Examination arrangement

Course content

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

Learning outcome

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.

Learning methods and activities

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

Further on evaluation

Final assessment is a written group report.

Appeals for reassessment apply to the final written group report.

The written report can be changed to an oral exam in the semester when the course is not taught.

Recommended previous knowledge

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

Course materials

Lecture notes from web and distributed materials.