Official message in regards to not granting a patent for Tenofovir in Brazil
GTPI’s message in regards to not granting a patent for Tenofovir in Brazil
It is with great satisfaction that we have become aware that the patent for the medicine Tenofovir (TDF), from Gilead, was not granted by the National Industrial property Institute (INPI). This medicine is used in the treatment of people who live with HIV/AIDS and currently it is vital for over 30,000 Brazilians. In 2006, several organizations which make up the Working Group on Intellectual Property (GTPI, in Portuguese) of the Brazilian Network for the Integration of Peoples (Rebrip, in Portuguese) have presented technical pre-grant oppositions to INPI, demonstrating that the product d in the patent request did not fulfill the inventive activity requirement indispensable condition for granting a patent in the country and that the d formulations were already of public knowledge in the 1980’s, when Brazil didn’t even recognize pharmaceutical patents.
Tenofovir’s patent has been questioned in several countries around the world, among them are the United States and India. Groups of people living with HIV/AIDS in India and the Brazilian Interdisciplinary AIDS Association (ABIA, acronym in Portuguese) have already opposed to granting two patent requests for the medicine in the Indian patent office and are still waiting for the final decision.
Not granting Tenofovir a patent will help to maintain the National STD/AIDS Program of the Brazilian Ministry of Health, since Brazil will be able to import or locally produce generic versions of the medicine. The sustainability of the National Program is fundamental for all those who are living with HIV/AIDS and must be part of society’s constant struggle. Currently, the medicine bought by the Brazilian government from Gilead is about 8 times more expensive than its generic Indian version. Indian, unlike Brazil, used the transition period granted to developing countries by he TRIPS Agreement, and for this reason it could produce generic versions of medicines until 2005 and still today enjoys the benefits brought by this decision.
We must reaffirm that the real inventor must receive merits and recognition for his invention. However, the industrial property system has been allowing the constitution of monopolies through unmerited patents, removing from public domain knowledge which can save lives. Social control and effective participation of organized civil society is the most efficient way to stop low quality patents from being granted. The denial to Tenofovir’s patent request is an important step towards broadening and maintaining access to essential medicines in the country, and is an important precedent for those who fight against the abuses of the current intellectual property system. New challenges are now posed, such as: the urgent need to turn the importation of generic versions feasible and to advance in the local production of affordable medicines.
Public hearing isolates INPI’s president and demonstrates greater coherence among Ministries
Published on November 6th, 2008
Discussion on patenting polymorphs and therapeutic second use polarizes Ministries and Parliamentarians on one side and INPI on the other
On October 30th, 2008, a public hearing took place in the Chamber of Deputies on the “Guidelines for Examination of Pharmaceutical Patents”, due to the revision of the guidelines for patenting of medicines which has been happening in the National Industrial Property Institute (INPI, in Portuguese) and intends to include patent protection for polymorphic forms and medical second use. The patent possibilities have been vastly criticized by several Ministries’ of Lula’s government, jeopardizing INPI’s policy in making these decisions only based on internal opinions.
INPI intends to establish a public policy to broaden the patentability scope for medicines in Brazil, including, for example, the possibility of granting patents for second use. Granting patents for a new use of a known pharmaceutical product allows broadening the scope of protection, granting another 20 years of exclusivity in the exploration of a previously known and protected medicine.
The public hearing included representatives of the Development, Industry and Commerce Ministry (MDIC, acronym in Portuguese); Foreign Affairs Ministry, Health Ministry and INPI’s president. Both the Health and the Foreign Affairs Ministries positioned themselves against these two forms of patenting, mainly based on the fact that such measures are considered TRIPS-Plus mechanisms and go against the Development Agenda of the World Intellectual Property Organization (WIPO) and the Global Strategy and Plan of Action on Innovation, Public Health and Intellectual Property (WHA 61.21), recently approved in the World Health Organization. The MDIC, in spite of not taking a stand in regards to the issue, backed up the other Ministries in the belief that the new guidelines should not be decided by INPI, but should be a consensus reached by the government.
Congressman Paulo Teixeira (from the Workers’ Party of São Paulo), which called for the public hearing, questioned the coherence among the policy adopted by INPI and the government’s policies in general, and agreed that it is not the role of an independent institute to formulate policies and that, therefore, INPI is going beyond its powers.
Parliamentarians Coruja (Popular Socialist Party of Santa Catarina) and Rita Camata (Brazilian Democratic Movement Party of Espirito Santo) agreed with the Ministry of Health’s position that broadening patentability to polymorphs and second use goes completely against the protection of public health and the access to medicines policy.
As a proposal for follow-up, the representative of the MDIC and coordinator of the Interministerial Group on Intellectual Property (GIPI, in Portuguese), Francelino Grando, agreed that is was not part of INPI’s responsibilities to establish rules and, as a result, the proposal of examinations guidelines was to be approved by GIPI.
As requested by some parliamentarians, it was agreed that the GIPI meetings for evaluating the examination guidelines would also involve some parliamentarians in the elaboration of position papers for Bills related to the topic.
According to INPI’s president, the revision of guidelines has the participation of technical experts of the institution, of the pharmaceutical companies, and academic experts. After this stage, the document was sent to INPI’s Attorney for revision and a supposed approval.
Since 2007, representatives of the civil society and members of the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/Rebrip, in Portuguese) have been following the revision process of pharmaceutical patent examination guidelines in INPI and were present in the public hearing. Several opinion and position papers and letters were elaborated by GTPI, in regards to the manner in which INPI conducted this guideline revision process and also in regards to patenting of polymorphs and therapeutic second use.
Guidelines for Medicine Patents What is in stake?
The manner in which a public organ defines the rules which will define the patents for essential goods such as medicines is of great importance for society as a whole. Patent protection of medicines has important implications for public health, since the government and consumers may become restricted to a single producer, which may charge high prices, affecting public and private budgets for the procurement of medicines. In short, patents allow monopoly over production and commercialization of essential medicines which directly impacts the lives of people, since it interferes in the population’s access to medicines.
Each country has the freedom to define its criteria for granting patents in the pharmaceutical sector, and the definition of broad patent criteria, such as for therapeutic second use patenting, may have negative implications on public health.
In this sense, adopting broad or strict criteria is a POLITICAL DECISION and, for this reason, it should include all interested sectors of society.
One year of compulsory licensing: where is the local production of efavirenz?
Message from the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/Rebrip, in Portuguese)
The month of May 2008 is a symbolic for movements fighting AIDS and in defense of the Brazilian right to health since it is marks the one year anniversary of the compulsory license for the antiretroviral (ARV) medicine Efavirenz. The compulsory license of the medicine was issued on May 4th, 2007.
Since the intellectual property agreement the TRIPS Agreement of the World Trade Organization (WTO) was put into force, and the consequent change in Brazilian Patent Law which began recognizing pharmaceutical patents new medicines for HIV?AIDS and for many other illnesses began being commercialized in monopoly situations and charged at high prices. The topic of intellectual property has been present in the agenda of health-related social movements, especially due to the threat posed by the prices of new technologies to the sustainability of universal access to treatment policies whose implementation in our country is a result of much struggle. Ever since, we have defended the use of the TRIPS Agreement’s flexibilities for the protection of public health, as is the case of compulsory licenses.
In this sense, we congratulate the current Health Minister, José Gomes Temporão, for having used this instrument, foreseen in the Brazilian and international legislations, in order to guarantee the continuity of the policy of fighting the HIV/AIDS epidemic in Brazil. We understand that this is also a result of national and international social mobilization throughout the last few years. The compulsory license has already brought benefits to Brazil, allowing great savings to be made, since the government started paying about a quarter of the price it used to pay for the same medicine.
In regards to the controversy and questioning about the Brazilian capacity in producing antiretrovirals, which appeared the last few years, several studies were held by organizations such as the Brazilian Interdisciplinary Aids Association, Médecins Sans Frontièrs, United Nation’s Development Program (UNDP) and Clinton Foundation confirming the national capacity to produce ARV medicines. However, the procurement of generic, cheaper versions of the medicine from Indian companies was seen as a temporary solution until local production by a public, national lab was started.
As announced by several media channels, the federal pharmaceutical laboratory, Farmanguinhos, has been promising the production of ARV medicines, such as the triple, fixed-dose combination (AZT+3TC+NVP) and the enteric formulation of didanosine. Efavirenz itself should be already in production, after a year of its compulsory license. However, until now, none of these promised medicines was made available in the Unified Health System. We do not want to wait so long until they become obsolete or inadequate, and then be made available. Given the evidence and revelations, a year after the compulsory licensing of efavirenz, civil society’s question to the government remains: where is the national efavirenz?
These facts bring up questions in regards to the lack of transparency on the price of these supposedly locally produced medicines, as well as to the current status of these productions. How is Brazil preparing itself to produce the medicines whose patents will soon expire and are widely used in the country?
After 2005, the current scenario presents no alternatives in international suppliers of generic versions. Our defense continues in favor of the local production as a strategic component of the sustainability of the policy which guarantees access to antiretrovirals and other essential medicines. We want local production to be based on transparent procedures and policies, and to rationalize the use of public resources.