University know-how the secret sauce for vaccine success

It has been difficult to keep track of the events concerning access to vaccines over the last few days. Just over a week ago, the EU Commission signalled their intention to trigger the Article 16 of the Northern Irish Protocol to prevent the flow of the Oxford/AstraZeneca Covid vaccine from the EU bloc into the UK.

The Commission backed down almost immediately but in the days that followed, there were reports that France and Germany were considering legal action against AstraZeneca to enforce the company's legal obligation to supply the vaccine. AstraZeneca responded by committing to increasing supplies of the vaccine to the EU community.

Recent reports suggest the Oxford team, led by Prof Sarah Gilbert, were aware of the threat of so-called "vaccine nationalism" as far back as January last year and that this had a major impact on their choice of pharmaceutical partner to manufacture the vaccine.

In particular, the Oxford team appears to have been wary of partnering with an American company due to the unpredictability of Trump and his “America First” policy. Although not noted for its vaccine development expertise, AstraZeneca seemed willing to accede to Oxford’s requests, in particular around supplying the UK early and selling the vaccine at cost in the early period of the pandemic.

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University IP

It is worth noting that the first three vaccines authorised for use in the West have all been developed using university intellectual property (IP) and expertise. The Oxford team developed a virus using a relatively standard adenovirus vector system and have partnered AstraZeneca to manufacture and distribute the vaccine.

It has received far less attention in the media, but the company behind one of the other vaccines, Germany's BioNTech, was originally a "spin out" of the Johannes Gutenberg-University Mainz. A "spin out" company is created out of a university using intellectual property developed by that university. BioNTech partnered Pfizer in developing and manufacturing a vaccine.

Finally, Moderna has also developed a vaccine based on IP created by an academic – at the University of Pennsylvania. Both the Moderna and BioNTech/Pfizer vaccines are based on a synthetic messenger RNA technology and this accounts for the onerous conditions of storage and distributions for these vaccines.

It has been reported that the technology behind the Oxford vaccine has received over £1 billion in public funding from the UK government to date. In addition to being derived from a university technology, BioNTech has also received significant direct funding from the federal German government. And the invention underpinning the Moderna vaccine was originally funded by the US National Institute of Health.

In 2016, Oxford established its own spin out company, named Vaccitech, to maximise the potential of IP associated with the vaccine platform technology. However it now appears as if AstraZeneca has an exclusive licence with Oxford "for the global development, production and supply of the university's potential Covid-19 vaccine candidate".

The decision to partner with AstraZeneca and the licensing terms for the agreement between the parties, and, in turn, the sublicensing and other contractual agreements between AstraZeneca and other parties, are likely to have a significant impact on the global supply of this key vaccine.

In a press release in April last year, it was revealed that the partners, including AstraZeneca, would work to distribute the vaccine with just the costs of production and distribution being covered for the duration of the pandemic. It is uncertain how the duration of the pandemic will be determined, but afterwards AstraZeneca will be allowed to sell the vaccine for a profit. Any royalties or payments back to Oxford will be re-invested in vaccine research.

It is likely that any licence to AstraZeneca includes access not only to a patent portfolio owned by Oxford, but also to any know-how associated with the production of the viral vector technology platform. The know-how can be considered to be the “secret sauce” acquired by scientists in developing the process and would not be disclosed in any patent filing, for example.

As mentioned, AstraZeneca does not have extensive experience in developing vaccines, and it is interesting to note that other companies AstraZeneca has partnered with have had difficulties in producing the vaccine. This has been put forward by the company as the reason for their difficulty in fulfilling their contractual obligations to the EU Commission.

In particular, reduced vaccine yields have been reported at the Novasep manufacturing facility in Belgium.

The Oxford/AstraZeneca vaccine requires the culture of cells for manufacturing the vaccine and this can be challenging and can vary from manufacturing plant to plant. BioNTech has also recently indicated that a problem with know-how is proving to be a bottleneck in the production of its synthetic RNA vaccine.

Contract publication

The publication of AstraZeneca’s contract with the EU Commission encouraged heated debate among legal experts around such issues as what constitutes “best reasonable efforts” and the importance of Belgian law.

However, other IP commentators have queried whether the IP and patents associated with the production of the Covid vaccines should be waived given the significant public monies used to finance the research and development into the vaccines.

Regardless, the Covid pandemic has illustrated the significance of university research and the quality and disruptive nature of the IP it generates. It has also highlighted the complexity of the university technology transfer ecosystem.

This complexity includes such issues as the right selection of commercial partner, the importance of an efficient transfer of technology, including the know-how connected with that technology, to commercial parties and the nature of the associated licensing agreements.