The Brazilian Attorney General has filed a brief with the Supreme Court of Brazil regarding the unconstituitonal nature of the pipeline provision and the patents granted under it. Should the action succeed, pipeline patenting and patents on medicines granted under the provision could be cancelled, saving the Brazilian government millions of dollars.
To give some background to those unfamiliar with the pipeline provision in Brazil’s patent law:
Under TRIPS, member states were required to accept patent applications from the date the Agreement came into force i.e. 1 January 1995. Developing countries were permitted an additional ten years, until 1 January 2005, within which to provide protection for pharmaceutical product patents. Brazil chose to start providing protection on pharmaceutical products from 1996.
More significantly, through Articles 230 and 231 of Law No. 9.279/96 (Industrial Property Act), Brazil introduced a ‘TRIPS-plus’ provision called pipeline protection. This provision guaranteed protection for patents on food and pharmaceutical products that were invented prior to the date the TRIPS Agreement came into force in 1995, provided such products were not already on the market anywhere and that there had not been any prior serious preparations to place the product on the market in Brazil. Therefore, patents on medicines which were filed in another country well before TRIPS came into force would be entitled to protection in Brazil.
To illustrate, a patent filed in the U.S. in 1990 and which was yet to be marketed as a product would be entitled to a patent in Brazil, even though technically such an invention would not be novel as it would be considered to be in the public domain before 1995 (the date TRIPS came about).
To date, 1,182 pipeline patents have been granted in Brazil. These include ritonavir, efavirenz and imatinib (Glivec).
The full press release by the Brazilian groups sponsoring the challenge is below:
GTPI/Rebrip blame pipeline patents for the exorbitant costs of drugs needed to combat the HIV/AIDS epidemic
Brazilian Attorney General Antonio Fernando Barros e Silva de Souza filed a brief with the Brazilian Supreme Court on April 24, 2009 challenging the constitutionality of articles 230 and 231 of the Intellectual Property Act of 1996 which deals with revalidation or “pipeline” patents. According the Public Attorney, a federal agency which represents the public interest, “knowledge which currently exists in the public domain is public property (…). This legislation indirectly promotes a de facto expropriation of public property in contradiction to the Brazilian Constitution.”
The pipeline makes it possible to retroactively patent already existing patented products in other countries. This has led to patent protection for foods, medicines and other products. A total of 1,182 patents have been filed through the pipeline, including those for major drugs used to treat such diseases as HIV/AIDS and leukemia.
The Attorney General’s response was driven in part by allegations made in a proposal co-filed in November 2007 by the Brazilian Network for the Integration of Peoples (Rebrib) and the National Federation of Pharmacists (FENAFAR). The allegations provided a detailed expert analysis in which economists underscored how the pipeline process drove up the cost of antiretroviral drugs purchased by the federal government to battle the AIDS epidemic between 2001 and 2007. According to the data, Brazil spent between US$420 million (WHO minimum price comparisons) and US$519 million (comparing with minimum prices used by Doctors without Borders-MSF) for the medications.
According to Cristina Pimenta, General Coordinator for the Brazilian Interdisciplinary AIDS Association (ABIA) which currently heads the Rebrip Intellectual Property Working Group (GTPI), “the pipeline process, instead of fomenting national development in the public interest, actually obstructs universal treatment access for people living with HIV/AIDS. It forces the government into constant negotiation with multinational companies to lower prices which are protected by the pipeline process even though more affordable generics are available on the international market.”
FENAFAR president Celia Chaves adds “this legislation hasn’t been good to anybody in Brazil – not for the domestic pharmaceutical industry nor for the population at-large. Everybody has been hurt by the pipeline process”. According to Eloisa Machado, legal counsel to organization Conectas Direitos Humanos, part of the intellectual property working group, “the constitutionality of this legislation must come into question at the Supreme Court’s hearings on health. Currently, the government is taking an incredible hit to guarantee access to these drugs for those in need because of the price gauging driven by the pipeline process. This constitutional challenge presents a wonderful opportunity for the Court to analyze the actual reasons as to why the government is paying such a high price for essential medications and to demystify the argument that such prices are justified to pay for the cost of innovation. Price gauging may just prove to be the fruit of unjustifiable monopolization.”
The sponsors of the proposal applaud the Attorney General’s constitutional challenge, and believe that it will unite those interested in the valiant fight for universal access to treatment.
The constitutional challenge was received by the Hon. Carmen Lucia Antunes Rocha, Supreme Court justice on April 27 who will evaluate possible suspension of the articles in question. The organizations expect that urgent action will be taken due to the dire effect of this legislation on the public health and access to treatment.
Pipeline patent examples:
Efavirenz, a medication whose compulsory license was recently issued, is protected by a patent obtained through the pipeline process. It did not meet the criteria for novelty when the patent was originally filed in Brazil which information about its invention had already been published outside Brazil five years prior. The active ingredient could have been manufactured in Brazil as it was in India.
Other basic medications used in the aresenal to fight the HIV/AIDS epidemic have also been protected by the pipeline, including lopinavir/ritonavir, abacavir, nelfinavir and amprenavir and thus withdrawn from the public domain. Cancer drugs such as Imatinib, sold commercially by the brand name Glivec®, have also come under protection by the pipeline. The drug is used to treat people living with chronic myeloid leukemia, which affects bone marrow, at a monthly cost of nearly US$4 thousand per patient.