2. ABIA is a 30-year AIDS NGO
GTPI is a collective of NGOs and social movements fighting against the
power of pharmaceutical corporations and against monopolies to guarantee
the right to health
3. Anvisa’s prior consent
• What is it? A two-step pharmaceutical patent applications
examination with the participation of the health sector in the
process.
• Structure: For the purpose of making judgments about patentability
criteria such as the requirement of an inventive step, ANVISA has
established a technical group of experts that understands
pharmaceutical innovation
• Motivation: “The joint work between the patent office and ANVISA
is a way to ensure the best technical standards in the process of
decision over pharmaceutical patents.” (Interministerial declaration
nº 92, from 1999)
• Compliance with international rules: TRIPS Council decitions and
article 8 of the TRIPS Agreement: “Members may, in formulating or
amending their laws and regulations, adopt measures necessary to
protect public health and nutrition, and to promote the public
interest in sectors of vital importance to their socio-economic and
technological development.”
4. Almost 15 years of positive results
• Relevance: Avoid consequences for public
health of an undeserved granting of a patent,
such as: delayed entry of generic medicines in
the market, unnecessary payment of royalties,
public health policies put at
risk,etcpharmaceutical patent applications.
• How: by guaranteeing strict interpretation of
the patentability criteria
• Under attack: Since its creation, the
ANVISA’s prior consent have been
attacked, either by the pharmaceutical
corporations or even by the Brazilian
patent office (INPI).
5. International reputation
“In addition to prescribing criteria to be applied by the patent offices, it would be
desirable to develop a close cooperation between, on the one hand, the ministries of
health and health regulatory authorities and, on the other, the patent offices, for the
examination of pharmaceutical patent applications. For instance, in Brazil, a (…)
Federal Law (…) introduced into the Industrial Property Code a requirement of “prior
consent” by the National Sanitary Supervision Agency (ANVISA) for the granting of
pharmaceutical patents”
(Guidelines for the examination of pharmaceutical patents - WHO - ICTSD –
UNCTAD – 2007)
“The Brazilian model is worth close study by other developing countries (…)It brings
together public health expertise, pharmacological expertise and patent examination
expertise, but in a way where the node of decision-making power is more likely to
attend to the goals of the patent social contract.”
(Peter Drahos – The Global Governance of Knowledge: Patent Offices and their
clients – 2010) Anu/Press
6. Fragility explored by pharma
• The law 9279, from 14 May 1996, which rules rights and obligation related to Industrial
property, reads in its article 229-C:
• “The granting of patents for pharmaceutical products and processes shall depend on the prior
consent of the Brazilian National Health Surveillance Agency – ANVISA” (included through law
number 10.196, from 2001)
• Ideal language proposed by ABIA/GTPI:
Art. 229-C. [...]
“§1º The Anvisa’s Prior consent referred in the caput of this article shall analyze the patentability
criteria, novelty, inventive step and industrial application and other necessary conditions and
criteria for the granting of a patent, given by this law.
7. Big pharma attacks
• Dennounce for UN rapporteur, press
work, political pressure resulting in
maintenance of Anvisa’s role (2011 -
2013)
• “drop the case” campaign, amicus
curiae brief, intervention by the
Federal prosecution officce with
reference to the HLP (2016/2017)
• Letters and protests, Sofosbuvir
decision (2017)
• International pressure?
2001-2011:MICRO LITIGATION
(case by case basis)
2011: ADMINISTRATIVE
ATTACK: AGU’S OPINION
2015: JUDICIAL CASE:
INTERFARMA vs ANVISA
2017: AUTOMATIC
APPROVAL
2017: ADMINISTRATIVE
ATTACK: PRES. DECREE
CIVIL SOCIETY REACTION
8. Conclusions
• Brazilian experience reveals that public health authorities need to follow-up patent
examination process of essential drugs and raise their voice on the impact
undeserved patents may have in public programs if granted. ANVISA works in the
technical level, and its performance highlights how patent applications are failing
to meet fundamental requirements. By doing so, they sound the alarm on “low
quality” patents and reinforce the need for stricter examination.
• The MoH participation in the patent examination is a way to ensure that a human
rights-based approach is incorporated in this field historically more close to the
private sector, lawyers and ministries of trade and industry.
