COVID-19 Licensing Challenges

• Published date: 18 June 2020
• Author: HGF Limited
• Subject Matter: Intellectual Property, Coronavirus (COVID-19), Licensing & Syndication, Patent, Operational Impacts and Strategy
• Law Firm: HGF Ltd

The taking of new therapies and technologies forward to meet the challenges of COVID-19 is happening at previously unprecedented rates. MHRA is taking flexible approaches to regulation during the COVID-19 outbreak.¹ This includes providing expedited scientific advice, and rapid reviews of clinical trials applications.

The speed of progress means that it is challenging for you to know:

• that you have freedom to operate (FTO) i.e. you will not infringe anyone else's therapy or technology, and do not need a licence; and
• on what terms to license in necessary technologies and license out your own technology, when the focus is on just getting help to patients now.

Whilst you should still look at your FTO position, there are some exemptions and non-assert/licensing arrangements that might help you out in the short-term.

Infringement exemptions

At the pure research stage, you may not need a patent licence. Can you rely on the experimental use exemption?² In other words is what you are doing for experimental purposes relating to the subject-matter of the patented invention. This exemption does not extend to testing/clinical trials.³

An additional exemption was introduced for activities conducted only to obtain an abridged marketing authorisation application.⁴ This is often known as the Bolar exemption. There is now also an exemption for anything done in or for the purposes of a medicinal product assessment.⁵ This includes any testing, course of testing or other activity undertaken with a view to providing data for obtaining or varying an authorisation to sell or supply, or offer to sell or supply, a medicinal product anywhere.⁶ Both of these exemptions only apply to medicinal products and not to medical devices.

Non-assert agreements/licences

So, what happens when you want to commercialise? You might be protected against infringement under an Open COVID Pledge. Various organisations, including Microsoft, Intel and Mitsubishi Electric, have made the following pledge:

. to make our intellectual property available free of charge for use in ending the COVID-19 pandemic and minimizing the impact of the disease.⁷

They will do this through a licence specifying the full terms. That licence will last until one year after the World Health Organization (WHO) declares the COVID-19 pandemic to have ended or 1 January 2023.

Over 80 Japanese organisations, including Canon, Kyoto University's Center for Genomic Medicine, Nissan and Toyota, have their own Open COVID...