Key takeaways
National courts have diverged on the interpretation of the EU Court of Justice’s latest decisions on SPCs for combination products – in particular on whether data in the application as filed are required for a combination product to meet the CJEU’s test of “falling under the invention” of the basic patent and be eligible for SPC protection in the EU. A further referral to the CJEU appears necessary to provide clarification to the pharmaceutical industry.
Background – patenting combination products
When preparing the first patent application directed to a pharmaceutical product, information regarding potential combination products is often included, especially those with a similar mode of action to the claimed product. However, as research into combination products typically takes place later in the research and development cycle, supporting data for combination products are not always available at the time this first application is filed. In the absence of such data,