Requirement for Disclosure of Either Prosecution Results and/or Prior Art

Question:

We are trying to identify the applicable regulations for obtaining an Access and Benefit Sharing (ABS) agreement and related permits for biological materials obtained in Malaysia. Our understanding is that there is a policy framework but no implementing laws or regulations at the national level, but that certain states, e.g., Sarawak and Sabah regulate such activity locally. Can you readily say what would be the appropriate procedure, for example where a Malaysian research institution is collaborating with a US corporation (our client) to obtain and test materials from Malaysia?

Please let us know if this is a more complex query than you can answer in a simple response.

Answer:
This does not come under Patent Laws. We have received feedback from the Ministry of Natural Resources and Environment with regards to Access and Benefit Sharing requirements in Malaysia. We provide herewith the information relevant to your enquiry.

At the moment there is no specific domestic law in Malaysia as you rightly pointed out on this matter (except for Sabah and Sarawak which have state laws). Malaysia is currently in the process of developing such a law. Nevertheless this matter is governed by the National Policy on Biological Diversity (1998) and as an interim measure when a Malaysian Research Institution is working with a foreign collaborator, the Economic Planning Unit (EPU) Guidelines applies.

(A) Application to conduct research in Malaysia

According to these guidelines a foreign researcher (having a Malaysian counterpart) who intends to conduct research in Malaysia is required to obtain prior permission by filing in the following documents:

(1) Application to conduct research in Malaysia (EPU/ Research Form 1); and
(2) Immigration Form Im 12 – Pin. 1/97

The above documents must be accompanied by:
(1) A research proposal containing objective, scope, methodology, conceptual definitions, location and schedule of research;
(2) Official letter from the financial sponsor stating the amount of financial assistance obtained and the term of contract (if applicable);
(3) Letter of consent from Malaysian counterpart;
(4) Identification of researchers (eg. Copy of passport);
(5) Application fee of MYR50

The EPU will coordinate with the relevant local parties (ministries/departments/agencies/state governments) to process the said application and will inform the applicant of the approval status. If approved and upon payment of a registration fee of MYR150, a researcher pass will be issued after which, the researcher is permitted to start the research.

(B) Conducting research in Malaysia

The researcher issued with a researcher pass is subject to the following:
(a) Code of Conduct when conducting research in Malaysia; and
(b) Collection and Distributing Specimens

The code of conduct makes mention of the following:

Any collection and distribution of specimens must be in accordance with the Guidelines for the Collection and Distribution of Specimens (enclosed herewith as Appendix B3). The researcher has to obtain written approval from the relevant department(s), stating details of the specimens if any and submit a copy of the letter of approval to EPU before taking the specimens out of the country.

The Guidelines for collection and distributing specimens is divided into there types of specimens being Herbarium Specimens, Museum Specimens and Living Specimens. The said guidelines spells out the mode of distribution of the said specimens to the relevant department(s) as deposits, as well as requirements of permits for the specimens to be kept for use by the researcher. Should you require more information on a specific biological material, kindly let us have further details on the same.