Litigation Case Study: Settlement of a Data Exclusivity Dispute

The problem:

A multinational pharmaceutical company headquartered in the United States has registered in Kazakhstan (through its Swiss subsidiary) an original drug (hereinafter the “OD”). A large generic company (Pakistan) has submitted documents in Kazakhstan for the examination of a generic drug containing the OD’s active ingredient with the aim of its subsequent registration.

The holder of the registration certificate for the OD filed a preventive claim with the Almaty Economic Court against the National Center for Expertise of Medicines and Medical Devices, the Committee for Quality Control and Safety of Goods and Services (formerly, the Pharmacy Committee) and the generic company in order to prevent the examination and registration of the generic drug before the expiration of the six-year data exclusivity period for the OD.

The data exclusivity institute was introduced into the Kazakhstan legislation in 2015 upon the country's accession to the WTO. See the useful information on data exclusivity in Kazakhstan:

Data Exclusivity: Legal Implications for Pharmaceutical Industry of Kazakhstan, Ravil Kassilgov, AIFC Academy of Law (webinar in Russian)

Pharmaceutical Data Exclusivity: Judicial Precedent in Kazakhstan

The outcome:

The dispute was settled by an out-of-court agreement of the parties. The parties involved in the settlement included not only the holder of the OD registration certificate and the generic company, but also the US company, a holder of patents for the OD. The parties managed to reach an agreement on the observance of the data exclusivity rights and patent rights with respect to the OD. Thus, the use of the data exclusivity institute as a remedy of the manufacturer of the original drug also contributed to the settlement of a potential patent dispute.

It should be noted that all court hearings, as well as negotiations between the parties, were held in a remote format, which did not prevent the achievement of peace.

The interests of the US and Swiss companies in the court and during the negotiations were represented by Ravil Kassilgov in cooperation with the Lidings’ Partner Boris Malakhov.