The Patent & Trademark Office in Brazil current has a backlog of around 170,000 cases. Rana Gosain explains what the PTO is doing to become more efficient.
During the last three years, the Brazilian Government has adopted plans to boost national industrialization in Brazil. For example, the ‘Plano Brasil Maior’ was adopted in August 2011 as
a general plan aimed at fostering industrial development of the country. In parallel with the industrial policy, the Ministry of Science and Technology (MCT) designed the second edition of the action plan on Science, Technology and Innovation for the period of 2011-2014, which includes measures to expand R&D in Brazil.
It was expected that during this period the Brazilian Patent & Trademark Office (PTO) would benefit from long-promised reforms to become efficient. In December 2011, the President of the Brazilian PTO published a paper detailing multiple projects, with the objective of harmonizing its IP practice with that of developed countries. Fortunately, some of these projects have already materialized and others are currently being implemented. There are a lot of expectations that the Brazilian PTO will finally be transformed into an efficient entity and, as a result, reduce the patent examination backlog, which currently stands at 170,000 cases, to a reasonable number by 2016.
The pharmaceutical IP law and practice has been subject to changes ever since article 229-C of Patent Law 9.279/96 was amended. Article 229-C of Patent Law 9279, as amended by Law 10196 (2001), empowers the National Health Surveillance Agency (ANVISA) to conduct a mandatory review of pharmaceutical patent applications, with the purpose of conceding or not prior approval. ANVISA’s role in reviewing pharma applications remains less than transparent and has brought about moot decisions on pharma patents.
The conflicting opinions on patentability issues between the PTO and ANVISA, has led to approximately 200 patent applications being undecided. In October 2009, the Brazilian Federal Attorney General (AGU) rendered Opinion No. 210, ruling that ANVISA should limit its examination to looking at the public health perspective, and that the Brazilian PTO is the only entity with jurisdiction to examine patentability issues. The AGU rendered a further opinion in January 2011 stating that ANVISA should not refuse to grant approval of pharma patent applications on the grounds of patentability requirements.
However, apparently, the AGU’s opinions are not binding, and the Federal Government has created an Inter-Ministerial Working Group comprising of representatives from the Ministry of Health, Ministry of Development, Industry and Foreign Trade, ANVISA, Brazilian PTO and the Attorney General of the Republic, to ultimately resolve the issue. The Group published a final report that was approved via Ordinance No. 1065 of May 25, 2012. The final report proposes that pharma patent applications should first be forwarded to ANVISA for approval. In the event ANVISA approves the application, it will be returned to the Brazilian PTO for further evaluation. The significant changes are that the workflow has been inverted, and that if ANVISA refuses to grant prior approval, the application will be shelved and the decision published in the Official Bulletin.
A further change in the administrative rules relating to prior consent procedure involving ANVISA was announced on April 15, 2013. According to new rules, ANVISA will only examine cases where the subject matter of a patent application is considered to be “contrary to public health”, in other words when the application relates to:
1) a pharmaceutical product or process which poses a health risk: a product, the use of which has been banned in Brazil, or a process producing such a product; or
2) i) a pharmaceutical product or process which is of interest to the policies or medicines or pharmaceutical assistance within the National Public Health System; and
3) ii) said product/process does not comply with the requirements of the Brazilian IP Law.
There is substantial concern that “strategic” products – which are of interest to the policies on medicines or pharmaceutical assistance within the National Public Health System – will not receive prior consent. At this stage it is not clear whether ANVISA will restrict its analysis to safety and efficacy or if it will continue to meddle with patentability issues. It is also not clear whether the “strategic” product list will be increased from time-to-time or continue to be limited to those listed in ANVISA’s resolution.
Brazil has already put in place regulations related to genetic resources, in the form of access and benefit sharing (ABS). In 2001, the Federal Government created the Genetic Heritage Management Council (CGEN), an organizational body composed of eight ministries and ten Federal organizations responsible for the deliberation and development of standards for access and benefit sharing in Brazil’s national territory. The Provisional Act 2.186/16/01 of August 23, 2001 establishes that access and remittance of genetic heritage components, and any associated traditional knowledge, for the purposes of scientific research, technological development or biodiversity prospecting, shall be subject to prior authorization by CGEN.
On November 10, 2006, CGEN published Resolution number 23, requiring that patent applicants should inform the Brazilian PTO whether the subject matter of the patent was obtained or not from access to samples of components of genetic resources, occurring as of June 30, 2000. This Resolution was revoked by subsequent Resolution MMA 34 of February 12, 2009 which stipulated that in compliance with provisional Act 2.186/16/01, the applicant should inform the PTO of the origin of the genetic material and authorized access number granted by the competent authority in those cases where the subject matter of the patent application was obtained via access to samples of components of genetic resources, occurring as of June 30, 2000.
As a result, the President of the Brazilian PTO has published related Resolutions regulating norms for patent applications whose subject matter has been obtained as a result of access to samples of components of genetic resources in Brazilian territory. An earlier Resolution had required applicants to submit information on access to samples of components of genetic resources when filing the patent application, but it was revoked in favor of Resolution 207/2009, which currently allows the applicants to submit the information after the filing of the applications at the PTO.
The Brazilian PTO has since issued numerous office actions calling upon applicants to inform them, within a time limit of 60 days, whether the subject matter was obtained via access to samples of components of genetic materials. Statistics show that the great majority of applicants have attended to these requirements by informing that no access to samples of genetic material was made. The Brazilian Association of Intellectual Property’s proposal is to allow the applicant to submit the information and authorization access number for those cases where access to samples of genetic material was made up to the conclusion of the examination proceedings. A flexible timeframe for providing the required authorized access number to the Brazilian PTO makes sense, as companies face a Herculean task to obtain the required permit from CGEN.
Recent statistics show that merely 137 authorizations for bioprospecting and technology development were granted by CGEN, 25 contracts for utilization and benefit sharing were endorsed by CGEN so far, and currently there are 300 requests being analyzed by CGEN, of which 112 are requests to regularize accesses which did not observe the requirements of provisional Act 2.186-16/2001.
The Ministry of Development and Industry and Foreign Trade is contemplating changes in the IP Regime, particularly in the Biotech area. In addition, Provisional Act No. 2.186-16/2001 is targeted in terms of improving access to samples of components of genetic resources in Brazilian territory.
The major concern presently is the delay of the Brazilian Congress in ratifying the Nagoya Protocol, the international agreement which establishes rules for access and benefit sharing (ABS) of genetic resources. Congress was entrusted with the issue in May 2012, with the purpose of creating a special commission for discussion and decision. So far, no progress has been made. The Nagoya Protocol will only enter into force when 50 countries have ratified.
In December last year, ANVISA launched the strategic alignment of its regulatory agenda for the next four years. The new model announced by the agency brings substantial changes, especially those that will allow for society’s participation.
At the launch, the Secretary of Science, Technology and Strategic Inputs at the Ministry of Health stressed the importance of introducing health innovations into the Public Health System. A key role of the ANVISA regulatory agenda is that it aligns the most important regulatory programs of the agency with the Federal Government’s “Brazil without misery” program. The goal of that program is to develop the local industrial Health Sector as a strategic area for national development.
The Strategic Goals for ANVISA for 2013-2016 include fostering science technology and health innovation, the integration and strengthening of International Operations, and the simplification and streamlining of administrative procedures at the organization, such as de-bureaucratization of processes and organization of drug approval applications. ANVISA has been strongly criticized for its
slow speed in approving research trials and innovative drugs and even generic drugs whose approval the Government has prioritized. As a result, the regulatory agency has promised to improve its framework, restructure the agency and implement electronic drug registration to meet the growing demand for drug registration. ANVISA) initiated on July 12, 2013 a public consultation (Consultation No. 22/13 at https://portal.anvisa.gov.br/) addressing new requirements for reporting manufacturing changes for active pharmaceutical ingredients (APIs). The proposal provides a classification system as to the types of possible changes and the reporting procedures that should be adopted in each case. The manufacturer will have to notify ANVISA of changes according to the impact on the safety of the product. For certain changes, the proposal is that the notification be made annually, while others require immediate communication to the agency after the changes have been implemented or even before their adoption. The deadline for comments is September 2, 2013.
Situation on rare diseases
Brazil lacks an official policy on rare diseases. Likewise, it lacks an official concept to define these diseases. Currently, there are some bills on rare diseases and orphan drugs under consideration
in Congress. Recently, the Pharmaceutical Research Industry Association has submitted a paper to Government Authorities, physicians, patients and other interested parties in defense of a National Policy for Rare Diseases in Brazil. It is expected that several initiatives will ensue, such as, seminars, discussions with Officials from the Federal Government, Congressmen, scientists and patients to ultimately achieve debates and collaboration for adopting such policy.
Rana Gosain, Senior Partner with the law firm Daniel Advogados
Born in former British Guiana in the West Indies and naturalized Brazilian, Rana is a registered Brazilian IP agent and a Brazilian attorney. Rana has worked in the Intellectual Property field for over 25 years and specializes in patent and design practice. Rana holds a post graduate degree in
Intellectual Property (PUC/RJ and Brazilian PTO – 1984). In the past he has served as Chairman of the Patent Commission in the Brazilian Intellectual Property Association.