AMENDING SECTION 84 PATENTS ACT 1983 TO ENCOMPASS THE HEALTH FLEXIBILITIES LEVERAGE

The significance of this study lies in its proposal to insert an appropriate provision into the Patents Act 1983 to embody the provisions of Article 31bis TRIPS Agreement. The methodology adopted in this study is library-based, and relies extensively on primary sources such as the Paris Convention, the TRIPS Agreement and the Patents Act 1983. This is further supported through secondary sources such as articles, books, websites and newspaper reports. The research question posed in this study aims to identify the most appropriate provision that should be incorporated into the Patents Act 1983 in addressing the public health flexibilities provided under Article 31bis. The purpose of this study is to demonstrate that Article 31bis is best incorporated into the Patents Act 1983, under the right of the government mechanism rather than through the compulsory license mechanism. Furthermore, the scope of this study is limited to issues that address the abuse of monopoly, granted by the patent system, with respect to the dire needs of public health. Hence, this paper discusses the mechanisms that address the abuse of the patent system under Article 5(A) Paris Convention, Articles 31 and 31bis UUMJLS 11(2), July 2020 (1-26) 2 TRIPS Agreement, the relevant corresponding provisions under the Patents Act 1983, and subsequently formulates new proposed amendments to Section 84 of the Patents Act 1983 to buttress the public health flexibilities provided under Article 31bis. The outcome of this study proposes that the provisions of Article 31bis should be incorporated into the Patents Act 1983 under the right of the government mechanism, by replacing the current Section 84 of the Patents Act 1983 with a newly proposed Section 84. 9-7


INTRODUCTION
According to Ricketson (1984) 1 , a patent is the monopolistic right bestowed upon the owner, to exploit his patented invention for a particular duration of time. The law of patent grants the owner of an invention, exclusive rights to the invention, by issuing a patent. Generally, the patent system is designed to stimulate innovation by granting protection, for a certain period of time to the patentee, to monopolize the exploitation of the patented invention exclusively, without any competition from the same or similar invention in the market. Moreover, this system is beneficial to everyone because the law dictates the disclosure of information in exchange for the grant of the patent. This helps spread the technical knowledge for the betterment of all (Bainbridge, 2012, p. 394) 2 . All members of the Paris Convention for the Protection of Industrial Property 1883 3 (Paris Convention) and the Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 4 (TRIPS Agreement) are obliged to provide a patent regime in their domestic intellectual property 1 Ricketson, S. (1984). The law of intellectual property. Sydney: The Law Book Company Limited. 2 Bainbridge, I. David. (2012). Intellectual property ( 9 th ed.) Pearson Education Limited. 3 Paris Convention for the Protection of Industrial Property 1883 (as amended on September 28, 1979), entered into force on June 3, 1984. 4 Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 came into effect on 1 January 1995. Malaysia has been a member of this Agreement since 1 January 1995. protection mechanism. Malaysia is a member of both the Paris Convention and the TRIPS Agreement. In Malaysia, patent rights are governed by the Patents Act 1983 5 (PA). The PA grants exclusive rights to the owners of the patent with respect to their inventions (Section 36 PA, 1983).
Although the TRIPS Agreement stresses the obligation of members to protect intellectual property rights, it also stipulates that member countries should establish well-balanced guidelines that protect these rights so as to combat any abuse arising from the intellectual property rights, particularly when there is a necessity to protect issues relating to public health and nutrition (Article 8, TRIPS Agreement, 1994). In adhering to good policy, law and governance, particularly with regards to patents, member countries must take aggressive steps to ensure a good balance of rights between patent owners as well as the advancement of public interest and national development goals (Azam, 2016, p.92) 6 . The most common approach governments employ to balance these rights is by introducing exemptions or exclusions to patent rights in their relevant intellectual property laws (Bagley, 2018(Bagley, , pp. 2480(Bagley, -2481 7 . Another common method employed to balance these rights is through the implementation of compulsory licenses (CL). CL is a legal measure adopted by many governments against patent abuse, particularly in relation to public health crisis (Kyung-Bok, 2019) 8 . It is a legal measure because this mechanism is approved under Article 5(A) of the Paris Convention, and Articles 31 and 31bis of the TRIPS Agreement. CL is a crucial mechanism when dealing with health-sensitive issues surrounding the patent law (Armouti, 2018, p.383) 9 . Of particular interest 5 Patents Act 1983, (Act 291), enforced October 1, 1986. 6 Azam, M. (2016) This study analyses the balance of rights between patents and public interest by examining the compulsory licensing mechanism envisaged under Article 5(A) of the Paris Convention, and Articles 31 and 31bis of the TRIPS Agreement. Thereafter, the findings will be cross-referenced to the corresponding provisions in the PA, and ultimately identify the provisions in the PA that are most suitable to be incorporated into the new provisions of Article 31bis, in relation to public health flexibilities. This study will review the two different mechanisms provided under the PA and with the inclusion of Article31bis of the TRIPS Agreement, the public health flexibilities provided under this Article which allow for the right of "legal infringement" on grounds of public health, will subsequently be vested with the Government under the ROG provision through the replacement of the current Section 84 of the PA with a newly proposed Section 84.

METHODOLOGY
This research adopts the doctrinal legal research methodology. The research methodology is purely library-based, and is mainly reliant on primary sources of information such as the Paris Convention, TRIPS Agreement and the PA. This is further supported by secondary sources, namely textbooks, journals and websites of relevant authorities. The websites of certain authorities are important as the provisions of Article 31bis had stemmed from a string of events under the purview of such authorities , and therefore had been widely reported. The research is theoretical, analytical and exploratory; where Article 5(A) of the Paris Convention, and Articles 31 and 31bis of the TRIPS Agreement are analysed and scrutinized, and thereafter, cross-referenced to the PA. This study explores the suitability of Article31bis in relation to the PA and concludes that Malaysia should amend the ROG provision, i.e. Section 84 of the PA to incorporate the public health flexibilities provided under Article 31bis by proposing an amended draft of a new Section 84 for the PA.

DISCUSSION
National policies on patents are often long-term policies that take into consideration various strategies that are based on economic, scientific and technological developments (Miyamoto, 2008, p.155) 11 . These policies are significantly important to public interest considerations which are based on normative, constitutional and 11 Miyamoto, T.(2008). International treaties and patent laws harmoniza- Miyamoto, T.(2008). International treaties and patent laws harmonization: today and beyond. Takenaka philosophical justifications (Sitorus, 2016, p. 85) 12 . The issues of public interest are usually issues that are related to the balancing of rights between a patent owner and the public. Article 7 of the TRIPS Agreement requires an international public interest consideration, whereby member countries in ensuring "protection and enforcement of intellectual property, should contribute to the promotion of technological innovation" for the mutual benefits of "producers and users" in a manner that is "conducive to social and economic welfare", and subsequently, to maintain a "balance of rights and obligations". Prior to the TRIPS Agreement, balancing of these rights was first incorporated into the Paris Convention via Article 5(A), whereby the mechanism used to prevent the abuse was expressly referred to therein as CL. The following sections will discuss the various provisions in the Paris Convention and the TRIPS Agreement concerning CL, and we will then make a cross-reference of these provisions to the corresponding provisions in the PA.

Article 5(A) Paris Convention
Article 5(A) of the Paris Convention which is titled "Patents: Importation of Articles; Failure to Work or Insufficient Working: Compulsory Licenses" allowed members of the Union to incorporate legislative measures into their laws, to prevent abuse of patent rights which may arise due to monopoly rights granted to the patent holders. This can be achieved through the issuance of CL in appropriate cases. An example provided to illustrate such abuse is the failure to work the invention which has been patented (Article 5(A)(2) of the Paris Convention, 1883 (Timble, 2016) 13 . "Failure to work" implies that the owner of an invention that has been granted a patent, had "failed to put into practice" his invention, within the country that issued the patent (Conteras, 2017, p 4)  stipulates a specific condition in the application of a CL, whereby a CL application will not be entertained on grounds that a patentee has failed to work the invention which had been patented, before the expiration of "4 years from the date of filing the patent application or 3 years from the date the grant of the patent" was awarded, or whichever period expired last (Article 5(A)(4) Paris Convention, 1883). General terms and conditions to grant CL are also specified therein, however, CL cannot be granted if the owner "justifies his inaction with legitimate reasons", and that the CL will be "nonexclusive and non-transferrable" (Article 5(A)(4) Paris Convention, 1883). There are many countries, for example Bahrain, Brazil, Chile, China and the Philippines (Visser, 2010, p.4) 15 , that have a CL provision in their patent system.
in Malaysia is considered and decided upon by MyIPO. The CL provisions under Part X stems from the provisions of Article 31 of the TRIPS Agreement. Such requirements for CL are the efforts that are needed to be undertaken to obtain the patentee's approval first, and the grant of CL can only be given for the supply of the patented product into the local market. The requirements in Article 31 herein will be further discussed in the following section.
The concise provisions regarding CL under Part X of the PA are solid and comply with Article 5(A) of the Paris Convention, and the decision to grant CL being vested in MyIPO, is indeed the correct approach chosen by the Malaysian Government. MyIPO is the statutory body that is in charge of intellectual property matters and is capable of assessing the reasons to grant a CL to an applicant in accordance to Part X, as the issues involved must be within the Malaysian territory. For this reason, the verification of information about these situations in the event that an issue arises may be easily obtained through investigations carried out by MyIPO. The availability of CL under the PA is important to Malaysia because being a developing country, balancing of rights between the patent owners and the public is indeed of utmost importance (Arega, 2019, p. 31) 16 . Thus far, there has been no application for a CL to MyIPO. Although issues relating to high prices of medicines had arisen in Malaysia, particularly medication for HIV and Hepatitis C, the provisions of CL under Part X of the PA were never put to use as no third party or generic manufacturers had applied to MyIPO for a CL to combat these rising prices. Therefore, to address these health problems, the Government invoked the ROG as can be seen in the following part. Hence, till today, MyIPO has no experience in dealing with issues in respect of the issuance of CL.

Article 31 TRIPS Agreement
Article 31 is titled "Other Use without Authorization of the Right Holder". Article 31 allows members to accommodate a provision in their laws allowing the use of an invention which has been patented, without acquiring consent from the patentee. This right was granted mainly to three parties; "a third party", "the government", or "other parties that are authorized by the government", where this right is subjected to certain rules 17 . Article 31 is a continuation of Article 30. Article 30 gives an option to member countries "to provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with the normal exploitation of the patent" in issue (Guan, 2016, pp. 423-424) 18 . Article 31 "gives permission" to third parties to use the invention that has been granted a patent, without the consent of the patentee, for reasons other than those provided under Article 30. Although Article 31 makes no reference to the term CL, it is nevertheless commonly referred to as the "CL provision" (Effingham, 2016, pp. 883-909;Raducanu, 2011;WTO;World Health Organization [WHO]) 19 . This is supported by the stringent rules that need to be 17 An example of such rules is the authorization of the use shall be based on individual merits and there shall be a right of judicial review of such authorization; the use is only authorized should efforts made to obtain the patentee's authorization had been futile. This rule is exempted in situations of national emergency, other circumstances of extreme urgency or in cases of public non-commercial use. Nevertheless, in such cases, the patentee shall be informed of this use as soon as possible.; the scope and duration of the use shall be limited to the purpose it was authorized The use shall be non-exclusive; the use shall be non-assignable; the use shall be predominantly for the supply of the local market only; the use shall be subject to adequate protection of the legitimate interest of the party so given the authorization and such authorization can be terminated when the reason for the authorization given, had ceased. The patentee is paid adequate remuneration for the use and issues related to adequacy shall be subject to judicial review; and for purposes of remedying a practice determined as anti-competitive. The use need not be subjected to the rule of obtaining the approval of the patentee first and the rule to supply for the domestic market only. 18  Malaysia, being a signatory to the TRIPS Agreement since 1995, has opted to use this system and has incorporated the provisions into the PA. Most of the rules and provisions stated in Article 31 have been incorporated into Part X PA. Hence, Part X consists of a combination of Article 5(A) of the Paris Convention and Article 31 of the TRIPS Agreement (only to the extent where this system is used by a third party). Subsequently, when "a Government or a party authorized by the Government" uses this system, the PA defines this utilization as the "Rights of Government", which has been specifically incorporated into Section 84. The PA clearly distinguishes CL from ROG. CL is applied by a third party strictly on grounds that are specified under Article 5(A) of the Paris Convention and under Part X of the PA, whereas ROG is invoked by the Government for the application of the system by "the Government or a third party that is authorized by the Government" on two specific grounds. Firstly, ROG is invoked in the event of "national emergency" or "public interest", such as "national security and health" issues (Article 31(b)). Secondly, it is granted when "a judicial or relevant authority has determined" that the patent owner had exploited his invention in an "anti-competitive" manner, (Article 31(c)). Although Article 31 does not distinguish between CL and ROG, the PA has demarcated these rights into two categories of rights that are used by different parties. This allows for a much simpler and clearer determination of rights to ensure an appropriate balance of rights between patent owners and the public 20 . Issues involving abuse of patent rights within the local territory is governed by MyIPO, while matters involving national interests are regulated by the Government.

Article 31bis TRIPS Agreement
Article 31bis is the newly inserted provision of the TRIPS Agreement, which was enforced in January 2017. It embodies the effort of the members of the WTO in recognising the need of a system to help the poorer member countries to gain easier access to medicine (Alsegard, 2004) 23 . Article 31bis clearly refers to the system envisaged therein as CL and provides flexibility to "countries with insufficient or inexistent manufacturing capabilities" to produce the pharmaceutical products which have been granted patents, without first obtaining the permission of the patentee, and this can be done strictly on reasons of public health flexibilities. Member countries of the WTO finally recognized this concern, particularly the need of those in the least developed countries (LDC) to have access to medicines through imports from other countries (WTO) 24 . The LDC lack the manufacturing capabilities, and therefore, these countries are not able to produce medicines to cater for their public health concern. Consequently, Article 31bis was introduced to allow CL to be invoked, whereby generic medicines can be made and there is no need to obtain authorization from the patentee to do this. the decision of Paragraph 6 therein, and has now been incorporated into Article 31bis.
It is indeed disheartening to note that as of 2019, the PA does not have a provision on the public health flexibilities provided by Article 31bis despite Malaysia being involved in "the Doha Declaration on TRIPS and Public Health" since 2001. Malaysia also accepted the "Protocol Amending the TRIPS Agreement" in December 2015 (WTO). It has been more than 2 years since this Protocol was enforced, however, Malaysia is yet to incorporate these flexibilities into the PA. As a developing country, Malaysia must address the global call on affordable access to medicines. As far as Malaysia is concerned, this call envisaged under Article 5(A) of the Paris Convention and Article 31 of the TRIPS Agreement has been implemented by incorporating the provisions on CL and ROG into the PA. However, the policy, law and governance in managing the country, especially with regards to public health concerns, must be expanded to benefit the less fortunate countries, particularly the LDC, through the integration of the provisions of Article 31bis into the PA.

RECOMMENDATIONS
Whilst the patent system's integrity must be enforced accordingly, it is simply just right for the public to have access to affordable medications, particularly in times of crisis involving public health (Halterman, 2018, p. 511) 27 . Therefore, this study proposes that Malaysia incorporates the provisions of Article 31bis into the PA by amending Section 84 to grant the Malaysian Government the right to expand the benefit it has provided to its citizens and to include the citizens of other lower income countries. Furthermore, the implementation of this mechanism will ensure adequate remuneration to the patent owner and provide assurances that the right will be exercised prudently and meticulously by the sovereignty of the country, based on the given situation. Invocation of the ROG would be the most appropriate mechanism to be adopted by Malaysia for 27 Halterman, C. (2018). Patent rights v public access: Interpreting the public interest factor in pharmaceutical patent infringement cases. Southern Illinois University Law Journal, 42 (3), 499-520.
purposes of Article 31bis, as the Government is in the best position to monitor recent developments within the global community. In addition, the ability of the Government to assess the need of other sovereign countries, in relation to the access of medicines, would eliminate any potential abuse of the public health flexibilities as cautioned under paragraph (4) Annex to Article 31bis.
A CL system under Part X would be inappropriate in such scenarios as the time and costs may be significantly expended, particularly since it is a pre-condition that a person seeking a CL must have first taken steps to ensure that he has attempted to obtain the consent of the patentee. This action alone will take time and would lead to unnecessary delays in putting into effect the main aim of Article 31bis. In addition, there is a possibility that the documents involved in the implementation of Article 31bis may require authentication. MyIPO, being the statutory body in charge of CL in Malaysia, may need verification from the Government on the authenticity of the documents submitted, and this may take more time. This was observed when Canada had access to the medicine regime through the CL system and was corresponding with the Canadian Intellectual Property Office in handling the application. However, it took 15 months before supply could be given to Rwanda during the crisis in 2007 due to the long processing time (Anderson, 2010, p. 180) 28 . This suggests that a CL system is an inappropriate system for the purposes of Article 31bis. Many African countries such as Namibia, Zanzibar and Botswana have incorporated this system into their legislations, whereby this right lies with their Ministers (Banda, 2016, p. 71) 29 . Envisaging the rights under Article 31bis at the Ministerial levels would be the most appropriate measure to address the issues related to Article 31bis. Essentially, when a sovereign country uses this right, it captures the attention of the international community, hence, ensuring a good monitoring system of use under Article 31bis. 28 Anderson, B. (2010). Better access to medicines. Why countries are getting tripped up and not ratifying Article 31-bis. Case Western Reserve Journal of Law, Technology and the Internet, 1(2), 165-182. 29 Banda, C. (2016). Intellectual property and access to essential pharmaceuticals: Recent law and policy reforms in the Southern Africa development community region. Maryland Journal of International Law, 31, 44-78.
Based on the above reasons, in order to ensure the elimination of abusive practices of the system under Article 31bis, this study proposes that the right to invoke this system should be placed under the purview of the Malaysian Government as a ROG pursuant to Section 84 of the PA, and not under the CL system pursuant to Part X of the PA. Furthermore, this study suggests substituting the existing Section 84 of the PA, with a new Section 84, whereby the current provision on ROG pursuant to Article 31 of the TRIPS Agreement is expanded to include the flexibilities provided under Article 31bis.
The new proposed Section 84 is set out here below where only the amended provisions are shown without much repetition of the existing provisions. The current existing Section 84 of the PA is reproduced in the Appendix, for ease of comparison and identification of the relevant amendments proposed to be made thereto.  (5)).
(9) …….. (the current subsection (7)). "patented invention" means any invention that has been patented in accordance with this Act and includes pharmaceutical products; "pharmaceutical product" means any patented product, or product manufactured through a patented process, of the pharmaceutical sector including but not limited to the active ingredients necessary for its manufacture and diagnostic kits needed for its use, which is required to address an epidemic problem; "TRIPS Agreement" means the Agreement on Trade-Related Aspects of Intellectual Property enforced on January 1, 1995 including any amendments thereto." The proposed amendments embodied in the above new Section 84 of the PA will grant the Government various flexibilities in invoking the provisions of Article 31 and Article 31bis, under a single provision in the PA.

CONCLUSION
Malaysia is indeed a TRIPS compliant member country and has set up a good legal protection mechanism for the enforcement of intellectual property rights. Although Malaysia highly respects and encourages the security of intellectual property, it has always attempted to strike a fair balance between the intellectual property rights owner and the wider interest of the public, particularly in respect of the law relating to patents. This requirement of balance for patent rights is enshrined in Article 5(A) of the Paris Convention and Articles 31 and 31bis of the TRIPS Agreement. These provisions allow governments to exercise some flexibilities, should there be abuse of patent rights. It is a human's right to have a right to healthcare, and there is no doubt that having easy access to medicines is also an embodied right. Malaysia garnered international attention when it provided easy access to medicines to Malaysians when the country was faced with public health problems in 2004 and 2017, signifying Malaysia's approach to the balance of rights while protecting intellectual property rights through the invocation of the ROG mechanism pursuant to Section 84 of the PA. Malaysia should fully endorse the new Article 31bis, particularly for supporting the LDC , by incorporating a provision into the PA to address the issue therein.
The incorporation of this Article into Section 84 of the PA under the ROG mechanism, would uphold the Government's sovereign position and concern towards public health issues, in the eyes of the world, since it is the Government itself that will be handling this issue directly and not merely an agency of the Government (MyIPO). It is proposed that the flexibilities under Article 31bis of the TRIPS Agreement be carried out via the ROG mechanism under Section 84 of the PA, and not the CL mechanism under Part X of the PA, because it shows the Government's sovereign handson approach when dealing with public health issues concerning its citizens and its country, as well as the rest of the world. In addition, the current Article 31 of the TRIPS Agreement provisions in respect of interference of patents on grounds of security and public health issues for use in domestic situations, are already embedded in the ROG mechanism under Section 84 of the PA. Therefore, it is simply prudent and logical that for purposes of Article 31bis (incorporated into the TRIPS Agreement pursuant to the provisions of Article 31 specially to address issues relating to public health crisis only, which includes the right of the country to now export the pharmaceutical products for use outside its country), these rights be inserted into the ROG mechanism under Section 84 of the PA and not the CL mechanism under Part X of the PA.
Suggestions of incorporating the flexibilities provided under Article 31bis of the TRIPS Agreement into Part X of the PA (if any), would set a double standard in the Government's approach towards public health crisis, whereby for issues of public health in its country, the sovereign decides, but for the public health crisis in other countries, a mere organization in charge of intellectual property viz. MyIPO would be the decision-maker. This double standard would not make Malaysia look good in the eyes of the world as Malaysia has always been recognized by the world as a champion for its efforts with regards to public health matters, both nationally and internationally. This great concern of "always being there and playing an important role during a public crisis situation" shown by Malaysia, can be evidenced based on Malaysia's public health-related actions taken in 2004 and 2017 and more so important, now, in 2020, where Malaysia is playing an active role by implementing hands-on actions in addressing the current Covid-19 pandemic, when it was one of the first few countries in the world to implement the "lockdown" mechanism, by introducing the Movement Control Order in its effort of curbing the pandemic. Malaysia's actions which are being carried out gracefully and calmly, is not only for the benefit of the Malaysians themselves but also for the benefit of the world at large.
This shows that Malaysia places utmost importance on issues relating to public health and as such, for purposes of Article 31bis of the TRIPS Agreement, the most appropriate mechanism is the ROG mechanism, which allows the Government of Malaysia to exercise the public health flexibilities and not the CL mechanism under the purview of an agency viz. MyIPO. Both the world at large, particularly the LDC , as well as Malaysians, stand to benefit from this proposal of envisaging Article 31bis of the TRIPS Agreement into Section 84 of the PA, as it is the sovereign of the state with access to all information in hand, that will immediately decide on a public health crisis, whether be it a crisis at the national or international level.