On 1 March 2021, the Eurasian Patent Office launched the Pharmaceutical Register , covering 8 jurisdictions, including Russia, Belarus, Kazakhstan
A demo-version is available on the official website of EAPO.
The new Register contains information on Eurasian patents protecting active substances of drugs.
The EAPO specifically indicates that the Pharmaceutical Register shall relate to the patents protecting pharmacologically active products (chemical compounds, including those described by the same structural formula, biotechnological products, compositions, combinations), production methods and medical use of the products.
The Pharmaceutical Register contains the following data for each drug:
- patent application number and date of filing
- Eurasian patent number and name
- patent holder
- patent validity period
- INN and marketing authorizations
- registered license agreements
A patent holder may file an application to include the drug in the Pharmaceutical Register. The application shall comprise INN, patent claims protecting pharmacologically active substance, information about drugs registered within the EAPO along with relevant evidence.
As of 1 March 2021, a demo version of the Pharmaceutical Register includes above 100 INNs and patents.
Similar registers have long been set up worldwide to settle disputes between patent holders and generic producers (e.g., the US Orange Book).
The EAPO Register will certainly lower the burden of proof for patent holders in infringement cases and make the possibility to challenge SPCs (a 3-month statute of limitation applies in most jurisdictions) more complicated. It will also help in regulatory and contractual issues for the local market.