When is a material a “substance or composition” or a “device”?
The European technical board of appeal has published their decision on T1252/20 relating to the question of “whether a…
In March 2020 the World Health Organisation declared the outbreak of Covid-19 a pandemic. Since then, globally there have been nearly 481 million confirmed cases and over 6 million deaths.
A key step towards tackling the pandemic has been the development and rollout of the Covid-19 vaccines. Just 11 months after the genetic sequencing of the SARS-CoV-2 virus was published, Pfizer & BioNtech gained temporary regulatory approval for a Covid-19 vaccine, closely followed by several other pharmaceutical companies. Whilst some companies are predicted to make significant profit from the vaccine, the development did come at a large financial cost to pharmaceutical companies, governments and not for profit organisations. Some companies such as AstraZeneca pledged to sell the Covid-19 vaccine doses at a price that only covers their overall costs, at least for the duration of the pandemic.
Given the high cost of the vaccine development, it would be expected that companies will seek to protect their investment with patents. In fact, much of the work done utilised experience from other previous patented vaccine developments, for example the patented use of mRNA based vaccines. The question is, are the earlier and later patents inhibiting manufacturing and therefore leading to reduced vaccination rates in lower-income countries?
In October 2020, South Africa and India proposed to the World Trade Organisation that there should be a temporary waiver from certain provisions of the Trade-Related aspects of Intellectual Property Rights (TRIPS) agreement for the prevention, containment and treatment of Covid-19 including a waiver on patents, copyrights, industrial design and trade secrets. They argued that the undisclosed (e.g. unpublished patent applications) and patented information would slow the timely access to affordable medical products including vaccines and medicines and the scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19. The document was revised in May 2021 and has been supported by a number of lower-income countries. The aim of this temporary waiver was to allow more countries to manufacture the vaccine and speed out global rollout however at the time it was known that it could take years to reach a conclusion to these discussions.
A WTO waiver would need to be unanimously agreed between all 164 WTO member states. A waiver would only remove the obligation for WTO member states to grant IP protection. It would not ensure that stakeholders can effectively benefit from the invention and related know-how.
Since the original proposal, there has been a lot of debate. European countries such as Germany have argued that such a waiver will pose a danger to future vaccine innovation. In May 2021 at the EU summit, French President Emmanuel Macron was quoted as saying “What is the current issue? It is not really about intellectual property. Can you give intellectual property to laboratories that do not know how to produce and will not produce tomorrow?” – which is also an argument supported by a number of scientific experts.
On the other hand, U.S. President Joe Biden backed a proposal to waive the rights to solely Covid-19 vaccines. This is a much narrower waiver than the originally proposed TRIPS waiver as it is exclusively for patents for Covid vaccines and not other means to fight Covid-19 such as health products and technologies including diagnostics, therapeutics, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture. Know-how and trade secrets related to the development and production of Covid-19 vaccines are also not covered by this waiver.
In December 2021 ALLEA (All European Academies) published a document highlighting the need to improve Covid-19 vaccination rollout in the global south. Whilst over 10 billion doses of the vaccine have been administered worldwide as of March 2022, low and middle income countries (LMIC), for example in Africa and South Asia, are still far behind others. These areas of high cases and low vaccine rollout pose a threat to prolonging the pandemic through further virus mutations.
ALLEA stated that the patent waiver is not the “silver bullet” in this case and that the following should be pursued not only for the Covid-19 pandemic, but also for future risks:
Massive vaccination campaigns, technology transfer and voluntary licences have all played a part in the global vaccine roll out in absence of an approved waiver.
As of March 2022, the European Union, the United States, India and South Africa have recently signed the narrower Covid-19 vaccine patent waiver, and it will be put forward to the other WTO members. However, based on the speed of the waiver being approved versus the urgency of the Covid-19 situation, it can be concluded that the patent waiver is likely not an adequate solution to the need to facilitate access to Covid-19 vaccines in low and middle income countries.
If you have any questions about the Covid-19 patent waiver, please get in touch to speak to one of our attorneys.