Data Exclusivity In Malaysia, Why?, How? And When?

In order prevent the incidence of unfair competition that arises from the use of proprietary test data by manufacturers of generic drugs to gain marketing approval in a given jurisdiction, the TRIPS agreement of the World Trade Organization (WTO) recognizes pre-clinical and clinical data among others, as data that should be subjected to exclusive use by the proprietors only (i.e. the product originators or innovators) and hence recognizes such data as a form of intellectual property right.

Specifically, under Article 39.3, member states party to the agreement are required to protect undisclosed test or other data, the origination of which involves a considerable effort against unfair commercial use. Malaysia, a member of the WTO and a party to the TRIPS agreement, has made provisions for Data Exclusivity via a directive under the Ministry of Health. Based on the directive, an application for data exclusivity can be made to the Director of Pharmaceutical Services via a Letter of Intent that accompanies an application for registration of a new drug product containing a new chemical entity or an application for a second indication of an existing drug product.

Aforementioned application for Data Exclusivity has to adhere to the following time-frame requirements which are referenced from the time of obtaining registrations or marketing approval, as well as grant of data exclusivity in the country of origin or any other country recognized and deemed appropriate by the Director of Pharmaceutical Services:

  1. an application for Data Exclusivity having regard to a new drug having a New Chemical Entity shall be made within eighteen (18) months; and
  2. an application for Data Exclusivity having regard to a second indication of a registered drug product shall be made within twelve (12) months.

The grant period of Data Exclusivity, is detailed as follows:

  1. not more than five (5) years in the case of a new chemical entity; and
  2. not more than three (3) years in the case of a second medical indication of a known drug.

According to the directive, a new chemical entity is defined as a product that contains an active moiety that has not been registered in accordance with the provisions of the Control of Drugs and Cosmetics Regulations 1984.

As we may be well aware, not all new drug products fall within the ambit of patentable subject matter. In such an instance, Data Exclusivity would be of paramount importance to protect the commercial interest of the product originator. Moreover, in Malaysia due to the fact that the average pendency period of patent applications prior to grant, being as long as 4-6 years on average and in view of the fact that there are no provisions for the extension of a patent term due to delays in processing a patent application in the Patent Office, the patent owner while waiting for the patent application to be granted, can further leverage on the provision of Data Exclusivity to strengthen commercial exclusivity of the drug product subject to the patent application process.

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