COVID and the patent system - science, law and politics
- AuthorChris Burnett
If there is one thing that the coronavirus pandemic has shown us, it is that collaboration and urgency can lead to rapid advances in technology. It has also shown us the interplay between science and politics with IP rights, and in particular the patent system, sitting in between.
United States proposing a waiver to COVID vaccine patent rights
The United States government is now proposing a waiver to patent rights covering coronavirus vaccines in order that supply be increased, which the EU is opposing. This article looks at the technology, the bottlenecks, the patent system and the relevant legal mechanisms, and asks whether or not this latest development is simply politics.
How has the vaccine been developed at such a fast rate?
The advances in technology have been impressive. The Moderna and Pfizer vaccines, which both use new mRNA technology (Messenger RNA, which is produced in the body as part of the protein synthesis pathway, is utilised in these vaccines to produce the coronavirus spike protein so that the immune system learns to recognise it) have been produced and authorised for medical use with a rapidity never before seen.
The AstraZeneca vaccine, albeit using proven technology, has also been developed and granted market authorisation far more quickly than would normally occur (by at least a decade, according to some estimates). One of the means of achieving this feat has been by running the trials and testing phases simultaneously, in order to produce enough data for the authorisations to be granted. Hundreds of millions of doses of vaccine have already been produced and distributed.
In the UK at least, the vaccination programme has already significantly curtailed hospital admission and death rates. Science provides us with a reason to be cheerful amongst the bad news.
Vaccine shortages and political drama
On the other hand, politics have been at play, with vaccine nationalism, wealthier countries being given a larger share of the vaccines, exportation being blocked, and the EU taking AstraZeneca to court.
From a technical point of view, one of the significant issues is that not enough vaccines are being produced to meet demand worldwide due to limited production capacity and shortages of raw materials. This situation is not always helped by the policies of certain countries and organisations relating to the exportation of said vaccines and raw materials.
The fact that the vaccines are produced by private companies (though often with public funding) serves to complicate these issues and provide ammunition for further ones. When AstraZeneca started producing their vaccine, a major issue with supply stemmed from having to address technical issues in their production plant in Belgium. A spike in global vaccine production could not happen overnight.
Issues with the general-purpose patent system
Sitting astride these issues is the general-purpose patent system.
In normal circumstances, a patent (a monopoly granted by a state for an invention for a time-limited duration in exchange for the public disclosure of the invention) for a pharmaceutical may be granted in respect of the active ingredient itself and later for the protection of methods of manufacture, particular formulations, second medical uses or dosage regimes.
The patent holder will then have a limited period of time from when the pharmaceutical is given marketing authorisation (which may take well over a decade due to the testing required) to sell it before the patent expires.
For this reason, pharmaceuticals may be afforded supplementary protection for up to a further five and a half years on top of the twenty-year monopoly normally afforded to the holder by a patent.
In this time, the pharmaceutical company must try to recoup the costs not only of the successful pharmaceutical but also of the many failed attempts that did not receive a marketing authorisation. They will also often try to turn a profit for shareholders!
For this reason, some pharmaceuticals which are for rare illnesses may be extremely expensive due to the low number of doses required worldwide. Once a patent has expired the drug will become generic and other manufacturers will be able to enter the market selling the same drug and the costs will subsequently fall.
It goes without saying that we are currently living in a global emergency and the monopolistic protection afforded to patent holders is under scrutiny. There are pharmaceuticals now authorised to treat COVID as well as vaccines to prevent it and furthermore, related goods such as PPH, ventilators and the like which may all be protected by way of patents.
A patent grants a monopoly which means that the patent holder can prevent others from making, selling, using a process or importing products that fall within the scope of their patent claims. Therefore, the patent holder may be able to prevent sufficient quantities of patented product from entering the market. Joe Biden is currently throwing his weight behind proposals before the World Trade Organisation (WTO) to waive patent rights covering coronavirus vaccines, a move to which the EU in particular are objecting.
This debate has often been held in ignorance of the fact that provisions already exist to accommodate states of emergency. For example, under UK law there are two relevant provisions.
Firstly, if a patent has been granted for over three years and supply of a patented invention is not meeting demand, or if there is an important technical advance of considerable economic significance, the exploitation of which is being prevented or hindered, and the patentee despite best efforts has not granted a licence to work the invention, then a compulsory licence can be sought from the government.
If granted, the patentee will be paid a royalty for the licence based on either an agreement between the parties or determined by a Court.
Patented inventions in the services of the Crown
However, of more relevance to the current situation is the provision relating to the use of patented inventions in the services of the Crown, or “Crown Use” provisions.
Crown use provisions allow for government departments (or persons authorised by a government department) to be permitted to do any act which would normally constitute an infringement of a patent.
The Crown use provisions specifically mention drugs and medicines. The relevant provision (s55) may be invoked for medicines and drugs which are required for the provision of primary medical services under the National Health Service Act 2006 (and devolved equivalents) including also pharmaceutical services, personal medical services and local pharmaceutical services. In return, compensation for loss of profits will be paid by the government to the patentee or exclusive licensee.
Furthermore, under Section 59, special provisions as to Crown use during an emergency are provided. The special provisions include the maintenance of supplies and services essential to the life and well being of the community.
There is a provision also for assisting the relief of suffering and the restoration and distribution of essential supplies and services in any country or territory outside the United Kingdom which is in grave distress as the result of war. As the list is non-exclusive, perhaps such a provision might also permit Crown use for assisting countries outside of the United Kingdom in times of pandemic.
Collaboration between global governments and multinational corporations
Effectively dealing with the COVID pandemic requires many governments and multinational corporations to work in collaboration and whilst the UK Patents Act specifically caters for such scenarios, legal provisions differ.
That said, whilst each country has its own intellectual property system, every WTO member has also signed up to the TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights), Article 31 of which relates to compulsory licences which may be granted in times of a national emergency.
Whilst this article specifies the supply of the domestic market of the member authorising such use, Article 31bis relates to pharmaceutical products and exporting countries - particularly in respect of compulsory licences for exporting pharmaceuticals to countries on the United Nations list of least developed countries. The TRIPS agreement sets minimum standards to be provided by signatories, so most countries will have emergency provisions.
Therefore, there are already legal mechanisms that can be used that do not require political showboating.
Whilst compensation does have to be provided for the rights holders, it is encouraging that the patent system should not be an absolute barrier to dealing with a global pandemic. Many rail against the patent system in ignorance of these provisions. Therefore, in my view, the most significant issues are political and technical; we must be willing to ramp up production of vaccines and life-saving equipment and to coordinate its distribution to the willing on a global scale.
If you require any more information or any advice on this topic, please contact Chris Burnett on 01206 217604 or via firstname.lastname@example.org.