What is real
is not external form.



CONSTANTIN BRANCUSI

Assisting a pharma lab in court

14.03.2019


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.

 

25.09.2020

Through similarity we found the difference

Lately, we’ve been working on a case which has proven to be quite difficult. After receiving a refusal for one of the trademarks we administer, because of the similarity to a previous trademark, we have still managed to pass the mark towards publication by pointing out certain aspects such as: the existence of a very ( learn more )

18.09.2020

Class down, trademark up

Between August and September 2020, we faced a fairly common issue in the world of intellectual property. We have identified a similar trademark to that of one of our clients. The next step was contacting and starting the negotiation procedure with the opposing party in order to waive the protection of one of the classes, ( learn more )

24.08.2020

The link between tea and religion? Trademark

Lately, we have worked on a refusal notice to help our client, a key player in the tea and agricultural products industry, in terms of preparing a strategy to get a trademark registered. In this regard, we are currently looking for arguments and trying to prove that the term underlying the name of this business ( learn more )