3.11.2 Pharmaceutical patents
3.11.2.1 Applications filed before the ratification of the treaty – the pipeline system
Specific considerations applied to patent applications that were filed before Brazil’s ratification of the TRIPS Agreement and that became known as the “pipeline.” Law No. 10,196/0190 (formerly Provisional Presidential Decree No. 2006/99, which was reissued 15 times) amended the LPI, establishing in Article 229 that patent applications filed up to December 31, 1994, concerning chemico-pharmaceutical products and drugs, as well as processes for obtaining or modifying them, should be rejected. In turn, Article 229-A of the LPI imposed the rejection of patent applications for processes for obtaining chemico-pharmaceutical products and drugs if they were filed between January 1, 1995, and May 14, 1997.
Law No. 10,196/01 also created Article 229-C of the LPI, according to which the granting of patents for pharmaceutical products and processes must have the prior consent of the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária; ANVISA). This procedure gave rise to several discussions, to the point that the Brazilian Intellectual Property Association (Associação Brasileira da Propriedade Intelectual), which brings together companies, firms of industrial property agents, law firms and experts in intellectual property matters, amended its Resolution No. 2, of January 27, 2000,91 to state that such a prior consent requirement was a trespass of the INPI’s substantive jurisdiction as established in Article 240 of the LPI and, in addition, directly violated the provisions of Article 4(A)(1) of the Paris Convention.92
Here, there was an issue of objective and subjective jurisdiction regarding the regulation for patent granting. Subsequently, the Brazilian Intellectual Property Association published a resolution in which it stated that ANVISA could not analyze or review the patentability requirements (novelty, inventive step and utility) and should limit itself to verifying whether the patent application is harmful to public health.93
3.11.2.2 Requirement for prior consent by the Brazilian Health Regulatory Agency (ANVISA) repealed
Law No. 14,19594 was published on August 26, 2021, with the aim of reducing bureaucracy in various areas of public administration. This law established that ANVISA no longer holds the prerogative of prior consent for the granting of pharmaceutical patents, repealing the former Article 229-C of the LPI. As the National Health Regulatory Agency, ANVISA has the primary role of protecting and promoting public health by regulating sanitary control over the production and marketing of products and services subject to health regulation. This includes pharmaceuticals, food, cosmetics, and medical devices, among others.
With this legislative change, the INPI once again became the sole government body responsible for the examination and granting of patents in the pharmaceutical area. The consequences were immediate: on August 31, 2021, INPI informed the public that it had received over 1,200 unexamined patent applications from ANVISA that it would now independently analyze.
The elimination of the need for prior consent from ANVISA is expected to contribute to the reduction of the average time for analysis and granting of such patents in the coming years, and therefore, encourage innovation in the pharmaceutical area.
Previously, when there was a divergence of opinions between INPI and ANVISA, the patent application review process would become stagnant within the administrative scope of INPI, leading directly to delays in the granting of pharmaceutical patents in the country. As Brazilian law formerly provided for a minimum term of 10 years for invention patents, counted from their granting (sole paragraph of Article 40 of LPI), patents could be extended beyond the 20-year term, delaying the entry of generic products into the market. However, this provision was also repealed by Law No. 14,195 of 2021 based on the declaration by the Supreme Federal Court in the Direct Action of Unconstitutionality (ADIN) No. 5,529 that the provision was unconstitutional.
3.11.2.3 New use and new therapeutic application
The LPI is silent on the protection of “use”: it does not provide for such claims expressly. For the INPI, second medical use claims are possible, provided that they are intended for a new and nonobvious therapeutic application and that the mechanism of drug action is different from that described for the first use. Thus, inventions related to substances or compositions that aim to protect use in the treatment of certain diseases, according to the INPI’s examination guidelines, can be one of two types:
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a product already known to be used outside the medical field has a new use as a drug, which is said to be the first medical use; or
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a product already known as a drug has a new therapeutic application, which is defined as a second medical use. Although legislation prevents the protection of products isolated from nature, such products are patentable when they are given practical use.
Regarding the second medical use, the solution found to disconnect the new use of a therapeutic method was to link that use to a drug manufacturing process. While claims for the use of the specific product are characterized for the treatment of a given disease, such uses are not considered inventions because they are therapeutic methods under our rules, though not according to the Treaty of Paris. Thus, claims in which the use of a specific product is characterized for the preparation of a drug to treat a given disease are accepted as well. This type of claim is known as a “Swiss formula,” and it aims to protect the second medical use of a known product.
Consequently, new and improved methods of extraction, purification, elucidation, synthesis or semisynthesis of natural compounds, the production of industrial drugs, and genetic engineering are considered patentable. When they are nonobvious, it is also possible to patent chemically modified natural compounds; pharmaceutical, nutraceutical or cosmetic compositions containing one or more natural or modified compounds; transgenic microorganisms and modified biological processes; and the first or second therapeutic use of a described compound. In addition, many patents, despite being granted, prove to be of little or no real value to their owners. This may be particularly true for patent applications for “new drugs,” especially those patented very early in their development process when there is still little certainty of their actual efficacy, low toxicity or economic viability.
DOU of Feb. 16, 2001.
Decree No. 75,572, of Apr. 8, 1975, DOU of April 10, 1975, art. 4 quarter (“The granting of a patent may not be rejected and a patent may not be invalidated because the patented product is on sale or obtained by a patented process subject to restrictions or limitations resulting from the national legislation”) (enacting the Paris Convention).