Pharmaceutical Research and Manufacturers of America - Policy Views - Issues Around The World - Special 301 Report


Dominican Republic

In September 1999, an industrial property bill was introduced in the Dominican Congress, intended to bring the Dominican Republic into conformity with the minimum standards of protection established under the TRIPS agreement. The bill, already approved by the Senate without consideration of modifications proposed by several professional and industry associations, has been brought to the Chamber of Deputies, and it is highly likely that this clearly non-TRIPS-compliant bill will be passed into law. Given the seriousness of recent developments in the Dominican Republic, PhRMA asks that the Dominican Republic be placed on the 2000 "Special 301" Priority Watch List.

Unfortunately, the bill in its present form, includes a number of elements of questionable consistency with TRIPS, namely:

1. Compulsory licensing: The industrial property bill contemplates the grant of automatic licenses on the sole basis of the denial of a contractual license. 180 days after the contractual license is requested, the administrative authorities must grant a compulsory license (operates automatically) to the third party requesting the same, without having to prove any fault by the patent holder or without requiring the third party to demonstrate technical or economic capabilities for the exploitation the patent.

This automatic license is in addition to compulsory licenses, which would be granted in cases of lack of exploitation, abuse due to non-competitive practices, public interest and cases of dependent patents.

2. Protection of Confidential Data is not contemplated, as required under TRIPS Article 39.3. This provision is not only absent in the bill, but to the contrary, in its Article 30, the bill specifically authorizes use of the patented invention by third parties for the purpose of obtaining health registration or approval for commercialization of a product, prior to the patent expiration date.

3. The bill discriminates between foreigners and nationals by requiring foreigners to post a bond to access local courts. This goes against the National Treatment stipulated by Article 3 of TRIPS. Further, an intellectual property bill focused on copyright, also before Congress, has eliminated the requirement.

4. The bill does not include the possibility of patenting distinct uses of previously patented inventions, excludes combinations of existing materials, and excludes microorganisms and non-biological methods and processes connected with living material. Additionally, it does not protect plant varieties, as required by TRIPS Article 27.3, by this or any other sui generis system. business or economic plans or non-biological methods and processes connected with living materials.

5. The bill contemplates international exhaustion of patent rights. Article 30 (d) of the bill authorizes the importation of products, provided the same have been placed in any market by anyone, even if the product has been placed in the market without the consent of the owner of the patent, or if it has been placed in the market in a country without intellectual property protection. This article goes significantly beyond the authorization of parallel imports.

Problems also persist in the area of enforcement. Principal examples are as follows:

a. The Department of Health continues to issue to third parties health registrations for products with patent protection, without the consent of the owner of the patent, and in spite of the patent owner´s formal opposition.

b. The Legal Counsel to the President, in a formal opinion issued on January 28, 2000, instructed the Department of Health to issue all health registrations without taking into consideration any oppositions made in view of registered patents.

c. The Department of Industry and Commerce is unresponsive in the issuance of patents and expedition of certifications that refer to previously filed patents.

Damage Estimate

PhRMA is currently studying methodology for estimating damages caused by the aforementioned trade barriers in the Dominican Republic (see Appendix B). The difficulty of making a damage estimate is heightened in cases such as this where damage is potential and prospective. Nonetheless, the situation in the Dominican Republic poses a threat to regimes in neighboring states, is being used by activist organizations as a potential precedent to weaken the fabric of the WTO TRIPS Agreement generally, and demonstrates the impact of other I.P. violator states (i.e. Argentina) in the region. If unchecked, damage will far exceed losses in the local market.