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 treaty and that became known as the “pipeline.” Law No. 10,196/0191 (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, 2000,92 to state that 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.93
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.94
3.11.2.2 Prior consent by the Brazilian Health Regulatory Agency (ANVISA)
The debate consists of knowing whether the prior consent requirement has, in addition to assisting in the technical examination without the concern related to the power “to deny consent,” in view of Article 31 of the LPI (which already provides for the submission of documents and information by the interested parties to support the technical examination). The institute allows for prior consent, which has been deemed relevant for national policies on access to drugs and has also been implemented in the intellectual property legislation of countries in the La Plata basin, such as Paraguay.
Regardless of the limits of ANVISA’s rulemaking power regarding its prior consent, there are currently two other public institutions performing similar work. In addition to assessing patentability requirements, ANVISA also observes aspects relevant for public health, such as whether the granting of the patent will result in limited access to drugs.
In the event of a difference of opinion between the INPI and ANVISA regarding the granting of protection, the patent is not granted, and the process is stayed within the administrative scope of the INPI. The direct consequence of this is that, in the event of a delay in the granting of pharmaceutical patents in the country, the foreign companies (that hold a large part of the filings in the area) may have their patents extended, delaying the entry of generic products into the market.
Conversely, some legal remedies can be used to alleviate this situation, such as compulsory licensing, provided for in the LPI (in cases of abuse of economic power, lack of commercial exploitation, national emergency or public interest) and the “Bolar exception” (an exception to the extension of patent protection, which specifically addresses the use of a currently patented invention for research without the need for authorization from the patent holder). In the latter case, acts intended exclusively for the production of information, data and test results for obtaining the registration needed to market the patented product do not constitute infringement.95
This issue was settled with the ratification of Opinion No. 337/PGF/AE/2011, by the Office of the General Counsel for the Federal Government, according to which ANVISA’s authority was established as being solely to examine whether a pharmaceutical product or process submitted to the patent process is potentially harmful to human health, which could lead to the rejection of the application by the INPI, regardless of the verification of the other criteria of incumbent upon this ANVISA’s body.
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:
- 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
- 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.