Under Eligible patents: As per dialogue with industry stakeholders on 11 March 2026, only API and method of use patent should be included.

All the others patents like formulation, polymorphs, salts, esters, dosage form , dosing regimen, manufacturing process and packaging patents should be excluded to prevent patent evergreening and cause the delay of generics entry into the market.

under 5.1.16.15- Should be stated as " Under the 12 months suspension period, NPRA shall proceed with the normal regulatory process regardless of the status of the court proceedings.

Under 6.2.3- This clause should be removed, as generics companies will not know of any pending patents by originators.

Patented drugs typically receive up to 20 years of exclusivity under WTO TRIPS standards, allowing innovators time to commercialise their inventions. After expiry, generic medicines can enter the market, improving affordability and access. The system aims to balance innovation with wider public access to treatment.
Malaysia’s commitment under the CPTPP shape the regulatory environment. Chapter 18 covers intellectual property, including patent linkage, which connects marketing approval for new pharmaceutical products with patent rights. CPTPP provisions take a procedural rather than restrictive approach by notifying patent holders of competing applications, allowing time for legal action and providing access to remedies such as injunctions. This preserves the courts’ role in resolving patent disputes while regulators focus on safety, quality and efficacy.
The NPRA requires patent declaration as part of the drug registration process to ensure that new generic products do not infringe existing patents. While NPRA requires compliance with intellectual property laws, it does not determine patent validity or scope, as it remains focus on regulating the safety, quality and efficacy of pharmaceutical products. In my view, NPRA should adopt a soft patent linkage to balance patent protection with timely generic market entry, consistent with Malaysia’s commitments under the Agreement. The CPTPP protects undisclosed test data for limited period (generally five years) and mandates, via the DCA, that applicants verify they are not infringing on existing patents during product registration.
In particular, the guidelines introduced by NPRA, such as the proposed 4 categories and the possibility of 12-month suspension of generic applications, may unintentionally create barriers to market entry. This could delay availability of generic medications. In this regard, the proposed guidelines may warrant reconsideration to ensure consistency with the Patents Act 1983, particularly section 37 on the limitations of rights. Additional requirements such as proof of service of notice and acknowledgment from patent holders, are not expressly required under the CPTPP provisions. Their impact on applicants, particularly generic manufacturers, may therefore merit further consideration to ensure that processes remain efficient and proportionate.
While respecting patent rights is understandable, extending NPRA’s role beyond regulatory function should be carefully considered. Patent validity and infringement are legal issues best determined by the courts. Maintaining that distinction, while ensuring patent holders are notified and able to seek timely remedies may better reflect Malaysia’s legal framework and the CPTPP approach. This would allow NPRA to continue performing its regulatory role effectively, while leaving patent disputes to be resolved through the appropriate legal channels.
Respectfully, NPRA should reconsider and withdraw the current guidelines and policies, and align with Chapter 18.50 to 18.53 of the CPTPP Agreement, which already provides a notification mechanism for pharmaceutical marketing applications. Any disputes or remedies should be pursued through the courts by the respective parties. It is hoped that these observations may be helpful in the ongoing review of the proposed guidelines, while ensuring consistency with the Patents Act 1983, alignment with international commitments, and continued support for public health objectives.

We would like to underscore the importance of explicitly including biologic products within the scope, given their increasing significance to public health systems globally. Biologics now account for a substantial share of modern medicines, representing approximately 40–50% of global pharmaceutical sales and an increasing proportion of new drug approvals, particularly in therapeutic areas such as oncology, immunology, rare diseases, diabetes, and vaccines. In recent years, biologics and other advanced therapies (including monoclonal antibodies, gene and cell therapies) have constituted a significant share of new innovative medicines approved by major regulatory authorities and are increasingly reflected in national and WHO‑aligned essential medicines lists.
In this context, it is important to clearly distinguish between the suspension of CPTPP Article 18.51 relating to data exclusivity and the patent linkage framework under Article 18.53, as these provisions serve different policy objectives. The suspension of data exclusivity should not be interpreted as limiting the consideration or application of a patient linkage mechanism to biologic products, particularly given their role in addressing unmet medical needs and supporting health system sustainability.
From a policy perspective, we support a patient linkage framework that appropriately encompasses both small‑molecule and biologic products, and that is designed to safeguard timely patient access, uphold the integrity and predictability of the regulatory system, support continued pharmaceutical and biopharmaceutical innovation, and strengthen Malaysia’s attractiveness as a destination for long‑term pharmaceutical and life‑sciences investment, while maintaining a balanced public health and innovation ecosystem.

biologics should be included in the scope as it pertains to many essential life-saving medicines, and the suspension of CPTPP Article 18.51 (data exclusivity) is distinct from the patent linkage framework under Article 18.53
We are supportive of a patient linkage system that promotes innovation

Biologics should be included in the scope as it pertains to many essential life-saving medicines. We are supportive of a patient linkage system that promotes innovation and strengthens Malaysia’s attractiveness for pharmaceutical investment.