On the other hand, accession to the Budapest Treaty could prove to be a hindrance to Malaysia’s responsibilities as a signatory of the Convention on Biological Diversity (CBD). Although not expected to be included in the first wave of amendments to Malaysia’s Patents Act, provisions to formally recognize Traditional Knowledge (TK) and Genetic Resource (GR) documents in the substantive examination procedure have been proposed in a subsequent wave of amendments. These provisions require submission of evidence of Prior Informed Consent (PIC) and Certificate of Origin (COO) during examination and TKs and GRs would be recognized as relevant prior art for search purposes. However, the strict secrecy surrounding deposits of biological materials made under the Treaty impairs the gathering of data on implementation of the CBD’s GR disclosure requirement for access and benefit-sharing, thereby, quite possibly hindering the reliable identification of GR misappropriation and any hope of mutually beneficial resolution of such misappropriation of valuable biological material and Malaysia’s natural biological resources.
As can be expected, there are currently a host of uncertainties on the implementation of the provisions of the Budapest Treaty in Malaysia and the impact whether positive or negative it could have on the local patent industry as well as on our nation’s rich biota heritage. It is hoped that the implementing regulations of the proposed amendments to the Patents Act, a draft of which has yet to be issued by MyIPO, would serve to clarify the situation rather than induce further ripples of uncertainty.