SouthNews: South Centre organized Exchange Among Asian Patent Authorities and Examiners on Patent Policies and Public Health

The South Centre organized an online regional course for patent offices’ authorities and examiners from Asian countries on 7-9 June 2022. The objective of the course was to deepen the knowledge of participants on the interpretation of claims in pharmaceutical patent applications in a manner that supports public health objectives. To this end, participants exchanged views of possible approaches and national experiences.

The virtual event was attended by senior officials and examiners from the patent offices of Bangladesh, India, Indonesia, Lao PDR, Malaysia, Myanmar, Pakistan, Sri Lanka, and Viet Nam. It had overall 70 participants attending.

Key takeaways from the course include:

While applying national laws, patent offices have an important policy space to promote access to medicines through appropriate patent examination practices. The role of the patent offices should be to serve the public interest and protect the society against the grant of unwarranted patents.
The patent offices can and should apply rigorous patentability criteria in a manner which is consistent with the respective applicable laws and public health, so as to avoid the misuse of the patent system.
Developing countries are not obliged to follow the practices and doctrines of developed countries’ patent offices but should rather use their policy space to devise their own standards and adopt robust patent examination practices. South-South cooperation can play an important role in that regard.
Patent policies should be aligned with other national policies such as health, industrial and technological policies.

The first day of the course was a high-level segment with the presence of patent authorities. Opening the course, Dr. Germán Velásquez, Special Adviser on Health, South Centre, presented the historical overview of access to medicines and intellectual property. He also briefed participants on the origins of the access to medicines movement and the impacts of intellectual property in relation to access to medicines. He also discussed developments at the World Health Organization.

Dr. Carlos Correa, Executive Director, South Centre, elaborated on the interface between intellectual property and public health, with a focus on the flexibilities of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). He highlighted how developed countries benefited from lax intellectual property rules and how after the enactment of the TRIPS Agreement, the policy space of developing countries has been substantially limited. He also made reference to TRIPS flexibilities available in the participant countries’ national patent laws.

Dr. Correa stressed that knowledge by its very nature is a public good and that medicines, in particular, should be treated more carefully in examining patent applications, keeping in mind their public health dimension. In this regard, patent offices should consider adopting practices or guidelines for examination of pharmaceutical patent applications that take into account such public health context. He referred in this context to the Guidelines for patent examination 2006 published by the WHO. The guidelines were intended to contribute to improving the transparency and efficacy of the patent system for pharmaceutical products, so that countries could pay more attention to patent examination procedures that avoid the negative effects on access to medicines of the grant of patents on developments that do not represent genuine innovations.

Dr. Viviana Munoz Tellez, Coordinator, Health, Intellectual Property and Biodiversity Programme, South Centre, provided an overview of the emerging patent landscape and access issues for COVID-19 products. She observed that donation strategies and voluntary licenses do not secure access to medicines, citing various examples. She stressed the need for rigorous examination of patent applications and for countries to make full use of TRIPS flexibilities.

Dr. Srividya Ravi examined the current patent landscape of COVID-19 vaccines and treatments, including monoclonal antibodies. She also underscored the need for transparency on prices of medicines by providing analysis of patents covering medicines in trials with examples to treat COVID-19. Nirmalya Syam, Senior Programme Officer of the South Centre, discussed the limitations of voluntary licences for therapeutics and experiences on compulsory licensing (CL) for COVID-19 products. He elaborated on the text of the TRIPS provisions and specifically on the grounds for issuing CLs as per Article 31 of the TRIPS Agreement. He also highlighted the government use authorization of antiretrovirals (ARVs) as an example of the use of such flexibilities in developing countries.

Subsequently, a panel discussion with patent office heads was held. It dealt with patent office practices, guidelines and tools for the application of TRIPS flexibilities in relation to pharmaceutical patents. Authorities from the patent offices of Indonesia, Malaysia and India reflected on the offices’ roles with respect to access to medicines with a focus on the following issues:

On the role of patent offices in access to medicines, Indonesia noted that they have government use regulations and provide guidance to applicants to comply with the patent rules with respect to pharmaceutical patents. Malaysia stressed that recent amendments in the patent laws have introduced some significant improvements such as removing the three-year waiting period to apply for a compulsory license, as well as the introduction of compulsory licenses for pharmaceutical products for exportations as laid down in Article 31 bis of the TRIPS Agreement. It also noted its cooperation with the Ministry of Health. India suggested having a ‘green channel’ approach to facilitate speedy compulsory license issuance to address the public health challenges. It stressed the importance of South-South cooperation to come up with a workable mechanism to face the pandemic situation.
On tools of robust examination standards/guidelines for pharmaceutical patents, India mentioned that its patent office has the mechanisms to make use of TRIPS flexibilities, and transparent laws which ensure that a patent application refers to a genuine innovation. Malaysia noted that the patent office has a substantive examination process and a system for third-party observations after the 18 months of publication of the patent, under which the general public can look into the publication document and give inputs for the examination. It also mentioned their guidelines for compulsory licenses. Indonesia commented that the TRIPS flexibilities are available to be utilized. The patent office has certain guidelines and ministry regulations with regard to pharmaceutical patents.
On the relationship between the patent office and the health ministry and other health agencies and on the role of South-South cooperation in promoting public health, Indonesia noted that while the patent office and the Ministry of Health function independently, dialogue between the two is necessary and important. As such, in situations of issuing CLs or government use, the Ministry of Health supplies reasons for their issuance. India stressed that the Indian patent office has a quasi-judicial function and is independent to decide over patentability criteria, but that other agencies do activities as to support public health issues. Malaysia noted that it also has a similar approach of functioning independently, however, the Health Ministry and the patent office come together to discuss and share useful information regarding the promotion of public health.

Dr. Carlos Correa summed up the roundtable discussion by highlighting India’s example of robust examination laws under section 3(d) in the 2005 amendment of its Patent Act. This also inspired countries like the Philippines, Ecuador and Indonesia to amend their laws to include such robust provisions, he noted. This inspiration, according to Dr. Correa, is a good example of South-South cooperation. He also mentioned that more countries should have patentability guidelines that ensure robust examination.

On the second day, Dr. Carlos Correa made a presentation on patentability criteria for pharmaceuticals. He addressed typical claims relating to pharmaceutical inventions: formulations, combinations, dosage/dose, salts, second medical uses, enantiomers, polymorphs, prodrugs, metabolites, methods of treatment, among others. Trends regarding the patentability of new molecular entities and patent publication were highlighted by him. He also described various patenting strategies and TRIPS flexibilities.

On both the second and third days of the course, these issues were further developed by Dr. Srividya Ravi, who carried out concrete exercises on typical claims with the participants, who also shared their respective practices. Discussions were facilitated with more case studies and the subsequent debate with the participants, including questions relating to approaches with regard to formulations and combinations, new salts, ethers, esters and other forms of existing pharmaceutical products. Claims covering a large range of compounds were also discussed. The discussion was also moderated by the South Centre staff and received additional comments by Dr. Carlos Correa. Examiners from the participating offices actively engaged in these discussions.

Dr. Srividya Ravi, concluded the course with a presentation on the patentability criteria for products of biological origin (biologicals). In particular, she briefed the participants about the examination of patent applications for monoclonal antibodies in relation to COVID-19. A discussion on how and whether countries in Asia have adopted or should/could adopt guidelines on biological inventions ensued.

During the final discussion, lessons learned and the prospects for future collaboration with the South Centre and between patent offices were discussed.

The South Centre continues to provide free, confidential technical assistance and training requests by patent offices, policymakers and other authorities from developing countries on IP and public health. See: https://ipaccessmeds.southcentre.int/.

Author: Shirin Syed, Intern, Health, Intellectual Property and Biodiversity Programme (HIPB), South Centre

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South Centre organized Exchange Among Asian Patent Authorities and Examiners on Patent Policies and Public Health