That title is a bit misleading, because Paxlovid does have patent protection. But that wasn't the case when it was first approved.
“Paxlovid” is the name given to Pfizer’s product for the treatment of COVID-19 infections. The product is actually a combination of two antivirals, ritonavir, which has been around since the 1990’s, and nirmatrelvir, which is brand-spanking new. (For an account of how this molecule was conceived in the first half of 2020, and how testing revealed some non-obvious choices of substituent groups, see here.) The two drugs are packaged as separate pills but sold in a single box as “Paxlovid”.
Paxlovid was first approved for use on an emergency basis in December 2021 for patients age 12 and up. It remains approved on an emergency use basis (the most recent update to the “FACT SHEET FOR PATIENTS, PARENTS, AND CAREGIVERS” was updated less than a week ago, on August 26, 2022), although a study published last week in the New England Journal of Medicine by a team of Israeli researchers concludes that nirmatrelvir does little for young patients. As practical matter, here in Israel it is available only to those aged 60 and over.
Pfizer filed a series of provisional applications covering nirmatrelvir (then called PF-07321332) between September 3, 2020 and May 29, 2021, culminating in a US non-provisional filed August 5, 2021. The corresponding PCT/IB2021/057281 was filed August 6, 2021 and published as WO 2021/250648 on December 16, 2021; it has since been nationalized in at least 20 countries. The first patent to issue in this series was US11351149B2, which issued on June 7, 2022 – more than five months after the initial emergency FDA approval. As of this writing, there is no Orange Book entry for nirmatrelvir, meaning the ‘149 patent is not listed in connection with the drug (which may be due to the authorization being an emergency use authorization rather than a standard FDA drug approval).
Pharma patents have been part of my work since I started in the patent field. I don’t recall any case in which a drug received approval before a patent covering the active ingredient had issued. Presumably, the even if standard FDA approval for Paxlovid is forthcoming in only a few years, the earlier initial emergency approval relative to the patent issuance will preclude the granting of a patent term extension for the ‘149 patent: if timing of patent issuance and FDA approval are such that 14 or more years of patent life remain at the time of FDA approval, no PTA will be forthcoming (35 U.S.C. §156(c)(3)).
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