Why things could get ugly over COVID-19 patents

In a time of crisis, access to appropriate pharmaceuticals is of paramount importance. At present there are six UK centres attempting to find an antiviral treatment for the COVID-19 virus.

There are many more other drug interventions being sought around the world to stop the rampage of the virus. The World Health Organization (WHO) lists at least 60 such projects.

Access to patented pharmaceutical subject matter is denied by the ownership of a patent.

However, with old drugs used to treat a novel disease come patents. For example, the patent rights to remdesivir, an experimental treatment for coronavirus, are held by the US company Gilead. Remdesivir is said by the WHO to be the only drug which might possess “real efficacy”. News reports claimed recently that the clinical trials of remdesivir failed but the company itself says otherwise.

The Wuhan Institute of Technology has also, for example, filed method patents. It seeks to protect the anti-malarial chloroquine.

In a recent press release, the German and Chinese companies BioNTech and Fosun Pharma are jointly conducting clinical trials of an mRNA vaccine technology and aim to “commercialise the vaccine in China … with BioNTech retaining full rights to develop and commercialise the vaccine in the rest of the world”.

In all these cases, any drugs whose patents are held by such foreign entities would only be supplied with the rights owner's consent and even then only upon the commercial terms dictated by them.

The UK government has always had the right to bypass the system by commandeering UK pharmaceutical patents, but it possesses no such right with respect to foreign patents. So, if the cure to COVID-19 is found, trialled, licensed and manufactured outside the UK, the government must be able to ensure its availability to the UK population. If the invention is discovered outside the UK, foreign patents rights will prevent the UK government accessing the drug.

At the international level the UK government might have retained the option to obtain an automatic right to license the drug for distribution within the UK—a “licence of right” to the patent over the export of pharmaceuticals made under foreign patents into the UK under article 31bis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The UK, along with member states of the EU, has opted out of the benefit of article 31bis of the TRIPS Agreement, a provision which permitted its right to import the active ingredient of a patented pharmaceutical without the consent of a foreign patent owner—provided, of course, it remunerated the patentee. So, in respect of a drug like remdesivir, owned by a US patentee, the UK could have accessed importation of that drug as of right. The opportunity now no longer exists.

The background to article 31bis began in 2001 for the purpose of developing rules for patents and access to medicines. In November that year, a WHO ministerial conference, “ Doha Declaration on TRIPS and Public Health”, resulted in an August 30, 2003, decision to waive export restrictions on pharmaceuticals on medicines and diagnostic tests manufactured under a compulsory licence. But negotiations ground to a halt over the meaning of “eligible importing member” which allowed 37 World Trade Organization (WTO) members, including the UK, to opt-out.

Opting back into article 31bis of the TRIPS Agreement might take too much time given the urgency that the crisis demands. Political pressure increased recently: a letter requesting that the UK and other WHO countries which opted out opt back in again was sent by interested parties on April 7, 2020.

Without membership of the article 31bis group, UK companies might wish to look to section 48A of the Patents Act 1977, which empowers the court to grant UK licences of right to use a patent filed by patentees of WTO member states. That would impact upon both UK and foreign drug inventors which protect their drugs in the UK. But it has no effect outside the UK to ensure supply of drugs protected by patents abroad.

If the UK remains unable to export the active ingredient from outside the UK into the UK—no doubt from the two main pharmaceutical manufacturing countries, India and China—then it might have to look to manufacturing such products itself here in the UK.

One fly in the ointment is US president Donald Trump’s removal of funding towards the WHO, which may impact upon whether section 48A would extend to inventions made in the US if the US is no longer a member to article 31bis.

Gilead is a US company. If the US no longer remains a member of the WHO, Gilead’s drug would not be imported into the UK without the company’s consent or its agreement on royalties, even if the UK was to opt into article 31bis.

But assuming the US is not the only player in town in relation to the manufacture of COVID-19 drugs, section 48A may remain the refuge for COVID-19 pharmaceuticals within the UK.

Mark Engelman is an IP barrister at Hardwicke chambers. He is also a research associate at St Edmunds College, Cambridge, and adjunct professor of law at Notre Dame University. He can be contacted at:  mark.engelman@hardwicke.co.uk