The scale of upcoming patent expirations for existing blockbuster pharmaceutical products, together with a diminished pipeline of new products have been well publicized. Against this, R&D efforts face further intensification and patent infringement remains an important risk for pharmaceutical companies undertaking drug development. R&D activities typically require the use of subject matter protected by third party patents, for example, the use of patented compounds as comparators in drug discovery or the use of patented assays as a research tool. A key area of long standing uncertainty concerns the extent to which national patent laws exempt such activities from patent infringement under so called “research exemptions”.
Please join us for a 60-minute webinar addressing the patent infringement risks faced by global businesses engaged in medical research. The session will include an analysis of:
- The scope of the research exemption in the US, the UK and Germany, including the key factors that determine whether the exemption applies
- The application of the exemption to "up-stream" activities (e.g., discovery or preclinical activities) in comparison to “down-stream” activities (e.g., clinical trials and regulatory filings)
- A case study to consider how the research exemption applies to typical R&D uses of subject matter protected by third-party patents, including the scenario involving use of a competitor’s patented compound in drug discovery activities
Presentation Audio (MP3)