[Ip-health] New guidelines for the examination of pharmaceutical patents adopted in Argentina

Gabriela Arguedas arguedas.gabriela at gmail.com
Tue May 29 09:45:57 PDT 2012


Congratulations to Argentina!

I hope this decision will become an example for all the Latin-american
countries.



2012/5/29 Carlos Correa <quiess at gmail.com>

> *Argentina adopts guidelines to examine patent applications for
> pharmaceuticals*
>
> The Ministry of Industry, the Ministry of Health and the National
> Industrial Property Institute of Argentina jointly adopted guidelines for
> the
> examination of patent applications for
> pharmaceutical inventions (an unofficial translation is reproduced below).
>
> The guidelines provide specific instructions regarding the application of
> the patentability standards in the pharmaceutical field. They are largely
> based on the working document,
> published by WHO, ICTSD, UNCTAD and UNDP, '*Guidelines* for the Examination
> of Pharmaceutical Patents: Developing a Public Health Perspective'
> (available at
>
> http://www.iprsonline.org/resources/docs/Correa_Patentability%20Guidelines.pdf
> ).
>
> Carlos Correa
>
> Joint Resolution 118/2012, 546/2012 and 107/2012 (Ministry of Industry,
> Ministry of Health and National Industrial Property Institute)
>
> Adoption of Guidelines for Patentability Examination of Patent Applications
> for Chemical and Pharmaceutical Inventions
>
> *Buenos Aires, 5/2/2012*
>
> *Date of publication in the Argentine Official Gazette: May 8, 2012*
>
>
>
> HAVING REVIEWED File No. 253-78027/11 of the NATIONAL INDUSTRIAL PROPERTY
> INSTITUTE Registry, a self-governing body within the former Ministry of
> Industry and Commerce of the Ministry of Industry, and :
>
> WHEREAS Law No. 24425 endorses the final negotiations of the Uruguay Round
> and the Marrakesh Agreement - and its Annexes - establishing the WORLD
> TRADE ORGANIZATION.
>
> WHEREAS the Agreement on Trade-Related Aspects of Intellectual Property
> Rights (TRIPS) - Annex 1C - establishes the requirements for patentability
> while granting member countries the power to determine the novelty and
> inventive step standards to be met by inventions to be patentable under
> their respective national laws.
>
> WHEREAS in the case of pharmaceutical inventions, this power was ratified
> by the Declaration on the Agreement on Trade-Related Aspects of
> Intellectual Property Rights (TRIPS) and Public Health, adopted by the
> Ministerial Conference of the WORLD TRADE ORGANIZATION in the City of Doha,
> QATAR, in November 2001.
>
> WHEREAS on December 4, 2009, during the XXVII Meeting of Ministers held in
> the City of Montevideo, Uruguay, the Ministers of Health of the Southern
> Common Market (MERCOSUR) remarked the importance of establishing common
> objectives for public policies and the intellectual property system,
> particularly in the development and application of patentability criteria
> in the region, particularly in view of the proliferation of patents whose
> subject matter is not properly an invention or which is only a marginal
> development; and whereas the Ministers agreed on that occasion to promote
> within the Southern Common Market (MERCOSUR) the adoption of criteria to
> protect public health through patentability guidelines or guides.
>
> WHEREAS, at multilateral level, the Global Strategy and Plan of Action on
> Public Health, Innovation and Intellectual Property endorsed as part of the
> WORLD HEALTH ORGANIZATION (WHO), a member body of the UNITED NATIONS (UN),
> proposes and establishes actions ratifying these aspects and which were
> approved by all its members.
>
> WHEREAS the ARGENTINE REPUBLIC is actively involved as a member of the
> WORLD HEALTH ORGANIZATION (WHO).
>
> WHEREAS the right to health is a corollary of the right to life protected
> implicitly in the unnamed guarantees (Section 33 of the ARGENTINE
> CONSTITUTION).
>
> WHEREAS Section 75, paragraph 22 of the Argentine Constitution grants
> constitutional status to several treaties relating to Human Rights which
> include, among others, the health protection concept
>
> WHEREAS, Section 4 of Law No. 24481 (as restated by Decree No. 260/96), on
> Patents and Utility Models, as amended, provides that any inventions,
> whether products or processes, are patentable provided they are new,
> involve an inventive step and are susceptible of industrial application,
> and establishes as Application Authority the NATIONAL INDUSTRIAL PROPERTY
> INSTITUTE, a self-governing body within the MINISTRY OF INDUSTRY.
>
> WHEREAS the National Patent Authority of the NATIONAL INDUSTRIAL PROPERTY
> INSTITUTE has expressed its opinion regarding the technical aspects of this
> measure.
>
> WHEREAS the SECRETARY OF HEALTH DETERMINANTS AND HEALTH RELATIONSHIPS of
> the MINISTRY OF HEALTH has expressed its opinion regarding the adequacy of
> this measure to the objectives of public health and access to medicines.
>
> WHEREAS the competent Legal Services have reviewed these presents under the
> provisions of Section 7, paragraph 7(d) of the National Administrative
> Procedures Act No. 19549.
>
> WHEREAS these Guidelines are issued pursuant to the powers granted by the
> Law of Ministries (consolidated by Decree 438/92) as amended and Law No.
> 24481 (as restated by Decree No. 260/96).
>
> NOW, Therefore, THE MINISTER OF INDUSTRY, THE MINISTER OF HEALTH AND THE
> PRESIDENT OF THE NATIONAL INDUSTRIAL PROPERTY INSTITUTE
>
> HAVE DECIDED:
>
> Section 1 - To issue the "GUIDELINES FOR PATENTABILITY EXAMINATION OF
> PATENT APPLICATIONS RELATING TO CHEMICAL AND PHARMACEUTICAL INVENTIONS",
> which are set forth in an Annex containing TEN (10) pages which is an
> integral part hereof .
>
> Section 2 - This resolution shall take effect as from the day following its
> publication in the Argentine Official Gazette and shall also apply to
> pending applications.
>
> Section 3 - Let it be known, published, and sent to the National Official
> Registry Office archives.
>
> Signed by:* - Debora A. Giorgi. - Juan L. Manzur. - Mario R. Aramburu.*
>
>
>
>
>
> *ANNEX*
>
>
>
> GUIDELINES FOR THE EXAMINATION OF PATENT APPLICATIONS RELATING TO CHEMICAL
> AND PHARMACEUTICAL INVENTIONS
>
>
>
> These Guidelines provide instructions for the patentability examination of
> patent applications relating to chemical and pharmaceutical inventions.
>
> The application of these Guidelines to patent applications is the
> responsibility of the National Patent Authority (in Spanish, Administración
> Nacional de Patentes, ANP). They are addressed primarily to the staff of
> the ANP, but they are also expected to be of assistance to the parties
> involved in the prosecution and practices related to patent applications.
>
> These Guidelines are intended to cover usual cases. Therefore, they must be
> considered as general instructions; any exception should be duly justified.
>
>
>
> *1) Considerations about molecular structures*
>
>
>
> (i) *Polymorphs.*
>
> Polymorphism is an inherent property of the solid-state of drugs used in
> the pharmaceutical industry (active ingredients and excipients). That is,
> it is not a man-made invention but a property of each substance. When
> referring to the phenomenon of polymorphism in a solid compound we are
> talking about the existence of different crystalline forms of the same
> substance.
>
> A substance may be present in more than one crystalline form, depending on
> environmental conditions (pressure, temperature, concentration, etc), which
> determine each crystal form.
>
> Solid compounds have a crystalline external appearance and an internal
> crystalline lattice, which is the one we are interested in, but which is
> not visible to us, and can only be appreciated using specific physical
> tests.
>
> In other words, a substance in the solid-state may exist as an amorphous
> solid and/or in different crystal forms corresponding to different
> arrangements of molecules in their internal structure, according to the
> physical conditions existing during their formation. These arrangements are
> specific of each polymorphic form and independent of any human
> intervention. An example of this independence is the occurrence of a new
> crystalline form in the capsules of a drug during storage without any human
> intervention.
>
> Such differences in the arrangement of atoms and/or molecules of the same
> substance in the crystal unit cell, may result in modifications of some
> physicochemical properties of pharmaceutical significance (such as melting
> point, solubility, dissolution profile, bioavailability), not to mention
> that the substance will naturally tend to its most stable form even without
> any human intervention.
>
> This evolution over time may occur or not, depending on the substance in
> question.
>
> 1. As polymorph claims are based on the mere identification and/or
> characterization of a new crystalline form of a substance already known in
> the art, they are not patentable, even if they have pharmacokinetic or
> stability differences with known solid forms (amorphous and/or crystalline
> forms) of the same substance.
>
> 2. Processes for obtaining polymorphs are a routine experimentation in the
> preparation of drugs. They are not patentable because it is obvious to try
> to obtain the most suitable pharmaceutically polymorph using conventional
> methods.
>
>
>
>
>
> (ii) *Pseudopolymorphs (hydrates and solvates).*
>
> Pseudopolymorphs are considered by the International Conference on
> Harmonization (ICH) within the "polymorphs" category. This type of compound
> is formed by the incorporation of solvent molecules into the crystal
> structure of chemicals.
>
> Pseudopolymorphs are also referred to as "solvates", and in the specific
> case in which the solvent is water, they are referred to as "hydrates".
> Solvated crystals exhibit a wide range of behaviors and in many cases
> solvent molecules are an integral part of the crystal structure.
>
> The ability to incorporate solvent molecules into the crystal structure of
> a chemical substance is an intrinsic property of that substance. For this
> reason it is not possible to "design" in advance the solvate to be obtained
> when a substance is exposed to solvation conditions (such as temperature,
> pressure, concentration) and different types of solvents.
>
> Although hydrates and solvates have a different chemical composition from
> the known active ingredients, hydrates are formed by exposing a chemical
> compound to certain hydration conditions, and solvates result from
> application of specific conditions. Consequently, they cannot be patented
> independently from their active ingredient.
>
> Consequently, processes to obtain pseudopolymorphs are a routine
> experimentation in the preparation of drugs and they are not patentable.
>
>
>
> (iii) *Enantiomers.*
>
> Chiral molecules can have one or more chiral centers. When they have a
> single chiral or asymmetry center there may be two different forms related
> to each other as non-superimposable mirror images, referred to as
> enantiomers.
>
> Enantiomeric compounds (or optical isomers) are stereoisomers whose mirror
> image is not superimposable and that due to the spatial arrangement of
> their atoms on the chiral center rotate the plane of the polarized light in
> opposite directions.
>
> When the molecules have more than one chiral center, the spatial
> arrangement obtained will show enantiomers as well as diastereomers, which
> are collectively called stereoisomers.
>
> When disclosing the molecular structure of a racemic compound (having both
> enantiomers in a 1:1 ratio) the novelty of the enantiomeric compounds
> forming it is also lost, since, being the molecular formula previously
> known (whether or not it is written in a three-dimensional form) the
> existence of enantiomers and diastereomers is necessarily revealed to a
> person skilled in the art. Therefore, they are not patentable even if the
> application describes different properties.
>
> However, the processes for the preparation of individual enantiomers may be
> patentable, provided they are new, involve an inventive step, and are
> clearly described and the result obtained therefrom are well characterized
> by means of spectroscopic data.
>
>
>
> *2) Considerations about generic structures*
>
>
>
> (iv) *Markush-type formula.*
>
> These are generic chemical structures, which can have multiple chemical
> substituents attached to a central core, covering a variety of compounds
> with properties that, despite not having been tested for all claimed
> compounds, can be inferred for the whole group.
>
> The Markush formula is often used for claiming a large number of compounds
> without the need of describing them individually.
>
> In the case of compounds described by Markush formulas, the disclosure of
> the basic structure, including all the possibilities of radical
> substitution, is equivalent to disclosing each of the compounds resulting
> from these substitutions.
>
> 1. The disclosure of a group of chemical compounds, even generically, is
> considered as a disclosure of all the components of that group, which in
> this way become part of the state of the art.
>
> 2. Compounds represented by a Markush formula shall be admissible only if
> unity of invention is demonstrated, if they comply with the requirements
> for patentability (novelty, inventive step and industrial application) and
> if the specification sufficiently describes how to obtain each of the
> compounds claimed under the Markush formula. Where an invention involves
> multiple compounds claimed under a Markush-type formula, a reasonably
> logical and proportional relationship between the scope of the claims and
> the related matter disclosed in the description shall be required. The
> description should include experimental procedures which, taking into
> account combinations of different substituents or reasonably acceptable
> equivalents thereof, are representative of the entire scope of the claimed
> matter. If the working examples are not sufficiently representative of the
> claimed scope of the invention, and therefore the claims lack sufficient
> support in the description, the applicant should be required to limit it.
>
> 3. For an adequate description of the compounds included in the claimed
> Markush formula, the embodiments of the invention described in the working
> examples should be representative of all the compounds to be protected. In
> all cases, these embodiments shall be perfectly exemplified by providing
> all the data characterizing the compound obtained by physicochemical
> characterization techniques (such as melting point, boiling point, -IR-
> infrared spectrum, proton nuclear magnetic resonance -1HNMR- and carbon
> 13-13CRMN-), indicating whether polymorphic compounds have been detected.
>
> 4. Thus, the protection of Markush formulas should be limited to the matter
> supported by the description, that can be effectively reproduced by a
> person skilled in the art and whose industrial application comes up
> unambiguously from the description.
>
>
>
>
>
> (v) *Selection Patent Applications.*
>
> Selection patent applications are those where a single element or small
> group of elements is selected from a larger group, and they are claimed
> independently, based on a characteristic or characteristics not previously
> attributed to the larger group.
>
> Selections can be made from products (chemical compounds, their salts,
> isomers, esters, compositions, etc) and/or processes (obtention of
> compounds or pharmaceutical compositions and others).
>
> 1. The disclosure of a group of chemical compounds (Markush formula) or
> groups of pharmaceutical compostions, even generically, discloses all the
> components of that group, which in this way become part of the state of the
> art.
>
> 2. There is no novelty in the selection of one or more elements already
> disclosed by the prior art, even though they may have different or improved
> properties, not previously demonstrated.
>
> 3. The discovery of a different or improved characteristic or property for
> a particular element or group of elements already known in the prior art
> does not mean that the product or process is novel.
>
> 4. Pharmaceutical compositions, their methods of preparation and
> medicaments containing them are not patentable if they are specifically
> related to an element or elements selected from a larger group of elements,
> since the product or process are not considered new.
>
>
>
>
>
> *3) Consideration of chemically related elements*
>
>
>
> (vi) *Salts, esters and other derivatives of known substances.*
>
> New salts of known active ingredients, esters of known alcohols, and other
> derivatives of known substances (such as amides and complexes) are deemed
> to be the same known substance and are not patentable.
>
>
>
> (vii) *Active metabolites.*
>
> In some cases, pharmaceutical compounds generate, when administered to a
> patient, an active metabolite, which is the product of the metabolism of
> the compound in the organism.
>
> Metabolites are products derived from the active ingredients used. They
> cannot be considered to have been "created" or "invented".
>
> Metabolites are not patentable independently from the active ingredient
> from which they derived, even though they may have safety and efficacy
> profiles differing from those of the parent molecule.
>
>
>
> (viii) *Prodrugs.*
>
> There are inactive compounds referred to as prodrugs, which when hydrolyzed
> or metabolized in an organism, can give rise to a therapeutically active
> ingredient.
>
> In some cases, patent claims protect a drug and the prodrug(s) thereof.
>
> A prodrug may produce benefits if it can be administered more easily than
> an active compound. Patents on prodrugs, if granted, should exclude from
> the claim the active ingredient as such, if the latter has already been
> disclosed or if it is not patentable.
>
> As any subject matter claimed in a patent, a prodrug must be sufficiently
> supported by the information provided in the specification. It must comply
> with the requirements of novelty, inventive step and industrial application
> and include a description of the best method of obtaining it with an
> adequate characterization of the product obtained.
>
> In addition, the application should contain evidence that the prodrug is
> inactive or less active than the claimed compound, that the generation of
> the active compound (in the organism) ensures an effective level thereof,
> while minimizing the direct metabolism of the prodrug.
>
>
>
> *4) Consideration of pharmacotechnical characteristics*
>
>
>
> (ix) *Formulations and Compositions.*
>
> Composition or formulation claims refer to the use of active ingredients
> and excipients or carriers pharmaceutically suitable such as diluents,
> binders, disintegrants, lubricants, coloring and flavoring agents.
>
> In some cases, a claimed formulation is associated with certain effects,
> such as controlled release of a drug at a given site in the body. To
> achieve this is part of the usual skill of a person specialized in the
> formulation of pharmaceutical products, who can select from existing
> manuals the suitable excipient to achieve the desired effect.
>
> Formulation techniques and the components which can be used to develop
> pharmaceutical products in their various forms are well known elements to a
> person skilled in the art.
>
> For example, the use of stabilizing agents in particular is not an
> inventive step (as pH buffers) nor the use of certain components to modify
> the bioavailability of a drug (a term which indicates the measurement of
> the actual speed and the total quantity of drug reaching the general
> circulation from an administered pharmaceutical form), as is widely known
> that the pharmaceutical form used can affect bioavailability.
>
> New forms and compositions as well as the processes for their preparation
> as a general rule should be considered obvious in view of the prior art.
>
> The same rule applies in relation to compositions or forms related to
> polymorphs.
>
> Likewise, claims related to pharmacokinetic parameters (such as Tmax, Cmax,
> plasma concentration), micronization of a known product or distribution by
> particle sizes should not be considered patentable.
>
> As an exception, formulation claims may be acceptable when they solve in a
> non obvious way a longstanding problem. In this case the description should
> include a description of the tests conducted and the results obtained.
>
>
>
> (x) *Combinations.*
>
> Combination Claims of previously known active ingredients, in some cases
> specify the specific compounds they include and the amounts they cover,
> while others only refer to a class of therapeutic compounds, such as
> antacids and anti-viral agents, without specifying which compounds are
> included.
>
> Most combinations have already been tested in medical practice by
> administering the components independently. Claims on combinations of
> previously known active ingredients in practical terms are equivalent to
> claims on medical treatments whose patentability is excluded.
>
>
>
> (xi) *Dosage/Dose.*
>
> Some patent applications are directed to inventions consisting of dosages
> of an existing product, such as once a day pediatric dosages or dosage
> forms. While at times they are filed as product claims, they are equivalent
> to claims on medical treatment methods, since dosage is not a product or
> process, but a dose of the product with which the therapeutic action is
> obtained for that use. Therefore, they are not patentable.
>
>
>
> (xii) *Second Medical Indication (New medical uses).*
>
> Use Claims, including a second medical indication (or other medical uses)
> of known compounds are not admissible. Often, applications are limited to
> describing pharmacological activity trials in order to confirm the
> discovery of further use possibilities. Patent applications for second
> medical indications (or other medical uses) are equivalent to therapeutic
> treatment methods and have no industrial application.
>
> This rule applies even if the claim is drafted under a "Swiss formula",
> that is, "use of x for the manufacture of a medicament for the treatment of
> "y" “, or its variants .
>
>
>
> (xiii) *Analogous Processes.*
>
> Patentability of products and processes should be evaluated according to
> the properties and characteristics of such products or processes,
> considered separately.
>
> Synthetic or manufacturing processes which are not new and inventive by
> themselves, should be considered non-patentable as such, even if their
> starting or intermediate materials or their final product are new and
> inventive. An example of this is the new salification of a known product.
>
>
>
> *5) Other considerations*
>
>
>
> (xiv) *Sufficiency and scope of the description.*
>
> For the purposes of any type of evaluation, any exemplary embodiments added
> to aid a better understanding of the claimed invention, as well as any data
> and/or information filed by request of the examiner, will be taken into
> account, as long as such information does not extend the scope originally
> disclosed in accordance with the provisions of Section 19 of Annex II of
> Decree No. 260 issued on March 20, 1996.
>
> In order to be patentable, manufacturing methods must allow to obtain an
> industrial result, therefore, manufacturing processes of active ingredients
> and other pharmaceutical components described in the specification must be
> reproducible and applicable on an industrial-scale without additional
> experimentation and/or substantial changes in the described physical and
> chemical parameters and their characterization.
>
> Extrapolation of these Guidelines to pharmaceutical and biotechnological
> inventions should be analyzed in each particular case.
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-- 
Dra. Gabriela Arguedas R.
Universidad de Costa Rica



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