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30 April 2020AmericasMark Engelman

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.

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29 April 2020   Gilead has escalated its dispute with the US federal government by filing a new lawsuit accusing it of improperly filing for patents covering HIV drug Truvada.
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