Leena Contarino and Ellie Purnell of HGF argue that it is time to create a database listing information about IP relating to the platform technologies that will be vital in finding treatments for covid-19
Development of covid-19 vaccines will inevitably produce valuable IP which will mostly exist in the form of patents. Many debates are currently underway as to how various stakeholders, such as governments and healthcare institutions around the world, will be able to gain access to the novel vaccines when they are likely to be patent protected. Calls to make all covid-19 vaccines freely available have been widespread and in some cases companies have already agreed either not to file patents on the novel treatments at all, or to provide royalty free licences to the patents they do file.
However, the situation is more complicated than simply allowing or agreeing access to the patent/s protecting the vaccines. In many instances, the new covid-19 vaccines will be built on proprietary platform technologies, such as viral vectors, mRNA-technology, nanoparticles and the like, which in themselves may be covered by multiple earlier patents owned by multiple different parties. Access to these platform technologies is also required if a novel vaccine incorporating the technology is to be produced and sold.
Given the critical need for speed in developing a covid-19 vaccine, collaboration and parallel vaccine development efforts with multiple approaches, by both private and public participants, are likely to produce the fastest results. For collaborators and investors to engage with research projects, knowing who owns the pre-existing patents covering the necessary parts for any given platform technology and knowing how long the exclusivity will last is important.
Equally, for the researchers themselves, who are looking for a novel covid-19 vaccine, pre-existing patent rights can prove a significant hurdle for new vaccine development. They must consider how to gain access to previous platform technologies they wish to use in the vaccine itself, and to manufacturing processes they wish to use to produce the vaccine.
There are currently no requirements or forums for a patentee or a licensee of a patent forming part of a platform technology to publicly list patents relating to such a platform. Therefore, to avoid the risk of infringement of these technologies, a time-consuming and often expensive freedom-to-operate analysis must be relied upon by any third party considering using the technology in developing a new vaccine.
Once the relevant patents and their owners have been identified, the interested party can then proceed to determine if there is a way to obtain access to use the technology. In the absence of legally binding pledges to provide free licenses or not to enforce IP relating to, for example, covid-19 vaccine development, licensing negotiations to secure access are often very time consuming. Such traditional procedures for gaining access to patent protected IP do not lend themselves well to innovation during a crisis.
Given the covid-19 pandemic, there has been considerable discussion around the topic of how to obtain quicker access to the resulting vaccine patents that will emerge. However, there has not been much discussion on the issue of accessing the background IP, such as the IP covering platform technologies.
Novel inventions are typically based on a mixture of previous platform technologies which are built upon and act as a springboard for further innovation. Such platform technology will typically become essential technology for research in a particular field. It seems that there is currently no means to aid researchers in identifying critical platform patents and in confirming who owns them. We consider this an area where there could be more transparency which would assist the scientific research community in becoming more responsive to critical needs.
There are models in place that could be used to establish a database for platform technology patents. For example, in the United States, companies that sell pharmaceuticals must list the patents that cover the drugs in the Orange Book maintained by the FDA. This is to assist generics manufacturers to assess when the patents expire so that they can plan to enter the market.
A similar, albeit more limited list, is also hosted by WIPO, which maintains a relatively recently established, voluntary ‘Pat-INFORMED’ database. Pat-INFORMED was developed by WIPO and the International Federation of Pharmaceutical Industrial Associations (IFPMA) in collaboration with 20 international pharmaceutical companies and lists patent documents covering authorised medicines in jurisdictions around the world. These databases are already regularly used by companies to identify patents covering medicines.
A database that lists patents relating to platform technologies could provide a resource for any stakeholder interested in the development of vaccines to identify existing proprietary technology. For example, in the case of vaccines, the database could list key patents relating to viral vectors, mRNA technology, nanoparticles, adjuvants and the like.
Naturally, establishing a database would require standardisation of nomenclature and significant industry collaboration. This is unlikely to come into existence in time to help with current covid-19 vaccine development. However, if the current crisis spurs development of such a database, it could provide a valuable resource to identify the relevant technology and owners in any given research field.
A platform technology list could also provide a way to provide an alternative access mechanism to allow interested parties to easily use technology covered under patents on the list. Those companies inputting their patents could agree for them to be collectively donated, licensed or otherwise negotiated to be accessible to stakeholders; for example, to private and public efforts for future vaccine development.
Alternatively, access to patents on the list could be secured through pre-agreed pools or bundles, in a similar manner to the medicines patent pool. Pooling of patents has been successfully established and used in the electronics and telecom fields. However, there are only limited examples and none thus far have been in the biopharma industry. One way to improve access to IP using a platform technology list could be to form several patent pools from within the list that relate to key areas of technology.
The general sharing of patent rights, regulatory test data and other information that could be useful for developing, eg, vaccines for covid-19, has not gained wide acceptance among the industry. However, an informative list that improves transparency on key patents and their owners in a given technological field could be a more achievable goal that would still accelerate access to critical patent information for researchers.
Transparency is a relatively simple stepping stone in improving the use of patents to collaborate. Identifying platform technologies and their owners in a public searchable database much like the Orange Book could provide a forum to easily disseminate the information contained in key patents to researchers. Even if biopharma is not ready to embrace the idea of patent pools and standardised licences, such a database would, at a minimum, provide an improved way of finding out who to reach out to when time is of the essence.