Cancelled Life Science Law
Developing new drugs is a very expensive and risky affair. Many
projects are started, but only very few are successful. The causes
for the low success rate are many, but part of the explanation is
that, even though one can theorize about a specific effect a
molecule can have, or even make it work in a laboratory, it may
turn out that the molecule in question does in real life (animal
models or otherwise) does not have the desired effect of for
instance inhibiting the production of certain chemical substance in
the body, it may be too toxic to be administered to living beings,
or it may have severe side effects. These things can only be found
out once the drug candidate is further tested, but by that time,
considerable investments in time and money are foregone.
The other side of the coin is that for many drugs, once they are
successful and obtain market approval, the innovation incentive
system provides for many benefits indeed, allowing pharmaceutical
companies to obtain (very) handsome rewards.
One of the most important objectives of pharmaceutical companies is to extend exclusivity as long as possible, so as to delay generic entry. Indeed, as long as there are exclusive rights on a specific medicinal product, generic versions of that product cannot enter the market. Once generic versions can enter the market, revenue can drop substantially. That is why IP and other exclusive rights are so important. The high revenues are not only necessary to recoup the investments made in developing and bringing new drugs to market, but they must also compensate for the failed drug candidates.
It is no surprise to read that pharmaceutical companies have over the years developed very intricate and complex strategies to delay generic entry indeed.
This course will provide an in-depth and practical insight into the world of drug development and the way strategies which pharmaceutical companies develop to optimise their exclusivity (sometimes quasi-monopoly) position in the market. Exclusive rights, be it patents or other rights, are of all consuming interest to pharmaceutical companies. As a very high human capital investment industry, they are largely defined by the intellectual property (IP) and other exclusive rights they hold.
This course should not be missed for various reasons:
- The pharmaceutical sector is of immediate relevance to all of us, as we have all taken and/or will take in the future drugs for ailments or diseases. The example that has affected everyone is the COVID-19 crisis which changed our lives fundamentally. COVID-19 has led to an unprecedented and frantic search for treatments and vaccines against the deadly virus, but it came at a gargantuan cost to society, financially and otherwise. It should consequently be of immediate interest to everyone.
- We all have an interest in seeing the best possible drugs developed so that (debilitating) diseases can be cured or at least treated
- We also have an interest in seeing all those drugs enter the market at an affordable price, so that patients and health care systems can afford them.
- This course takes you on a journey into how drug development works and how the process for drug approval works
- It provides insight into IP and other exclusive rights strategies developed and used by the pharmaceutical industry in a unique proposition that you will not find anywhere else in Europe, partly due to the fact the course director has been intimately involved in some of those strategies during his period in private practice.
- It exposes uses and abuses of exclusive rights, and gives insight into how pharmaceutical companies have tried to use (and still do so) their exclusivity position in a specific product market in a manner to delay competition, by way of making de facto agreements that are contrary to competition, or by abusing their dominant position in a product market.
- This is a cross-disciplinary course, as you will gain insight into various areas of the law, such as pharmaceutical regulation, IP rights, competition law, procedural law and human rights relating to health. Moreover, this course also provides you with an insight into some of the science and technology, without it being a requirement that you master that very technology yourself, as this course is obviously a course in legal studies. However, gaining at least some basic insight will be very beneficial for whatever career path you would like to go into in the area of life science.
- This course will not only provide a practical insight, but it will also provide students with the necessary knowledge and skills to use the insights acquired during this course in real life, be it in industry or in private practice (and in both sectors, knowledge of and experience with life science is very important indeed).
- As the only university in Europe offering a course such as the present one, students will have a clear comparative advantage for later professional purposes.
- This course will be very useful for everyone who is interested in working in private practice, the judiciary, industry, consultancy and policy making.
- As this course is taught in English, it will provide you with a fantastic opportunity to combine the chance to learn more about legal aspects of a societally crucial industry, and improve your legal English lsanguage skills, a conditio sine qua non to work in legal practice later (be it as a civil servant, in-house counsel or as a practicing lawyer in a law firm).
Structure of the course:
Part 1: A discussion of the business environment in life sciences, with an overview of the various types of drugs (small molecules and biologics), some introductory insight into how drug development and marketing works, and some preliminary insight into the various business models businesses in the life science space can and will follow
Part 2: A discussion of the law and economics of innovation and innovation incentives. In this part we will provide an overview of the economics relating to innovation, and the economics of IP and other exclusive rights
Part 3: With the knowledge gained in Part 2, the present part of the course will provide an in-depth overview of the patent system relating to life science, this being the most important exclusivity right used by industry. We will discuss what type of subject matter can be patent protected, ranging from chemicals, biological materials to plants. We will subsequently discuss the various patentability requirements that need to be fulfilled and the parameters to pass those requirements successfully. Subsequently we will discuss the various patent infringement issues that arise in the area of life science, and how the case law resolves those. After having discussed the patent system, we will discuss the so-called Supplementary Protection Certificates (SPCs), which have been specifically created for (bio)pharmaceutical products. An SPC provides an additional term of protection (5 years max), above and beyond the standard patent term of 20 years. The system has been created to compensate for what is called regulatory loss of effective patent protection. Before a drug can enter the market, it must be authorised first (so-called marketing authorisation (MA), and in order to gain such MA, very expensive and lengthy clinical trials need to be carried out. During that period, the patent cannot be enforced, as there is no product on the market. This can often take many years (between 5 and 10 years). The SPC system compensates, at least partly, for that loss of effective patent protection.
Part 4 will discuss pharmaceutical regulation. How does the drug development process work, what are the various stages, and how does a pharmaceutical company obtain a MA. The various routes towards a MA and the requirements that need to be fulfilled will be discussed. With that knowledge, we can then move on to what is called regulatory exclusivities, i.e., data and market exclusivity, which is an entirely separate stream of exclusive rights, entirely independent from the patent system, with its own requirements and procedures. Those regulatory exclusivities are extremely important for pharmaceutical companies, but are never discussed in traditional IP courses. The present course remedies this, in view of their strategic importance. This part 4 will also allow us to discuss how pharmaceutical companies have developed very complex strategies, where they try to optimise protection, both under the traditional patent system and under the regulatory exclusivities system. We will in this part of the course also discuss some specific topics, such as the special case of antibiotics, biologics and orphan drugs, the latter having its own separate legal system.
Part 5 will cover the very important area of competition law. Most of you know that at least some pharmaceutical companies have abused their dominant position on the market for commercial gain, and we will discuss strategies which are not tolerable from a competition law point of view, and which ones might. There is some very interesting case law, which we will analyse. In this connection, we will also have a closer look at the issue of excessive pricing, with examples where some companies thought that they could get away with 2000% (sic!) price hikes. Besides abuse of dominant position, the competition law system equally prohibits (de facto) agreements between companies which harm competition. There is a long list of cases where pharmaceutical companies have attempted to make (de facto) agreements with a view to delay generic entry, and hence competition. The most important case law will be scrutinised here.
Part 6 of the course will discuss the very important issue of access to drugs and globalisation. The COVID-19 pandemic has shown a shameful inequity in access to vaccines and therapeutics. This part of the course will discuss some human rights aspects relating to health and life science, and will discuss options to tackle these problems. One option is compulsory licensing, but there are other instruments such as IP waivers, or Advance Market Commitments (AMCs), where the production of vaccines or other drugs is prefinanced by governments so as to take away some of the risks from pharmaceutical companies which would make them reluctant to produce those very much needed drugs and vaccines in the first place. There are still other things that could be done, and we will discuss those in this part of the course.
All students are strongly encouraged to contribute actively to class-room discussions.
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 life science industry
- the basic legal rules concerning the protection and/or regulation of an object, subject and contents within the life science 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 life science law issues.
- identifying specific problems and legal arguments within life science 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.
The course includes the following types of learning activities:
- brainstorming questions;
- policy debates and in class discussions;
- case solving exercises;
- exam preparation training;
- each seminar starts with a Q&A session, where students can ask questions, make observations, or ask for clarification
- Folder of selected articles, cases, commentaries and reports. Some of these will be made available through ABSALON, or will be available through the University Library.
Ca. 750 pp. in total
Additional cases and supplementary materials - selected and made available by the teachers - These are optional readings for students that want to dive deeper into the issues.
It is illegal to share digital textbooks with each other without permission from the copyright holder.
No prior specialised knowledge is required for this course.
In line with Faculty rules and practice
- 15 ECTS
- Type of assessment
Oral examination, 20 min.
- Type of assessment details
- Oral exam with preparation, 20 minutes
- Marking scale
- 7-point grading scale
- Censorship form
- External censorship
Criteria for exam assessment
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.
Single subject courses (day)
- Course number
- 15 ECTS
- Programme level
- Full Degree Master
Full Degree Master choice
- Students enrolled at Faculty of Law or holding a pre-approval: No tuition fee
- Professionals: Please visit our website
Please see timetable for teaching hours
- Faculty of Law
- Sven Jean R Bostyn (11-787b6a7333677478797e73456f7a7733707a336970)
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