Compulsory licensing and governmental use of patents has been under significant scrutiny since the start of the pandemic. From the outset, questions arose of whether the problem of supplying the public with sufficient quantities of vaccines and COVID-19 medicines as well as medical devices such as non-invasive and invasive ventilators, masks etc. could be easily solved by a forced use of patents, be it by compulsory licensing of competitors or even governmental use orders.
At our upcoming Pharma forum, we'll focus on this topic from a German perspective, including the guiding case law provided by the Federal Supreme Court and the application of the compulsory licenses provision of the Patent Act.
Requirements for Governmental Use Orders and Compulsory Licenses
First, we'll consider the requirements for the grant of a governmental use order and a compulsory license in comparison. As patent property rights are protected by the Constitution and because any encroachment in fundamental rights must meet fairness and equitable requirements, we will focus on restrictions of their scope and whether the possibility of a compulsory license by a competitor excludes the grant of a governmental use order.
Leading case law: HIV drug and Alirocumab
Next, we'll take a closer look on the two recent leading cases on compulsory licenses decided by the German Federal Supreme Court – HIV drug (2017) and Alirocumab (2019) – and on how the Federal Supreme Court applied the requirement of "public interest" in those cases.
Practical issues
Finally, we'll discuss the practical implications of compulsory licenses and governmental use orders. Insofar as completely new medicines developed during the pandemic, the related intellectual property rights will (broadly) still be in application stage and not yet even granted as patents. Data and market exclusivity provisions will still apply to the clinical data, as well.
Any competitor or anybody who might use a patent based compulsory license or governmental use order, respectively, will also need a marketing authorisation for the manufacture and distribution of the (patented) medicines and vaccines. However, there are no corresponding compulsory measures in the regulatory law.
The legal situation will differ between newly developed medicines and second medical use of already known treatments that have generic authorisations. Already, it's clear to see that there's no easy solution and no "one size fits all" solution (see our FAQ page for more).
Would a general waiver of patents help to globally solve the shortage of vaccines?
Bearing this in mind and looking at the recent political discussion about a potential waiver of COVID-19 related patents to globally cope with the pandemic, we'll consider why simply lifting patent protection will not help to solve practical limitations in the manufacturing and supply capacities (a handy summary is available here).
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