In pharmaceutical law, our expertise covers the clinical and technical development (including GCP and GMP) and subsequent approval of medicinal products in the German and European marketing authorisation systems – within both the centralised and decentralised procedure – right through their marketing. We particular focus in our regulatory advice do the area of orphan drugs, legal issues related to the Paediatric regulation, and pharmacovigilance as well as product liability issues.
The range of our services includes pharmaceutical contract law, in particular clinical trials and observational studies, as well as distribution schemes such as co-marketing and co-promotion contracts.
In the field of regulatory exclusivity rights (regulatory data protection, orphan market exclusivity and the paediatric extension of exclusivity rights), our lawyers have decades of experience in Germany and Europe based on particularly extensive practical knowledge, which applies in particular to third-party opposition proceedings. This includes administrative and civil law proceedings in Germany and legal proceedings before the European Court of Justice as well as representation in patent infringement proceedings.
In addition to traditional product borderline questions, we also advise our clients comprehensively on the constantly changing possibilities of different product classifications – from composition, presentation to marketing and advertising. Here, the delineation of medicinal products to the product classes medical devices, biocides and foods (classic foods such as teas or cough drops as well as Bach flowers and dietary supplements) is one of our regular fields of activity.
In the field of medical devices, our consulting ranges from conformity and certification procedures to subsequent sales. The delineation of medical devices in particular to medicinal products has been the subject of our regulatory advice since the beginning of the independent rules for medical devices. We also advise on the challenges related to the new Medical Device Regulation (MDR).
The promotion of medicines and medical devices continues to be a significant part of market access activities. We advise our clients in their advertising campaigns and the compliance with the German Law on Advertising in the Field of Health Care, with the general competition law rules and we run related lawsuits (preliminary and main proceedings).
The delimitation of food supplements in particular to medicinal products and medical devices belongs to our competence in the same way as legal advice to questions on advertisement related to the health claims regulation as well as the consultation and assistance with health claims applications.
We have extensive experience and expertise in the support of patent infringement proceedings in Germany and coordination across Europe. The support of our clients in the area of supplementary protection certificate (SPC) as well as a possible pediatric extension thereof is one of our core competences.