Jessica Chong discusses the importance of data exclusivity in protecting pharmaceutical test data from exploitation and how to obtain protection.
The drugs war between big pharmaceutical corporations and generic drugs manufacturers rages on, with no end in sight. Pharmaceutical companies invest heavily in research and development of new drugs, conducting tests and trials for years – only for generic manufacturers to swoop in and produce essentially the same drug at a fraction of the investment and offer them at a lower price to consumers.
Enter: data exclusivity. Aimed at the protection of undisclosed, unpublished and non-public domain pharmaceutical test data, the data exclusivity regime administered by the National Pharmaceutical Regulatory Agency (“NPRA”) prevents generic manufacturers from exploiting clinical test data before entering the market and undercutting prices of branded drugs.
How does Data Exclusivity protect innovators?
In Malaysia, every new pharmaceutical drug must be registered with the NPRA before it can be sold in the market.[1] As part of the registration requirements, applicants must adduce evidence proving the drug’s quality, safety and efficacy.[2]
If a clinical data is protected under data exclusivity, it cannot be used as evidence of quality, safety and efficacy of a drug by other manufacturers without the innovator’s consent.[3] Generic manufacturers would therefore be forced to conduct its own trials to obtain the relevant data, which will require considerable time, effort and investment.
Data exclusivity is a form of protection outside the patent regime. It is provided for under the Control of Drugs and Cosmetics Regulations 1984 (“CDCR 1984”) and the Sale of Drugs Act 1952. Since the data exclusivity regime was introduced nearly 15 years ago in 2011, the NPRA has granted data exclusivity in respect of a total of 108 new drugs containing a new chemical entity[4] and 25 second indications of registered drugs.[5]
How to apply?
An application for data exclusivity should be made via a Letter of Intent (“LOI”) addressed to the Director of Pharmaceutical Services (“Director”) of the NPRA, in conjunction with an application for either:
- Registration of a new drug product containing a new chemical entity, i.e. a product containing an active moiety[6] that has not been registered under the CDCR 1984; or
- A second indication of a registered drug product, i.e. therapeutic indications applied subsequent to the first indication which was approved when the drug product was first registered.[7] Such application must contain reports of new clinical investigations.
Conditions for Grant of Data Exclusivity
The following conditions must be fulfilled before an application for data exclusivity will be granted:[8]
| New drug product containing a new chemical entity | Second indication for registered drug product | ||
| Timeline for application[9] | 18 months from date of first registration or market authorisation. | 12 months from date of first registration or market authorisation. | |
| Data exclusivity granted in country of origin[10] | Data exclusivity / test data protection is granted in the country of origin, or in any country recognised by the Director. | Data exclusivity / test data protection is granted in the country of origin, or in any country recognised by the Director. | |
| Nature of data to be protected[11] |
|
|
|
How long does Data Exclusivity protection last?
The period of protection for data exclusivity is decided on a case-by-case basis.[12] The maximum term of protection that may be granted is:
- 5 years, for a new drug product containing a new chemical entity;[13] or
- 3 years, for a second indication. This period of data exclusivity covers the data concerning the second indication only.[14]
Exemptions
Data exclusivity protection will not apply to the detriment of public health, i.e. where:[15]
- compulsory licences have been issued;
- other measures are to be implemented in order to protect public health and ensure access to medicines for all; or
- it will prevent the Malaysian Government from taking necessary action to protect public health or other urgent circumstances.
Dissatisfied with the NPRA’s decision?
The Director’s decision on whether or not to grant data exclusivity may be appealed by an aggrieved person[16] within 14 days from the date the decision is made known,[17] to the Minister of Health whose decision on appeal would be final. [18]
Any supporting data or documents is to be submitted to the Director within the following timelines:[19]
- 120 days, for applications of new drug products containing a new chemical entity; or
- 90 days, for applications of second indications.
Conclusion
The data exclusivity regime rewards drug manufacturers for their tireless efforts in conducting extensive research and clinical trials and incentivises them to continue making such investments, to the benefit of society as a whole. The short period of data exclusivity ensures these manufacturers will be able to profit off the fruits of their labour, yet prevents the establishment of a monopoly with the effect of restricting access to what might be life-changing medicines.
Further, its independence from the patent system in Malaysia means even drugs that are not patentable in Malaysia may still enjoy some protections under data exclusivity. Drug innovators should thus consider protection under the data exclusivity regime to maximise their potential profits.
Jessica is an Associate at Wong Jin Nee & Teo. Her practice covers a wide range of fields relating to intellectual property litigation, brand protection and enforcement, regulatory compliance, franchising and trademark prosecution.
[1] Regulation 7, Control of Drugs and Cosmetics Regulations 1984 (“CDCR 1984”).
[2] For a full list of requirements for registration, see Appendix 15: Requirements For Full Evaluation And Abridged Evaluation, Drug Registration Guidance Document (DRGD) Third Edition, Ninth Revision January 2025.
[3] Paragraph 4.7, Directive on Data Exclusivity, 1 March 2011 (“DE Directive”).
[4] Register of Data Exclusivity (updated 18 February 2025), NPRA.
[5] Register of Data Exclusivity for AI (updated 04 August 2022), NPRA.
[6] An active moiety is defined as the molecule or ion responsible for the physiological or pharmacological action of the drug substance (excluding appended portions of the molecule that cause the drug to be an ester, salt or other non-covalent derivative of the molecule). See paragraph 3.2, DE Directive.
[7] Paragraph 3.3, DE Directive.
[8] Paragraph 4.1, DE Directive.
[9] Paragraph 4.2, DE Directive.
[10] Paragraph 4.2, DE Directive.
[11] Paragraph 4.3, DE Directive.
[12] Paragraph 4.4, DE Directive.
[13] Paragraph 4.5(i), DE Directive.
[14] Paragraph 4.5(ii), DE Directive.
[15] Paragraph 5, DE Directive.
[16] Paragraph 6.1, DE Directive.
[17] Paragraph 6.1, DE Directive.
[18] Paragraph 6.1, DE Directive.
[19] Paragraph 6.2, DE Directive.