Protecting your Innovation - Workshop on Intellectual Property and Regulatory Exclusivity in Biotech and 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).
Module 1: Intellectual Property
- Patents: Process of filing and granting patents in Europe and the world
- Patentable subject-matter in the field of medicine: Overview and second medical use (new medical purpose)
- Digression: Patenting of medical devices with "double function"
- Supplementary Protection Certificates (SPCs): Definition and explanation, case law, comparison to other legislation, future of SPCs
- Patent litigation: Enforcement - case law; "Skinny labelling" - consequences for healthcare system and health insurance
- Practical Exercise 1: "Skinny labelling"
Module 2: Regulatory Exclusivity and Reimbursement
- Regulatory exclusivity in Europe and other countries: Overview, regulatory exclusivity, market access, research exclusivity, paediatric medicines exclusivity in the EU, manufacturing waiver
- Digression: Biosimilars
- Reimbursement and pricing negotiations with health insurance (AMNOG in force since 2011 with smaller amendments in 2013 and 2014): Benefit assessment of medicinal products, AMNOG process (result, risk, comparison to other countries)
- Practical Exercise 2: Reimbursement and pricing negotiations with health insurance (DE)
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.