Brazilian Patent Statute under attack: Second use inventions, polymorphs and inventive step (Part III)
November 10, 2017

by Rodrigo Maior and Douglas Leite There are currently over 30 bills pending in the Brazilian Congress that were drafted for the purpose of amending the Brazilian Patent Statute (Law # 9,279/96)1. Some of these bills were drafted with the aim of limiting the patentability of second use inventions and of new forms of compounds (also known as polymorphs) and to raise the bar for inventive step in Brazil. This brief article presents an overview thereof. The above mentioned pending bills seem to have been strongly influenced by the 2005 amendments to the Indian Patent Law available at http://ipindia.nic.in/ipr/patent/eVersion_ActRules/sections-index.htm. The bills seek to build on the Brazilian Law requirements and contain provisions that are similar in the corresponding Indian legislation. However, some terms contained in the Brazilian bills are even stricter than those in the Indian legislation. I. Second use inventions and polymorphs The Brazilian Patent Statute (Law # 9,279/96) does not currently have any specific provisions restricting the patentability of second use inventions or polymorphs. Hence, the Brazilian Patent and Trademark Office (BRPTO) will accept claims covering these subject matters as long as they meet standard patentability requirements. The BRPTO has recently released the second part of its draft patent examination guidelines for public consultation. In light of the above, it is worth noting that the draft guidelines do not contain any restriction for second use inventions or polymorphs. The draft guidelines can be accessed here. Second use inventions are protected in Brazil through ‘Swiss-type claims’, as methods of treatment are not considered as patentable subject matter2. As for polymorphs, the draft guidelines provide that they shall be defined by their physicochemical properties and they will be patentable as long as they meet novelty, inventive step and industrial applicability requirements. The local generic pharmaceutical companies are applying pressure through strong lobbying, to limit the patentability of such inventions or to render them entirely unpatentable. Bill # 3,995/2008 was presented in September 2008 with the aim of amending the Patent Statute and to determine that second medical use inventions and polymorphs shall be considered as unpatentable subject matter. According to the bill, “[t]he following are not considered to be inventions or utility models: (...) the new crystalline form of a substance comprised in the prior art; and (…) the modification of a patented product or therapeutic substance for which it has been found an utility or use different from the one explored by the patentee”. This bill is currently pending in the House of Representatives and has received a favorable opinion from the Social Security and Family Committee. On the other hand, the Economic Development, Industry and Trading Committee rendered a negative opinion in respect of the bill and the Committee has thereby suggested that it be rejected. Currently, the bill is awaiting the analysis of the Constitution, Justice and Citizenship Committee. Bill # 5,402/20133, which was presented in April 2013, also deals with the patentability of second use inventions and polymorphs. Unlike bill # 3,995/2008 mentioned above, this bill does not treat these subject matters as unpatentable but rather suggests stricter requirements for their patentability. According to this bill, “any new property or new use of a known substance, or the mere use of a known process [shall not be considered an invention] unless said known process results in a new product”. In respect of polymorphs, the bill states that “new forms of known substances that do not result in an enhancement of the known efficacy of said substance [shall be not be considered an invention] . This bill has not yet passed through any of the Committees of the House of Representatives. II. Inventive Step In line with the patent laws of most countries, the Brazilian Patent Statute determines that “[a]n invention shall be taken to involve inventive step when, for a person skilled in the art, it does not derive in an evident or obvious manner from the state of the art”. The standard for inventive step applied by the BRPTO and local courts does not differ much from the standards applied in Europe or in the United States. The new draft guidelines also set out assessment criteria that resemble the ones applied by the EPO and the USPTO. However, bill # 5,402/13, mentioned in the section above, seeks to amend the law to include stricter standards for an invention to be considered as not obvious and therefore patentable in Brazil. An invention should meet the inventive step requirement if, despite not deriving in an evident or obvious manner from the state of the art, it also involves a significant technical advancement in comparison to the state of art. Therefore, if bill # 5,402/13 ever matures into legislation, the bar for inventive step in Brazil would be raised higher than in most countries. The inventive step requirement was formally introduced in the Brazilian legislation in 1996, under the Brazilian Patent Statute (Law # 9,279/96). Since this time, the courts and the BRPTO have been trying to improve and perfect the required standards. However, despite these efforts, it appears that Brazil still has not reached the level of predictability as seen in other legal systems. The inclusion of the “significant technical advancement” requirement to the assessment of inventive step would take Brazil a few steps backwards in terms of its development and cause the analysis of inventive step requirements to be even less predictable in Brazil. III. Actual risks Despite the existence of multiple bills seeking to amend the Brazilian Patent law (Law # 9.279/96), the Brazilian Patent Statute has only been amended once since May 1997, when it entered into force. Moreover, the current version of the Patent Statute was enacted as the result of intense debates with many different civil society groups and meets the international standards of IP protection set by the TRIPs Agreement. Therefore, although it is important to be aware of the various bills pending in Congress seeking to amend the Patent Statute and the significance of the changes they propose, it is not likely that there will be major amendments to Law #9.279/96 in the short term. This is the third article regarding the changes proposed in bill #5402/2013 and others for reforming the Brazilian Patent Statute. Click here and here to see the previous article and do not miss our next issues.

1 Please check the previous issues of Prevail in order to know more information about the bills seeking to amend the Patent Statute. A timeline with all the bills is available at http://teste.localhost/licks/site/pdf/Timeline_ReformLaw9279.pdf. 2 Art. 10. The following are not considered to be inventions or utility models: VIII - operating or surgical techniques and therapeutic or diagnostic methods, for use on the human or animal body. 3 Bill # 5,402/2013 intends to implement significant changes in Law # 9,279/96 concerning different issues.

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