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. 24,4252. 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
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.
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.
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.
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 nonpatentable. 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 1115, 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.
5
Argentine Supreme Court, Pfizer case (21/05/2002).
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
6
According to information provided by the Argentine Ministry of Public Health and Environment.
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.
7
Argentine Supreme Court, "Unilever vs. INPI", 24/10/2000.
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.
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.