Updates To Malaysia’s Proposed Patent Linkage Framework

Malaysia’s pharmaceutical intellectual-property landscape is approaching a major regulatory change. Driven by its ratification of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) on 30th September 2022, Malaysia is actively drafting its inaugural patent linkage framework. The patent linkage system is scheduled to be officially implemented on 1 May 2027 to fulfil Malaysia’s CPTPP commitments.

The National Pharmaceutical Regulatory Agency (NPRA) recently issued the Draft Guideline on Implementation of Patent Linkage for Pharmaceutical Products, with the public consultation period running from 1 April 2026 to 1 May 2026. With the consultation now closed and the proposal moving into the finalisation phase, pharmaceutical innovators, generic manufacturers, and legal practitioners should closely assess how the forthcoming framework may affect regulatory timelines, patent enforcement strategy and market-entry planning.

For details regarding the draft guideline and the consultation closure report, please refer to the Unified Public Consultation website.

Key mechanics of the NPRA draft guideline

The draft guideline establishes an administrative connection between the regulatory registration of pharmaceutical products and the patent status of the corresponding new drug product. The key mechanics of the proposed system is outlined below.

Scope of implementation:

• The patent linkage system will be applicable to pharmaceutical products intended for human use. However, biologics (e.g. vaccines, anti-toxins / biopharmaceuticals, cell and gene therapy products (CGTPs), advance therapies and other medicinal products derived from human blood or human plasma) are expressly excluded.
• The patent linkage system covers product patents claiming active pharmaceutical ingredients, formulations, polymorphs, salts, esters, dosage forms, and/or dosing regimens, and patents claiming the approved medical uses (indication) of the registered NDP.
• Manufacturing process and packaging patents are excluded.
• Public Health Exemptions: The linkage system will not apply during public health emergencies or the implementation of urgent national measures, or when a compulsory license or government-use authorization is actively deployed.

Registration mechanism for new and existing registered products:

• For the new registration of a pharmaceutical product by a patent owner or licensee where a corresponding patent is already in force or a patent application has been filed with MyIPO, a Category 2 application must be made. Further details are discussed below.
• For an existing registered pharmaceutical product, when a new patent is granted or the patent status changes, the Product Registration Holders (PRH) for New Drug Products (NDP) must notify NPRA through the NPRA’s online regulatory platform (QUEST3+ system) within 30 days from the date of grant of the patent by the Intellectual Property Corporation of Malaysia (MyIPO).
• In broad terms, the proposed mechanism resembles the Orange Book system in the United States. However, unlike the Orange Book, the proposal does not appear to establish a separate, consolidated public patent register. Rather, the information will be publicly available through a product search in the QUEST3+ system, alongside other regulatory information.

• New registration applications for pharmaceutical products are divided into four categories:
  • Category 1: No patent is in force for the relevant pharmaceutical product.
  • Category 2: A patent is in force, and the applicant is the patent owner or a licensee and PRH for the NDP.
  • Category 3: A patent is in force, and the applicant is neither the owner nor a licensee, but undertakes not to market the product until the patent expires.
  • Category 4: A patent is in force, and the applicant is neither the owner nor a licensee but asserts that the patent is invalid or will not be infringed, or intends to market the product before patent expiry.

For a Category 4 application, the process workflow is outlined below:

• The 45-Day notification window: Generic applicants must notify the patent holder (i.e. the patent owner or licensee, as recorded in the MyIPO IPOnline System) and the PRH of the NDP (as recorded in the QUEST system) by serving a written notice if their submission overlaps with an active listed patent. Upon acknowledgement of receipt of the notice, a mandatory 45-day administrative hold is triggered, during which the NPRA holds back its registration decision.
• Automatic 12-Month suspension: If the patent holder files a patent infringement lawsuit within that 45-day window, the NPRA enforces an automatic 12-month stay on the generic drug’s marketing approval.
• Termination of suspension period: Suspension may end earlier if: (i) a final court decision is issued; (ii) the case is dismissed or withdrawn; (iii) the parties reach settlement; or (iv) the relevant patent expires. Otherwise, upon expiry of the 12-month suspension period, NPRA shall proceed with the normal regulatory process regardless of the status of the court proceedings.

Comparison with Singapore

As a forerunner in Southeast Asia, Singapore introduced its patent linkage scheme in 2004. Under Singapore’’s patent drug linkage system, an applicant seeking to register a therapeutic product which utilises patented elements is required to submit a declaration to the Health Science Authority (HSA), which includes information on the relevant patent and the patent proprietor relating to the therapeutic product. Where the applicant is not the patent proprietor, HSA then requires the applicant to serve a notice on the patent proprietor.

In this respect, Malaysia’s proposed framework is similar to Singapore’s patent linkage system, with both requiring applicant declarations and notification to affected patent proprietors, including a 45-day notification period. However, a key difference is that Singapore’s patent linkage system does not exclude biologics. The administrative structures also differ. Malaysia expressly divides applications into four categories and requires holders of existing new drug registrations to update relevant patent information through the NPRA’s online regulatory platform. Singapore does not appear to use the same classification or adopt a similar information disclosure system.

Another key difference is the potential regulatory delay. Malaysia proposes a 45-day notification period followed by a suspension of up to 12 months if timely legal proceedings are commenced. However, in Singapore, the patent proprietor may seek court relief that can halt the marketing-approval process for up to 30 months. Malaysia’s proposed maximum suspension is materially shorter.

Our thoughts

The proposed framework is a welcome step toward giving patent proprietors notice and an opportunity to act before approval of a potentially infringing generic product. However, several aspects of the draft materially weaken the potential protection.

First, the framework expressly omits biologics. This omission leaves biologic innovators without the benefit of the proposed linkage system, even though biologic products may involve substantial research investment and complex patent portfolios. The draft provides no substantive reason for the different treatment and no timetable for bringing biologics within the framework. At minimum, the final guideline warrants an explanation for the omission and a phased pathway for extending patent linkage to biologics and biosimilar applications.

Second, a fixed 12-month suspension period may not provide sufficient time for a Malaysian court to determine a complex pharmaceutical patent dispute. The deadline risks allowing regulatory approval—and potentially market entry—before validity or infringement has been resolved, shifting the burden to the patent proprietor to obtain prompt injunctive relief. This may undermine the stated objective of giving proprietors an adequate opportunity to pursue remedies before an allegedly infringing product reaches the market.

It is to be noted that the final form of the framework has not yet been approved. As mentioned above, the final consultation ended in May 2026. Based on the feedback, it remains to hope, that the final framework could adopt a longer suspension period or, alternatively, permit the court to extend the initial stay based on the merits, progress of the proceedings, conduct of the parties, and risk of irreparable harm. For example, a 30-month suspension period should be considered to align the framework with longer periods used in other jurisdictions such as Singapore and the United States.

Addressing both issues would provide more consistent protection across pharmaceutical technologies and make the linkage mechanism more effective.

Strategic takeaways

As the Ministry of Health reviews the feedback from public consultations, pharmaceutical patent owners should prepare for the operational shifts ahead:

• Portfolio auditing: Pharmaceutical patent holders should ensure that their MyIPO patent registrations are consistent with their NPRA regulatory dossiers, and promptly update the NPRA online platform upon the grant of any relevant patent.
• Litigation readiness: Because an automatic stay relies on launching a lawsuit within a strict 45-day window, patent owners need rapid-response protocols to draft and file complaints immediately upon receiving a generic notification.
• Contact information maintenance: Patent owners should ensure that their correspondence address recorded with MyIPO is accurate and up to date, as written notices and other communications will be sent directly to the patent owner, rather than through the patent agent on record for the patent.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.