Asp

Aspartic acid

Asx

Aspartic acid ou asparagine

Ces

Cysteine

Glu

Glutamic acid

Gln

Glutamine

Glx

Glutamine or Glutamic acid

Gle

Glycine

His

Histidine

He

Isoleucine

Leu

Leucine

Les

Lysine

Met

Methionine

Phe

Phenylalanine

Pro

Proline

Ser

Serine

Thr

Threonine

Trp

Tryptophan

Ter

Tyrosine

Val

Valine

Xaa

Unknown or other

“The sequence of nucleotides must be listed with a maximum of 16 codons or 60 bases per line, while the amino acid sequence must contain 16 amino acids per line” (items 16.3.4.8 and 16.3.4.12).

The use or commercialization of a patented product that has been placed legally in the market by the owner or his licensee shall not be considered patent infringement provided it is not used for commercial multiplication or propagation of patented living matter (Law No. 9,279, Article 43, Section VI).

Regulatory Act No. 127, item 4.16 further provides for Access to Biological Material: “The biological material that supplements the specification of the patent application, in accordance with the sole paragraph of Article 24 of the IPL, shall be made publicly accessible to technically skilled persons on the date of publication of the application” (paragraph 16.4.1). “The person or entity filing the application or the patent owner shall not be able to prevent or hinder access, except when able to prove the existence of reasons of a technical or legal nature” (item 16.4.1.1). “In the event provided in the preceding item, INPI shall take the necessary steps to reach a decision concerning the reasons claimed by the applicant or owner for preventing access to the biological material” (item 16.4.1.1.1). “Should INPI decide against the claim of the applicant or owner, the same shall be served notice to, within 60 (sixty) days, take such applicable measures as may be required to make the biological material available” (item 16.4.1.1.2).

Plant Variety Protection Act

Law No. 9,456 dated April 25, 1997 establishes Plant Variety Protection. For a protected plant variety, users must return part of profits earned from its use to those who bred it, so that society is always the beneficiary of technological advancement.

A “plant variety” means “a variety of any plant genus or species that is clearly distinguishable from other known plant varieties by a minimum margin of descriptors and by its own denomination, is homogenous and stable in its descriptors throughout successive generations and belongs to a species useful in farming and forestry, being described in a publicly available and accessible specialized publication, including the component lines of hybrids.” A “breeder” is “the individual who breeds a plant variety and establishes descriptors (morphological, physiological, biochemical or molecular characteristics that are genetically inherited and used to identify the plant variety) that differentiate it from any other.”

Along with the aforementioned law, the National Plant Varieties Protection Service (SNPC) [Serviço Nacional de Proteção de Cultivares] was created, under the Ministry of Agriculture, Livestock and Food Supply (MAPA) [Ministério da Agricultura, Pecuária e Abastecimento], as the body in charge of protecting plant varieties in the country, and which is responsible for processing all steps involved in obtaining legal protection of new varieties and essentially derived plant varieties – from preparing and submitting documents for approval by the Ministry of Agriculture, Livestock and Supply and publishing the extracts of applications for protection in the Brazil’s Federal Official Gazette [Diário Oficial da União (D.O.U.)] and in specialized journals, to determining the performance of field trials and laboratory tests for the differentiation of the plant variety when deemed necessary and finalizing compliance with the laws pertaining to protection and the right to protection.

The National Plant Variety Protection Commission (CNPC) [Comissão Nacional de Proteção de Cultivares] was created, which serves the SNPC a consultative and advisory capacity. It mainly has the following functions: suggesting rules and regulations on the protection of plant varieties and advising the SNPC on matters relating to the protection of plant varieties, particularly on national conventions and agreements.

In general, Brazil’s legal structure for plant varieties and breeder’s rights is one of the best such structures in the world, including two important provisions which have been highlighted by the director of the Brazilian Association of Seeds (ABRASSEM) [Associação Brasileira de Sementes], Claudio Manuel da Silva (SILVA, 1997):

In addition, all plant varieties which were already known and commercialized in Brazil before July 1996 are public domain and may be used by any farmer, even for seed production.

Intellectual property and research institutes

For the purposes of characterizing the intellectual property situation in Brazil, an analysis makes it possible to conclude that this issue is not a priority in most education and research institutions.

Some factors common to education and research institutions, such the ones listed below, make it possible to identify the major deficiencies giving rise to this lack of a patent culture:

In turn, an Intellectual Property Policy would provide some institutional mechanisms which would facilitate it being understood and applied as a return on investments made in research and development (R&D) and a leveraging of institutional competitiveness. Some activities that could guide the routine for patent applications are listed below:

These laws will facilitate establishing strategic alliances in the fields of production and technology (innovation and research networks, joint ventures), and in funding. Here in Brazil, unlike what occurs in developed countries, most public institutions do not provide adequate patent protection to inventions generated in their laboratories. Several of them still lack clear rules on how to proceed with claims for privileges and benefit sharing. This situation becomes worse when private companies are partners of the projects, leading the companies to lose interest in new partnerships with the public sector (MOREIRA FILHO, 1998).

In Brazil, in the case of the absence of a specific contract between employee and company, the employee should seek support from one or more of the following institutions:

Some universities in Brazil, such as the University of São Paulo (USP) have agreements with their teachers and researchers, giving half the ownership of patents to researchers and the other half to the university, which, in turn, also returns a part of its 50% of the inventor’s research center.

In general, there is some negligence on the part of universities and research centers to clarify to the researcher the principles of patent law and the encouragement of patenting, which may cause the researcher to give more importance to the scientific publication of the work rather than to the patent, which often leads to loss of the rights to the patent.

Patents reward inventive effort with a return on investment to the university and to the researcher. Publishing without a patent only communicates the inventive effort, without financial return. The patent is automatically published 18 months after the filing of the application, but the researcher can have the information published, after filing the application, whenever they see fit, either in specialized scientific journals, or in lectures or papers. Therefore, the patent does not prevent publication; on the contrary, it requires publication. Again, the researcher, after describing the invention and depositing it at Brazil’s National Institute of Industrial Property (INPI), may make it available for publication immediately. The following outlines specific steps that a research on an invention should follow (WOLFF, 1998):

Thus, to alert researchers about the importance of patenting, it is necessary to explain to them the principles of patent law and give them incentives to use patents by letting them participate in royalties. It is worth mentioning that these incentives could come from development agencies themselves, through special funds to help pay patent application costs, raised from the projects they have sponsored, including the hiring of specialized offices.

Chapter 3
Intellectual property protection in Paraguay

Introduction

Industrial property in Paraguay is protected by Law No. 1,630, on Invention Patents48. This law protects inventions, giving two types of industrial property rights: invention patents and utility model patents. Its enforcement agency is the Directorate of Intellectual Property (DPI) [Dirección General de Propiedad Intelectual] of the Ministry of Industry and Commerce (MIC) [Ministerio de Industria y Comercio]. In the same context of industrial property, trademarks are regulated by Law No 1,29449. In the field of agricultural production, breeder’s rights are protected by Law No. 385, on Seeds and Protection of Plant Varieties50. Paraguay has been a signatory to the UPOV Convention since 1995 (ALVAREZ, 2000).

Invention patent law

Patentability

Inventions of new products or procedures that involve an inventive step and are capable of industrial application shall be patentable.

The following shall not be considered inventions:

  1. Simple discoveries, scientific theories and mathematical methods.
  2. Purely aesthetic creations.
  3. Methods, schemes, plans, and principles for economics, business, advertising, and publicity, and methods relating to purely mental or intellectual activities, or in the area of games.
  4. Computer programs considered in isolation.
  5. Methods of diagnosis, therapy, or surgical treatment of people and animals.
  6. Different ways of reproducing information.

The following are excluded from patent protection:

  1. Inventions whose commercial exploitation must necessarily be prevented to protect public order or morals, to protect health and life or to preserve animals and plants and to prevent serious harm to the environment.
  2. Plants and animals, other than microorganisms, and essentially biological procedures for the production of plants or animals, other than non-biological or microbiological procedures.

Also, products or procedures included in the state of the art, as set forth in this law, may not be the subject of a new patent by virtue of being assigned a different use than the one described in the initial patent.

Ownership of rights

The inventor or his heirs are entitled to obtain a patent. The applicant for a patent may be an individual or corporation, domestic or foreign.

Ownership of rights in the context of an employment contract

When an invention has been made in pursuance or execution of a work or service contract, or an employment contract, the person who commissioned the work or service, or the employer, shall be entitled to obtain a patent, as applicable, unless the contract specifies otherwise.

When an employee who is not bound by an employment contract to exercise inventive activities makes an invention within the field of activities of their employer, or by using data or means to which they have access by virtue of their employment, they must give written notice of this fact to their employer. If the employer has an interest in the invention, they must notify the employee of this in writing and, in this case, the right to obtain a patent shall be accorded to the employer from the start. The employee shall be entitled to an equitable compensation taking into account the estimated economic value of the invention. Such compensation is irrevocable. In all cases, the inventor shall be entitled to be recognized as the creator of the invention and mentioned as such in the patent. Any agreement shall be void by which the inventor, before having made the invention, waives any of their previously mentioned rights pertaining to the invention.

Term of protection

A patent on an invention shall have a non-renewable term of 20 years from the date of filing the application in the country.

Patents on microorganisms

When the invention pertains to a product or procedure relating to any biological material that is not publicly available and cannot be described so that the invention can be performed by a person having ordinary skill in the art, the description must be supplemented by the deposit of the material at a depositary institution recognized by the Directorate of Industrial Property (DGPI) [Dirección General de la Propiedad Intelectual]. Such deposit shall not be required if a deposit has been made in some WTO member country, or if proof of novelty has been performed by the authority of such countries.

Rights conferred

A patent gives its owner the exclusive rights to exploit the invention.

Exceptions to the rights protected

The patent does not give the right to prevent:

  1. Acts performed exclusively for purposes of experimentation and non-commercial use.
  2. Acts performed exclusively for teaching or scientific or academic research.
  3. Acts of trade conducted by a third party in relation to a product protected by the patent after it has been lawfully introduced into commerce in any country.
  4. Use of the invention until 30 days prior to expiration of the patent for experimental purposes and in order to gather information required for approval of a product by the responsible authority, for marketing after the patent expires.
  5. Acts done by a person who in good faith and prior to the patent application filing date or, in the case of a priority patent, the application filing date of the corresponding priority patent, was already in the country producing or publicly using the procedure which constitutes the invention, or who had already made preparations for such production or use.

Licenses

The patent owner or applicant may grant a license for the exploitation of the invention, which shall have legal effects on third parties, after it has been filed at DGPI. The licensee may not transfer the license or grant sublicenses. The license is not exclusive; the licensor may grant other licenses for exploitation in the country, as well as exploit it himself in the country. If exclusivity has been granted, the licensor may not perform exploitation on its own in the country.

Compulsory licenses and other uses without permission of the owner

Compulsory licensing or other uses without the authorization of the patent owner due to reasons of public interest: For reasons of health emergency, defense, national security, socio-economic and technological development of certain strategic sectors, as well as when exceptional circumstances may affect the national interest, the Executive branch may grant compulsory licenses or other uses without the authorization of the patent owner, whose scope and duration shall be determined in the respective decree.

Compulsory licenses and other uses without permission of the owner due to anti-competitive practices: Compulsory licenses in respect of an invention patent may be granted when the competent authority, using a procedure that gives the owner the right to defense and other guarantees, has determined that the owner has practiced anti-competitive activities, abuse of the rights conferred by the patent or abuse of dominant market position.

Anti-competitive practices shall be understood to include the following situations: (a) setting excessively high prices of the patented product in comparison of the average in the international market; (b) existence of offers to supply the market at prices significantly below those offered by the patent owner; (c) refusal to adequately and regularly supply the local market with the raw materials or patented product on reasonable commercial terms; (d) when the efficient exploitation in the country of a patented invention that contributes to technological development is prevented or impeded by the patent owner; (e) other cases covered by special laws.

When the application is submitted by technology industry sectors that did not enjoy protection in the country at the time the law went into effect, and when the pending patent comprises the raw material from which the final product is developed, the licensee is required to purchase such raw materials, molecule or ingredient from the patent owner or from such party as designated by him. The price shall the same as what they offer in the international market. If there is a preferential price for affiliates, the patent owner must offer the licensee the same price.

Compulsory licenses due to lack of exploitation: Any interested party may request a compulsory license, three years after the grant of the patent or four years from date of filing the application if the invention has not been exploited or if effective and serious preparations for such purposes have not been carried out, or even when exploitation has been interrupted for a period exceeding one year, provided that such lack of exploitation is not attributable to force majeure, which shall be considered to include, in addition to situations recognized as such by law, objective difficulties of a legal-technical nature beyond the control of the patent owner which make it impossible to exploit the invention. Lack of technical or economic resources, or lack of economic feasibility of exploitation, when beyond the control of the patent owner, should also be recognized.

Other compulsory licenses and uses without permission of the owner: When a potential user has attempted to obtain the grant of a license from a patent owner on reasonable commercial terms and conditions and such attempts have not been effective after an elapsed period of 90 days from the date on which the license was applied for, the Directorate of Industrial Property (DGPI) may allow other uses without the owner’s authorization.

Remuneration to the owner in case of compulsory licenses

The owner of a patent which has been subject to compulsory license shall receive adequate compensation in accordance with the circumstances of the case, the economic value of the license and the average license fees in the given sector in commercial license agreements between independent parties. If agreement cannot be reached, the amount and form of payment of compensation shall be set by the administrative authority. The applicant for an obligatory license must demonstrate the technical and financial capabilities to carry out the exploitation. A compulsory license cannot be granted on an exclusive basis, cannot be subject to assignment or sublicense, and can only be transferred along with the company or establishment or part of same which is exploiting the license. Licenses shall be granted mainly to supply the domestic market.

Dependent patents

A compulsory license shall be granted to allow the exploitation of a new patent (“the second patent”) that can not be exploited without infringing another patent (“the first patent”), provided that the following conditions are met:

  1. The invention claimed in the second patent must involve an important technical advance in relation to the invention claimed in the first patent.
  2. The first patent owner must have the right to cross-license on reasonable terms to use the invention claimed in the second patent.
  3. The use granted by the first patent first cannot be assigned without cancelling the second patent.

Records and disclosure

After a period 18 months, counted from the date of filing of the patent application or of the priority patent application if a right of priority has been invoked, the DGPI shall proceed to make the application public and order its publication. The DGPI shall enter in the corresponding registry and publish in its official public record the resolutions and decisions regarding the granting of patents and compulsory licenses and the revocation, annulment or cancellation of patents.

Confidentiality

Every patent application shall be kept secret until its publication. This confidentiality also applies to any application which was withdrawn or abandoned before its publication.

Foreign patents

For the purpose of verifying compliance with patentability requirements, the applicant shall submit to the Directorate of Intellectual Property (DGPI), together with their corresponding translation, the following documents for foreign applications for the same invention being claimed: a copy of the application and the accompanying documents, a copy of the results of novelty tests performed and a copy of the patent or title of protection which has been granted.

Transitional arrangements

In accordance with Article 65 of TRIPS on Transitional Arrangements, the current law entered into force for pharmaceutical products, as of January 1, 2003. Applications for patents for these products filed since January 1, 1995, directed to new products, processes or procedures with respect to the state of the art, and having capacity for industrial application, shall be handled in accordance with the requirements and the provisions of law. The duration of patents so granted shall be that resulting from applying the established provisions regarding duration of the patent.

Utility models51

A utility model is an invention consisting of a shape, configuration or arrangement of components of an artifact, tool, instrument, mechanism or other object, or some part of them, allowing better or different operation, use or manufacture of the object which incorporates it, or providing some assistance or technical effect that it did not previously have. These shall be protected by patenting.

The terms in Chapter 8 on general provisions regarding invention patents are also applied to utility model patents, subject to the special provisions contained in the present section. A utility model shall be protected when it is capable of industrial application and has novelty. It shall not be considered novel when it presents only minor or secondary differences that do not add any utilitarian characteristic discernible in the state of the art.

The following cannot be the subject of a utility model patent: (a) procedures; (b) substances or chemical or metallurgical compositions, or of any other type; (c) matter excluded from patent protection for inventions in accordance with this law.

Trademarks52

In Paraguay, trademarks are protected by Law No. 1,294. Under this law, trademarks are any signs which serve to distinguish goods or services. Trademarks may consist of one or more words, slogans, emblems, monograms, stamps, cartoons, embossed designs, names, invented words, letters and numbers with distinctive shapes or combination, or distinct combinations and arrangements of colors, labels, and containers. Trademarks may also include the shape, presentation or treatment of products or their containers or wrappers, or the means or place of sale of the products or services in question.

The registration of a trademark gives its owner the right to exclusive use of the mark, and the right to bring any actions and measures before the proper authorities regarding infringement of those rights. It also grants the right to object to the registration and use of any other sign that could directly or indirectly induce confusion or association between products or services which relate to each other. The owner of a trademark for products or services registered abroad shall enjoy the guarantees that this law grants, once the mark has been registered in the country. The owner or his authorized agents are the only individuals entitled to apply for registration. The registration of a trademark is valid for 10 years and may be extended indefinitely, for the same duration.

Directorate of Intellectual Property (DGPI)53

The Directorate of Intellectual Property (DGPI) [Dirección General de Propiedad Intelectual] of Paraguay’s Ministry of Industry and Commerce (MIC) [Ministerio de Industria y Comercio] is the competent authority having administrative jurisdiction in matters of patents and trademarks. The DGPI is headed by the person designated by the Executive branch, nominated by the MIC.

The DGPI shall publish an official bulletin which shall include the judicial acts required by this law, registrations granted and their renewals, as well as resolutions and final judicial decisions related to the revocation, annulment or cancellation of any registration. The Director of the DGPI must be a citizen of Paraguay, older than 30 years, a lawyer and person of recognized moral repute. This person may not perform other paid activity, except for teaching.

Protection of plant varieties

The Law on Seeds and the Protection of Plant Varieties has the following objectives:

Requirements for protection

Protected plant varieties must meet the following requirements:

  1. Distinctness: The plant variety must be clearly distinct from any other, through one or more phenotypic or genotypic traits, whose existence on the date of filing is well known.
  2. Homogeneity: The plant variety must be sufficiently uniform in its relevant traits, taking into account expected variation due to the particularities of sexual reproduction or vegetative propagation.
  3. Stability: The traits belonging to the plant variety must remain unchanged over successive generations or, in the case of a particular cycle of reproduction or multiplication, at the end of each cycle.
  4. Novelty: A variety shall not be considered novel for the purposes of this law if, prior to filing the application for registration, it has been sold or given to others by the breeder or with his consent within the national territory, or if, within the territory of another State, it has been delivered or given to others by the breeder or with his consent, for more than six years prior to filing the registration application in the case of vines, forest trees, fruit trees and ornamental trees, or more than 4 years for other species.

The varieties of the following species are protected by this law: cotton, rice, canola, sunflower, corn, soybeans, sorghum and wheat. Species not mentioned may be included in the registry by resolution of Paraguay’s Ministry of Agriculture and Livestock (MAG) [Ministerio de Agricultura y Ganadería], upon proposal by the Directorate of Seeds (DS) [Dirección de Semillas], with a previous report to the Technical Committee for Qualifying Plant Varieties, and as required for the needs of domestic agriculture.

Scope of protection

The breeder’s right consists in submitting production and marketing of seeds of the protected variety to prior authorization from the breeder, except as provided in Article 37. The authorization granted by the breeder must be communicated by him to the Directorate of Seeds. At the Directorate of Seeds, the National Registry of Protected Plants is established, in order to safeguard the breeder’s rights.

Exceptions to the rights protected

The protection of a plant variety does not prevent other people from using it for experimental purposes or for creating a new plant variety, which can be inscribed with the name of its breeder, without the consent of the breeder of the original plant variety that was used to obtain it, and provided that the original plant variety is not permanently used to produce the new one.

The breeder’s right is not harmed by a farmer who plants and saves seeds of a protected plant for their own use, or who uses or sells, as raw material or as food, the product of that plant variety.

Restrictions on the exercise of rights protected

The Ministry of Agriculture and Livestock, upon proposal by the Directorate of Seeds and prior finding by the National Seeds Council, may declare a protected plant variety to be of “restricted public use,” if it decides that such resolution is necessary to ensure an adequate supply of seeds and that the breeder is not satisfactorily supplying public needs. The proposal must indicate the term of the declaration of restricted public use. If need be, the extension of the term shall specified by a new resolution, according to the procedure in the relevant article.

During the period in which the declaration of restricted public use is in force, the Directorate of may grant the right to produce the seeds of the corresponding plant variety to individuals or companies listed in the National Registry of Seed Producers, which is referred to in Article 44. In this case, the breeder of the plant variety shall receive a compensation from the seed producer, and the Directorate of Seeds may participate as a mediator for such purposes.

Term of protection

The title of the breeder shall be valid for 15 to 20 years, depending on the species or species group, and in accordance with the provisions of the regulations. The title must include the dates of issuance and expiration.

National treatment and right of priority

Plant varieties of foreign origin may be entered in the National Registry of Protected Plants with the title of breeder in effect in the country of origin. To this end, foreign breeders shall enjoy the same rights as nationals, in regard to the recognition and protection of the breeder’s rights upon fulfillment of the requirements and provisions established by law. The application for registration of plant varieties from other countries must be filed by the legal representative of the person, having permanent residence in the country and sponsored by an agronomist or forestry engineer, whose title is inscribed in the National Registry of Agronomists and Forestry Engineers.

Revocation or termination of the rights protected

The breeder’s right shall be declared void if it is proved that at the time of grant of the right:

  1. The conditions set forth in Article 12, paragraph (a) and in Article 25 of this law were not effectively complied with.
  2. The conditions set forth in Article 12, paragraphs (b) and (c) were not effectively complied with, if the grant of the breeder’s right was based solely upon information and documents provided by the applicant.

Directorate of Seeds

The Ministry of Agriculture and Livestock is the competent authority in matters of seeds. It monitors compliance with the provisions of the law and enforces them through its technical body, the Directorate of Seeds. The Directorate of Seeds performs the following functions:

Chapter 4
Protection of intellectual property in Uruguay

General framework of intellectual property protection

Article 7 of Uruguay’s Constitution enshrines the general protection of the rights of all its inhabitants to enjoy their work and property, among other rights, of which no one can be deprived, except according to laws that are established for reasons of general interest. Article 32 defines “property” as an inviolable right and restricts the cases in which someone can be deprived of it, for reasons of necessity or public utility established by law and always with fair and prior compensation (ALDABALDE, 1998ab).

Article 36 provides that “every person can devote themselves to work, farming, industry, trade, profession or any other lawful activity, except limitations in the public interest established by law.” The relevant rights are protected in a generic way by Article 33 of the Constitution, which states that “intellectual work, the rights of the author, inventor or artist shall be recognized and protected by law.”

Patent law for inventions, utility models and industrial designs

Law No. 17,164 gathers in a single body of law all provisions governing Invention Patents, Utility Models and Industrial Designs, repealing Law No. 10,089 and Decree-Law No. 14,54954. Property rights arising from inventions, utility models and industrial designs shall be protected by patents, which shall be credited with the corresponding titles. The author shall be mentioned as such in the patent granted, and in publications and official documents related to it, except in the case of express written waiver.

Domestic or foreign individuals or entities may be patent owners. The regulations on national treatment and the right of priority, established in the international agreements ratified by the country in regard to patents, shall apply on equal terms to nationals who are party to those agreements and persons connected with them. In cases of lack of international agreement, foreign nationals have the same rights as nationals. Enforcement of provisions may be limited in cases involving nationals of countries that do not grant adequate reciprocity.

Patentability

New inventions of products or procedures are patentable if they represent an inventive step and are capable of industrial application. The invention shall be considered novel if it is not found in prior art, understanding this to be the set of technical knowledge made public before the date of filing the patent application, or in the case of priority, through an oral or written description, or through exploitation, or by any other means of dissemination or communication in the country in such a away that enables it to be executed. An “inventive step” is assumed when the invention does not follow in an obvious manner from prior art, for a person having ordinary skill in the art. It is considered capable of industrial application when its object can be used in industry, understood in its widest sense.

Novelty shall not be affected by disclosure of the invention made during the year preceding the date of filing the application or the priority that is being claimed, provided that it derives directly or indirectly from acts performed by the inventor, his heirs or others on the basis of directly or indirectly obtained information.

Items not considered inventions

The following shall not be considered inventions:

  1. Discoveries, scientific theories and mathematical methods.
  2. Plants and animals other than microorganisms and essentially biological procedures for the production of plants or animals, except for non-biological or microbiological procedures.
  3. Schemes, plans, or game rules, or business, accounting, financial, educational, publishing, lottery or supervision methods or principles.
  4. Literary or artistic works, any aesthetic creation and scientific works.
  5. Computer programs considered in isolation.
  6. Different ways of reproducing information.
  7. Biological and genetic material as it exists in nature.

Items not patentable

The following are not patentable:

  1. Diagnostic, therapeutic and surgical methods for treatment of humans or animals.
  2. Inventions contrary to public order, public morality, public health, nutrition, population, safety and the environment.

Ownership of rights

The right to the patent belongs to the inventor or his heirs and can be transferred inter vivos or upon death. If multiple people make the same invention independently, the patent shall be granted to the one who files the first patent application or invokes the earliest priority date for this invention.

Ownership of rights in the context of an employment contract 

When an invention has been made in pursuance of a contract of employment, work or service whose total or partial objective is research activity, the patent right arising from it belongs to the employer, unless otherwise specified. In cases where the employee’s personal contribution to the invention and its importance for the company obviously exceed the explicit or implicit content of the employment relationship, the employee shall be entitled to additional remuneration.

When the worker makes an invention related to his professional activity in the company and is influenced in obtaining the invention predominantly by knowledge or use of facilities provided by this company (if the employee is not required to do research), the employee must communicate this in writing to their employer. If the employer notifies in writing its interest in the invention, the patent right shall belong to them jointly.

Inventions made during a working relationship not included in the previous articles belong exclusively to their author. Any contractual provision less favorable than those provided to the inventor shall be void.

Periods of protection

An invention patent has a term of 20 years, counted from the date of application. Models and drawings have a period of 10 years from the date of application, subject to renewal for five years.

Patents on microorganisms

For applications related to microorganisms, the deposit of biological material necessary for the description of the object shall be performed at institutions authorized by the National Directorate of Industrial Property of the Ministry of Industry, Energy and Mining (MIEM) [Ministerio de Industria, Energía y Minería], until ratification of international conventions on the matter.

Rights conferred

A patent gives its owner the right to prevent third parties from performing, without the owner’s authorization, any of the following acts:

  1. If the patent was granted for a product: to manufacture it, offer it for sale, sell it or use it, import it or store it for any of these purposes.
  2. If the patent was granted for a specific type of procedure: to use it as well as perform any of the acts listed in item (a) with respect to products obtained by means of that procedure.

Exceptions to the rights protected

The rights conferred by a patent do not cover the following acts:

  1. Acts performed in the private sphere and for non-industrial or non-commercial purposes, provided they do not cause an economic loss to the patent owner.
  2. The preparation of a medication for an individual patient under a prescription, and prepared under the direction of a qualified professional.
  3. Acts performed solely for purposes of experimentation, including preparation for future commercial exploitation, performed in the period of one year preceding the expiration date.
  4. Acts executed for teaching or scientific or academic research.
  5. Importation or introduction of small quantities of goods not commercial in nature, forming part of the baggage of travelers or sent in small packages.

The patent owner cannot prevent acts which are performed, including those without disclosure, by third parties in good faith, who as of the date of filing or priority as the case may be, are already manufacturing in the country the product or procedure which is the subject of the invention, or who have made serious preparations to carry out manufacture, use or exploitation. Such acts may be continued in order to meet the needs of the company, as corresponding to those needs and the products obtained.

Inventions encompassed by monopolies granted in favor of the State or individuals are patentable. Their industrial or commercial exploitation can be accomplished only with the consent of the holder of the monopoly or after its expiration. Rights to an application filed or a patent granted may be expropriated by the State in accordance with relevant regulations. Expropriation may be limited to the right to use the application or patent for the needs of the State.

Licenses

The patent owner or applicant may grant licenses for the exploitation of the patented item, which shall become effective against third parties, as of the entry of such licenses at the corresponding registry. The following regulations shall apply:

  1. The license shall be extended to all acts of exploitation or commercialization of the patented item during its entire term, throughout the country and with respect to any application of said item.
  2. The licensee may not assign or transfer their license or grant sublicenses.
  3. The license shall not be exclusive; the licensor may grant other licenses for exploitation of the patent in the country or exploit it for themselves.
  4. Without prejudice to the powers granted by the owner and given the lack of initiative, the licensee may adopt measures to protect the patent.

It is prohibited to establish, in contractual licenses, covenants or conditions that produce a negative effect on competition, constitute unfair competition, or make possible an abuse by the patent owner or its dominant market position.

Offer of license

The owner of an invention patent who resides in the country may authorize the exploitation of the patent to any person who demonstrates the technical and economic suitability to perform it efficiently. The patent on offer shall have its annual fees reduced by half. The offer shall be governed by conventional regulations regarding licenses. In case of lack of agreement on the remuneration for the license, any party may invoke the procedure provided in Articles 74 and 75 of Law No. 17,164.

Compulsory licenses and other uses without the permission of the patent owner

Due to lack of exploitation of the patent: Any interested person may request a compulsory license, once three years have passed since the granting of the patent, or 4 years since the date the application was filed, whichever term is later, if the invention has not been exploited or effective and serious preparations for that purpose have not been made or if the operation has been interrupted for more than one year, provided there has been no circumstances of force majeure.

The exploitation of a patent includes making, using, importing and any other type of commercial activity performed in relation to the patented item. For these purposes, the exploitation of the patent held by a representative or licensee shall be deemed as being performed by the owner. In addition to those circumstances generally recognized by law, objective difficulties of a technical and legal nature shall be considered force majeure, such as the delay of public bodies to issue permits, beyond the control of the patent owner and which make it impossible to exploit the item.

Due to reasons of public interest: In special situations that may affect the public interest, defense or national security, economic, social and technological development of certain strategic sectors for the country, as well as health emergencies or other similar circumstances of public interest, the Executive branch, via an express resolution, may grant compulsory licenses or other uses without the authorization of the patent owner, the scope and duration of which must be adequate to the purpose for which they were granted. The right of the patent owner may be limited in circumstances of lack or insufficiency of commercial supply to meet the needs of the market.

Due to anti-competitive practices: The National Directorate of Industrial Property, via an express resolution, may grant compulsory licensing of a patent if the competent authority, by means of an administrative or judicial proceeding that gives the owner the right to defense and other guarantees, has determined that the owner has engaged in anti-competitive practices, or abuse of the rights conferred by the patent or of its market dominance. The situations indicated may include the following:

  1. Pricing which is comparatively excessive when compared to the international market for the patented product.
  2. The existence of offers to supply the market at prices significantly below those offered by the patent owner.
  3. Inability to adequately and regularly supply local markets with raw materials or the patented product on reasonable commercial terms.
  4. Hindrance or harm to business or production activities in the country.
  5. Acts which unreasonably restrict trade or which result hindrance of technology transfer.

Once more than two years have passed since the granting of the first compulsory license or other uses, due to reasons of anti-competitive practices or abuse of the rights conferred by the patent, if the patent owner again engages in these acts or in practices giving rise to the unlawful acts, the patent right may be revoked.

Other compulsory licenses and other uses without permission of the owner

Any interested person may obtain a compulsory license or other uses without permission of the patent owner, if they have applied for a contractual license from the patent owner, and it has not been acquired on commercially reasonable terms suitable to the country within 90 days following the application. In all cases, the National Directorate of Industrial Property shall grant a compulsory license or other uses without authorization from the owner, if the applicant demonstrates that:

  1. It has the technical and economic capabilities to handle the proposed exploitation. Technical capacity shall be evaluated by the competent authority, according to specific regulations in force in the country and each industry. The term “economic capacity” is understood to mean the capability of fulfilling the obligations which derive from the exploitation to be performed.
  2. It has a corporate structure which allows it to contribute to developing the market for the licensed product on a local scale.
  3. When the patent refers to a raw material from which the applicant desires to develop a final product, the interested party may perform this development themselves or it may be performed by others inside the country, except in cases of the inability to produce it in the country.

When dealing with areas of technology which were not protected at the time the law went into effect, and the where patent comprises raw material from which it is desired to develop a final product, the licensee is obligated to purchase said raw material, molecule or ingredient from the patent owner or from such party as the patent owner may designate, at the same price as the international market, and the patent owner shall be obligated to sell it.

The licensee may acquire the raw material from another provider when this other provider offers a lower price than the price offered by the patent owner in the country. In this case, the licensee must demonstrate that the raw material acquired in this way was placed into lawful trade in the country or abroad, by the patent owner, by a third party lawfully entitled with the patent owner’s consent.

Once a compulsory license has been granted, the patent owner is required to submit all the information needed to exploit the licensed object: technical knowledge, manufacturing protocols, and techniques for analysis and verification. It is also required to authorize the use of patents for components and manufacturing processes related to the licensed patent. A refusal without cause by the patent owner to provide the technical knowledge and technology transfer necessary in order to achieve the desired goal, or failure to sell the raw material when that is the subject of the patent, implies the loss of the patent owner’s rights to royalties.

The patent shall expire when, once two years have passed since granting the first compulsory license, or other uses, without authorization of the owner, it is not possible for the licensee to exploit the object of the license, required for reasons attributable to the patent owner or his contractual licensee.

Dependent patents

When the patented invention or utility model cannot be exploited in the country without infringing a prior patent, the patent owner or a licensee, for any patent they hold, may request the granting of a compulsory license in respect of the other, dependent patent, as needed to exploit it and prevent infringement thereof. When one patent has as its object a product and the other has a process, it shall be considered that there is dependency between the patents for their exploitation.

A license or use without authorization of the owner, whose purpose is to permit the exploitation of a dependent patent, shall be granted under the following conditions:

  1. The invention claimed in the second patent must assume a significant technical advance, which has a considerable economic importance in relation to the invention claimed in the first patent.
  2. The owner of the first patent shall be entitled to obtain a cross-license on reasonable terms to use the invention claimed in the second patent.
  3. The assignment of the authorized use of the first patent shall include that of the second.

The compulsory license and other uses without authorization of the owner may be revoked if any of the following conditions are found to occur:

  1. Lack of exploitation by the licensee, once the time limits for the start have expired, established by the resolution granting the patent, paragraph E of Article 77 of Law No. 17,174.
  2. Engaging in anti-competitive practices or abuse of the right by the licensee.
  3. Breach of the terms of the concession.

Actions and sanctions

The owner of a patent may file actions against parties which engage in acts violating any rights derived from the patent and may also seek compensation for those acts which have been carried out between the publication of the application and the granting of the patent. They may also claim compensation for harmful acts committed since the filing of the application, where the infringer obtains, by any means, knowledge of its contents before publication, taking into account the date of commencement of exploitation. Parties who illegally sell or distribute products shall only be responsible for damages caused when there is evidence that they were aware of the violation.

Anyone who defrauds any of the rights protected by invention patents, utility models or industrial designs shall be punished by 6 months to 3 years in prison. In any case, there shall be confiscation of the objects produced in infringement and the instruments used predominantly for the development, whose fate shall be decided after consultation with the National Directorate of Industrial Property.

Records and disclosure

Patent records are public and can be consulted by anyone interested, using the methods established by regulation. The patent application shall be kept secret until its publication. Applications which are cancelled or abandoned before publication shall also be kept secret. The National Directorate of Industrial Property shall register the acts and contracts for commercial and industrial patents and for those which change, affect or limit the rights emerging therefrom. In particular, records shall be made of:

  1. Conventional licenses, licensing deals, compulsory licensing and other uses without permission from the patent owner and others, contained in Chapter V of Title II of Law No. 17,164, as well as its modifications.
  2. Injunctions, prohibitions to innovate and other acts that affect the use or disposition of patent rights.
  3. Gifts and other rights that limit or affect patent rights.

Once the required formalities and procedures have been performed, the patent application shall be published in the Bulletin of Industrial Property, 18 months from the day following its presentation or the day after the priority date, in this case. Publication may be moved earlier on request by the applicant.

Technology transfer

A register is created for contracts whose purpose is technology transfer, research and development, franchise contracts and the like, which affect third parties, based on the description thereof.

Confidentiality

Any persons who are involved in processing applications for rights covered by this law are required to maintain secrecy regarding the content of the information. Violation shall be considered gross misconduct. Any persons in the National Directorate of Industrial Property who are involved in processing the rights conferred by this law may not act directly or indirectly in any such proceedings, by or on behalf of third parties, until 2 years have passed since the date on which the relationship ended. Failure to comply with the foregoing provision shall be grounds for:

  1. Removal from office, if the person responsible is a civil servant.
  2. Dismissal, the case of a person bound by contract with the National Directorate of Industrial Property.
  3. Fine, if the person is involved before the expiration of the above-mentioned two-year period

Transitional arrangements

Substances, materials or products obtained by chemical means or processes, and food or chemical-pharmaceutical substances, materials and products and medication of any kind may obtain patent protection under the law, when the first patent application was presented in any member country of the World Trade Organization on or after January 1, 1995, and if they are not commercialized in the country or abroad or if, on the date of the granting of the patent, serious and effective preparations to exploit the object to which the patent is directed have not been made by others in the country, provided that the patent application was filed with the National Directorate of Industrial Property on or after 1 January 1995.

Special transitional arrangements in developing countries

Inventions of pharmaceuticals and agricultural chemicals before November 1, 2001 shall not be patentable. Notwithstanding this, an invention patent may be requested for those products, in accordance with the provisions and requirements of this law, giving the date established in the foregoing paragraph as the deadline for the granting thereof. When patents for pharmaceuticals and agricultural chemicals claim the right of priority under Article 4 of the Paris Convention for the Protection of Industrial Property, in no case may the first deposit be prior to January 1, 1994.

Law on marks used in manufacturing, trade and agriculture

The Trademark Law55 established registration of licenses for brands, for manufactured goods brands, and for embargoes, as well as protection of advertising phrases, collective marks, and certification or guarantee marks. The following may be used as trademarks: names of objects or people’s names, in a particular form, emblems, monograms, prints, stamps, seals, stickers and reliefs, words or brand names, letters and numbers with drawings forming special combinations, wrappers and containers of objects, and other symbols with which it is desired to distinguish the artifacts of a business, the objects of a trade or agricultural, extractive, forestry and livestock products.

Protection of plant varieties

Production, certification, marketing, export and import

The conditions under which seeds are produced, commercialized or transported within the country are established and adjusted according to quality standards, in accordance with the rules set forth in the Seeds Law56, which creates the National Seeds Institute (INASE) [Instituto Nacional de Semillas] and National Registry of Cultivars [Registro Nacional de Cultivares], under its responsibility. Only those varieties which have been listed in this Registry shall be allowed to be certified and marketed in the country. Regulations may provide for exceptions regarding species required to be listed in this registry in order to be marketed.

Article 66 regulates property protection of new varieties. INASE maintains the National Cultivar Property Registry [Registro Nacional de la Propiedad de Cultivares], which aims to recognize and guarantee breeder’s rights for new plant varieties, by the issuance and registration of a property title, in accordance with the International Convention for the Protection of New Varieties of Plants57.

Requirements for protection

To be the object of protection, a plant variety must meet the following requirements:

  1. Be new: This means that the variety must not have been offered for sale or marketed with the consent of the breeder within that country before the date of filing for protection, and beyond, for more than 6 years in the case of vines and trees, or more than 4 years in the case of other plants.
  2. Be clearly different from any plant variety whose existence is common knowledge at the time of filing for protection in respect to at least one morphological, physiological, cytological, chemical or other important characteristic which is unchanging and which is likely to be described and recognized with precision.
  3. Be sufficiently homogeneous in all of its traits, according to its system of reproduction or multiplication.
  4. Remain stable in its essential traits, i.e., at the end of each cycle of multiplication performed in the manner prescribed by its breeder, the variety must retain the traits described by the breeder.

It shall not be considered prejudicial to the novelty of a plant variety for it to have been offered for sale or marketed in the country with the consent of the breeder, for a period of up to 4 years preceding the application for protection of the species to which the plant variety belongs, provided that such application is filed before the period of 4 months after the decision of INASE.

Scope of protection

The property title duly registered in the National Cultivar Property Registry shall enable its owner to conduct, in relation to their property rights, all legal transactions permissible by law, giving the owner the exclusive right as well as the right to consult and grant prior authorization for introduction in the country, production for commercial purposes, sale, marketing in the country and abroad or donation in accordance with this law and its regulations, the elements of sexual reproduction or vegetative propagation of the plant variety in question .

Exceptions to the rights protected

The plant variety covered by the property title may be used without this use granting rights to the title owner for any type of compensation, if: the product of its cultivation is used or sold as raw material or food; if seeds are planted and set aside for own use, but not for marketing; if other breeders use it for experimental purposes or as a source of genetic material for the creation of new plant varieties, where the plant variety is not used repeatedly and systematically to produce other crops commercially.

Restrictions on the exercise of protected rights

The Executive branch may declare a property title to be of “public use” for a period not exceeding two years, subject to prior and adequate compensation to the owner, when it is considered to be of general interest to have the product of its cultivation. The Executive branch may take emergency possession of the plant variety declared to be of “public use” as provided by Article 19 of Decree-Law No. 15,173/81.

Term of protection

The validity of the property title shall go into force from the moment of its provisional issuance, and may not be less than 15 years nor more than 20, in accordance with the species concerned and as established by regulation.

National treatment and right of priority

Breeders living abroad shall enjoy the same rights as breeders located in the country, provided that the laws of their country recognize and protect their rights as breeders. When a breeder who lives abroad wishes to register a plant variety, they must: (a) provide for such purposes a legal domicile in Uruguay, or appoint an authorized representative in the country; (b) include, in the relevant application, the duly authenticated official history of the country origin which they believe permits them to register the plant variety; (c) undertake to comply with all Uruguayan laws and regulations on plant variety property.

When a breeder who lives abroad, in a country that is part of a bilateral or multilateral agreement with Uruguay in the matter, has filed applications to register as a plant variety in one or more of those States, Uruguay shall enjoy a period of priority of 12 months, counted from the filing date of the first application. The application in Uruguay will be deemed to have been filed on the date of submission of the first application.

Revocation or termination of protected rights

A plant variety property title shall be revoked or expire, in accordance with each case, for the following reasons: (a) at the request of the owner, due to the completion of the legal period of property protection; (b) when it no longer meets the conditions of homogeneity and stability; (c) when the rights holder is not able to provide breeding material that allows producing the plant variety, as defined at the time of when the title was granted; (d) where it is demonstrated that the title was obtained by fraud on the part of third parties; e) when the National Seeds Institute legally proves that when property title was granted, the plant variety did not meet the requirements of the law.

Regulatory public bodies

National Directorate of Industrial Property

This refers to the Executive Unit of the Ministry of Industry, Energy and Minerals, responsible for managing and protecting intellectual property rights, which are taken to be the set of provisions that protect both the activity manifested by innovative new products, new procedures or new designs, as well as commercial activity, by identifying unique products and services offered in the market.

The Directorate is responsible for registering licenses for brands, for manufactured goods brands, and for embargoes, as well as for protecting advertising phrases, collective marks, and certification or guarantee marks. In 1999, the Directorate obtained the ISO 9002 quality certification in the field of marks, a circumstance that allowed the development of a Quality Management System geared towards customer satisfaction, promoting the concept of total quality. In the area of inventions, it is responsible for enforcing Law No. 17,164, dealing with the adequacy of national legislation for international obligations undertaken with approval of the TRIPS Agreement.

The Directorate has a strong policy of openness to all citizens, initiated by the Technical Committees, which include representatives from the state and private sectors. This area also includes issuing publications on the subject and organizing various events at the national and international level, in order to provide greater dissemination. The professionals and staff who provide services to the Directorate have outstanding technical training acquired in continuous specialization nationwide, as well as specialized courses abroad.

National Seeds Institute

This is a non-governmental body of public law whose main goals are: 1) promoting the production and use of better seeds with proven identity and superior quality, to stimulate the development of the national seed industry; 2) supporting the collection and use of new national plant genetic materials as well as those of external origin which are adapted to country conditions; 3) protecting plant genetic discoveries and creations, granting the corresponding titles; 4) promoting the export of seeds; 5) monitoring regulatory compliance in this area; and 6) proposing regulations on production, certification, marketing, export and import of seeds, and protection of plant genetic creations and discoveries.

Its main duties are: promoting the development of the activity with seeds, monitoring production and marketing and advising the Executive branch on matters of seed policy, issuing its findings in advance. Its responsibilities include organizing and operating the National Registry of Plant Varieties. To be registered in this institution, the plant varieties must be different from those already registered, they must be sufficiently homogeneous in their set of traits, in accordance with their system of reproduction or multiplication, and they must meet stability conditions allowing their identification. They are also received by the National Registry of Seed Breeders, Manufacturers and Traders. The National Seeds Institutes is also responsible for maintaining the National Cultivar Property Registry and granting the corresponding titles, in accordance with national regulations and international agreements.

The National Seeds Institute is also responsible for: (a) seed certification at the national and international levels, observing bilateral, multilateral and international agreements; (b) maintaining the official seed laboratory of the country, for performing analyses, and granting the appropriate certificates in observance of bilateral, multilateral and international agreements; (c) enabling and performing audits of private labs for analysis of seeds; (d) transacting and resolving issues of import and export of seeds.

Its main organs are the Board of Directors and the National Seeds Council [Consejo Nacional de Semillas], which are composed of one representative from each of the following institutions: the School of Agriculture, the National Institute of Agricultural Research (INIA) [Instituto Nacional de Investigación Agropecuaria], the Agricultural Engineers Association [Asociación de Ingenieros Agrónomos], the National Farm Board [Junta Nacional de la Granja], the National Agricultural Planning Institute [Instituto Plan Agropecuario], the Honorary National Citrus Planning Commission [Comisión Honoraria Nacional del Plan Citrícola], and the National Viticulture Institute [Instituto Nacional de Vinicultura], acting in the Plenary with members of the Board of Directors and the Executive Director. It also has a User Committee, composed of representative from the following institutions: the Rural Federation [Federación Rural], the Federated Agricultural Cooperatives [Cooperativas Agrarias Federadas], the National Rural Development Commission [Comisión Nacional de Fomento Rural], the Rural Association of Uruguay [Asociación Rural del Uruguay], the Rice Growers Association [Asociación Cultivadores de Arroz], the National Milk Producers Association [Asociación Nacional de Productores de Leche], the Farmer’s Confederation of Uruguay [Confederación Granjera del Uruguay], the Uruguayan Federation of CREA Groups [Federación Uruguaya de los Grupos CREA] [Consorcios Regionales de Experimentación Agrícola] and the Canelones Association of Agricultural Producers [Asociación de Productores Agrícolas de Canelones]. The Plenary meets quarterly.