Technology and Knowledge Diffusion

The experience of Biovac, a public-private vaccine developer and manufacturer that was founded in 2003 in South Africa, gives a sense of how organizations move along this pathway. In 2021, Pfizer announced that Biovac would become a partner for manufacturing the Pfizer-BioNTetch mRNA vaccine for distribution within the African Union. Biovac had already worked with Pfizer and other international tech transfer partners, such as Sanofi Pasteur, for many years. This enabled the organization to improve its technical and scientific capacity. Biovac’s various collaborations included producing innovative, complex vaccines such as Pfizer’s polyvalent pneumococcal vaccine, Prevenar 13.

Continuing its progression via backwards integration towards the highest value activities in manufacturing, Biovac recently announced a tech transfer and licensing deal with the non-profit International Vaccine Institute, headquartered in South Korea, to manufacture an oral cholera vaccine. This project will enable the Biovac Institute to gain capacity to manufacture drug substance, a step in the vaccine manufacturing value chain that does not yet exist in Africa.

Click here for the press release.

The 11th Asia Regulatory Conference was recently held from 17-21 October 2022 by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the Singapore Association of Pharmaceutical Industries (SAPI). The conference, which took the form of short topic specific webinars, covered ways in which the regulatory landscape could be improved, and what this means for patients, regulators, and industry. Some topics that were covered included regulatory agilities and why this is important to patients, harmonization of regulatory approval, the changing regulatory landscape of Biotherapeutics and Advanced Therapy Medical Products, the effectiveness of the ICH and the importance of delivery the same quality of regulatory standard to patients everywhere. There was a wide range of speakers lending their view including representatives from both AstraZeneca who spoke on the lessons learned throughout COVID-19 in regard to regulatory approval and Pfizer who spoke on their experience with Post Approval Change Management
Protocol (PACMP).

Click here to watch the full video. The AstraZeneca talk begins at 35:52.

Preparing for the next pandemic is a priority for many national public-health leaders and requires them to lay the groundwork to mount an effective vaccine response.

Decision makers could set the stage for vaccine resilience by defining what their countries and regions need; assessing the local capacity to scale production of vaccine doses; identifying gaps and weaknesses in their national and regional vaccine value chains.

Read the full article here.

On 5 October 2022, the Geneva Network organized a panel about the possible future implications of expanding the scope of the TRIPS waiver, in particular in relation to innovation and availability of diagnostics, therapeutics, and vaccines for health crises. Innovation Council’s Executive Director Jennifer Brant took part in this panel to share information about how bio-manufacturing infrastructure can be extended, and what policy actions governments can take to accelerate the process. She expressed the view that the June 2022 TRIPS waiver should be tested, and that evidence should be tabled as to the need to expand the waiver’s scope to cover additional categories of COVID health products, before WTO Members take further action.

Click here to watch the virtual meeting.

In the coming months WTO Members will continue to discuss whether to modify the TRIPS waiver that was agreed in June 2022 to include COVID therapeutics and diagnostics. Geneva Network has prepared a policy brief that explains why it could be counterproductive to expand the scope of the waiver in this way. The brief is authored by Philip Stevens of the Geneva Network and Prof. Mark Schultz, Director of the Intellectual Property and Technology Law Program at the University of Akron School of Law.

The WIPO Secretariat has compiled a selection of case studies and success stories obtained from various areas of WIPO, that showcase the use of IP rights by Small and Medium-sized Enterprises (SMEs). They provide a comprehensive overview on how IP is used by entrepreneurs, inventors and creators, to add value to their products, support business growth, create employment and promote economic development.

These stories will be presented from the 17th to the 22nd of October 2022 during the Twenty-Ninth Session of the Committee on Development and Intellectual Property (CDIP).

Read the full story.

The United States Patent and Trademark Office (USPTO) became a technology partner to the global green-technology platform of the World Intellectual Property Organization (WIPO). WIPO GREEN is a public-private partnership established by WIPO in 2013. Its 145 international partners include major technology companies, intellectual property (IP) offices, business groups, research institutes, and nongovernmental organizations.

The USPTO’s contributions to WIPO GREEN include its own initiatives that are designed to address the challenge of climate change, including:

• The USPTO Climate Change Mitigation Pilot Program, which accelerates the examination of patent applications involving innovations to reduce greenhouse gas emissions
• The soon-to-be-announced Patents for Humanity: Clean Energy Technologies awards competition, a green technology–focused version of the USPTO’s highly successful Patents for Humanity awards competition

Click here to read more.

Moderna has sued Pfizer and BioNTech for patent infringement, claiming that its rivals’ Covid-19 shot copied technology that Moderna had developed years before the pandemic.

This sets up what could become a protracted and expensive legal battle between the companies behind coronavirus vaccines that have saved millions of lives worldwide and raised hopes for future medical products using similar messenger RNA, or mRNA, technology.

Read the full story here.

This paper introduces biologics, describes opportunities in the sector, and provides insights about the processes for manufacturing them. It also identifies the diverse pathways that countries have used in recent years to develop bio-manufacturing capacity. Finally, it looks to the future to identify the government policies and technology solutions that will enable more countries to join global value chains and to produce these life-saving treatments more safely, quickly, and cost-effectively – to the benefit of patients everywhere.

Click here for the full story.