PLHIVs in Argentina file patent opposition against Gilead/BMS ARV combination Atripla

 

Argentina, December 4 , 2013.-

For the first time in Argentina organized communities filed a pre-grant opposition against a patent for a combination of antiretrovirals with priority use in the country.

A pricing study conducted by RedLAM “Latin American Network for Access to Medicines”, showed that for example the TDF + FTC + EFV is drug that is sold exclusively in Argentina under the name and trademark “ATRIPLA ®” that costs the public program provision about  U.S.$ 2605 per person per year.

It is a compound for which the U.S. Company Gilead Sciences, along with Bristol Myers Squibb Laboratories pursue a pharmaceutical patent which is in the review phase at the National Institute of Industrial Property (INPI).

This prompted the concern of the activists and organizations of people with HIV who have filed today a Health Safeguard, an opposition against the patent application of TDF + FTC + EFV.

This drug is very important for our people because it is easy administration in a single daily dose, ie in one pill per day …” said Pablo Garcia, Secretary General of Argentina Network of Positive People, an organization that has been working in the country since 1998 to improve the quality of life of people with HIV, signer of the opposition.

In May 2012, Argentina has passed new guidelines for the examination of pharmaceutical patents that instruct examiners at INPI.

These guidelines indicate that combinations of existing compounds, as is the case with ATRIPLA ®, Tenofovir + including + Efavirenz Emtricitabine (TDF + FTC + EFV) are not patentable, attentive lack of novelty and inventive step to justify the granting of a new patent on these active ingredients that are in public domain.

It is very usual lately that pharmaceutical companies try to patent the same molecules making just small changes, or combining existing drugs, this is called “evergreening ”  said Jose Maria Di Bello, signer of the opposition.

The new manual for the examination of pharmaceuticals patent applications in Argentina, is a joint resolution adopted by the Ministry of Health (MS 546/2012), the Ministry of Industry (MI 118/2012 ), and the National Institute of Industrial Property (INPI 107 / 2012), establish internal guidelines to stop this abusive practice public health, revealing the great impact that pharmaceutical patents have on access to medicines.

We welcome the establishment of new guidelines for examination of pharmaceutical patents in our country which takes particularly into account the needs of public health of our population” said Lorena Di Giano, Executive Director of the Foundation GEP, signer of the opposition with the INPI.

The practices of evergreening are used by the multinational pharmaceutical industry to extend monopolies on essential medicines to treat diseases like HIV – AIDS, cancer, Hepatitis C, among others, to charge exorbitant prices for drugs that are in the international market in generic versions of quality at affordable prices.

As the case of the drug TDF + FTC + EFV that its generic version in India is sell for US$139 per person per year, according to Doctors without Borders (MSF) in its publication Untangling the web.

We are concerned about the sustainability of the Drug Supply Program, and even more when new treatment guidelines indicates more people will need to start antiretroviral treatment early and as we see prices are getting higher because of the protection of patents …” said Pablo Garcia.

Argentina´s national patent legislation has mechanisms to be used in cases of abuse of of the patent system and therefore we have filed the opposition to the patent filed by Gilead Sciences and Bristol Myers …” Lorena Di Giano expressed Executive Director of GEP Foundation and General Coordinator of RedLAM.

Pharmaceutical Patents delay the entry in the market of generic drugs, prevent price competition and put great challenges for access to population health …” said Alex Freyre, President of the GEP Foundation.

To ensure “universal access” to antiretroviral medications, Argentina takes extremely high investments, currently meaning an investment of more than 90% of the budget allocated to the DNS and ETS (National AIDS and Sexually Transmitted Diseases Department), Ministry of Health of the Nation.

According to information provided by the DNS and ETS, the budget allocated to purchase ARVs increased significantly in recent years, from $ 33.7 million in 2006 to $ 45.2 million in 2009 and $ 75 million in 2011. This is due to several causes, the incorporation of new drugs to the list of drugs procured by public program in 2009, and the rising cost of antiretroviral procured by the DNS and ETS.

The price of new generation drugs impacts significantly the budget allocated to the DNS and ETS. Most of these drugs have patent or have a patent application pending before the National Institute of Industrial Property (INPI).

We hope that INPI examines patent applications TDF + FTC + EFV promptly as it does not fulfill with legal requirements of art. 4 of patent law (24481) (national patent law).

Representatives of signatory organizations held a meeting with the President of the INPI, Roberto Aramburu, at the time of the filing of the opposition, for the purposes of defining a joint work.

Organizations which supports the opposition to ATRIPLA ® Patent:

•           Red Argentina de Personas Positivas (Redar Positiva)

•           Fundación Buenos Aires SIDA

•           Fundación Grupo Efecto Positivo (Fundación GEP)

•           Vox Asociación Civil

•           Gente Buena del Sur Asociación Civil

•           RAJAP -Red Argentina de Jóvenes Positivos

•           Red Formoseña de Personas que  Viven con VIH

•           Asociación Civil Nokanchis

This entry was posted in Compulsory Licensing, Evergreening, Generics, Hepatitis C, HIV/Aids, IP Rights, IPR Enforcement, Patent examination system, Patents, Post-grant opposition, Pricing, Tuberculosis (TB) and tagged , , . Bookmark the permalink.

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