PATENTS IN ARGENTINA - Sanchez Lupi



PATENTS IN ARGENTINA

1. The Patent Legal System in Argentina

A patent is the grant of property right, issued by the National Patent Administration, the government agency that depends from the Industrial Property Institute, INPI, to the inventor of a new product or process ("Invention")[1]. The duration of a patent grant is 20 years from the filing of the application date. During these 20 years, a patent will provide its owner with the exclusive right to prevent others from exploiting the invention within the national territory of Argentina (patents do not provide worldwide protection). After the 20-year period, the invention becomes public.

a. Applicable Treaties, Laws and Regulations

The Argentine legal system protects inventions and utility models as follows:

1) National Constitution: article 17 of the Argentine Constitution grant the inventors the exclusive property over theirs inventions during the term provided by law;

2) International Treaties: Argentina is a member of the Paris Convention, adopted by law No. 17,011; and ratified TRIPS, adopted by law No. 24,425[2]. Argentina is not a member of the Patent Cooperation Treaty (PCT)[3];

3) Patent Law: Patent and Utility Models Law No. 24,481 passed on 1995, amended by Law No. 24,572, and Law No. 25,859, and its Regulatory Executive Order No. 260 of 1996 (hereinafter "Patent Law).

This Chapter deals with patents and utility models. In order for an invention to be patentable, it must be novel, involve an inventive activity and be capable of industrial application. Additionally, it must not be an invention excluded by Law. Owner benefit from patent grants because they allow them to exploit the inventions in exclusive, and provides legal tools to protect the invention from unauthorized use from third parties. At the same time, the public in general benefits from a patent because everyone can legally access the content of the invention.

2. Conditions of Patentability

In order to be patentable, an invention must meet three conditions stated by the Patent Law: a. Novelty; b. Inventive activity; and c. industrial application.

a. Novelty

An invention is novel when it is not known in the state of the art. State of the art refers to all and any technical knowledge known before the filing of the patent application, or the priority recognized by law. There must be absolute novelty, which means that the invention must be novel worldwide.[4] In order to determine whether an invention is novel or not, a preliminary search must be conducted in Argentina and in the rest of the world. The Technical Information Department of INPI is in charge of conducting such search and to determine the novelty of the invention.

The Patent Law considers that an invention is new even if its application is filed made within a year after such invention was disclosed (i.e.; one year grace period). There is no uniformity on this matter in other countries; thus it can occur that a county considers that the disclosure made prior to the filing destroyed the novelty, preventing its patentability.

b. Inventive Activity

Inventive activity is a creative process, or its products, which does not obviously derive from the art for a person used to such technology (paragraph d) of art. 4.). Thus, an invention must not be obvious or predictable to an average person versed on the field where such invention was made.

c. Industrial Application

Industrial Application means that an invention must lead to obtain an industrial result or product. Industrial means serial production or production in industrial scale of products or services. By contrast, a literary work is not serial and it is unique.

3. Non-Patentable Products or Processes

Some products or process are not patentables, because they may not be inventions, they many find protection in other laws, for public policy reasons, or because they attempt against the moral and good manners of the population. The following matters are not patentable:

a. Discoveries

Discoveries, natural phenomena, and forces of nature are not patentable because they are not a creative activity but a mere observation of something existing in nature. However, practical uses and process for obtaining such discoveries, phenomena and forces can be a patentable invention, for example if a new process of water purification is invented, the process and the device to make potable water are patentable, but water itself is not.

b. Raw materials preexisting in nature

Raw materials preexisting in nature are not patentable for the same reason stated above, they are not an invention, but a mere observation of something already existing in nature. However, the process for obtaining raw materials and the product obtained by such process are patentable. Also, raw materials' new properties are not patentable, but a new application of such properties is patentable. For example, aloe vera is a preexisting raw material in nature, and therefore non-patentable. However, for process of creating an aloe vera cream is patentable, the same as the cream.

c. Plants, animals and their essentially biological reproductive process

New species of animals and vegetables and the process for obtaining them, are not patentable. However, the substance that produces a biological change in a specie and the process for obtaining such substance are patentable.

d. Preexisting Biological and Genetic Material

Biological and genetic material preexisting in nature or its replica, in animal, human, and vegetable essentially biological reproductive processes are not patentable. See below for more detain in biotechnological inventions.

e. Literary and artistic works, aesthetic creations or scientific theories

Literary and artistic works are protected by Copyright Law, No. 11.723, and thus, not patentable. Scientific works or theories are not patentable because they lack direct practical use.

f. Intellectual Creations

Intellectual creations, including plans, rules and methods, such as mathematical methods, for conducting intellectual activities, for games or economic-commercial activities, and computer programs are not patentables. The form of presentation of information is not patentable, the same as study, analysis, exhibition, or publicity methods, accounting techniques, negotiation systems, etc. Computer programs will be reviewed in more detail below.

g. Surgical and therapeutic methods and diagnosis treatment for animals and humans

Surgical and therapeutic methods, and methods for treatment of diseases are not patentable. It makes no different whether these are conventional methods or if they involve a special technique, such as laser, as long as they are performed on alive organisms. However, therapeutic methods invented for other reasons than curing a disease are patentable, for example, the formula of a hair shampoo.

h. Exclusions for public policy

Inventions against public policy, morality, good health or life of human beings or animals, vegetable preservation, or that might cause serious damages to the environment are not patentable.

4. Special Cases

Due to their economic importance and their constant evolution, biotechnological, pharmaceutical and software inventions have had a different treatment throughout the years. Below, these inventions are discussed in greater detail.

a. Biotechnological Inventions

The general rules regarding biotechnological inventions is that they are patentable if they meet the patentability conditions stated above (novelty, inventive activity and industrial application). Patent law, authors and case law have provided limits on what is patentable in the biotech field.

These matters are not patentable:

1) Discoveries

As it happens with natural phenomena and natural forces, discoveries are not inventions but mere observations of existing things. However, practical use of such discoveries can be a patentable invention.

2) Alive matter - Microorganisms

Alive matter in natural state and substances that preexist in nature (originated in nature without human intervention) are not patentable. However, alive matter and substances obtained with human intervention are patentable. For example, organisms artificially obtained by genetic manipulation of microorganisms.

Microorganisms are the result of a technical microbiological process, such as isolation, replica or modification. Thus, even if a microorganism is alive, since is the man who identifies it, isolates it or points out its practical utility, it is patentable. Culture, products, equipment used to isolate, identify, purify and cultivate microorganisms (for example, substances improved by a culture process, or a new formula of new stub) are patentable. The same as with any other patent application, an invention must meet the conditions of novelty, inventive activity and industrial utility. In order to be novel, a microorganism must not be characterized as such in the state of the art, and a process for obtaining it does not have to exist.

3) Preexisting Biologic and genetic material

Biological and genetic material preexisting in nature or its replica, in animal, human, and vegetable essentially biological reproductive processes, are not patentable. Thus, plants, animals, human beings, processes essentially biological for their reproduction or preexisting substances in nature, are not patentables. For example, the dog's breeding outcome is not patentable. However, the biotechnical procedure for obtaining transgenic plants is patentable. New species (vegetal or animals) and the process for obtaining them are not patentable, but the substance capable of producing a biological mutation in plants is patentale. The process used to obtain this substance is also patentable. Biological processes in which humans had an important intervention are patentable.

4) Raw materials preexisting in nature

Raw materials preexisting in nature are not patentable. However, the artificial process for obtaining such material and the products obtained are patentable.

5) The human body

The human body, all and every part and element of it (for example, a protein or a hormone) is not patentable. However, human's genetic information is patentable if the invention complies with the patentability conditions of novelty, inventive activity and industrial application.

b. Pharmaceutical Inventions

At present, the National Patent Administration (INPI) issues pharmaceutical patents both to new pharmaceutical products and to processes. The new Patent Law, No. 24,481 (passed in 1995), amended the old system applied under law No. 111 (passed in 1864). Under the old law, patents were issued only to pharmaceutical processes, and denied to pharmaceutical products. The National Patent Administration started issuing patents on pharmaceutical products after October 23, 2000, because the law provided a 5-year grace period counted from 1995.

1) Transition Period

Patents on pharmaceutical products are not issued if their application was filed before January 1, 1995, or a priority date prior to January 1, 1994 was invoked. This limit also applies to applications filed for pharmaceutical products described but not claimed in the application of processes filed under law 111[5], and to divisional applications. From January 1, 1995 (or January 1, 1994, if priority is invoked), to October 23, 2000, protection was granted by keeping the application on hold.. On October 23, 2000, INPI started granting patents on pharmaceutical products.

2) Divisional Patents

When an inventor files an application of a patent that contains several inventions, such application can be divided into as many applications as independent inventions are contained. This subdivision of patents is known as divisional patents. In these cases, the applicant can use the date of each divisional application or the date of the initial filing, whichever is best for the applicant in order to claim priority.

The Supreme Court has stated that patents on pharmaceutical products can not be issued if their filing invokes a priority to claim pharmaceutical products described, but not claimed, in the request of pharmaceutical process filed under law No. 111.

3) Patents of Revalidation

Regarding patents of revalidation (patents that revalidate in Argentina a patent already issued in a foreign country), the Supreme Court has decided that revalidation filed after January 1 1995 must be rejected. The rationale behind the Supreme Court's decision is that TRIPS have entered into effect on January 1, 1995, amending patents of revalidation.

4) Generics

On September 2002, Argentina passed Law No. 25,649, which adopted the system of prescription of drugs by their generic name. According to this law, it is mandatory for dentists and doctors to prescribe medicine by using the drug's generic name (active principle) or the internationally known name of the medicine, followed by the pharmaceutical form and dose or unit, and indicating the concentration degree. Also, according to the new law, the pharmacists must inform consumers about trade names that contain the same active principle, amount of units, and concentration, as well as prices of the different products. Thus, consumer can choose the drug prescribed by the doctor in consultation with the pharmacist at the drugstore.

The law intends to benefit low-income consumers by providing them access to medicines, and free choice to select among all medicine existing in the market. However, the law confuses terminology when refers to "generics " instead of "similar medicine or copies," as explained below:

Original Drug ("original"): An original drug has a new active principle. Security and therapeutic effectiveness studies have been conducted on the drug's active principle. The laboratory that created a new drug patents it and sells it as a trademark. Once the patent expires, the active principle can be commercialized freely as generic by other laboratories.

Generic Drug ("Generics"): Generics have identical form, identical qualitative and quantitative pharmaceutical composition to the original drug. Therapeutic equivalence has been demonstrated by studies of bioequivalence and biodisposability, thus the exchangeability of the generic with the original drug can be guaranteed. Generics can be sold only when the patent of the original drug has expired. Generics are commercialized and distributed with the active principle's name, and not as trademark.

Similar or Copied Drugs ("Similar Drug"): A Similar Drug contains the same active principle and complies with the same quality criteria as the original medicine, but is not identical to the original because their exchangeability has not been guaranteed by any government agency. Without such guarantee, the drug is only similar to the original, but not truly the same. Usually, Similar Drugs are sold in the market as trademarks. For example, the medicine Lotrial by Roemmers laboratory is similar to Renitec by Merck & Co (both have the same active principle, enalapril). Also, Enalapril Richet by Richet is similar to Renitec by Merck & Co [6].

In Argentina, generics do not exist. Almost the entire Argentine market is comprised of Similar Drugs, because there are not studies to guarantee therapeutic equivalence. Thus, when the law promotes prescription drugs by using their generic names, it is only promoting prescription medicine with the same active principle, similar to the original, but without guarantees about the therapeutic equivalence with respect to the original drug. The National Medicine and Medical Technology Administration, ANMAT, is the government agency in charge of approving Similar Drugs.

c. Software Patents

Some countries, such as the US, issue software patents. On the contrary, the Argentine Patent Law excludes computer programs as patentable inventions.

Despite such exclusion, the debate on the patentabilidad of software in Argentina continues.

The Argentine Patent Law excludes computer programs as such because they are considered an intellectual creation without industrial character. Software, as an intangible creation is protected by copyrights. Thus, the rule is clear in Argentina: computer programs as such are not patentable inventions, it does not make any different whether the program is loaded onto a computer, or not, or whether the program is registered in a recording device or not. However, an object, such as a device, apparatus, disposition or method related to a computation program (for example a machine controlled by a computer program), is patentable.

5. Patent Grant

A patent can be granted to any person or entity, argentine or foreign, with domicile (legal or residence), in Argentina.

Usually, the inventor and the patent holder are the same person, but they can differ, for example, when inventors assign their rights to a third person, as it is common in employment relationships. In these cases, inventors or their heirs have the right to be mentioned as such in the patent grant, but they don't enjoy economic rights (such as using the invention exclusively).

Three rules applies to inventions created during an employment relationship:

a. Work for Hire

1) Inventions Made by an Employee During an employment relationship which main purpose consists on creating such inventions.

These inventions belong to the employer. The employee will have the right to receive an additional compensation if the employee's personal contribution and the importance of the invention clearly exceed the purpose of the employment relationship;

2) Inventions made by an employee during an employment relationship which main purpose does not consist on making such inventions, but the invention was made with knowledge acquired within the company or by means provided by the company.

These inventions belong to the employer only if the employer exploits or files a patent application within 90 days since the invention was made. The employee has the right to be fairly compensated. In case that the company licenses the invention to a third party, the employee has the right to claim the payment of up to FIFTY Percent (50%) of the royalties collected by the company.

3) Inventions made by the employee during an employment relationship, different from cases 1) and 2) mentioned above

These inventions belong to the employee.

Patent Law considers that an invention was developed during the course of an employment relationship when the patent application was filed within one year after the employment relationship ends. It is important to point out that employee's anticipatory renunciations to collect a just compensation or to be mentioned as author in the patent title are not valid.

6. Rights granted by a Patent

Patent owners can reveal the invention's content while keeping the exclusive right to exclude others from making, using, offering for sale, selling or importing the invention. Patent law grants the patent holder the right to file civil and criminal actions as stated below. Like any intangible property, patents are transferable during the holders' life or after their death. A patent holder has the right to exploit the invention or to transfer it to third parties. Patent holders can assign the patent in whole or in part. To be valid vis-à-vis third parties, the assignment must be registered with INPI.

Despite having ample rights, Patent Law states limitations to the holder's exclusive rights. Patents will not be effective against:

a. Anyone who, in the private or academic field and without intent to profit, makes experimental, scientific, technological or teaching activities, and in doing such activities reproduces a patented product or process;

b. Any qualified professional who, as part of his profession, prepares drugs by unit in execution of a medical prescription;

c. Anyone who uses, imports or commercializes the patented invention which was legally placed in commerce;

d. Anyone who uses the patented invention in a foreign vehicle that circulates in the territory of the Argentine Republic, if the invention is required to use such vehicle.

7. Filing the Application

The applicant must file an application with the National Patent Administration (INPI). During the first 90 days from the filing date, INPI conducts a preliminary examination to evaluate the application and to solve any formal defects. After the preliminary examination is conducted, and within 18 months from the filing date, the application is published and an in-depth examination is conducted to evaluate if the invention fulfills the legal conditions of novelty, inventive activity and industrial application. Any person can present an opposition against the issuing of the patent based on lack or insufficiency of the legal conditions required to issue a patent and to provide documentary evidence. Currently, INPI takes approximately 5 years to make an in-depth examination. Patents are issued for 20 years, counted from the filing of the application, and cannot be renewed.

Filing an application is not guarantee that the patent will be issued, it only grants the right to start the process that will end with the issuance or rejection of a patent. After the filing of the application, the patent can be commercialized, but the applicant can be sued by a third party who has the same patented invention or has previously filed an application to obtain a patent for the same invention.

8. Priority

Argentina is a member of the Paris Convention for the Protection of the Industrial Property. One of the most important benefits of the Convention is to provide priority to applicants who filed an application to obtain a patent and a priority application in any member country. The date the application is filed is key to determine the novelty condition of an invention according to the state of the art on that day [7]. The certificate of priority must be requested at the governmental office that receives the filing of the application, for example INPI in Argentina. With this certificate, the applicant has the right to invoke the Argentine priority when filing a new application in any other country member of the Convention. Thus, when the applicant files a second application in another country, the novelty condition will be reviewed taking into account the filing date date in Argentina. The Certificate of priority is valid if the second application is filed within one year from filing the first application.

9. Patent Loss

Once obtained, a patent can expired in the following cases:

a. Lack of Payment of the Annual Cannon. If the annual canon is not paid at INPI within 180 days after the due date, the patent expires without further notice;

b. After 20 years. A patent expires after 20 years of the filing of the application;

c. Renounce. The holder of the patent can renounce to it any time; and

d. Lack of Exploitation: When a patent holder grants a license to a third party who does cannot exploit the invention within two years due to patent holder's fault, then the patent expires.

10. Assignment and Licenses. Voluntary and Compulsory Licenses

Patents can be licensed or assigned in full or in part. Assignment of patents must always be registered with INPI to be valid vis-à-vis third parties. License agreements must not restrict commerce, production, competition or technological development of licensees.

In certain cases, Patent Law provides that patent holders must license its invention to third parties. INPI grants this permits without the holder's authorization. This permit is known as compulsory license. Usually, compensation fixed by INPI is granted to the patent holder. In all cases where INPI grants a compulsory license, the patent holder can appeal to justice to overturn INPI's decision. Compulsory licenses are granted in the following cases:

a. Refusal To Deal.

INPI can grant a compulsory license without holder's authorization when the holder of a patent refuses to license his patent in commercially reasonable terms to a potential user who is able to supply the market. Compulsory license can be granted only after an unsuccessful request has been made to the patent holder, and 150 days have elapsed from the date of such request.

b. Lack of Exploitation.

If the invention has not been exploited after three years from the date a patent was issued, or four years from the date the application was filed, any person can request INPI authorization to use the invention. Exploitation means sufficient distribution and commercialization to satisfy the national demand in reasonable commercial conditions. INPI must notify the holder of the patent, who can oppose the following defenses: force majeure, preliminary activity to exploit the invention, or interruption of the exploitation for a period shorter than one year. When compulsory license is granted, the patent holder has the right to seek compensation, and the amount has to be related to the economic value of the license and the average royalties paid in similar license agreements.

c. Unfair Competition Practices.

Patent Law enumerates unfair competition practices and provides that INPI can grant compulsory license of a patent without authorization of the holder if any such unfair competition practices is observed. The unfair competition practices mentioned in the Law are the following: fix pricing; refusal to supply the local market in reasonable commercial conditions, obstruction of commercial or productive activities and any other conduct punishable under the Unfair Competition Law.

d. Sanitary Emergency or National Security.

Whenever a sanitary emergency or national security exists, the President of the Nation has the power to exploit certain patents. Additionally, INPI can grant licenses for noncommercial public use any time the government is interested in exploiting an invention.

e. Secondary Patents.

Exploitation of a patent (first patent) without authorization of its holder is allowed to permit the exploitation of a second patent. INPI can grant this type of secondary licenses if the following requirements are met:

1) The secondary patent implies a significant technical improvement and it has considerable economic importance with respect to the first patent;

2) The holder of the first patent must have the right to obtain a crossed license to exploit the invention protected by the secondary patent; and

3) Assignment of the first patent can be done without assigning the secondary patent;

Regarding secondary patents, there is a difference between "Patent of Addition or Improvement" and "dependent patent": a) A Patent of addition or improvement is a patent issued to someone who has improved an existing patented invention. The main objective of the first and second patent is exactly the same, and the only difference between the two inventions is the improvement introduced to the first invention. For example, a new process to obtain a patented product is protected with a secondary patent of the first patent. A secondary patent is also issued when the invention consists on a new use of a patented product. The holder of the first and second patent can be the same person or not. b) Dependent Patent is a patent issued to someone who, in order to exploit her own invention, must use an invention patented by another person. Thus, there are two different inventions, but in order to exploit her own invention, the holder must use other invention as well.

11. Legal protection and Legal Actions

The Argentine legal system makes it available to patent holders several legal actions to ensure the exclusive right to prevent third parties from interfering with his exploitation of the invention and to collect money damages, if applicable.

a. Legal Protection against Criminal Acts

The Patent Law states several conducts that are criminal offenses. These crimes are punished with sanctions that range from fine to imprisonment for up to four years. In case of repetition of the offense, there is a double punishment. Argentine courts can (and usually do) suspend the application of the sentence if the accused does not have any prior criminal records and punishment is 3 years or less in prison. Criminal actions are public, which means that any interested party, who was damaged or who has knowledge of the crime, or the Public Prosecutor can file these actions. A patent holder can either file a complaint (participating on the criminal process as a victim), or can make a mere statement. Licensees can act as plaintiffs or make a statement. In order for the licensee to be able to file a complaint, the licensee must: a) enjoy an exclusive license; and b) notify the patent holder without success. Criminal Federal Judges are competent to handle patent criminal cases.

The Crimes stated below are punished with fine and prison of six months to three years:

1) Fraud

Fraud is the illicit use of counterfeited or legitimate patented products;

2) Manufacture, Production and Commercialization

This criminal offense consists on producing, importing, selling, and offering for sale, commercializing, or introducing into the Argentine territory products that infringe patent holders' rights. The accused must have intended to commit the crime (i.e., must act knowingly).

The punishment is increased by a third, ranging from nine months to four years in prison, plus fine, when the accused has a special relationship with the inventor, has access to the invention and commits the following crimes:

3) Usurpation or Disclosure of an invention not yet protected by law

This crime can only be committed by a partner, agent, adviser or employee of the inventor;

4) Corruption

Any person who obtains disclosure of an invention by means of corrupting the partner, agent, adviser, or the employee of the inventor;

5) Trade Secrets Violation

The personnel of the National Patents Administration are obliged to keep all the information related to the inventions confidential. Thus, any trade secret violation is a criminal offense. This crime applies only to the National Patent Administration's personnel, but not to the entire National Institute of Industrial Property (INPI);

Finally, anyone who is not a patent holder and who mentions in his products or publicity a patent that does not exists or that belongs to another, or induces the public to error as to the existence of such patents is punished with fine.

b. Civil Legal Protection

A patent holder or its licensee can file a complain in civil or criminal court to collect compensatory damages. Typical damages awarded are compensatory damages, loss of profits, currency inflation, and any and all damages suffered and proven by the plaintiff. Also, injunctive relief is available as explained below.

c. Injunctive Relieve

On January 8, 2004, law No. 25,859 was passed and introduced modifications to the Patent Law, especially with regard to injunctive relief. Prior to this law, courts applied TRIPS, in particular article 50, jointly with local rules of civil procedure. Now the following rules apply.

Plaintiff, after posting a bond, can request any of the following measures: i) Seizure of the infringing products, or description of the procedure; ii) the inventory or embargo of the infringing products and any machine specially destined to manufacture the products or performing the process.

Judges can order such measures whenever: 1) there is a reasonable probability that the patent will still be hold valid if the defendant argues that the patent is void, and there is reasonable probability that the patent is infringed. These two issues should be checked by a court expert; 2) Any delay in granting the injunctive relief will cause irreparable harm to plaintiff; 3) the irreparable harm that can be caused to plaintiff is greater than the one that can be caused to defendant if such injunction is erroneously granted;

Only in exceptional cases, the judge can declare an injunctive relief inaudita altera parte;

When the subject matter of an injunctive relief is a process, defendant must prove that the process used to obtain the product differs from the patented process. Thus, there is an inversion of the burden of proof, which usually is on the plaintiff. However, if the product obtained as a result of the process is not new, the judge can order the plaintiff to prove that the process used by the defendant infringes his patent [8];

If no injunctive relief was granted, plaintiff can request the court that defendant posts a bond to cover possible damages and to continue exploiting the invention.

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[1] According to the Patent Law, "invention" is defined as any human creation capable of transforming matter or energy for the benefit of mankind. Thus, invention is any product or process capable of doing something new or providing a new technical solution to a problem.

[2] The WTO treaty, TRIPS (Trade-related Aspects of Intellectual Property Rights), in Spanish ADPIC (Aspectos de los Derechos de Propiedad Intelectual relacionados al Comercio), was signed in Marrakech, in April 1994, and states the minimum Intellectual Property protection standards to be implemented in every member countries.

[3] The Patent Cooperation Treaty (PCT) simplifies and reduces costs of protecting patents internationally. An inventor can secure patent protection simultaneously in all member countries, more than one hundred, by filing one single international patent application.

[4] Argentina is not a member of the Strasbourg Agreement that stated the International Patent Classification (IPC), however, it uses this classification. The patent classification mentioned before is used to search and establish the novelty condition of an invention or to determine the state of the art of an invention in the technological field. The IPC works as a hierarchical system whereby technology is divided in sections, classes, subclasses, and groups. IPC is periodically revised to adjust it to technology changes. The current edition of the IPC is No. 7 and will be in force until December 31, 2005. Then, on January 1, 2006, edition No. 8 will take into effect. This Agreement has been signed by 55 countries so far.

[5] Argentine Supreme Court, Pfizer case (21/05/2002).

[6] According to information provided by the Argentine Ministry of Public Health and Environment.

[7] Argentine Supreme Court, "Unilever vs. INPI", 24/10/2000.

[8] The Federal Court of Appeals, in the case "Eli Lilly & Co. (11/10/01), had the opportunity to decide the issue of inversion of burden of proof in a patent case related to a process to obtain a pharmaceutical product. In this case, the Court of Appeals stated that defendants had the burden of proving that they were not using the process protected by the patent Eli Lilli, thus, inverting the burden of proof that as general rule corresponds to plaintiffs.

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