The current coronavirus pandemic provides a unique opportunity for the life sciences sector to invent, and to do so on an international scale. The race is on to develop a vaccine, effective therapies, and accurate tests for the virus required by every country in the world, but such innovations typically take years to discover and refine. The only way to move quicker in such research is to collaborate and cooperate to provide resources and expertise as needed, but this provides significant challenges for intellectual property (IP).
Individual companies that conduct research and development in the life sciences field are generally highly protective of their intellectual property, perhaps more so than other fields, because inventions can take decades to come to market and require such an enormous amount of investment in R&D. A typical vaccine takes around 10-15 years to come to market after being invented, protected, and then tested through clinical trials. This is a complex and costly procedure which leads R&D companies to rely on patents to secure their monopoly and ensure income when the product finally reaches fruition. These companies usually file a high number of patent applications, closely monitor competitors activities, and are active in enforcing their patents. Collaborations do take place, but are unfortunately slow to occur, requiring extensive agreements and funding.
Whilst patent applications are being filed around coronavirus technologies, the sudden need for solutions to this pandemic crisis has prompted many companies to take a different approach. A huge number of collaborations and co-operations are already underway, with protection of IP seemingly taking a back seat. Not only that, but companies and governments are acting to waive pre-existing IP rights. Such an "opensource" style research and access to otherwise patent protected IP is unprecedented.
Many patent laws around the world have provisions for times in which an invention under patent protection is so necessary, that the exclusivity provided by the patent can be removed. Such provisions are known as compulsory licences. Compulsory licences are a means by which a government can authorise third parties to make, sell, or use a patented invention. They are not a common occurrence. In the
Although compulsory licences are rare, since the coronavirus outbreak several countries have announced broad compulsory licensing of almost any technology useful in the fight against coronavirus on a level that has never been seen before.
In mid-
On 22nd March, Gilead announced that it would be rescinding valuable orphan drug status for its widely touted anti-viral therapy; Remdesivir 6, in order to accelerate its production in the US. Remdesivir is a nucleotide analogue prodrug originally tested in Ebola patients. It has been identified by many as the most promising candidate treatment for COVID-19, despite the lack of data to support its effectiveness. The worldwide interest in the drug has sparked other countries to take different actions in an attempt to secure access. In
Meanwhile in
In the
Although enforced licensing or use seems like an easy way to ensure access to key inventions, it is vital that the patent holders subject are fairly compensated for such compulsory licences or crown use to ensure that income from innovation, which is relied upon for current and future R&D, is not compromised. The pipeline of new medicines is typically funded by the sales of previous patent protected drugs, and is a very expensive process. There are also logistical difficulties with compulsory licensing or crown use of pharmaceutical products. Whilst companies may initially be keen to produce previously patent protected drugs, in reality there is a huge amount of rigorous set-up for manufacturing drugs, and supply of key excipients or other ingredients often with high grade and purity needs to be obtained, which could be problematic. Such issues could actually cause a delay in the provision of desirable therapies, despite the access permitted by such measures.
In the midst of the current pandemic, there have been calls from researchers and governments for the usual IP strategies and agendas pursued by companies to be side-lined, and for cooperation and collaboration to be prioritised in whatever way possible. Compulsory licensing is one way to achieve this, and is already being exploited in an unprecedented way to ensure access to the most promising medical advancements to treat coronavirus. It remains to be seen if the even more obscure crown use provisions will be utilised in the
In view of the humanitarian need and the pressure of public opinion, it is encouraging that in most cases, companies are choosing to waive their patent rights before being forced to do so. Pre-empting possible compulsory licence requests or crown use has so far allowed companies to maintain relatively good public opinion and avoid creating PR issues. In a time when the spotlight is firmly on the healthcare sector, these companies are keen to show that they are not providing barriers to finding an effective treatment, and perhaps make the most of the opportunity to improve their public reputation.
Footnotes
1 https://www.gov.uk/guidance/the-patent-act-1977/section-48-licences-of-right-and-compulsory-licences-compulsory-licences-general
2 https://www.keionline.org/chilean-covid-resolution?_sm_au_=iVVvns5WHQ11sMDPvMFckK0232C0F
3 https://www.keionline.org/wp-content/uploads/ES-Ecuador-CL-resolution.pdf
4 https://www.keionline.org/wp-content/uploads/A-Permit-to-the-State-to-Exploit-an-Invention-Pursuant-to-Chapter-Six-Article-Three-of-the-Patents-Law-5727-1967.pdf?_sm_au_=iVVvns5WHQ11sMDPvMFckK0232C0F
5 https://www.ft.com/content/5a7a9658-6d1f-11ea-89df-41bea055720b
6 https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-request-to-rescind-remdesivir-orphan-drug-designation
7https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7156563/#!po=56.2500
8 https://www.ftm.nl/artikelen/roche-releases-recipe-after-public-pressure-while-european-commission-considers-intervention-due-to-coronavirus-test
9 https://www.gov.uk/guidance/manual-of-patent-practice-mopp/section-55-use-of-patented-inventions-for-services-of-the-crown
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