A write-up on recent developments in life sciences sector by Khoo Guan Huat and Marie-Julie Wan Ullok
The Malaysian government acknowledges the need to increase its focus and attention on the life sciences sector as a means of generating significant economic growth for the country. To this end, various funds administered by relevant ministries and governmental bodies have been established to assist at all stages of intellectual property development, from research and development, technology transfer to commercialization of a particular product.
In addition to financial incentives, the Government has sought to increase awareness of and participation in the creation and enforcement of intellectual property rights. This article highlights some of the key regulatory and legal developments which have taken place in recent years in the life sciences sector in Malaysia.
PROTECTION OF NEW PLANT VARIETIES ACT 2004
A combination of rich natural resources and diverse cultural backgrounds has established, and continues to foster, a strong interest in the practice of traditional and complementary medicine in Malaysia. This has led to some impetus in examining how investment in and the development of new plant varieties can be encouraged or otherwise useful in contributing to the advent of intellectual property rights.
For this and other reasons, the Government introduced the Protection of New Plant Varieties Regulations 2008. These regulations came into operation on 20 October 2008 for the purpose of carrying into effect the provisions of the Protection of New Plant Varieties Act 2004 (“PNPVA”) (which came into force on 1 January 2007), thereby enabling the application for protection of new plant varieties by breeders, farmers, local communities or indigenous people, among others.
There are two categories of applicants under the PNPVA – where a plant variety is bred or discovered by a farmer, a local community or indigenous people, the plant variety must be new, distinct and identifiable to qualify for protection. In respect of all other applicants, however, the plant variety must be new, distinct, uniform and stable. In cases where the plant variety has been developed from traditional varieties, an application must be accompanied by the prior written consent of the authority representing the local community or the indigenous people.
A plant variety is considered new if on the filing date of the application, it has not been sold or otherwise disposed of on a commercial basis by or with the consent of the breeder:-
(a) within Malaysia – earlier than 1 year before the filing date of the application;
(b) outside Malaysia – earlier than 6 years before the filing date of the application in respect of trees and vines, or earlier than 4 years before the filing date in respect of other plant varieties.
To be distinct, the plant variety must, on the filing date of the application, be clearly distinguishable from any other plant variety, the existence of which is a matter of common knowledge.
To satisfy the requirements of uniformity and stability, the plant variety must be sufficiently uniform in its relevant characteristics (subject to expected variations from its propagation) and remain unchanged after repeated propagation.
To qualify as being identifiable, the plant variety must be capable of being distinguished from any other plant grouping by the expression of one characteristic which is identifiable:-
- • either within individual plants or a group of plants; and
- • by any person skilled in the relevant art.
Upon registration, an applicant is granted the exclusive right to commercially exploit the registered variety for:-
- • 15 years for a plant variety that is new, distinct and identifiable; or
- • 20 years for a plant variety that is new, distinct, uniform and stable.
The PNPVA also provides for the establishment of the Plant Varieties Board whose functions include, among others, the examination of new plant varieties, assessment for registrability under the PNPVA, imposition of terms and conditions for the research and experimental use or export of any registered plant variety developed from local genetic resources or by indigenous people, maintaining the Register of New Plant Varieties and administering the Plant Varieties Fund.
The Board comprises Directors General of various governmental agricultural departments and representatives of the Ministries of Agriculture and Agro-Based Industry; Plantation Industries and Commodities; Domestic Trade, Cooperatives and Consumerism; Domestic Trade and Consumer Affairs; and Science, Technology and Innovations respectively.
The PNPVA also provides for enforcement against infringement by way of civil action (for damages, injunction or any other legal remedy).
At the same time, the Protection of New Plant Varieties (Prescribed Size of a Holding) Regulations 2008 also came into operation, whereby the prescribed size of a holding for farming operations shall not exceed 0.2 hectares.
BIOSAFETY ACT 2007
Following concerns on the possible risks to the environment and human health associated with the use of biotechnological products, the BioSafety Act 2007 (“BA”) came into force on 1 December 2009. The BA follows the general scheme of the Cartagena Protocol on Biosafety, recognizing both the potential advantages offered by modern biotechnology and the simultaneous need for protection of human health and the environment from the possible adverse effects of modern biotechnology.
The BA provides for the appointment of a National Biosafety Board (“Board”) that will be responsible for regulating the release, importation, exportation and contained use of any living modified organisms (“LMOs”) derived from modern biotechnology and the products of such organisms.
Applications for the use of LMOs in any of the aforementioned activities are to be made to the Board, which consists of representatives from the relevant ministries, viz. the Ministry of Natural Resources and the Environment, Ministry of Health, Ministry of Agriculture and Agro-based Industry, Ministry of Plantation Industries and Commodities, Ministry of Domestic Trade, Cooperatives and Consumerism, Ministry of International Trade and Industry and the Ministry of Science, Technology and Innovation, as well as other persons who have specialized knowledge or experience in biosafety-related issues.
The aforesaid applications will be vetted by the Genetic Modification Advisory Committee (“GMAC”), the appointment of which is also provided for under the BA, and whose function it will be to provide expert scientific and technical advice to the Board. GMAC consists of experts from various science-based and other relevant disciplines. Indeed, it is anticipated that the scientific assessments undertaken by GMAC will be pivotal in the Board’s decision-making.
Among other notable features, the BA acknowledges the need for public participation by allowing for the public disclosure of applications, although this is expressly subject to requirements of confidentiality vis-à-vis commercial or industrial information. The criteria for grant of confidentiality are identical to those contained in the WTO Trade Related Intellectual Property Rights Agreement.
Additionally, the BA mandates the identification and labeling of all LMOs or products derived thereof in a prescribed manner, in addition to other applicable labeling laws. The BA also acknowledges the need to consider religious and cultural sensitivities of the Malaysian public, a factor that will necessarily be of some influence in the Board’s decision-making process.
There are also provisions for enforcement of the BA and institution of prosecution with written consent of the Public Prosecutor.
ACCESS AND BENEFIT SHARING BILL
Malaysia is also in the process of formulating the Access and Benefit Sharing Bill (“ABS Bill”). The ABS Bill has the objective of regulating the sustainable use of biological resources in the country, ensuring the equitable sharing of any benefits obtained from the use of such resources and to protect against bio-piracy.
Essentially, the Bill intends to ensure that industries and scientific communities that use domestic biological resources share the benefits arising from research and development with the communities that use and maintain them as part of their livelihood. Parties wishing to conduct any research and development activities or participate in the commercial use of local biodiversity resources will be required to apply for specific permits for such activities.
CONTROL OF TOBACCO PRODUCT (AMENDMENT) REGULATIONS 2008
In following recent trends to discourage smoking and to encourage environmental consciousness and awareness, the Control of Tobacco Product (Amendment) Regulations 2008 was passed. These regulations amended the Control of Tobacco Product Regulations 2004.
The new regulations now mandate the display of a graphic health warning on cigarette packs. This is provided by the new Paragraph 4 of the Control of Tobacco Product (Amendment) Regulations 2008 which amends Rule 15 of the Control of Tobacco Product (Amendment) Regulations 2004. The forms of the health warnings are found in the amended Fifth Schedule of the Control of Tobacco Product (Amendment) Regulations 2004.
NOTABLE COURT CASES
Dedicated intellectual property courts were established in Malaysia in 2007 to address, among others, the backlog of intellectual property cases and the constraints faced by intellectual property owners typically needing to enforce their intellectual property rights without delay.
While the life sciences sector is active in Malaysia with numerous multinational biotechnology, biomedical technologies and pharmaceutical companies having a presence in the country, to date, relatively few cases involving life sciences have been filed in Malaysia. Nevertheless, the steady rise in the number of court cases, particularly those involving patent rights, in recent years suggests that parties are now acutely aware of their intellectual property rights and will not hesitate to enforce these rights, or to obtain an order to prevent infringement of such rights.
A significant case recently dealt with by the Courts involved an action filed by a large multinational pharmaceutical company against Warner-Lambert and Pfizer. In this case, the plaintiff sought a declaration that its atorvastatin product does not infringe the patent for Warner-Lambert/Pfizer’s atorvastatin product, the blockbuster drug Lipitor. On 7 May 2009, the plaintiff successfully obtained a declaration that its atorvastatin product does not infringe the Warner-Lambert/Pfizer atorvastatin patent, allowing the plaintiff to freely market its product in Malaysia.
Another notable case that is pending involves a claim for infringement of a process patent. The patent in suit relates to a process to manufacture docetaxel trihydrate, an active ingredient that is used in an oncological drug. Proceedings were commenced in 2006 by a leading pharmaceuticals company against Dabur Pharma Ltd, an Indian generics drug manufacturer.
In the course of the proceedings, the patentee filed a motion for and successfully obtained an interim injunction to restrain Dabur Pharma Ltd from offering for sale, authorizing others to sell or selling its Daxotel product, an oncological drug with docetaxel trihydrate as its active ingredient. Subsequently, with the injunction still in place and trial pending, Dabur Pharma Ltd was taken over by Fresenius SE, a German company in early 2009.
Following an agreement between the parties, both the action against Dabur Pharma Ltd and its Malaysian representative, as well as the latter’s counterclaim for revocation of the patent in suit, were withdrawn with the agreement that a fresh action is to be filed against Fresenius Kabi Oncology Limited, and its Malaysian counterpart, Fresenius Kabi (Malaysia) Sdn Bhd, who is the holder of the marketing authorization of Daxotel in Malaysia. It is anticipated that the full trial of the matter will be heard in 2010/2011.
In another notable matter, a German medical devices manufacturer commenced an action against Terumo Corporation of Japan, for infringement of a patent involving a safety intravenous catheter. The patentee successfully obtained an interim injunction against Terumo in September 2009, restraining Terumo from, among others, selling the accused product in Malaysia. The matter is expected to proceed to trial within the next year. The patentee has a large manufacturing facility in Penang, an island state located at the North West region of Malaysia.
Malaysia has moved a long way in recent years towards encouraging the creation, maintenance and enforcement of intellectual property rights, not least in the life sciences sector. The regulatory landscape continues to evolve and new laws are expected to be implemented in the near future. It is expected that the combination of a continuously evolving regulatory landscape, governmental policy and the increasing awareness amongst the industry will continue to move development forward in the area of life sciences.
KHOO GUAN HUAT (
MARIE-JULIE WAN ULLOK (
This is an updated version of an article which was first published in Managing Intellectual Property December 2009/January 2010. For further information please visit www.managingip.com