Brazil was the fourth country in the world to enact a patent law (in 1809) and it was also a founding member of the Paris Convention in 1882. Therefore, while Brazil is not new to a patent regime unlike other developing nations, there has been a recent legislative review that may lead to major patent law reforms. The Parliamentary Committee released a report titled "Brazilian Patent Reform: Innovation Towards Competitiveness" on October 9, 2013 at an event held at the Brazilian Chamber of Deputies. Some of the proposals include eliminating patent term extensions and data exclusivity, restricting patents on new forms and new uses of known substances, heightening the inventive step requirement (following the ruling in the Novartis case by the Indian Supreme Court), adopting government use procedures, and clarifying the role of Brazil's drug regulatory agency in the patent examination system. This report was developed through a long consultative process consisting of over seven workshops in 2011 and 2012, by a technical team. This article seeks to review some of the key reforms proposed in this report.
Limiting patent term to 20 years with no extensions
Article 2 of the proposed Bill No. H.R. 5402/2013 limits patents to a 20-year term by revoking Article 40 of Law no. 92790 of 14th May, 1996 which grants patent protection beyond 20 years where the date of granting a patent exceeds 10 years. Article 33 of the TRIPs only mandates that the term of protection for a patent shall not end before the expiration of a period of twenty years counted from the filing date and therefore, granting any further extension of the term is only a “TRIPs +” measure. This would make Brazil’s laws more akin to the Indian position, where similar patent term extensions do not exist.
Disallowing patents on new uses or new forms of known substances
Article 3 of the proposed Bill No. H.R. 5402/2013 seeks to amend the law to add the following exclusions to patentable subject matter:
"The following are not considered to be inventions or utility models:
X – any new property or new use of a known substance, or the mere use of a known process, unless this known process results in a new product;
XI – new forms of known substances that do not result in an improvement in the known efficacy of the substance.
For the purposes of this article, salts, esters, ethers, polymorphs, metabolites, pure form, size of particles, isomers, mixtures of isomers, complexes, combinations and other derivatives of a known substance shall be considered the same substance, unless they significantly differ in terms of properties regarding efficacy."
One would immediately notice that the exclusion mirrors Section 3(d) of the Patents Act, 1970, the constitutional validity of which was upheld by the Madras High Court in Novartis v. UOI. Recently, the Supreme Court in Novartis A.G. v. UOI & Ors. [(2013) 6 SCC 1], recognized Section 3(d) as setting up a second tier of qualifying standard, where under new forms of known pharmaceutical substances may be considered patentable subject matter only if evidence as to enhanced therapeutic efficacy (its ability to cure a disease or treat a condition) is presented. Other physio-chemical advantages not connected with therapeutic efficacy would be considered irrelevant to the analysis.
The Report argues that the proposed amendment is in line with Brazil’s TRIPs obligation. Referring to Article 27.1 of the TRIPs, it has been argued that terms “new”, “inventive step” and “industrial application” are not specifically defined, granting members the interpretive freedom to adopt loose or strict standards of patentability according to their own needs and circumstances. It is this “constructive ambiguity” that the Report relies upon. According to the Report, inventions forbidden by the proposed provisions are, and should be expressly understood, as mere codifications of longstanding requirements of patent law. The proposed provisions thus represent the considered view of the drafters that new uses and new forms of existing substances (without significantly enhanced efficacy) should not be considered “inventions” per se due to lack novelty and/or inventive step. New uses are ordinarily discovered through routine/obvious investigations of existing substances and thus lack novelty and/or inventive step.
Heightening the inventive step requirement
Article 3 of the proposed Bill No. H.R. 5402/2013 seeks to amend Article 13 of the current law which states that “The invention carries inventive activity when, for a person skilled in the art, it does not derive in an obvious or evident manner from the state of the art" by adding the phrase, "provided it represents a significant technical advance in regards to the state of the art.” Effectively, this addition would bring the definition of “inventive step” in Brazilian law along the lines of the definition of “inventive step” in Section 2(ja) of the Patents Act, 1970. The Report refers to how jurisdictions around the world are taking steps to tighten-up the inventive step analysis and informs that the proposed heightened standard is merely in continuation of this trend.
Brazil has historically shown leadership in promoting and defending access to affordable medicines such as by way of compulsory licenses (or threats to issue such licenses). The proposed reforms can be seen as evidence of continuing international momentum from developing countries towards enabling better access to medicines. The patent system is being considered as one of the key elements in this matrix and the proposal in Brazil indicates the increasing trend in tweaking patent systems in order to effectuate a public policy goal.
[ The authors are respectively Associate and Principal Associate, IPR Practice, Lakshmikumaran & Sridharan, New Delhi ]