The information contained includes:
- The application number
- Patent number
- The title of invention
- Patentee’s data
- Patent’s term of validity
- Renewal information
- Information on drug registrations in EAPO member states
- Information on registered license agreements
The Pharmaceutical Register was formed on the basis of the EAPO’s own sources of information, a number of external specialist databases, as well as information provided by the holders of Eurasian patents. The trial version shown on the first day of launch contained information on patents related to more than 100 INNs.
Patent holders may submit an application to include their patents in the Register. The application must relate to Eurasian patents covering pharmacologically active products (chemical compounds, including those described by the same structural formula, biotechnological products, compositions and combinations), production methods and medical uses of these products. The application should contain the following information:
- Eurasian patent number
- Identification of claims relating to a pharmacologically active product
- Information about relevant medicinal products registered in the EAPO member states
- Country where the registration of the medicinal product was obtained
- Proprietary name
- Number, date, validity period, and holder of the state registration of the medicinal product
- Additional materials helping to compare the patented substance with the INN specified in the application.
To a certain extent, the EAPO’s Register is similar to the publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the Orange Book), which identifies drug products approved on the basis of safety and effectiveness by the US Food and Drug Administration (FDA). However, the EAPO’s Register focuses on patent rights and provides no link to the national and regional pharmaceutical regulators.
The EAPO Pharmaceutical Register is expected to simplify the running of freedom to operate (FTO) searches, help the patentees in enforcing their rights and facilitate the making of license agreements. Experts also believe that the Register will help simplify the process of registration of generic drugs, stimulate development in the pharmaceutical industry and have a positive impact on the investment climate in the region.
FICPI’s view and involvement
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