Note: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.
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.