The State of São Paulo Forum on NGO/AIDS submitted a request letter on the compulsory licensing of sofosbuvir at the Republic Presidency, on September 24, at 9:25 am. One week before, the National Institute on Intellectual Property (INPI), granted the patent of the Hepatitis C drug to Gilead Sciences.
Addressed to the President of The Republic, the requests Michel Temer to evaluate the letter arguments based on the Article 71 of the Law n° 9.729, the Brazilian Law of Patent, and its guidelines. Signed by the president of FOAESP, Rodrigo Pinheiro, the letter emphasizes that, in the name of the public health good and the guarantee of the universal access, as it is provided by the Constitution of 1988, the enactment will save, from the Unified Health System funds, almost a billion Reais per year.
Check out the fully document below:
São Paulo, September 24, 2018.
Mr. Michel Temer
Brazilian Federal Republic
Palácio do Planalto
Praça dos Três Poderes
BRASÍLIA – DF
Copy to: Gilberto Occhi, Minister of Health and the National Health Council
Ref: Declaration of Public Interest Regarding to Compulsory Licensing
The State of São Paulo Forum on NGO/AIDS is a group formed in 1997, which represents more than a hundred Civil Society Organizations on the human rights of people living with HIV/AIDS (PLWHA) and their confections, and the appreciation of the Unified Health System (SUS). Last week, we publicly repudiated the patent grant of the drug sofosbuvir to the North American Pharmaceutical Company, Gilead Sciences, by the National Institute of Intellectual Property (INPI).
Based on the public interest, claimed through the Art. 71 of the Law n° 9.279, from May 14, 1996, regulated by the decrees n° 3.201, from 10/06/99 and n° 4.830, from 09/04/03, in 2007, Brazilian Government decreed the compulsory licensing of efavirenz, drug used on the treatment of HIV, prescribed, at that time, to about 40% of HIV infected people.
As well as the Working Group on Intellectual Property (GTPI), FOAESP considers the INPI decision erroneous and off balance, since the grant of patent had already been denied, besides the concession goes against technical arguments that proved the formula does not fill minimal criteria presumed by law, as sufficiency of disclosure and inventiveness that makes the grant of patent undeserved.
Besides the arguments above, the INPI decision inhibits the production of the generic drug in Brazil, that would save about a billion reais of the public funds, and jeopardizes the universal access to treatment for all Hepatitis C infected person, as assured by the Clinical Protocol and Therapeutic Guidelines for Hepatitis C and Co-infections, once the Constitutional Amendment 95/2016 “freezes" health spending. The decisions go against the Hepatitis C Elimination Plan for 2030, signed by the country at the World Health Organization.
Facing the arguments presented, and aiming to guarantee the access to treatment, the FOAESP requests, for the best of the Brazilian Public Health and the public interest, that the Republic Presidency declares the compulsory licensing of sofosbuvir, as provided by the Brazilian Law of Patent and the Trips Agreement, from the World Trade Organization, aiming to ensure the universal access to health as granted by the 1988 Brazilian Constitution.
Looking forward to your response,