Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:
The main regulatory bodies for pharmaceuticals and medical devices are the:
All of the above legislation and regulatory bodies are under the purview of the Malaysian Ministry of Health (MOH).
Appeals may be made against the decisions of the regulatory bodies in accordance with the procedure set out in the applicable Act or Regulations.
Under Regulation 18, CDCR 1984:
Nevertheless, a person who is adversely affected by a decision, action or omission in relation to the exercise of a public duty or function shall also be entitled to make an application to the court for judicial review, pursuant to Order 53 of the Rules of Court 2012. The remedies which may be sought under the judicial review application are:
Pharmaceutical products are categorised into:
Pharmaceutical products which contain scheduled poison(s) under the PA 1952 may be categorised into different groups: Group A for products with high toxicity, Group B for prescription medicines, Group C for non-prescription medicines and Group D for products for laboratory use and with different registration requirements for each category of products.
The wholesale and retail sale of pharmaceutical products are governed by s.15 and s.16 of the PA 1952 respectively.
Medical devices are classified into four Classes, ie, Class A, B, C and D based on the risk associated with the vulnerability of the human body, the technical design and the manufacture of the medical device with different registration requirements and registration fees. The classification rules are based on:
Clinical trials are regulated in Malaysia by the NPRA or the MDA and are reviewed by Institutional Review Boards/Independent Ethics Committees (IRBs/IECs) of the organisation conducting the trials. Approvals from the Medical Research & Ethics Committee (MREC) for trials are required for trials using MOH’s facilities.
The NPRA ensures the quality, efficacy and safety of pharmaceuticals in Malaysia prior to release in the Malaysian market and acts as a Secretariat to the DCA.
The MDA implements and enforces the MDA 2012 to address public health and safety issues related to medical devices and to facilitate the medical device trade and industry.
The DCA is empowered to review matters related to product registration and to approve or reject applications for a clinical trial import licence (CTIL) or a clinical trial exemption (CTX).
A CTIL is a clinical trial import licence issued to import any product for purposes of clinical trials.
A CTX is the authorisation to manufacture any product(s) solely for the purpose of producing samples for clinical trials.
The applicable clinical trial guidelines in Malaysia are as follows:
Directives from the Director of Pharmaceutical Services (DPS) of the PB on the regulation of clinical trials include the following:
Before commencing any clinical trial involving product(s), the investigator/sponsor/contract research organisation (CRO) must have secured the approval of the relevant IRB/IEC and the CTIL/CTX for the importation/manufacturing of the product locally for the study.
The following products will require a CTIL/CTX:
The committees to whom the application should be submitted will depend on the location or facility where the clinical trial will be conducted:
Government health facilities under the MOH
Under the Malaysian National Institute of Health’s Guidelines for Conducting Research in MOH Institutions and Facilities, all clinical trials involving MOH facilities must register with the NMRR and obtain prior approval from the MOH.
Universities or private institutions
Applications are to be submitted to the respective IRB/IEC of the university or institution, which will review and approve the trial proposal as per the functions of the MREC.
If the university or institution concerned does not have its own IRB/IEC, applications can be submitted to the MREC or any such committees of other universities or private institutions.
All ethics committees must be registered with the DCA.
The application to the IRB/IEC is made by the investigator, that is, the person responsible for the conduct of the trial, or where conducted by a team, the person who is the leader of the team (principal investigator), subject to the particular policies of that IRB/IEC.
Section 3.1.2 of the Guideline for Good Clinical Practice provides for the list of documentation to be submitted to the IRB/IEC for approval, which includes the following:
There are no statutory requirements for clinical trials, nor for the results to be made publicly available.
Nonetheless, some organisations have voluntarily published their data, eg, Novartis providing technical results and trial summaries for patients from Phase 1 through 4 interventional trials for innovative products within one year of trial completion, at their website https://www.novctrd.com/CtrdWeb/trialresults.nov.
There are no restrictions for using online tools to support clinical trials. Volunteers may be recruited through various online portals, such as https://clinicalresearch.my/iamaware/fact/ and https://my.gsk.com/en-gb/research/trials-in-people/become-a-clinical-research-volunteer/.
The resulting data from the clinical trials would be considered as “sensitive personal data” under s.4 of the Personal Data Protection Act 2010 (PDPA 2010), which defines sensitive personal data as any personal data consisting of information as to the physical or mental health or condition of a data subject.
Under s.40 of the PDPA 2010, any disclosure or processing of sensitive personal data may only be made if the data subject has given his or her explicit consent to do so, or if any of the special circumstances set out in s.40(1)(b) of the PDPA 2010 is satisfied.
Creation of a database containing personal or sensitive data constitutes “processing” of data under the PDPA 2010 and thus would be subject to the seven Personal Data Principles, namely (a) the General Principle; (b) the Notice and Choice Principle; (c) the Disclosure Principle; (d) the Security Principle; (e) the Retention Principle; (f) the Data Integrity Principle; and (g) the Access Principle, as set out in s.5 to s.12 of the PDPA 2010.
Further, a data user/processing body which falls under any of the classes under the Personal Data Protection (Class of Data Users) Order 2013 would also need to obtain a certificate of registration in accordance with s.12 to s.20 of the PDPA 2010 prior to processing of personal data.
The NPRA uses the following criteria to assist in the classification of products as to whether a product is pharmaceutical or a medical device:
The NPRA’s requirements for the registration of biologics/biopharmaceuticals products are aligned with the scientific guidelines and recommendations for quality, clinical efficacy and safety and non-clinical of the World Health Organization (WHO), the European Medicines Agency (EMA) and the International Conference of Harmonisation (ICH).
Every biologic is regulated as a new product and also considered "high risk"; both substance and drug-product production must comply with Good Manufacturing Practice strictly and in accordance with the ASEAN Common Technical Dossier (ACTD) format.
The registration/marketing authorisations shall be valid for five years or any such period as specified in the Authority database (unless sooner suspended or cancelled by the Authority). The renewal of product registration should be submitted within six months prior to the expiry of the validity period of a product registration, together with the appropriate fee.
To obtain a marketing authorisation for both pharmaceuticals and medical devices, the product must be registered with the relevant authorities.
The registration process may be summarised as follows:
Pre-submission of Application
The applicant needs to determine the category of the product, ie, whether it is a:
Method of Evaluation
There are four methods of evaluating the application, ie:
The following general requirements for full evaluation which are in accordance with ASEAN ACTD/ ACTR or ICH guidelines:
For an abridged evaluation, a bio-availability study and a bio-equivalence study are required.
Submission of Application
Application for product registration shall be submitted only via the online QUEST system at http://bpfk.moh.gov.my/. To conduct transactions via QUEST system, the applicant must first register a membership for the QUEST system with the NPCB and purchase a USB Token that contains a User Digital Certificate, from MSC Trustgate.com Sdn. Bhd., which shall be installed to the applicant’s computer.
Decisions of the Authority
A regulatory decision shall be made based on the outcome of the evaluation of the submitted documentation, and samples (if applicable). An application may be approved or rejected by the Authority, and the Authority decision will be sent via email/ official letter to the product registration-holder.
The registration status of a product shall be valid for five years or any such period as specified in the Authority database (unless the registration is suspended or cancelled by the Authority).Upon approval for product registration by the Authority, applicants shall fulfil all commitments and conditions imposed during approval of the product registration and shall be responsible for the maintenance of the product in terms of quality, safety and efficacy throughout the validity period of registration. Failure to do so may result in rejection of an application for renewal of product registration. The Authority shall be notified of any changes to the product’s efficacy, quality and safety.
Any person who is aggrieved by the decision of the Authority or the Director of Pharmaceutical Services may make a written appeal to the Minister of Health Malaysia. Re-submission for the product registration of a rejected application due to reason of safety and efficacy shall not be accepted within two years after the rejection. However, if the product is registered in the reference countries, submission of application can be made earlier.
Variation of Marketing Authorisation
There are two types of variations which may be made to a marketing authorisation:
Transfer of Marketing Authorisation
It is permissible to transfer the market authorisation from one marketing authorisation-holder to another. The requirements for transfer are found in Directive (3)dlm.BPFK/PPP/07/25 and also on the NPRA’s website at https://npra.gov.my/index.php/en/change-of-product-registration-holder-coh. Upon the approval of the transfer of marketing authorisation, the former product registration-holder shall no longer have marketing authorisation over the registered product.
The licence required to manufacture or supply a product does not apply to the dispensing of any drug for the purpose of it being used for medical treatment of a patient or animal by a pharmacist, a fully licensed medical or dental or veterinary practitioner or a person employed in a governmental hospital or dispensary to dispense drugs.
Under Regulation 15(6) of the CDCR 1984, any person who wishes to import or manufacture any product solely for the purpose of treatment of any person suffering from a life-threatening illness may on application be exempted from having to obtain marketing authorisation.
Product registration-holders of pharmaceutical products are required to carry out pharmacovigilance. Pursuant to the CDCR 1984, product registration-holders shall inform the Director of Pharmaceutical Services immediately of any adverse reaction arising from the use of the registered product.
All product registration-holders must ensure that a pharmacovigilance system is in place by the company and appropriate action is taken, when necessary.
Product registration-holders are required to monitor and report any product safety issues that arise locally or internationally to the NPRA and comply with all safety-related directives issued by the NPRA.
The product registration may be cancelled if the product registration-holder fails to inform the NPRA of any serious adverse reactions upon receipt of such reports. For further information, reference may also be made to the Malaysian Pharmacovigilance Guidelines available at https://npra.gov.my/images/Guidelines_Central/Guidelines_on_Reporting_and_Monitoring%20_(MADRAC)/Malaysian_Pharmacovigilance_Guidelines_2nd_Edition_2016.pdf.
In relation to medical devices, s.38 MDA 2012 requires the holder of a marketing authorisation to monitor the safety and performance of the medical device and put in place a post-market surveillance system.
All information declared in the registration form for marketing authorisations of pharmaceuticals are confidential and are not accessible to third parties.
In relation to medical devices, the applicant must apply to the MDA for confidentiality of any information relating to the application. The grant of confidentiality is at the discretion of the authority and consideration will be given to the criteria stated in s.68(3) of MDA 2012. If confidentiality is not granted, s.69 of MDA 2012 stipulates that,subject to the discretion of the authority, the public may have access to such information relating to the application.
Information relating to individuals is governed by the PDPA 2010. Any disclosure or processing of sensitive personal data may only be made if the data subject has given his or her explicit consent to do so. Notwithstanding the requirement for explicit consent from the data subject, s.40 of the Act also allows the processing of sensitive personal data where:
Regulation 7 and Regulation 18A of the Control of Drugs and Cosmetics Regulations 1984 prohibits the illegal distribution of drugs and cosmetics products.
S.5(2) of the Medical Devices Act 2012 provides that any person who imports, exports, or places in the market an unregistered medical device commits an offence, and shall be liable to a fine not exceeding MYR2,000,000 or to imprisonment for a term not exceeding three years, or to both.
Issues relating to counterfeiting are dealt with under the Trademarks Act 2019.
Under s.82(1) of the Trademarks Act 2019, any person may file an application to the Registrar, stating:
Upon approval by the Registrar, the importation of any infringing goods into Malaysia for the duration of the period specified in the approval shall be prohibited. An approval shall remain in force until the end of the 60-day period commencing on the day of the approval, unless withdrawn earlier by the applicant. Where goods have been seized pursuant to the application, the applicant must take action for infringement within the retention period, otherwise the goods shall be released back to the importer and the applicant may be further liable for loss or damage suffered by the importer as a result of the seizure.
Under the Regulation 7(1) of the CDCR 1984, except as otherwise provided in these Regulations, no person shall manufacture, sell, supply, import or possess or administer any product unless the product is a registered product and the person holds the appropriate licence required and issued under these Regulations. The Director of Pharmaceutical Services grants the authorisation.
In relation to a licence application for pharmaceutical products, an online application can be made through Quest3+. Borang BPFK-413: Application for Licence for Registered Products (Manufacturer’s Licence, Import Licence, and Wholesaler’s Licence). The forms can be found in https://www.npra.gov.my/index.php/en/appformscomplicense.html. Once the Manufacturer’s Licence is granted, he or she can manufacture registered products in their premises and can sell by wholesale or supply the registered products.
The Manufacturer’s Licence for pharmaceutical products is valid for one year, starting from January 1st to December 31st of the same year.
All establishments, ie, manufacturer, authorised representative (AR), importer and distributor must apply for an establishment licence. However, only manufacturers and ARs need to apply for medical device registration under s.15 of the MDA 2012. The MDA grants the authorisation of an establishment licence.
The application for an establishment licence can be made by sending an email to MeDC@St2.0, according to MDA’s Official Website (https://portal.mda.gov.my/industry/establishment-licence/how-to-apply-for-establishment-licence.html) There is a flow chart of the application process provided on the website. With the establishment licence, the manufacturer can import, export or place any registered medical device in the Market.
The validity of the establishment licence is three years and an establishment can start to renew the licence one year prior to the expiry date.
The establishments engaged in wholesale of pharmaceutical products are subject to licensing requirements under the CDCR 1984. Any company carrying out the manufacture, import, or wholesale of any registered products needs to have a Manufacturer’s Licence, Import Licence, or Wholesale Licence. The Licensing Unit, Centre for Compliance and Licensing (CCL) is involved in the activity of issuance of the relevant licence.
For licences on the wholesale of poisons, they are issued by The Director-General of Health, or the Director of Pharmaceutical Services or the Director of Medical and Health Services of any State, duly appointed in writing by the Director General of Health to be a Licensing Officer of any State or the Federal Territory pursuant to S.28 of the Poisons Act 1952.
A licence application for pharmaceutical products is by online application made through Quest3+. Borang BPFK-413: Application for Licence for Registered Products (Manufacturer’s Licence, Import Licence, and Wholesaler’s Licence). The forms can be found in https://www.npra.gov.my/index.php/en/appformscomplicense.html.
Once the Wholesaler’s Licence is granted, the licence-holder can sell by wholesale or supply registered products from their premises. The Wholesaler’s Licence for pharmaceutical products is valid for one year starting from January 1st to December 31st of the same year.
For Medical Devices, a distributor shall obtain an establishment licence to conduct its activity. The MDA grants the authorisation for establishment licences. The application for an establishment licence can be made by sending an email to MeDC@St2.0, according to Medical Devices Authority’s official website at https://portal.mda.gov.my/industry/establishment-licence/how-to-apply-for-establishment-licence.html with a flow chart of the application process.
With an establishment licence, a distributor can import, export or place any registered medical device in the market. For Medical Devices, the validity of the establishment licence is three years and an establishment can start to renew the licence one year prior to the expiry date.
The classifications of drugs can be found in the First Schedule of Poisons Act 1952 where drugs are classified into Group A Poison, Group B Poison, Group C Poison, and Group D poison.
Group A Poison
High-toxicity medicines, eg, alclofenac, amidopyrine, avoparcin.
Group B Poison
Used in treatment where the doctor’s diagnosis is needed to recognise the symptoms. Can be dispensed only against prescription, eg, nifedipine, olanzapine, ramipril.
Group C Poison
Used in treatment where the symptoms are easily recognised. Can be dispensed without prescription, eg, ibuprofen, piroxicam, mefenamic acid.
Group D Poison
Chemicals for laboratory, eg, cetyl chloride, ethylidene diacetate, methyl bromide.
The CDCR 1984 governs the import and export of pharmaceutical and medical devices. Under the Regulation 7(1) of CDCR 1984, except as otherwise provided in these Regulations, no person shall manufacture, sell, supply, import or possess or administer any product unless the product is a registered product and the person holds the appropriate licence required and issued under these Regulations.
S.12 of the Customs Act 1967 further prohibits the importation and exportation of any dangerous drugs specified in Parts III, IV, and V of the First Schedule of the Customs Act 1967, unless otherwise authorised by the Minister.
The Medical Devices Act 2012 governs the import and export of medical devices.
At the point of entry, import regulations are applied and enforced by the Royal Malaysian Customs Department, specifically the Import Management & Enforcement Unit and Export Management & Enforcement Unit under the Customs Division. Thereafter, they are then enforced by the NPRA and Ministry of Health.
There are no specific requirements to apply for and hold an Import Licence (for the import and sale by wholesale or supply of registered products).
However, in relation to a Clinical Trial Import Licence (for the import of any product for purposes of clinical trials, notwithstanding that the product is not a registered product), only an investigator or an authorised person from a locally registered pharmaceutical company/sponsor/CRO with a permanent address in Malaysia can act as an importer of record of pharmaceuticals and medical devices in the country.
An application for a CTIL/CTX containing a "poison/drug" should be made by a Poison Licence Type A holder for a pharmacist in the private sector or an ARC holder for a public pharmacist. However, it should be noted that the holder of a CTIL/CTX for a particular product need not necessarily conduct the clinical trial himself or herself.
The importation of pharmaceuticals and medical devices are subject to prior authorisations stated in Regulation 7 of the CDCR 1984, s.8 Poisons Act 1952, and s.15 Medical Devices Act 2012.
There are exemptions regarding those authorisations. Special exemptions for the importation of products that are not registered with the DCA may be granted for the treatment of life-threatening illnesses, as provided under Regulation 15 (6) of the CDCR Regulations 1984.
Licences are required prior to the importation of any poison into Malaysia under s.8 of the Poisons Act 1952.
The categories of licences can be found in s.26(2)(a) of the Poisons Act 1952:
S.30 of the Poisons Act 1952 further states that any psychotropic substances listed in the Third Schedule of the Act cannot be imported, exported, manufactured, compounded, mixed, dispensed, sold, supplied, administered, possessed or used unless it is in accordance with the regulations applicable under the Poisons Act 1952.
S.12 of the Customs Act 1967 further prohibits the importation and exportation of any dangerous drugs specified in Parts III, IV, and V of the First Schedule of the Customs Act 1967, unless otherwise authorised by the Minister.
Malaysia has already signed and implemented seven bilateral FTAs with Japan, Pakistan, India, New Zealand, Chile, Australia and Turkey. At the ASEAN level, Malaysia has six regional FTAs with the ASEAN Free Trade Agreement (AFTA), China, Korea, Japan, Australia, New Zealand and India.
Prices of pharmaceuticals and medical devices are not regulated in Malaysia. Nonetheless, in the public sector, the MOH indirectly controls and reduces medicine price with bulk purchases through concession supply and national tenders to provide accessible and affordable medicines.
Currently, the price level of a pharmaceutical or medical device does not depend on the prices for the same product in other countries.
In the Medicine Price Monitoring Report 2017 issued by the MOH, a comparison of price based on the international reference price was made against the procurement price in the public and private sector in Malaysia. Pursuant to this, there have been discussions on the introduction of drug price regulations; however, no concrete actions have been taken to date.
In Malaysia the government-based and publicly funded sector provide health services which are tax-funded and administered by the Ministry of Health through its central, state and district offices. The policies and programmes are centrally formulated, funded and administered.
There is no formal reimbursement system in Malaysia for pharmaceuticals or medical devices.
Although health technology assessments (HTA) in Malaysia play a role in the formulation of drug policies, cost-effectiveness evidence is currently not mandatory, but is of interest to the decision-makers.
In Malaysia, the prescription and dispensing of pharmaceuticals are currently governed by the Poisons Act 1952 (Revised 1989), the Poisons Regulations 1952 and the Poisons (Psychotropic Substances) Regulations 1989.
Where any poison is sold or supplied as a dispensed medicine or as an ingredient in a dispensed medicine, the seller or supplier shall, on the day on which that poison or medicine is sold or supplied, enter or cause to be entered in a Prescription Book certain information, eg, the date of sale, the serial number of the entry, the name of the poison and the ingredients of the medicine, quantity supplied, etc.
There are no specific rules that govern medical apps in Malaysia. However, the definition of medical devices under s.2 of the MDA 2012 includes:
As such, the MDA 2012 shall apply to medical apps used for the purposes which fall within the definition of a medical device under the Act. The application for the registration for medical device is in turn governed by s.6 of the MDA 2012.
Telemedicine in Malaysia is governed by the Telemedicine Act 1997. Telemedicine is defined as the practice of medicine using audio, visual and data communications.
S.3 of the Telemedicine Act provides that only a fully registered medical practitioner holding a valid practising certificate or a medical practitioner who is registered or licensed outside Malaysia and holds a certificate to practise telemedicine issued by the council and practises telemedicine from outside Malaysia through a fully registered medical practitioner holding a valid practising certificate is authorised to practise in Malaysia.
S.2 of the MASA 1956 defines an advertisement to include any notice, circular, report, commentary, pamphlet, label, wrapper, or other document, and any announcement made orally or by any means of producing or transmitting light or sound. The Guideline on Advertising of Medicines and Medicinal Products to General Public lists online advertising as an example of advertisement under the definition in S.2.
The MASA 1956 governs any online advertising of medicines and medical devices in Malaysia. As advertising on online platform is regulated, conditions imposed by the MASA 1956 shall be followed. Accordingly, online advertisement is subject to approval from the Medical Advertisement Board.
Currently, there is no legislation on electronic prescriptions in Malaysia. However, in 2019, there was a proposal to include electronic prescriptions via the Poisons Act (Amendment) Bill 2019.
Under S.13 of the Poisons Act 1952, it is against the law to sell or supply medicine without a licence. A seller can be fined up to RM3,000 or receive one-year term of imprisonment for the first offence.
The sale of medicines and medical devices online is not regulated by any specific piece of legislation but the seller must comply with the Consumer Protection (Electronic Trading Transaction) Regulations 2012.
In short, online sales of medicines and medical devices is permitted in Malaysia as long as the seller has a licence and complies with the Consumer Protection (Electronic Trading Transaction) Regulations 2012.
Health-related information is regulated as sensitive personal data as defined in S.4 of the PDPA 2010. Sensitive personal data includes personal data consisting of information as to the physical or mental health or condition of a data subject.
The processing of such information is governed by S.40 of the PDPA 2010. It is stated that sensitive personal data may only be processed if the data subject has given his or her explicit consent or that the processing is necessary under certain circumstances set out in the PDPA 2010.
In terms of the storing of information in cloud platforms, the Malaysian Department of Personal Data Protection issued a Personal Data Protection Standard 2015, which states that transfer of personal data through cloud platforms is not permitted unless with written consent by an officer authorised by the top management of the data user organisation. It is a requirement that transfer of personal data through cloud platforms must comply with personal data protection principles in Malaysia, as well as with personal data protection laws of other countries.
For licence agreements, deal structures are generally royalty-based and triggers of royalty payment would commonly be tied to sales. Licences are usually non-exclusive and limited by territories or by field-of-use, as licensors would like to keep open the options of venturing into different territories/fields either by themselves or with another licensee.
For early-stage businesses, it is also common for parties to enter into a collaboration/research agreement prior to licensing. In this case, development of the product may be done by one party (in consideration of payment usually tied to satisfactory results), or the parties may co-develop the product.
Legal provisions for the resolution of disputes should be drafted in a manner to facilitate speedy resolution. Provisions for good-faith discussions, compelled mediation, and subsequently arbitration with fixed timelines are commonly used for dispute resolution.
“Commercially reasonable effort” clauses are recommended and “best-endeavour clauses” are often used and are recognised by the courts to be a contractual obligation, albeit not an absolute one. In practice, parties to an agreement should set out the scope of work, timelines, milestones and service levels to be met, if applicable.
Given that the licence agreement is entered into between the entities, a change in control of one party would not affect the licence as the entity remains the same (albeit under a different ownership). To avoid this, clauses permitting a party adversely affected by a change of ownership/control of the other party to terminate the agreement should be included in the agreement.
The parties may contractually agree for the licensor to obtain rights to clinical data and IP generated pursuant to the licence agreement. Otherwise, the default positions in the various IP legislation, in particular the Patents Act 1983 and the Copyright Act 1987 in relation to the ownership of the IP created, will apply.
Where the rights to a patent for an invention made by an employee have not been dealt with by agreement, then an invention made by an employee is to belong to his or her employer or the person who commissioned the work. Where the employee is not required to engage in any inventive activity in the contract of employment and the employee had used data or means placed at his or her disposal by his or her employer, the right to the patent for any such invention shall be deemed to accrue to the employer.
Similarly, in the case of a copyrighted work, where the copyrighted work is made in the course of the author's employment, or is commissioned under a contract of service, the copyright is deemed transferred to the author's employer or to the person who commissioned the work, as the case may be, subject to any agreement between the parties excluding or limiting such transfer.
Patent rights in Malaysia are governed by the Patents Act 1983, together with the Patents Regulations 1986.
The issue most commonly encountered by pharmaceutical and medical devices products under the legislation is patent infringement.
There is no specific patentability requirement for pharmaceuticals or medical devices.
The patenting of second and subsequent medical uses are expressly permitted under s.14(4) of the Patents Act 1983. Inventions in relation to new dosage regimes or selected patient populations are patentable in Malaysia if they satisfy the novelty and inventiveness patentability requirements.
A patent is infringed when a product or process falling within the scope of the protection of the patent, as defined by the claims in the patent, is exploited without the patentee's consent.
S.35 of the Patents Act states that terms of protection of a patent shall be for 20 years. There is currently no provision that provides for patent-term extension in Malaysia.
The patentee's exclusive right to exploit a patent is the exclusive right to use the patented product or patented process and the right to make, import, offer for sale or sell the patented product and any product obtained directly by means of the patented process. A patent is infringed when there is any unauthorised exploitation of a patent.
However, s.37(1A) of the Patents Act 1983 provides that “the rights under the patent shall not extend to acts done to make, use, offer to sell or sell a patented invention solely for uses reasonably related to the development and submission of information to the relevant authority which regulates the manufacture, use or sale of drugs.” Accordingly, applications for marketing authorisation for drugs (but not medical devices) will not infringe the patent.
A cause of action for “imminent infringement” is also available in Malaysia and is provided for under s.59(1) of the Patents Act 1983, which states that: “The owner of the patent shall have the same right against any person who has performed acts which make it likely that an infringement will occur, which in this Part is referred to as an “imminent infringement”. It is arguable an application for marketing authorisation constitutes “imminent infringement” of a subsisting patent in relation to the product.
In Malaysia, the Bolar exemption is encapsulated in s.37(1) of the Patents Act 1983, which limits the rights under the patent only to acts done for industrial or commercial purposes and not to acts done only for scientific research. S.37(1A) further states that “the rights under the patent shall not extend to acts done to make, use, offer to sell or sell a patented invention solely for uses reasonably related to the development and submission of information to the relevant authority which regulates the manufacture, use or sale of drugs.” As such, applications for marketing authorisation of drugs will not infringe the patent. It should be highlighted that the applicability of s.37(1A) is limited to drugs and thus does not cover medical devices.
The following are defences to a patent-infringement action:
Under s.49 of the Patents Act 1983, an application for a compulsory licence may be made to the Registrar on two grounds:
A compulsory licence may be granted when an invention cannot be worked in Malaysia without infringing a patent granted on the basis of an application benefiting from an earlier priority date.
Under s.84 of the Patents Act 1983, the Government may exploit a patented invention under a government-use licence, even without the consent of patent-owner where there is national emergency or where the public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy as determined by the Government, so requires.
A patentee may bring a civil action against an infringer at the High Court. A patent-infringement action generally begins by filing a writ of summons against the infringer. The procedure to be complied with for an action by Writ is governed by Order 6 and 10 of the Rules of Court 2012.
A plaintiff in an infringement action may claim and obtain:
A defendant in an infringement action may counterclaim for an invalidation of the patent on the following grounds:
At the pre-submission stage of the application to the NPRA, the potential generic entrant shall provide the NPRA with a declaration that it shall comply with all legal provisions in Malaysia, and conform to the Patent Act 1983 and shall not market, sell, offer for sale, or store any registered product containing any patented active ingredient(s) of which the patent duration has yet to expire.
A potential generic entrant who qualifies as an interested person shall have the right to apply for a declaration from the court against the owner of a patent that the performance of a specific act does not constitute an infringement of the patent, provided that the act in question is not already the subject of infringement proceedings. These proceedings for a declaration of non-infringement may be instituted together with the invalidation proceedings.
Issues of counterfeits are generally dealt with under the Trademarks Act 2019. In addition to civil remedies pursuant to trade-mark infringement, any person who counterfeits a registered trade-mark commits an offence and would be liable to criminal sanctions as well.
Issues of counterfeiting may also involve intellectual property rights regarding the packaging/container of the pharmaceutical and medical device, which are in turn governed by the Industrial Designs Act 1996. An infringement proceeding for industrial designs is by way of a civil action taken by the owner against any person who has infringed the rights conferred by the registered industrial design, as provided under S.33 of the Industrial Designs Act 1996.
The Trademarks Act 2019 does not impose any restrictions on trade marks that can be used for pharmaceuticals and medical devices.
In the now-repealed Trade Marks Act 1976, parallel imports were allowed on the principle of exhaustion of rights which is encapsulated in s.40(1)(d) and s.40(1)(dd), which reads:
“(1) Notwithstanding anything contained in this Act, the following acts do not constitute an infringement of a trade mark
(d) in relation to goods connected in the course of trade with the registered proprietor or a registered user of the trade mark if, as to those goods or a bulk of which they form part, the registered proprietor or the registered user in conforming to the permitted use has applied the trade mark and has not subsequently removed or obliterated it or has at any time expressly or impliedly consented to the use of the trade mark;
(dd) the use by a person of a trade mark in relation to goods or services to which the registered proprietor or registered user has at any time expressly or impliedly consented to…”
However, in the new Trademarks Act 2019, only s.40(1)(dd) was retained in s.55(3)(c) of the Trademarks Act 2019, hence it is unclear as to whether the previous case laws discussing s.40(d) and s.40(dd) remains applicable.
The Trademarks Act 2019 allows for the shape of goods or their packaging to be registered as a trade mark, as long as it fulfils the general requirements for registration. Hence, a registered mark for the shape or packaging will be granted trade-mark rights.
Unregistered trade dress or design for pharmaceuticals, medical devices or their packaging may be protected in Malaysia under the common law tort of passing off. To establish a claim for passing off, the following elements must be satisfied:
Furthermore, trade dress or design of pharmaceuticals and medical devices such as tablets may further be registered and protected under the Industrial Design Act 1996, as they fall under the definition of “features of shape, configuration, pattern or ornament applied to an article by any industrial process or means”.
In Malaysia, protection of undisclosed, unpublished and non-public domain pharmaceutical test data is protected under the Directive No 2 on Data Exclusivity 2011 (the Directive) which was issued by the Director of Pharmaceutical Services under Regulation 29 of the Control of Drugs and Cosmetics Regulations 1984. The Directive provides data exclusivity only for new chemical entities and second indications.
The data-exclusivity period runs from the date the new drug or the second indication is first registered or granted marketing authorisation and data exclusivity or test data protection in the country of origin or any country recognised by the Director of Pharmaceutical Services. The period for data exclusivity granted is determined on a case-by-case basis by the Director of Pharmaceutical Services and it shall not be more than five years for a new drug product containing a new chemical entity and three years for second indication of a registered drug product.
Data exclusivity is not automatically conferred upon approval of a drug. The interested party must make a separate application for data exclusivity.
An application for data exclusivity can be made via a Letter of Intent in conjunction with the application for registration of a new drug product containing a new chemical entity or application for a second indication of a registered drug product.
Shearn Delamore & Co.
7th Floor, Wisma Hamzah-Kwong Hing
No 1 Leboh Ampang
50100 Kuala Lumpur