Enforcement Of Patents Or Patentability Requirements Relating To Trips In Malaysia

Question
Whether Malaysia had/has some issues re-enforcement of patents or patentability requirement relating to TRIPS?

Answer
Malaysia is a signatory to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), and has been since 1995 when Malaysia became a member of the World Trade Organization (WTO). The major points of TRIPS are covered in the Malaysian Patents Act (1983) & Regulations as follows :

Malaysia makes patents available for any inventions, whether products or processes, in all fields of technology without discrimination, subject to the normal tests of novelty, inventiveness and industrial applicability. Accordingly Malaysian legislation provides that patents be available and patent rights enjoyable without discrimination as to the place of invention and whether products are imported or locally produced (equivalent to Article 27.1 TRIPS).

NON-PATENTABLE INVENTIONS

In Malaysia, non-patentable inventions include inventions contrary to ordre public or morality, and those inventions which contain information that may be prejudicial to the nation. Also excluded from patentability are diagnostic therapeutic and surgical methods for the treatment of humans or animals (TRIPS Article 27.3(a)). Plants and animal varieties or essentially biological processes for the production of plants and animals, other than man- made living microorganisms, microbiological processes and the products of such processes, are also excluded.

The recent passing of the Protection of New Plant Varieties Bill 2004 has allowed Malaysia to accede to TRIPS article 27.3 (b) and gives breeders of new varieties of plants and seeds the right to receive legislative protection.

RIGHTS

The exclusive rights conferred to the owner of a patent in Malaysia include the right to exploit the patented invention; to assign or transmit the patent; and to conclude license contracts. The rights given to product patents cover making, using, offering for sale, selling, and importing for these purposes. Process patent protection rights cover not only use of the process but also products obtained directly by the process. Patent owners also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts (TRIPS Article 28).

Limited exceptions to the rules do exist in Malaysia, such as the rights not extending to those acts done only for scientific research, or to the use of the patented invention on any foreign vessel, aircraft, spacecraft or land vehicle temporarily in Malaysia. Such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties (TRIPS Article 30).

In accordance with TRIPS Article 33, the term of protection available in Malaysia is a period of 20 years counted from the filing date, for all patents filed after 1" August 2001.article 33.

INVALIDATION AND INFRINEGEMENT

Invalidation, infringement and revocation rulings are possible in Malaysia.

Malaysian patent applications must be disclosed in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and requires the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, in cases where priority is claimed, at the priority date of the application (TRIPS Article 29.1).

TRIPS Article 34 is covered in Malaysia as the Court overseeing an infringement case has the right to order the defendant to prove the act in question does not constitute an infringement, by for example proving that the process to obtain an identical product is different from a patented process, where certain conditions indicating a likelihood that the protected process was used are met.

COMPULSORY LICENSING

The Malaysian Patents Act does provide for compulsory licensing, but such licenses are made subject to conditions aimed at protecting the legitimate interests of the right holder. Where there is a 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, or where a judicial or relevant authority has determined that the manner of exploitation by the owner of the patent or his licensee is anti-competitive, the Minister may decided to allow a Government agency or a third party the rights to exploit a patented invention. In cases not involving anti¬competitive practice, conditions include the requirement to pay adequate remuneration in the circumstances of each case, taking into account the economic value of the licence; and a requirement that decisions be subject to judicial or other independent review by a distinct higher authority. the Act also allows for importation of patented products that are already in the other countries' market (parallel import). Article 31.

ISSUES IMPORTANT TO THE PHARMACEUTICAL INDUSTRY

In Malaysia, to date there is no provision on data exclusivity to comply with TRIPS Article 39.3 that directly addresses the issue of Data Exclusivity for pharmaceuticals even though the Parliament of Malaysia has already passed amendments to several acts, such as the Copyright Act the Patent Act, and the Trademarks Act.

The Malaysian government is on working towards the complete implementation of TRIPS.