[Ip-health] Public Hearing Isolates Brazil Patent Office President and Demonstrates Harmony among Ministers

[Gabriela Chaves]

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(from the Working Group on Intellectual Property from the Brazilian Network
for the Integration of Peoples - GTPI/Rebrip)

Public Hearing Isolates Brazil Patent Office President and Demonstrates
Harmony among Ministers

Discussion of polymorphs and second-use patents pits ministers and congress
against the Brazilian Patent Office.

On October 30, 2008 the lower house of the Brazilian Congress, the House of
Deputies, held a public hearing on “Patent Examination Guidelines”.  The
hearing came as the result of revisions proposed by the Brazilian Patent
Office (INPI) which intends to expand patent protection for polymorphs and
second-use drugs.

Several ministers within the Lula administration have taken issue with the
proposed expansion, placing in check the Patent Office’s ability to decide the
matter internally.

Currently the Patent Office intends to institute a public policy which
broadens the scope of Brazilian drug patents, including those for second-use
drugs which would grant 20 years of additional exclusivity for medications
which are already known and which have been protected previously.

The public hearing was attended by representatives of the Ministry for
Development, Industry and Commerce (MDIC); Ministry for Foreign Affairs,
Ministry of Health and the president of the INPI.  The Ministry of Health and
the Ministry for Foreign Affairs opposed both types of patents since they are
considered TRIPS-plus.

They believe that the proposed guidelines contradict the Development Agenda of
the World Intellectual Property Organization (WIPO), as well as the Global
Strategy and Action Plan for Innovation, Public Health and Intellectual
Property (WHA 61.21), which was recently approved by the World Health
Organization (WHO).  While the MDIC did not go into depth in its defense, it
did back the other two ministries, arguing that the guidelines should reflect
a consensus within the government and not the Patent Office alone.

The hearing was called by Deputy Paulo Teixeira (PT/SP) who questioned the
inconsistency between the policy adopted by the Patent Office and that of the
government in general, thus focusing attention on argument that the Patent
Office overstepped its authority by trying to enact regulations unilaterally.

Deputies Fernando Coruja (PPS/SC) and Rita Camata (PMDB/ES) agreed with the
position taken by the Ministry of Health that extending patent rights to
polymorphs and second-use forms weakens public health protection and drug
accessibility policy.

Francelino Grando, representative of the MDIC and coordinator of the
Interministerial Intellectual Property Working Group (GIPI) agreed that the
Patent Office does not have independent authority to establish regulations,
and that any proposed change in guidelines be referred to the GIPI for
approval.

At the suggestion of some of the deputies, hearing participants agreed that
members of Congress involved in drafting patent legislation be present at the
GIPI guideline revision meetings.

The Patent Office president stated that revised guidelines are now drafted by
Office specialists, “industry specialists” and academic experts, and then
forwarded on to its legal department for review and supposed approval.

Representatives of civil society and members of the Working Group on
Intellectual Property of the Brazilian Network for the Integration of Peoples
(GTIP/Rebrip) have been following this process since 2007 and were present at
the hearing. Numerous statements, position papers and letters were submitted
by the working group about the Patent Office’s guideline revision of
secondary-use and polymorphic form patents.  In this way, the working group
acts as a watchdog for civil society, attent to whatever proposals the public
hearings generate.

Drug Patent Guidelines – What is at risk?

The way in which a public agency defines patent regulations for essential
items such as medications is of utmost importance to all of society.  Drug
patent protections have significant implications on public health.  Access to
medications by government and consumers can be restricted to a single producer
who is free to charge high prices, thereby causing a drain on public and
private coffers.

As a result of such patents, single companies can monopolize the production
and sale of essential medications.  This restricts public access to these
substances, hurting people directly.

Each nation has the right to define patent concession criteria for
pharmaceutical companies.  Public health can be adversely affected by broad
application of patent rights, such as in the case of second-use drugs.

The scope of criteria is therefore a POLITICAL DECISION and should include all
the sectors of society involved.

Working Group on Intellectual Property from the Brazilian Network for the
Integration of Peoples (GTPI/Rebrip)