It was announced last week (16 November 2021) that Pfizer has agreed a voluntary licence with the UN-backed Medicines Patent Pool for Pfizer’s oral COVID-19 antiviral treatment candidate, PF-07321332. PF-07321332 has not yet been approved by regulators but has shown promising results in controlling symptoms of COVID-19. Recent interim analysis from Pfizer’s Phase 2/3 trial showed an 89% reduction in risk of COVID-19-related hospitalization or death compared to placebo in patients treated within three days of symptom onset. It will be administered with a low dose of ritonavir (a repurposed HIV antiviral medicine) which helps slow the breakdown of PF-07321332 in the body.
The MPP was established in 2010 with the goal of increasing access to, and facilitating the development of, life-saving medicines for low and middle income countries. To date MPP has focussed on treatments for HIV, hepatitis C and tuberculosis as well as other patented essential medicines on the WHO’s Model List of Essential Medicines. In 2020, its mandate was expanded to include COVID-19 treatments.
- The agreement between Pfizer and the MPP, which has been published on MPP’s website, enables MPP to grant non-exclusive licences under Pfizer’s patents and know-how relating to PF-07321332 to sub-licensees in 95 low and middle income countries (covering around 53% of the world’s population).
- The agreement will enable MPP to facilitate additional production and distribution of the product, pending regulatory authorisation or approval, with the goal of facilitating greater access to the global population.
- Sub-licences will be granted on the same terms to all sub-licensees (with the form of sub-licence agreement appended to the agreement between Pfizer and MPP).
- The licence will be royalty free until the WHO declares the end of the current Public Health Emergency of International Concern. After that period, Pfizer will be entitled to receive royalties of 5% of net sales of the product to governmental authorities or public purchasers, and 10% of net sales to commercial entities.
- Pfizer has agreed to forgo royalties entirely on sales to low-income countries.
The voluntary licensing deal between Pfizer and MPP is the second in recent weeks. Merck Sharp & Dohme (MSD) also granted a license to MPP on similar terms in October this year for molnupiravir (MK-4482/ EIDD-2801), an investigational oral COVID-19 antiviral medicine.
The concept of patent pools and voluntary licensing is far from new, however there has previously been some reluctance from patent holders to sign up. One of the oft-cited concerns being the risk of parallel imports of the patented product from patent pool countries into other territories, potentially jeopardising a patent holder’s returns in higher income countries. Patent holders have also previously raised concerns about quality control, geographical scope (particular which middle income countries are in-scope), control over clinical data and access to improvements. However, the current pandemic, and the resulting exceptional global medical need for COVID-19 treatments, means that the potential benefits of patent pools are gaining more attention. Where ensuring quick global access to a medicine is high priority (as in the current pandemic) a patent pool or voluntary licensing model (such as that used by MPP), represents a potentially quick route to market for patent holders in low and middle income countries. Other potential advantages for patent holders include the possibility of reducing transaction and administration costs (as compared with a direct licensing model); generation of royalty income from a potentially broader market; the ability to agree standard terms to protect the patent holder’s IP and to regulate quality control; and not least, potential reputational benefits for the patent holder.
As more treatments for COVID-19 continue to be developed, it will be interesting to see whether other patent holders follow suit with Pfizer and MSD in pursuing a patent pool or voluntary licensing strategy in low and middle income countries.
This agreement could help us to reach more people more quickly as soon as the medicine is approved and, when coupled with increased access to testing, bring benefits to millions.”