[Pharm-policy] EU Aide Memoire objecting to DR patent legislation

[Thiru Balasubramaniam]

http://www.cptech.org/ip/health/c/dr/euobjection.html

English translation



This an English translation of the European Union's "aide memoire" which
lists objections to the Dominican Republic's industrial property
legislation which they deem TRIPS-inconsistent. The changes recommended
refer to an earilier draft of the patent law; the version that has
passed both chambers deviates only slightly from this earlier draft.
This is not an official document. It was passed around at a conference
in Santo Domingo many months ago when the US Ambassador to the Dominican
Republic convened a meeting on intellectual property. The attendees
included Dominican senators and deputies, and the respective ambassadors
of the EU and Mexico. The EU was represented by the French ambassador. 


Thiru

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AIDE MEMOIRE

FOREIGN INVESTORS' PRINCIPAL CONCERNS WITH THE INTELLECTUAL PROPERTY
LEGISLATION

FEE FOR FOREIGNERS TO BRING JUDICIAL ACTIONS FOR RIGHTS VIOLATIONS

The bill does not eliminate the requirement of a judicial fee from
foreigners seeking to file a claim against a rights violator. A foreign
claimant must pay a deposit to guarantee the legal costs and possible
damages awarded the defendant. This violates Article 3 of TRIPS, which
establishes that countries must accord "national treatment" to
foreigners, i.e., treatment that is equal to that granted to nationals.

The absence of "national treatment" is also in violation of several
treaties for promoting and protecting investment that the Dominican
Republic is party to.

PATENTS FOR INVENTIONS. ARTICLE 2)1)i)

Article 2, paragraph 1, letter i, excludes from protection inventions
that are a technical improvement on products already patented.
Additionally, the proposed legislation does not assure any
confidentiality in the protection of data submitted to government
authorities in the patent application process.  These two elements are
inconsistent with article 27, paragraph 3, letter b, and article 39,
paragraph 2, of the TRIPS.

VIOLATION OF THE RIGHT TO EXCLUSIVE USE. ARTICLE 30 D) AND 30 E).

TRIPS Article 28 recognizes the right of exclusive use by the patent
holder. It expressly includes the rights of importation and the
exclusive use of the product or process by the patent holder. 

Article 30 of the proposed legislation, letter d) states that: any third
party may import a patent protected product, even from countries that do
not protect intellectual property, such as India. This is not about
"parallel importation" or "intentional exhaustion" of intellectual
property rights; rather, this statutory language will open the doors to
piracy.

NULLITY OF A PATENT. ARTICLE 34 7)

Article 34, paragraph 7, of the bill indicates that the determination of
the nullity of a patent will be made without the participation of a
legal authority or an ad hoc administrative authority. As a result, the
patent holder will be deprived of the legitimate right of defense.

This article is inconsistent with the TRIPS accord, which in articles 42
et seq stipulates the necessity of establishing a fair and equitable
legal or administrative structure for rights holders.

LOCAL PRODUCTION AND IMPORTATION OF THE PATENTED PRODUCT OR PROCESS IS
REQUIRED. ARTICLE 39:

Article 27.1 of TRIPS provides that patent rights are not to be subject
to discrimination between imported and nationally manufactured products.
In other words, it is sufficient to import or to produce locally in
order to comply with TRIPS.

Article 39 of the legislation requires that the patented product or
process be manufactured in the Dominican Republic and imported at the
same time.  Where the patent is not worked locally, compulsory licenses
may be granted.

COMPULSORY LICENSES FOR PATENTED INVENTIONS CONTEMPLATED IN ARTICLE 40.1

TRIPS Articles 30 and 31 provides the possibility of "Limited
Exceptions" to patent rights through the concession of compulsory
licenses for justified reasons and subject to specific conditions.
Article 40.01 of the legislation provides for the grant of compulsory
licenses without justifiable cause, and
automatically awards them 180 days after they are requested. This will
cause the compulsory license to be unlimited and general, rather than a
limited exception.

SPECIAL CASE OF PHARMACEUTICAL PRODUCTS

In an administrative communication, number 0093 on January 28, 2000,
directed to the Public Health Secretariat, the Legal Office of the
Executive authorizes the Department of Pharmaceutical Products of the
Secretariat to grant to Dominican laboratories and importers the health
registrations that would allow them to manufacture or distribute
medicines containing patented substances. This procedure, which does not
take into account the rights of patent holders, leaves the door open for
the manufacture and importation of illegal products.