Intellectual property rights over ‘integrated’ medical devices: the potential health impacts and bioethical implications of rightsholders’ control

Abstract

Despite extensive literature examining intellectual property rights (IPRs) and access to health, there has been limited examination of how IPRs can potentially impact the development, access to, delivery of, and use of medical devices. This article fills this gap, focusing on patent and copyright protections applicable to elements of medical devices that are attachable to or implanted into the human body, such as prostheses or pacemakers. Although the human body itself is not patentable in Europe (Article 5, Biotechnology Directive), elements of medical devices created outside the body are patentable. Moreover, certain aspects of such medical devices can be subject to copyright, and other types of IPRs. This article provides an overview of the types of IPRs that can apply over attachable and implantable medical devices. Following this, and focusing specifically on copyright and patent rights, it argues that such IPRs, alongside incentivizing technological development in certain contexts, also give rightsholders significant control over key aspects of how individuals use and access IP-protected elements of such devices, with the potential for health-related impacts and bioethical implications. Accordingly, the article argues that greater understanding and scrutiny are needed within the health law and bioethics communities around the potential impacts of IPRs over medical devices.

I. INTRODUCTION

The human body is not patentable in Europe.¹ However, various elements of emerging ‘technologies’, including medical device technologies are patentable, even where such devices are intended to become part of the human body.² Similarly, other intellectual property rights (IPRs) do not apply to the human body itself, but may apply over certain aspects of medical devices attached to or which operate within the body. This article provides an overview of the main types of IPRs that can apply specifically over intangible aspects of ‘medical devices’ that are integrated with the human body, that is devices that are attachable to the human body, such as limb prostheses, or devices which are implantable within the human body, such as pacemakers.³ It focuses on the role of patents and copyright law in this context, because such IPRs are often the most relevant IPRs in terms of their potential to be used in a way that can impact the development, access, and use of such devices. Building on the work of Quigley and Aydihongbe on the challenges for law posed by the integration of persons and goods in the medical device context including challenges for intellectual property rights, and upon prior work by one of the authors on the bioethical issues posed by how patents can apply over technologies related to how we treat, use and modify the human body more generally,⁴ this article argues that how IPRs can be used over aspects of integrated medical device technologies needs far deeper consideration within the health law and bioethics communities because it can give rise to a range of health impacts with the potential to lead to bioethical implications, including implications for device-users’ autonomy and dignity interests.⁵ Rightsholders’ use of IPRs over such devices can also, in some cases, limit healthcare practitioners’ and healthcare systems’ clinical autonomy by impacting the types of medical devices that are accessible.

In making such arguments, this article makes two key contributions. First, although there is extensive literature on the implications of patents for access to medicines, there is a dearth of literature on IPRs and access to medical devices.⁶ Moreover, there is limited literature on this issue written specifically for a health law and bioethics audience, which examines in detail how IPRs can apply to medical devices, and the potential ways that the grant and/or the existence and use of IPRs over various aspects of medical devices may give rise to potential health implications. This article fills this gap by probing how IP protections could apply to elements of medical devices and highlighting how certain uses of such rights can pose access to health implications.⁷ Secondly, and relatedly, this article demonstrates the potential for such IPRs, focusing on patent and copyright law, to be used in a manner that can impact the development, access, delivery, and use of medical devices, as well as highlighting some of the related bioethical implications that can arise. This analysis is intended to serve as a starting point for others within the health law and bioethics communities to probe further the role of IPRs in the medical device context. It calls for a deeper and more nuanced examination of the potential role of IPRs as a tool to incentivize the development of medical devices in certain contexts, and how this can (or should), be considered alongside the potential bioethical implications that can arise.

The article is structured as follows: Section II outlines the broad range of ‘technologies’ that are considered as ‘medical devices’. It defines what is meant by ‘integrated’ medical devices for the purposes of this article, and provides a justification for the focus on IPRs over integrated devices. Section III provides an overview of the main types of IPRs that can apply over integrated medical devices. This overview is provided to enable broader consideration of the role of IPRs over medical devices within the health law and bioethics communities. As this overview is directed specifically at this audience, it assumes limited knowledge of IPRs. Thus, it is framed in general terms and explains key IPR principles where relevant to medical devices to encourage greater engagement with such issues by these communities in the future. This overview provides the necessary foundations for the analysis that follows. Section IV demonstrates how rightsholders’ use of such IPRs—focusing specifically on patent and copyright protections—can potentially impact the access, delivery, development, and use of integrated medical devices, with knock-on bioethical and health implications. Section V concludes by arguing that, given these implications, the use of IPRs over integrated medical devices (and their component parts) requires greater examination within health law and bioethics contexts.

II. IPRs OVER CONNECTABLE AND NON-CONNECTABLE MEDICAL DEVICES

The relationship between IPRs and access to health is contested, and we recognize that patents and other types of IPRs can have both an incentivizing function and can also be used in ways that impact access to health. For instance, there is considerable literature examining IPRs and access to medicines. On the one hand, some authors argue that IPRs are necessary to incentivize the development of new medicines.⁸ For example, Scherer highlights evidence indicating that the IP system has an important role in the research and development investment decisions of health technology manufacturers.⁹ This is because the IP system, particularly the exclusivity of the patent system,¹⁰ provides a pathway for manufacturers to generate an income stream from a technology, which offers a means to secure a return on their investment.¹¹ In making this point, this article is not suggesting IPRs are the only or most efficient incentivization tool for the development of new health-technologies. Instead, IPRs typically provide incentives for certain types of innovation in certain contexts, such as where they are driven by market demand and the ability of markets to pay.¹² This health innovation model, however, can – and does – lead to inequities and exclusions; for example, the IPR based incentives model can contribute to limited innovation for medicines for conditions primarily affecting low- and middle-income countries.¹³ However, a critical analysis of these issues is beyond the scope of this article; instead, here, it is taken that IPRs can be a key factor to incentivize certain types of innovation.

On the other hand, the exclusive powers conferred on rightsholders by IPRs can be used in a manner that creates barriers for access to medicines, as the exclusivity of IPRs enables rightsholders to charge high prices for medicines and other health-technologies, which may as a result be inaccessible for those who need access.¹⁴ How patents and other IPRs are used can also impact the available supplies of medicines and vaccines, and who can obtain such medicines and vaccines first.

Yet, despite considerable discussion of IPRs and access to medicines and vaccines, there has been limited scrutiny over how IPRs can affect access, delivery, and use of medical devices.¹⁵ Such issues received greater attention during the COVID-19 pandemic,¹⁶ particularly when reports emerged that attempts to address shortages of ventilator equipment for COVID-19 patients using 3D-printed parts could be threatened by IP infringement claims.¹⁷ These claims were later refuted.¹⁸ However, as one of us has argued elsewhere, it is legally plausible that IPRs could be used in such a manner, regardless of the health impacts, which demonstrates the need for scrutiny of this area.¹⁹ This article offers an examination of the multi-faceted role and impact of IPRs over medical devices focusing on the potential impacts of IPRs over how integrated medical devices are developed, accessed and used.

Before delving into the types of IPRs that arise over integrated medical devices, this section outlines what the term ‘medical device’ ordinarily encompasses, how the term ‘integrated’ medical device is defined for the purposes of this article, and the rationale for taking this focus.

A. ‘Medical device’: Definitional scope within existing European frameworks

There is no standardized definition for ‘medical device’, and where specific definitions have been adopted, including within legislation and literature on ‘medical devices’, a broad definition is often used, thereby accommodating an expansive range of devices.²⁰ For example, the European Union’s Regulation on Medical Devices (Regulation (EU) 2017/745) describes a ‘medical device’ as:

…any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. [Emphasis added]²¹

Thus, within this European regulatory context, ‘medical device’ is an umbrella term that captures a range of instruments, machines, and tools, ranging from syringes to pacemakers.²² The World Health Organization (WHO) adopts a similar broad definition.²³ Aronson and others describe a ‘medical device’ as a ‘contrivance designed and manufactured for use in health and not solely medicinal or nutritional’.²⁴ Racchi and others state that ‘medical devices’ ‘are very wide-ranging products, such as apparatus/instruments, software and materials (ie substances)’.²⁵ The expansive nature of ‘medical devices’ as a classification is demonstrated by the fact that software programmes,²⁶ or 3D bio-printed tissues,²⁷ can be classified as medical devices in certain circumstances.

A range of factors are relevant for medical device classification. For instance, medical devices are often distinguishable from pharmaceuticals by how they achieve their therapeutic functions,²⁸ as under relevant EU laws, medical devices do not achieve their objectives ‘by pharmacological, immunological or metabolic means’.²⁹ The WHO adopts similar distinguishing features.³⁰ Moreover, the intention of the manufacturer of the device is important in determining classification as a medical device.³¹ A detailed examination of how medical devices are classified is beyond the scope of this article. It suffices here to recognize that the term ‘medical device’ captures a wide range of different types of devices that interact with the human body in a myriad of different ways.

B. ‘Integrated’ medical devices and the human body

This article focuses specifically on ‘medical devices’ that are integrated with the human body. This notion of ‘integration’ draws on Quigley and Ayihongbe’s conception of the ‘integrated’ nature of persons and goods in the context of how certain medical devices can become integrated with, or become part of, the human body.³² More specifically, for the purposes of this article, we are using the term ‘integrated’ to mean medical devices that are attachable to the human body or implantable in the human body, where such devices are intended to alter or augment the appearance or functions of the human body. Thus, the implications of IPRs over non-attachable and non-implantable medical devices, such as stethoscopes, are beyond the scope of this article.

This article focuses specifically on IPRs that can apply over integrated medical devices for two reasons: First, integrated medical devices are intended to be attached to or implanted within the human body and will often seek to alter, functionally or aesthetically, an element/aspect of the human body. In some instances, such as in the case of a pacemaker the operation of such devices can have significant health implications. Moreover, how IPRs operate and can be used over such devices, as will be discussed further below, can, in certain contexts, impact how such devices are developed, accessed, used, and modified. Thus, it will be argued that IPRs and how such rights are used can have health-related implications, with knock-on potential bioethical implications including for individual’s autonomy (and access to such devices) and dignity interests.³³ 

Secondly, and relatedly, although the human body is not patentable in Europe, integrated medical devices are patentable and can also be subject to other forms of IPRs. Integrated medical devices are created in a technical manner outside the human body, yet when they become integrated with the body (by being implanted or attached to the body), they could be seen as becoming a part of the human body.³⁴ This gives pause for thought on the extent to which the patentability of—and use of patents over—such devices is coherent with Article 5 of the Biotechnology Directive, which stipulates that the human body itself is unpatentable.³⁵ Further scrutiny is thus needed over the effects and broader health and bioethical implications of the grant or use of patents (and use of other IPRs) over such ‘technologies’, which this article provides.

Furthermore, the article uses two sub-categories of integrated medical devices, namely: (i) non-connectable integrated medical devices and (ii) connectable integrated medical devices. Under category (i), the term ‘non-connectable’ integrated device refers to devices that operate with no connection to an external control system outside the body. These devices are intended to be attached to or implanted in the human body, for example, to maintain the healthy functioning of the human body, or to fulfil primarily cosmetic purposes.³⁶ Examples include but are not limited to heart stents, artificial joints, certain types of prosthetics, etc. These devices will often be controlled manually by the physical actions of the device-user or have a merely aesthetic function. Category (ii) refers to connectable integrated medical devices, that is devices that are connected to or controlled by an external device or source, which collects, stores, and/or transmits data to a third party that controls how such data are used and, potentially, can affect or impact how the device functions. Examples of connectable integrated medical devices include artificial pancreas systems, pacemakers, etc. Such connectable devices rely on an external source to operate, which is often controlled by the rightsholder or manufacturer, such as via a mobile phone app—whose software code underpinning its operation may be protected by IPRs held by the rightsholder. The link between the device and manufacturer or rightsholder is often ongoing for connectable devices, even after such devices are implanted or attached to the human body.

These further classifications—connectable and non-connectable integrated medical devices—are used in this article. This is because IPRs may apply differently to elements of connectable versus non-connectable integrated medical devices due to the differing nature of these technologies and the varying levels of ongoing control that rightsholders have over the day-to-day functioning of a device in these two contexts.

III. IPRs AND INTEGRATED MEDICAL DEVICES: AN OVERVIEW

This section provides a general overview of the main types of IPRs that can arise over elements of integrated medical devices in Europe and how these rights, in general terms, can be used by rightsholders over connectable and non-connectable medical devices.³⁷ This provides the foundations for analysing the potential health and bioethical implications posed by how IPRs can be used over such devices, examined in Section IV. Importantly, multiple types of IPRs often apply over different aspects of a medical device, which may be held by different rightsholders, and as in other contexts, rightsholders may seek to strategically layer different types of IPRs to strengthen the exclusivity they have over an invention, a point discussed further below. Indeed, given how the IPR system is designed and operates, it can be expected that many rightsholders (often for-profit companies) would seek to maximize the breadth and length of their proprietary protection and to strategically use IPRs in this way. In making such arguments, we are not seeking to question whether IPRs should be granted over medical devices (or their component parts) per se. Instead, our focus is on illuminating the breadth of discretion rightsholders have once patents are granted (or other types of IPRs apply) over medical devices, which enables such IP rightsholders to exert considerable control over various aspects of how the IP-protected technologies are developed, used, and accessed.

Turning to the main types of IPRs applicable over integrated medical devices, the following key categories can be identified:

A. Patents and integrated medical devices

A patent allows rightsholders to exclude others from using a patented invention, within the jurisdiction that the patent is granted in, for a minimum of 20 years.³⁸ Prior to delving into how patents apply over elements of medical devices, a note on jurisdictional scope is needed. There is no global patent system. However, the TRIPS Agreement sets out minimum standards around patentability, which applies in all World Trade Organization Member States. Alongside this, national and regional laws apply depending on the jurisdiction. This article focuses on the European context. For patents, ‘European’ is used to mean the laws applicable under the European Patent Convention 1963, as amended (EPC), which apply to 39 States, including all European Union (EU) states and several non-EU States. The EU adopted the Biotechnology Directive 98/44/EC, which applies to the patentability of biotechnologies in the EU, and this Directive was adopted as supplementary interpretation for the EPC. Thus, for patents, this section refers primarily to the TRIPS Agreement, EPC and, where relevant, the Biotechnology Directive. The institutional complexities of the European patent system are beyond the scope of this article.³⁹

Article 27(2) of the TRIPS Agreement (and Article 52(1) EPC) states that patents must be made available for inventions in all fields of technology, provided that the invention is new, involves an inventive step and is capable of industrial application.⁴⁰

Thus, medical device technologies or related technologies are patentable under TRIPS. Moreover, a patent can be granted for both a final product (or element(s) of that product) and the process(es) of making/using that product. Furthermore, a rightsholder can hold patents over the product (or elements of that product) and over a related process simultaneously. Under European patent law⁴¹ and the international TRIPS framework,⁴² certain inventions are not patentable. However, there is no exclusion from patentability against medical devices per se; instead, medical devices are treated the same as other patentable technologies, regardless of the purpose of the underlying patented ‘technology’ and how the device is intended to interact with or operate within (or in relation to) the human body.⁴³ Indeed, once a patent is granted, patentable inventions are treated as fungible within the patent system, and ‘[n]o consideration is made of the effects of such patents and the associated licenses consequent upon the nature of the “invention” in question’.⁴⁴

Moreover, whilst Article 5 of the Biotechnology Directive 98/44EC states that the human body itself is not patentable in Europe,⁴⁵ medical devices are not considered part of the human body at the point of their production. Hence, medical devices would not fall within the Article 5 exclusion at the point of the development or production of such technologies.⁴⁶ Furthermore, the Directive applies only to biotechnological inventions, not to other categories of inventions. Accordingly, even though one could potentially argue that when a device is later implanted into the human body, it becomes ‘part of the body’ at that stage,⁴⁷ this would not affect the patentability of the invention at the grant stage under this provision.

Furthermore, Article 53(a) EPC (and Article 6 of the Biotechnology Directive 98/444EC)—the so-called morality provision—states that inventions will not be patentable if their commercial exploitation is against ordre public or morality. However, this provision is often interpreted in a light-touch manner by the European Patent Office (EPO).⁴⁸ There are differing views on the extent to which this provision should be more broadly interpreted to deny patents at the grant stage.⁴⁹ In practice, legal challenges to patentability based on the morality provision are rarely successful. The EPO guidelines for patent examination state that this provision should be used to deny patentability only in ‘rare and extreme’ circumstances, where ‘it is probable that the public in general would regard the invention as so abhorrent that the grant of patent rights would be inconceivable’.⁵⁰ It has not been used to deny patents over medical devices by virtue of these being integrated with the human body per se, or given how patents over such devices could be used including, in ways which they could be used to limit access to such devices (discussed below). Given the high threshold that the EPO applies around this provision, it is unlikely it would apply it to deny patents over medical devices generally.

Alongside the morality provision, Article 53(c) EPC excludes methods of treating humans and animals, including surgical and diagnostic methods and therapies. However, in practice, this provision only excludes from patentability methods practised on or in the human body. It expressly does not exclude the patentability of any products used in such contexts, which could include tools used such as medical devices. Nonetheless, where surgical or therapeutic methods are needed for the medical device to function, it could in certain contexts potentially fall under this exclusion.⁵¹ Thus, a case-by-case assessment of the patent claims is needed in certain contexts.

A patent claim related to a medical device could also take the form of a ‘methods’ claim. Moreover, whilst the exclusion under Article 53(c) is typically construed narrowly,⁵² this exclusion may be relevant to ‘methods’ claims related to medical devices that perform a diagnostic, surgical or therapeutic function within the human body. Thus, whilst a methods claim related to the use of a medical device does not directly fall foul of Article 53(c), however, for example, a device could be excluded from patentability where the claimed method involves a method of operating the device that requires, as a functional step, the surgical or therapeutic treatment of the body.⁵³ However, certain patent claims could be drafted to avoid claiming such aspects, thereby potentially avoiding the exclusion under Article 53(c). Moreover, regarding the methods of diagnosis exclusion, based on how this exclusion is applied,⁵⁴ it would likely only exclude a method from patentability where it carries out a complete diagnostic function, not just an interim step.

For connectable medical devices, patents may, in some cases, extend to certain aspects of the software within a device necessary for it to perform a technical function. Under European patent law, Article 52(2)(c) excludes ‘computer programs as such’ from patentability under the EPC. However, this does not exclude all computer programs from patentability. The EPO Board of Appeal, in IBM (T1173/97), held that:

…a computer program claimed by itself is not excluded from patentability if the program, when running on a computer or loaded into a computer, brings about, or is capable of bringing about, a technical effect which goes beyond the “normal” physical interactions between the program (software) and the computer (hardware) on which it is run.⁵⁵

A computer program that does not have a technical function would not be patentable under the EPC. Its patentability is tied to, among other requirements, having a technical effect or contributing to a technical solution. Some computer programs, which form part of a medical device, may have technical and non-technical features, and questions have arisen around whether inventions with a mixture of technical and non-technical features are patentable.⁵⁶ In Case T154/04 Duns Licensing Associates, it was held that patent claims could have technical and non-technical elements, but non-technical features of the claim are not considered if they do not resolve the claimed technical problem, and for the invention to be patentable, there must be a technical problem at stake.⁵⁷ A deeper exploration of such EPO decisions is beyond the scope of this article. For the purposes of the arguments here, based on existing EPO decisions, a computer program that forms part of a medical device may be patentable where it contributes to, or has, a technical effect. Technical effects could range from fulfilling or contributing to enabling a technical function or action of the device.

In short, patents are available over various aspects of integrated medical devices, including parts of the device, certain aspects of technical processes and methods through which a device operates, technical processes for the development and production of devices, and in some instances, patents may be available over aspects of computer programs within such devices that have a technical function.

B. Copyright and integrated medical devices

Copyright protection extends primarily to original works of art, literary, and scientific works and in the EU context, subsists, generally, in the original author during their lifetime and for 70 years after their death.⁵⁸ Copyright also subsists in ‘computer programs’, which are protected as literary works under EU copyright law (Directive 2009/24/EC),⁵⁹ where a ‘computer program’ is defined as including ‘programs in any form, including those which are incorporated into hardware’.⁶⁰ The term ‘computer program’ here could include source code, object code, assembly code,⁶¹ and other preparatory materials that can be protected by copyright.⁶² Software, firmware, and their source codes have become integral features of connectable integrated medical devices. For example, software programs embedded within such devices often control how medical devices operate.⁶³ In the case of connectable medical devices, this can include how such devices interact with the device-user’s body, such as for example, performing prescribing and diagnosing functions. Thus, copyright over the underlying codes required for such applications and programs to operate is a key IP protection applicable in medical device contexts.

In terms of the potential implications that copyright can have for the operation of medical devices—a point discussed in more detail in Section IV—in general terms, copyright prevents unauthorized persons from making copies of the protected work. It also empowers rightsholders to prevent the distribution, reproduction, and unlawful performance or broadcast of the copyright-protected work. Thus, copyright could be used to prevent the making of unauthorized copies of the underlying protected code by third parties and in some cases could be used to prevent modification of this software (if that modification would involve copying of the code). Indeed, many manufacturers of software-embedded devices embed digital locks on the device, which can lock the device if modification of the code (including, for repair or updating purposes) is attempted. Attempts to change copyright-protected code within a device (even, for example, if the intended outcome is to facilitate a change in how the device itself operates) could be a violation of copyright⁶⁴; we discuss such issues in more detail in Section IV.

C. Other IPRs and integrated medical devices

Copyright and patents are the main focus of this article as these are key IPRs relevant to medical devices. These IPRs can impact the use of medical devices, which in turn impacts device-users, healthcare practitioners, and healthcare systems. However, for the purposes of completeness, several other types of IPRs can apply to medical devices and must be noted, focusing here specifically on design rights, trademarks, and trade secret protection.

First, design rights may be applicable over elements of the external features of a medical device, including lines, contours, shapes, textures, or colours. Article 4 of the Regulation 6/2002 stipulates the conditions that must be fulfilled before a design is protected in the EU.⁶⁵ It must be new, meaning there are no identical designs in the public domain; the design must have an individual character, meaning that a user can distinguish the design from other designs in the public domain.⁶⁶ Under Article 12, a registered design will be protected for 5 years, and it remains renewable for 25 years. Apart from the conditions stipulated in Article 4, designs considered contrary to public policy and principles of morality cannot be protected. Unlike a patent, the protection offered by a design right does not extend to the functional aspect of a design—Article 8 of the Regulation prohibits the registration of designs that are defined by their technical functions. However, design rights could be used as part of rightsholder(s)’ strategies to protect the aesthetic appearance and design of a medical device. Moreover, when combined with other forms of IP protection, including patents, rightsholders could use design rights over elements of medical devices to strengthen their scope of protection and control over how products are manufactured and appear.⁶⁷

Secondly, trademark protection may apply to the brand name and potentially other aspects (where non-traditional trademarks may apply) of a medical device.⁶⁸ Trademark protection could extend to certain aspects relevant to the medical device context, including specific words, signs, images, colours, the shape of goods, packaging, etc.⁶⁹ A trademark is eligible for protection if it is distinctive and therefore capable of distinguishing the goods and/or services of its proprietor from the goods and/or services of other undertakings.⁷⁰ The core function of a trademark is to act as a badge of origin and to secure the distinctiveness of products/services. For example, a brand name of a medical device may be protected by a trademark, which enables the trademark proprietor to prevent third parties from using the mark.

Relatedly, Calboli argues that the protection of non-conventional trademarks (shapes,⁷¹ colours, texture, etc.) can act as a means for rightsholders to extend their control over health technologies.⁷² Calboli observes that empirical evidence suggests that patients may become accustomed to a particular look or feel of a health-related product and may wish to continue using that particular product or one that looks similar to the originator product, even after patent rights relevant to that product have expired and generic versions are available.⁷³ However, trademarks over aspects of the shape, colour, or texture could limit competitors’ ability to provide a similar-looking health technology. Moreover, because there is high demand for such simliar looking products, these other IP protections can enable high prices for originator products to be maintained even after patents expire. Some patients may not be able to afford such prices. Moreover, generic companies may have to consider the potential threat of trademark infringement related to generic products. Thus, Calboli has argued that ‘non-traditional trademarks may delay or altogether block access to these therapies after the patents’ expiration’⁷⁴ and may do so for an extensive period.⁷⁵ When trademarks are overlapped with other IPRs over different elements of the medical device, this solidifies rightsholders’ control over a technology, including a medical device.

Third, and finally, similar to how IPRs can operate in the access to medicines context,⁷⁶ in the medical device context, trade secret protection can also be used alongside other IPRs over key aspects of medical devices, thereby increasing rightsholders’ control. Trade secret protection operates by entities maintaining confidentiality around certain aspects of know-how or information related to, for example, the manufacture or use of, an invention. It is generally used where information or knowledge about, for example, a technique or method needed to produce a technology or invention, would be difficult for others to find out or reverse engineer. In such cases, keeping such information secret can be used to protect this technology from third-party use. In the context of medical devices, for example, trade secret protection could be used to protect certain aspects of how a medical device (or its parts) is manufactured.⁷⁷

D. Reflection: IPRs and connectable or non-connectable integrated medical devices

In sum, a range of IPRs can apply over different elements of connectable and non-connectable medical devices. This section will now reflect briefly on the potential IPRs that can arise in each category prior to examining the potential health and bioethical implications of how such IPRs can be used over medical devices in Section IV.

First, for integrated non-connectable medical devices, taking a prosthetic device as an example, IPRs applicable in such contexts could include patents over components of the device or over the processes to manufacture or use that device (or its component parts). Moreover, the structural appearance, texture, and colour aspects of a device could potentially be protected through design rights. Trademarks may apply over the brand name of the device or a non-traditional mark over aspects such as the shape of the device. Copyright could apply, for example, over other aspects of the device, such as over the instructions around the use of the device.

Similarly, if we consider IPRs over ‘connectable medical devices’, taking a connectable ‘insulin pump’ device as an example, connectable insulin pumps are increasingly designed to interact directly with continuous glucose monitors (CGMs) and remote controls to create a closed-loop artificial pancreas system, which can monitor blood glucose levels and re-adjust based on the device-user’s needs to maintain healthy glucose levels. The insulin pump is typically connected to a software program, which operates via an external device, such as a mobile phone app.⁷⁸ A connectable insulin pump like this can have both software and hardware components, which could be protected by different types of IPRs. For example, hardware components making up the physical device may be protected by patents, while appearance components may be protected by design rights. Trademarks could apply over the brand or shape, which may distinguish the device from other insulin pumps. Alongside this, certain aspects of the software components of a connectable medical device could be patentable if they bring about a technical effect, and relevant aspects of code underpinning software within the device could be protected by copyright.

IPRs over connectable and non-connectable devices can be used to develop or maintain an income stream for rightsholders, thereby protecting rightsholders’ economic interests. This, in turn, as noted, can act to incentivize (and encourage investment in) the development of certain types of medical device technologies. However, alongside this, as noted, IPRs give considerable discretion to rightsholders over key aspects of how a protected technology or subject-matter is used, accessed, modified (depending on the IPR), and such IPRs can be used by rightsholders in a manner that can have negative impacts on access to and use of such devices, with health and bioethical implications. The potential bioethical and health implications of IPRs over medical device technologies have received limited scrutiny to date which we will now consider.

In making such arguments, this article does not argue that IPRs should not be granted to medical devices. Instead, the key point in the analysis that follows is that the breadth of discretion granted to rightsholders by virtue of IPRs needs deeper and more nuanced consideration in medical device contexts due to how medical devices relate to the human body. This includes consideration – as one of us has argued elsewhere – of the need for licensing conditions over how IPRs over medical devices can be used which could limit the potential bioethical and health implications at stake, as far as possible, whilst maintaining the incentivising role of IPRs.⁷⁹

IV. THE POTENTIAL HEALTH AND BIOETHICAL IMPLICATIONS OF HOW IPRs CAN BE USED OVER INTEGRATED MEDICAL DEVICES

This section examines some of the main health and bioethical implications that can arise around how IPRs are used over (elements of) integrated medical devices, with particular reference to patent and copyright protection. In doing so, it highlights the lack of avenues to directly engage with such health and bioethical implications posed by how IPRs could be used over elements of integrated medical devices in Europe. Instead, once a ‘technology’ is deemed patentable, as noted, that technology is treated as fungible with other technologiesunder patent law.⁸⁰ Put simply, provided a technology or subject-matter is deemed to be patentable or copyrightable, once it is IP protected, IP decision-making systems are often agnostic to the nature of the underlying protected technology or subject-matter and how the use of patents or copyright protection over elements of that technology could impact access to or delivery of health care.⁸¹

This section argues that IPRs over elements of integrated medical device technologies can have four main potential health implications, depending on how rightsholders use such IPRs: (A) impacting—including the potential to hinder—access to medical devices for individual device-users and within health systems; (B) impacting access to repair services and/or the production of repair parts for integrated medical devices; (C) impacting device-users’ ability to modify (or engage third parties to modify) their medical devices to suit their health needs or broader preferences (there are broader safety/ethical considerations here which we acknowledge and discuss below); and (D) impacting, including the potential to impede the development of new or improved integrated medical devices. In each context, where relevant, the analysis will indicate how the use of IPRs has the potential to give rise to bioethical issues.

In making such arguments, the section does not aim to provide a comprehensive analysis of all potential health or bioethical implications that IPRs over integrated medical devices can contribute to. It also does not seek to suggest that IPRs will always have negative implications in the medical device context. This article recognises that IPRs are also an important incentive for the development of medical devices. Furthermore, it is not necessarily the existence of an IPR over medical device components that is at issue; rather, it is often how such rights can be used by rightsholders that can give rise to or exacerbate health/bioethical concerns. Moreover, in some cases, it may be a combination of how different types of IPRs are used over a medical device (together with other factors) that culminates in such access or other health-related implications.

A. IPRs and potential impacts on access to medical devices

First, as with other types of patentable technologies, patents and other IPRs allow rightsholders the ability to exclude others from using the underlying IP-protected technology. This allows rightsholders a key role in setting the terms of access to the technology, including the price they are willing to offer for the use of the patented technology. For example, rightsholders may refuse to license the patented technology to third parties, which can enable the rightsholder(s) to become the sole provider of the technology, enabling the rightsholder(s) to limit the supplies available. This, in turn, can enable rightsholders to exert a higher price for access to that technology, as creating a market with limited supplies and only one supplier forces the market to bear such costs to gain access.⁸²

Such issues are exacerbated by the fact that, as discussed above, a range of different types of IPRs generally apply to connectable and non-connectable medical devices, and such rights are often strategically layered to increase rightsholder(s)’ control and extend the duration of IP protection.⁸³ If rightsholders refuse to license a patent to third parties, the technologies needed to develop a specific medical device may become unavailable or in short supply. ⁸⁴ This can have a knock-on effect on access to that device—where the price is significantly high, individuals may be unable to afford it, or public health systems may not be able to provide access due to finite public health budgets.

Various examples of IPRs affecting access to connectable and non-connectable devices illustrate this point. For example, advances in prosthetics give rise to significant potential benefits for device-users, including advances in exoskeletons, which have a range of uses including therapeutic uses and aiding mobility for device-users. Yet, the costs of such devices can be prohibitive in some cases,⁸⁵ and such costs are a key barrier for device-users in accessing or using these devices.⁸⁶ For example, if we consider the bionic BiOM Ankle prosthetic, a device that offers a flexible joint at the ankle,⁸⁷ allowing the device-user more movement than previous prosthetics on the market, the cost of this device has previously been reported as impacting affordability and hence access to the device. In 2013, in the USA, it was suggested at that time, that:

The BiOM ankle, though, still has one big problem: It’s “prohibitively expensive,” Albuquerque says. At about $50,000, it costs up to $40,000 more than a standard prosthesis, and isn’t covered by Medicare, Medicaid, or most insurers. That means most amputees can’t afford it.⁸⁸

Similarly, the first exoskeletons approved by the US FDA were reported as being priced between US$69,000 and 85,000.⁸⁹ Other devices, such as the Esko, which is more akin to a mechanical robot attached to the body, were initially reported as costing upwards of US$100,000 per patient—such devices were generally bought or used by clinics for a group of patients rather than by individual patients.⁹⁰ In the UK, the cost of the Esko in 2017 was reportedly approx. £98,000.⁹¹ In 2016, it was reported that developments such as lightweight exoskeleton devices, including the Phoenix exoskeleton, aimed to reduce costs to US$40,000 or less per device,⁹² but such prices mean it would still be (likely) unaffordable for many to have a customizable exoskeleton.⁹³

Whilst we recognize that IPRs are not the only factor that impact the costs of the device, other factors include the costs of materials needed to make such devices and the development and manufacturing costs, etc. Nonetheless, IPRs, including patents, can be a key relevant factor in this context as they mean rightsholders can gain a potential monopoly right, thereby reducing competition in the market for a device or part, which means the market is likely to bear higher prices if there are no or limited alternatives. IPRs that can apply over elements of such technologies provide rightsholders with significant control over the terms they can set for third parties to access such technologies and enable rightsholders to adopt strategies which potentially block third parties from using or producing the patented technology. Where such technologies relate to integrated medical devices, the use of IPRs in this manner can pose health implications as it can impact, individuals’ and clinics’ ability to access and use prosthetic devices and potentially offer (access to) customizable devices where these are clinically indicated such as for rehabilitation purposes. Lack of access to such technologies can potentially impact users’ quality of life and health, and could have knock-on effects on their broader dignity interests by limiting access to appropriate health services.

There are no mandatory legal provisions in European patent law (at the licensing or grant stage) which specify conditions for how patents over medical device technologies should be licensed to address or mitigate the access-to-health implications arising from how such patents can be used. States can use compulsory licensing mechanisms in patent law to mandate rightsholders to license their patent rights over technologies in certain circumstances.⁹⁴ Many States have avenues under which the State could grant a compulsory license, such as where a voluntary license was unreasonably refused. However, compulsory licensing is not necessarily a solution to such issues, as compulsory licenses must be applied for on a patent-by-patent basis, and must be sought in each national State separately. Additionally, compulsory licenses only apply to patents, not other IPRs that may arise over medical devices.⁹⁵ As medical devices will generally be covered by a range of IPRs, compulsory licenses typically only address one part of the IP hurdles to broadening access. Hence, existing avenues, such as compulsory licenses, are of limited effectiveness. They are also not designed to address the types of issues related to how IPRs could be used over key aspects of integrated medical devices. Given the relatively recent nature of integrated medical device technologies, such issues were likely not envisaged at the time of the drafting of the Paris Convention in 1883, which is the basis for the current compulsory licensing legal framework at a regional level in Europe.⁹⁶

We acknowledge here that there are some avenues outside of patent law at the national level to limit the potential impacts of such IPRs on access to health in such contexts. For example, in some jurisdictions, the grant of a tailored final injunction can be made when infringement against the use of an IP-protected technology is found and where granting a full injunction against the use of the infringing technology is contrary to public interests. For example, in Edwards Lifesciences LLC v Boston Scientific SCIMED INC.,⁹⁷ where a transcatheter heart valve (THV), the Sapien 3, produced by Edwards, was found to infringe a patent held by Boston Scientific, an injunction was sought against its use. However, the injunction was tailored so that it did not apply to a cohort of patients who needed access to the Sapien 3, the infringing device, where there was no other suitable device available on the market for these patients. The court held that ordering an immediate injunction against using the valve in the context of patients with no alternative device would have deprived them of needed health care.⁹⁸ Thus, a stay was placed on the injunction for this patient cohort, to permit the ‘continued implantation of the Sapien 3 for a period of 12 months’ in order to facilitate time for the re-training of clinicians to use an alternative device. However, the court gave permission for Edwards ‘to apply to extend the stay if it turns out that the period required for re-training is longer than that’.⁹⁹ Thus, a tailored injunction was used to mitigate against access to health issues arising from the full enforcement of the relevant patent.

The facts of the case starkly illustrate the impact that patent use and enforcement can have on access to health, as without the tailored injunction, enforcing the patent fully could mean an infringing device could no longer be used, regardless of the health context. The exception here was allowed because of the public health impacts for a specific category of patients. However, a tailored injunction is a discretionary equitable remedy (a point discussed below). Had this tailored remedy not been provided and if the injunction had required clinicians to stop using the Sapien 3 for all patients, this could have had significant health consequences for any cohorts of patients who had no alternative devices. Moreover, any use of such an alternative device for such patients would need to be approved, which can take considerable time.¹⁰⁰ Clinicians and specialist nurses participating in such procedures would require retraining to adopt alternative devices approved for such patients.¹⁰¹ Indeed, the court found that:

Expediting such training and proctoring will inevitably disrupt waiting lists. Patients waiting to be treated by clinicians who have to be diverted into training will suffer. So too will patients who would otherwise be treated by the proctor.¹⁰²

The potential impacts of enforcing the patent in this context on clinical autonomy is also alluded to in the judgment, at para 58; the court stated:

He [Prof Brecker] is in little doubt that individual operators [clinicians etc] will feel uncomfortable at not being able to use a device that they have become familiar with and may feel less confident at first in treating patients with a new device. Dr Rawlins (who is already familiar with the Sapien 3) considers that it will take approximately 50 implantations to become fully familiar with the Evolut R and to maximise clinical outcomes using it.

Here, we see clear illustrations of how general patent enforcement could impact both access to and delivery of health care in certain medical device contexts, with such issues being averted in this case via tailoring the injunction on the basis of public health issues at stake. However, injunctions are equitable remedies granted on a case-by-case basis and whether injunctions can be tailored – whereby typically damages will be awarded in lieu in certain contexts – is also considered on a case-by-case basis, with high thresholds applying. Such solutions are often time-limited and are not designed as a general avenue to address the potential impact of patents (and other IPRs) over access to medical devices. Furthermore, in some instances, it is at least plausible that the threat of patent infringement litigation may lead a medical device provider to halt the production and provision of the alleged infringing device, given the high costs of patent litigation. Where this happens, a challenge like the one in the Edwards case may not come before a court; parties may settle in advance of litigation going to court, and as part of such settlements in many cases the alleged infringer would agree to stop using the alleged infringing technology. In such instances, device-users may be deprived of a medical device that may be necessary for their health needs, and this could have serious consequences.

B. Repairing IP-protected medical devices: Potential impacts of IPRs on Repair and Bioethical Implications

Secondly, the hardware components of connectable and non-connectable devices may need replacement or repair. However, as medical device parts are typically protected by a range of IPRs, including patents, the production of a new part to replace an old part of a medical device could constitute patent infringement if it was found to constitute the act of ‘making that product’.¹⁰³ In determining whether making a new part infringes a patent, much will depend on how integral a part is to the patented technology in question.¹⁰⁴ If a third party were to make such parts (without a license from the rightsholder) that are deemed essential to the patented technology, even if they were making such parts for the purposes of repairing an existing device, they could be infringing the patent. Hence, rightsholders not only control making of a device itself, they can also have some control over the supply or making of repair parts for medical devices in certain contexts.¹⁰⁵ In practice, commerical services for the maintenance/repair of such devices may only be legally possible by rightsholders (or their licensees), which can lead to high costs and other limitations on access to such repair/maintenance services, as discussed below.

Furthermore, in the connectable device context, the ongoing control exercised by rightsholders over devices, which is impacted by a range of factors including IPRs, has the potential to directly impact device users’ ability to use existing devices in certain contexts. This is illustrated by considering, for example, the case of the Second Sight Argus bionic eye,¹⁰⁶ where over 350 people had Second Sight’s Argus bionic eye medical devices implanted into their body, allowing them to regain a form of ‘vision’.¹⁰⁷ To have these devices implanted, patients were required to undergo surgical procedures to fit these devices within their bodies. In 2020, Second Sight, the company that manufactured the devices ran into financial difficulties, and some device-users reported their devices stopped working or started malfunctioning. Such device-users also reported that they were no longer able to obtain device upgrades at that time as these were not being produced by the company.¹⁰⁸ This effectively meant device-users lost the form of ‘vision’ they had regained since having the technology implanted, causing significant distress.¹⁰⁹

As one of us has discussed elsewhere,¹¹⁰ the Second Sight issues were not caused by IPRs; rather, such issues arose largely due to financial issues of the company, and a key difficulty here for device-users was the lack of ongoing legal obligations on a manufacturer to continue to provide upgrades and services for this medical device. However, IPRs could, at least in theory, also be used in a manner that could lead to a simliar scenario arising.¹¹¹ For example, a rightsholder of a patentable component of a medical device may decide they no longer wish to produce software upgrades for an existing medical device; however, they would still retain IPRs over that medical device (or elements of this). Rightsholders could refuse to license third parties to produce such upgrades for the underlying code embedded in the device to enable it to operate. Moreover, changing or copying this code, which may be needed to upgrade it, could constitute copyright infringement if undertaken by third parties. Thus, device-users may be left with no upgrades being provided by the rightsholder, and third parties may be unable to provide upgrades due to IPRs and other factors. Indeed, it may be in the financial interests of rightsholders to adopt such strategies that enable them to block existing device updgrades or repairs, thereby creating a need or market for new devices.¹¹² The result could be that a device-user loses the use of the original device and must change devices, which may impose additional costs and, in some cases, these upgrades or new devices may be inaccessible to the device-user. Furthermore, changing a device may not be the preference of the device-user if they have become familiar with the existing medical device and trust that device.¹¹³ In such cases, IPRs could be used to impact users’ autonomy over which device or use they can obtain, alongside having a practical effect on their access to healthcare more generally.

Despite such implications, no tailored provisions in European patent law require rightsholders to provide ongoing maintenance or repairs of patent-protected hardware components or processes for medical devices. There are also no mandatory copyright provisions that require rightsholders to enable (or at least not restrict) third parties to upgrade codes within medical devices where this is required for existing devices to function (even when rightsholders do not provide this themselves).¹¹⁴ Whilst this issue could be dealt with by other areas of law, such as via regulatory conditions on the approval of a technology for use, contractual requirements, or legislative provisions, currently, such issues are in many cases left at the voluntary discretion of rightsholders or licensees given (amongst other factors) the discretion given to them by virtue of how IPRs operate.¹¹⁵

C. Impacts of IPRs on the modification of medical devices

Thirdly, IPRs can be used in a way that impacts the extent to which, if any, device-users can modify (or have modified by third parties) existing devices.¹¹⁶ Device-users may wish to modify their devices for a range of reasons. For example, the first commercially produced hybrid-closed-loop artificial pancreas systems (used to manage certain types of diabetes) to monitor and provide automated insulin were not released until 2016 in the USA (MiniMed 670G (Medtronic).¹¹⁷ Prior to this, diabetes patients and their families campaigned for closed-loop systems. Under the #WeAreNotWaiting campaign, members of the diabetes community sought to make DIY closed-loop or artificial pancreas systems for use.¹¹⁸ Groups such as OpenAPS launched a website in February 2015 that provided information for Type 1 diabetes patients on closed-loop systems, including instructions on how to make DIY systems.¹¹⁹ There are safety and ethical issues around device-users making their own medical devices or altering existing medical devices—as users’ modifications could pose health risks. However, there are also an increasing number of groups seeking to modify their personal medical devices or have these devices modified by third parties for a range of reasons.¹²⁰

Such individuals or groups can face challenges around modifying existing medical devices, including challenges posed by IPRs. Where IPRs, including patents, apply over hardware and software components of a device or copyright over the source code, a third party that modifies such devices for sale or distribution to the public could be infringing applicable patents or copyright protection. Accordingly, IPRs could be used to limit the ability of third parties to modify devices or tools to achieve this for sale. Moreover, the threat of IP infringement litigation may deter such actions.

A medical device-user could, in theory, modify their medical device for personal use and not infringe applicable patents, as under many national patent laws, acts done for personal and non-commercial use typically would not constitute patent infringement.¹²¹ However, medical device-users may be unable to modify their own devices, given the technical skills that would likely be needed, or may be concerned about the risks of doing so. Instead, they may want to request a third-party provider to modify the device to their requirements. However, unless rightsholders have licensing agreements in place for such purposes with that third party, actions that modify patented components of a medical device for commercial purposes by a third party could amount to patent infringement (or an infringment of other IPRs applicable).¹²²

For example, to modify how a connectable device, such as an artificial pancreas system, operates, one may need to copy or change the source code. If that source code is protected by copyright, changes to this code could be an infringement of the applicable copyright. To date, such IP avenues do not appear to have been pursued by rightsholders.¹²³ However, this does not mean such IPRs will not be enforced in this way in future.

Furthermore, rightsholders may use technological restrictions on a medical device that prevents it from being modified, and IPRs can be used to maintain such restrictions. For example, in the USA, some of the initial artificial DIY pancreas closed-loop systems were reportedly only possible due to a security flaw in an older Medtronic insulin pump produced before 2015, which allowed users to hack the pump and connect it with the CGM.¹²⁴ That flaw was subsequently addressed by the manufacturer. Thus, people who wished to set up or use DIY systems needed to procure an older insulin pump with this flaw.¹²⁵ Regardless of why device-users wished to alter such devices, generally (under relevant IP laws), they do not have legal recourse to force manufacturers to allow them or third parties to make devices modifiable. Instead, rightsholders can argue that technical fixes that block third parties’ ability to modify devices are needed to protect underlying copyright protections, and attempts to change these, including tampering with the technical fixes, could violate IPRs. Hence, IPRs can be used to bolster technological avenues that stop users and third parties from modifying devices.¹²⁶

Here, we concede that rightsholders may have valid concerns about medical devices being modified by device-users or third parties on the device users’ behalf. Given the potential health and safety implications, liability issues or uncertainties may arise in the event of risks materializing as a result of modifications,¹²⁷ and modifications may also be contrary to medical device regulations. Moreover, relatedly, IPRs are not the only legal instrument or sole factor impacting freedom of third-party modification. The broader issues around IPRs and repair of medical devices, are beyond the scope of this article.¹²⁸ Our key point is that, given how IPRs operate, the current system allows rightsholders to use various types of IPRs in a way that extends their control not just over the sale of the device but also (especially for connectable devices) in a way that could impact the modification of devices. In short, depending on how such rightsholders use relevant IPRs, their choices can restrict device-users’ ability to modify or repair such medical devices.¹²⁹ Here, we acknowledge that the use of IPRs in this way aligns with how IPRs, including patents, ordinarily operate in other technological contexts. However, given the nature of the underlying patented technology—the integrated medical device—and its relationship with how the human body functions, our core argument is that such implications around the use of IPRs over such technologies warrant deeper consideration and recognition within the health law and bioethics contexts.

Importantly, we are not necessarily suggesting here that DIY modification of medical devices should be facilitated; this normative issue is beyond the scope of this article. Instead, our point is that IPRs are one factor that can impact the extent to which third parties can legally modify medical devices and the extent to which users can have their devices modified by entities that are not the rightsholders. This could impact the device-user’s autonomy over their health-care options, as well as their human dignity, if the device they have is not working as effectively as could be possible without such modification. To date, there has been limited scrutiny of the impacts of such IPRs on device-users’ experiences. We argue that such IPR issues warrant greater nuanced consideration—alongside the broader legal and regulatory questions which arise here—from the health law and bioethics communities.

D. IPRs and the development of integrated medical devices

Finally, given the multiple types of IPRs that can apply over medical devices, such rights can both encourage but also limit the ability of manufacturers and researchers to produce new devices or develop existing devices. This issue is not unique to medical devices; it stems from the double-edged nature of IPRs, which, on the one hand, can be used to incentivize new technological developments, for example, in the case of patents, by providing rightsholders with the ability to stop others from using their invention for the duration of patent right. On the other hand, the exclusive nature of IPRs means that third parties who need to use, for example, a patent-protected technology as part of an intended new technology, are unable to do so without a license from the original rightsholder, who may refuse this.¹³⁰ Complex layers of IPRs over existing technologies can arise, which makes this issue more difficult.¹³¹ Thus, existing patents and other IPRs over elements of a medical device can be used in a manner that blocks innovation. Third parties may have to change proposed devices or invent around existing patent-protected technologies. Rightsholders may try to ‘evergreen’ patent rights, i.e., seeking to develop minor changes on an existing part of a medical device technology, to apply for new patents on this and extend their patent protection.¹³² Moreover, by combining patent, trade secret, copyright, and trademark protections over different aspects of devices, the breadth and length of control that rightsholders have can be strategically extended beyond, for example, an initial 20-year patent grant.¹³³ As in other fields, the role of IPRs can be used to block competitor products and processes, which is indeed part of how IPRs operate. A nuanced examination of the grant and use of patents (and use of other IPRs) is needed, as without any IPRs certain types of innovation may be disincentivized. However, certain uses of IPRs over elements of medical device technologies, also has the potential to hinder the development of new devices (or to hinder developments on existing devices).

V. CONCLUDING REFLECTIONS

This article has demonstrated that IPRs over integrated medical devices, and how rightsholders can use such rights, may impact how device-users can access, use, repair, and modify such devices; it can also limit how such devices can be developed, used and modified by third parties. This may give rise to health-related implications. For instance, depending on how IPRs are implemented and enforced, it may lead to high costs for a device, leading to implications for access; it may also constrain the development of new health technologies and even impact the ability to modify (including repair) existing medical devices.¹³⁴ In public health systems, where IPRs over health technologies are used in a way that leads to high costs, this can lead to difficulties for public health systems in providing access to such devices for all individuals who clinically need them. It may exacerbate healthcare rationing issues, and may impact the availability of suitable devices (if any) for potential device-users, and for clinical care. Accordingly, IPRs can be used to constrain patients’ and healthcare systems’ use and accessibility of medical devices, with knock-on implications for bioethical interests.

Having said this, IPRs also play a role in incentivizing the development of medical device technology. They can be used to provide an income stream for rightsholders to recoup the costs associated with developing these technologies. Within the current health innovation model, this is often a key consideration for certain actors, particularly companies, around their investments in technologies for research and development purposes. Here, we are not arguing that this is the only (or most efficient) viable health innovation model, such issues are beyond the scope of this article. Instead, our point is that, aside from the economic function of patents, the discretion given to rightsholders (by virtue of how patents and other IPRs operate) over the protected technology can can pose considerable health and bioethical implications. We acknowledge here that it is not the existence of IPRs over medical devices per se that leads to potential health implications; instead, it is often how such IPRs can be used over IP protected technologies, which typically does not distinguish between whether the technology in question relates to a medical device or other context.

There are limited avenues to directly engage with the health and bioethical implications of how IPRs can be used over integrated medical devices under existing IP systems, and there has been limited examination of these issues for medical devices. This article has sought to fill this gap and to argue that deeper consideration is needed around the breadth (and limits) of rightsholders’ discretion over how they use IPRs related to medical devices, given the health and bioethical implications at stake. This could be achieved by licensing restrictions or principles that enable rightsholders to obtain some of the benefits of patent (or other IP protection) but limit, in certain contexts, how such patents (and other IPRs) can be used to address potential bioethical issues that can arise. The purpose of this article is not to develop what such licensing principles would look like; instead, it has aimed to elucidate, as a first step, the need for greater scrutiny over rightsholders’ discretion around how they use IPRs—particularly patents—over integrated medical devices. In doing so, our core argument is that greater interdisciplinary scrutiny is vital around the discretion given to rightsholders over how they use IPRs related to integrated medical devices, given the potential health and bioethical implications at stake.

Footnotes

Funding

This work is funded by the EU (ERC, PatentsInHumans, Project No. 101042147). Views and opinions expressed are, however, those of the authors only and do not necessarily reflect those of the EU or the European Research Council Executive Agency. Neither the EU nor the granting authority can be held responsible for them. The authors would like to thank the anonymous peer reviewers, and Dr Karen Walsh and Sinéad Masterson for their very helpful feedback on earlier drafts. We would also like to thank the organiser, Prof Naomi Hawkins, and attendees of the ‘Planting Seeds for the Future of IP Law Conference – A conference in honour of Margaret Llewelyn" at Sheffield University (8 June 2023), and the attendees of the ERC PatentsInHumans International Workshop (29–30 April 2024), Maynooth University where we presented earlier versions of this paper for the very helpful feedback received on these earlier drafts. Any errors or omissions that remain are the authors’ own.

Conflict of Interest

One of the authors, Prof AM McMahon, is a member of the International Editorial Advisory Board of the Medical Law Review. However, the Medical Law Review operates a double-blind anonymized peer review process. The author is not involved in any aspect of the peer review process related to this article.