[Pharm-policy] PhRMA's Dec 3, 1999 NTE submission: Dominican Republic

[James Love]

PhRMA's Dec 3, 1999 NTE submission: Dominican Republic

http://www.phyma.org/issues/intl/dominican.html

Dominican Republic

                 Intellectual Property Protection

On September 1999 an industrial property bill was introduced to
Congress. The purpose of the bill is to bring the Dominican
Republic into conformity with the minimum standards of protection
established under the TRIPS agreement. The bill has already been
approved by the Senate and is now before the Chamber of Deputies.
Approval of the same is regarded as imminent.

Unfortunately, the bill in its present form, includes a number of
elements of questionable consistency with TRIPS compliant,
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 to the third party requesting the
same, without having to prove any fault by the patent holder or
without requiring the third party to have any technical
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.Article 39 of TRIPS contemplates the protection of
undisclosed tests or other data filed before sanitary authorities
as a precondition of approving the marketing of a pharmaceutical,
agricultural or chemical product. This provision is not only
absent in the bill, but to the contrary, the bill includes an
authorization of all uses of a patent which are necessary to
obtain health registration or approval for commercialization of a
product. 

   3.The bill discriminates between foreigners and nationals by
requiring foreigners to place a bond in an amount sufficient to
cover court costs and legal fees in cases where they appear as
plaintiffs in a lawsuit. This goes against the National Treatment
stipulated by Article 3 of TRIPS. The intellectual property bill
(copyright) also before Congress, expressly states that the
aforementioned bond will not be required.

   4.The bill excludes patenting of second uses, does not include
protection for vegetable obtentions, business or economic plans
or non-biological methods and processes connected with living
materials. 

Additionally, the Department of Health continues its practice to
issue health registrations (equivalent to a permission to
commercialize) to products that violate locally registered
patents in spite of legal requests to the contrary.


-- 
James Love
http://www.cptech.org
mailto:love@cptech.org
voice 1.202.387.8030