On November 16, 2021, Pfizer and the Medicines Patent Pool (MPP) announced at voluntary license to patented inventions and know-how to manufacture a two drug combination to treat COVID-19. The MPP announcement is here and here.
Additional comments on the license are available here: https://twitter.com/jamie_love/thread/1460588361429696515
The Pfizer brand for the treatment is Paxlovid, and involves the combination of two protease inhibitors, PF-07321332 and ritonavir.
The license is similar to the recent license announced between the MPP and Merck for molnupiravir, but with some differences. The Pfizer license excludes seventeen countries that were included in the Merck license, but adds seven others, for a net change of ten countries (among other geographic differences, the Pfizer license includes fewer island countries, and more Central Asian countries). KEI has prepared a Google Sheet (available here) that compares the population and per capita income for the countries in and out of the licensed area. Like the Merck license, the Pfizer license targets countries with lower per capita incomes ($2600 per year on average, compared to more than $20,000 per year on average for countries out of the licensed area).
The Pfizer license allows manufacturing to take place anywhere, as long as sales take place in the licensed area. This is an important feature for addressing COVID-19, as there is a pressing need to rapidly scale manufacturing, and it is the same approach embraced by Merck in its MPP license.
Like the Merck license, the Pfizer agreement provides a path to selling outside of the 95-country licensed territory, in countries where there is no patent or where a compulsory license has been granted, so long as the manufacturer has licensed the patents, but not the know-how. The Pfizer license avoids some of the problematic and confusing language on termination for patent challenges found in the Merck license (which were included at the insistence of Emory University.
What is probably more significant is that the Pfizer drug seems to have a less risky safety profile than Merck’s molnupiravir, making it a possible test-and-treat drug. Any drug that can be safely used following early infections has a potentially large number of persons who will benefit, assuming the pricing is affordable and regulators agree with Pfizer that the drug is both highly effective and safe.
Paxlovid requires 300 mg of PF-07321332 and 100 mg of ritonavir twice a day for 5 days, or 4,000 mg per course of treatment. Both drugs are relatively easy to manufacture. Molnupiravir requires 8,000 mg of the API per course of treatment. Both Paxlovid and molnupiravir are not expensive to manufacture as generics.
Like Merck, Pfizer is making its license royalty free during the emergency, which among other things, will make the licenses easier to manage.
Comment by James Love, Director of KEI:
-
“Pfizer’s license with the Medicines Patent Pool (MPP) will allow the rapid scale up of manufacturing of what appears to be an effective and safe treatment for COVID-19. The licensed territory is large and underserved by vaccine manufacturers, making inexpensive to manufacture therapeutics particularly important. The manufacture anywhere feature of the license provides the right model for scaling manufacturing in a pandemic, where speed and decentralization are desired. Countries outside of the licensed area have the possibility of granting compulsory licenses on patents, and if pricing and affordability are a barrier to access, they should do just that. Pfizer deserves credit for engaging with the MPP and agreeing to transparency, open and procompetitive licensing in the middle of a pandemic for this product.”
ANNEX: Exclusions and additions in the Pfizer license, when compared to the Merck/MPP license for molnupiravir
The following countries are in the molnupiravir license, but not in the Paxlovid license (i.e. exclusions):
Cuba
Dominica
Fiji
Grenada
Guyana
Iraq
Jamaica
Libya
Maldives
Marshall Islands
Mauritius
Paraguay
Seychelles
St. Lucia
St. Vincent and the Grenadines
Suriname
Tuvalu
The following countries are in the Paxlovid license, but not in the molnupiravir license (i.e.additions):
Armenia
Georgia
Jordan
Kosovo
Kyrgyz Republic
Ukraine
West Bank and Gaza