Patents and Trademarks
Skrine / Malaysia
The key facts about patents and trademarks in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.
1. What are the basic requirements to obtain patent and trademark protection?
- Patent and trademark laws in Malaysia are mainly codified in statutes, but its jurisprudence is derived from the United Kingdom’s common law. Thus, there are similarities between the two jurisprudences, including the recognition of the tort of passing off as a cause of action.
- The Patents Act 1983 (“PA 1983”) provides for the protection of patentable inventions and utility innovations. An invention may be or may relate to a product or a process.1 A patentable invention must2(i) be novel, (ii) involve an inventive step, and (iii) be industrially applicable. An innovation includes a new product or process, or any new improvements to a known product or process, including an invention3 To obtain utility innovation protection, the innovation must4 be (i) new, and (ii) industrially applicable.
- Trademark protection is now governed by the Trademarks Act 2019 (“TMA 2019”) which repealed Trade Marks Act 1976. The TMA 2019 explicitly affords protection to non-traditional signs such as shape of goods or their packaging, colour, sound, scent, hologram, positioning, and sequence of motion, so long as5 the sign is (i) capable of being represented graphically, and (ii) capable of distinguishing goods or services of one undertaking from another. Prior use is not necessary to apply for the registration of a trademark; a bona fide proprietor may apply if the proprietor is using or intends to use the trademark in the course of trade.6
2. What agencies or bodies regulate patents and trademarks?
- The Intellectual Property Corporation of Malaysia (“MyIPO”), which houses the Registrar of Patents and the Registrar of Trademarks, is the agency responsible for regulating the registration or recordal of intellectual property rights in Malaysia.
- While the Registrar of Trademarks may hear applications to revoke a registered trademark and preside over opposition proceedings under certain provisions of the TMA 2019, the Registrar of Patents does not have similar powers for patents under the PA 1983. There are no opposition proceedings under the PA 1983 and invalidation actions are heard by the High Court at first instance.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
1. The PA 1983 proscribes the following as non-patentable inventions7 (and innovations)8:
- discoveries, scientific theories, and mathematical methods;
- plant or animal varieties or essentially biological processes for the production of plants or animals, other than man-made living micro-organisms, micro-biological processes, and the products of such micro-organism processes;
- schemes, rules, or methods for doing business,
- performing purely mental acts or playing games;
- methods for the treatment of human or animal body by surgery or therapy, and diagnostic methods practiced on the human or animal body (except for products used in any such methods);
2. The Registrar of Patents will also refuse to grant patent protection9 (or utility innovation protection)10:
- where the performance of any act in respect of the claimed invention is contrary to public order or morality;
- where it appears that the grant of patent protection would be prejudicial to the interest or security of the nation.
3. The application for the registration of a trademark may be refused for various reasons including the following non-exhaustive list11:
- if the use of the trademark is likely to deceive or cause confusion to the public or contrary to any written law;
- if it is of such a nature as to deceive or mislead the public as to the nature, quality or geographical origin of the goods or services;
- the trademarks are contrary to public interest or to morality;
- the trademarks contain or consist of any scandalous or offensive matter or would otherwise not be entitled to protection by any court of law;
- the trademarks contain a matter which is in the opinion of the Registrar is or might be prejudicial to the interest or security of the country;
- the trademarks contain or consist of the name or representation of another person whether living or dead unless the applicant furnishes the Registrar with the consent of that person, if living, or of the representative of that person if deceased;
- the trademarks contain or consist of a flag of a country, national emblem, emblem, insignia or royal arms unless the applicant furnishes the Registrar with the authorisation of the competent authorities or international intergovernmental organisation;
- the trademarks contain or consist of a word which is commonly used as or is the accepted name of any single chemical element or single chemical compound, as distinguished from a mixture, or which is declared by the World Health Organization as an international non-proprietary name or which is deceptively similar to such name (there are exceptions to this);
- the trademarks contain or consists of “Patent”, “Patented”, “By Royal Letters Patent”, “Registered”, “Registered Design”, and “Copyright” or words to the like effect in any language whatsoever, or a sign similar to any of those signs as is likely to be taken for that sign; or
- if the trademark is identical or there is a likelihood of confusion with an earlier trademark and the goods or services for which the trademark is applied for are identical with the goods or services of the earlier trademark.
4. How can patents and trademarks be revoked?
1. Patent and utility innovation invalidation actions must be filed in the High Court, not at the Registry of Patents. Grounds for invalidation include12:
- the invention or innovation does not fulfil the requirements set out in the PA 1983;
- the invention or innovation is excluded from protection under the PA 1983;
- the description or claim does not comply with the requirements of the PA 1983 and the Patent Regulations 1986 (“PR 1986”);
- the necessary drawings have not been furnished to the Registry;
- the right to the patent or utility innovation does not belong to the person to whom the patent was granted;
- incomplete or incorrect information has been deliberately provided or caused to be provided to the Registrar of Patents.
2. Under the TMA 2019, the Registrar of Trademarks has the power to revoke the registration of a trademark where:
- the Registrar failed to take into account (i) a validly filed notice of opposition or (ii) a validly filed application for extension of time to oppose the registration, when it decided to register the trademark13, or
- if the Registrar is satisfied that the registration should be revoked considering Malaysia’s obligations under an international agreement or convention or any special circumstances.
3. An aggrieved person may apply to the High Court for the revocation of a trademark registration on, among others, the following grounds14:
- if there is no good faith use of the trademark for a continuous period of three years and there are no proper reasons for the non-use;
- in the instance of genericide as a result of any action or omission on the part of the registered proprietor;
- if the use of the trademark is liable to mislead the public;
- if the application for registration should have been refused by the Registrar of Trademarks based on the absolute grounds for refusal of registration such as if the trademark is not capable of distinguishing the registered proprietor’s goods or services or is devoid of distinctive character, or if the trademark consists exclusively of signs or indications which may serve, in trade, to designate the characteristics of the goods or services, or if the trademark consists exclusively of signs or indications which have become customary in the local language or established practices of the trade;
- if there is an earlier trademark right;
- if the registration was obtained by fraud or misrepresentation.
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
- Patent applications may claim priority of one or more earlier national, regional, or international applications filed pursuant to the Paris Convention for the Protection of Industrial Property or the Patent Cooperation Treaty.15 The Malaysian application must be made within 12 months of the earlier application.16
- The PR 1986 allows requests for modified substantive examination (a simplified examination process) of international applications to be made if a corresponding Australian, Japanese, South Korean, UK, US, or European patent has been granted for the same invention.17
- Malaysia has acceded to the Madrid Protocol and under the TMA 2019, brand owners may designate Malaysia in the international applications for registration of trademarks.
- Separately, trademark applications may claim priority from applications filed in a member state of the Paris Convention18 or any country declared to have arrangements with Malaysia for the reciprocal protection of trademarks.19 The Malaysian application must be made within 6 months of the earlier application.20
- An applicant for registration of a trademark may apply for temporary protection of a trademark which is the subject matter of an exhibition at an official or officially recognised international exhibition held in Malaysia or in any member state of the Paris Convention or declared foreign country.21
- A well-known trademark is entitled to protection regardless if the trademark has been registered in Malaysia or if the proprietor does not carry on business or has any goodwill in Malaysia.22
6. Are there any non-patent/ trademark barriers to competition to protect medicines or devices?
- All medicines must obtain prior marketing authorisation from the National Pharmaceutical Regulatory Agency. The marketing authorisation holder may also apply for data exclusivity.
- All medical devices must register with the Medical Device Authority prior to being imported, exported, or placed in the market. Any establishment intending to import, export, or place in the market any registered medical device must first obtain an establishment license from the Medical Device Authority.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
There are no specific restrictions on the types of medicines or devices that can be granted patent or trademark protection save for the general restrictions as described above.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
- The PA 1983 is equivocal as to whether a patent licence agreement must be entered into the Register of Patents; it provides that “where a licence contract is concluded between the parties, the contracting parties shall inform the Registrar accordingly”23. It is unclear as to whether this provision applies to all licence agreements or only licence agreements which have been initiated or negotiated by way of the mechanism set out in the preceding sub-sections 42(1) and 42(2). This issue has yet to be determined by the Malaysian courts but there may be risks associated with not recording such licences if the Malaysian courts ultimately determine that section 42(3) renders such recordals mandatory, including potential quasi-criminal liabilities for causing false entries in the Register.24 it is advisable that out of abundance of caution, all licence agreements are to be entered into the Register.
- The TMA 2019 suggests25 that a licence agreement should be approved by the Registrar of Trademarks, but the consequences for failure to apply for approval do not appear to apply to licence agreements.26 The TMA 2019 deems27 notice of a licence if the particulars of the licence have been entered in the Register, but the provision does not mandate a requirement to apply for approval of the licence agreement. Unlike the position under the Trade Marks Act 1976, the TMA 2019 allows28 for licensees to take action against infringers in certain circumstances and in relation to revocation actions for non-use, the TMA 2019 will consider use with the registered proprietor’s consent29 to be use of the trademark without having to register the licence agreement. However, there may still be some risks associated with the non-registration of licence agreements: paragraph 12(1) of the Guidelines of Trademarks 2019 issued by the MyIPO suggests that the MyIPO requires the particulars of licensing agreements to be registered and the TMA 2019 requires compliance30 with guidelines issued by the Registrar of Trademarks. Failure to comply may render an application as withdrawn, lapsed, refused, revoked, or as determined by the Registrar or may be an offence and shall, on conviction, be liable to a fine not exceeding MYR10,000.00.31
—————————-
- PA 1983, section 12
- PA 1983, section 11
- PA 1983, section 17
- PA 1983, section 17
- TMA 2019, section 3(1)
- TMA 2019, section 17(1)(a)
- PA 1983, section 13(1)
- PA 1983, section 17A(1)
- PA 1983, sections 31 and 85
- PA 1983, section 17A
- TMA 2019, sections 23(1), 23(5) and 24
- PA 1983, sections 17A and 56
- TMA 2019, section 4591)
- TMA 2019, sections 46 and 47
- PA 1983, section 27(1)
- PA 1983, section 27(1A)
- PR 1986, regulation 27A
- TMA 2019, section 26(1)
- TMA 2019, section 27
- TMA 2019, section 26(1)
- TMA 2019, section 28
- TMA 2019, section 76
- PA 1983, section 42(3)
- PA 1983, section 63
- TMA 2019, section 65(1)
- TMA 2019, section 65(4)
- TMA 2019, section 69(5)
- TMA 2019, section 70(3)
- TMA 2019, section 46(1)(a)
- TMA 2019, section 160(3)
- TMA 2019, section 160(6)