Challenging unmerited patents. Presented by Jose Maria di Bello, FGEP, Argentina.

1. Roundtable IV
Challenging unmerited patents
Civil Society Patent Challenges: Successes and
Challenges
José María Di Bello – Secretary of the Fundación GEP

2. Fundación Grupo Efecto Positivo
It works to improve the quality of life of people with HIV and
hepatitis c, with an emphasis on access to medication.
Access to Medicines Program (PAM) with the objective of:
• Eliminate access barriers through the adoption and use of the
TRIPS health safeguards and the national patent law.
• Promote price competition.
• Promote the local production of medicines.

3. We are part of and coordinate the Latin
American Network for Access to Medicines
Argentina
Brasil
Colombia
México
Perú

4. Oposiciones a las patentes

5. Oposiciones en Argentina
PEDIDO DE PATENTE AÑO ESTADO
TDF+EFV+FTC 2013 Pendiente
TDF /FTC (Truvada) 2015 Desistida forzosa
LPV/r (Kaletra
comprimidos)
2016 Rechazada
Sofosbuvir Pro-droga 2015 Rechazada
Sofosbuvir Compuesto
base
2017 Pendiente

6. Oposiciones en Argentina
December 4, 2013
• Opposition to EFV + FTC + TDF (Atripla® -Gilead).
Price in Argentina: US $ 2,632 (Gilead) per person per year
Generic version in the international market: US $ 139
(Aspen) per person per year
Argentina 2015 made a purchase of this drug to Cipla, a producer
in India, which meant a saving of 20 million dollars.

7. Oposiciones en Argentina
Opposition to FTC + TDF (Truvada® -Gilead) (2015)
Price in Argentina: US $ 2,304 (Gilead) per person per year
Generic version in the international market: US $ 74 (Aspen) per
person per year.
2016 the company withdrew the request, in the same year,
Argentine producers obtained sanitary registration. Today there is
price competition in the tenders.

8. ARGENTINA - SOFOSBUVIR
May 18, 2015 - Submission of opposition to the
patent request

9. Sofosbuvir first purchase price in Argentina
Ministry of Health of the Nation, nov 2015

10. Patent Landscape of DAAs in Argentina
1 SOFOSBUVIR PRODRUG AR066898A1 Rechazada
2 SOFOSBUVIR BASE
COMPOUND
AR044566A1 Pendiente
3 SOFOSBUVIR DIVISIONAL AR082064A2 Desistida
forzosa
4 SOFOSBUVIR DIVISIONAL AR082067A1 Desistida
forzosa
5 SOFOSBUVIR DIVISIONAL AR82068A2 Desistida
forzosa
6 SOFOSBUVIR DIVISIONAL AR082066A2 Desistida
forzosa

11. Solicitudes de patentes sobre Sofosbuvir in
Argentina
9 SOFOSBUVIR PROCESS AR088580A1 Desistida
forzosa
10 SOFOSBUVIR BASE
COMPOUND
(ESTEREOSELECTIVA DE
ACTIVOS QUE CONTIENEN
FOSFORO)
AR080819A1 Desistida
forzosa
11 SOFOSBUVIR BASE
COMPOUND
(FOSFORAMIDATO DE
NUCLEOSIDO DE PURINA)
AR081813A1 Desistida
forzosa
12 SOFOSBUVIR +
LEDIPASVIR COMBINATION
AR095131A1 Pendiente

12. Patentes otorgadas sobre Sofosbuvir in
Argentina
1 SOFOSBUVIR LDV
COMPOUNDS FAMILY
PROCESS.
AR 076765A1 Otorgada
2 SOFOSBUVIR PROCESS -
COMPOUND ISOPROPIL -
ALANIL FORFORAMIDATO.
AR082937A1 Otorgada

13. Civil society as well as local producers
are making use of patent oppositions
using the provision of art. 28
of the Nacional patent Law

14. Sofosbuvir Registration by ANMAT*
MEDICINE COMPANY REGISTRATION # BY
ANMAT
Sofosbuvir 400 mg Richmond SACIF 57811
Sofosbuvir 400 mg GADOR/GILEAD 57812
Sofobuvir 400 mg ULTRA PHARMA SA 57952
Sofosbuvir 400 mg ELEA SACIFYA 58203
Sofosbuvir 400 +
ledipasvir 90
GADOR SA 58113
• ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnologías Médica
is the National Regulatory Ahuthority.

15. we must protect the generic
versions that are already on the
market

16. Argentina adopted the Guidelines for the
Examination of Patentability of Chemical-
Pharmaceutical Inventions
Resolución Conjunta MI 118/2012, MS
546/2012 e INPI 107/2012

17. Defense of the Patentability
Guidelines in Argentina
• The Guidelines establish RIGOROUS CRITERIA on
how to apply the patentability requirements
(novelty, inventive activity and industrial
application).
• These do not add new requirements
• These instruct the examiners.

18.  the guidelines are a measure in favor of
Public Health that allow an adequate
administration of the patent system;
 Adopted in exercise of the rights included in
TRIPS.
 Measures that against the abuse of the
patent system. Anti evergreening.

19. These are judicialized:
• CAEMe and others against National State s
/ Nullity of Administrative Act.
• Question of State
• Fundación GEP intervenes as a third party
interested in the judicial file.

20. As part of the actions to promote
and guarantee the use of the
Safeguards in Health, we include in
the draft of the new HIV Law, the
declaration of national public
interest of the Safeguards present
in our Patent Law.
Incidence in the National Congress
In the last two years we have been
asked in the Chamber of National
Deputies, to present the report of our
Price Observatories for treatments for
HIV and Hepatitis C

23. Distribution of purchases of medicines of the year 2016 according to the origin of the capital of
the offering laboratory
How to face these realities? Transnational corporations govern our countries
imposing themselves beyond the patents

24. UNAIDS “4th 90”:
Affordability of
Medicines
In the attempt to address unaffordable prices
problem, FGEP proposed to the Ministry of Health
to include a “fourth 90” in the strategy that
represents 90% of medicines and other
commodities to be acquired at fair prices. This
goal will guarantee availability and access to HIV
medicines, diagnosis supplies and prevention for
all.

25. UN Human Rights Council
adopted Resolution 26/9
in June 2014 that
mandated to develop “an
international legally
binding instrument on
TNCs and other business
enterprises with respect
to human rights” and
created a UN Human
Rights Council Open-
Ended Inter-
Governmental Working
Group (OEIGWG) that met
every year the last, 3rd
Complementary
measures

26. ¡Muchas Gracias!
www.fgep.org
www.redlam.org