Effective Europe-wide Enforcement of Pharmaceutical Patents against Generics
Problem & Action Needed
Our client is a major pharmaceutical company which markets its medicinal products globally. For one of its blockbuster products, substance patent protection was about to expire, and a formulation patent provided for just a few weeks of additional protection for the original product. It was feared that some of the numerous generics companies that had obtained marketing authorizations would not respect the formulation patent or would even launch their product several days or weeks before expiry of the substance patent protection in order to achieve an advantage over their competitors.
HOFFMANN EITLE’s Team
The team was led by an experienced German attorney-at-law from our patent litigation and licensing team specialized in pharma patent litigation and the coordination of Europe-wide enforcement of originators’ patents against unauthorized early market entry of generic products. A litigation-experienced partner from the chemistry department headed the patent-attorney side. Associates were involved in the project for specific tasks where necessary. For litigation activities outside Germany, we cooperated with litigator teams having the relevant experience in pharma patent enforcement projects against generics companies in their country.
The project started more than two years before the expected loss of exclusivity by preparing and sending information/warning letters, observing of competitors’ activities, filing requests for border measures, preparing templates for legal documents, etc. As soon as an early advertisement of the first generic products appeared shortly before expiry of substance patent protection, preliminary injunctions were obtained within one day. Upon launch of several generics upon expiry of substance patent protection, products were purchased and analyzed speedily, expert opinions prepared and preliminary injunctions obtained. Despite the limited remaining term of the formulation patent, the generics had to be removed from the market. Infringing products were seized and kept in custody by a court bailiff. The generics paid significant settlement amounts to get seized products back to be able to Launch these as soon as the formulation patent has expired. All in all, 14 preliminary injunctions were obtained and several settlements concluded that involved significant payments to our client.