Technology and Knowledge Diffusion

Innovation Council released a statement to the WIPO Standing Committee on the Law of Patents presenting recent research on tech transfer. We highlighted the work we did with two Innovation Council members, Merck Life Science and Biovac.

With Merck Life Science, Innovation Council published a paper called Making Biologics, which found four pathways for building bio-manufacturing and innovative capacity that required collaboration, tech transfer, and IP protection.  One uncovered strategy involved building vaccine production capacity through a process of “backwards integration,” that involved working with tech transfer partners to gain expertise to ultimately help perform R&D. Biovac demonstrated an example of a backwards integration success story through their work.

See here for our full statement.

Merck Life Science recently published a whitepaper titled “From Bench to Market: Vaccines Technology Transfer.” It covers an overview of the technology transfer process that was needed to aid global manufacturing capacities to inoculate global populations with COVID-19 vaccines. It also describes how the development and optimization of a platform to manufacture a vaccine for tropical diseases was subsequently leveraged for the SARS-CoV-2 vaccine process development and transferred to Biofarma, a leading vaccine manufacturer in Indonesia.

See here for the full paper.

Innovation Council sat down with Julia Spencer, Associate Vice President for Global Multilateral Engagement & Strategic Alliances at MSD, to discuss the development, manufacture, and broad global diffusion of the company’s COVID-19 therapeutic, molnupiravir. The interview touches on a range of topics, including the risks taken by innovators to scale manufacturing as rapidly as possible, voluntary licensing and the establishment of global production networks to ensure adequate global supply, the critical importance of demand forecasting, and factors such as lack of testing that impacted the uptake of molnupiravir in some countries.

The following document is an account of the statement made by Innovation Council at the World Intellectual Property Organization surrounding the EU standard essential patents (SEPs) regulation. We provide a summary of discussions that took place in WIPO and highlight common misconceptions about SEPs in the real economy before ending with some key takeaways.

Click here to read our statement.

The following document is an account of the statement made by Innovation Council at the World Intellectual Property Organization surrounding the role of intellectual property during COVID. We emphasize how IP was crucial in fostering collaboration, investments, and expanding biomanufacturing capacity.

Click here to read our statement.

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.

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 2023, IAM.

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 proposal that is fundamentally flawed and unbalanced, by Florian Mueller, 29 March 2023, FOSS Patents.

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.

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.

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.

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.