Pharmaceutical and Biotechnology Patents in Argentina
Alicia Alvarez Berkenwald
BERKEN IP- ARGENTINA
I. Introduction
This paper aims to introduce some patentability issues particular to Argentina that currently apply
to the Pharmaceutical and Agricultural fields. Specifically, it deals with patentable subject matter
and scope of protection, taking into consideration the applicable law in the country and the
practice of the Argentine Patent Office (AR PTO). Some issues applicable to all kinds of
inventions as well as a concise description of basic litigation issues and the procedure to obtain a
marketing authorization for pharmaceutical products are also conveyed.
Market information is included to emphasize the attractiveness of the Argentine market for
pharmaceutical and agricultural businesses.
II. Pharmaceutical and Agricultural Market Data
In Argentina, both the Pharmaceutical and Agricultural Markets rank among the most important
ones in the country.
The pharmaceutical market is very attractive to investors in terms of turnover and profitability. In
2010, the annual turnover reached USD 4 billion, this number is expected to be at least doubled
by 20191.
12,9
13,1
12,3
11,4
10,5
10,1
2008
2009
7,6
10,0
9,1
9,6
12,0
10,6
14,0
10,9
UNITS PER CAPITA PER YEAR
16,0
14,6
18,0
14,1
CONSUMPTION PER CAPITA
CONSUMPTION
PER
(
CAPITA
15,1
As exhibited in the graph below, the consumption trend of pharmaceutical products shows a
steady increase since 2003 up until today.
8,0
6,0
4,0
2,0
1999
2000
2001
2002
Source: CID LATINA 12/2010
1
El Argentino, September 14, 2010
2003
2004
2005
2006
2007
2010
2011
2012
USD
4.659
2.625
3.876
3.088
3.730
1.790
1.309
2.000
2.342
2000
3.000
2.076
1999
3.655
3.937
4.000
3.931
USD (Mio)
5.000
5.497
6.000
5.170
7.000
1.000
0
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
Source: CID LATINA 12/2010
The market is shared between Argentine and foreign companies. Big multinational
pharmaceutical companies have facilities in Argentina and medium and small foreign
pharmaceutical companies are present in the market through licenses and marketing agreements
with local partners.
Over 50% of the market is owned by Argentine companies 2; several of them take the lead in
terms of number of units sold. The average annual turnover corresponds to international
companies in a 42% and to national ones in a 58%. There are several big Argentine companies
with modern and well qualified facilities, which have attained a “Good Manufacturing Practices”
certification. These companies that produce “branded generics” of good quality and reliability,
have grown under the old patent law without patent protection for pharmaceutical products.
Today they are very important in terms of production, quality and export capabilities. They invest
in R+D, are competitors and sometimes partner with multinational pharmaceutical companies in
different projects.
There are also very small and quite new laboratories that complying only with basic GMP. They
also register and launch generics into the market.
In the Human/Agriculture Biotech area, more than 60 new Argentine companies have emerged3.
Their emergence is explained in part by the government’s support through a promotional law
issued in 2008 that provides funds for developing biotech enterprises4.
Argentina offers exceptional natural conditions for flourishing agriculture related businesses. The
country is the 2nd world producer of GM crops, following the US, and the 3rd world producer of
biofuel, after Germany and Spain. The biofuel industry has grown 2250% since 2006 and the
installed capacity is expected to exceed 3 million tons by 2012. 5
2
El Argentino, September 14, 2010
Foro Argentino de Biotecnología, Informe Sectorial 2010
4 Ley de promoción y desarrollo de la biotecnología moderna.Nº 26.270, July 4, 2007
5 La Nación Newspaper, April 19, 2011
3
2
Current highlights in this area include:
- Production of human growth hormone by a pharmaceutical dairy farm which is breeding
genetically engineered cows, and
- Soybean overgrowth when compared to other crops.
III. General Patent Issues
A. Patent Protection in Argentina
Argentine Federal Constitution recognizes and protects patents. Indeed, Section 17 of the
Federal Constitution provides that “Every author or inventor is the exclusive owner of his
work, invention, or discovery for the term granted by law”.
International Treaties fall below the Federal Constitution - which is the supreme law of
the country - and have a higher hierarchy than national laws6.
Among the most relevant International Treaties is the Paris Convention 7 and the
TRIPS agreement.8 After the adoption of TRIPS, a new Patent Law (PL Nº 24481) is
enacted in 1995.
B. Argentina is not a PCT member country
The Patent Cooperation Treaty has not been adopted by Argentina yet. Although new
projects enter the Congress every year, no resolution has been issued in this sense. As a
consequence, only priority according to the Paris Convention can be claimed when filing
a patent application in Argentina.
C. Grace term, disclosure MUST be declared at filing date
According to Art 5 PL, in Argentina a patent application can be validly filed even if the
invention was made public within the 12 months prior to the AR filing date or the priority
filing date.
Certain conditions shall be met: First, only a publication made by the inventor or its
successor in rights, through any communication media or at any congress or fair is
considered non-prejudicial disclosure. Second, it must be declared at the date of filing in
AR, submitting a copy of the disclosure made.
Publications of patent applications made by a foreign Patent Office are excluded from the
grace term, thus, it is not possible to validly file an already published patent application9.
D. Examination according to the date of request
6
Section 31 and Section 75 subsection 22 of the Federal Constitution
Adopted by Law 17.011 of November 10, 1966. The approved text in Argentina is from March 20, 1883, as revised at Brussels
on December 14, 1900, at Washington on June 2, 1911, at The Hague on November 6, 1925, at London on June 2, 1934, at
Lisbon on October 31, and at Stockholm on July 14, 1967. The amendment of September 28, 1979 was not approved by
Argentina.
8 Approved in Argentina by law 24.425 of December 7, 1994, published in the Official Gazette on January 5, 1995
9 Guidelines for Examination, part A, chapter 3, point 2.7
7
3
Art. 27 of the PL establishes a 3-year-term as from AR filing date to request Substantive
Examination, paying the corresponding fee. Failure to comply with the request in due
term will deem the application abandoned, without possibility of restoration.
To define the chronological order for conducting examination, the AR PTO takes into
account the date of substantive examination request by the applicant10.
As the AR PTO has an important backlog, especially in the Pharmaceutical and Biotech
fields, it is advisable to request examination as soon as possible.
E. No provisional protection
The AR PL has no specific provisions for provisional rights after publication of a patent
application.
Due to this circumstance, it is usual practice in Argentina that, as soon as an applicant is
aware of any use or preparation for commercial use of a product or process covered by a
patent application, he sends a formal warning notification to the user, reserving the right
to claim compensation. However, there are no judicial precedents ordering a
compensation for non authorized uses previous to the grant of a patent.
F. No Continuation or CIP applications
Only independent or additional patents can be granted in Argentina. There is no
possibility of filing Continuation or Continuation-in-Part applications.
G. Only one independent claim allowed
Art 22 PL provides that the scope of protection of a patent shall be defined by the claims,
which must be clear and concise. Moreover, the PL states that the first claim shall refer to
the main object and all other claims shall be “subordinated” to the first one.
Section 22 c) of Regulatory Decree implementing the PL, states that the first claim is the
only independent one.
This practice is not new for the Argentine Patent system, since it was developed under the
former patent law – in force from 1864 to 1995 - and put into practice by Argentine
Courts in several cases.
At present time, Examiners request the applicants to maintain the first claim as the main
and most important claim and the only independent one, subordinating all secondary
claims to the first one. Divisional applications can be filed, provided the parent
application is still pending11.
H. Litigation still infrequent
In Argentina, patent litigation is infrequent. The number of legal actions and decisions is
minor: since issuance of the new PL in 1996, only 5/6 actions are initiated per year and
not more than 10 relevant decisions on patent infringement have been ruled since then.
10
11
Guidelines for Examination, AR PTO 2003, Chapter VI, section 1.2
Resolution 198/2010, AR PTO
4
According to the Argentine legal system, patentees have the possibility to initiate different
civil or criminal legal actions to ensure their exclusive right, to prevent third parties from
interfering with the exploitation of their invention and to collect damages, if applicable.
Since Criminal Actions are complex and Criminal Courts are mainly devoted to other
kind of criminal matters, patent disputes are usually performed at Civil Courts.
The object of a civil action is the cease of the infringing activities and recovering the
expenses incurred and the profits lost (no punitive damages shall be awarded). The most
recent decision awarded 30% of the total turnover of the infringing products to the
patentee12. However, being Argentina a Civil Law country, decisions made in previous
cases are not binding for the Courts. The expected time for reaching a decision is 4-6
years.
1. Civil and commercial proceedings
In Argentina, legal proceedings begin with a mandatory Mediation Hearing and
are conducted in written form, without the intervention of a Jury and without a
Discovery procedure.
A lawsuit starts when a plaintiff files a complaint offering evidence, and the
defendant files the answer likewise. Afterwards, both parties shall prove the
evidence offered and submit their respective written closing statements.
The Judge constructs claims with the help of an Expert appointed by the Court13,
who plays an essential role in patent disputes.
The expert is an impartial third party with special expertise in the appropriate
technical domain, and is requested to render an opinion on the controversial facts
of the lawsuit14.
Apart from the Expert designated by the Court, each party may also appoint
“technical consultants” to advise them to defend their position in the case.
Then, the Lower Court Judge shall render a sufficiently grounded final judgment.
If the losing party appeals the judgment, the procedure shall continue at the Court
of Appeals. Subsequently, the Court of Appeals shall affirm, reverse or modify the
Lower Court’s judgment.
Federal Civil and Commercial Court of Appeals of the Capital, Panel II, “Merial LTD. C/ Calvo, Ricardo H. y otro s/ Cese de
Uso de Patentes. Daños y Perjuicios”, December 28, 2010, file nº 2373/2003; “Merial LTD. C/ Labyes S.A. y otro s/ Cese de Uso
de Patentes. Daños y Perjuicios”, November 11, 2009, file nº 6631/2003; and “Ipesa S.A. v. Uniroyal Chemical Company Inc.”,
March 14, 2006, Lexis Nexis 7/16544.
13 In Argentina this evidence is called “prueba pericial”, experts are called “peritos” and expert opinion is called “dictamen
pericial”.
14 Section 457 Civil and Commercial Procedure Federal Court.
12
5
Following the decision of the Court of Appeals it is possible to file an
“extraordinary appeal” before the Federal Supreme Court of Justice (“Corte
Suprema de Justicia de la Nación”) only for the so-called “federal matters”,
excluding in principle issues of ordinary law and issues of fact.
Specifically, patent disputes about the interpretation of the Patent Law and of
International Treaties, and about their compatibility are considered “federal
matters”15. Otherwise, ordinary patent disputes16 in principle are not considered
“federal matters” and therefore, they fall outside the extraordinary appeal.
2. Preliminary Injunctions
Art. 83 to 87 PL provide for the right of the patentee to request preliminary
injunctions.
For a Preliminary Injunction to be granted the following statutory requirements
must be met:
• Likelihood of the patent to be deemed valid if ever challenged
• Irreparable harm to the patentee
• Balance of hardships
• Likelihood of infringement
• Appointment of an Official Expert to analyze validity of the patent and
the likelihood of infringement
• Posting of a Bond to the plaintiff
In principle, the granting of Preliminary Injunctions requires the intervention of
both parties. In exceptional cases, i.e. when the risk of destruction of evidence is
demonstrated, the Judge may order the injunction without intervention of the
defendant (inaudita altera parte).
IV. Pharmaceutical and Biotechnology Patent Issues
A. Patentability of plants, animals, their parts and components
The most important change introduced by the new Patent Law passed in 1995, is the
patentability of pharmaceutical products, which until then were protected only through
process patents. The new law includes specific provisions for the protection of living
matter which are unclear and allow several interpretations.
In 1996, an Executive Decree implementing the Patent Law is passed. Despite the fact
that it is a regulation of lower status, the decree sets further limitations to patentability
than those established by the law. For example, the PL contains no provisions regarding
15
In fact, patent disputes configure a simple federal issue when it is necessary to determine the scope of the above mentioned
norms to render a judgment. Furthermore, patent disputes could configure a complex federal issue when the discussion is about
the compatibility between the Patent Law, the International Treaties and the Constitution.
16 “Ordinary patent disputes” refers to fact issues in patents infringements, nullity or cancellation lawsuits, and denial of patent
applications, among others, not involving simple and complex federal issues.
6
patentability of genetically modified plants and animals while the Decree provides for the
exclusion of patent protection for any kind of plant or animal.
In 2002, a working team -made up of professionals from the Secretary of Agriculture and
the Patent Office- is created in order to provide clear definitions and patentability criteria
for biotechnology inventions. These are the basis for the Guidelines for Patentability
published by the Patent Office in December 2003. These guidelines adopt an even
narrower interpretation of both the PL and the Decree, thus leading to a gap of protection
not encountered in other countries’ legislations. Consequently, several potentially
valuable plant or animal creations lack protection for not being encompassed by any of
the available systems17.
Today, new examination guidelines are being drafted by the same working team, but the
discussion is not open to the public.
The criteria adopted by the working team 18 and published as “Guidelines for Examination
of Patent application” in 2003, are the following:
1. Discoveries are not considered inventions. The same applies to any kind of
living matter and substances pre-existing in nature or identical to a natural
element. Substances pre-existing in nature that have been isolated and
purified are still considered discoveries and therefore, not inventions;
2. Among the living matter not considered an invention are animals, their parts
or components that lead to a whole individual. The same can be said about
plants, their propagation material and plant parts or components that may
lead to a whole individual;
3. Plant varieties are not patentable and can be protected by the Seeds Act and
UPOV 78;
4. Microorganisms are not considered patentable subject matter, either if they
pre-exist in nature or if they are identical to a natural element. This exclusion
applies even if the microorganisms have been isolated from the environment
and purified. On the other hand, modified microorganisms can be protected
through patents;
5. Other classifications of living matter different from plants or animals, i.e.
multi-cell fungi, pre-existing in nature or identical to a natural element, even
isolated and purified, are not patentable, unless they have been modified;
6. As to cells, those that may lead to a whole plant or animal are not considered
patentable, i.e.: embryonic cells, callus cells. However, as cells are
17
Rapela, Miguel Angel; Witthaus, Mónica et al. Innovación y Propiedad Intelectual en mejoramiento vegetal y biotecnología
agrícola, Editorial Heliasta, 2006, p. 269.
18 Comisión Mixta de Biotecnología; Administración Nacional de Patentes; 2003.
7
considered the smallest living matter19, their parts may constitute patentable
subject matter, in the same way as substances;
7. Substances modified as to their natural state and synthetic substances that are
different from natural ones, are considered patentable. For example DNA,
genes, plasmids, proteins, enzymes, etc., which are not identical to a natural
element.
9. Essentially biological processes are not patentable. These are defined as:
“Series of steps that result in obtaining plants or animals and that are
accomplished to a great extent by action of phenomena existing in nature”.
Claims directed to the natural reproduction of life, specially plants, fall into
the “essentially biological” category, for example, a process for breeding a
plant by crossing and selection.
10. Microbiological processes are eligible for patent protection, being these
understood as: “Industrial processes that use, apply or result in a
microorganism”. A genetic engineering process for obtaining a plant or
animal is generally considered microbiological and hence, patentable. In
some cases, a process can include biological and microbiological stages.
When this occurs, human intervention is relevant to determine patentability.
B. Plants protected by Plant Breeders´ Rights
In Argentina, seeds have been protected through national laws for more that seventy
years, being a “seed” understood as all the propagating material of a plant20. The Seeds
Act (Nº 20247) was passed in 1973 and later modified in 1994
On an international stand, since 1994 Argentina is a member of the International Union
for the Protection of New Varieties of Plants, also known as UPOV. Argentina adheres to
the UPOV 78 Act, which provides that: (i) Property of any plant variety can be registered
by the breeder to obtain exclusive rights; (ii) Each country may protect a plant variety
through Plant Breeders’ Rights (PBR) or through Patents, but not through both. As in
Argentina all kinds of plant varieties may obtain protection through Plant Breeders’
Rights (PBR), patent protection cannot be granted.
It should be noted that, given the restrictive criteria adopted by both the Executive Decree
(1996) and the Guidelines for Patentability (2003), those plant creations that do not
comply with the requirements established by either the PL or the PBR system, fall within
the non-protection arena. This scenario would not necessarily need a law reform in order
to be reverted, but simply a modification of the present decree and guidelines, or even just
a ruling by the Supreme Court of Justice setting a precedent as regards the
unconstitutionality of the case, restoring the law pyramid to its habitual position21.
19
Examination guidelines(Part C, Chapter IV 2.1.7.4)
20
Resolución 22, Secretaría de Agricultura, Ganadería, Pesca y Alimentos. January 24, 2006.
Rapela, Miguel Angel; Witthaus, Mónica et al. Op. Cit. p. 269.
21
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C. Example of a patent granted in Argentina: AR Patent No. 002169 B1–
Equivalent to US Patent No US6,268,549 B1
The application was filed on May 31, 1996. It refers to the HPPD gene, a chimeric gene,
and its use for obtaining plants which are tolerant to certain herbicides.
The application also describes gene isolation and the construction of chimeric genes. The
HPPD amino acid sequence is known from prior art.
1. Claims originally filed related to:
Isolated DNA sequence from a gene of non-human origin ... characterized by the
fact that:
– It expresses a HPPD (hydroxy phenyl pyruvate dioxygenase)
Sequence … 1, characterized by the fact that:
– It is of bacterial or vegetable origin
Process for isolating the gene …
Chimeric gene for genetically transforming plants, the gene comprising:
– at least a promoter sequence from a gene normally expressed in
plants
– an heterologous codifying sequence
– at least a polyadenylation sequence
2. Substantive Examination Report (2005)
Several documents were cited as relevant prior art and the following objections
were raised by the Examiner:
Claim 1: isolated genetic material is excluded from patentability:
Claims 2-7: isolated sequences are a way of presenting information and excluded
from patentability
Claim 16: Cell, excluded from patentability if a plant can be regenerated
therefrom.
3. Reply to the Office Action (2006)
In view of the documents cited, arguments were filed indicating that prior art only
disclosed the HPPD sequence, but not the gene encoding it or its role in relation to
herbicide tolerance. Isolated sequences and plants were eliminated.
a. Granted claim set:.
1. A chimeric gene comprising, in the direction of transcription:
at least one promoter regulation sequence from a gene expressing itself
naturally in plants, a heterologous coding sequence under control of the
promoter regulation sequence, and at least one polyadenylation sequence,
characterized in that the coding sequence expresses HPPD.
…
11. Vector comprising a chimeric gene according to claim 1 to 10.
9
12. Plant cell comprising a chimeric gene according to claim 1 to 11, with the
proviso that said cell is not able to give rise to a plant.
…
13. A method of selective herbicidal treatment of plants, which comprises
applying an HPPD-inhibiting herbicide to a plant containing the chimeric gene
of claim 1. (the plant itself is not claimed as in US and EP)
4. Counterpart Patents: Comparison with equivalent patents in USA and Europe.
a. US 6,268,549 B1 (granted in 2001)
1. An isolated gene which expresses a hydroxyphenylpyruvate dioxygenase
(HPPD) from Pseudomonas.
2. Sequence according to claim 1, characterized in that it is from Pseudomonas
fluorescens.
3. Chimeric gene comprising, in the direction of transcription:
at least one promoter regulation sequence from a gene expressing itself
naturally in plants, a heterologous coding sequence under control of the
promoter regulation sequence, and at least one polyadenylation sequence,
characterized in that the coding sequence expresses HPPD. similar to AR
…
8. A vector comprising a chimeric gene according to claim 3. similar to AR
9. A plant which contains the chimeric gene as claimed in claim 3.
10. A method of selective herbicidal treatment of plants, which comprises
applying an HPPD-inhibiting herbicide to the plant as claimed in claim 9.
b. EP 0828837 (granted 2008)
1. A chimeric gene comprising, in the direction of transcription:
- at least one promoter regulation sequence from a gene expressing itself
naturally in plants,
-a transit peptide sequence of a plant gene coding for a plastid localization
enzyme between the promoter regulation sequence and the coding sequence,
- a heterologous coding sequence,
- at least one termination regulation of polyadenylation sequence,
characterized in that the heterologous coding sequence is the coding sequence
of a gene which expresses a expresses HPPD. similar to AR
…
16. Vector utilizable for the genetic transformation of plants characterized it
comprises a chimeric gene according to one of claims 1 to 15. similar to AR
…
17. Plant cell, comprising a chimeric gene according to one of claims 1 to 15.
…
19. Plant comprising in its genome, an effective quantity of a chimeric gene
according to one of claims 1 to 15.
…
22. Method of transformation of plants to make them tolerant to HPPD
inhibitors.
10
…
26. Method of selective herbicidal treatment of plants, which comprises
applying an HPPD-inhibiting herbicide to a transformed plant comprising cells
according to claim 17.
D. Pharmaceuticals: No patents for new uses of a drug
The AR patent law has no provision explicitly directed to the patentability of second and
further medical uses. Therefore, second and further medical uses should be patentable if
they meet patentability requirements.
However, the Guidelines for Examination and the policies adopted by the AR PTO Office
have excluded the new uses of a known pharmaceutical product from patentability. Until
now, no judicial resolution has reversed or confirmed the AR PTO’s criteria.
Particularly, the Guidelines for Examination22, based on the exclusion of patentability of
treatments to the human and animal body set for Art 6 e) PL. define:
1. If an invention describes a medical application of a product X for treating an
illness Y and the claims are drafted as “use of product X to treat illness Y”
such claim will be considered equivalent to “method of treatment of illness
Y using product X”.
2. If an invention describes a second or further medical application of a product
X (known for a first medical use) for treating an illness Y and the claims are
drafted as “Swiss claims”, like “use of product X to manufacture a
medicament for treating illness Y” such claim will be considered lacking
novelty, since novelty of a “use claim” cannot be derived from a new
medical application.
3. If an invention describes a new medical application of a product X (known
for a first medical use) for treating an illness Y and the claims are drafted as
“Process to manufacture a medicament for treating illness Y characterized in
that it uses product X” such claim will be considered lacking novelty, since
novelty of a process can only be acknowledged for new combination of
steps, new technical conditions (e.g. new starting materials, new
intermediates) and/or new ways of carrying it out.
4. If an invention describes several medical uses of a new product X, use
secondary claims in the Swiss style form for each of the uses shall be
granted, provided the invention complies with the unity of invention
requirement.
V. Pharmaceutical Regulatory Issues
A. Registration by “similarity”
22
Guidelines for examination, Part C, Chapter IV, Patentability, point 4, Industrial Application
11
Registration of pharmaceutical products in Argentina is governed by Argentine Medicine
Law Nº 16463, Confidentiality Law Nº 24766, its Regulatory Decree 150/1992, among
other regulatory and complementary norms.
According to the aforementioned, pharmaceutical products are registered by similarity,
submitting a very simple dossier that includes neither pre-clinical nor clinical information.
Similarity means that if a similar product has been registered and authorized previously in
Argentina or in any of the Annex I Countries, then subsequent applicants are not required
to submit an "International Registration Dossier" (IRD). An IRD would only be required
for new chemical entities (i.e., products not previously approved in Argentina or in any
countries).
Annex I countries are those that qualify and that are also listed by applicable regulations as
countries having high sanitary surveillance standards, namely: United States, Japan,
Sweden, Switzerland, Israel, Canada, Austria, Germany, France, United Kingdom,
Holland (Netherlands), Belgium, Denmark, Spain and Italy.
Thus, if a previous registration/approval of a similar product exists in Argentina or in any
of the Annex I Countries, in order to obtain the corresponding registration of a similar
product, applicants shall provide the Regulatory Health Agency with information only on
the product, labels, name of the Technical Director, etc. that is, only with formalities, not
technical information.
Once the Marketing Authorization is granted, the following step shall be the approval of
the first batch, control methods and specifications. Then the product shall be ready for
launching.
This kind of registration is valid for most therapeutic classes with the exception of
retroviral, immunosuppressive agents and safety risk products (specially anticonvulsants
and anti-epileptics) which are the ones where bioequivalence studies are required.
B. No linkage between Patents and Marketing Authorizations
At the time of filing a request for marketing authorization, no information on patent
protection in Argentina is required, since there is no linkage between the Health
Regulatory Agency and the AR PTO. As a consequence, even if a product has patent
protection in Argentina, it is possible for a third party to obtain a marketing authorization.
The patent infringement shall occur only if the product is launched into the market.
As the Regulatory Decree implementing the rules for obtaining marketing authorizations
by third parties expressly authorizes registration based on a foreign approval and it does
not require the direct submission of confidential information, protection of confidential
12
information under TRIPS is not applicable to bar registration/marketing of pharmaceutical
products by third parties.23
VI. Suggestions and Tips
Summarizing:
Even though the patent system in Argentina may be considered to provide feeble protection for
pharmaceutical and biotech inventions, patents are still the safest and most effective means to
protect them.
In Argentina, there are no alternative or complementary measures to patents to successfully
protect a product in a very attractive and competitive market.
Very few cases reach the Courts each year and their resolution show the recognition of the rights
of the IP holders.
My suggestions are: for new products, new formulations and new processes include Argentina in
the filing list. As in most countries, patents on polymorphs and pharmaceutical dosage forms are
more difficult to obtain and to enforce.
If the invention is disclosed within the year before the priority date, remember declaring the
disclosure at the date of filing in Argentina.
Consider paying the examination fee as soon as possible, since the date of request determines the
chronological order of substantive examination.
And please remember that Argentina is not a PCT member country yet.
Federal Civil and Commercial Court of Appeals of the Capital, Panel III, “Novartis Pharma AG c/ Monte Verde S.A. s/ Cese de
Uso de Información Confidencial”, February 1, 2011, file nº 5619/2005.
23
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