Pharmaceutical regulations

In the area of pharmaceutical regulation, the role of the French patent litigator is to advise and represent clients in matters relating to the regulation of drugs and health products. He can assist pharmaceutical companies, medical device manufacturers, health care service providers and other parties involved in the health products supply chain in navigating the complex array of laws and regulations that govern this industry.

The attorney can also assist clients in filing marketing authorization (“MA”) applications with the appropriate bodies, negotiating commercial agreements, evaluating intellectual property issues, managing regulatory compliance issues, and representing clients in pharmaceutical regulatory litigation. He can also inform clients about the latest regulatory trends and developments and the potential consequences for their business activities.

The numerous regulations that govern Marketing Authorizations (MA) in the pharmaceutical sector must be aligned with industrial property, particularly with patents.

Thus, for example, the time required to obtain a marketing authorization will be compensated for by the granting of a supplementary protection certificate (known as a “SPC”), which will extend the duration of protection, in order to compensate for this time.

In the same way, this knowledge of the regulations will be essential in the context of seizure-counterfeiting if it is envisaged to carry it out with an authority in charge of issuing marketing authorizations, such as the ANSM.