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With a contribution on Paediatric Extension of Duration by Peter von Czettritz.
In many cases, it is near the end of the usual 20 year duration of a patent, that high revenue medicines, being mostly very research-intensive, become their most lucrative after a long period of development and procedures required for obtaining a marketing authorisation. A supplementary Protection Certificate (SPC) allows up to a 5-year extension of patent protection. Obtaining this extension of patent protection at this time offers enormous business opportunities. Without the supplementary certificate, profits would be reduced by approximately 70 to 80%. By submitting the results of paediatric studies, the recently added option of extending the Protection Certificate by an additional 6 months, has given the SPC even more significance.
The economic relevance accorded to this subject conflicts tremendously with the widespread insecurity when judging this complex matter. This is caused, on the one hand, by the very general wording of the regulation and, on the other hand, by very inconsistent judicial practice, resulting in substantial differences in granting practice within the community.
At the moment the particularly current topics in case law, for example, are the prerequisites for obtaining an extension for combination preparations as well as the protective effect of a certificate against combination preparations. Another current topic concerns the question of negative durations of certificates. These topics are handled in this commentary in detail to provide the user extensive support in argumentation before a Court as well as before a national Patent Office. This commentary covers mainly German, British and European judicial practice.
This new commentary provides the user practical assistance with everyday questions and contributes likewise to an in-depth understanding of this field of law. Of interest to users are also those proceedings at the Patent Office and Courts which have not been made public. The author obtained access to a large number of files dealing with certificates with the GPTO and the Federal Patent Court, allowing for an in-depth knowledge of this topic.
Since pharmaceutical companies in Germany are frequently part of enterprises operating worldwide and moreover an application of SPCs is possible in most other countries of the European Community, this commentary is written in both the German and English language (synoptical text), allowing for access of this information to users from other countries of the Community. The currentness of these complex SPC topics is underlined by the unusual high number of preliminary questions momentarily pending before the ECJ. The preliminary questions on this matter before the ECJ are extensively covered and relevant argumentation for different opinions is provided.
Dr. Christopher Brückner is a pharmacist and patent attorney continuously involved in topics concerning the pharmaceutical industry. Peter von Czettritz, attorney-at-law and expert on questions involving the pharmaceutical industry and regulatory law, provides a complete introduction in a special section on the substantial and formal prerequisites for obtaining a 6-month extension of the duration of a certificate by submitting the results of paediatric studies. This provides the user easy access to this newly created possibility.
In the future, this commentary will become the standard reference on this topic not only for applicants and attorneys, but also for Patent Offices and Courts throughout Germany and Europe.