SouthNews No. 435, 20 January 2023

Second Global Forum on Intellectual Property, Access to Medicines and Innovation Report

By Vitor Ido

On 22-23 September 2022, the South Centre convened its Second Global Forum on Intellectual Property, Access to Medicines and Innovation at the Centre International de Conférences Genève (CICG), Geneva, open to online participation. Attendees included capital-based policymakers from Ministries of Health, Foreign Affairs, Competition and intellectual property offices, representatives of permanent missions in Geneva, academics and judges based in Africa, Latin America, Asia, Australia and Europe. The Forum allowed for in depth discussions on how to implement the flexibilities allowed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’) to promote public health, in follow up to the first Global Forum organized in 2019 in Munich, Germany (see the online open access book from Springer published as an outcome of this event available here).

Amid the persistence of the COVID-19 pandemic, the stark unequal access to health technologies in the Global South, and emerging areas such as patenting strategies for biological products, use of competition law to ensure access to medicines, transfer of know-how to expand manufacturing capacity, the 2nd Global Forum aimed at fostering informed discussions and seeking ways forward to some of the policy and regulatory challenges faced by developing countries.

The South Centre provides technical assistance to developing countries’ officials, based in capitals, Geneva and New York, to make full use of TRIPS flexibilities. This assistance includes support to multilateral negotiations, assessment of national legislations and administrative procedures (such as those for government use, compulsory licensing and use of competition law), trainings on patent examination of pharmaceuticals, among others. [1]

Some of the main takeaways of the Forum are the following:

  • The COVID-19 pandemic response was highly deficient, as evidenced by the inequity in global access to vaccines and treatments. The tough negotiations of the so-called ‘TRIPS waiver’ at the World Trade Organization (WTO) concluded with a limited outcome that does little to address the problem of access to the needed technologies and products. There have been missed opportunities during the COVID-19 pandemic to make broader use of the existing TRIPS flexibilities to advance access to medical technologies. These include compulsory licenses, parallel importation and the security exception under Article 73 of the TRIPS Agreement. Deep reforms may be needed in the future to ensure access to technologies including revisiting incentives for innovation based on significant public investment. The negotiations of a pandemic instrument at the World Health Organization (WHO) offers an opportunity in this respect.

  • Voluntary licenses depend on the willingness of pharmaceutical companies and are therefore insufficient to address public health needs, requiring a better enablement of compulsory licensing and government use licenses. Licensing models to facilitate access (i.e., the Medicines Patent Pool – MPP) and non-profit research and development (R&D) partnership models (i.e., the Drugs for Neglected Diseases Initiative – DNDi) should be promoted and further extended.

  • Parallel imports are an important but underused tool; their implementation depends on legal doctrines adopted by each country in accordance with their policy space. Such imports should be admitted when the products were put on the market of the exporting country under a compulsory license, and not only by the right owner or his licensee.

  • Greater transparency with respect to pricing, contractual terms and conditions, and patent status of pharmaceutical products is a growing global demand and a mechanism for improving accountability, including via litigation (e.g., for the disclosure of terms and conditions of supply contracts).

  • Compulsory licensing mechanisms need to be streamlined, including a facilitated procedure with a broad range of grounds for issuance, the potential inclusion of trade secrets, know-how and patent applications as part of their scope, and clarification on the role of different governmental agencies involved.

  • Competition law has become an increasingly relevant area of action, with a growing number of cases and investigations around the world (both in developed and developing countries) in the area of pharmaceuticals, and with potential of expansion, requiring further analysis and cooperation.

  • Products of biological origin, such as monoclonal antibodies, and those produced with new technologies such as CRISPR and CAR-T, are among the most expensive and least affordable in the Global South. In such a context, the examination of patent applications on such products are an increasingly important area for countries to craft appropriate policies under their ample policy space to define patentability criteria to prevent frivolous applications from receiving patent protection; this requires further cooperation and sharing of expertise.

  • Free trade agreements (FTAs) should not hamper the use of the TRIPS flexibilities, but rather promote it – which may require a different conceptualization of such agreements. Concrete implementation of such flexibilities may provide useful examples for ongoing and future negotiations; the Intellectual Property (IP) Protocol to the African Continental Free Trade Agreement (AfCFTA) has the potential to become a landmark development in this regard.

  • The judiciary plays a pivotal role in defining the contours of IP protection despite the differences in legal traditions, institutional frameworks (such as the existence of specialized courts), and national laws. There are important precedents in the Global South, such as in India, Brazil, Kenya and South Africa, whose experience should be shared more widely.

  • South-South cooperation is a key tool to achieve the broader policy goals of equitable and affordable access to health technologies, and the role of the South Centre is crucial in that regard.

Below is a short summary of the Global Forum sessions:

Plenary Session I – Opening Remarks

Prof. Carlos M. Correa, Executive Director of the South Centre, delivered the welcome address of the conference and made a presentation on ‘TRIPS Flexibilities for Public Health and Scope of Implementation’. He started by describing the complex linkage between IP and public health. As an outcome of the first Global Forum organized in 2019 by the South Centre, an open access and freely accessible book was published on the implementation of TRIPS flexibilities.[2] Prof. Correa highlighted that the objectives of the forum were to identify tendencies in these themes, the role of private and public actors, including civil society, and provide concrete policy recommendations. This is aligned with the South Centre’s mandate as an intergovernmental organization providing policy orientation to developing countries, he added.

Prof. Correa then provided an overview of the context in which the forum is situated: the COVID-19 pandemic put in evidence that IP can generate significant obstacles for access to medicines and vaccines. The proposal for a TRIPS waiver originally tabled by India and South Africa, subsequently supported by over 60 co-sponsors, sought to address the huge inequality in access to COVID-19 related products and technologies, despite declarations of solidarity and cooperation by developed countries. In this sense, developing countries cannot depend on voluntary solutions and need to use legal means consistently with international law. These include the use of the exception of national security under Art. 73 of TRIPS to suspend its obligations, the use of compulsory licenses (CLs) and government use, the adoption of rigorous patentability criteria to examine pharmaceutical patent applications (thus avoiding evergreening, the practices by companies to extend their monopolies and preventing generic competition), the use of Art. 30 of the TRIPS Agreement to allow for manufacturing of medicines for exports to other countries, and waivers such as the proposal tabled at the World Trade Organization by India and South Africa. In the current context, there is also an important discussion at the WHO on a potential ‘pandemic treaty’, which cannot and should not ignore the impact of IP on access to medicines and vaccines.

In addition, he said governments should give more attention to IP policies and integrate them into the broader spectrum of national policies, including public health and development. In practice, studies show that many countries are not sufficiently making use of TRIPS flexibilities. During the COVID-19 pandemic, for example, few countries took measures such as compulsory licensing, and many countries need to revise laws and policies to integrate and use such flexibilities. This policy space needs to be used and the South Centre has contributed for the past 25 years with technical assistance, trainings and publications in that regard. He concluded by recalling the Forum’s objective of providing concrete recommendations for the use of such flexibilities, and to ensure a genuine balance between IP, public health and innovation.

This was followed by ambassadorial addresses by H. E. Brajendra Navnit, Ambassador and Permanent Representative of India to the WTO, and H. E. Khalil Hasmi, Ambassador, Permanent Mission of Pakistan to the United Nations and Other International Organizations in Geneva.

The Ambassadors delineated the impact of the COVID-19 pandemic to the global economy. The necessity for a multilateral system designed to provide equal rights to everyone was highlighted, and contrasted with the difficulties posed to countries to make effective use of TRIPS flexibilities. The multilateral system should recognize that developed countries have obligations related to transfer of technology and that the IP system should be aligned with public policy goals such as public health. Noting the role of the South Centre in promoting those objectives and the contributions that the Centre has made in this area, both ambassadorial speeches made reference to their respective experiences and on how to make the multilateral system work better for all.

A video of South Centre’s Activities to Support Implementation of TRIPS Flexibilities for Public Health was presented to the participants, also available via the following link: https://www.youtube.com/watch?v=kPzydtyG26k.

Plenary Session II - Health Innovation and Access

Dr. Mariangela Simão, Assistant Director-General, Access to Medicines and Health Products, World Health Organization, delivered a special address on the intersection between health innovation and access. She provided data on the concrete impact of the pandemic to global health, as well as the indirect consequences in disease burdens other than COVID-19, the limitations to access and vaccination across the Global South, among others. The pandemic, in this sense, reinforced and deepened existing problems and inequalities. The longstanding issue of unaffordability and lack of access to treatments and new therapies is no longer a matter which concerns exclusively developing countries, she added: upper-income countries now also struggle with increasingly unaffordable medical technologies such as cancer drugs. In this context, a key element of the global health debate is demands for increased transparency, which is elucidated by the groundbreaking 2019 World Health Assembly (WHA) resolution on transparency on prices in the pharmaceutical sector, spearheaded by Italy. This resolution can contribute to improve transparency with respect to pricing, but the issue of the costs of R&D remained outside the resolution. Dr. Simão also described the very high burden on household income due to healthcare expenditures, medicines being a significant element of out-of-pocket spending and leading millions to poverty during the pandemic. This takes place in a context of changes in the disease burden, as non-communicable diseases (NCDs) continue to increase and have become the major cause of deaths globally, including in low and middle-income countries. She also referred to the ongoing discussions on outbreak response and pandemic preparedness, in which inequality continues to be a key feature. The unequal access to COVID-19 vaccines around the world, especially in low-income countries, has led to up to 600.000 deaths which could have been averted, according to a June 2022 report published by The Lancet. For this reason, technology transfer, manufacturing capacity and health-driven R&D are core issues for future pandemic preparedness and response, she concluded. She also referred to areas where the WHO continues to work with a crucial role, including its Essential Medicines List, its prequalification of medicines program, and efforts to broader access to generic and biosimilar medicines.

Plenary Session III - The 2022 WTO TRIPS Decision: Implementation and Extension

Prof. Carlos Correa discussed in detail the implementation of the TRIPS Decision of the 12th WTO Ministerial Conference for COVID-19 vaccines. This Decision provided a limited solution to developing countries in their efforts to ensure broader access to COVID-19 vaccines, but could still be utilized. He described the scope and purpose of the authorizations mentioned in the Decision, the fact that no prior negotiation for the issuance of a compulsory license or government use would be needed, among other aspects. He discussed the implications of other international commitments such as those ingrained in FTAs and international investment agreements, and the respective defenses that countries may formulate to implement the waiver adopted under the Decision. He equally discussed the conditions and the possibility for re-exportation of vaccines under the Decision, which could facilitate access on a global scale, especially for countries without manufacturing capacity.[3]

Prof. Susan K. Sell, Australian National University, (virtually) discussed the implications of the TRIPS Decision for Future Pandemics. She provided a historical overview and the political economy of the TRIPS Agreement, situating the current discussion within the broader geopolitical scenario of the 21st century capitalism, which includes a neoliberal approach to the pharmaceutical sector, and a growing power of pharmaceutical companies. Market concentration, the blockade of initiatives that would go against shareholder value and profits, tax evasion, short-term orientation of policies and increased financialization, are elements of this broader context, directly impacting the functioning of innovation and health policies. COVID-19 brought issues of vaccine nationalism and philanthro-capitalism, but also an opportunity to rethink the current system, as even wealthy countries recognized the tension between IP and access, and made use of measures such as compulsory licensing (for example, in Israel). In addition, competition law and public health law were deployed (e.g., by the European Commission and France, respectively). She concluded by mentioning some potential lessons learned from the pandemic, including the acknowledgement of the big role of governments in the R&D of COVID-19 vaccines, as well as the pitfalls in the current model of production, distribution and delivery. The experiences from the TRIPS waiver negotiation, the recognition of social safety as a legitimate public responsibility, and how these will be translated into future norms (such as the WHO ongoing discussions on a potential pandemic preparedness and response instrument) are issues on the table.

Mr. Marumo Nkomo, Counsellor, South African Permanent Mission to the WTO, provided an overview of the ongoing negotiations for extension of the TRIPS Decision to therapeutics and diagnostics. He highlighted the importance and necessity of extending the Decision to technologies beyond vaccines so that it covers therapeutics and diagnostics, and made a call for developing countries to align their positions to ensure a successful outcome, even despite the continued reluctance and obstacles posed by developed countries.

Plenary Session IV - Panel Discussion on Licensing and Transparency

This panel focused on transparency mechanisms, licensing approaches and implications for procurement and local production, moderated by Prof. Suerie Moon, from the Graduate Institute, Geneva. The session debated a variety of approaches and concrete experiences with respect to licensing, noting their interconnectedness and complementarity, while also noting the need to identify the limits of voluntary licenses and the space for the concrete use of compulsory licensing. Prof. Moon initiated the discussions by describing the rise of the issue of transparency in global health, describing in particular the WHA 2019 Transparency Resolution which endorsed increased transparency on medicines net prices, and greater transparency on pharmaceutical patents, clinical trial results and other determinants of pricing along the value chain from laboratory to patient. Since then, the issue continued to be addressed in the context of national policies, such as in Italy and France. She also made reference to the concept of what would constitute a ‘fair’ pricing for medicines, and concluded by making reference to the need for more transparency, understood as a global public good, towards public policies and to promote cooperation between governments.

Ms. Pascale Boulet, from Drugs for Neglected Diseases Initiative – DNDi, presented the organization’s unique R&D model which is not based on the conventional IP incentive. Equitable access and affordability are key principles, making the results of the research available to the wider research community and under terms and conditions to ensure that DNDi partners cannot use IP to impede access to DNDi products or follow-on research. This enabled DNDi to successfully develop and deliver 12 novel treatments for neglected diseases which particularly affect developing and least developed countries. In addition, multiple other treatments are in clinical trials and with a broad range of R&D partnership with various organizations around the world. Mrs. Boulet also described specificities of the DNDi model of licensing, including those pertaining to pre-existing IP owned by partners (such as patents, confidential know-how, as well as data) via non-exclusive and sub-licensable rights to DNDi.

Ms. Nataliya Omelchuk, from Medicines Patent Pool – MPP, provided an overview of the organization’s goals and activities, based on non-exclusive, voluntary and transparent licenses with pharmaceutical firms to facilitate early entry of generic manufacturers in low and middle-income countries. MPP, founded in 2010, originally addressed HIV/AIDS, but its mandate has been progressively expanded to include Hepatitis C, Tuberculosis, patented essential medicines and COVID-19. This has enabled wide access to medical technologies and is an alternative to the low bargaining power which individual entities (such as Ministries of Health of developing countries) may have. Ms. Omelchuk provided two case studies: Dolutegravir (DTG), an antiretroviral drug, and patented COVID-19 treatments (Molnupiravir and Nirmatrelvir).

Ms. Erika Dueñas, World Health Organization (WHO), made an overview of the WHO’s activities in the area of intellectual property, technology transfer and R&D, including the COVID-19 Technology Access Pool (C-TAP) initiative launched during the COVID-19 pandemic, which is a voluntary pooling mechanism designed to share technologies to combat the pandemic, and the so-called mRNA hub in South Africa. She referred to the governance of this model and the successful endeavors of the organization towards broader access to medicines, including the technical assistance provided to Member States.

Finally, Prof. Sudip Chaudhuri, from the Centre for Development Studies, Thiruvananthapuram, India, noted that while certainly important, voluntary licenses have the pivotal limitation of depending on the willingness of pharmaceutical companies. As such, there is a continued need for the adequate and facilitated use of compulsory licenses to achieve broader access to medicines, which depends also on rapid and appropriate mechanisms for their use, as well as safeguarding national interests from foreign political and economic pressures exerted by developed countries.

Expert Breakout Sessions on Compulsory Licensing and Government Use

In parallel from the plenary sessions, the Global Forum convened two expert breakout sessions for in-depth discussions on compulsory licensing and government use, bringing together different perspectives from various regions/countries. The sessions focused on hurdles for the utilization of such mechanisms and discussed concrete suggestions for its improvement, taking into account the specificities of local contexts.

The first breakout session dealt with Facilitating Use of Compulsory Licenses and the Role of Relevant Authorities, with comments by Dr. Yuanqiong Hu (Médécins sans Frontières - MSF), Prof. Dr. Muhammad Zaheer Abbas (Queensland University of Technology), Ms. Erika Dueñas (WHO), and Dr. Viviana Muñoz (South Centre). The following issues were highlighted as main gaps during these discussions: lack of political will (both on importing and exporting country), lack of technical knowledge across government ministries and agencies, structural failure of the Paragraph 6 / Article 31bis of TRIPS system (which was used only once – Rwanda-Canada – and attempted, without success, by Bolivia and Canadian generic pharmaceutical firm Byolise for the importation of COVID-19 vaccines), lack of transparency and uncertainty of procedures (e.g., Canada’s Access to Medicines Regime (CAMR)). In terms of the ways forward to improve the use of compulsory licenses/government use, the expert group discussed: ensuring a national pathway as part of a public health policy strategy, improving legislation (administrative procedures, separation of compulsory licensing from government use licenses, simplification of process and scope), facilitating their implementation (i.e., identification of target product, no requirement of prior unsuccessful negotiation or voluntary licensing, identification of sources to manufacture/import and registration of the product, collaboration between national agencies and ministries, support and technical assistance from organizations such as South Centre and WHO, trainings to different authorities on the TRIPS flexibilities to withstand the pressure against use of CLs), including a clear designation of the role of authorities (e.g., patent office: provide patent information; Ministry of Trade: when overseeing patent office, on trade risk; Ministry of Health: identify target products, identify need for government use; regulatory agency; highest level – Presidency or Prime Minister; judicial authorities, if there is judicial review, to adopt a supportive view with respect to the IP and public health link). In addition, the group discussed how a robust application of patentability criteria reduces the need for such measures, as well as the need for broader reforms of the TRIPS Agreement and to stand up to the pressure against the use of CLs, such as that exerted by pharmaceutical companies and the United States Trade Representative (USTR) Section 301 Report, working in cooperation with patient groups and organizations to that aim.

The second breakout session focused on Scope of Authorizations, with Dr. Bruno Braz de Castro (Independent Consultant), Prof. Olga Gurgula (Brunel University), and Dr. Vitor Ido (South Centre) as commentators. It aimed at exploring what are the current pitfalls with respect to what is currently included in the scope of compulsory licenses and government uses. In this regard, the group discussed the inclusion of trade secrets as part of a compulsory license (i.e., not only the patents but also additional undisclosed information such as know-how for manufacturing capacity of vaccines), the possibility of issuing compulsory licenses for patent applications, and the ways to identify anti-competitive conducts for the issuance of compulsory licenses by antitrust authorities. While in some cases and countries new legislation would need to be enacted, in others a novel interpretation of existing rules would suffice. Experiences such as that of Brazil and Ukraine were discussed. Brazil’s recent compulsory licensing regime for emergencies (2021) included patent applications and contains obligations to ensure additional information is provided for the manufacturing of a product subject to such a license. Under competition law, doctrinal interpretations matter substantially: oftentimes, the use of compulsory licenses as remedies for anti-competitive conducts are rendered impossible due to the adoption of doctrines which do not recognize various abuses. Institutional diversity (the fact that countries have different priorities and capacities), the need for more cooperation and sharing of information between distinct stakeholders (policymakers, judiciary, competition authorities, IP offices, Ministries of Health and Trade) were also pointed out as key elements to understand and explore the viability of such options.

Plenary Session V - Implementation of TRIPS Flexibilities for Parallel Importation of Medicines

Mr. Nirmalya Syam, Senior Programme Officer, South Centre, made a presentation on how to implement and expand the use of parallel imports of medicines to promote access (i.e., the importation into a country without the authorization of the right holder after the first lawful release of the patented medicine in a foreign market by the right holder). After describing the legal basis for such mechanism, based on the concept of exhaustion of rights, he described the importance of such flexibility in particular to countries without manufacturing capacity who therefore depend on imports of medicines for their supply. Since countries have under TRIPS the discretion to define their exhaustion regime(s), he explained the different possible approaches to parallel imports, based on national/regional/international exhaustion regimes. Some countries have broad international exhaustion regimes, while others have mixed regimes which are national but considering international exhaustion for pharmaceuticals (thus facilitating competition and access to patented medical technologies). Mr. Syam highlighted the main barriers to parallel imports, including labelling and packaging regulations, contractual export restrictions, free trade agreements’ restrictions on parallel imports (e.g. US-Morocco), and enforcement action (such as civil, criminal and border measures) which in practice restrain their use. He concluded the presentation with concrete measures to facilitate parallel importation, including: the applicability of an international exhaustion regime including for products put on the market by a compulsory licensee, access to full information about placing a product legitimately in a market, information about cost advantage of importation from some countries, a waiver of IP enforcement measures (e.g. on patents and trademarks) in an importing country (see, in that sense, Roma Drug v. GlaxoSmithKline, Supreme Court of the Philippines, 2009, which decriminalized parallel importation of drugs), not to apply injunctions in lawsuits (opting for other remedies instead), safeguarding parallel imports in FTA negotiations, and avoiding statutory and contractual restrictions.

Plenary Session VI - Panel Discussion on TRIPS Plus Provisions in FTAs and Investment Agreements

The subsequent panel dealt with the longstanding issue of how free trade agreements (FTAs) and international investment agreements (IIAs) may contain TRIPS-Plus provisions which establish IP protections beyond the standards set forth by the TRIPS Agreement. As such, they constrain the policy space of developing countries, expand patent and other IP protection, and reduce access to health technologies. Such clauses have been historically included in trade negotiations with developing countries by the developed countries, especially the US, the EU and Japan. In the case of IIAs, the inclusion of IP as a category of investment may give rise to disputes based on alleged indirect expropriation or other claimed investors’ rights– even in cases where lawful and legitimate TRIPS flexibilities have been utilized. In more recent times, some positive experiences have been reported, such as the lack of substantive TRIPS-Plus provisions in high-level agreements such as the EU-Mercosur FTA, despite the initial attempt to include those by the European Union. Defense arguments in investment agreements, including those based on recent WTO case law and the inclusion of waiver provisions based on public health, have also been a more positive trend.[4]

Prof. Amaka Vanni, University of Leeds, made a presentation on the current ongoing negotiations of the IP Protocol of the African Continental Free Trade Area – AfCFTA. She highlighted that a change in mindset is needed: Africa should adopt an overarching and active perspective so that the upcoming protocol not only integrates TRIPS flexibilities for public health but also promotes them, creating continental policy cohesion and enhancing the policy tools of African countries, such as cross-regional imports and exports of medicines. As of now, the continental development is deterred by fragmentation, limitations in manufacturing capacity of pharmaceuticals, and different policy goals across sub-regions. In addition, the Protocol should provide for capacity building activities including transfer of technology and the building of pharmaceutical value chains. She concluded by noting that prior negative experiences should not be replicated and Africa as a continent should instead take a leadership role and inaugurate a new, post-colonial and active role in international policy-making.

Prof. Lin Xiuquin, Xiamen University, (virtually) delved into the IP provisions in the Regional Comprehensive Economic Partnership (RCEP) and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), with a focus on the patent linkage regime. The CPTPP does contain TRIPS-Plus provisions, while the RCEP generally does not. In practice, however, countries signing RCEP had already committed to integrating CPTPP provisions. Prof. Lin mentioned the empirical evidence which notes a detrimental impact of patent linkage regimes on access to medicines in many countries. However, she also highlighted how the concrete implementation of such a regime can be supportive of more information regarding patent applications and regulatory regimes, and be less constraining to access to medicines. By providing examples of Chinese contemporary law and practice, she detailed how this can be the case.

Day 2 – 23 September 2022

The second day of the Global Forum, 23 September 2022, started with a summary of the breakout expert sessions from Day 1, by Prof. Dr. Muhammad Zaheer Abbas (Queensland University of Technology) and Prof. Olga Gurgula (Brunel University).

Plenary Session VII - TRIPS Flexibilities on Examination of Applications

The TRIPS Agreement does not define what ‘inventions’ are and provides therefore leeway for countries to define the patentability criteria (novelty, inventive step or non-obviousness, industrial applicability). As such, this is a paramount TRIPS flexibility which may ensure that only real innovations are granted patent protection. The issue of biological products in this regard has become increasingly important: products such as vaccines (including those of mRNA), monoclonal antibodies, and technologies such as CRISPR and CAR-T are all of biological origin. A major concern relates to the lack of access to biologicals due to high prices and shortage of manufacturing capacity. Patents, by providing exclusive rights, have a crucial impact in impeding wide access.

In this context, this session delved with the issue of patentability criteria as a key TRIPS flexibility, with a focus on the field of chemical and biological products and processes. Prof. Carlos M. Correa, Executive Director, South Centre, made an overview of the topic and provided examples of typical claims relating to pharmaceutical patents and examination approaches on biological products and processes. One example is the concept utilized for the notion of sufficiency of disclosure in patent applications and the doctrine of generic v. specific disclosure of the invention.

Ms. Srividya Ravi, Independent Consultant, provided a summary of the main findings of a workshop organized by the South Centre on 21 September 2022 with a number of IP offices on the examination on patent applications of biologicals. The following were the main findings of the workshop:

- There is wide recognition that there is a growing number of patent applications on biologicals;

- The vast majority of claims on biologicals in the participating offices relate to antibodies (including monoclonal antibodies);

- Divisional patents, patent applications with broad claims, insufficient disclosure, how to determine the inventive step, are common issues to be addressed;

- There is a need to get access to databases not available now to carry out appropriate searches:

- Some offices have developed specific guidelines and put in place teams to examine applications on biologicals, while others rely on prior internal practices – in both cases, constant update of the practices and trainings are required as the technology is evolving rapidly;

- There are differences in terms of the patentability standards applied in the countries participating in the workshop; some also apply exclusions from patentability (established in their national laws or developed through patent offices’ practices and guidelines) relating to certain biological claims.

For more information on this event, please refer to: https://us5.campaign-archive.com/?u=fa9cf38799136b5660f367ba6&id=2242fc1459

Plenary Session VIII - Panel Discussion on IP and Competition Law

The subsequent session addressed the area of competition law and policy as a TRIPS flexibility.

Dr. Ricardo Medeiros de Castro, Brazilian Competition Commission (CADE), Brazil, detailed and provided comments on the Eli Lilly case, considered a landmark case in Brazil on sham litigation intersecting with the abuse of intellectual property in the pharmaceutical sector.[5] He described the intertwined set of events which misled judicial authorities and the Brazilian IP office. In the case, the filing of multiple parallel proceedings with incorrect information, jointly with abusive conducts in the IP patent application procedure, ultimately led to the determination of sham litigation by the company to the detriment of consumers and access. Dr. Castro made comments on the impact of the decision and the necessity to continue investigating practices and the sharing of experiences transnationally.

Dr. Bruno Braz de Castro, Independent Consultant, Minas Gerais, Brazil, made a presentation on Excessive and Exploitative Pricing as Anti-Competitive Conducts. It was partly based on a recent South Centre research paper.[6] He described how case law in Brazil addressed excessive and exploitative pricing, and defended the need for different doctrines and perspectives to be adopted under competition law to adequately address anti-competitive conducts beyond the existing practices. One key issue is the intertwinement between price regulation and competition law: many have advocated for a certain ‘immunity’ from competition scrutiny due to the existence of price regulation, which is incorrect. He concluded by noting that since 2016, the framework for Brazilian price regulation for medicines explicitly includes the possibility of extraordinary negative price adjustment “according to the economic and competitive reality, preserving market balance and competitiveness” (CMED Resolution 02/2016). In light of this possibility, there is an increased need for competition advocacy in the context of price regulation, by CADE or other stakeholders and organizations. Proceedings concerning abuse of dominant position may include, as part of the remedies, the recommendation of extraordinary negative price adjustment by the Medicines Market Regulation Chamber (Câmara de Regulação do Mercado de Medicamentos - CMED).

Dr. Behrang Kianzad, University of Copenhagen, (virtually) focused on ‘Approaches to IP and Competition in the EU’. He made reference to the vast number of recent cases at the European Commission (EC) level (such as Aspen Pharma – Italy, Pfizer/Flynn – UK, CD Pharma – Denmark, Aspen – European Commission, and Leadiant – Netherlands), described the legal and policy approach adopted by the EC under competition law, and presented a critique of current practices to interpret it, particularly with respect to excessive pricing. By referring to the idea of complementarity between competition and IP, rather than conflict, he noted that both are part of a modern industrial policy – common aims but different means. In this context, possible clashes do exist, such as those related to refusal to deal, pay-for-delay agreements, excessive pricing, evergreening in patent applications, sham litigation, abuse of regulatory system, among others. He further developed the notion of excessive pricing via the United Brands case, noting that at least 93 cases have been reported between 1971-2021 in the EU Member States (EU Commission, General Court and the Court of Justice of the European Union). He concluded by noting the necessity to treat life-saving medicines differently given their unique function. By proposing a novel interpretation of the issue, he argued that there is no causal relationship between excessive mark-ups and investments in R&D as confirmed by a few empirical studies, which is even more the case in developing countries, and argued that this approach seems to have been adopted in more recent cases.

Ms. Judit Rius Sanjuan, United Nations Development Programme (UNDP), made a presentation on TRIPS flexibilities and competition law, with a focus on the work undertaken by UNDP in this area. She referred to how competition law and policy have become a tool used by both developed and developing countries. Investigations and sanctions in multiple cases, pharmaceutical sector inquiries, legislative and regulatory changes have all taken place. Oftentimes, investigations and requests for more transparency ensure positive outcomes in terms of access to health technologies even without a final sanction. Multiple actors are also now involved, including civil society organizations, regulatory agencies and various stakeholders. Anti-competitive practices have been identified across the whole value chain of pharmaceutical production and distribution and also in relation to both originator and generic companies. An increasing trend is the scrutiny of regulatory and IP abuses, but it remains a somehow ‘neglected’ TRIPS flexibility; more countries should make use of the diversity of tools enabled by competition law and policy. The UNDP has published a series of documents on competition law and policy, which provide an analysis and presents options for their utilization to improve access to medicines around the world.

Plenary Session IX - Panel Discussion on the Role of the Judiciary for Use of TRIPS Flexibilities

The last panel enabled a discussion between judges from different jurisdictions on the role of the judiciary in both promoting and sometimes limiting the use of TRIPS flexibilities. Judges define the contours of IP protection by interpreting laws in concrete cases, and given the growing number of litigation on IP and public health, such role has become more prominent than ever. Some landmark cases in certain jurisdictions in developing countries have sought to achieve a balance in different ways, deploying different arguments (such as the right to health, the balance between public and private interest in patent law, competition arguments, constitutional provisions, among others). This session discussed different experiences and also explored aspects related to the broader socio-economic contexts in which such decisions have been taken, such as the high disease burden and the availability of generic competition, as well as the institutional configuration of judicial branches (such as specialized or semi-specialized IP courts, the interaction with competition authorities, and the dialogue with key stakeholders).

Judge Brian Spilg, from South Africa, described the South African legal system and explored the potentiality of deploying competition, constitutional, and IP arguments in the adjudication of patent cases affecting public health. South Africa has had previous experiences in that regard, and its national legislation is explicit in mandating broader socio-economic and inclusion goals (including in competition and IP laws, and its Constitution). Judge Spilg elaborated on possible avenues for a legal interpretation which is coherent with different sub-fields of law having in view the socio-economic consequences of court decisions and their role in ensuring the enforcement of individual rights.

Justice Mumbi Ngugi, from Kenya, described the landmark Patricia Asero Ochieng case by the High Court of Kenya, which she delivered. Such case struck down parts of the then Kenyan Anticounterfeiting law, which conflated lawful generic medicines with counterfeits. As such, the law curbed access to essential medicines such as those for HIV/AIDS, in a country with a high disease burden and a major necessity with respect to access. The right to health and the requirement by the Kenyan Constitution of transforming society in a structural manner have been elements considered in the decision and provide the basis for further reflections on the role of the judiciary in public health.

Judge Marcia Nunes de Barros, from Brazil, described the successful experience of federal courts in the country in dealing with IP cases, supported by the necessary expertise to ensure a balance between public and private rights in addressing cases such as those on the validity of patents. She mentioned landmark cases decided by the Brazilian courts, including the Supreme Court ruling in May 2022 on the unconstitutionality of automatic patent term extensions. She also addressed the need for continued capacity-building, particularly in light of forum shopping attempts by litigators to bring cases to courts without the required expertise.

Closing Session

The event was closed by Dr. Carlos Correa, who thanked all the speakers, the participants, the South Centre staff, the CICG staff, and the interpreters, who allowed for the successful realization of the 2nd Global IP Forum.

[1] In order to receive support from the South Centre, please refer to the dedicated website: https://ipaccessmeds.southcentre.int/ and reach out to us via email to Dr. Viviana Muñoz-Tellez (munoz@southcentre.int).

[2] Carlos Correa & Reto Hilty (eds.), Access to Medicines and Vaccine: Implementing Flexibilities Under Intellectual Property Law (Springer, 2022). Available from https://link.springer.com/book/10.1007/978-3-030-83114-1.

[3] On the ways to implement the referred to Decision, see Carlos M. Correa and Nirmalya Syam, The WTO TRIPS Decision on COVID-19 Vaccines: What Is Needed To Implement It?, Research Paper, No. 169 (Geneva, South Centre, 2022). Available from https://www.southcentre.int/wp-content/uploads/2022/11/RP169_The-WTO-TRIPS-Decision-on-COVID-19-Vaccines_EN.pdf.

[4] See South Centre webinar: https://www.youtube.com/watch?v=4tLswcXpAxo

[5] For a summary of the case, please also refer to: Pablo Leurquin, “Competition Law and Intellectual Property: A Study Drawing from The Eli Lilly Case on ‘Sham Litigation’ in Brazil”, SouthViews No. 240, 1 September 2022 (South Centre). Available from https://www.southcentre.int/southviews-no-240-1-september-2022/.

[6] See: Bruno Braz de Castro, Brazilian Competition Law and Access to Health in Brazil: Exploitative Pricing in the Pharmaceutical Sector, Research Paper, No. 143 (Geneva, South Centre, 2022). Available from https://www.southcentre.int/research-paper-143-11-january-2022/.

Author: Vitor Ido is Programme Officer of the Health, Intellectual Property and Biodiversity Programme (HIPB) of the South Centre.

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