NATIONAL SERVICE OF
INTELLECTUAL RIGHTS
CASE No.
SENADI-2019-41050
"TETRACYCLIC HETEROCYCLE COMPOUNDS USEFUL AS HIV INTEGRASE
INHIBITORS"
APPLICANT:
MERCK SHARP & DOHME CORP.
APPLICATION TYPE: PCT PATENTS OF INVENTION
NATIONAL SERVICE OF INTELLECTUAL RIGHTS SENADI
NATIONAL DIRECTORATE OF INDUSTRIAL PROPERTY – PATENT MANAGEMENT UNIT.Quito D. M., October 08, 2019, at 16:00 hours.- 1) Within the referred procedure, add to the case
the opposition petition filed by Asociación de Laboratorios Farmacéuticos (ALAFAR), on
Monday, September 23, 2019, by virtue of Art. 43 regarding patents, Art. 85 referring to utility
model or, Art. 123 dealing with industrial designs of Andean Decision 486, the applicant will apply
the respective article according to the modality requested. 2) Transfer the content of the same to
the applicant, so within the time limits established in accordance with the above mentioned
articles, it can present arguments; present documents or redraft the claims or the description of
the invention, if deemed convenient.
This administrative act is signed by the delegation of the National Director of Industrial Property,
by means of Resolution No. 002-2019-DNPI-SENADI of January 31, 2019.
Let it be notified.(SEAL)
(signature)
Ing. Diana Armijos
DELEGATE OF THE NATIONAL DIRECTOR OF INDUSTRIAL PROPERTY
Reason.- The aforesaid decision was notified to MERCK SHARP & DOHME CORP., to SENADI
locker No. 1490, and to Asociación de Laboratorios Farmacéuticos (ALAFAR) in locker IEPI
No. 28005, given in the city of Quito the day,
Certified by.- 10 OCT 2019
(SEAL)
(signature)
Ab. Alexandra Legna
DELEGATE OF DOCUMENTATION AND ARCHIVE MANAGEMENT
PATENT MANAGEMENT UNIT
Case No. SENADI-2019-41050
MISTER NATIONAL DIRECTOR OF INDUSTRIAL PROPERTY OF THE NATIONAL SERVICE
OF INTELLECTUAL RIGHTS (SENADI).Atty. Leda Alfonso Trujillo, as court attorney of ASOCIACIÓN DE LABORATORIOS
FARMACÉUTICOS (ALAFAR), as evidenced on the Book of Powers of Attorney of SENADI
under No. IEPI_LP_2018_11401; under the right granted to my client by article 42 of Decision
486 "Common Regime on Industrial Property” of the Andean Community Commission and article
142 of the Intellectual Property Law (as set out in the Transitional Provision of the Organic Code
of Social Economy of Knowledge, Creativity and lnnovation, adjusted to what is stated on the
third paragraph: “(...) what is not regulated, temporarily the Intellectual Property Law will be
applied , while the respective regulations are requested"), within the legal term established, I set
out the following opposition to the patent application named "TETRACYCLIC HETEROCYCLE
COMPOUNDS USEFUL AS HIV INTEGRASE INHIBITORS" identified with case No. SENADI2019-41050 and published on the Intellectual Property Gazette No. 652, corresponding to June,
2019.
l. BACKGROUND
On June 07, 2019, MERCK SHARP & DOHME CORP. filed before the National Directorate of
Industrial Property, the patent application identified with number SENADI-2019-41050 and with
a declaration of priority in:
Country
United States
Priority claims
Number
US No. 62/429,470
Date
12/02/2016
II. FACTUAL AND LEGAL GROUNDS
The supposed invention "TETRACYCLIC HETEROCYCLE COMPOUNDS USEFUL AS HIV
INTEGRASE INHIBITORS" is not subject to patent protection, as it contravenes express
provisions of Decision 486 and the Organic Code of the Social Economy of Knowledge, Creativity
and Innovation.
The present application involves in its specification and claims new forms of administration such
as crystals of a derivative of pyrid[3,4-d]pyrimidine or a solvent thereof that have inhibitory activity
against cyclin-dependent kinase 4 and/or cyclin-dependent kinase 6 (hereinafter also referred to
as "CDK4/6") and are useful for the prevention or treatment of rheumatoid arthritis,
arteriosclerosis, pulmonary fibrosis, cerebral infarction and/or cancer.
This application does not comply with the patentability requirements as set out below:
2.1
DOCUMENTS ON THE PRIOR ART
In Ecuador, there is document with application Number:

2017-23551 named: HISTONE DEMETHYLASE INHIBITORS
Also, the following document is also identified:
JPW02016194831 (A1)
Abstract of corresponding document: EP3305785 (A1)
The purpose of the present invention is to provide a compound having an excellent CDK4/6
inhibiting activity. The present invention is a compound represented by general formula (1)
ora pharmaceutically acceptable salt thereof.
2.2
TECHNICAL AND LEGAL ARGUMENTS
2.2.1 The alleged invention to be protected cannot be considered as a product.
The claims characterize a pharmaceutical composition, concepts that are not within the
patentability requirements according to Art. 14 in Decision 486 of the Andean Community
Commission, since it is required that inventions are of PRODUCT1, definition that according to
the International Classification of Patents. Version 2009, consists of:
"category of matter consisting of an object or composition of matter resulting from a procedure and defined
by its structural features or its physical or chemical properties”. (The remarks are ours)
The concept of pharmaceutical composition DOES NOT COMPLY with the concept of
PRODUCT. The concept of composition according to the dictionary of synonyms2 is an
analogous term of mixture, a concept that according to the dictionary 3 and chemistry, consists of
the following:
"Association of several bodies without a combination thereof." (The remarks are ours)
___________________
1
Page 36 of the web page:
http://cip.oepm.es/pdf/GUIA_2019.pdf
2
Corripio F,. Diccionario práctico de sinónimos y antónimos (Practical dictionary of synonyms and
antonyms, in English). Larousse. Ed. Argentina SA.
1988. Page 263
3
García-Pelayo and Gross R. Diccionario básico de la lengua española (Basic dictionary of the Spanish
language, in English). Larousse. Ed. Mexico. 1979. Page 367
Therefore, the OBJECT that turns out to be the supposed PRODUCT is not defined either by its
structural features, nor by its physical or chemical properties.
Similarly, in the following electronic references, we find definitions of compositions or
formulations:

http://www.ub.es/legmh/capitols/sunyenegre.pdf
“It was necessary to provide these substances with a pharmaceutical form allowing their
administration in a known and controlled quantity (therapeutic dose), by the most appropriate
route, in a stable, safe and effective manner. This way, the medical research led to new
pharmaceutical forms that would ensure such conditions."

http://es.wikipedia.org/wiki/Forma_gal%C3%A9nica
"Medical form or pharmaceutical form is the individualized disposition to which medicinal
substances (active principles) and excipients (pharmacologically inactive matter) are adapted to
make a drug. In other words, the external provision given to medicinal substances to facilitate
their administration.
The first objective of medical forms is to normalize the dosage of a drug, which is the reason they
are also known as dosage units. Initially, they were developed to establish units that had a fixed
dose of a drug that could treat a certain pathology".
Regarding the aforesaid, it is necessary to emphasize the forms of administration belong to the
pharmaceutical technique, as can be seen in the following document: Gennaro R. Alfonso.
Remington Farmacia, 19th Edition. Panamericana. Spain 1988, which reads as follows on page
2415:
"The application of medicinal substances on the skin or in the various body orifices is undoubtedly
a concept as old as humanity. Ancient Egyptian papyrus describe a variety of these medications
for external use. Galen described its use in ancient Rome as a precursor to current evanescent
creams.
Medications are applied in a variety of ways that reflect the scientific inventiveness and
imagination of pharmacists through the centuries."
(The remarks are ours)
What is proposed in the present application is the action of mixing the mentioned compounds
using the technique described worldwide and presenting them as typical and characterizing the
mentioned active principles.
Moreover, the Andean Community Court of Justice has ruled on the definition of product, as
stated in the following electronic reference, corresponding to Process 89-AI-200, page 30,
section 4.1.2.1. The applicable community regulations. The Community Legal Order and second
use patents, on its relevant part points out:

http://intranet.comunidadandina.org/documents/Gacetas/gace722.pdf
"Article 1 of the Decision determines, literally:
"Member Countries shall grant patents for inventions of products or procedures in all fields
of technology, as long as they are new, have an inventive step and are susceptible of
industrial applicability.
From the analysis of the transcribed provision, it is concluded, in first place, that in the
Andean Countries, with the intervention of their respective National Authorities,
"PATENTS OF INVENTION" may be granted for products or procedures in all fields of
technology. It cannot be inferred from the text of this article, the possibility of
patenting any other kind or nature of creations other than inventions such as, for
example, uses or, specifically, second uses." (The remarks are ours)
2.2.2 Claims characterize a therapeutic method
The claims characterize a method of therapeutic treatment that involves active principles
described in the state of the art, for the above reasons, and to the extent that therapeutic
treatment methods are NOT considered patentable according to Decision 486 of the Commission
of the CAN; as it does not meet the requirements of patentability. This is explained in the following
bibliographies:
Goodman & Gilman's text, "The pharmacological bases of therapeutics" 9th Edition.
Interamericana. 1996, Mexico, page 47, states:
"Since all patients differ in their reactions or responses to drugs, each therapeutic
'encounter' should be considered as an experiment, in which a hypothesis is
tested. The scientific basis for this hypothesis comes from the database
generated in human witness studies, during the various stages to obtain and study
the agent, and the experience gained after its commercial distribution.”
“Individualization of treatment in a particular patient requires basic knowledge of
pharmacokinetics and pharmacodynamics. There are countless factors that affect the
reaction of a subject to a drug; for example, age, disease of organs by which the drug
is eliminated (kidneys or liver), the concomitant use of other pharmaceutical products,
food and chemical substances (drug interaction); the previous administration of the
same drug or other similar (tolerance), and various genetic factors influencing the
kinetics and toxicity of drugs (pharmacogenetics)”.
A clear conclusion is that therapeutic treatment methods are NOT the result of human
creativity, which is essential requirement of an invention; nor do they have the character of
replicability"4.
________________________
4
Moscoso A. Raúl. Propiedad intelectual e innovación tecnológica en el Ecuador. Abya Yala. Quito. 2000. Pag. 37-38.
Professor Otero José Manuel, in his work "La invención y las excepciones a la patentabilidad en
la Decisión 486 del Acuerdo de Cartagena” (The invention and patentability exceptions in
Decision 486 of the Cartagena Agreement, in English). Patent Conference. Quito, 2000, page
31, states the following:
"d).- therapeutic or surgical methods for the treatment of humans or animals, as well as diagnostic
methods applied to humans and animals.
This prohibition derives from Article 27(3)(a) of the TRIPS Agreement and it adheres exclusively to
therapeutic, surgical or diagnostic methods. The ban is based on ethical considerations and the
purpose is keeping it at the margin of any economic methods that are necessary to preserve the
health of human beings or animals (see GOMEZ SEGADE, OP. CIT. PP. 91 and 92).
In the Spanish Patent Law, which in this point follows the European Patent Convention, these
methods are not considered patentability "exceptions", rather they are non-patentable inventions
because they lack the requirement of "industrial applicability".
In this sense, Fernando Fuentes Pinzón in his book "La moral, la ética y la bioética como
limitantes sociales a la protección de las invenciones por la vía de las patentes" (Morality,
ethics and bioethics as social constraints to the protection of inventions through patents, in
English) Frónesis. [online]. Dec. 2006, vol. 13, no.3 [cited December 07, 2011] pages 9-31, the
same that is available in the World Wide Web:
<http://www.scielo.org.ve/scielo.php?script=sci_arttext&pid=S1315- 62682006000300002&1ng
=es& nrm=iso>. JSSN 1315-6268 Frónesis ISSN 1315- 6268 printed version, states:
"3. Exclusion of protection to Patentable Inventions, for ethical reasons, moral or bioethical.
3.1. The prohibition of protection against therapeutic or surgical methods for human or
animal treatment, as well as diagnostic methods.
By method we may understand a system of conduct or behavior, which could be considered as
information that does not generate a product, an example of which would be the method for HIV
treatment with three types of tablets (which is not intended to detract from the research and
intellectual contribution thereof), but the provision is express: "The following will not be patentable:
(omission) (d) therapeutic or surgical methods for the treatment of humans or animals, as well as
the diagnostic methods applied to human beings or animals.” (Dec. 486: Art. 20). Therefore, it will
be applicable if this procedure has as object the human or animal treatment, when they are methods
of cure (therapeutic), operation or cut of the body (surgical) or prevention (diagnosis). However,
another type of method, such as that used for the sterilization of insects, could be patentable, even
if such objects are used for curing.
Without any doubt that therapeutic or surgical methods could be considered as process or
procedure inventions, since they can comply with the material requirements of patentability:
novelty, inventive step and industrial applicability, however, extra-legal reasons have deprived them
of the invention concept, thus Salvador Bergel (1996: 36) comments: "this prohibition (omission)
finds its foundation more in the consideration of ethical order than in legal principles, privileging in
this way all that it does to the health care and protection, both for human beings and animals.
The express patentability exclusion of this innovation type is not based on invention law, but on
ethical concepts that anticipate a greater value for the life and health of living beings, than for the
exclusive commercial exploitation of that knowledge. Being the exclusion matter of medical
procedures and the application of medical limitations, ethical character to its protection, it will be
possible to place it as an eminent bioethical prerogative embodied in the Ibero-American legislation
on patents".
Finally, in the electronic reference:

http://www.wipo.int/edocs/mdocs/scp/en/scp_15/scp_15_3-annex4.pdf
Corresponding to publication: SCP/15/3. ANNEX IV. Exclusions from patentable subject matter
that promote public health objectives. Shamnad Basheer, Shashwat Purohit and Prashant
Reddy1. The following is specified literally on page 3:
"The patenting of medical treatment methods for human beings is, however, a
complicated issue, since it is not only linked to patent law but also to medical law. Medical
law has its origin in the Hippocratic oath, and its purpose is the preservation of human
life. Since patent law aims to promote innovation by rewarding inventors, its purpose is
very different from medical law. Therefore, there is a political public interest that in order
to guarantee the best possible medical treatment, doctors must have the freedom to
choose the treatment”.22
Also, an approach of these interests in conflict can be found in several legal
pronouncements. As an example, Judge Jacob stated in case Bristol-Myers Squibb Co.
v. Baker, Norton Pharmaceuticals Inc that "the purpose of limitation is simply to prevent
the patent right from directly interfering in the treatment that the physician offers to the
patient”.
2.2.3 The application lacks novelty
With the documents of the prior art, previously exposed and the following legal regulations, it is
concluded that the application lacks the novelty requirement:
Decision 486 of the Andean Community Commission, reads as follows
"Art. 16.- An invention shall be considered new when it is not comprised in the prior art.
The prior art shall include anything which has been made accessible to the public by written or oral
description, use, marketing or any other means prior to the filing date of the patent application or
the recognized priority, where applicable.
Only for the purpose of determining the novelty, the content of a patent application in process before
the competent national office, is also going to be considered within the prior art, with filing or priority
date prior to the filing or priority date of the application under examination, as long as the said is
included in the application of prior date, when it is published or the deadline provided in Article 40
is elapsed.
Art. 40.- Within eighteen months after the filing date in the Member Country concerned or,
where priority is claimed, after the application date, the file shall assume a public nature and shall
be open for consultation. The competent national office shall accordingly order the publication of
that application, in conformity with pertinent national provisions.” (The remarks are ours)
2.2.4 About crystalline forms
Among the patentability requirements according to the current regulations, it is specified that
invention patents will be granted to products; the form is the appearance or external appearance
of the bodies5 and therefore the PRODUCT requirement is not met. Regarding polymorphism, it
is necessary to detail that the SENADI (formerly known as IEPI) has pronounced on the subject,
as well:
Application
Title of the applications with rejecting resolutions
SP 03-4921
Anticholinergic crystalline, method for its production, and use thereof in
the production of a drug
Crystalline telmisartan sodium salt and its use as an angiotensin
antagonist
Crystal modification of a n-phenyl-2-pyrimidine derivative, process
for its manufacture and use
Crystalline antifungal polymorphous
SP 04-5089
SP 98-2588
SP 98-2686
Polymorphism, in terms of Remington's Pharmaceutical Sciences6 is "the ability of any element
or compound to crystallize into more than one crystalline system”.
The discovery of polymorphism as the property of chemical entities was attributed to the
pharmacist Martín Enrique Klaproth in 1798. The thesis according to which the same chemical
elements can adopt different solid forms - polymorphs - and show different physical properties,
is attributed to Louis Jacques Thénard (1777- 1857) and Jean Baptiste Biot (1774-1862).
Polymorphism is an inherent property of all molecules and its reporting is a simple discovery, the
substances have the intrinsic capacity to manifest in different crystalline orderings7, which is why
the possibility that such substances manifest in polymorphic ordinances is predictable and
obvious. The finding and reporting of such polymorphs does not involve inventive step, because
_______________________
5
García -Pelayo and Gross R., Larousse Diccionario básico de la lengua española (Basic dictionary of the Spanish
language, in English). Ed. Larousse. Buenos Aires. Argentina. 1979. Page 250.
6
Remington's Pharmaceutical Sciences. 16th. Mack Pub. Co. Pennsylvania. 1980. P. 180-181.
7
“Those who study the polymorphism are coming to the conclusion that all compounds, organic and inorganic, can
crystallize in different crystalline or polymorphic forms. In fact, the more diligent the study of a chemical entity, the greater
the number of polymorphs to be discovered." (Underlining out of text). Giron, D., Thermochimica acta 248-1-59, Elsevier
Science B.V., 1995. Pages 3 to 11.
it simply deals with the discovery of the known subject matter property, as defined in the
Patentability Examination Guide of the European Patent Office8.
From the above, it is obvious that the polymorphic property is reported in the chemical entities
that have been studied by mankind, leaving to their activity the task of discovering, characterizing
and reporting the forms identified in each case, procedures that lack creative contribution.
Polymorphs are not new products and therefore lack novelty. In a polymorph the initial molecular
chemical structure does not change, but presents a different accommodation of its repetitive unit
in space, which confers it a different crystalline form. Hence, when we speak of polymor phs of a
molecule, they are always named in Roman numerals or alphabetical order (for example, forms
I, II, A, B, etc.), depending on their discovery or the amount of solvent molecules it retains. A
polymorph is never designated with a new chemical name because it is the same substance.
From another point of view, no innovations are reported in the matter of crystalline ordering, since
polymorphs, to date, necessarily manifest themselves under one of the seven known crystalline
systems: triclinic, monoclinic, orthorhombic, tetragonal, trigonal, hexagonal and cubic, without the
chance to modify this chemical nature tendency.
A novel and inventive contribution would be creating a crystalline system different from those
mentioned, for example, of pentagonal ordering, something that does not happen in patent
applications like the present one, since they are limited to describe a process of change from one
known system to another of the compound. This shows that the applicant's claim is limited to
presenting simple changes between crystalline habits without them implying a solution to any
technical problem.
Obtaining and characterizing different morphologies of a crystal, lacks inventive step: The
crystalline habit is the description of the macroscopic external appearance of a crystal. This
appearance depends on manipulative factors such as temperature, pressure, crystallization
speed, saturation concentration, and even the influence of foreign substances and force fields
outside the crystal9.
Once the crystalline habit of a substance is known, it is easy to report by applying common
analytical methods, a large number of morphological variations of that habit, without their
characterization involving changes in the essential geometric arrangement of the crystal, or
alteration of the chemical properties thereof.
The alterations in the crystalline habit that do not suppose variations in the internal crystalline
network of the molecule, do not report any technical progress, insofar as they simply show a
____________________
8
"If a man finds out a new property of a known material or article, that is mere discovery and unpatentable. To find a
substance freely occurring in nature is also mere discovery and therefore unpatentable. Guidelines for examination in the
European Patent Office.- EPO Pub. 1999, Part C, chapter IV, page 36.
9
J. Garrido. Forma y estructura de los Cristales (Form and structure of Crystals, in English), (op. cit.), chapter V, page
204
different macroscopic structure, as described in Thermochimica Acta (1995) 1-5910.
Considering the aforesaid, the characterization of simple morphological modifications in the
crystalline habit is easy to obtain by means of variations in the previously mentioned parameters,
being a graphic example the simple alteration in minutes of the crystallization time, an obvious
concept for a technician in the matter and sufficient reason to reiterate the lack of inventive step.
For the sake of discussion, even if there were differences in the matter of dissolution between
polymorphs, it is a fact that the advantage in this field is the amorphous forms, which shows that
obtaining "crystalline" forms does not solve technical problem and is limited to reporting a simple
discovery11, a category other than "products and procedures" which may be the subject of a
patent in the light of the Andean regulations.
It is obvious that a polymorph can show different physical properties than the initial molecule,
without the discovery of such differences having an inventive step. As it is obvious that a
polymorph is a different arrangement of the same chemical entity, so it is that this feature can
lead to physical alterations compared to the initial molecule12.
Between a polymorph reported as novel and the initial form of the first patent, as explained, there
can be minor and predictable differences in physical matter, which do not represent any effect
on the indication or pharmacological action of the substance, for a substance to be absorbed and
act in systemic form it must be dissolved, the moment from which the physical differences
between the polymorph and the initial form disappear. It is clear that such differences do not
depend on the exclusive use of different polymorphs and habits, as it has been said, they can be
induced differently but equally effectively by the simple addition of appropriate excipients.
Polymorph patents do not reward an inventive effort: The patent regime is by nature of restrictive
application. This means only the new creations complying with the requirements established
____________________________
10
Op. cit. Page 2
11
In fact, "In the discovery, the inventive spirit does not act, but the speculative spirit and faculties of observation; so in
the discovery we remain in the field of science and speculative intellect, while with the invention we penetrate the domain
of realization and practical intellect. The distinction between invention and discovery is important in our study, because
not being the latter a creation or invention, it cannot be object of privilege secured by Law, which protects only the technical
inventions. Gama Ciqueira quoted by Raúl Moscoso. Intellectual Property and Technological Innovation in Ecuador. Ed.
Abya-Yala. 2000. Page 37.
12
It is enough to review what was said on the subject in the Remington's Pharmaceutical Sciences, quoting "(...) the
solubility, melting point, density, hardness, shape of crystals, optical and electrical properties, steam pressure, stability,
etc. vary depending on the polymorphic form". (Underlined out of text).
may be subject to the privilege of patent protection. If the thesis is generalized by virtue of which
any modification of a known molecule that does not suppose technical contribution is patentable
- thesis that would not even reach the field of utility models - it would be rewarding those who
simply modify an invention in an innocuous and obvious way, in detriment of those who dedicate
efforts and resources to the development of the initial molecule.
2.2.5
The application fails to comply with current Industrial Property regulations
Finally, it is necessary to point out the Social Economy Organic Code of Knowledge, Creativity
and Innovation, published on the Official Register No. 899, state in its article 268, that what is
taken into account in points 3, 4 and 5 will NOT be considered inventions:
3. A new form of a substance, including salts, esters, ethers, complexes, combinations and
other derivatives;
4. Polymorphs, metabolites, pure forms, particle size and isomers;
5. Uses and any new property or new use of a known substance or use of a known process,
machine or apparatus.
With the technical and legal arguments previously expressed and based on the mentioned
documents; it is demonstrated that the patent application does not constitute a PRODUCT
invention, and lacks inventive step. In addition, it incurs in the patentability exclusion of
therapeutic method and forms of presentation.
In such virtue, Mr. Director, you will be able to verify the patent application No. SENADI- 201941050 named “TETRACYCLIC HETEROCYCLE COMPOUNDS USEFUL AS HIV INTEGRASE
INHIBITORS” cannot be protected.
III. ALAFAR HAS A LEGITIMATE INTEREST
Decision 486 authorizes the filing of a supported opposition to a patent application by "whoever
has legitimate interest" (Art. 42), and the Intellectual Property Law (Art. 142) indicates that
“whoever has a legitimate interest may file once the supported opposition that might challenge
the patentability or ownership of the invention”.
In order to demonstrate that my client, ALAFAR, undoubtedly has a legitimate interest in filing
opposition, we must establish the purpose that seeks the filing of an opposition is to prevent
products or procedures that do not comply with the requirements of Decision 486 and Organic
Code of Social Economy of Creativity Knowledge and Innovation can be registered as patents
for invention and enjoy preferential treatment in trading.
Therefore, with the filing of this opposition, ALAFAR seeks not only to defend an individual and
direct interest, but also the collective and public interest, because, by trying to prevent the
granting of patents for exclusive exploitation on products or procedures that are in the prior art
or prohibited by Law, the benefit will not only be to LAFAR, but to the whole society. The
formation of illegitimate monopolies and oligopolies, expressly prohibited by our Constitution,
will be avoided.
However, it should also be noted that the Andean Court of Justice has recognized the
legitimate interest of ALAFAR, in the text of the judgment issued within Process 39-IP-98, in
which the District Court No. 1 of the Administrative Contentious requested the prejudicial
interpretation of Articles 1, 2, 3, 4, 5, 6, 7 and 143 of Decision 344. Conclusion number 1, found
on page 15 of said judgment, textually states:
“Under Community Law, the right for individual or collective persons to submit observations
derives from the legitimate interest in being affected by a patent granting. This would be evident
in the case of an Association of Pharmaceutical Companies regarding the granting of a
pharmaceutical patent”.
IV. CLAIM
Considering this background and based on Articles 14, 15, 16, 18 and 20 of Decision 486 and
other relevant provisions of the Organic Code of the Social Economy of Knowledge, Creativity
and Innovation, I request the rejection of protection for this patent application No. SENADI2019-41050 named “TETRACYCLIC HETEROCYCLE COMPOUNDS USEFUL AS HIV
INTEGRASE INHIBITORS, once this opposition is processed, because it is clearly contrary to
the legal regulations of Ecuador, in addition to attacking the interests that I represent. This
opposition will be processed according with the provisions of Articles 42 onwards of Decision
486.
I request, Mr. Director, that you comply with the faculties granted to you by Article 46 of
Decision 486, and with the obligation imposed by Article 144 of the Intellectual Property Law
(as established in the Third Transitory Provision of the Organic Code of the Social Economy
of Knowledge, Creativity and Innovation) please require the report of experts or appropriate
scientific or technological bodies to give their opinion on the inventive step and carry out a
patentability examination of the invention, within the term provided by law.
V.
SUMMONSES AND NOTIFICATIONS
The applicant shall be summoned to the address indicated in the patent application No.
SENADI-2019-41050. The notifications corresponding to me will be received in the physical
box SENADI-UIO No. 52 and/or in the virtual box No. 28005.
Sincerely,
(signature)
ATTY. LEDA ALFONSO TRUJILLO
PROFESSIONAL LICENSE No. 17-2002-194
ATTORNEYS FORUM