8. Proposed Guidelines are Beyond the Authority of NPRA

The proposed Guidelines are issued by the Senior Director of Pharmaceutical Services “pursuant to Regulation 8 of the Control of Drugs and Cosmetics Regulations 1984”. Section 2 of the Guidelines asserts that the Guidelines ensure “regulatory neutrality”. Thereafter Section 6.3.2 of the Guidelines states that NPRA will “refrain from assessing, interpreting or adjudicating the validity, scope, ownership, enforceability or alleged infringement of any patent”. It further adds in Section 6.3.3 that “All matters relating to patent rights, including validity or infringement, shall remain within the exclusive jurisdiction of the courts or other competent adjudicating authorities”.

While claiming NPRA will not be involved in any patent-related matters, the proposed Guidelines require Category 2, 3 and 4 applicants to list their patents. For Category 3 applicants, the Guidelines permit registration but requires the generic PRH to ensure that the generic product is marketed only after expiry of the corresponding patent. This essentially amounts to patent enforcement via regulatory conditions, even though the Patents Act recognises patent enforcement to be the responsibility of the patent holder and done using court processes. Section 37(1A) of the Patents Act reinforces that regulatory submission acts are exempt, so the regulatory approval pathway itself should not be transformed into a patent-control/linked mechanism.

For Category 4 applicants, the Guidelines state that NPRA shall commence a 45-day notification period during which period no regulatory approval decision will be granted, followed by an automatic 12 month suspension of the regulatory approval process, if legal proceedings are initiated by the originator/patent holder.

These stay mechanisms effectively turn NPRA into a patent-enforcement gatekeeper even though patent-related matters fall under the authority of MyIPO, and patent enforcement matters within the jurisdiction of the court system. It is also highlighted above (in part 7) that NPRA’s proposal to impose a stay on regulatory approval undermines the Rules of Court 2012 and established Malaysian law, and amounts to a extrajudicial quasi-injunctive mechanism that is beyond NPRA´s jurisdiction and power.

NPRA says it will only check procedural compliance and will not assess patent validity, scope or infringement. However, its procedural verification is tied to mandatory regulatory consequences that affect approval timing and market entry. This is not “regulatory neutrality”. On the contrary, that combination makes NPRA the operational gateway for private patent enforcement which exceeds its health-regulatory remit.

From this perspective, NPRA’s proposed Guidelines are clearly beyond its statutory role under the Sale of Drugs Act 1952 (SDA) and the Control of Drugs and Cosmetics Regulations 1984 which regulate product registration on public health grounds, principally quality, safety and efficacy. The Guideline’s 45-day notification period and 12-month suspension period are not tied to any deficiency in product quality, safety or efficacy; they are made available only to facilitate enforcement of patents which is a private right.

Under the Patents Act 1983, the proper forum for scrutiny of infringement allegations is the court. Section 59(2) recognises imminent infringement actions and section 60(2) allows the patent holder to seek injunctions from the court, where the legal system can weigh the merits and courts regularly require an undertaking as to damages which serves as a promise by the patent holder to compensate the defendant for any losses suffered if it is later determined that the injunction should not have been granted. The undertaking mitigates the risk of unfairness to the generic applicant if the patent is not ultimately upheld. NPRA has no comparable adjudicative mandate, and no clear statutory power to create de facto injunctive relief by suspending regulatory approvals at great cost to the generic applicant.

In our view, the proposed Guidelines cannot be justified under Regulation 8 or NPRA’s parent legislation, the SDA as NPRA is using its health-registration powers to facilitate private patent enforcement. NPRA does not have the legal authority to suspend regulatory decisions as a patent enforcement remedy.