Evolution of the Vaccine Industry in the Asia-Pacific Region
Merck Life Science has released a paper on trends in vaccine manufacturing in the Asia Pacific Region. The paper includes research from interviews with nearly forty industry executives, plus interviews from research institutes in ten different countries. The COVID pandemic highlighted the potential of mRNA vaccines, with 87% of respondents looking to focus on mRNA vaccines as a critical modality in the future. Furthermore, survey respondents cited process development and technology transfer expertise as key needs when adopting new technology. Merck Life Science considers that it will be some time before mRNA becomes the dominant modality, given the need for production processes and the regulatory landscape to evolve in the meantime. The company expects that most vaccine producers will want to have capabilities relating to multiple vaccine modalities, as they invest to expand facilities and incorporate bioprocessing 4.0.
Click here to read the full paper.
Innovation Council Member Q&A: The African Vaccine Manufacturing Initiative (AVMI)
New EU Regulatory Regime for SEPs Will Upend Mobile Telecommunications Sector
This article from IP scholar Adam Mossoff presents the proposed EU SEP Regulation, which is due to
be released on 26 April by DG GROW.
According to Mossoff, the leaked SEP Regulation would be counterproductive to a range of European
goals, including ongoing innovation in cellular technology and a central role in standardization. He
points out that available evidence suggests that, at best, the SEP Regulation is unnecessary – and
that, at worst, it could stunt innovation and economic growth in the EU in the years to come.
A concern raised by the author is that the EUIPO has no previous patent law experience, yet the SEP
Regulation plans to hand full control of important SEP issues to the EUIPO. The EUIPO would
determine what patents are able to be classed as essential, thus, SEPs, along with the appropriate
royalty rates for licensing such SEPs, in addition to mandating public disclosure of licensing
agreements. Furthermore, it would also be able to prohibit licensing or litigation of SEPs that have
not been confirmed as essential, that have not been registered, or that have set a different royalty
rate for the relevant SEPs.
The author argues that, if adopted, the SEP Regulation would destabilize the global
telecommunications market as well as strongly favouring IP users over innovators.
Furthermore, Mossoff notes that this type of regulation could be advantageous for China, which
could leverage it to continue discriminatory treatment against Western innovators in cellular
technology. Overall, he expresses concern that the new EU SEP Regulation would negatively affect
technological innovation and economic growth in the EU by destroying incentives for SEP owners to
continue investing in R&D and participating in open standardization processes.
Click here to read the full article:
New EU Regulatory Regime for SEPs will Upend Mobile Telecommunications Sector, by Adam
Mossoff, 12 April 2023, IPWatchdog.
For further reading, additional resources about the leaked SEP Regulation include:
The European Commission’s SEP licensing plans are terrible on every level, by Joff Wild, 30 March
Exclusive: EU patent body to oversee tech-standard patent royalties – EU draft rule, by Foo Yun
Chee, 28 March 2023, Reuters.
European Commission departs from best practices in hasty preparation of standard-essential patent
policy proposal that is fundamentally flawed and unbalanced, by Florian Mueller, 29 March 2023,
European Commission to propose radical new SEP/FRAND regime with major consequences for
patent owners, by Adam Houldsworth, 29 March 2023, IAM.
European Commission set to give EUIPO responsibility for standard essential patents: big challenges
lie ahead, by Trevor Little, 29 March 2023, World Trademark Review.
Proposed EU SEP regulation will also harm net licensees: implementers of standard-essential patents
must be careful what they wish for, by Florian Mueller, 2 April 2023, FOSS Patents.
Why Voluntary Licensing is Best for Increasing Access to Medicines
The Geneva Network recently published analysis about the benefits from voluntarily licensing in the health space. The author argues that voluntary licensing was crucial during COVID-19, aiding the quick and large scale production of vaccines and therapeutics. Overall, it is noted that voluntary licensing can enable long term knowledge transfer, cooperation between companies, and increased flexibility and speed in the innovation process.
Click here to read the full story.
AI and the Bio-Pharmaceutical Sector
The World Intellectual Property Organization (WIPO) recently hosted discussions about the relationship between artificial intelligence (AI) and intellectual property (IP). Mr. Corey Salsberg, a globally recognized attorney in the fields of IP and innovation law and policy, and Vice President and Global Head of IP Affairs for Novartis, was invited to take part in the second panel featuring Stories from Innovators – A Real Life Business View on AI Innovation. This note is based on his remarks, which provide examples from Novartis’ R&D and other activities to illustrate how AI can be applied to enhance bio-pharma innovation, along with the related IP implications.
Click here to read more.
Biovac and IVI Enter Deal to Develop Oral Cholera Vaccine
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.
11th Asia Regulatory Conference
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
Click here to watch the full video. The AstraZeneca talk begins at 35:52.
Building Greater Resilience in Vaccine Manufacturing – McKinsey & Company
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.
Seminar hosted by the Geneva Network about Availability of COVID Solutions
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.