What is real
is not external form.”
Starting with 2016, we are representing a reputable French pharmaceutical laboratory in some files / procedures that overlook the way in which clinical trials are being carried out in Romania. These studies impact both the local and the European medical community. For this reason, the courts in Romania, where our client operates these studies, want to ensure that the optimal conditions are met for the conduct of the respective studies. Conditions that materialize in respecting good practice in conducting Phase II clinical trials (our case). Phase II clinical trials set out the following: efficacy of the drug tested, efficacy in disease prevention, and appropriate dosage levels.
To start a clinical trial in Romania you need the approval from two national forums: the National Medicines Agency and the National Ethics Commission. Once these approvals have been obtained under the current legislation, the clinical trial may begin. The legislation is comprised on a set of regulations called “Good Clinical Practice.”
We are still in the process of carrying out these procedures, which we expect to be finalized sometime during this year/2019. Throughout this period, we provided consultancy services that consisted of monitoring the initial file and analyzing the papers and requests coming from the parties involved. We also proposed to the client the strategy and recommendations we considered appropriate to combat the actions filed against its rights and interests.
Our experience and years of practice thought us that, although the interest of our clients and the purpose of our services is the same, the way to deliverance can be spurred with different problems, and the methods of solving them are often diverse. Context. Our client, an important European producer of materials in the transport ( learn more )
Since last November, we are handling the case of a chocolate and sweets Swiss manufacturer who wants to register two brands in Canada in order to enter and sell its’ company products on the local market. Following the filing of the trademark applications, we have been notified by the Canadian Intellectual Property Office (CIPO) that ( learn more )
Situations can vary. We have already expressed our opinion in other materials on how we proceed when the trademark our customer wishes to register is already in use on the market. But what happens when the customer is the one that owns the trademark that a competitor wishes to register for the marketed products? The ( learn more )