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.
A large part of our team has been present at the most important IP-event held this year in Boston, in May 2019. Our colleagues have met several partners and colleagues. They have also negotiated, during face-to-face meetings, key aspects of pending deals in the name of our clients. It was also another year when our ( learn more )
Among our recent large mandates, we are proud to count the IP due-diligence performed in the name of a famous US investment-fund, who just bought a network of private clinics in Eastern-Europe. The focus is not only on the brand itself, but also on additional good-will which can be captured through several assets including websites, ( learn more )
We represent an important Swiss company in the FMCG industry, in relation to a foreign patent extended to Europe. Our task is to help them in preparing the file able to stop the expansion of the patent to Europe. The difficulty resides in the need to find earlier public documentation, a soft-skill necessary in this ( learn more )