India’s Distinct but Opposing Patent Model Is Under Pressure: Prospects and Challenges in the Global Arena

Abstract

The Indian patent model is a powerful and well-balanced model that not only complies with the requirements of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) but also considers domestic needs and national interest. This study endorses India’s approach of fully availing itself of public health flexibilities provided in the TRIPS Agreement. India’s well thought out patent model contradicts with the pro-patentee approaches taken by the European Union, the USA and Japan. This study emphasises the challenges and pressures faced by the Indian patent model because of the closer harmonisation agenda being pushed by some high-income countries through bilateral and multilateral free trade agreements. This study argues that in order to effectively respond to harmonisation demands, India needs to be proactive in terms of building regional coalitions and transmitting its model to other like-minded Association of Southeast Asian Nations (ASEAN) countries with similar interests. This is a viable approach because most of the ASEAN countries, despite different levels of development and industry, are facing similar challenges in terms of universal access to affordable medicines.

Introduction

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) ¹ provided mandatory patent protection to inventions in all fields of technology but provided certain public health safeguards to deal with practical implications of product patents in the field of biopharmaceuticals (Abbas, 2020a; Abbas & Riaz, 2013). Prior to signing the TRIPS Agreement, India had excluded pharmaceutical drugs from product patent protection (The Patents Act, 1970). India’s process patent regime created a feasible arrangement for the growth of its robust generic drug industry. By adopting this approach, India not only provided cheaper drugs to its own population but also took pride in being ‘the pharmacy of the developing world’ because of its role as a major supplier of generic medicines (Tenni et al., 2023). Excluding pharmaceutical drugs from product patent protection was no longer an option after signing up to TRIPS.

India, having a well-established generic drug industry, faced opposition by many interest groups and stakeholders to the implementation of TRIPS (Tenni et al., 2023). India’s obligations under TRIPS also conflicted with the constitutional obligation under Article 47 of the Constitution of India to provide the right to health to citizens. ² Keeping in view the potential impact of pharmaceutical product patents on the generic drug industry, public health and consumer welfare, India was under pressure to implement TRIPS in a manner that aligned with India’s domestic needs, constitutional obligations and national interest.

India availed itself of the public health flexibilities to minimise the impact of its obligations under TRIPS. By making use of the policy latitude provided under TRIPS, India crafted three distinct legislative provisions to allow three channels of compulsory licensing. The option of ordinary compulsory licensing is provided under Section 84 of the Patents Act, 1970. The option of government use is provided under Section 92. The option of export-oriented fast-track compulsory licensing is provided under Section 92(A) of the Act. India provided a detailed compulsory licensing regime, but these provisions have largely remained underused. In March 2012, India, at the request of Natco, issued a compulsory license for Sorafenib Tosylate (Nexavar), Bayer’s cancer drug. This was the first and only compulsory license issued by India (Tenni et al., 2023).

Another flexibility is in relation to patentability criteria. By not defining the key terms ‘novelty’ and ‘inventive step’, the TRIPS Agreement provided policy space to define and apply patentability criteria domestically. Under Section 3(d) of the Patents Act (1970), India excluded derivatives of known substances from patent protection unless the condition of ‘enhanced efficacy’ is met. Section 3(d) was purposefully designed to combat manipulative evergreening of pharmaceutical patents where claimed inventions lacked additional therapeutic benefits. India also defined inventive step under Section 2(ja) of the Patents Act (1970) and added additional requirements of ‘technical advance’ and ‘economic significance’ to the inventive step threshold.

Patent opposition is one of the TRIPS flexibilities. Patent opposition is a time-bound administrative process within a patent office, for third parties to raise arguments and provide evidence against the validity of a patent (Weatherall et al., 2011). This procedure is used as a safeguard to make sure that only those inventions make it to grant that meet the requirements of patentability under national patent laws. The TRIPS Agreement did not provide any specific guidelines on patent opposition proceedings. This treaty, however, prescribed some general procedural requirements that may be applicable to opposition procedures (Manu, 2017). Article 62(2) of the TRIPS Agreement (1995) requires the Member States to make sure that the procedures for grant or registration of IP rights do not cause ‘unwarranted curtailment of the period of protection’ (Abbas, 2020a; Lawson, 2004).

Taking benefit of the TRIPS flexibility, India provided a detailed legislative framework for both pre-grant and post-grant patent opposition to fully avail itself of this TRIPS’ procedural flexibility. Previously, since 1970, India had provided only a pre-grant opposition system. ³ In 2004, under the Patents (Amendment) Ordinance, ⁴ the Indian patent regime provided for both pre-grant representation and post-grant opposition proceedings. One of the grounds of invoking patent opposition proceedings in India, under Sections 25(1)(f) and 25(2)(f) of the Patents Act, 1970, is that ‘the subject of any claim of the complete specification is not an invention within the meaning of this Act, or is not patentable under this Act’. This ground of patent opposition links the Indian opposition proceedings with Section 3(d) (Abbas, 2020a). Moreover, under Sections 25(1)(e) and 25(2)(e), patents can be opposed on the ground of obviousness or lack of inventive step. This ground links the Indian opposition proceedings with Section 2(ja). Sections 3(d) and 2(ja) are, therefore, a very important component of the Indian patent opposition proceedings. This nexus of two distinct TRIPS flexibilities is a prominent feature of the Indian patent opposition model. India, therefore, used its procedural mechanisms of patent opposition to reinforce its heightened patentability requirements.

India’s patent opposition model appears to be exemplary when compared with the approaches taken by other developing and emerging economies, such as South Africa, Brazil and China. South Africa not only adopted lenient patentability standards but also allowed patent protections without substantive examination. ⁵ South Africa lacks any effective mechanism to ward off unwarranted patents (Ward, 2014). Brazil, under its Industrial Property Law (Lei da Propriedade) of 1996, provided post-grant opposition procedure. Before a patent is granted, third parties are allowed limited participation. Brazil does not provide a full-fledged pre-grant opposition procedure. China provides only post-grant opposition procedures in Patent Law of the People’s Republic of China. None of these countries set an example in terms of using the policy latitude provided under the TRIPS Agreement. They do not have mechanisms in place to prevent the grant of low-quality patents. As a result, unwarranted patents can create barriers and undermine the public interest by delaying price-reducing generic competition.

India’s exemplary patent model faces pressures for closer harmonisation in a globalised intellectual property system in the WTO-plus era. The Indian opposition model is a powerful and well-balanced model that complies both with the TRIPS requirements and domestic needs of developing countries. The Indian patent model is, however, distinctively different from patent models of the Trilateral Patent Offices: the European Patent Office (EPO), the United States Patent and Trademark Office and the Japan Patent Office (JPO). As a conflicting model, the Indian patent model is subjected to even more pressures for harmonisation.

Historically, national patent systems maintained diversity in terms of both administration and standard setting because of considerable differences in domestic needs and national goals of each country (Abbott et al., 2013). The WTO TRIPS Agreement acknowledged this need for diversity and did not cover all of the issues relevant to patent law so that the WTO member states retain considerable flexibility to tailor their national patent laws in line with their domestic needs. The developed countries, however, oppose national variations and aggressively push for closer upward harmonisation of both substantive and procedural patent laws through bilateral and regional trade negotiations outside the WTO.

Achieving a balance between the public interest in having access to affordable medicines and the corporate interest in maximising profits has been a long-standing issue around intellectual property and public health. India’s patent model is an example of how to achieve this balance by remaining within the latitude provided by the TRIPS Agreement. This study emphasises the challenges faced by the Indian patent model because of the harmonisation agenda being pushed by the trilateral offices under free trade agreements (FTAs). This study argues that in order to effectively respond to harmonisation demands, India needs to be proactive in terms of building regional coalitions and transmitting its model to other like-minded countries with similar interests.

FTAs and Harmonisation Demands: Challenges for India

The patent opposition procedures provided by the European Union (EU), the USA and Japan conflict with the Indian patent opposition model. The European Patent Convention (EPC) ⁶ provides for a supra-national post-grant third-party opposition procedure (Abbas, 2020, 2020b). This inter partes administrative procedure allows third parties to file a notice of opposition at the EPO within nine months after the grant of a European patent is published (Abbas, 2020b). ⁷ Any natural or legal person, other than the patent owner, may file a patent opposition. ⁸ The EU provides limited opportunities to third parties to challenge pending patent applications. Preventing the grant of questionable patents is a superior policy option as compared to revoking the granted patents because questionable patents, even if revoked later, have a substantial negative impact. This is important given the fact that the EPO grants patents for 28 countries, and its patenting decisions impact a population of more than 450 million (Gaessler et al., 2017).

In the USA, the Leahy-Smith America Invents Act (AIA) ⁹ introduced two post-grant patent invalidation proceedings: post-grant review and inter partes review. The challengers are required under Section 322(b) of 35 U.S.C. to disclose the real party behind the petition. This requirement makes the procedure less attractive for petitioners because the petitioners are vulnerable to a counter-attack in the form of patent infringement litigation. Moreover, the US procedure generates troublesome legal estoppel. The challenger is not allowed under Section 315(c) of 35 U.S.C. to bring a future action on any issues that were actually raised in the review proceedings or could potentially be raised during such proceedings. Facts determined during these proceedings cannot be challenged in a future action. These harsh estoppel provisions make the procedure less attractive to potential challengers as they have to choose this procedure to the exclusion of other invalidity mechanisms. The US approach of trying to limit patent opposition undermines the public interest.

Japan has provided a post-grant patent opposition mechanism since April 2014 under Tokkoho to no Ichibu o Kaiseisuru Horitsu (Law No. 36 of 2014). An opposition may be filed under Article 113 by any person within six months of the publication of the grant of the patent. The Japanese model is less attractive for those having a significant interest in the registered patent as this procedure does not allow opponents to bring petitions anonymously (JPO). The petitioners are vulnerable to a counter-attack in the form of patent infringement litigation. Moreover, Japan provides the shortest timeframe of only six months for filing post-grant oppositions. Furthermore, Japan does not provide any mechanism for third parties to challenge pending patent applications.

As compared to patent invalidation models of the EU, the USA and Japan, the Indian patent opposition model is a much more powerful and balanced model that complies not only with the TRIPS requirements but also with India’s domestic needs and national interests. As the Indian model is distinctively different from patent models of the Trilateral Patent Offices, it is facing pressures for closer harmonisation in a globalised intellectual property system in the WTO-plus era. The high-income countries oppose national variations and aggressively push for closer harmonisation of both substantive and procedural patent laws through bilateral and regional trade negotiations outside the WTO. The following sections discuss harmonisation pressures for India’s conflicting model and how India can respond to these pressures.

Shift from Multilateralism to Bilateralism

The Doha Declaration 2001 was a landmark development in terms of stabilising the relationship between the TRIPS Agreement and public health (Abbas, 2017). In the post-Doha period, the developing countries, lacking political and economic power, started using the strategy of forming like-minded coalitions to move the negotiations in favour of public health and global justice (Gostin, 2014). The developed countries, on the other hand, tried to push their closer harmonisation agenda through a proposal of a Substantive Patent Law Treaty (SPLT) that sought to limit policy space for the WTO member states (Abbott et al., 2013). Substantive harmonisation at the multilateral level could not be realised as the proposal faced strong resistance from the developing world (Abbott et al., 2013). The WTO ministerial meetings in Seattle (1999) and Cancún (2003) and stiff resistance to the proposal for SPLT clearly indicated that the developed countries had ‘lost control of the WTO [and WIPO] agenda in the face of resistance from developing countries’ (Flint & Payne, 2013).

Faced with the increasing sensitivity to public health concerns at the WTO, economically advanced countries started to seek alternative forums to pursue their expansionist or maximalist protection of intellectual property agenda (Correa, 2017). It is a well-established and well-documented fact that since the adoption of the Doha Declaration, industrialised countries like the USA and European Union have negotiated higher TRIPS-Plus intellectual property standards and greater trade liberalisation outside the multilateral WTO forum (Correa, 2017). The US standard bilateral FTA template ‘attempts to conform patent law in the counterpart country to the substantive standards in force in the USA and arguably provides in some respects even stronger patent protection than under domestic USA law’ (Abbott et al., 2013).

Through FTAs, the USA secured TRIPS-Plus intellectual property standards in more than 20 countries, including Australia, Jordan, Morocco, South Korea, Chile, Singapore and Bahrain (Townsend et al., 2018). In December 2018, the USA signed the United States–Mexico–Canada Agreement (USMCA) that is a rebranded version of the 25-year-old North America Free Trade Agreement (NAFTA) (Kilic, 2018). The text of the USMCA or NAFTA 2.0 ‘incorporates almost all [the] pro-monopoly pharma-friendly patent-related provisions’ (Kilic, 2018). As noted by Jerome Reichman, ‘[h]igh-protectionist vision of intellectual property law has become a kind of latter-day religion promoted by the special interests that have long dominated the political scene in the United States’ (Reichman, 2009).

Following the footsteps of the USA, EU and Japan also started negotiating wide-ranging WTO-Plus measures in their FTAs (Antons & Hilty, 2015; Löfgren, 2017). In 2005, the European Commission established a link between intellectual property enforcement and economic development and proposed a strategy of adopting stronger and stricter intellectual property protection and enforcement measures that exceed the minimum TRIPS standards. The negotiating texts of the EU–India FTA’s intellectual property chapter, leaked in 2009, 2010 and 2011, suggested that the EU was following the strategy of demanding ambitious TRIPS-Plus intellectual property standards (Löfgren, 2017).

Likewise, Japan has contributed significantly towards promoting the adoption of expanded intellectual property standards (Townsend et al., 2018). In Japan, Nippon Keidanren (Japan’s Business Federation) presses the government to negotiate TRIPS-Plus measures through FTAs (Ono, 2015). Japan negotiated FTAs with several countries including Singapore, Mexico, Malaysia, Philippines, Thailand, Indonesia, Chile, Brunei Darussalam, Vietnam, India, Australia, Switzerland and Peru (Ono, 2015). Many of the FTAs negotiated by Japan include an independent intellectual property chapter incorporating TRIPS-Plus provisions (Ono, 2015).

Shift from Bilateralism to Plurilateralism

In the next phase, the focus of WTO-Plus activities shifted from bilateralism to plurilateralism. In October 2011, a US-led group of can-do allies, comprising of Australia, Japan, Canada, Singapore, South Korea, New Zealand and Morocco, signed the Anti-Counterfeiting Trade Agreement (ACTA). In 2012, the EU and Mexico also signed this agreement. ACTA, which is not a trade agreement but an intellectual property agreement, focused purely on further protecting the corporate interests with ‘unprecedented protection’ while overlooking the importance of access to knowledge, access to generic medicines and technology transfer for socio-economic development of member states (Legge et al., 2014). After rejection by the European Parliament in July 2012, in the wake of civil society mobilisation at a global level, the future of ACTA looked uncertain. To come into force, ACTA requires ratification by at least six countries. So far, only Japan has ratified the agreement (Townsend et al., 2018). ACTA is not the only example of a plurilateral agreement that includes TRIPS-Plus provisions.

In March 2010, the US-led negotiations commenced for Trans-Pacific Partnership (TPP) agreement, a much broader and unprecedented trade deal (Gleeson et al., 2018). Initially, eight Pacific Rim countries (the USA, Australia, New Zealand, Singapore, Brunei Darussalam, Vietnam, Peru and Chile) took part in negotiations (Townsend et al., 2018). Malaysia joined by the end of 2010, Canada and Mexico joined in 2012 and Japan was the last country to join negotiations in May 2013 (Townsend et al., 2018). In October 2015, these twelve Pacific Rim countries concluded the TPP agreement that included substantial TRIPS-Plus provisions (Townsend et al., 2016). These provisions were designed to ‘lengthen, broaden, and strengthen patent-related monopolies on medicine and erect new monopoly protections on regulatory data as well’ (Baker, 2016). The twelve member countries signed the TPP in February 2016. Japan and New Zealand went one step ahead and also ratified the TPP. Ratification by at least six of the original twelve negotiating countries, including the USA, was required for the TPP to come into force (Gleeson et al., 2018).

In January 2017, the USA, the prime mover of the TPP negotiations, decided to withdraw from the TPP (The White House, 2017). During the election campaign, Donald Trump had loudly and clearly opposed the TPP (Yu, 2017). He followed through and officially withdrew from the TPP by signing a memorandum (The White House, 2017). The memorandum signed by Donald Trump stated that ‘it is the intention of [his new] Administration to deal directly with individual countries on a one-on-one (or bilateral) basis in negotiating future trade deals’ (The White House, 2017). The concerns about ratcheting up of intellectual property standards are not assuaged by the withdrawal of the USA from TPP. The USA may rejoin the TPP in the future (McBride et al., 2021). More importantly, the USA and other champions of enhanced intellectual property rights, like EU and Japan, may apply the same intellectual property chapter template for their future bilateral and plurilateral trade negotiations.

After the withdrawal of the USA, the future of TPP looked uncertain until negotiations resumed at Hanoi, Vietnam, in May 2017, between the remaining eleven TPP partners under Japan’s leadership (Pusceddu, 2018). A new agreement called the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) was concluded in Tokyo, Japan, on 23 January 2018 (Yu, 2020). Its text was announced in February 2018, and it was signed in March 2018 (Pusceddu, 2018). Some of the controversial provisions of the TPP, like data exclusivity provisions and patent term extensions, have been suspended in the transition from the TPP to the CPTPP (Pusceddu, 2018; Townsend et al., 2018; Yu, 2020). The presence of such provisions in the intellectual property chapter is still a problem for weaker members of CPTPP because ‘the suspension itself is not definitive and may not ensure that said provisions will remain suspended in the future’ (Pusceddu, 2018).

The harmonisation demands of the Trilateral Patent Offices conflict with the Indian patent model. For instance, the expanded patentability criterion is a prominent feature of most of the FTAs negotiated by the USA. The USA allows patent protection for incremental changes or new forms of old drugs as there is no provision in the US patent laws to require increased or enhanced efficacy. The USA transmits this model through its FTAs. For instance, Korea–US FTA, under Article 18.8(1) provided patent protection for new uses of a known product (Hsu, 2016). Article QQ.E.1 of the May 2014 draft of TPP clearly allowed manipulative evergreening of drug patents:

A party may not deny a patent solely on the basis that the product did not result in enhanced efficacy of the known product when the applicant has set forth distinguishing features establishing that the invention is new, involves an inventive step, and is capable of industrial application. (Correa, 2017)

This provision, proposed by the USA and Australia, was opposed by other negotiating countries and could not become part of the subsequent drafts. The May (2015) draft of TPP included the following revised provision as Article 18(37)(2):

Each Party confirms that patents are available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product. A party may limit those new processes to those that do not claim the use of the product as such.

The expanded patentability criteria visibly conflict with Section 3(d), the Indian anti-evergreening provision. Under this provision, ‘India allows patents on new drugs but not new uses of old drugs or new forms of known drugs that do not increase therapeutic efficacy’ (Kapczynski, 2015). India’s Section 3(d) has been regularly cited by the US Trade Representative (USTR) for keeping India on the USTR Special 301 list (Correa, 2017). The US–India Business Council pushes for a withdrawal of Section 3(d) in India (Aginam, 2013). In December 2014, the report of an investigation on India, launched by the US International Trade Commission, one-sidedly reflected the stand of drug corporations and attacked India’s use of Section 3(d) (IANS English, 2015). Moreover, the hospitable thresholds for inventive step demanded by the USA and its allies conflict with the strict inventive step standards adopted by India under Section 2(ja). See, for instance, Trans-Pacific Partnership, ¹⁰ Chapter 18, Footnote 30.

Furthermore, the US precludes the adoption of pre-grant opposition procedures under many of its FTAs and plainly requires the opposition proceedings, if any, to be only post-grant. See, for instance, US–Singapore FTA, Article 16(7)(4); US Bahrain FTA, Article 14(8)(4); and US–Republic of South Korea FTA, Article 18(8)(4). While negotiating the TPP, initial proposals of the USA required parties to preclude pre-grant opposition procedures (Townsend et al., 2018). The USA historically resisted the adoption of pre-grant opposition procedures with a view that such procedures cause unnecessary delay in the issuance of patents (Ho, 2014). In the early 1990s, the USTR had issues with the Japanese pre-grant opposition procedures. In 1994, when Japan abolished its pre-grant opposition procedures, the USTR pressure was arguably one of the contributing factors (Tessensohn & Yamamoto, 2003). The USTR (2014) in its Special 301 Report criticised countries that provided pre-grant opposition procedures to challenge patent applications. The US model, promoted through FTAs, is, therefore, in clear conflict with the Indian model that makes the combined use of higher substantive threshold standards and pre-grant opposition procedures. The challenges for the Indian patent model are quite obvious as it clashes with the patent model pursued and promoted by some of the most powerful countries in the world.

So far, India has been keen in terms of safeguarding its patent model even in the TRIPS-Plus FTAs environment. While negotiating the India–Japan Comprehensive Economic Cooperation Agreement (India–Japan CEPA), India did not compromise its freedom to use public health safeguards (Löfgren, 2017). It was an achievement for India that the final signed version of the India–Japan CEPA did not include the TRIPS-Plus provisions that Japan originally demanded (Antons & Hilty, 2015; Löfgren, 2017). Similarly, in the case of negotiations for the EU–India Broad Based Trade and Investment Agreement, in 2012, the EU had to drop its initial proposal for patent term extensions. A press release of European Union Delegation to Thailand said: ‘The EU fully recognises India’s right to issue compulsory licensing for medicines and has no intention of weakening India’s capacity to manufacture and export medicines to other developing countries, including Thailand.’ Prior to this, a press release issued by the Indian Prime Minister Office (2011) had made it clear that ‘the Indian side shall not take any obligation beyond TRIPS/ Domestic Law’.

The Indian precedent of successfully resisting TRIPS-Plus demands of the EU and Japan offers hope for other developing countries. India maintained its leadership role, in terms of resisting unbalanced promotion of intellectual property standards, even in the most challenging era of bilateralism and plurilateralism. India, as a leader of the developing world, should play a pivotal role in terms of establishing and shaping a pro-development and pro-health negotiating agenda—that accommodates local conditions and puts public health at an overarching place—for bilateral and plurilateral trade and investment negotiations. As noted by Locknie Hsu (2016):

The regulatory space needs to be managed in a manner that ensures that public health is not viewed as a secondary matter to economic imperatives; this is a balancing act which policymakers increasingly have to grapple with in this new age of innovation-driven national progress in Asia.

Just preserving its model will not suffice for India to avert isolation in the global arena. India needs to be proactive in terms of transmitting its patent model to other like-minded countries with similar interests and domestic needs. India should not comply with greater harmonisation demands of high-income countries. Instead, India should adopt a networked approach to combat these economic and political pressures.

The RCEP and ASEAN: Prospects for the Indian Patent Model

The Regional Comprehensive Economic Partnership (RCEP)—negotiated between the Association of Southeast Asian Nations (ASEAN) ¹¹ and six bilateral dialogue partners of ASEAN ¹² —provided a viable opportunity for India to promote its patent model by pursuing a pro-development negotiating agenda. RCEP provided a favourable forum ‘to defend against political pressures from countries outside the region seeking to transpose externally developed patent norms ahead of a regional approach’ (Abbott et al., 2013).

The sixteen countries that took part in the RCEP negotiations, initiated in November 2012, include the 10 members of ASEAN (Singapore, Thailand, Philippines, Malaysia, Indonesia, Vietnam, Myanmar, Cambodia, Brunei Darussalam and Laos), the members of ASEAN-Plus Three (Japan, China and South Korea) and the 3 members of ASEAN Plus Six (Australia, New Zealand and India) (Antons & Hilty, 2015; Yu, 2017). It is important to note that RCEP parties ‘account for almost half of the world’s population’ (Yu, 2017) and seven of RCEP countries are also parties to CPTPP. RCEP negotiations truly portraited a battle of the models because of the strong presence of Japan and India. Japan, together with Australia and South Korea (Townsend et al., 2018, 2016), ambitiously promoted TRIPS-Plus provisions during RCEP negotiations (Gleeson et al., 2018). Japan’s and South Korea’s initial proposals, as suggested by a draft leaked in October 2014, demanded patent linkage, patent protection for new uses and new forms of known substances, patent term extension and data exclusivity (Townsend et al., 2018).

Other RCEP countries, especially India, resisted Japan’s TPP-style proposals (Townsend et al., 2016). India categorically opposed any provisions that exceed TRIPS standards (Townsend et al., 2018). India particularly opposed the inclusion of TRIPS-Plus provisions related to pharmaceutical patents (Sharma, 2019). Japan’s initial proposal for the protection of new uses for or new forms of known substances was in direct conflict with India’s anti-evergreening provision Section 3(d) (Yu, 2020). Because of India’s strong resistance, the RCEP’s intellectual property chapter, leaked in February 2015, neither included patent linkage provisions nor provided patent protection for new uses and new forms of known substances (Townsend et al., 2018). Japan and Korea proposed the patent term extension ‘for a period of time during which a patented invention cannot be worked due to marketing or regulatory approval process’ (Sharma, 2019). Japan and Korea also proposed a data exclusivity regime for five years. This proposal aimed at preventing generic pharmaceutical producers from relying upon clinical trial data (Sharma, 2019). Japan’s proposals for the patent term extension and data exclusivity were also opposed by India and other RCEP countries. These proposals, however, remained bracketed in the text of the leaked chapter (Townsend et al., 2018).

After eight years of negotiations, China and 14 other Asia-Pacific countries signed the RCEP in November 2020 (Kurlantzick, 2020). The new tariff regime under the RCEP kicked in from 2022 (Bhattacharya, 2020). India was part of RCEP negotiations from the start and actively participated in the 7th RCEP Intersessional Ministerial Meeting in November 2018 (Sharma, 2019). India surprisingly pulled out in November 2019 when the negotiations reached the final stages (Bhattacharya, 2020). India was keen to be a part of RCEP and maintained a positive outlook because of its business interests in Southeast Asia (Sharma, 2019). The negotiations, however, failed to address India’s concerns about potential influx of imports from China, resulting in pressure on many Indian industries (Bhattacharya, 2020). China’s dominance prevented India from steering the wheel in its direction in the norm-setting process. The RCEP is arguably a China-backed trade agreement.

Both China and India held key positions in the RCEP negotiations. Power struggle between China and India could be anticipated. The two regional powers have ongoing territorial disputes (Han & Sun, 2020). In the recent past, India’s diplomatic relations with China were disturbed because of military clashes. As noted by an Indian analyst, ‘Indian-Chinese relations are complicated by layers of rivalry, mistrust and occasional cooperation, not to mention actual geographical disputes’ (Han & Sun, 2020). The door is open for India’s potential return to the RCEP but ‘clashes in the Himalayas since then make signing a deal that involves China even harder’ (Lee, 2020). It is unfortunate because the balance of regional powers is negatively impacted as a result of India’s absence from the RCEP.

India can still promote its patent model even after opting out of the RCEP. ASEAN is India’s fourth largest trading partner and having positive relations with ASEAN is a key pillar of India’s foreign policy (Bhattacharya, 2020). India needs to identify like-minded ASEAN countries and garner their support. This networked approach will strengthen India’s position in the global arena. There are bright prospects for India because most of the ASEAN countries, despite different levels of development and industry, are facing similar challenges in terms of access to medicines. TRIPS-Plus measures must be a cause of concern for these countries as they would create additional costs and further restrict access to health technologies. Less-resourceful ASEAN countries are cognizant of the practical consequences of enhanced intellectual property protection. Thailand, for instance, has been a prominent opponent of TRIPS-Plus standards in FTAs (Townsend et al., 2016).

According to the Bali Concord III, one of the key resolves of ASEAN countries is to ‘[e]nsure access to adequate and affordable healthcare, medical services, as well as accessibility to safe, non-counterfeit, affordable, and effective medication’. Some of the ASEAN countries, such as Indonesia, Philippines and Laos, articulated national-level policies for generic substitution (Hsu, 2016). The Philippines replicated India’s anti-evergreening provision, Section 3(d), in its national legislation, Universally Accessible Cheaper and Quality Medicines Act ¹³ to prevent weak secondary patenting in the pharma sector. The Philippines also abolished its patent linkage system as another pro-access measure (Townsend et al., 2018). There are bright prospects for India if it engages in meaningful networking with ASEAN countries. As noted by Peter Yu, ‘ASEAN includes a few middle-income countries that have strong potential to shape Asian intellectual property developments’ (Yu, 2020).

Several ASEAN countries are taking pro-health measures at national levels with no established policy to deal with the issue of access to medicines at the regional level. India can play a leadership role in terms of devising a clear and coordinated regional approach in this important but underdeveloped policy area. There is a crucial need to set intellectual property norms that are tailored to specific needs, interests and priorities of the region. India should gather support for a pro-health intellectual property system and a generic substitution policy that is informed by India’s well thought out patent model. This engagement would also comply with India’s ‘Act East Policy’ (Chaisse et al., 2017) introduced by PM Modi in 2014. ¹⁴

Conclusion

India’s distinctive patent model, being an opposing model, faces serious challenges in the TRIPS-Plus environment where big players, such as the United States, the EU and Japan, are promoting their competing models through FTAs and RTAs. The expanded patentability criteria, almost always demanded by the USA in its FTAs, visibly conflict with the Indian anti-evergreening provision Section 3(d). India’s Section 3(d) has been regularly cited by the USTR for keeping India on the USTR Special 301 list (Correa, 2017). Moreover, the hospitable thresholds for inventive step demanded by the USA and its allies conflict with the strict inventive step standards adopted by India. More importantly, the USA precludes the adoption of pre-grant opposition procedures under many of its FTAs and plainly requires the opposition proceedings, if any, to be only post-grant. See, for instance, US–Singapore FTA, Article 16(7)(4); US Bahrain FTA, Article 14(8)(4); and US–Republic of South Korea FTA, Article 18(8)(4). India needs to be vigilant in not only defending but also promoting its patent model in order to combat harmonisation pressures.

India needs to be proactive in terms of regional coalition building and transmitting its patent model to other like-minded countries with similar interests. India’s TRIPS-compliant patent model is transferrable to other WTO Member States. Even if a country does not have indigenous technological capability, it may use higher threshold standards in combination with procedural safeguard of patent opposition to ward off unwarranted patents and to combat manipulative evergreening of drug patents. ASEAN provides a viable opportunity for India to promote this model by networking with like-minded ASEAN countries to pursue a pro-development agenda. To counter harmonisation pressures, India should garner support of developing countries facing similar public health problems. This networked approach will strengthen India’s position. It is critical for India to be politically supported by other developing countries in order to uphold and safeguard its patent model which has been a target of serious criticism from high-income countries and brand-name pharmaceutical corporations.