Russia / Eurasia: EAPO launches its Pharmaceutical Register
On March 1, 2021, the Eurasian Patent Office (EAPO) launched a new data base on its web site, the so-called “EAPO Pharmaceutical Register”. Currently this online Register is available to the public in Russian language only, the English version is expected soon.
In particular, this Register includes the following information:
- INN (or combination of INNs) of pharmaceutical and veterinary preparations,
- the originator’s brand names of these preparations (in the EA contracting states),
- EA patents which are considered to be relevant for these INNs,
- legal status and expected expiry dates of these EA patents in the individual EA contracting states,
- SPC/PTEs which have been granted (nationally),
- oppositions against the EA patents,
- registered license agreements.
The following information is NOT included in the EA Pharmaceutical Register:
- national patents (e.g. RU national patents) which provide protection for INNs and medicaments,
- invalidity actions which have been initiated against the national portion of an EA patent before the corresponding national authority (e.g. the Chamber for Patent Disputes at the RU PTO),
- other forms of exclusivity (orphan drug status, data/marketing exclusivity period etc.) of an INN or medicament.
The Register includes compound patents (incl. small and large molecules), as well as formulations patents (incl. pharmaceutical compositions and combinations of AIs), second medical use patents (incl. Swiss type and German type claim format), and also manufacturing process patents.
Currently, this Register includes 177 INNs and combinations thereof, and 271 patents which are considered to be relevant for these INNs in the EA contracting states. The initial Register has been compiled by the EAPO without input from patentees and/or holders of marketing authorizations, apparently on the basis of the SPCs that have been granted by the EA PO so far.
Starting from March 1, 2021, however, the owners of Eurasian patents can submit to the EAPO a request for introduction of a corresponding EA patent into the EAPO Pharmaceutical Register, if this patent covers any INN (or combination of INNs). Such a request may be submitted either as hard copy or through the EAPO-ONLINE system (for registered users). The EAPO will then check the information which was provided by the patent holders and, if this information has been verified, the EA PO will include the corresponding patent and/or INN in the EAPO Pharmaceutical Register.
The Pharmaceutical Register does not implement a real patent linkage system, which would include a mechanism for preventing a generic drug from getting Marketing Authorization before expiry of the originator’s patents. However, undoubtedly the Register is helpful to facilitate identifying and locating Eurasian pharmaceutical patents that have issued, their status and expected expiry dates in each of the EA contracting states, incl. patent term extensions (PTE/SPC) as far as granted.
In this context, it will of course be of advantage for patent holders of originator preparations to have their patents included in this Register, as this is an official register of a well-known International Authority and thus illustrates in a vivid manner the existence of patent protection for a given medicament or INN, which in turn should have a strong impact on generic manufacturers, and also on customers.