Protecting your Innovation - Workshop on Intellectual Property and Regulatory Exclusivity in Biotech & Pharma
After course completion, attendees will have developed a good understanding of intellectual property and regulatory concepts at the complex interface between these fields. The attendees will be able to define the exclusivity period of a pharmaceutical product in light of patent rights, supplementary protection certificates (SPCs), litigation outcomes and regulatory considerations. A further learning goal is to convey a basic understanding of reimbursement mechanisms in Germany including negotiation strategies with public health insurance in the context of regulatory and scientific requirements. The successful participation will be certified by the Gläsernes Labor Akademie (GLA).
When, how and for how long can I protect and monetize my biotech or pharma innovation? Being able to answer these questions is crucial whenever a Biotech or Pharma company decides to discover their products to the public and to the market - therefore we have set up this new workshop with two modules:
- Intellectual Property: Patents, Supplementary Protection Certificates (SPCs) and Litigation
- Regulatory Exclusivity and Reimbursement
Some experience in the field of intellectual property protection in the context of the biotech and pharma industry is required. For example, attendance to the GLA Biotech & Pharma Summer School. Since the workshop will focus on the specificities and challenges of this sector, the attendee should be at least partially familiar with the following general concepts of intellectual property protection:
- Basics of intellectual property protection (incentivising innovation by granting time-limited monopoly, invention has to be novel, inventive and enabled)
- Life cycle of a patent (from drafting to infringement lawsuit): Pre-grant, i.e. strategy, research and application, further actions such as opposition, appeal, invalidity/nullity, infringement, licensing, cooperation
The course is directed to staff from pharmaceutical or biotech companies who are bringing or planning to bring their products to the market, as well as life science researchers who are generally interested in the interplay between IP and regulatory approaches.