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BCI and BMI: Therapeutic Treatment Or Human Enhancement?

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BCI and BMI: Therapeutic Treatment Or Human Enhancement? BCI and BMI: Therapeutic treatment or human enhancement? A comparative study on the exclusion of patentability of methods of treatment using brain-computer and brain-machine interfaces under Article 53c EPC and US patent law. Student: Merel Hazes (ANR 844426) First reader: J.P. Waterson Second reader: M.H.M. Schellekens Thesis focus group: Intellectual Property and Automated Systems LL.M Law and Technology, Tilburg Law School, Tilburg Institute for Law, Technology, and Society, Tilburg University May 2018 2 Acknowledgements First and foremost, I would like to express my sincerest gratitude to my supervisor John Waterson, for repeatedly reading my work and providing me with helpful and constructive feedback. Furthermore, I want to thank Maurice Schellekens, for giving me new insights after I had been working on this thesis for months. Your feedback has helped me to increase the value of my thesis. Last but definitely not least, I would like to thank my friends Sanne and Martha. I am glad we were in our Law and Technology journey together. You motivated me during the tough times, and you were there to celebrate this year’s achievements. We were in it together, and my year would not have been the same without you. 3 Table of Contents Acknowledgements ...................................................................................................................... 3 CHAPTER 1: ................................................................................................................................ 6 INTRODUCTION ....................................................................................................................... 6 1.1 Introduction ......................................................................................................................... 6 1.2 Aim of the research .............................................................................................................. 9 1.3 Research questions .............................................................................................................. 9 1.4 Methodology ........................................................................................................................ 9 1.5 Outline of the chapters ...................................................................................................... 10 CHAPTER 2: .............................................................................................................................. 11 DIFFERENTIATING TREATMENT FROM ENHANCEMENT ....................................... 11 2.1 Article 53(c) EPC .............................................................................................................. 11 2.2 Neuroprosthesis ................................................................................................................. 11 2.2.1 BCI and BMI .............................................................................................................. 12 2.3 Enhancement ..................................................................................................................... 12 2.3.1 The search for a new definition of ‘human enhancement’ ......................................... 13 2.4 Treatment ........................................................................................................................... 14 2.4.1 Treatment by surgery ................................................................................................. 14 2.5 Neuroprosthesis: enhancement or treatment? ................................................................... 16 2.6 Conclusion ......................................................................................................................... 16 CHAPTER 3: .............................................................................................................................. 18 TREATMENT BY THERAPY ................................................................................................. 18 3.1 From Article 52(4) to Article 53(c) ................................................................................... 18 3.1 The concept of ‘therapeutic treatment’ ............................................................................. 19 3.1.1. Performance improvement ........................................................................................ 20 3.1.2. Curative and non-curative therapy ............................................................................ 20 3.2 The concept of ‘non-therapeutic treatment’ ...................................................................... 21 3.2.1 Cosmetic methods ...................................................................................................... 21 3.2.2 Pharmaceuticals .......................................................................................................... 23 3.3 Neuroprosthesis: therapeutic treatment? .......................................................................... 23 3.3.1 The blade runner ........................................................................................................ 24 3.3.2 Autonomy enhancement ............................................................................................. 25 3.3.3 Defining ‘human enhancement’ ................................................................................. 26 3.4 Avoiding the ‘therapy’ exception ....................................................................................... 26 3.5 Conclusion ......................................................................................................................... 27 CHAPTER 4: .............................................................................................................................. 29 A DIFFERENT APPROACH ................................................................................................... 29 4.1 Patent-eligible subject matter in the US ............................................................................ 29 4.1.1 The patent-eligibility test in US case law .................................................................. 30 4.1.2 The two-step test ........................................................................................................ 31 4.2 Patent-eligibility of methods of treatment ......................................................................... 32 4.3 The US rule on limited enforcement .................................................................................. 33 4.4 The US system applied to neuroprosthesis ........................................................................ 34 4.5 Comparing the EPC and USC ........................................................................................... 35 4.6 Discussion on the desirability of patenting methods of treatment .................................... 36 4.6.1 Historical development .............................................................................................. 37 4.6.2 Evaluation .................................................................................................................. 38 4.6.3 Evaluation with regard to neuroprosthesis ................................................................. 39 4 CHAPTER 5: .............................................................................................................................. 40 CONCLUSION .......................................................................................................................... 40 5.1 Most relevant findings ....................................................................................................... 40 5.1 Answer to the research question ........................................................................................ 41 Bibliography ............................................................................................................................... 43 5 CHAPTER 1: INTRODUCTION 1.1 Introduction While in the midst of the fourth industrial revolution, emerging technologies are developing rapidly. Radical change is all around us. New technologies allow us to combine physical, digital and biological worlds, challenging all disciplines and at a certain level even challenging the fundamental ideas of what being human actually means.1 More than ever, we live in a world in which one has the ability to improve himself. Not only by hard work and dedication, but also by the use of technological means. Means that are employed for healthcare purposes or for purely enhancement purposes. Human enhancement is defined in different ways, it can be defined as improvement in capacities, abilities and level of performance.2 If one would prefer a broader interpretation, human enhancement could be defined as any modifying intervention on the human body.3 Since ethics scholars approach the subject in different ways, there is not one clear definition of human enhancement.4 With the development of technologies that are capable of human enhancement, legal questions arise. This research focuses on some of those legal questions that are pointed at the field of patent law. To protect their technological inventions, inventors will most likely try to patent them. The European Patent Convention (EPC) allows for and gives the requirements of the establishment of patents. According to Article 52 EPC, in order for an invention to be patent eligible it needs to i. be novel, ii. involve an inventive step, and iii. be industrially applicable. However, in Article 53, the EPC provides for a
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