Patenting and Commercialization of Biotech and Medtech Inventions

Topics that will be covered in the course include

• Patenting: Principles, process, national/international laws, regulations and practice, similarities/differences between European and US patenting laws and practise.
• IPR strategies: Scientific/commercial aspects, how to develop an IP strategy to accelerate the innovation process and to safeguard IP investments, mastering freedom to operate in the Biotech/MedTech industry, Patent litigations, infringements and enforcements.
• Licensing: Models and negotiation strategies.
• Clinical testing: Design, implementation, analysis and presentation of clinical trials, adaptive clinical trial designs.
• Bio-tech/Med-tech business development: Strategy and organization when transferring a scientific idea into a commercial product/business, business plan development, product pipeline analysis, market analysis, market potential prediction, alliance structures and negotiation conditions, capital capture (pre-seed, seed, VC).

Target group: Masters and PhD students, Tech Trans personnel, Biotech/Medtech staff, university academic staff

Knowledge:

• The candidate shall have knowledge about:
• Aspects involved in transforming a research project to commercial product..
• IP management
• Patenting; basics, process, national/international law, regulations, practising, similarities/differences.
• Scientific versus commercial aspects on patenting strategy/IP evaluations.
• Processes involved in transforming a research product to a clinical product.
• Models for sale of IP, licensing versus sale.
• Business development: IP, business plan, coworkers, financing.

Experiences:

The candidate can:

• Identify and describe the different processes important for conservation of intellectual property of an invention and how to commercialize.
• Criteria and processes for sale of IP, including business development.

General competence:

The candidate can:

• Identify and explain principles in processes regulating protection and sale of IP.

The course is held intensively during one week during the months march/april. Lectures and case-based work in groups are repeated for every theme in the course. Oral presentation of work in groups by students. Written assignments are to be submitted two/three weeks after completion of the intensive part of the course. These are performed in groups.

Submission written project assignment. Evaluation: grade by letter