Uganda exercises TRIPS flexibilities for pharmaceutical products
The Ugandan Patent Office has recently objected to the grant of patents for pharmaceutical inventions following notification of grant by the African Regional Intellectual Property Organisation (ARIPO), where Uganda is a designated State. This objection is based on the national patent law of Uganda as it relates to the flexibilities regarding the application of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to pharmaceutical products in least developed countries (LDCs).
The Harare Protocol was adopted in 1982, as a result of this, ARIPO is empowered to grant patents on behalf of its contracting states. Currently, there are eighteen contracting states that may be designated in an ARIPO patent application. When filing an ARIPO application, an applicant is required to designate the member states where protection is required. The official fees payable, as well as renewal fees (which are also paid on pending ARIPO applications) are directly linked to the number of member states designated.
A patent granted by ARIPO has, in each designated State, the same effect as a patent granted under the applicable national law. Once the ARIPO office decides to grant a patent, each designated member country is notified of the decision and has a six-month period in which to notify ARIPO that the patent will have no effect in its territory due to:
- the invention not being patentable under the provisions of the Harare Protocol, or
- the national law of the member country because of the nature of the invention.
According to the Harare Protocol, claims related to medical indications or use must be drafted in one or more of the prescribed formats. The protocol makes it clear that claims directed to methods of medical treatment or diagnosis performed on the human or animal body are not permissable. However, the prescribed formats do allow for the patentability of substances or compositions for use in such methods, as well as so-called Swiss-type claims.
Recently, in response to a notification of a decision to grant issued by ARIPO, the Ugandan Patent Office has indicated that patents directed to pharmaceutical inventions are excluded from patent protection and will not be granted in Uganda based on Section 8(3)(f) of the Ugandan Industrial Property Act, 2014, which reads:
"8(3) The following shall not be regarded as inventions and shall be excluded from patent protection— (f) pharmaceutical products and test data until 1st January 2016 or such other period as may be granted to Uganda or least developed countries by the Council responsible for administering the Agreement on trade related aspects of intellectual property under the World Trade Organization."
The Council of the World Trade Organization, which administers the TRIPS Agreement, has agreed that LDCs have the option to exclude pharmaceutical products from patent protection and has extended the period to exercise this exclusion until 1 January 2033.
It is clear that Uganda is exercising its right to exclude patent protection for pharmaceutical products. It is thus recommended that Uganda not be designated in an ARIPO application concerning pharmaceutical products.