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16 June 2008
It is a well-known fact that innovative research plays a fundamental role in the pharmaceutical industry. The results of scientific activities must be legally protected to encourage research and innovative processes and their subsequent positive effect on social welfare. In this sense, there are a number of mechanisms for legal protection, among which, the patent system plays a major role.
Some of the relevant characteristics of the pharmaceutical industry are as follows:
In light of these characteristics - in particular, the last two bullet points above - it can be logically concluded that in this field it is necessary and relevant to have a system encouraging research investment and promoting therapeutic progress. This system is the patent protection system.
Following the enactment of Patent Act 24.481 (as amended by Act 24.572), in the last decade pharmaceutical products have been patentable. In the case of procedures for developing new medicines, such procedures were already patentable by virtue of the previous Act 111 and they remain protected under the existing rules in force.
Section 4 of the Patent Act sets forth that inventions are patentable “as long as they are novel, involve inventive activity and are susceptible of industrial application”. This provision applies clearly in the case of an inventor who finds a property or use in a product or active principle which was unknown up to that moment and requests directly a patent for the new product. However, what happens in relation to new uses of an existing product? Although this issue arises in every field of technology, it is particularly relevant in the pharmaceutical industry, where patents related to those new uses are usually known as patents of second medical uses. A well-known example is the active principle 'Sildenafil', which is currently marketed under the trademark VIAGRA as a therapeutic remedy for erectile dysfunction; previously this principle was known for treating angina.
The concept of invention is applicable to any branch of science. An invention occurs when a means (known or unknown) is adopted and, through its functioning, a result (which may also be known) is obtained which has never been achieved by using such means. The main factor to take into consideration is the novelty of the cause-effect relationship between the means employed and the result obtained. Therefore, there should be no difficulty in accepting the patentability of the first therapeutic or pharmaceutical indication of a known product, even though this limits the product patent to its scope of application: the therapeutic or pharmaceutical purpose.
Based on this concept of invention, the first therapeutic indication, as well as the second and subsequent therapeutic indications, of a substance or composition included in the state of the art should logically be patentable, as long as these therapeutic indications are not already included in the state of the art and comply with the requirements of inventive activity and industrial application. In all these cases, a new cause-effect relationship has been created, thereby providing society with new knowledge and benefits. Likewise, second and subsequent therapeutic indications of a known product should also be patentable, since it is unreasonable to discriminate by applying a certain legal treatment to the first use of an invention and a different legal treatment to its other successive and novel uses.
Section 54 of the European Patent Convention sets forth that any substance or composition included in the state of the art for use in a diagnostic method or human or animal treatment method for surgical or therapeutic purposes is patentable, as long as such use for these methods is not included in the state of the art. This is the case of a known product which has not been used until that moment as a medicinal product. Pursuant to this rule, identification of the first therapeutic indication of a known product is patentable.
Those who criticize this position state that identification of a new pharmaceutical use of a known product is equivalent to identifying a new therapeutic method, and that its patentability would be against the prohibition of patent medical methods regulated by Section 52 of the European Patent Convention.
In response to this position, it can be stated that patentability prohibitions should be expressly determined. The General Agreement on Tariffs and Trade and the Agreement on Trade-Related Aspects of Intellectual Property Rights do not exclude the patentability of patents of use. In addition, it cannot be argued that the prohibition on patenting therapeutic methods is equivalent to extending the exclusion to patents of use. The therapeutic or pharmaceutical effect of a medicine is essentially different from a therapeutic method. Therapeutic methods refer to the ways and procedures by which illnesses are treated.
Institute of Industrial Property Resolution 243/2003 does not exclude the patentability of patents of use. Section 2.1(3c) establishes that:
“it is not necessary for all characteristics to be expressed in terms of a structural limitation. Functional characteristics may be included in a claim...Therefore, claims related to the use of the invention shall be allowed, in the sense of its technical application, as long as it complies with the requirements of Section 4 of the Patent Act and is not included in the exclusions of Section 6 of the Patent Act.”
The Institute of Industrial Property’s solution is completely different when the rule refers to the therapeutic indications of a medicinal product. Its guidelines, which confirm Circular Letter 008/2002 on this matter, exclude the patentability of second medical uses. These rules establish that if an invention describes a new medical application of product X (known) for the treatment of disease Y and claims are expressed as a direct claim of use, “use of product X for the treatment of disease Y” would be considered equivalent to a “therapeutic treatment method of disease Y which employs product X”, and therefore will be excluded from protection pursuant to Section 6(e) of the Patent Act.
The alleged difficulty in patenting a new therapeutic indication of a known substance derives from: (i) the impossibility of claiming the product due to a lack of novelty; and (ii) the impossibility of claiming use since, according to the Institute of Industrial Property’s criterion, this would be equivalent to a therapeutic method.
The subject matter of a patent is an invention. Section 4 of the Patent Act states that “product or procedure inventions shall be patentable”. This is complemented by the invention definition provided by Section 4(a): “For the purposes of this act, all human creation allowing transformation of matter or energy for human use shall be considered invention.”
Although this is not the most suitable definition of the concept of ‘invention’, the first, second and subsequent pharmaceutical indications of a substance are all hypotheses wherein human intervention (human creation) has allowed a transformation for the substance's undeniable human use.
If this is considered a therapeutic method, Section 6(e) of the Patent Act has made a mistake, since its nature of invention cannot be ignored.
As regards the novelty objection, it is clear that first, second and subsequent therapeutic applications are all novel. Section 4(b) of the Patent Act clarifies the concept of novelty by establishing that “all inventions not included in the state of the art shall be considered novel”. The rule for the specific case being analyzed refers to the term ‘invention’, but is not limited to the concept of ‘product’. An invention occurs when a means (known or unknown) is adopted and through its functioning a result (which may also be known) is obtained which has never been achieved by using such means.
Consequently, if a chemical agent is already known for producing digestive effects and subsequently, as a result of new investigations, it is determined that the same agent supplied under a different dose causes the elimination or noticeable decrease of a migraine, the following questions arise: was such agent with its effects on migraine included in the state of the art? The answer is no. Has anybody ever made an oral or written description or worked such chemical agent with such results? In this case, the answer is also clearly no. Therefore, it is an invention of a novel product that deserves to be protected by an invention patent.
Under current legislation, pharmaceutical products are patentable and, due to their nature, entail therapeutic effects. However, therapeutic treatment methods include neither medicinal products nor their applications. Since every type of instrument or device used to implement therapeutic, surgical or diagnostic treatment methods is patentable, so must be the products, substances or compositions that can be used for the application of a therapeutic treatment method, provided that they comply with the requirements listed in Section 4 of the Patent Act.
As a result, many disagree with the Institute of Industrial Property’s interpretations in Circular Letter 008/2002 and Resolution 243/2003 as regards the scope of the prohibition set forth in Section 6(e) of the Patent Act, as such section should not be an obstacle for the patentability of first, second or subsequent therapeutic applications through claims of use.
Taking into consideration the accepted worldwide definition of ‘invention’ and the definition set forth in Section 4(a) of the Patent Act: first, second and subsequent therapeutic indications of a substance or composition included in the state of the art should be patentable, as long as these therapeutic indications are not already included in the state of the art and comply with the requirements of inventive activity and industrial application. These criteria are the most suitable as the main purpose of patent protection in this field is to provide legal encouragement in order to promote the introduction of new pharmaceutical products in the market and their consequent impact on social welfare and human health.
The patentability of new medical uses will strongly encourage and promote research and development projects of known substances - projects that otherwise would be economically impracticable.
For further information on this topic please contact Carlos Octavio Mitelman or Daniel R Zuccherino at Obligado & Cia by telephone (+54 11 4114 1100) or by fax (+54 11 4311 5675) or by email (firstname.lastname@example.org or email@example.com).
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