6. Proposed Guidelines Undermine Use of TRIPS Flexibilities

A major concern with the proposed guidelines is the undermining of TRIPS flexibilities.

(a) Nullifies the benefit of “Bolar exception”

The purpose of the Bolar exception in Section 37(1A) of the Patents Act 1983 is to allow a generic company to apply for registration before the expiration of the patent term so that the generic can enter the market as soon as the patent expires. However, NPRA’s proposed introduction of a complicated system for implementing Article 18.53 of the CPTPP, means that the benefit of this exception will be nullified. Generic companies which believe that their products do not infringe existing patents, will fall within Category 4, and will face the possibility of legal action, with their registration process automatically suspended.

(b) Undermines use of TRIPS flexibilities to curb patent evergreening.

An important flexibility available under the TRIPS Agreement is the right to define the patentability criteria in a way that limits patent evergreening, a major concern in Malaysia. Yet the proposed Guidelines entrench this practice. By effectively recognising secondary patents within the regulatory framework, NPRA’s approach also undermines incentives for MyIPO to fully utilise TRIPS flexibilities, including adopting stricter patentability standards and more rigorous examination practices.