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 USD 99.

1. What are the basic requirements to obtain patent and trademark protection?

The Malaysian jurisprudence on patent and trade mark protection is derived from the United Kingdom’s common law and mainly codified in statutes. Thus, there are similarities between the two jurisprudences, including the recognition of a cause of action for the tort of passing off. Patent protection is governed by the Patents Act 1983 (“PA 1983”) and trade mark protection by the Trade Marks Act 1976 (“TMA 1976”). Please take note that in July 2019, the Malaysian House of Representatives passed the Trademarks Bill 2019; there will be changes to the trade mark protection landscape in Malaysia in the future.

An invention may be or may relate to a product or a process. To obtain patent protection, the invention must:

• Be new; and
• Involve an inventive step; and
• Be industrially applicable.

An innovation includes a new product or process, or any new improvement to a known product or process, including an invention. To obtain utility innovation protection, the innovation must be:

• New; and
• Industrially applicable.

To obtain registration for a trade mark, the mark must be distinctive in some manner, e.g. a special representation of a name or an invented word. Under the TMA 1976, a ‘mark’ does not include non-traditional marks such as colour and sound; but the Trademarks Bill 2019 indicates that protection will be afforded to non-traditional marks including scents in the future.

2. What agencies or bodies regulate patents and trademarks?

The Intellectual Property Corporation of Malaysia (MyIPO) is responsible for regulating the registration or recordal of intellectual property rights in Malaysia.

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

The PA 1983 proscribes the following as non-patentable inventions (and innovations):

• 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);

The Registrar of Patents will also refuse to grant patent protection (or utility innovation protection):

• 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.

The TMA 1976 proscribes the registration of marks or parts of marks which, among others:

• are likely to deceive or cause confusion to the public;
• would be contrary to the law;
• include scandalous or offensive matter;
• would not be entitled to protection by any court of law;
• include matter that is or may be prejudicial to the interest or security of the nation;
• are identical with or so nearly resembles well-known marks in Malaysia for the same goods or services;
• are well-known marks registered in Malaysia for goods or services not the same as those in respect of which registration is applied for;
• include indications which will mislead the public as to the true place of origin of the goods;
• include references to “Patent”, “Patented”, “By Royal Letters Patent”, “Registered”, “Registered Design”, “Copyright”, “To counterfeit this is a forgery”, “Registered Trade Mark”, and “Registered Service Mark” in any language;
• include any mark specifically declared to be a prohibited mark including references to or representations of the hibiscus, the Malaysian monarchs or heads of states, the royal palaces or buildings owned by any government, the word “ASEAN”, and the Geneva cross;
• are identical or so nearly resemble trade marks already registered for the same or closely related goods or services;
• include words commonly used and accepted as the name of any single chemical element or compound in respect of chemical substances or preparations.

4. How can patents and trademarks be revoked?

Patent and utility innovation invalidation actions must be filed in the High Court, not at the Registry of Patents. Grounds for invalidation include:

• 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.

An application to expunge any entry or remove any trade mark in the Register of Trade Marks must be filed in the High Court, not at the Registry of Trade Marks. Grounds for expungement include:

• the entry being made in the Register without sufficient cause;
• the entry remains in the Register wrongfully;
• the entry was made pursuant to fraud in the registration, assignment, or transmission of the registered trade mark;
• the trade mark was registered without an intention in good faith to use the trademark;
• no good faith use of the trade mark for a continuous period of at least 3 years from the date of registration until one month before the date of the expungement/ removal application.

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. The Malaysian application must be made within 12 months of the earlier application.

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.

Trade mark applications may claim priority from applications filed in a member state of the Paris Convention or any country declared to have arrangements with Malaysia for the reciprocal protection of trade marks. The Malaysian application must be made within 6 months of the earlier application.

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 licence 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 trade mark 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”. However, 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. it is advisable that out of abundance of caution, all licence agreements are to be entered into the Register.

The TMA 1976 does not expressly require a license agreement to be approved or entered on the Register of Trade Marks; however, please note that there are also risks associated with the non-recordal of such licences. An unregistered licensee, unlike a registered user, may not institute infringement proceedings in his own name when the registered proprietor refuses to take infringement proceedings. Further, the registered trade mark may be open to challenge for non-use by the registered proprietor or registered user.