Insights

With the US’s move to purchase the full stock of remdesivir – a patented drug (one out of only two) that is proven to work against COVID-19 – for the coming three months, talk of EU Member States resorting to the Compulsory Patent Licensing regime, is ripe.

Under this legal regime, Member States may authorise individuals to make use of patented products without the consent of the patent holder, where such use is necessary in very limited scenarios, including a public health crisis.

In the words of Article 40 of Malta’s Patents and Designs Act (Chapter 417 of the Laws of Malta), “Where the national security or public safety so requires, the Minister may authorise, even without the agreement of the proprietor of the patent or the patent application, by notice published in the prescribed form, a Government agency or a person designated in the said notice to make, use or sell an invention to which a patent or an application for a patent relates, subject to payment of equitable remuneration to the proprietor of the patent or the application for the patent.”

The COVID-19 pandemic would seem to fall squarely within the above scenario.

Such a licence would allow for the manufacture of generics in Malta. Whether local law goes so far as to allow for the purchasing and importation of generics produced in countries that, due to their legal system, have fallen outside the patent protection granted to the patent right holder (in this case, Gilead), such as India, is moot. Whilst legal commentaries relating to the UK’s compulsory licence regime suggest that it may extend this far, one will note that, unlike under our law, the “importation” of protected goods is specifically included as one of the activities that may be authorized through a compulsory licence issued “for services of the Crown” (see the UK’s “Patents Act 1977”, Section 55). This uncertainty ought to be immediately addressed by the Maltese legislator who would not be the first to specifically address the subject of patents in view of the Coronavirus pandemic. Germany, for instance, issued specific legislation in March to address the possibility of limiting patents in view of the pandemic.

If granted by the Minister responsible for the protection of industrial property in Malta, such a compulsory licence will be on a non-exclusive, non-assignable basis, and will immediately terminate when the situation that gave rise to the need for the licence comes to an end.

The issuing of a compulsory licence is subject to appeal by the patent right holder to the First Hall of the Civil Court.

The European Patent Office’s publication on Compulsory Licensing, which highlights the legal position in EPO Member States, can be viewed here.