Pharma Patents in the Pandemic

In 2020, the number of international patent applications filed via WIPO continued to grow amid the COVID-19 pandemic, and within the field of technology, medical technology took 3rd  place with 6.6%. Many of us experienced a rush to claim antiviral usage of inventions that prior to 2020 might not have had that as their foremost aspect.

There is currently in particular a noticeable renewed interest in vaccine and antibody-related patents, as well as in second medical treatment patents for use in the COVID-19 spectrum.

Second medical use refers to the use of a known drug for a new therapeutic purpose. The advantage compared to developing a new drug from scratch is that the existing drug has already shown itself to be safe in the context of the original use. Developing and obtaining marketing authorization for the new medical indication can thus be quicker and more cost-effective.

In relation to COVID-19, several existing drugs with beneficial effects have been identified, e.g. Dexamethasone, a cheap steroid that has saved about a million lives, and Tocilizumab, originally a rheumatoid arthritis drug that reduces the risk of mortality in hospital patients.

Patents on medical inventions provide legal protection against being copied, and COVID-related inventions, both second medical uses and vaccines, are no exception.

Patents give inventors the rights to exclude third parties from commercializing their discoveries in exchange for laying public the new technology. This often means that the patent holder has a better chance ofmaking money from them – which is an incentive to encourage innovation, getting a return on the costly investments needed to develop new medicines.

But these are not normal times

Apparently, when it comes to the pandemic, in contrast to the rush to patents by originators in the field, in the public eye, patents and big pharma have become the hindrance for world protection, and the need for public availability of new research insights in this field far outweighs the individual inventor´s rights.

Large pharmaceutical companies usually have the financial muscles to keep secret know-how for a longer time. Scientists working outside this setting, e.g. at universities, need to regularly publish their scientific discoveries. In normal times, this can easily be combined with the need for absolute novelty for the patenting process. In pandemic times, though, there has been a rush to publish online long before an article has even been peer-reviewed and approved for publishing. E.g., in 2020 research outcomes related to the SARS CoV-2 pandemic were made openly available, including research papers (from preprints – MedRxiv and bioRxiv – to different mechanisms for waiving Article Processing Charges (APCs) or new specific Open Research platforms, as Elsevier or The Lancet). This is said to be in the interest of a quicker than normal sharing of information in the COVID-related fields, but brings with it not only unforeseen lack of novelty, making patenting impossible in large parts of the world, but also a clear questionability of scientific quality of the prematurely published research.

Last autumn, developing nations led by India and South Africa proposed to the World Trade Organization (WTO) that the patents on vaccinations and other Covid-related items should be waived, at least temporarily, a proposal that was recently supported by the US.

The argument is that, given the extreme nature of the pandemic, the recipe should be made widely available in order for vaccines to be produced locally in bulk by other manufacturers and thus reach the public in these countries quicker and at a lower cost. An overlooked factor is, however, that without access to all the know-how and necessary equipment and ingredients, a patent waiver might result in quality, safety, and efficacy issues and possibly even in counterfeits. This is particularly relevant for the novel-type vaccines which were developed by BioNTech/Pfizer and Moderna.

What is often forgotten in the present pandemic patent debate is that in certain circumstances, TRIPS allows any country to exploit a protected invention without the consent of the right holder in order to address public need., thus already offeringwell-considered solutions to situations that are not normal. Governments can impose compulsory licenses on vaccine makers, compelling them to share their know-howand tooverseeing the production process along the way. This solution also allows for compensations to the pharmaceutical companies, effectively leaving incitement to research and development in place.

It is easy to claim that exceptional times need exceptional solutions, but in all honesty, what makes the present pandemic essentially different from other catastrophic world-wide health situations? If we do not allow renumeration for research and development in medical areas of utter importance, such as not only viral pandemics such as COVID-19 or HIV, but e.g. malaria or cancer research, development of medicines for these indications will stagnate.

The patent system is an effective incentive to encourage innovation and to develop new medicines, a task that can simply not be achieved without the pharmaceutical sector, especially in times that are not normal.