Legal and economic perspectives on fair and equitable benefit sharing in the Nagoya Protocol.

Adopted in 2010 as a supplementary agreement to the 1992 Convention on Biological Diversity, the Nagoya Protocol (NP) mandates the fair and equitable sharing of benefits arising from the use of genetic resources provided by Indigenous peoples. Member states must newly enact or amend domestic laws to align with the NP. Consequently, many countries are currently implementing legislative, administrative, and policy measures to ensure fair benefit sharing from the use of Indigenous genetic resources. We examined the inclusion of intellectual property (IP) protection in the sharing of benefits from research and development that utilizes Indigenous genetic resources. The NP does not specify guidelines for IP-related benefit sharing, leaving each member state to establish its own rules. We used an economics-based approach to explore the optimal scope and duration of IP protection for maximizing stakeholder interests, including those of Indigenous peoples, at the national level. The optimal duration of IP protection was when the marginal social cost and benefit of IP protection were equal. When this point occurred varied depending on various factors, such as the type of genetic resources in the country, existence of alternatives, number of users, and competing actors. The optimal scope of IP protection was when the social benefit of investment in fundamental research equaled the social benefit of application development. Likewise, this point of implementation also varied based on various factors, such as the type, uniqueness, potential for further discovery, and diversity of providers in the country.

Perspectivas legales y económicas del reparto justo y equitativo de beneficios en el Protocolo de Nagoya Resumen Adoptado en 2010 como un acuerdo complementario del Convenio sobre la Diversidad Biológica de 1992, el Protocolo de Nagoya establece el reparto justo y equitativo de los beneficios derivados del uso de los recursos genéticos proporcionados por los pueblos indígenas. Los Estados miembros deben promulgar o modificar su legislación nacional para adaptarla al Protocolo de Nagoya. En consecuencia, muchos países están aplicando actualmente medidas legislativas, administrativas y políticas para garantizar una participación justa en los beneficios derivados del uso de los recursos genéticos indígenas. Examinamos la inclusión de la protección de la propiedad intelectual (PI) en la participación en los beneficios derivados de la investigación y el desarrollo que utilizan recursos genéticos indígenas. El Protocolo de Nagoya no especifica directrices para la participación en los beneficios relacionados con la PI, dejando que cada Estado miembro establezca sus propias normas. Usamos un enfoque económico para estudiar el alcance y la duración óptimos de la protección de la propiedad intelectual con el fin de maximizar los intereses de los actores, incluidos los de los pueblos indígenas, a escala nacional. La duración óptima de la protección de la PI ocurría cuando el costo social marginal y el beneficio de la protección de la PI eran iguales. El momento en que se produce este punto varía en función de diversos factores, como el tipo de recursos genéticos del país, la existencia de alternativas, el número de usuarios y los actores que compiten entre sí. El alcance óptimo de la protección de la PI ocurría cuando el beneficio social de la inversión en investigación fundamental igualaba al beneficio social del desarrollo de aplicaciones. Asimismo, este punto de aplicación también varió en función de diversos factores, como el tipo, la singularidad, el potencial de nuevos descubrimientos y la diversidad de proveedores en el país.

Designing the global vaccine supply chain: balancing intellectual property rights with post COVID-19 vaccine equity.

This article aims to propose practical solutions that coordinate the conflicting interests between the global community and the pharmaceutical industry on the intellectual property (IP) waiver for COVID-19 vaccines and facilitate a more equitable vaccine supply chain in the post-COVID-19 world. We critically conducted a narrative literature review to identify procedural and practical issues in the current vaccine supply chain. The search was conducted across various academic disciplines, including biomedical science, life science, law and social science, using resources such as PubMed, Web of Science, Scopus and Westlaw. After screening 731 articles, 55 studies were selected for review. The narrative review revealed several critical barriers that hinder vaccine supply in less-developed countries (LDCs) as follows: (1) WTO Trade-Related Aspects of Intellectual Property Rights (TRIPs) waiver requests may not be granted due to its stringent consensus rule; (2) the current compulsory license system may not work due to the complexity of IP rights covering COVID-19 vaccine technologies; (3) only a few LDCs have domestic companies capable of manufacturing vaccines, and (4) political and economic tensions among countries exacerbate existing barriers to vaccine distribution in LDCs. Based on these findings, we proposed a comprehensive compulsory license system, which combines TRIPS's compulsory license system with the third-party beneficiary mechanism under Common Law. This integrated approach offers a balanced solution that ensures fair compensation for vaccine developers while facilitating broader vaccine access.

Structural characterization of the α-mating factor prepro-peptide for secretion of recombinant proteins in Pichia pastoris.

The methylotrophic yeast Pichia pastoris has been used extensively for expressing recombinant proteins because it combines the ease of genetic manipulation, the ability to provide complex posttranslational modifications and the capacity for efficient protein secretion. The most successful and commonly used secretion signal leader in Pichia pastoris has been the alpha mating factor (MATα) prepro secretion signal. However, limitations exist as some proteins cannot be secreted efficiently, leading to strategies to enhance secretion efficiency by modifying the secretion signal leader. Based on a Jpred secondary structure prediction and knob-socket modeling of tertiary structure, numerous deletions and duplications of the MATα prepro leader were engineered to evaluate the correlation between predicted secondary structure and the secretion level of the reporters horseradish peroxidase (HRP) and Candida antarctica lipase B. In addition, circular dichroism analyses were completed for the wild type and several mutant pro-peptides to evaluate actual differences in secondary structure. The results lead to a new model of MATα pro-peptide signal leader, which suggests that the N and C-termini of MATα pro-peptide need to be presented in a specific orientation for proper interaction with the cellular secretion machinery and for efficient protein secretion.