Intellectual property (IP) is a key building block for any successful and sustainable innovative industry, especially in high risk research. The biopharmaceutical industry’s ability to respond to COVID-19 and other epidemics with such speed and strength is a tribute to IP and to the sustainable innovation that it generates.
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Combating COVID-19 is clearly the major challenge of the current time. Getting hold of a vaccine and finding a treatment are key objectives for political leaders. A vaccine in particular will be pivotal to protecting citizens from further infections and getting economies back on track.
So how have the life sciences industries and particularly the innovative biopharmaceutical industry responded to this innovation challenge? Moreover, what role does intellectual property have in this response? The answer to both is encouraging. and this is important to us at Ideas Matter as we seek to bring to the public attention a greater understanding of the critical contribution that IP makes to our economies and our societies.
Early on in the unfolding crisis the biopharmaceutical industry publicly committed to “channel its innovation, mobilize its knowhow, pool its expertise and share its manufacturing capacity“ to help deliver what could amount to billions of new vaccines to stop the spread of pandemic.
Many companies have repeatedly committed to supply such vaccines at a not-for-profit price during the pandemic period to help ensure equitable access to all in need anywhere in the world.
Significantly, the biopharmaceutical industry appears to be able to do this because it has built a sustainable and responsive business model based on IP. It is this IP-based model which has been able to attract long term investment for high-risk research and development and enabled the industry to build a strong medical science base.
Significantly, even the current medicines that are being investigated for possible use to combat COVID-19 were originally developed for their current use thanks to IP. This is the case equally for those currently under patent protection or those now off-patent.
It is also interesting to see how an IP researched-based industry is also responding so quickly to working in partnerships with other stakeholders, Product Development Partnerships (PDPs) and governments.
A recent press conference, hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) based in Geneva and featuring the heads of four multinational pharma companies highlighted the industry’s recent efforts and progress in developing effective coronavirus vaccines, and addressed questions about how IP relates to this important objective.
As of late May, the World Health Organization (WHO) reported that there are currently 10 candidate COVID-19 vaccines in clinical evaluation and 115 candidate vaccines in pre-clinical evaluation. Several biopharmaceutical companies are researching vaccine candidates and are collaborating and sharing data and existing technologies that can be leveraged to allow a rapid upscale of production once a vaccine candidate is identified.
Companies are also sharing other technologies, for example those that act as an adjuvant that can boost the effectiveness of a potential vaccine.
In the words of the IFPMA, “A new vaccine to protect people from COVID-19 holds the greatest promise of ending the pandemic, but there are no guarantees that one will be found. The biopharmaceutical industry is working at unparalleled speed and sparing no resources to develop safe and effective COVID-19 vaccines in record time.”
It was impressive watching company leaders from AstraZeneca, GlaxoSmithKline, Johnson & Johnson and Pfizer explaining at the press conference last week their own companies’ initiatives for vaccine-related development and testing activities and plans, the challenges they face given the volume and speed of results being sought, and their commitment to equitable access.
Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson, explained “Up to 15 billion vaccines might be needed and not all candidates could go all over the world depending on features. I think somewhere between 5 and 10 different vaccines will definitely be needed to serve the whole.”
“The hope of many people is that we will have a vaccine, hopefully before the end of this year,” said Pascal Soriot, Executive Director and CEO of AstraZeneca. “The capacity will continue increasing next year, if those vaccines are successful, of course, both in terms of manufacturing capacity but also additional vaccines becoming available.”
Development of the vaccines is being done with the companies’ unprecedented commitments to sharing data, to collaborating, and to working in partnerships with academia, other pharma companies, biotech companies, and governments. In April, for example, the IFPMA became a founding partner of the ACT Accelerator, along with WHO, Gavi, the Vaccine Alliance, and CEPI (the Coalition for Epidemic Preparedness), which are working together with companies to help develop a vaccine and scale it up.
Many pharmaceutical companies are also committed, as part of their partnership with R&D funders, to supply these vaccines at a not-for-profit price.
“Equitable access to vaccines over the world is important to make sure we stop the pandemic,” said Johnson & Johnson’s Stoffels. “For the pandemic period, we will supply [vaccines] all over the world at a not-for-profit price.”
How does this square with the need and practice of protecting IP in newly discovered medicines and other technologies to promote ongoing innovation? After all, there have been some calls for compulsory licensing or other limitations on IP with respect to coronavirus vaccines.
“The industry is already doing all the right things, and to some extent I feel that the focus on IP in vaccines shows a lack of understanding,” says IFPMA’s Cueni. “In vaccines it's all about know-how. It is about experience. It is about the ability of scaling up. In the history of IP, there's never been compulsory licensing for a vaccine. It really doesn't solve the problem. The industry is doing all the right things, which is all that is asked for.”
Dr. Albert Bourla, Chairman and Chief Executive Officer of Pfizer, says that talk of taking anyone’s IP is ‘dangerous’. “There’s a push right now to find a solution to this pandemic and the risks that we are taking are billions of dollars, and the chances that we are getting a vaccine are still not very good…. At this stage people are investing their billions to find the solution. To have a discussion that if you discover it, we are going to take your IP, I think that’s dangerous.”
Emma Walmsley, CEO of GlaxoSmithKline, points out that IP is not in fact a barrier to access, citing the successful distribution of affordable HIV AIDS drugs to developing countries for the past six years under agreed IP licensing terms.
AstraZeneca’s Pascal Soriot explained, “IP is a fundamental part of our industry. And if you don't protect IP, then essentially there's no incentive for anybody to innovate. Now, what is important is that companies want to provide their products at no profit like we are doing right now in case of pandemic or crisis when it's needed. But I don't know that necessarily challenging IP … is the solution to this issue. The solution for this issue is really to have a robust pharmaceutical industry that steps up to help when needed and do it at no profit.”
In any case where IP licensing is gauged as helpful, for example to help expand the manufacturing base in lower- and middle-income countries, companies have already responded in such way. Gilead, which has had the first and so far only approved treatment for COVID-19, has already announced voluntary licensing agreements with Indian and Pakistani generic companies to supply 127 countries. The IFPMA has also declared its support for the expansion of the Medicines Patent Pool’s mandate to cover COVID-19 as one of several options to help in increasing supply. However, these options only address a small part of the overall challenge for innovation and access of COVID treatments.
It is clear that IP is a key building block for any successful and sustainable innovative industry, especially in high risk research. The biopharmaceutical industry’s ability to respond to COVID-19 and other epidemics with such speed and strength is a tribute to IP and to the sustainable innovation that it generates.