It is proposed for NPRA to do notification by publishing on the NPRA's website like the UK and NZ. UK is NPRA's reference country and since the notification system works and also fulfills the CPTPP agreement, NPRA should consider to follow suit. This lightens the burdens and hassle of both the industry and regulators. Any legal proceedings will be on the responsibility of the patent owner and not the regulators nor the industry. NPRA would have already fulfilled their obligation and can focus on the accessibility of products to the rakyat.

Proposing for NPRA to extend timeframe between issuance of directive and actual implementation.

MOPI appreciates the opportunity to provide feedback on the proposed implementation of the Patent Linkage framework in Malaysia.

MOPI acknowledges Malaysia’s obligation under the CPTPP, specifically Article 18.53, to implement a mechanism for notifying patent holders prior to the marketing of generic pharmaceutical products and to provide adequate opportunity for patent holders to seek legal remedies. MOPI recommends that NPRA limit implementation to a notification-based system in line with these requirements.

However, MOPI is concerned that the proposed framework, as presented, goes beyond the requirements of the CPTPP and may result in unintended consequences, particularly in delaying access to affordable generic medicines.

In particular, MOPI does not support the introduction of a 45-day notification hold period and a 12-month suspension period for Category 4 applications. These measures are not required under CPTPP Article 18.53 and may lead to delays in the approval and market entry of generic products, with potential implications on healthcare costs and patient access.

MOPI also notes that the proposed scope of patent eligibility is overly broad. The inclusion of secondary patents, such as formulations, polymorphs, salts, esters, dosage forms, and dosing regimens, may extend market exclusivity beyond the original product patent and could hinder timely access to generics. MOPI recommends that the scope be limited to product patents covering active pharmaceutical ingredients (APIs).

Further, MOPI recommends that the applicability of the Patent Linkage system be limited to patent holders from CPTPP member countries, as there is no requirement to extend such benefits to non-CPTPP jurisdictions.

With respect to process implementation, MOPI emphasises that regulatory approval by NPRA should not be delayed where submissions meet all regulatory requirements. Patent disputes should remain within the jurisdiction of the courts, consistent with the principle that regulatory approval should remain separate from patent enforcement, with patent disputes to be resolved by the courts.

In summary, MOPI recommends that Malaysia adopts a simple and effective notification mechanism that complies with CPTPP obligations without introducing additional regulatory barriers that may delay access to generic medicines.

A detailed set of comments and recommendations is provided in the attached document for NPRA’s further consideration.

On behalf of my organisation, we acknowledges the implementation of patent linkage by NPRA and support a framework that balances intellectual property protection with timely patient access to medicines. Our role remains aligned with NPRA requirements, focusing on quality, safety, and efficacy, while complying with administrative patent linkage processes.

On another note, we want to highlight several concerns:
1) Risk of delayed product approval may impact time-to-market for generics.
2) Uncertainty in patent status may affect product launch timelines, supply planning and our commercial strategy.

Hence, we hope NPRA can consider our suggestion:
1) Provide clear and detailed guidance on patent declaration format, notification procedures and defined timelines for regulatory status.
2) Consistency in implementation to ensure regulatory predictability and efficient submission planning.

The introduction of a “hard linkage” mechanism—particularly the provision for a potential 12-month suspension of product registration upon initiation of patent litigation—may inadvertently delay the entry of generic medicines. This could limit timely access to more affordable treatment options and increase healthcare costs. A notification-based (“soft linkage”) approach may be more appropriate, allowing patent holders to take independent legal action without directly impacting the regulatory approval timeline.

The proposed framework appears to expand the role of NPRA beyond its core mandate of evaluating the safety, quality, and efficacy of pharmaceutical products. Administrative requirements such as verifying proof of notification and managing suspension periods may impose additional operational burdens and introduce complexities that are more legal than scientific in nature. It is important to ensure that regulatory resources remain focused on public health priorities.

In addition, the broad scope of patent coverage—including secondary patents such as formulations, polymorphs, and dosage regimens—raises concerns regarding potential “evergreening” practices. Limiting the scope of linkage to primary patents (e.g., active pharmaceutical ingredients) could help mitigate the risk of unnecessary barriers to generic market entry while still respecting legitimate patent rights.

Furthermore, the proposed mechanism may shift part of the responsibility for patent enforcement onto regulatory processes and generic applicants, whereas patent rights are fundamentally private rights that should be enforced by the patent holder through the judicial system.

Dear NPRA, on behalf of ITPC Global we would like to submit a comment on patent linkage mechanism suggested. We believe mechanism will undermine access to medicines for Malaysian population and local generic industry development, as it: 1) endorses patent evergreening, 2) goes beyond Malaysia obligations under CPTPP, 3) duplicates administrative and budgetary resources of executive and judicial powers and violates constitutional principle of executive and judicial powers separation. Please see detailed analysis in attached submission.

The proposed patent linkage implementation may result in serious concerns:

1) Delays in generic entry as the mechanism could act as a new barrier, potentially stalling NPRA approvals for generics by months or years if a patent holder initiates a lawsuit during the registration process.

2) Increased in healthcare costs as delays in the availability of cheaper generic alternatives could lead to substantially higher medicine expenditures for both the government and private citizens.

3) Strengthened monopolies as this will effectively moves the "battleground" from the courts to the regulatory approval stage, potentially extending the market exclusivity of brand-name drugs.

The implementation of a patent linkage system is a positive step to Malaysia fulfilling its obligations under the Comprehensive and Progressive Agreement for Transpacific Partnership (CPTPP). We welcome the opportunity to comment on the Draft Guideline on Implementation of Patent Linkage for Pharmaceutical Products in Malaysia published by NPRA.

1. The patent linkage system is likely to increase litigation costs for generic manufacturers, which will ultimately be passed on to patients, making medicines more expensive.

2. There is no incentive for Category‑4 generic applicants, as no additional benefit is granted after a successful patent challenge. This discourages generic companies from developing patent‑protected drugs and ultimately delays the entry of generic medicines into the Malaysian market.

3. There is no clear mechanism to prevent multiple suspension periods arising from later‑listed patents. For instance, an innovator’s patent applications may be granted and listed in the patent linkage system after a generic dossier has already been filed, may resulting in an additional suspension period for the same Category‑4 generic applicant.

4. The lack of a distinct regulatory category for generic applications that carve out patented secondary indications obliges applicants to proceed under Category‑4, thereby imposing avoidable suspension periods on generic manufacturers.

5. The Malaysian market have tender‑based system in hospitals. Delays arising from the patent linkage framework—such as suspension periods, notification holds, and unnecessary litigation initiated by innovator companies against generics—can postpone generic drug approvals. These delays may prevent generic companies from meeting tender deadlines, ultimately delaying the entry of more affordable generic medicines into the market.

Comments on the draft guidelines:
1) Definition of GENERIC PRODUCT (page 3) - To include 'or products that have been registered before'
2) Annex A - Notification hold for 45 days => days are defined as calendar days or working days? We would like to suggest calendar days.
c) Annex B - upon written notice, PRH NPD is given 7 days to acknowledge => what happens if no acknowledgment given within 7 days? Will the registration process being hold? And again, the days should be define as calendar days or working days. We would want to suggest calendar days, to be consistent throughout.

On behalf of Malaysian AIDS Council, we would like to share our concerns in regards to this patent linkage guideline which could seriously impacting access to affordable medicine for Malaysia. Our view is expressed in the attachment,

While we understand the need to establish a notification system, we propose a more flexibile timeline to notify the patent holder/PRH of the NCE, i.e. to include the period after the corresponding generic is approved by DCA, as this is still align with the Article 18.53.1 of the CPTPP.

Please see attachment below

the rationale for setting the automatic stay period at 12 months, given that such a lengthy suspension and which can delay the generic entry or regulatory process approval

The proposed patent linkage guidelines appear inconsistent with Section 37 of the Patents Act 1983, which outlines limitations of patent rights. Any regulatory framework should avoid extending patent enforcement into the marketing approval process handled by National Pharmaceutical Regulatory Agency (NPRA).

The proposed patent linkage mechanism may create an environment where patent holders can initiate unnecessary legal proceedings, even against non-infringing products, leading to delays in registration. This shifts the system from a “soft” notification framework under the CPTPP Agreement to a “hard” linkage model that restricts competition and slows the entry of affordable medicines.

The proposed implementation of a Patent Linkage System in Malaysia, as outlined in the NPRA draft guidelines, introduces a "hard linkage" mechanism that ties the scientific approval of generic medicines to the patent status of originator drugs.
The following points are of concern:
1. Excessive Administrative Burden on Regulatory Bodies
The guideline requires the National Pharmaceutical Regulatory Agency (NPRA) to verify "evidence of service" and manage a 45-day notification period and a 12-month suspension period (Sections 5.1.6.10, 5.1.6.13).
This shifts the NPRA’s focus away from its core mandate of ensuring the safety, quality, and efficacy of medicines. It essentially turns a health regulator into a "patent gatekeeper," a role that requires legal expertise the agency explicitly states it will not exercise (Section 6.3.2).
2. Unjustified Delays for Generic Competitors
Section 5.1.6.13 outlines a 12-month suspension of registration approval if a patent holder initiates legal proceedings.
This "automatic stay" can be exploited by originator companies to block generic entry even if the patent in question is weak or invalid. Because generic manufacturers often operate on thin margins, a one-year delay can be financially devastating and prevents the public from accessing cheaper alternatives.
3. Scope of Patent Coverage is Too Broad
Section 4.4 states that linkage applies to patents claiming formulations, polymorphs, salts, esters, dosage forms, and dosing regimens.
Including these "secondary" patents encourages "evergreening," where companies extend their monopoly by making minor, non-therapeutic changes to a drug. Critics argue linkage should only apply to the primary Active Pharmaceutical Ingredient (API) to prevent abuse of the system.
4. Burden of Enforcement Shifted to the Public
Section 1.5 admits that generic manufacturers must now "navigate the patent landscape" before gaining approval.
Patent rights are private rights. Traditionally, it is the patent holder's responsibility to monitor the market and sue for infringement. This system shifts the burden and cost of enforcement onto the government (through administrative oversight) and the public (through delayed competition).
5. Potential Conflict with Public Health Flexibility
While Section 7.1 mentions that the guideline won't stop the government from taking action for "public health crises," the administrative machinery of linkage creates a default "pro-patent" environment.
In practice, the complexity of navigating Category 3 and Category 4 applications (Section 5.1.2) may discourage generic companies from even attempting to register products, leading to less competition and higher long-term healthcare costs for Malaysia.
While the stated objective is to enhance transparency and predictability, the proposed framework will in practice delay access to affordable medicines, weaken Malaysia’s generic industry, and burden NPRA with responsibilities outside its scientific mandate. Therefore, we respectfully but firmly oppose the introduction of a hard patent linkage system in Malaysia.

I am Andrew Tan Tze Tho, the President of Kuala Lumpur AIDS Support Services Society (KLASS), a non-profit organisation founded in 2001 by allies from medical professionals, volunteers, private sector, affected communities and People Living with HIV (PLHIV). We provide complete sexual health & HIV services, Treatment Literacy for HIV/AIDS, Co-infections and Opportunistic Infections related to HIV/AIDS, to community and paramedics. Access to HIV treatment has been essential to our members, especially the PLHIV and we have been advocating for affordable HIV treatment for all since our establishment.

NPRA’s draft patent linkage guidelines are deeply concerning to us at KLASS, and we are of the opinion that it does not fit its purpose. The key principle of patent linkage underlying assumptions and objectives are flawed, and is against the National Medicines Policy and the National Generic Medicines Framework that Ministry of Health has been implementing to ensure access to affordable treatment. As part of the patient group, we see these new regulations planned go against protecting our access to affordable medicine (especially generic medication), and instead, protect the benefits of originator pharmaceutical companies. We urge NPRA to withdraw the guidelines and engage patient groups & civil society organisations for meaningful consultation, before any further steps are taken to implement Article 18.53 of the CPTPP. Our concerns include the following:

• The draft guidelines exceed CPTPP requirements. Article 18.53.1 does not require patent listing, regular updates of patent information, a 45-day window for legal action, or a 12-month stay on regulatory approval. Notably, countries such as New Zealand, the UK, and Australia have not adopted such measures.
• A 12-month stay on regulatory approval is simply unacceptable - NPRA as a regulatory agency should not delay the pharmaceutical product safety assessment pending patent holder response. Patent should not be linked at all to product safety assessment from patient perspective.
• The draft guidelines risk facilitating patent evergreening by including secondary patents. This allows originator companies to extend exclusivity periods and delay generic competition. As a result, more products may fall into restrictive Category 4, enabling originator companies to suspend registration processes and postpone generic market entry.

We fear that this new regulation will affect the life-saving HIV medication access for our community – generic medication access is essential to our PLHIV community. Evidence from other countries shows patent linkage systems requiring patent listing and suspension of the regulatory process are vulnerable to abuse, delaying generic entry which further increases medicine prices for patients and the public health system. Ultimately, these guidelines will worsen the problem of access to affordable treatment in Malaysia.

Following NPRA’s proposal to introduce a Patent Linkage System, we wish to provide some feedback and comments on the proposed scope of implementation, categories of patent linkage and operational procedures of the system. Our response on the proposed Patent Linkage is enclosed. Thank you.

i am with similar stand to one of the anonymous with following comments:

In upholding Malaysia’s mandatory treaty obligations as a member of the CPTPP, while at the same time ensuring the timely availability of generics for the Malaysian population, please consider the following:

(1)The scope of implementation should exclude formulations, polymorphs, salts, esters, dosage forms, or dosing regimens from the linkage mechanism.

(2)For export only (FEO) products should be excluded. Since the CPTPP is a trade agreement meant to facilitate commerce, patent linkage should only apply to products entering the Malaysian market. Restricting exports undermines Malaysia’s competitiveness as a regional manufacturing hub. In addition, patent protection is territorial and should not therefore extend to products intended solely for export.

(3)The suspension period of 12 months should be removed. Article 18.53 is fully satisfied by the 45-day notification period, which provides the patent holder adequate time and opportunity to initiate a legal action. Please refer to the draft guideline in the public consultation document. By virtue of Para 5.1.6.13, it is implied that legal proceedings ought to have been taken by the patent holder within the 45-day period. There is no need for the suspension period of 12 months, which only serves to complicate the process and delay early availability of cost-effective generic medicines. (Para 5.1.6.13 Where NPRA receives satisfactory evidence that legal proceedings have been initiated by the PRH NDP or patent owner or patent licensee within the 45-day notification period, the approval decision shall be suspended for up to twelve (12) months commencing from the date of expiry of the 45-day notification period.)

Also, please find our comment for the draft guideline as attached.

Please find our comments enclosed. We sincerely hope that NPRA will consider the suggestions and feedback prior to finalizing the proposed patent linkage mechanism, as the current proposal goes beyond a simple notification mechanism and risks creating a regulatory gatekeeping system that is broader than necessary for CPTPP implementation and difficult to reconcile with the structure of the Patents Act 1983, procedurally uncertain in operation, and potentially harmful to timely generic entry, medicine affordability, and the legitimate commercial interests of the generic pharmaceutical sector. Thank you.

We would appreciate it if NPRA could further clarify whether evaluation activities will continue, particularly with respect to ongoing correspondence and regulatory review during the 45 days notification period and 12 months suspension period.

Specifically, we seek confirmation on whether queries, responses, and assessment communications will remain active during this period, to ensure alignment on timelines and expectations.

Thank you for the opportunity to comment on these important draft Guidelines on patent linkage. Please find attached my comments.

The People’s Health Forum is gravely concerned about the direct consequences of implementing the Patent Linkage proposal. We advocate for 'health for people, not profits'.

Please find attached our full comments on the grounds for objection to the patent linkage draft guidelines.

PT Foundation appreciates the efforts by the National Pharmaceutical Regulatory Agency (NPRA) and the Ministry of Health in engaging stakeholders on the proposed implementation of Patent Linkage in Malaysia. We recognise that this initiative is driven by Malaysia’s obligations under the CPTPP, which require the establishment of notification mechanisms, legal remedies, and pre-market dispute resolution processes . We also acknowledge the stated policy objective to balance patent protection with continued access to medicines.

From a public health and community perspective, PT Foundation remains concerned about the potential unintended consequences of this mechanism on timely access to affordable medicines—particularly generic drugs that are essential for HIV, STI, and harm reduction treatment. While the proposal states that patent linkage does not prevent generic entry , the introduction of notification and suspension periods—especially the potential 12-month delay triggered by legal proceedings—may indirectly slow down market entry of generics, affecting affordability and treatment continuity for vulnerable populations.

For the communities we serve, including people living with HIV, access to affordable antiretroviral therapy (ART) is critical to sustaining viral suppression and achieving public health targets such as U=U. Any delay in generic availability could increase treatment costs, strain public health budgets, and risk disruptions in care. This is particularly relevant given that patent linkage applies broadly to pharmaceutical products for human use, including imported products , which may further impact supply dynamics.

We note that NPRA maintains a regulatory-neutral role and does not determine patent validity or infringement, leaving such matters to the courts . However, in practice, the administrative processes—such as the 45-day notification period and potential suspension—may still create barriers that disproportionately affect generic manufacturers, especially smaller players. This could lead to reduced competition and higher medicine prices.

PT Foundation strongly supports the inclusion of safeguards such as non-application during public health emergencies and compulsory licensing scenarios . However, we recommend further strengthening these safeguards to ensure they are practical, clearly defined, and easily triggered when needed.

In engaging stakeholders, we propose the following:

Enhanced transparency on how cases triggering suspension periods are monitored and reported.
Clear timelines and accountability mechanisms to prevent unnecessary delays in generic approvals.
Public health impact assessments prior to full implementation, especially on essential medicines like ART and STI treatments.
Multi-stakeholder oversight platform, including civil society and public health organisations, to continuously review the impact of patent linkage on access to medicines.

In conclusion, while PT Foundation supports Malaysia’s commitment to international obligations, we urge that implementation be carefully calibrated to prioritise public health outcomes. Ensuring equitable, timely, and affordable access to medicines must remain central to this policy.

Please find following comments from Johnson & Johnson Sdn Bhd:

1. Biologics are pharmaceutical products and should be included in the scope of patent linkage system.

2. All the timelines in the guideline should be specified by calendar day or working day for better clarity.

3. The PRH of the generic product shall serve a written notice to patent owner/patent licensee and the PRH of the NDP for both category 3 and 4. In category 3 application, the PRH of the generic product shall serve a written notice to the patent owner/patent licensee and the PRH of the NDP, including a statement that the product shall not be marketed until after the expiry of all patents listed for the NDP.

4. The written notice shall be acknowledged by the patent owner/patent licensee and PRH NDP at least within thirty (30) days. The deadline of 7 days is not sufficient to allow acknowledgment by the patent owner.

5. To clarify and to elaborate in detail how is the written notice from PRH of generic product to the patent owner/ patent licensee and PRH of the NDP? Hardcopy submission or via email is sufficient? What documents to be responded?

6. Current 45 days of notification period is too short to determine if legal action is necessary, especially in large companies. A timeline of at least 3 months would be sufficient to taking a decision on legal action and notify, in writing to the Director of NPRA of such decision.

7. Current 12 months of suspension period is too short for the completion of legal action. Propose for 30 months, the same as Singapore.

8. For Category 3 applications, the PRH of the generic product shall ensure that the product is marketed only after all patents of the corresponding NDP has expired.

Thank you for considering all the comments/proposals as we establishing a robust patent linkage system in Malaysia.

We appreciate NPRA’s efforts to introduce a patent linkage framework in line with Malaysia’s international commitments, including under the CPTPP, and welcome the opportunity to provide feedback.
Please find attached file for the elaborated points.
We respectfully submit that additional clarity on notification points, recipients, and timeline triggers will improve predictability, reduce post marketing disputes, and better align the framework with the intended objectives of patent linkage under CPTPP.

We echo the concerns raised in other feedback regarding the proposed timelines for Category 4 Applications, particularly given the need to coordinate closely with patent and legal teams at our headquarters. Patent linkage matters involve significant legal and commercial implications and therefore require adequate time for proper assessment and response.
First, the draft provides a period of seven (7) days for acknowledgment of receipt of the notice by way of an official acknowledgment or delivery stamp. We respectfully propose extending this period to twenty (20) working days to allow sufficient time for internal review and coordination.
Second, the draft provides a forty five (45) day window for the patent holder to initiate legal proceedings. We propose extending this timeline to sixty (60) days, which would be more appropriate given the complexity of patent matters and the need to obtain legal instructions and approvals at a global level.
With respect to the twelve (12) month suspension period triggered upon initiation of legal proceedings, we are of the view that this duration may be insufficient, as patent litigation commonly extends beyond twelve months. In this regard, the suspension period of thirty (30) months proposed under the 2024 draft is more realistic and is more closely aligned with international best practices in jurisdictions such as Singapore and the United States.
We further propose that, during the suspension period and while the patent proceedings remain ongoing, NPRA should recognise and give effect to any interim relief granted by the competent court.

Feedback on Implementation of Patent Linkage for Pharmaceutical Products in Malaysia

The Malaysian government has reportedly saved more than RM900 million over the past two years by prioritizing the use of generic medicines across healthcare sectors, according to an article published on New Strait Times, in Jan 2026.

The recent proposal on implementation of a hard patent linkage system in Malaysia under the CPTPP, however, raises serious concerns for public health and the competitiveness of the domestic generic pharmaceutical industry. While intended to strengthen intellectual property protection, the current proposal goes beyond CPTPP requirements and risks delaying access to affordable medicines.

Patent linkage introduces patent enforcement into the drug registration process, shifting NPRA’s role from its core scientific mandate. The proposed system includes automatic suspensions of up to 12 months upon the initiation of patent litigation. This creates a high risk of strategic litigation by originator companies to delay generic entry, regardless of patent strength. Such delays restrict patient access to affordable treatments in a healthcare system that relies heavily on generics for cost containment.

Experience from other CPTPP countries such as Australia, New Zealand, and Brunei demonstrates that CPTPP obligations can be met through soft linkage notification approaches. In these jurisdictions, regulators do not link drug approval to patent status; instead, transparency measures allow patent holders to monitor applications. This approach supports timely generic entry and maintains regulatory efficiency.

This proposal also increases risks of patent evergreening, particularly through broad inclusion of secondary patents, and lacks clarity to prevent multiple suspension periods arising from later listed patents. Additionally, mandatory notification and disclosure requirements increase legal, financial, and administrative burdens especially for local SMEs and risk exposing confidential commercial information.

In view of these, Malaysia should consider adopting a soft linkage system that ensures transparency without automatic regulatory delays, minimizes litigation risk, and supports continued access to affordable medicines while maintaining a balanced approach to intellectual property protection.

On behalf of Novugen Pharma Sdn. Bhd.

NPRA’s proposed hard patent linkage system represents a significant departure from global best practices and raises serious concerns for healthcare affordability, regulatory integrity, and the long term competitiveness of the domestic pharmaceutical sector. While the stated aim is to protect intellectual property, the framework risks creating structural barriers that delay generic entry, inflate costs, and weaken Malaysia’s generic industry.

The most immediate consequence of hard linkage is the automatic 12 month suspension of regulatory approval whenever litigation is initiated. This mechanism allows originator companies to block competition regardless of the strength of their claims. For generic manufacturers, this creates uncertainty and disrupts production planning, ultimately slowing the availability of affordable medicines.

The inclusion of secondary patents—covering salts, polymorphs, and formulations—poses a significant risk of evergreening. Such practices extend exclusivity far beyond the original patent protections, delaying generic competition even after primary patents have expired. This not only prolongs monopolies but also undermines the balance between innovation incentives and public health needs. Without stricter criteria for patent listing, Malaysia risks enabling repeated extensions of exclusivity that serve corporate interests at the expense of patients.
Hard linkage threatens these savings by delaying generic substitution and prolonging reliance on higher priced originator drugs. The financial impact will be felt across both public procurement and private healthcare, increasing overall expenditure and reducing the efficiency of Malaysia’s healthcare system. Patients will face higher costs, while the government’s ability to contain spending will be weakened.

Local manufacturers will bear the brunt of compliance obligations under the proposed system. Mandatory notifications, patent declarations, and disclosure of sensitive data increase operational complexity and legal exposure. Local generic pharma often lack the resources to manage prolonged litigation or continuous patent monitoring, leaving them vulnerable to competitive disadvantages. Over time, this could discourage investment in Malaysia’s generic industry and reduce its role in regional supply chains.

Countries such as Australia, New Zealand, and Brunei have avoided hard linkage, relying instead on transparency and judicial enforcement. Their regulators approve medicines based on safety, quality, and efficacy, while patent disputes remain in the courts. Malaysia’s approach exceeds treaty obligations, locking in unnecessary constraints that risk weakening its domestic industry. The result will be delayed patient access, higher medicine costs, and reduced confidence in Malaysia’s regulatory system. Over time, it may erode the strength of the domestic generic industry and diminish Malaysia’s role in regional supply chains.

Malaysia should adopt a soft linkage model—ensuring transparency through publication of application information, while avoiding automatic regulatory delays and unnecessary litigation triggers. This approach would balance intellectual property protection with timely access to affordable medicines, safeguard NPRA’s scientific role, and support the sustainability of Malaysia’s pharmaceutical sector.

We appreciate the opportunity to provide feedback on the Draft Guideline. We strongly support the MOH and NPRA’s effort to align Malaysia’s IP framework with international standards.

We note that biologics appear to be excluded from the scope of implementation. Biologics represent some of the most advanced and resource-intensive innovations in modern medicine. Excluding them may discourage the introduction of complex, cutting-edge therapies to the MY market. We kindly request the NPRA to clarify the rationale for this exclusion and strongly advocate for the inclusion of biologics within the patent linkage framework.

The draft excludes manufacturing process and packaging patents. However, in pharmaceutical development, innovative manufacturing processes and specialized packaging (such as delivery devices) are often integral to a drug’s stability, efficacy and safety profile. We request a review of this exclusion.

Regarding Category 3 applications, the current draft states that the registered product shall not be marketed until after the expiry patent. However, the previous 2024 draft included a provision stating that the application “may not be made earlier than 18 months before the patent expires”, we propose reinstating the 18-month threshold to ensure a balanced and orderly process (avoid burdening NPRA assessing applications years before patent expires).

The draft provides a 45-day window for the patent holder to initiate legal proceedings. We propose extending this to 60 days. Innovators operate on a global scale, upon receiving a notice, local personnel must coordinate extensively with global patent and legal teams across multiple time zones to conduct a thorough evaluation. A 60-day window provides a realistic timeline to seek proper legal advice and ensures that any subsequent actions are carefully considered and legally sound.

The draft proposes a 12-month suspension period upon the initiation of legal proceedings. The earlier draft in 2024 proposed a 30-month suspension period, which is much closer to international best practices in jurisdictions like SG and US. Complex patent litigation rarely concludes within 12 months. A premature lifting of the suspension could result in irreversible market damage to the innovator before the court has reached a verdict. Restoring the 30 months period is vital to protect the commercial viability of innovations.

Further to the point above, if the patent holder applies for an extension due to ongoing complex litigation, there should be a mechanism to extend the 12-month suspension accordingly.

PRH needs to notify NPRA within 30 days from the date of grant of patent. This timeframe is operationally challenging, especially if there are ongoing regulatory variations that are critical. To avoid unintentional non-compliance due to administrative bottlenecks, we propose extending this notification wind

We welcome the introduction of a requirement for product owners to list relevant patents, which represents a positive step toward transparency in the Malaysian system. However, several important concerns should be addressed to ensure that the mechanism functions fairly and does not unintentionally delay generic market entry.

First, although certain categories of patents are explicitly excluded (e.g. manufacturing processes, packaging, and non-product claims such as formulations or dosing regimens unless claimed as product patents), the system appears to rely primarily on self-declaration by the product owner. There does not appear to be a substantive review of whether listed patents are in fact relevant to the approved product.

This creates a risk that patentees may list patents that do not directly cover the product—such as patents relating to variants, analytical methods, or other peripheral aspects—in order to delay generic entry. In the absence of an independent verification mechanism, the system may be vulnerable to strategic over-listing.

It is currently unclear whether there are effective safeguards or penalties in place to address inaccurate or abusive patent listings. To mitigate this risk, consideration should be given to:
-introducing a mechanism to assess patent relevance, and/or
-establishing clear penalties or sanctions for bad-faith or misleading listings.

Second, the proposed framework is likely to increase the cost burden on generic manufacturers. Generic companies may be required to incur significant legal costs to demonstrate non-infringement or to challenge patents that may not be valid or relevant. This could result in:
-delayed entry of generic medicines,
-increased development and litigation costs, and
-reduced affordability and access to medicines.

We therefore encourage the Government of Malaysia to carefully balance the protection of patent rights with the need to ensure timely access to affordable medicines, and to avoid creating unnecessary barriers to legitimate generic competition.

Malaysia regulatory framework enables generic players to freely conduct R&D and BA/BE studies on the basis that it is not for commercial purposes. They are not required to make a declaration that they do not intend to market the product before patent expiration. They should not be asked to do so. The current system is sufficient, and the local public regulatory system should not be used to enforce patent laws. Local generic companies and countries must be allowed freedom and flexibility as required for national needs.

NPRA’s proposed Guidelines introduces a 45-day notification period during which NPRA withholds generic registration decisions and further provides for an automatic 12-month suspension of the generic approval process if the patent holder initiates legal action, which goes beyond Malaysia obligations under the CPTPP.

New Zealand and the United Kingdom—both CPTPP parties— with GNI/capita 4 times larger than Malaysia have made clear that compliance with Article 18.53 of CPTPP does not necessitate such measures.

Article 18.53 of the CPTPP only requires Malaysia to provide:
1) “a system to provide notice to a patent holder or to allow for a patent holder to be notified prior to the marketing” of a generic product.
This can be implemented in a soft manner by requiring only the notification that a third party is seeking to market a generic product during the term of an applicable patent (without any withholding or suspension of the generic approval process by NPRA).

2) “adequate time and opportunity for such a patent holder to seek, prior to the marketing of an allegedly infringing product, available remedies and … procedures, such as judicial or administrative proceedings, and expeditious remedies, such as preliminary injunctions…”
The 45-day notification period followed by an automatic 12-month suspension is unjustified and unnecessary, as such remedies are already available under Malaysia’s judicial system and can be obtained rapidly, often within 24 hours (Section 60 of the Malaysian Patents Act recognizes the possibility of the patent holder to apply for an injunction including for situations when the patent holder can prove imminent infringement).

Generic companies which believe that their product does not infringe existing patents will not be willing to make Category 3 Applications (eg. that they do not intend to market the product before the expiration of the patent) and, as a result, will likely face the possibility of legal action, with their registration process automatically suspended and delayed.

If adopted unchanged, the impact will therefore be to delay generic approval timelines and therefore access to competitive affordable treatments in Malaysia.

Comments on the draft guideline have been included in the attached document.

The Pharmaceutical Association of Malaysia (PhAMA) wishes to express its appreciation
to the Government of Malaysia for its commitment to strengthening Malaysia’s intellectual property and regulatory framework, including the implementation of a soft patent linkage system in Malaysia pursuant to Malaysia’s agreement under the ratified Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).

PhAMA acknowledges that the finalization of the implementation of a soft patent linkage process is currently underway and is being led by the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health, with a pilot phase anticipated in Q4 2026 and a full implementation targeted for May 2027. We appreciate the continued engagement and consultation efforts undertaken by the Government and NPRA in developing a system that is pragmatic and fit for purpose within the Malaysian regulatory and legal landscape.

The fundamental purpose of a soft patent linkage system is to provide a transparent and
predictable mechanism that prevents patent infringement prior to market entry, while at
the same time preserving timely access to medicines once patent rights have lawfully
expired.

PhAMA firmly believes that the successful implementation of soft patent linkage in Malaysia should balance the interests of innovator and generic manufacturers, while drawing on relevant international practices in other countries that have implemented patent linkage under similar international obligations.

In this regard, PhAMA respectfully requests that the Government give due consideration to PhAMA’s proposals on:
• a 45-days notification period and a 12-months stay period (where legal proceedings are commenced); and
• the inclusion of biologics within the patent linkage framework.

PhAMA remains committed to working constructively with the Government, NPRA, and all relevant stakeholders to support the development of a patent linkage system that that safeguards patient access, upholds regulatory integrity, promotes innovation and strengthens Malaysia’s attractiveness as a destination for innovative pharmaceutical and biopharmaceutical investment.

Thank you for your consideration.

Response from The National Cancer Society of Malaysia - refer to the documents attached

Together Against Cancer has advocated for Malaysian cancer patients for more than 10 years. The proposed NPRA Guidelines on Patent Linkage for Pharmaceutical Products will delay access to affordable life-saving generic medicines and impose a direct, measurable cost on patients. We are extremely concerned and strongly call on the Government to withdraw these Guidelines and conduct consultation with patient organisations and civil society before any policy is finalised.

Please find attached the document setting out our full rationale for the review of the guidelines.

I am writing this submission in my personal capacity as a father to two children living with rare conditions - Spinal Muscular Atrophy (SMA), and Growth Hormone Deficiency (GHD) resulting from a pituitary microadenoma. This submission is offered with deep respect for the NPRA’s mission to safeguard public health through scientific excellence.

For families like mine, the NPRA is the gateway to hope. However, I am concerned that the proposed patent linkage guidelines may inadvertently compromise the agency’s core mission of ensuring timely access to safe and effective medicines for all Malaysians.
Please see attachment for full submission.

Comments on Draft Guidelines On Implementation of Patent Linkage For Pharmaceutical Products in Malaysia

Consumers Association of Penang (CAP), Federation of Malaysian Consumers Associations (FOMCA), Malaysian AIDS Council (MAC), National Cancer Society of Malaysia
and Third World Network (TWN)

1. Introduction

We urge the National Pharmaceutical Regulatory Agency (NPRA) to withdraw the proposed Guidelines on Implementation of Patent Linkage for Pharmaceutical Products in Malaysia and to undertake meaningful consultations with civil society organizations and patient advocacy organisations on the best way to approach implementation of Article 18.53 of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).

The proposed Guidelines are CPTPP-plus going well beyond what is required under Article 18.53 of the CPTPP and will have serious adverse consequences for both the generic industry and access to affordable pharmaceutical products in Malaysia.

Please see attachment for full submission.

The “soft” patent linkage approach under the CPTPP Agreement is limited to notification and judicial recourse. Notification should be positioned post-approval and prior to market entry, rather than during evaluation. The proposed framework by National Pharmaceutical Regulatory Agency (NPRA) may delay approvals and disadvantage local generic manufacturers and importers.

Comments for NPRA have been included in the draft guideline attached.

Please refer attached file for feedback on the proposed Draft Guideline on Implementation of Patent Linkage for Pharmaceutical Products in Malaysia.pdf

In Malaysia, medical inflation is projected to climb to 16% in 2026, up from an estimated 15% in 2025. Expediting the availability of generic medicines is a critical strategy for containing medical inflation. By providing high-quality alternatives at a fraction of the cost of brand-name originators, generic medicines ensure that essential treatments remain affordable, effectively curbing the momentum of escalating healthcare expenses. 

In upholding Malaysia’s mandatory treaty obligations as a member of the CPTPP, while at the same time ensuring the timely availability of generics for the Malaysian population, please consider the following:

(1)The scope of implementation should exclude formulations, polymorphs, salts, esters, dosage forms, or dosing regimens from the linkage mechanism.

(2)For export only (FEO) products should be excluded. Since the CPTPP is a trade agreement meant to facilitate commerce, patent linkage should only apply to products entering the Malaysian market. Restricting exports undermines Malaysia’s competitiveness as a regional manufacturing hub. In addition, patent protection is territorial and should not therefore extend to products intended solely for export.

(3)The suspension period of 12 months should be removed. Article 18.53 is fully satisfied by the 45-day notification period, which provides the patent holder adequate time and opportunity to initiate a legal action. Please refer to the draft guideline in the public consultation document. By virtue of Para 5.1.6.13, it is implied that legal proceedings ought to have been taken by the patent holder within the 45-day period. There is no need for the suspension period of 12 months, which only serves to complicate the process and delay early availability of cost-effective generic medicines. (Para 5.1.6.13 Where NPRA receives satisfactory evidence that legal proceedings have been initiated by the PRH NDP or patent owner or patent licensee within the 45-day notification period, the approval decision shall be suspended for up to twelve (12) months commencing from the date of expiry of the 45-day notification period.)

1) On Page 4, it was noted that "Pending or published applications are not considered ‘in force’". Could you please clarify this further?
What if registration approval has already been granted to a PRH (Generic), while the PRH (NDP) is still applying for MyIPO?
In this case, is the PRH (Generic) allowed to market the product?

2) For applications classified as For Export Only (FEO), does the patent linkage refer only to patents granted by MyIPO, or to those in the respective importing country?
If so, how should the patent expiry date be defined?

3) In cases where a product is already considered a generic overseas, but the specific API/Route of Administration has never been registered in Malaysia, a PRH (Generic) may register it as a New Drug Product (NDP). In such situations, will the patent linkage refer to this PRH (Generic)?

Attached are my comments on the Draft Guidelines.

We would like to express our concerns and do not agree with the current draft guideline on the implementation of patent linkage.

1. Notification Requirement
NPRA Proposal: PRH generic to submit notice with acknowledgment receipt to patent owner and PRH NDP
Industry Position: PRH generic should only be required to submit proof of notification to PRH NDP
→ This is sufficient and avoids unnecessary administrative burden.
2. Suspension Period
NPRA Proposal: 12-month suspension period
Industry Position: No suspension period
→ A suspension mechanism will delay access to affordable generics and goes beyond what is necessary.
3. Scope of Implementation
NPRA Proposal: Applicable to all countries
Industry Position: Should be limited only to member countries of CPTPP
→ Implementation should not exceed treaty obligations.
4. Registration Application for FEO Products
Industry Position: Should focus only on participating CPTPP countries, not beyond.
5. Eligible Patents
NPRA Proposal: Broad inclusion, including secondary patents
Industry Position: Limit only to API (Active Pharmaceutical Ingredient)
→ This avoids “evergreening” and ensures fair market competition.
6. Categories of Patents
NPRA Proposal: Multiple categories
Industry Position: Remove the 4 categories and adopt a simpler, more straightforward approach.
7. Role of NPRA

NPRA must maintain its regulatory mandate. Its primary role is to ensure that registered products are:

Safe
Of good quality
Efficacious

NPRA should not:

Decide on patent infringement
Determine patent validity
Interpret the scope of patents
8. Recommended Approach

NPRA is encouraged to:

Learn from other countries that have implemented patent linkage, including their challenges and outcomes
Benchmark against other CPTPP member countries
Adopt a minimalist “notification approach”, sufficient to meet CPTPP requirements
9. CPTPP Compliance (Article 18.53.1)

To align with Article 18.53.1 of CPTPP, we recommend removing the following requirements:

Patent listing
Multiple patent categories
Suspension of the regulatory process
Mandatory service of notice to patent holder

Conclusion

Patent linkage should be implemented in a balanced and proportionate manner, ensuring compliance with CPTPP while avoiding unnecessary barriers to generic market entry. A simplified notification-based system would be the most appropriate approach.

First, the patent linkage policy is intended to fulfil the requirements of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), which Malaysia has ratified and joined. It was not proposed for public health reasons. A patent is a property right and a private matter for the parties involved to resolve through legal channels. However, the National Pharmaceutical Regulatory Agency (NPRA) is responsible for ensuring medicines meet safety, efficacy, and quality standards before approval for marketing and sale. Patents and marketing authorisations should not be linked, as this adds duties outside the NPRA’s original role and has no direct health relevance.

Since this policy change is for CPTPP compliance, the government should adopt only the minimum requirement under Article 18.53(1), which requires a system to notify patent holders, or allow them to be notified, before a pharmaceutical product is marketed. The NPRA may help convey notices, but patent disputes should not interfere with its work in processing drug registration and approvals. The NPRA should not become an arbiter in legal disputes that delay drug registration. If the current proposal is accepted, generic market entry will likely be delayed because originator companies would be encouraged to file questionable secondary patents to extend protection for their products. This practice, known as patent evergreening, already exists and would likely worsen under the proposal.

The Malaysian public is already facing medical inflation, including rising medicine prices. A 2025 Ministry of Health Malaysia report found that between 2012 and 2022, wholesale median medicine prices rose by 15–40%, while retail median prices increased by 16–33.6%, with no decreases recorded. Government procurement data also showed that switching from originator to generic medicines could save taxpayers an average of RM6.8 million per procurement. If originator medicines continue to be used, there is a 25% chance costs will be even higher, while in 75% of cases savings average only 12% compared with a switch to generics. If the proposal proceeds, what will be the budget impact on procurement, and how will it affect the public, especially cancer and rare disease patients waiting for generics to reduce costs?

The Ministry of Health should not allow originator companies to undermine the government’s National Medicines Policy, especially the National Generic Medicines Framework, which promotes more affordable generics. In 2024, the Federal Government spent RM3.46 billion on medicine procurement, of which 70.12% was for generic medicines. This policy allows the government to purchase more medicines to meet public demand.

The proposed patent linkage policy would only delay generic medicines without health benefits. Therefore, I propose:
(i) Do away the 12-month suspension and notification periods, the most controversial feature that would delay generics and encourage patent evergreening.
(ii) Replace the patent list with a simple notification system. Generic companies could notify patent holders before marketing through private communication (copying the NPRA), public notice such as on the NPRA website, or both. Public notice is the simplest and least burdensome option, especially for the NPRA.

As the product registration holder (PRH) for pharmaceutical products, we strongly object to the proposal to expand the patent review framework to cover all secondary patents. This approach could delay the entry of generic medicines into the market, ultimately affecting patient access to more affordable treatment options. We are also concerned about the proposed 12-month suspension period for Category 4 applications. Such a pause in the evaluation process would likely lead to delays in approvals, create challenges for business planning and supply continuity, and reduce the timely availability of cost-effective medicines. Therefore, please carefully reconsider the proposed measures, taking into account their potential impact on the generics industry, healthcare costs, and patient access to essential medicines.

We refer to the recent clarification and the proposed implementation concerning patent considerations in product registration by the National Pharmaceutical Regulatory Agency (NPRA) and the Intellectual Property Corporation of Malaysia (MyIPO).

As the product registration holder for generic pharmaceutical products, we wish to formally express our strong disagreement with the proposed expansion of the scope of patent considerations.

We are particularly concerned that the proposal extends the patent review framework to include all secondary patents. Such an expanded scope may create significant barriers to the timely registration and market entry of generic pharmaceutical products, which are essential in ensuring broader patient access to affordable medicines. In our view, the inclusion of secondary patents goes beyond the original intent of the registration framework and may lead to unnecessary regulatory complexity and uncertainty.

In addition, we strongly object to the proposed 12-month suspension period, during which the regulatory process for Category 4 products would be halted. This suspension would result in substantial delays in product approvals, disrupt business planning and supply continuity, and adversely affect the availability of cost-effective treatment options in the market.

Given these concerns, we respectfully urge NPRA and MyIPO to reconsider the proposed implementation and its broader implications on the generic pharmaceutical industry, healthcare affordability, and patient access to essential medicines.

We refer to the recent clarification and the proposed implementation concerning patent considerations in product registration by the National Pharmaceutical Regulatory Agency (NPRA) and the Intellectual Property Corporation of Malaysia (MyIPO).

As the product registration holder for generic pharmaceutical products, we wish to formally express our strong disagreement with the proposed expansion of the scope of patent considerations.

We are particularly concerned that the proposal extends the patent review framework to include all secondary patents. Such an expanded scope may create significant barriers to the timely registration and market entry of generic pharmaceutical products, which are essential in ensuring broader patient access to affordable medicines. In our view, the inclusion of secondary patents goes beyond the original intent of the registration framework and may lead to unnecessary regulatory complexity and uncertainty.

In addition, we strongly object to the proposed 12-month suspension period, during which the regulatory process for Category 4 products would be halted. This suspension would result in substantial delays in product approvals, disrupt business planning and supply continuity, and adversely affect the availability of cost-effective treatment options in the market.

Given these concerns, we respectfully urge NPRA and MyIPO to reconsider the proposed implementation and its broader implications on the generic pharmaceutical industry, healthcare affordability, and patient access to essential medicines.

Evergreening medicine patents limit access to affordable healthcare by granting manufacturers perpetual monopolies, often resulting in exorbitant prices, which restricts patient access. These protections are meant to incentivize research, not hinder competition and keep essential treatments out of reach, particularly for low-income patients, in a nation where healthcare is highly subsidized. In order to strike a balance between patent rights and medicines accessibility, please revert to the older proposal for API & indication only or adopt the Indian Patent Law Section 3(d) is to stop the evergreening of patents. Evergreening happens when companies try to extend their patents by making small changes to existing products, like creating a new form of a drug (e.g., a different salt or crystal structure) without improving its actual benefits. This can delay the production of affordable generic drugs, which are vital for people in India and other developing countries. By requiring new forms of known substances to show "enhanced efficacy," Section 3(d) ensures that only meaningful innovations get patent protection, balancing innovation with public access to medicines.

We refer to the recent clarification and proposed implementation concerning patent considerations in product registration by the National Pharmaceutical Regulatory Agency (NPRA) and the Intellectual Property Corporation of Malaysia (MyIPO).
As a product registration holder for generic pharmaceutical products, we would like to formally express our disagreement with the expanded scope of patent consideration.
1. Expansion Beyond Established NPRA Scope
Based on the existing NPRA guideline, patent considerations have been limited to specific aspects such as indication and method of administration. However, the recent position indicating that product registration should be withheld based on all listed patents represents a significant expansion beyond the current regulatory framework.
This shift effectively introduces a broader patent linkage mechanism that was not originally предусмотрed under NPRA’s established approach.

2. Unfair Burden on Generic Product Holders
Requiring generic applicants to account for all listed patents—including those not directly relevant to the approved indication or method of use—places an unreasonable and disproportionate burden on generic product holders.
In practice, this may include secondary patents (e.g., formulation, process, polymorphs) that should not prevent regulatory approval, as such matters are more appropriately addressed through established legal patent enforcement mechanisms.
3. Impact on Patient Access and Public Health
The requirement to consider all listed patents prior to registration is likely to delay the approval and market entry of generic medicines.
Such delays will directly impact patient access to affordable treatments, particularly in therapeutic areas where cost remains a critical factor. Timely availability of generics is essential to support healthcare sustainability and ensure broader access to medicines in Malaysia.
4. Misalignment with International Regulatory Practices
The expanded approach appears inconsistent with international best practices:
Many jurisdictions maintain a clear separation between regulatory approval and patent enforcement.
Regulatory authorities typically do not assess the full patent landscape as a condition for marketing approval.
The World Health Organization (WHO) supports policies that facilitate timely access to generic medicines without unnecessary regulatory barriers.
5. Risk of Significant Delays
Based on our assessment, this expanded requirement may result in delays of approximately 6–12 months or longer, due to:
Increased complexity in evaluating multiple patents
Greater uncertainty in submission and approval pathways
Potential for additional queries and regulatory challenges
6. Recommendation
In light of the above, we respectfully recommend that:
The scope of patent consideration be maintained in line with the existing NPRA guideline (limited to indication and method of administration);
Broader patent matters, including secondary patents, continue to be addressed through appropriate legal channels rather than through the regulatory approval process;
Alternatively, if a patent linkage mechanism is to be considered, it should follow a notification-based approach as implemented in jurisdictions such as the United Kingdom and New Zealand, which does not delay regulatory approval; and
Further consultation be conducted with industry stakeholders to ensure a balanced, transparent, and practical implementation.

The proposed patent linkage guidelines appear inconsistent with Section 37 of the Patents Act 1983. Notification mechanisms should not interfere with the scientific evaluation process by National Pharmaceutical Regulatory Agency (NPRA), and should instead take place post-approval. The current approach may introduce unnecessary delays and barriers for generic entry.

While patent protection is recognized under the WTO TRIPS Agreement, such considerations should not be incorporated into the product registration process. The role of Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) must remain confined to the scientific evaluation of medicinal products, specifically in terms of safety, quality, and efficacy.

The inclusion of patent-related requirements within the registration dossier would extend NPRA’s mandate beyond its regulatory function and may result in unnecessary delays in product approval. Patent matters are more appropriately addressed through judicial mechanisms. Where applicable, notification to patent holders should occur only after the grant of marketing approval and prior to commercialization, ensuring that any disputes can be resolved without impacting regulatory timelines.

Furthermore, pre-approval patent linkage measures, including imposed waiting periods or regulatory “stop-clock” mechanisms, risk delaying the entry of generic medicines into the market. This may discourage participation by local generic manufacturers, reduce market competition, and contribute to sustained high medicine prices.

In view of the above, it is recommended that patent-related requirements be omitted from the product registration dossier to preserve regulatory efficiency and facilitate timely access to affordable medicines.

Malaysia’s access to affordable medicines depends on timely generic entry. A post-approval notification system aligns with the CPTPP Agreement while avoiding unnecessary delays such as 45-day waiting periods and 12-month stop-clocks, which may otherwise sustain monopoly pricing. The implementation of patent linkage in its current form may incentivize patent holders to file additional or secondary patents to prolong exclusivity. Such practices, combined with regulatory delays and potential litigation, transform the system into a “hard” linkage model that undermines timely access to generics and discourages innovation by generic players.

Article 18.53 (1) (a) to (c) requires only a NOTIFICATION system which allows a patent holder adequate time and remedy to pursue remedies such as an injunction before an alleged infringing product is marketed. NPRA must not over implement. It should specifically reject any system that delays registration of generics because patents are claimed/exist, as patents and marketing approval are separate issues.
The proposed guidelines are beyond NPRA´s mandate which is to regulate drugs based on considerations of safety, quality and efficacy. Current marketing approval and patent laws and systems provide adequate protection to product registration holders and are sufficient compliance of article 18.53(1)(a) to (c). NPRA already notifies the public of marketing approval of drugs, and temporary injunctions in Malaysia can be obtained as quickly as 24 to 48 hours in Malaysia in deserving cases. The automatic stay of 45 days upon the submission of a Category 4 application is a strong form of linkage. It in effect operates an interim injunction, usurping existing legal framework in Malaysia – it is the High Court that decides matters of validity and infringement of patents and whether temporary remedies should be granted on established procedure and law, and only where sufficient evidence justifies it. It also undermines section 37 (1A) of the Patents Act which specifically states that patent rights do not extend to acts required for the development and submission of information to NPRA precisely so that marketing approval of much needed generics are not delayed to ensure that patents, which are essentially private rights, do not jeopardise the public health needs of the nation.
PL is proven to increase healthcare spending by delaying generic entry and prolonging the high cost of originator drugs. This effect is precisely intended by innovators that use PL as part of patent evergreening strategy which includes other mechanisms such as patent thickets, product hopping, pricing strategies, denigration and misuse of regulatory procedures. PL is meant to delay the timing of generic launch, often without grounds. Latest statistics from the US show that up to 70% of patents are invalidated when challenged.
The guidelines will jeopardize Malaysia´s medicine security. In terms of investment in pharmaceutical manufacturing, MyCC´s Pharmaceutical Sector report clearly shows that innovator activity in Malaysia is largely limited to importing with domestic genetic manufacturers being the main production base. The system proposed will act as a deterrent for generic manufacturing whether local or foreign, especially by smaller companies, as it will create volatility in market entry, increase operating costs and lower revenue with increased litigation risks and delayed product launches. Malaysia´s Generic Medicines Policy requires support for domestic pharmaceutical manufacturing,
The guidelines will also increase public healthcare provision. The future will see a significant population of elderly with low retirement savings according to EPF. As out of pocket healthcare financing is substantial, any rise in healthcare cost will be directly borne by the rakyat. Many have given up insurance policies as premiums rise beyond means.
The guidelines must be withdrawn.

Biologics and biosimilars should be expressly excluded from Malaysia’s patent linkage system because the scientific, regulatory, and public‑health characteristics of these products differ fundamentally from small‑molecule drugs. Extending patent linkage to biologics would create disproportionate regulatory barriers, delay patient access to affordable biosimilars, increase healthcare costs, and undermine national biosimilar policy objectives without providing commensurate intellectual property protection benefits.

1. The proposed patent linkage framework risks delaying generic entry by requiring regulatory action contingent on patent disputes. This approach is inconsistent with the intent of the CPTPP Agreement, which places dispute resolution within the courts rather than regulatory authorities.

2. The role of National Pharmaceutical Regulatory Agency (NPRA) should remain limited to quality, safety, and efficacy. Expanding its role into patent linkage enforcement risks delaying generic approvals, discouraging local industry participation, and maintaining monopolistic pricing for medicines.

- A “soft” patent linkage system should ensure notification without interfering in regulatory approval timelines. Implementing notification post-approval but prior to marketing preserves the role of National Pharmaceutical Regulatory Agency (NPRA) and avoids delays that could limit competition, discourage local players, and maintain high medicine costs.

-Malaysia’s obligations under the WTO TRIPS Agreement and CPTPP Agreement support timely access to affordable generics after patent expiry. The proposed patent linkage framework by National Pharmaceutical Regulatory Agency (NPRA) appears to exceed “soft linkage” requirements and may delay market entry. It is recommended that implementation aligns strictly with CPTPP provisions without introducing additional barriers.

- The role of National Pharmaceutical Regulatory Agency (NPRA) should remain focused on product quality, safety, and efficacy, without involvement in patent disputes. Patent enforcement should remain within the judicial system as envisioned under the CPTPP Agreement.

- A “soft” patent linkage system should not interfere with regulatory approval. However, the proposed framework risks becoming a “hard” linkage by enabling patent holders to initiate judicial actions that delay registration, even where generic applicants have confirmed non-infringement. This may discourage local generic development and create unnecessary barriers to market entry.

1. On timing of notification (post-approval vs during approval)

While post-approval notification is intended to protect regulatory timelines, delaying notification until that stage may create last-minute legal disputes just before market entry. Allowing notification during the approval phase helps identify patent issues earlier, reducing the risk of sudden injunctions and market disruption. If designed properly, this step does not need to delay approval, but instead improves coordination and predictability.

2. On impact to generic entry and regulatory burden

Although the framework is said to hinder first generic entry by adding procedural steps, early notification can actually benefit generic manufacturers by giving them clearer visibility of patent risks before launch. Rather than causing delays, it may prevent costly post-approval litigation and product withdrawal. With proper safeguards, the process can remain efficient while ensuring that both patent holders and generics operate with greater legal certainty.

The proposed patent linkage guidelines appear inconsistent with Section 37 of the Patents Act 1983, which outlines limitations of patent rights, and any regulatory framework should avoid extending patent enforcement into the marketing approval process handled by the National Pharmaceutical Regulatory Agency (NPRA). Furthermore, while the concept of “soft” patent linkage under the CPTPP Agreement is limited to notification and dispute resolution through judicial mechanisms, the current proposal by NPRA introduces procedural requirements that may hinder generic access and should be reconsidered to maintain regulatory neutrality.

The additional requirements proposed by the National Pharmaceutical Regulatory Agency (NPRA) are not stipulated under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership. The framework should remain a straightforward notification mechanism, implemented after product approval and prior to marketing, without introducing additional administrative steps that may delay generic entry. The current proposal risks creating unnecessary regulatory burden, enabling early disputes, and indirectly slowing down access to more affordable medicines. This approach goes beyond what is required under the agreement and may impact timely market competition.

Malaysia’s commitment to affordable healthcare depends on timely access to generic medicines following patent expiry. Any patent linkage system implemented by the National Pharmaceutical Regulatory Agency (NPRA) should avoid introducing unnecessary procedural burdens that may delay such access.

The proposed mechanism risks enabling patent holders to initiate premature or unsubstantiated legal proceedings, including against non-infringing products, which could delay the registration of generics. This would effectively shift Malaysia’s current approach from a “soft” notification based framework under the CPTPP Agreement to a more “hard” linkage model, potentially limiting competition and slowing the entry of affordable medicines.

Malaysia’s international commitments under the WTO TRIPS Agreement and the CPTPP Agreement are intended to strike a careful balance between patent protection and public access to affordable medicines. In this context, patent linkage should remain a “soft” mechanism, limited to notification, without interfering in the regulatory approval process.

The proposed implementation by the National Pharmaceutical Regulatory Agency (NPRA) appears to depart from this principle and introduces characteristics of a “hard” patent linkage system. By embedding patent considerations into the drug registration pathway, including a 45-day notification period and the possibility of a 12-month stop-clock, the framework risks significantly delaying the approval of generic products. These delays may disproportionately impact local manufacturers and importers, particularly those pursuing first generic entry, thereby extending market exclusivity and maintaining high medicine costs for the public.

In addition, the requirement to notify patent holders during the evaluation stage may encourage premature and unnecessary legal actions, even in cases where applicants have clearly stated that their products do not infringe existing patents (e.g., Category 4). This may further incentivize originator companies to pursue secondary or overlapping patent filings as a strategy to delay generic competition, ultimately discouraging innovation and participation among generic players.

Such an approach is not aligned with the intent of the Patents Act 1983, particularly Section 37, which limits the scope of patent rights, nor with the CPTPP provisions that place dispute resolution within the courts rather than the regulatory authority.

It is therefore proposed that notification to patent holders should take place only after marketing approval has been granted, but prior to product commercialization. This approach would ensure compliance with international obligations while preserving efficient regulatory timelines, minimizing unnecessary litigation, supporting local industry growth, and facilitating timely access to affordable generic medicines.

Subject: Refined Stakeholder Comments on the Implementation of Patent Linkage
1. Core Principle: Regulatory Neutrality
We strongly advocate for a “Soft Linkage” approach. The primary mandate of the NPRA is to ensure the safety, quality, and efficacy of pharmaceutical products.
• Comment: The onus of defending a patent remains strictly with the patent holder. The role of the regulatory body should be limited to the administrative notification mechanism.
• Recommendation: The NPRA should proceed with the registration process as per usual timelines. Regulatory approval should not be contingent on the resolution of private legal disputes unless a court of law has issued a formal injunction.
2. Notification Responsibility (CPTPP Compliance)
Under the current interpretation of international agreements, the flow of information must be managed by the regulatory authority to maintain transparency and fairness.
• Position: The responsibility to serve notification of a generic filing rests with the Government (NPRA), not the generic applicant.
• Rationale: Requiring the generic company to notify the originator creates an unnecessary barrier and potentially exposes the generic manufacturer to premature litigation. The NPRA, as the central regulatory body, is the appropriate party to manage this notification to ensure it is done consistently and within the legal framework of the CPTPP.
3. Scope of Linkage: API and Indication Only
We propose a strict limitation on the types of patents that qualify for the linkage and notification mechanism to prevent "evergreening" tactics that delay generic entry.
• NCE/API Focus: Patent linkage should apply exclusively to the Active Pharmaceutical Ingredient (API) compound, specifically New Chemical Entities (NCEs) invented by the patent holder.
• Approved Scope: We agree that notifications regarding the API and the specific Medical Indication are acceptable.
• Exclusion of Formulation Patents: We object to the inclusion of product formulation patents (e.g., specific excipients, delivery mechanisms, or coatings) in the linkage scope.
• Rationale: Formulation patents are often used to artificially extend exclusivity beyond the life of the original NCE patent. Excluding them ensures that the primary innovation is respected while preventing secondary patents from blocking affordable generic versions of the same drug.
4. Objection to Mandatory 12-Month Suspensions
We formally object to any proposal that allows for an automatic 12-month suspension of generic registration.
• Impact: A mandatory stay acts as a de facto patent extension without judicial oversight. It penalizes the generic manufacturer before any infringement has been proven.
Counter-Proposal: If a patent holder believes an infringement exists, they must seek a court-ordered interlocutory injunction. In the absence of such an order, the NPRA must grant the marketing authorization (MAL number) immediately upon completion of the technical evaluation to ensure drugs reach the market in time at affordable prices

We strongly advocate for a “Soft Linkage” approach. The primary mandate of the NPRA is to ensure the safety, quality, and efficacy of pharmaceutical products. It should not be burdened with the role of a "patent police" or a preliminary tribunal for intellectual property disputes.
• Comment: The onus of defending a patent must remain strictly with the patent holder. The role of the regulatory body should be limited to the notification mechanism required under international agreements (like the CPTPP).
• Recommendation: Once the generic manufacturer provides the necessary patent declaration, the NPRA should proceed with the registration process as per standard timelines. Regulatory approval should not be contingent on the resolution of private legal disputes unless a court of law has issued a formal injunction.

We would like to propose that NPRA consider implementing a notification system similar to those adopted in New Zealand or the UK.

In New Zealand, the drug regulatory authority publishes details of new generic applications on its website within a few days of receipt. Such notification is considered sufficient to meet the requirements of CPTPP.

This approach may help to enhance transparency and further improve regulatory efficiency.

The introduction of patent linkage in Malaysia has important implications for the general population, particularly in relation to access to affordable medicines. While it is intended to strengthen intellectual property protection and align Malaysia with international trade commitments such as the CPTPP, its practical effect may be an increase in the time it takes for cheaper generic medicines to reach patients.

Patent linkage works by requiring generic drug manufacturers to declare the patent status of their products and notify patent holders when applying for regulatory approval. This creates an opportunity for patent disputes to be raised earlier in the approval process. Although the system does not automatically prevent generics from being registered, it can lead to delays if legal challenges or interim restrictions arise. Even short delays can extend the period during which originator pharmaceutical companies maintain market exclusivity.

For the general population, the most immediate impact is on medicine affordability. In Malaysia’s mixed public and private healthcare system, many patients—especially those using private healthcare—pay for medicines out of pocket. When generic alternatives are delayed, patients must continue purchasing higher-priced brand-name drugs for longer periods. This can place significant financial pressure on households, particularly for individuals managing chronic conditions such as diabetes, hypertension, or cardiovascular disease, where long-term medication is essential.

These cost pressures can influence patient behaviour. Some individuals may postpone starting treatment, reduce prescribed dosages, or stop medication altogether due to financial constraints. Such responses are not medical choices but economic ones, and they can lead to worsening health conditions over time. As a result, delayed access to affordable medicines can contribute to poorer health outcomes at the population level.

The effects also extend to the public healthcare system. When generics are delayed, government procurement programs may need to purchase higher-cost medicines for longer periods. This reduces the overall efficiency of healthcare spending and can limit the number of patients who can be treated within existing budgets. In practical terms, this may contribute to longer waiting times, tighter formulary restrictions, or prioritization of treatments based on cost considerations.

Another important concern is the potential for increased health inequality. When medicine prices remain high, access becomes more closely linked to income. Higher-income groups are more able to afford originator drugs, while lower-income populations may have to wait for generics to become available. This can widen disparities in access to healthcare and health outcomes across different socio-economic groups.

In conclusion, patent linkage in Malaysia may improve the structure of intellectual property enforcement, but it also risks delaying access to affordable medicines. For the general population, this means higher short-term healthcare costs, increased financial pressure on households, and potential widening of health inequalities. Careful implementation and strong public health safeguards will be important to balance innovation incentives with equitable access to essential medicines.

I write to express strong concerns regarding the proposed hard patent linkage guideline. While patent linkage aims to promote innovation, it is critical to recognize that innovators already receive a 20‑year exclusivity period to recoup their investments and generate revenue. Introducing hard patent linkage on top of this creates an unnecessary second layer of protection that risks extending market monopolies without delivering meaningful additional innovation for Malaysia. More importantly, we must confront the hard fact that the cost of living in Malaysia is already high, with rising pressures on essential goods and healthcare. Implementing a system that clearly favours patent holders will delay the entry of cheaper generic medicines, force patients and public hospitals to pay higher prices for longer, and place an unfair burden on ordinary Malaysians. There is no public health justification to further increase financial pressure on the rakyat by closing the door on early generic competition. Notably, even wealthier nations such as New Zealand and the United Kingdom have deliberately chosen only a soft patent linkage approach. Under their model, the regulatory authority merely publishes new generic applications or marketing authorizations as a notification to patent holders. No automatic stay or refusal of generic approval occurs. Any patent disputes are left to be resolved through the appropriate legal channels – courts or intellectual property tribunals – where injunctions are granted only after proper judicial scrutiny. This balanced system respects patent rights while safeguarding timely access to affordable medicines. Hard patent linkage, by contrast, empowers patent holders to block generics administratively without ever proving infringement in court, inviting potential abuse such as frivolous claims or sequential patent listings to extend monopolies. Therefore, I strongly urge the authorities to reject the hard patent linkage proposal. Instead, Malaysia should adopt a soft linkage model based on publication and notification, with any genuine disputes resolved through independent legal proceedings. This approach aligns with international best practices from richer countries, protects innovation without sacrificing public welfare, and prevents further escalation of living costs for Malaysians. A cost‑impact assessment on medicine prices and household healthcare expenditure should also be conducted before any linkage mechanism is finalized. Access to affordable, quality generics is a matter of public health and economic fairness. Hard patent linkage is neither necessary nor appropriate for Malaysia at this time.

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.

Biologics should be included in the scope as it pertains to many essential life-saving medicines. We need a patient linkage system that safeguards patient access to safe and regulated biosimilars.

Patented drugs retain exclusivity as single-source products during the 20-year patent period in accordance with the WTO TRIPS Agreement. Thereafter, the WTO TRIPS Agreement allows for the timely entry of generic drugs into the market at affordable prices for the public in Malaysia and other parts of the world.
Through the CPTPP bilateral agreement, Malaysia has agreed to provide a “soft” patent linkage for pharmaceutical products covering both exports and imports. This is once again taken into account to ensure a sustainable and timely supply of generic medicines entering the market. Under Chapter 18, Articles 18.50 to 18.53 of the CPTPP Agreement, the provisions are as follows,

“Party” refers to NPRA, the authority responsible for granting marketing approval for new pharmaceutical products.

(a) A system to provide notice to the patent holder, or to allow the patent holder to be notified, prior to the marketing of a pharmaceutical product, where another person is seeking to market that product during the term of an applicable patent.
(b) Adequate time for the patent holder to seek remedies.
(c) Judicial or administrative proceedings, and expeditious remedies such as preliminary injunctions or equivalent effective provisional measures, for the timely resolution of disputes concerning the validity or infringement of an applicable patent claiming an approved pharmaceutical product or its approved method of use.

In giving effect to its obligations under the CPTPP Agreement, Malaysia is required to ensure consistency with its existing domestic legal framework, including the Patents Act 1983.
In view of these three (3) agreed terms under the CPTPP Agreement, I am of the opinion that the drug control authority, NPRA, should adopt the “soft” patent linkage approach, which is in line with Malaysia’s commitment under the Agreement.
However, the proposed guidelines and implementation of patent linkage, as published on the MPC website and UPC platforms, appear to be inconsistent with the Patents Act 1983, particularly Section 37 (Limitations of Rights). The policy objectives introduced by NPRA, particularly the proposed four (4) categories and the potential suspension of up to 12 months for generic applications, may impose additional barriers that affect the timely entry of generics into the market.
In addition, the requirement for NPRA to await court outcomes and decisions prior to screening, evaluation, and granting of marketing approval for new and licensed products may result in unnecessary delays. This approach is a breach of the current provisions of the Patents Act 1983, Section 37, and further requirements and conditions set by NPRA include:
1. Proof of evidence of serving notice
2. Request for acknowledgement from the patent holder
The above terms are not included in the CPTPP Agreement. We respectfully request NPRA to reconsider and withdraw the current guidelines and policies, and instead align with Chapter 18.50 to 18.53 of the CPTPP Agreement. The Agreement provides a notification mechanism to inform the patent holder of a marketing application for a pharmaceutical product, while any disputes or remedies should be pursued through the courts by the respective parties, namely the patent holder and the generic applicant.
I would also like to state categorically that NPRA has no role in patent matters or any disputes arising therefrom.

Refer to the Patent Declaration Form Section 4, kindly clarify who shall be authorised to sign the declaration? Under what circumstances, an evidence of authorisation need to be submitted?

I am of the opinion that biologics should be included in the scope as it concerns 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. I am supportive of a patient linkage system that safeguards patient access, uploads regulatory integrity, promotes innovation and strengthens Malaysia’s attractiveness for pharmaceutical investment.

For me, I personally feel that 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

I'm also supportive of a patient linkage system that:
• safeguards patient access,
• upholds regulatory integrity,
• promotes innovation,
• strengthens Malaysia’s attractiveness for pharmaceutical investment.

I’m supportive of a patient linkage system that safeguards patient access and promotes medical innovation. In addition, 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.