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| Udgave: |
Jura Kandidatuddannelsen 2012/2013 |
| ECTS points: |
10 ECTS |
| Punkter: |
10 ECTS |
| Skemagruppe: |
A1 |
Semester: |
Spring |
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| Uddannelsesdel: |
Kandidat niveau |
| Kontaktpersoner: |
Fagansvarlig: Timo Minssen |
| Andre undervisere: |
Assistant Professor Timo Minssen (CIIR - course coordinator)
Dr. Jesper Thorsen (European Patent Attorney at Inspicos) |
| Undervisnings- periode: |
Every thursday 10-13
1. day: Thursday 7. february 2013 |
| Formål: |
The pharmaceutical industry is one of the largest, but also one of the most heavily regulated sectors in the world. The industry is characterized by different areas of law converging to create a legal landscape that can be difficult to navigate for legal professionals. Pharmaceutical law is therefore a much coveted area of expertise within most IP departments at larger law firms or companies and organizations. This is particularly true for the Øresund region with its high concentration of major biotech firms, medtech corporations and pharmaceutical companies, including some of the biggest companies in Denmark. The significance of the sector and the fascinating law and science related to it makes it a highly interesting area for law students to explore and study.
In Europe, a significant part of pharmaceutical law is harmonized within the EU, although important regulatory areas remain non-harmonized, such as drug pricing and reimbursement. The industry is influenced by general areas of EU law, such as competition law, free movement of goods and - most importantly – by intellectual property law (IP) at the international, European and national level. But it is also affected by EU regulatory law targeted specifically at the industry, including approval of medicinal products, data/marketing exclusivities and clinical trials.
The aim of this course is to describe and explain selected legal issues that are crucial to the pharmaceutical sector with a focus on patent law, regulatory rules related to the market approval procedure and competition law.
In order to understand how these legal aspects influence the pharmaceutical industry in the context of rapid legal, political, economic and scientific changes, it is important to gain a practical understanding of the business dynamics of the industry and some basic knowledge of drug development and the science on which it is based.
The legal issues involved in this area are unusually compelling: In few other areas is there a similar need for an overall understanding of such a broad spectrum of interlocking legal disciplines. It is also a highly global industry and legal counseling will typically include international aspects, e.g. in the context of cross-border transactions, patent disputes or regulatory approval strategies. In this respect, it is relevant in some areas to introduce comparisons with the US legal system, which often informs EU law and influences European legislators and authorities, as well as companies’ legal strategies.
Against this background, the course is designed to provide students with a broad and practical understanding of the industry and various legal disciplines that affect it by presenting them around their importance to each step in the lifecycle of a pharmaceutical product – from invention to commercialization. |
| Indhold: |
This is a comprehensive and practical course for students with an interest in the legal aspects of the pharmaceutical industry. Besides providing students with the necessary theoretical knowledge, this course entails a unique opportunity to gain practical insights both through practitioner-lectures and field trips to law firms and companies in the Medicon Valley. It is targeted towards students that consider a career in life sciences - be it as in-house counsel with a pharmaceutical/life science company or as a legal expert at a consulting firm or in relevant agencies and organizations. Due to the great variety of legal aspect covered, the course will be relevant also for students with a general interest in IP, EU, competition, international, and comparative law or public policy.
To add practical relevance, the course follows the approach of presenting issues through the various stages of (bio-)pharmaceutical product development and commercialization. The focus is on substantive legal issues at an EU level, rather than at the national level. Students will read and discuss real-life scenarios aimed at developing analytical thinking and reflective judgment.
More specifically, the course will be taught in 17 lectures of 2 hours each. It will thus comprise 34 hours of teaching. The lectures are divided into four main- segments reflecting the typical chronological stages of pharmaceutical product development and commercialization: Part I will provide the students with a very basic scientific overview and a first overview of the legal landscape and relevant issues. Then, part II will deal with selected legal aspects of research regulation and the protection of research results through patents. We will concentrate on the most important patentability requirements and discuss their application vis-à-vis pharmaceutical inventions. Part III will focus on specific regulatory aspects and the legal procedure for conducting clinical trials and securing marketing approval. Finally, part IV will discuss selected post-grant issues, including the interface between IPR & competition law. The last two hours are reserved for a Q & A session. |
| Kompetence- beskrivelse: |
The main objective of the course is to enable the students to:
- Present the content, relevance and interrelationship of specific legal disciplines, as well as basic scientific and business aspects that are of particular importance to the pharmaceutical industry.
- Present & explain solutions and legal arguments in a systematic and coherent manner that demonstrates overview, as well as in-depth knowledge and understanding of specific pharmaceutical law issues.
- Explain the basic legal rules concerning the protection and/or regulation of an object, subject and contents within the pharmaceutical law disciplines.
- Critically reflect and put into perspective the interdisciplinary differences and similarities of the legal and scientific areas involved.
- Identify specific problems and legal arguments within pharmaceutical law on the basis of complex material.
- Analyze to what extent identified problems can be solved in practice by exploiting diverse legal disciplines and arguments.
- Combine different academic approaches, such as legal methods of interpretation, in connection with the analysis.
- Discuss the pros and cons of applying the various disciplines/solutions within complex problem areas.
- Make academically reasoned arguments and decisions for different solutions including a critical weighing of the legal arguments and choices.
- Communicate and formulate the acquired knowledge and arguments professionally and linguistically correct and in a structured & coherent way.
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| Eksamensform: |
Written without supervision (homework assignment) 3 days |
| Eksamen: |
21. - 24. and 27. May 2013 (preliminary dates) |
| Kursus hjemmeside: |
 |
| Bemærkninger: |
The students will be divided into groups. Each group is expected to present cases that will be discussed in class.
- The teachers will make intensive use of ABSALON. The students should therefore be well acquainted with the system.
- Further internal and external teachers might be involved in due course.
- Field trips to major pharmaceutical companies and law firms are an option.
- Basic skills in European law are recommended.
- Lawyers who have just started to practice in the pharmaceutical sector and want get a better understanding of the area can be accepted after payment of a fee specified and determined by the University.
- Specific topics and legal developments of major practical relevance might be developed further and be marketed in the form of practitioner seminars.
More information:(http://jura.ku.dk/pdf/uddannelsesservice/european-pharmaceutical-law/
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| Undervisnings- sprog: |
Kun engelsk
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| Sidst redigeret: |
30/1-2013 |