Perspectives of regulatory bodies on intellectual property for 3D-printed medical products

How does the European Patent Office (EPO) perceive patents for 3D-printed medical products?


Academic Paper, 2021

20 Pages, Grade: 1,3


Excerpt


Table of Contents

1. Introduction

2. Patents & 3D-Printing
2.1 The Conventional Perspective on Patents
2.2 Critical & Agnostic Perspectives
2.3 Why 3D-Printing is Special
2.4 Challenges for Policymakers

3. EPO’s perspective on Patents for 3D-printed medical products
3.1. Methodological Note
3.2 Key Results

4. Conclusion

5. Bibliography

Perspectives of regulatory bodies on intellectual property for 3D-printed medical products

How does the European Patent Office (EPO) as a regulatory body perceive patents for 3D-printed medical products?

In this paper, I will investigate the perspective of the European Patent Office (EPO) on intellectual property rights, particularly patents, for 3D-printed medical products. As a powerful regulatory body, the EPO is a key stakeholder in the regulation and handling of emerging technologies. As such a technology, 3D-printing may call policymakers to adapt the regulatory framework to deal with the specialties of 3D-printing and to increase legal certainty. Policymakers can profit from its insights for various reasons: What kind of new regulation may be needed largely depends on how executive organs such as EPO (attempt to) handle the respective technology. Also, insights from practitioners may help policymakers to identify issues that have been neglected by existing legislation – such as the implications of emerging technologies like 3D-printing. The paper is organized as follows. First, I will sketch the debate about IP and innovation. Second, I will discuss the relevance and possible implications of 3D-printing for this debate, and outline resulting challenges for policymakers. Third, I will approach my research question with an analysis of written communication by EPO and a semistructured expert interview with an EPO member. A key finding is that the EPO perceives IP rights for 3D-printed medical products as positive, but not as crucial, as it expects decisive innovation to happen at the level of 3D-printers and the materials they use.

1. Introduction

Imagine a world where almost everything we need can be manufactured at home and low cost, based on shared design files other people made in their spare time, of which they have plenty, as they live in a world of cornucopia and free-floating innovation. Jeremy Rifkin coined the term “zero marginal cost society”1 for such a scenario, based on the notion that due to technological innovation the reproduction of products, once they are invented, is almost for free.2 As Rifkin argues, this phenomenon already damaged publishers and entertainment industry, and is now spilling over to other industries such as energy, education, and the manufacturing industry due to 3D-printing.3 Instead of big corporations, “prosumers”, people inventing, producing, and sharing what they need all by themselves, will cover the needs of humankind.4 Would this not be a very desirable world to live in? For this vision of the “zero marginal cost society”5, 3D-printing or additive manufacturing (AM) is crucial, as it is thought to provide the potential to replace all or a substantial fraction of alternative ways to make goods.6

However, this vision seems to have limits. First, there are technological restrictions on what 3D-printers can produce and at which speed7, especially those that are suitable for home-use (cf. Fig. 1).8 At this point, it is hard to imagine how, based on this technology, everything or a substantial part of what end-users need can be 3D-printed. Also, 3D-printers are much slower than alternative manufacturing methods, which limits their suitability for large-scale production.9 Still, 3D-printers excel at making custom-made, high-quality products at a fraction of the cost other methods would entail.10 This makes AM interesting especially for the medical sector where the costs for high-quality, custom-made medical products – such as hip implants or dentures – can be substantially reduced.11 Consequently, in the health sector more AM-related patent applications can be observed than in any other sector in 2018.12

Abbildung in dieser Leseprobe nicht enthalten

Fig. 1: Heterogeneity of 3D-printing

The second limit to Rifkin’s vision is a legal one. In most legal systems, technical inventions and products can be protected by different kinds of intellectual property (IP) rights such as patents, designs, or trademarks.13 In a world where the mentioned technical difficulties are solved, but the IP system sustained, the assumption that products can be reproduced at almost zero marginal cost does not hold for all products that are subject to patents or other IP rights. In this light, 3D-printing may call policymakers to adapt the regulatory framework to deal with the specialties of 3D-printing, and also to increase legal certainty.14

In practice, patent decisions are taken by certain regulatory bodies such as the Deutsches Marken- und Patentamt or the European Patent Office (EPO). Since these bodies take decisions on what may be patentable, its perspective on IP for 3D-printed products matters for practical reasons. But policymakers can profit from their insights even further: What kind of new regulation may be needed largely depends on how bodies such as EPO (attempt to) handle the emerging technology. Additionally, insights from practitioners may help policymakers to identify issues that have been neglected by existing legislation – such as the implications of emerging technologies like 3D-printing. Therefore, in this paper I will investigate the perspective of the European Patent Office (EPO) on intellectual property rights, particularly patents, for 3D-printed medical products, as these can count as an instance where 3D-printing is already in use an its usefulness uncontested. The paper is organized as follows: First, I will sketch the debate about IP and innovation. Second, I will discuss the relevance and possible implications of 3D-printing for this debate, and outline resulting challenges for policymakers. Third, I will approach my research question with an analysis of written communication by EPO and a semistructured expert interview with a leading EPO member.15

2. Patents & 3D-Printing

2.1 The Conventional Perspective on Patents

The widespread perspective on patents that I will refer to as the conventional perspective holds that IP in general and patents in particular stimulate innovation and creativity. Therefore, patents are thought to be crucial and inevitable to uphold economic competitiveness, and high employment.16 As two leading members of the European Patent Office put it recently: “By effectively protecting their intellectual property, innovative companies can secure financing, grow, collaborate and create value.”17 . The same intuition is reflected in the US-Constitution, written more than 200 years earlier: "The Congress shall have Power (...) To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”.18 This clause indicates that the constitution assumes a positive relationship between patents and innovation, since the purpose of the mentioned “exclusive Right” is “to promote the Progress of Science and useful Arts”, i.e., to foster technological and non-technological innovation.19

In its essential form, this widespread argument backing the conventional perspective on patents can be represented as follows:

P1: Innovation should be fostered.

P2: Sustaining the patent system fosters innovation.

Conclusion: The patent system should be sustained.

In this paper, I will focus on arguments concerned with the second premise (P2) because regarding medical products and the medical sector at large, the benefits of innovation are hardly controversial.20

Patents as financial incentive

The classical argument in favor of P2 is the assertion that patents incentivize innovation.21,22 When an invention is protected by a patent, innovators can monetize the invention either by commercializing it themselves, or by charging license fees.

This common-sense argument can be formulated more precisely by employing the terminology from New Institutional Economics.23 As North and Thomas famously argued, while the social rate of return determines how beneficial a certain kind of economic behavior is for society at large, the private rate of return determines what kind of economic behavior individuals actually display.24,25 So, it is the task of institutions – understood as all kinds of formal or informal norms that channel human behavior26 – to ensure that the private rate of return converges to the social rate of return.27 In this sense, a patent can be seen as channeling the inventors’ behavior in a way that is socially desirable, by means of giving them a financial incentive.

Disclosure of Technical Details

A second argument refers to the fact that the inventors have to disclose their invention when they apply for a patent.28 Therefore, other inventors, researchers, or companies are able to study the technical details of the invention and use them, paying royalties to the patent holder or waiting until the patent expires.29 I understand this not as a distinct argument in favor of the patent system, but as an additional argument backing the usefulness of patents in fostering innovation, i.e., an argument holding that P2 is true.

2.2 Critical & Agnostic Perspectives

Critical Perspective 1: The Tragedy of the Anticommons

One important argument criticizing P2 is the assertion that it results in a ‘tragedy of the anticommons’. The term was coined by legal scholar Michael Heller.30 Together with Rebecca Eisenberger, he applied it to questions of patents and innovation, concluding that they stifle innovation.31 The ‘tragedy of the anticommons’ refers to a systematic underuse of shared resources.32 It is caused by confusing or unclear system of IP rights where too many rightholders are able to prevent each other from using shared resources in the form of knowledge that is protected by property rights. For example, when an inventor has a new idea that would be very beneficial, but then realizes that this invention violates hundreds of patents or it is not even clear who the rightholders are, the inventor may decide that they do not want to take the risk, and the invention never has a chance to benefit the world. The argument suggests that abandoning or at least reducing the number of patents may stimulate innovation as this can increase the use of shared (knowledge) resources.

Agnostic positions

However, proponents of the patent system can handle objections of this kind by portraying patents as a necessary evil.33 Whereas they admit some negative side effects, they argue that these are outweighed by their positive effect. As a textbook on economic growth points out:

It would be [good] to make the existing discoveries freely available to all producers, but this practice fails to provide the...incentives for further inventions. A tradeoff arises between restrictions on the use of existing ideas and the rewards to inventive activity.34

In a very similar fashion, a German textbook35 points out that it is the task of the legal framework to find a balance between the welfare losses due to monopolies on the goods market induced by patents, and the welfare gains due to increased competition on the ‘markets of ideas’.36 Therefore, the legal framework creates rights to protect innovation, but limits them at the same time.37 Both positions, in spite of defending the patent system, are not unanimously enthusiastic about it; they defend it only for contingent, empirical reasons. In this sense, they are agnostic towards patents. If one could demonstrate that the costs of the patent system (monetary and non-monetary) exceed its use, authors inclined to this position would probably support its restriction or even abolishment.

Critical Perspective 2: Against Intellectual Monopoly

Boldrin and Levin famously made this case.38 Their aim was to show that patents are in fact an unnecessary evil.39 They quote a number of case studies indicating that innovation can flourish in the absence of patents, and that patents often stifle innovation.40 As they argue, first mover advantages41 and impatience effects42 provide enough reward for innovative people or businesses. Technological progress is viewed as occurring spontaneously because people make incremental changes to improve products or processes, and, importantly, that the monetary incentives provided by the patent system do not or not significantly contribute to this process.43

[...]


1 Jeremy Rifkin, Die Null-Grenzkosten-Gesellschaft. Das Internet der Dinge, Kollaboratives Gemeingut und der Rückzug des Kapitalismus, trans. Bernhard Schmid (Frankfurt/New York 2014: Campus Verlag).

2 Rifkin, Die Null-Grenzkosten-Gesellschaft, p. 13.

3 Rifkin, Die Null-Grenzkosten-Gesellschaft, p. 14.

4 Ibid.

5 Rifkin, Die Null-Grenzkosten-Gesellschaft

6 Rifkin, Die Null-Grenzkosten-Gesellschaft, p. 14, p. 41 .

7 European Patent Office (EPO), Patents and additive manufacturing. Trends in 3D printing technologies. July 2020, p. 23.

8 Cameron Coward, 3D Printing, (New York: Alpha Books, published by Penguin Group), p. 9 et seqq.

9 EPO, Patents and additive manufacturing. Trends in 3D printing technologies. July 2020, p. 23.

10 EPO, Patents and additive manufacturing, p. 20.

11 EPO, Patents and additive manufacturing, p. 21, p. 22 (Table 1)

12 EPO, Patents and additive manufacturing, p. 12.

13 Rochelle Dreyfuss/Justine Pila, “Intellectual Property Law: An Anatomical Overview.” In: The Oxford Handbook of Intellectual Property Law, edited by Rochelle Dreyfuss and Justine Pila. Print Publication Apr. 2018, Online Publication Jul. 2017, p. 3.

14 It has been questioned by some scholars which part of the AM process may be protectable, digital blueprints, unmodified or modified scans, or the product itself (John Hornick, “3D Printing and IP Rights: The Elephant in the Room”, Santa Clara L. Review 801, Vol. 55, No. 4, 801-8018, 2015, p. 812). It is also seen as a domain in which different IP rights overlap (EPO, Patents and additive manufacturing, p. 20).

15 Appendix 1.

16 EPO/EUIPO, Intellectual property rights and firm performance in the European Union Firm-level analysis report, February 2021, p. 2.

17 European Patent Office/European Union Intellectual Property Office, Intellectual property rights and firm performance in the European Union Firm-level analysis report, February 2021.

18 U.S. Const. art. I, section 8, clause 8.

19 However, the constitution does not state that congress must do so, as John Hornick (“3D Printing and IP Rights: The Elephant in the Room”, Santa Clara L. Review 801, Vol. 55, No. 4, 801-8018, 2015, p. 818) has pointed out.

20 The notion that the benefits of innovation are not necessary or self-evident is put forward under the notion of responsible stagnation. However, the respective arguments hardly apply to the medical sector. (Cf. Stevienna de Saille & Fabien Medvecky (2016) “Innovation for a steady state: a case for responsible stagnation”, Economy and Society, 45:1, 1-23, DOI: 10.1080/03085147.2016.1143727).

21 Hans-Bernd Schäfer, Claus Ott, Lehrbuch der ökonomischen Analyse des Zivilrechts. Dritte, überarbeitete und erweiterte Auflage. Springer-Verlag, Berlin, Heidelberg

22 European Patent Office/European Union Intellectual Property Office, IPR-intensive industries and economic performance in the European Union. Industry-Level Analysis Report. Third edition. A joint project between the European Patent Office and the European Union Intellectual Property Office. September 2019, p. 2.

23 This school of thought attempted to refine neoclassical approaches by critically assessing some of the neoclassical assumptions such as perfect information or full rationality (cf. Claude Menard and Mary M. Shirley, “The Contribution of Douglass North to New Institutional Economics”, Institutions, Property Rights, and Economic Growth, pp. 11-29, ed. S. Galiani and I. Sened (Cambridge, UK: Cambridge University Press), p. 22.

24 Douglass C. North/Robert Paul Thomas. The Rise of the Western World: A New Economic History (Cambridge, U.K.: Cambridge University Press 1973), p.1

25 These concepts are defined as follows: “The private rate of return is the sum of the net receipts which the economic unit receives from undertaking an activity. The social rate of return is the total net benefit (…) that society gains from the same activity” (Douglass C. North/Robert Paul Thomas. The Rise of the Western World: A New Economic History (Cambridge, U.K.: Cambridge University Press 1973), p.1).

26 Ibid.

27 Ibid.

28 European Patent Office/European Union Intellectual Property Office, IPR-intensive industries and economic performance in the European Union. Industry-Level Analysis Report. Third edition. A joint project between the European Patent Office and the European Union Intellectual Property Office. September 2019, p. 2.

29 Ibid.

305 Michael Heller, “The Tragedy of the Anticommons”, 111 Harv. L. Rev. 621-688, January 1998.

31 Michael A. Heller and Rebecca S. Eisenberg, “Can Patents Deter Innovation? The Anticommons in Biomedical Research,” Science 280, no. 5364 (May 1, 1998): 698–701, doi:10.1126/science.280.5364.698

32 Heller/Eisenberg, “Can Patents Deter Innovation?“, p. 698

33 Michele Boldrin/David K. Levine, Against Intellectual Monopoly. (Cambridge, UK: Cambridge University Press 2008). p. 6.

34 Robert. J Barro, Xavier Sala-i-Martin, Economic Growth. Second Edition (Cambridge, Massachusetts: The MIT Press), October 2003, quoted after Boldrin/Levine, Against intellectual monopoly. (Cambridge, UK: Cambridge University Press 2008), p. 6.

35 Hans-Bernd Schäfer, Claus Ott. Lehrbuch der ökonomischen Analyse des Zivilrechts. Dritte, überarbeitete und erweiterte Auflage. Hans-Bernd Schäfer, Claus Ott. Springer-Verlag, Berlin, Heidelberg

36 Hans-Bernd Schäfer, Claus Ott. Lehrbuch der ökonomischen Analyse des Zivilrechts. Dritte, überarbeitete und erweiterte Auflage, p. 577

37 Hans-Bernd Schäfer, Claus Ott. Lehrbuch der ökonomischen Analyse des Zivilrechts. Dritte, überarbeitete und erweiterte Auflage, 578.

38 Michele Boldrin/David K. Levine, Against Intellectual Monopoly. (Cambridge, UK: Cambridge University Press 2008

39 Michele Boldrin/David K. Levine, Against Intellectual Monopoly, p. 6.

40 Michele Boldrin/David K. Levine, Against Intellectual Monopoly, p. 1 et seqq.

41 Michele Boldrin/David K. Levine, Against Intellectual Monopoly, p. 14

42 Michele Boldrin/David K. Levine, Against Intellectual Monopoly, p. 10, p. 15,

43 Michele Boldrin/David K. Levine, Against Intellectual Monopoly, p. 7 et seqq.

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Details

Title
Perspectives of regulatory bodies on intellectual property for 3D-printed medical products
Subtitle
How does the European Patent Office (EPO) perceive patents for 3D-printed medical products?
College
Technical University of Munich  (MCTS)
Grade
1,3
Author
Year
2021
Pages
20
Catalog Number
V1119525
ISBN (eBook)
9783346513328
ISBN (Book)
9783346513335
Language
English
Keywords
3D-Printing, European Patent Office, Medical Products, Policy Making, Technology, Legislation, Patents
Quote paper
Philipp Neudert (Author), 2021, Perspectives of regulatory bodies on intellectual property for 3D-printed medical products, Munich, GRIN Verlag, https://www.grin.com/document/1119525

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