On Friday, December 3, 2021, KEI requested an open public interest license to allow the exploitation of PF-07321332 (marketed in combination with ritonavir under the brand Paxlovid) in the Dominican Republic. PF-07321332, being developed by Pfizer, has shown promising results as a COVID-19 treatment. PF-07321332 is claimed in P2021-0232, a pending patent application filed by Pfizer in the Dominican Republic.
In November 2021, Pfizer entered into a voluntary license with the Medicines Patent Pool (MPP) to facilitate the global production and distribution of PF-07321332. The Pfizer license to the MPP allows the manufacture anywhere in the world and will create a large supply of generic versions of the PF-07321332 oral antiviral globally, but has more restrictive provisions regarding the sale and use of the drug. The agreement authorizes the sale of PF-07321332 either in a 95-country licensed area, which excludes the Dominican Republic, or in countries where there are no granted patents or patent applications pending. The MPP agreement also states that sublicensees can distribute PF-07321332 in countries that grant compulsory licenses.
KEI’s request seeks to enable generic manufacturers, including but not limited to companies that enter into agreements with the MPP, to supply the Dominican market.
Article 46 of the industrial property law in the Dominican Republic authorizes the grant of open licenses under public interest grounds. If granted, anyone capable of exploiting the inventions in the Dominican Republic can apply for such an open license. The open license can be issued over granted patents as well as pending applications. Article 46 provides that the patent office “shall” issue the license, indicating that its grant is mandatory. Moreover, article 46 authorizes the grant of licenses for use by or on behalf of the government. Our filing requests both an open and a government use license.
As required by the trade agreement with the United States and Central America (DR-CAFTA), the Dominican Republic provides test data exclusivity for pharmaceutical products. KEI asked the Dominican Republic to waive those provisions with regards to the PF-07321332 antiviral, and separately has written to Ambassador Katherine Tai asking that USTR provide KEI and the Dominican Republic government with a letter stating it will not enforce Article 15.10 of US-DR-CAFTA
KEI told the patent office that we will withdraw our request for a compulsory license if Pfizer agrees to add the Dominican Republic to the list of countries in the territory as set forth in Exhibit C of their license agreement with the MPP.
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Where was the request filed
KEI sent the request to the vice president of the Dominican Republic and the patent office. A copy was also sent to the Minister of Health. All have acknowledged receipt.
Next steps
Article 43 of Law 20-00 states that the patent office has to notify Pfizer of the request made by KEI. The notification has to be done within 30 days after the request was filed.
Pfizer has to send a reply to the request filed by KEI within 60 days after being notified by the patent office. If Pfizer fails to reply within 60 days after the notification, KEI’s request for a compulsory license will be considered granted according to article 43 of Law 20-00.
If Pfizer responds within the 60 days deadline and opposes the request made by KEI, the patent office is required to schedule a hearing to mediate. If KEI and Pfizer fail to reach an agreement on the terms, the patent office has to set a reasonable remuneration.
Exclusive Rights in Regulatory Test Data
KEI also expects the office of the vice president of the Dominican Republic to issue a formal response on our request for a waiver of the data exclusivity provision in order to register and sell generic versions of Paxlovid in the country.
Who can take the license
Under article 46 of the patent law in the Dominican Republic, “any interested person” can request a compulsory license based on public interest grounds. If granted, the license will be left open to any party that can exploit the inventions in the Dominican Republic.
Terms of the license
KEI proposes that the license include payments to Pfizer equal to 10 percent of the sales price of the generic product, and require companies to disclose the prices charged and the quantities of drugs sold, consistent with the WHO resolution on transparency WHA78.2.
Option to withdraw
KEI will withdraw the request if Pfizer agrees to add the Dominican Republic to the list of countries in the territory as set forth in Exhibit C of their license agreement with the MPP.