JJUB55065U European Pharmaceutical Law, IPR & the Life Sciences – from research to market approval, commercialization and distribution

Volume 2014/2015
This course intends to give students a deep understanding of a variety of legal issues that are crucial to the pharma and life science sectors before and after their products have received market approval (MA) by the relevant authorities. It is a comprehensive and practical course for students with an interest in the legal aspects of the pharmaceutical and biomedical 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 aspects covered, the course will be relevant also for students with a general interest in IP, EU law, biomedical law, international and comparative law or public policy. 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 an understanding of the business dynamics of the industry and some basic knowledge of drug development and the science on which it is based. 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 research and invention to market approval, commercialization and distribution. 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. On the pre-MA stage the course will address the regulation of research & development, the protection of inventions stemming from areas such as stem cell research, gene-technology and personalized medicine, through patents, SPCs and regulatory exclusivities, as well as the regulatory framework related to the MA procedure. On the post MA level special emphasis will be laid on patent litigation, technology transfer & licensing, regulatory rules related to pharmacovigilance and product safety, the marketing of pharmaceutical products, parallel trade, competition law and access to medicine. More specifically, the course will be taught in 18 lectures of 3 hours each, including Q & A lectures. It will thus comprise 54 hours of teaching.
The lectures are divided into eight main- segments reflecting the typical chronological stages of pharmaceutical product development and commercialization:
  • Part I provides the students with a basic scientific preface and a first overview of the business environment, the legal landscape and the most central issues that will be addressed throughout the course.
  • Part II will deal with selected legal aspects of research regulation.
  • Part III will address the protection of research results through patents and SPCs. We will concentrate on the most important patentability requirements and discuss their application vis-à-vis pharmaceutical, biotech and life science inventions during the patent prosecution procedure.
  • Part IV will focus on specific regulatory aspects and the legal procedure for conducting clinical trials and securing marketing approval.
  • Part V will deal with selected legal aspects that will have to be considered after a pharmaceutical product has received market approval, including topics such as pharmacovigilance, product safety regulations, pricing, transparency and ethical problems, as well as legal issues related to advertising and marketing/promoting the product.
  • Part VI will focus on post grant IPR litigation, including the process and considerations regarding the enforcement of patents/SPC rights and regulatory data and marketing exclusivities. This part will also address technology transfer and licensing issues.
  • Part VII addresses the interface between IPRs with EU competition law and general EU, for example in the context of pharmaceutical patent settlements and parallel trade.
  • Finally part VIII will deal with the debates related to compulsory licensing and access to medicine in both the “developed” and developing world.
Learning Outcome
The basic learning outcomes that shall result from the course are fundamental to the understanding of the subject and therefore generally apply to BA students. All students will be expected to contribute actively to class-room discussions, regardless of degree level. The assessment by oral examination, however, will take into account the different expectations for BA  students.
Before this background the learning outcome of the course can be defined as follows:
1) Knowledge: All students should acquire knowledge about
   • 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
   • the basic legal rules concerning the protection and/or regulation of an object, subject and contents within the pharmaceutical law disciplines
2) Skills: All students should acquire skills in
   • presenting & explaining 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.
   • identifying specific problems and legal arguments within pharmaceutical law on the basis of complex material.
Master students should acquire additional skills in:
   • discussing the pros and cons of applying the various disciplines/solutions within complex problem areas.
   • making academically reasoned arguments and decisions for different solutions including a critical weighing of the legal arguments and choices.
3) Competences: All students should acquire competences in:
   • Critically reflect and put into perspective the interdisciplinary differences and similarities of the legal and scientific areas involved.
   • Analyze to what extent identified problems can be solved in practice by exploiting diverse legal disciplines and arguments.
Master students should acquire additional competences in:
   • combining different academic approaches, such as legal methods of interpretation, in connection with the analysis.
   • communicating and formulating the acquired knowledge and arguments professionally and linguistically correct and in a structured & coherent way.

Mandatory readings

• Folder of selected articles, cases, commentaries and reports. Some of these will be made available through ABSALON, other will be distributed in class before each lecture.

Ca. 750 pp. in total 

• 2. Optional readings - Additional cases and supplementary materials - selected and made available by the teachers - These are optional readings for students that want to dwell deeper into the issues. 

As stated in the course-content, this course intends to give students a deep understanding of a variety of legal issues that are crucial to the pharma and life science sectors before and after their products have received market approval by the relevant authorities.
The course method is to go beyond passive listening; interaction, group work, case studies and student-presentations are an essential part of the class. Field trips into the pharmaceutical industry, law firms and authorities, group discussions and presentations will be structured around introductory or explanatory lectures. Material provided in the classroom and as preparatory reading will consist of newspaper articles, research papers, reports, and case law.
-The students will be divided into groups. Each group is expected to present cases that will be discussed in class.
- Reasonable understanding of English is mandatory
- 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 or scientists 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 is available at : http:/​/​jura.ku.dk/​pdf/​uddannelsesservice/​fag_kurser/​kandidat/​Supp_Info__European_Pharma.pdf/​ (This document will be updated before the start of the course)
  • Category
  • Hours
  • Preparation
  • 358,5
  • Seminar
  • 54
  • Total
  • 412,5
Type of assessment
Oral examination, 20 minutes with preparation
Exam registration requirements
It is one of the objectives of the course to equip students with the ability to engage in academic discussions and to be able to present and explain legal challenges. It is therefore mandatory to prepare one short in class-presentation of a selected case or problem area.
Marking scale
7-point grading scale
Censorship form
External censorship
Exam period
1. - 5. December 2014 (preliminary dates)
Criteria for exam assesment
The objective of the examination is to determine the extent to which the students have acquired the knowledge and competencies, which are defined in the learning objectives of the course.
The exam will be closely linked to this course-plan and the content of the actual lectures, as the students focus on the material they must master at the exam during their study activity and learning process.
Before this background the students are evaluated by:
- their knowledge of the applicable law and procedures
- their skills in identifying, presenting & explaining solutions and legal arguments in a systematic and coherent manner
- their ability/competence to analyze and discuss how the identified problems could/should be solved in practice by exploiting diverse legal disciplines and arguments More specific information on the scope and the precise topics of the examination will be provided in the Q&A lectures.
As indicated in the description of the learning outcomes the evaluation of the students will also depend on if the students are participating on the bachelor or master level.