Mechanism for the granting of patents known as “pipeline” patents violates the Federal Constitution
On November 28th, the National Federation of Pharmacists (FENAFAR), on behalf of the Brazilian Network for the Integration of Peoples (Rebrip), presented to the General Attorney of the Republic, Mr. Antônio Fernando Barros e Silva e Souza, evidence that demonstrates the unconstitutionality of two articles of the Brazilian Industrial Property Law (Law 9.279/96). According to the authors of the case, articles 230 and 231 of Law no. 9.279, that created the patent granting mechanism known as the “pipeline”, violate the constitutional principles that impose the supremacy of society’s interest and the pursuit of the country’s technological and economic development over intellectual property protections (art. 5, XXIX). They argue that the granting of pipeline patents also violates the society’s acquired right (art. 5, XXXVI); implied due legal process (art. 5, LIV) and the principle of equal treatment before the law (art. 5, caput).
The pipeline mechanism is an institution created by the Industrial Property Law that allowed the filling of patents in technological fields that, prior to 1996, had not yet been granted in Brazil. The mechanism made it possible to obtain patent protections for pharmaceutical and food products (among other products). The requests for patents via the pipeline mechanism are only subject to a formal analysis and they follow the terms of the patent granted in foreign countries. They are not submitted to a technical evaluation of the product’s ability to meet patentability requirements – novelty, inventiveness and industrial application – conducted by the Brazilian patent office, the National Institute of Industrial Property (INPI in Portuguese). In total, 1 182 patents were filed under the pipeline mechanism, many of which are for essential medicines used in the treatment of HIV/AIDS and leukemia, for example. Many of the products for which patents had been granted through this mechanism were already in public domain prior to 1996.
A study elaborated by economists calculated the hypothetical financial losses caused by the adoption of the pipeline mechanism in the case of government purchases of five anti-retroviral drugs (ARVs), during the period 2001-2007. The results show that, due to the granting of unmerited patent protections for these medicines, the Brazilian state paid an additional US$ 420 million, when prices paid were compared to the World Health Organisation’s minimum prices, and an extra US$ 519 million, when compared to the minimum prices of Doctors Without Borders (MSF) for the ARVs.
In the opinion of Cristina Pimenta, General Coordinator of the Brazilian Interdisciplinary AIDS Organisation (ABIA), the organisation currently coordinating the Rebrip’s Working Group on Intellectual Property, “instead of contributing to the development of the country and serving public interest, the pipeline mechanism only serves as an obstacle to universal access and gratuity of treatment for people with HIV/AIDS”. FENAFAR’s president, Célia Chaves, adds, “no gain has been made by this concession – neither for the national pharmaceutical industry and sector, nor for the population in general. All were harmed by pipeline patents”.
Rebrip and FENAFAR hope to have the current case approved by the General Attorney of the Republic, so that it will be sent to the Federal Supreme Court in the form of a direct action of unconstitutionality.
Examples of pipeline patents
Efavirenz, a medicine for which a compulsory license was recently issued, is protected by a patent granted through the pipeline mechanism. In other words, when the patent of this drug was filed in Brazil, it no longer met the novelty requirement, as the information on the invention had already been published abroad five years earlier. This active ingredient could have been produced in Brazil, as it was in India.
Other medicines that are fundamental for curbing the HIV/AIDS epidemic, such as lopinavir/ritonavir, abacavir, nelfinavir and amprenavir, also were protected by the pipeline mechanism, and as such, were withdrawn from public domain without any evaluation of its importance in terms of the country’s interests. Furthermore, the medicine for cancer – imatinib or Glivec (brand name) – was also protected by the pipeline mechanism. This drug, used to treat people living with Chronic Myeloid Leukemia, currently costs R$ 10 000,000 (ten thousand Brasilian reals) per month, per patient.
Renata Reis (ABIA/GTPI/Rebrip): +55 21 – 9114 1838
Eloísa Machado (Conectas Direitos Humanos): +55 11 – 3884 7440
Zizia (Fenafar): +55 11 – 3259 1191
Fátima Mello (Rebrip):+55 21 – 2536 7650
Renata (Fenafar, Press Advisor):+55 11 – 9327 1747
Cláudio Oliveira (ABIA, Press Advisor):+55 21 – 2223 1040 / +55 21 9202 6534