BRICS sign MoU on Health Regulation

On October 23rd, Brazil, Russia, India, China, and South Africa, the BRICS, signed a Memorandum of Understanding (MoU) on health regulation during the 5th Meeting of BRICS Health Regulatory Authorities. The meeting took place at the Pan-American Health Organization’s headquarters in Brasilia, Brazil.

The countries’ main goal is to promote cooperation and to share best practices in regulating medical products, pursuing to harmonize their sanitary norms. The MoU is expected to ensure greater communication and collaboration between the health sector regulators. It also has the potential to increase the trade of pharmaceuticals and medical devices among the countries. 

Together, China, Brazil, and India have a US$ 150.5 billion market on pharmaceuticals and a US$ 112 billion on medical devices.

Brazil sets a new chapter in its public health policy

During a seminar hosted by the Brazilian Association of the Pharmaceutical Research Industry (INTERFARMA) last week in Brasilia, the Minister of Health, Luiz Henrique Mandetta, said the country should never compulsory license drug patents, since this practice harms both the inventiveness and the investments made in R&D by private companies. This sets a new tone on the government’s position towards intellectual property for pharmaceutical products. 

“There is no good in threatening to break patents. The country should never do this. We have to watch over the inventiveness and the time spent by researchers over the research counter. I know that each one of you spend hundreds of thousands of dollars to establish your compliance system [to comply with law and regulation], and that this is now mandatory inside the companies”, said Mandetta. 

The Minister of Health’s speech is in line with the Ministry of Economy’s liberal positioning. The statement that “the country will not set a public health policy based on patent breaking” sets a new chapter in the Brazilian public health policy. The Minister addressed healthcare sector executives and stated that, since the private sector is the one responsible for providing drug production, the Government’s role should be to stimulate production initiatives.

During INTERFARMA’s seminar, the Minister of Health affirmed his commitment with innovation, as well as with providing public access to new pharmaceutical technologies through the Brazilian National Healthcare System (SUS). He also said the Government is currently revising the model it uses to incorporate healthcare therapies.

 “The Ministry of Health has great expectations regarding the healthcare sector. The 21st century will be a wonderful century to live in. Each one of you can be in the imminence of announcing the next step, the next breakthrough. After deciphering the human genome and putting it at science and the pharmaceutical industry’s disposal, we knew we would have a century of innovations in genetics”, he said.

The seminar was attended by the Minister of Health, the Presidents of the House of Representatives and the Senate, Congressmen, the Brazilian Patent and Trademark Office’s (INPI) President, executives of the healthcare sector and other public officials. There were presented panels about intellectual property, the country’s economic landscape, innovation and clinical research.

Eduardo Hallak, partner at Licks Attorneys, also attended the event.

Public officials attend the Seminar “Healthcare Technological Innovations and its Value for Patients”. Photo: INTERFARMA.

Mercosul and European Union close free trade deal

This Friday, June 28th, Mercosul and the European Union finalized the negotiations between the two regional blocs.

The accord that includes goods, services, investments and government purchases, has been under discussion for two decades between Europeans and South Americans. Talks started in June 1999. Offers were exchanged in 2004 but disappointed both parties and were interrupted. In 2010, the two blocs started again to switch proposals.

The final round of negotiations was initiated by technicians last week. Ministers from Mercosul and the EU were called on Thursday 27th and are putting an end to meetings in Brussels.

The agreement between Mercosul and the EU is a landmark. It is the second most important treaty signed by the Europeans – only after the one signed with Japan – and is the most ambitious achieved by Mercosul.

The agreement will enable most products to be commercialized between the two blocs without taxes. The Europeans will rapidly eliminate taxes but will maintain import quotas for some agricultural products. Concerning Mercosul, it could take up to a decade for the most part of aliquots to be suppress.

Agrochemicals debated in Brazilian Senate

On June 12th, a debate about the “Importance of governmental politics on industrial property to fight against the negative impacts of agrobusiness”, requested by Senator Lasier Martins (Podemos/RS), was organized in the Senate by the Commission of Agriculture and Agrarian reform (CRA).  

Panelists discussed the negative impacts of the chemical industry on agrobusiness, as well as the need to modernize the Brazilian agriculture and the possibility for generic pesticides to reduce the costs of national production.  

Participants also highlighted the influence of system of industrial property (IP) over various sectors of the economy, and mechanisms safeguarding the IP system are motors for innovation and development. The IP system thus needs to adapt its legal framework to fit new reality of the country’s industrial sector.  

They mentioned the importance of reducing the patent backlog, and more specifically the backlog per examiner leading to delays in evaluations. The average time for analysis is ten years, which affects competitiveness. The BRPTO must hence be strengthened as an institution to increase its productivity and should continue taking steps in this regard. 

Proposal authorizes BRPTO to conclude agreements and partnerships to streamline patents

Bill #2334/19 authorizes the signature of covenants or partnerships between the Brazilian Patent and Trademark Office (BRPTO) and public or private entities. The text seeks to alter the Brazilian IP Statute(9.279/96), which also refers to the authority’s competences.   

The proposal suggests including the following sections to Article 239 of the Brazilian IP Statute:  

“Art. 239 …  

IV – Sign covenants and partnerships with civil society organizations and public institutions focused on capacitation and training to provide support, assistance and guidance to interested parties when requesting the patent registration;  

V – Sign covenants and partnerships with civil society organizations and public institutions destined to the realization of actions prior to technical patent registration decisions”.  

The proposal is under examination by Congress. Congressman Marcos Pereira (PRB-SP), affirmed that the patent registration process in Brazil, currently under the exclusive responsibility of the BRPTO, has been criticized mainly due to its backlog – eleven years in average.  

“With this proposal, the objective is to allow the BRPTO to sign covenants and partnerships, either to decentralize its activities or to train professionals who can help in the task of granting registration”, affirmed the Congressman.  

With regards to decentralization, the proposal refers to the good results attained by other countries, like Japan, where companies linked to the patent organization, and the recruitment of temporary professionals enabled the backlog’s reduction by more than 50%.  

As for the training of professionals, close to 50% of demands include mistakes that slows down the process even more, so it is valid to consider the possibility of the BRPTO training also other stakeholders to provide guidance for the filing of applications with less mistakes, hence accelerating the registration grant.  

Brazil’s involvement in international organizations strengthened after votes by Senate

The Senate Plenary approved on May 30th the international agreement on Brazil’s greater involvement in the Organization for Economic Co-operation and Development (OECD).

Bill #59/2019 institutionalized the country’s participation in various OECD forums and established the mechanisms to define future guidelines. It will reinforce the coordination of the Brazilian government’s participation inside the organization, handled by an interministerial work group, supervised by the Ministry of External Relations.

Bill #59/2019 institutionalized the country’s participation in various OECD forums and established the mechanisms to define future guidelines. It will reinforce the coordination of the Brazilian government’s participation inside the organization, handled by an interministerial work group, supervised by the Ministry of External Relations.

On May 23rd, the United States officially declared their support for Brazil’s entry in the OECD. Donald Trump had already suggested, during President Bolsonaro’s trip to the US last March, that his government would back up Brazil’s demand. Rapporteur Senator Antonio Anastasia highlighted that the entity encourages its members to adopt converging standards in commercial, financial, environmental and social matters. He estimates that the internalization of the accord should be helpful to Brazil during the country’s integration process as a full OECD member. 

The Plenary also approved an accord about the amendment to voting powers in the International Financial Corporation (IFC), an organ of the World Bank, in favor of developing countries. This alteration increases the participation of basic votes from 1.88% to 5.55%. As such, the voting power of developing nations, like Brazil, increased from 33.4% to 44.1%. Basic votes are distributed equally among member states, while share votes are distributed proportionally based on the capital held by each country. According to Rapporteur Senator Antonio Anastasia, this agreement is “favorable to Brazil”, as it will hold 2.27% participation in the IFC.

Brazilian Senate approves Regulatory Agencies’ Legal Framework

The bill intents to regulate “the management, the organization, the decision process and the social control” of the federal regulatory agencies in Brazil.  

The Brazilian Senate’s floor approved on May 30, 2019 the text of the General Law of Regulatory Agencies (Bill S. 52 of 2013 or PLS 52/2013), which establishes a variety of measures that aim to guarantee the transparency and autonomy of these institutions, as well as to avoid the interference of private sector interests on regulatory requirements. The bill also deals with the interaction between regulatory agencies and competition agencies, as well as the operational interaction between regulatory agencies and federal, state, and municipal regulatory bodies. 

According to the new legal framework, every agency will have to present an annual activity report to the Brazilian Congress. Among other information that will need to be presented, the agencies will have to justify their expenditure and present the results of the regulatory actions and inspections they conducted. The bill also promotes adjusting the specific bills that have created the federal regulatory agencies, such as the ANATEL, ANVISA and ANS. 

Agencies will also have to establish the so-called “management contracts” with the Ministries to which they are linked. These contracts should present goals to be attained, establish frameworks and determine funding sources to their activities. Also, agencies will have to appoint an ombudsman to work with their respective Board of Directors. Furthermore, the bill determines that politicians or their relatives cannot be appointed to management positions inside federal agencies. Officials in these positions will now hold a maximum term of 4 years with a single renewal.  

BRPTO confirms partnership to facilitate patent application and grant

The Brazilian Patent and Trademark Office (BRPTO) signed on May 24th a protocol of intentions with the Aeronautical Engineering Institute (ITA), and a cooperation agreement with the Research Foundation of São Paulo (FAPESP).

The announcement was made in parallel of the event “Engineering Education for the Future” (EEF) organized in São José dos Campos (São Paulo State).

Cláudio Vilar Furtado, BRPTO’s President, indeed affirmed that a closer relation with ITA and FAPESP has been a priority of the institute. Today, the BRPTO has partnerships with 13 universities in the country.  

The objective of the partnership with ITA is to promote and expand the use of the intellectual property (IP) system by ITA, as it includes the training of human capital in IP, the exchange of personnel and development of joint knowledge. It thus provides students and researchers more information on the patent application and grant.

The agreement with FAPESP will make technical information available, and link efforts, competencies and technical knowledge for the development of projects, studies and research in the IP domain.

BRPTO takes on the pro tempore presidency of IP BRICS

During the 11th BRICS Heads of Intellectual Property Offices (HIPO) meeting held in Cape Town – South Africa on April 14-16, the pro tempore presidency of the IP BRICS was transferred to the BRPTO, which will be responsible for the coordination of the block’s activities for a year.   

Among heads of institutions, Cláudio Vilar Furtado (BRPTO), Grigory Ivliev (Rospatent-Russia), O.P. Gupta (CGPDTM-India), Shen Changyu (CNIPA-China) and Rory Voller (CIPC-South Africa) attended the meeting. The delegation of the BRPTO was also composed of Alexandre Dantas (Directorate of Patents) and Erica de Holanda Leite (International Relations Coordination).  

Themes that were discussed during the meeting: IP promotion for small and medium companies; exchange of IP databases; IP dissemination; and consensus-building in international forums.  

The BRPTO presented its new projects in the area of patents – the technical examination of patents with Markush formulas, and the management of the workload using data about the volume of patent applications – that should be developed in 2019.  

INPIがIP BRICSの議長国に就任

4月14日~16日にかけて南アフリカのケープタウンで開かれた「第11回BRICS 知的財産権長官会合」で、ブラジル特許庁(INPI)が「IP BRICS」の臨時議長国を務めることが決定した。INPIは今後一年にわたり、BRICS加盟国の活動の調整に責任を負う。

会合にはINPIのクラウジオ・ヴィラール・フルタード(Cláudio Vilar Furtado)長官、ロシア連邦特許庁のグレゴリー・イヴリエヴ(Grigory Ivliev)長官、インド特許意匠商標総局のO・P・グプタ(O. P. Gupta)局長、中国国家知識産局の申長雨(Shen Changyu)局長、南アフリカ共和国企業・知的財産登録庁のロリー・ヴォッレル(Rory Voller)長官が出席した。ブラジルからはフルタード氏のほか、特許部のアレシャンドレ・ダンタス氏、国際関係調整部のエリカ・デ・オランダ氏が参加した。

会合では、中小企業向けの知的財産権保護の促進、知的財産データベースの交換、特許審査の手順・プロセス、知的財産情報の普及、国際フォーラムにおける合意形成などについて議論された。

INPIからは、マーカッシュ形式の技術特許審査に加え、今年進展するとみられる、特許出願件数に関するデータを用いた作業量管理などの特許分野の新プロジェクトが紹介された。