Last week, Professor Brook Baker filed an Amicus Brief responding to four of the arguments made by Pfizer against the compulsory license requested by KEI in the Dominican Republic to allow the distribution of the generic version of Paxlovid. His brief was officially filed with the patent office. Professor Baker summarizes his brief as follows.
This submission is limited to four general points relevant to the compulsory license petition pending for decision at the Dominican Republic Patent Office relating to Pfizer’s COVID-19 antiviral, Paxlovid. More particularly, it responds to central arguments put forth by Pfizer in its opposition to the compulsory license petition filed by Knowledge Ecology International (KEI). The first point is that the relevant human rights at stake in this petition are the rights of Dominican Republic people to have expanded, expedited, affordable, and equitable access to nirmatrelvir + ritonavir for outpatient use to prevent disease progression, hospitalization, and even death. The primacy of the people’s right to health is directly contrary to Pfizer’s assertion of a nearly inviolate human right to its intellectual property. However, Pfizer has no enforceable human rights to the patent and data rights it asserts over Paxlovid and to the contrary is violating its human rights duties by filing this opposition. The second point is that even the intellectual property rights that Pfizer does have are constrained ab initio by the possibility of a compulsory license; at the time they filed for a patent application covering Paxlovid, the government’s right to issue a compulsory license for stated purposes was fully authorized in Dominican Republic law. The third point is that Pfizer’s opposition is duplicitous in that its voluntary license with the Medicines Patent Pool and its sublicensees directly allows for countries like the Dominican Republic, excluded from the territorial coverage of the voluntary license and sublicenses, to issue compulsory licenses that would allow generic sublicensees to sell generic nirmatrelvir + ritonavir to them. By filing its 44-page opposition to this compulsory license request, Pfizer recants and undermines the right it freely negotiated with the MPP.
The fourth point is perhaps the easiest. Neither the TRIPS Agreement nor that Dominican Republic compulsory licensing law requires a separate executive declaration of the need for and grounds for a compulsory license request on a particular medicine. As clarified by the Doha Declaration on the TRIPS Agreement and Public Health, countries have total freedom to decide the “grounds” for compulsory licenses and can do so on stated policy grounds, not merely on the basis of case-by-case advance executive declaration. This understanding of the right to state broad and multiple grounds that justify the issuance of compulsory licenses is codified in the law of virtually every country that issues compulsory licenses. There are particular compulsory licenses rules in the special circumstances where a government faces an emergency or matter of extreme urgency – for example, the elimination of the requirement to engage in negotiations for a voluntary license on reasonable commercial terms – but even in such urgent circumstances a formal executive pronouncement is not a TRIPS requirement. The emergency or urgency can be recognized by the authority that grants the compulsory license. In sum, Pfizer seeks to complicate and undermine widely recognized procedural simplicities by imposing a dual process – first executive declaration on the need for a compulsory license as a gateway barrier and only thereafter and secondarily case-by-case consideration of the actual compulsory license application to be considered, in the case of the Dominican Republic, on broad public interest grounds.