Institutional double vision: Launching a pharmaceutical brand in Poland
On 3 March 2017 The Polish Patent Office (PPO) and the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) issued a joint communication on issues to be taken into account when launching new pharmaceutical brands in Poland. However, both authorities ignored the fact that the same work is being done twice.
State of play
A marketing authorisation (MA) is required to launch a new pharmaceutical product. Nevertheless the approval of the product’s brand in the course of MA proceedings does not alone afford satisfactory protection. This is why businesses should also have their pharmaceutical brands registered as trade marks.
To that end a new brand must undergo two independent examinations carried out by different authorities under different laws. For instance, granting MAs is entrusted to the URPL and is governed by the Pharmaceutical Law of 6 September 2001, whilst the PPO handles trade mark registration, a process governed by the Industrial Property Law of 30 June 2000. As these outcomes are independent, obtaining an MA does not guarantee its holder trade mark protection for the new brand, nor does obtaining a trade mark for the new brand guarantee that it will be approved as the name or brand of the pharmaceutical.
Paradoxically, the scope of these two examinations partly overlaps due to similar criteria being applied by both authorities.
- Earlier marks/brands. An MA for pharmaceuticals under a certain brand may be refused on the basis of an identical or similar existing brand of pharmaceuticals, and a trade mark application may be rejected upon an opposition based on an identical or similar earlier trade mark. Since most pharmaceutical brands are registered trade marks, both the PPO and URPL actually take into account the same items.
- A pharmaceutical brand should not be confused with an international non-proprietary name (“INN”) for that pharmaceutical’s active ingredient, and a trade mark should have distinctive character. Since trade marks for pharmaceuticals are considered devoid of distinctive character if identical (or almost identical) to relevant INNs, INNs are taken into account by both authorities.
- Both pharmaceutical brands and trade marks should not deceive the public, e.g. as to therapeutic indications.
Performing two independent examinations assessing similar grounds for refusal creates an obvious overlap. Perhaps it would be more beneficial if the PPO and URPL cooperated more closely with each other so that one authority could benefit from the expertise of the other (e.g. the PPO’s expertise in visual, oral and conceptual comparison of marks, and URPL’s expertise with regards to INNs) in order to avoid duplicating the work and to provide the applicant with a clear answer from both the regulatory pharmaceutical and trade mark perspective. Nevertheless, since the joint communication sticks firmly to the existing status quo, for now the PPO and UPRP seem to be happy with underlining their separate areas of expertise rather than developing closer cooperation.
Originally published in BrandWrites 8th Edition.