Defending public health from abusive patents in Argentina

Fundación Grupo Efecto Positivo defends Argentina’s public health from the abusive patents by multinational pharmaceutical companies

Fundación Grupo Efecto Positivo (FGEP), announced in a press conference on November 30th two new actions to defend public health policies. FGEP works to guarantee access to essential medicines and treatments for HIV and Hepatitis C in Argentina and Latin America, and is a partner in the ITPC-led UNITAID-funded consortium to make medicines more affordable. Dr. Daniel Gollán, Argentina’s Minister of Health, joined the conference, as well as prominent government officials and civil society representatives.
The two actions are the latest steps taken by FGEP to challenge the unfair practices of companies that use cynical strategies to protect their drugs from market competition.  In May 2015, FGEP pursued an opposition to a patent application for sofosbuvir (prodrug that cures Hepatitis C), and a joint collaboration with the Ministries of Industry and Health to apply health safeguards in relation to intellectual property claims. FGEP together with the government is calling for a fourth ‘90’ goal to be added to the “90-90-90” strategy initiated by UNAIDS – for 90% of HIV treatments to be available at an affordable price.
“Medicines are not merchandise: they’re social goods to preserve health,” explains Lorena Di Giano, Executive Director, of FGEP. “We have to be vigilant to preserve and protect public health from the commercial interests of pharmaceutical companies.”

Judiciary application to stand for Public Health Policies

FGEP entered as an interested third party – in defense of public health and access to medicines – in the judiciary file that the Argentinian Chamber of Medicinal Specialties (CAEME in spanish) along with 26 foreign pharmaceutical companies have presented against the Argentinian State (Ministry of Health, Ministry of Industry and the National Institute of Industrial Property). These companies aim for the annulment of a Joint Resolution that approved in 2012 the Guides for the Exam of Pharmaceutical Patents. These guides are considered a world example in terms of public health policies, since they guarantee adequate administration of the medicinal patents system, and prevent abuses from the multinational pharmaceutical companies.
The Guides for the Exam of Pharmaceutical Patents – also known as ‘Anti-Evergreening Resolution’- are an important tool to rationally establish an interpretation of the requisites stated in article 4th of Argentina’s patent law (Law 24.481) in relation to ‘novelty’, ‘inventive step’ and ‘industrial application’. All countries belonging to the WTO and signatories of the TRIPS agreement have the faculty to define their patentability criteria. This represents a vital opportunity to protect public health, as it provides each country with the right and freedom to nationally define what is patentable and what is not.
FGEP, with its presentation as interested third party, aims to support Argentina’s right to defend public health against the abuse of multinational pharmaceutical companies that are attacking these Guides for the Exam of Pharmaceutical Patents as they set high standards for patent request analysis in terms of novelty and inventive step, therefore preventing unnecessary monopolies in the local medicine market that would result in a barrier for the access to treatment for HIV, HepC and other diseases.
Since the adoption of these legitimate measures to protect public health affects their commercial interests, multinational pharmaceutical companies are suing the Argentinian State, in a clear strike against its national sanitary sovereignty:.

Opposition to a Patent Application for HIV treatment medicine

At the same time, FGEP also filed an opposition at the National Institute of Industrial Property to a patent application for an essential medicine for HIV treatment (lopinavir+ritonavir, commercial name ‘Kaletra’). The opposition argues and demonstrates how the patent application from the American company Abbott does not meet the legal patentability requirements and should therefore be rejected. The patent application for Lpr/Rtv (tablet) is still pending in Argentina. Abbott’s claim for a patent on the basis of the varying doses and methods, doesn’t comply with Argentinian law and the anti-evergreening resolution and are therefore not patentable due to lack of novelty and invention.
FGEP’s preliminary investigation demonstrates that the vast public investment required to acquire this product has a strong impact on the Ministry of Health’s budget: on its latest purchase, the Ministry spent over U$S 10 million (U$S 1,35 per unit) which represents 23% of the total budget for HIV treatment medicines. However, there are generic versions available in India, manufactured by Aurobindo and Mylan laboratories, being sold at U$S 0.183 per unit. If Argentina could buy the generic version at this price, it could save over U$S 9 million dollars, a 90% price reduction.
Lopinavir and Ritonavir (both together and separately) already have several granted patents in Argentina guaranteeing a legal monopoly until 2018. Abbott’s application would extend the patent until 2025, meaning another seven years of exclusivity to manufacture, sell and import the product at artificially high prices, at personal cost to people who won’t get treatment.
With its listing as as an interested third party in the Judicial File and the opposition to this unwarranted patent request, FGEP defends of public policies that protect the fundamental human right to health against commercial interests and abuses.