10.6092/issn.2038-3460/18105
Intellectual property rights (IPR), and patents in particular, play a central role the commercialisation of new knowledge and techniques in the life sciences. This paper analyses the effects of the patent ecosystem using the sociology of valuation and evaluation. Specifically, the patent ecosystem can be interrogated in terms of which activities, entities or choices it valorises and which it disincentivises. This will be illustrated using three case studies of emerging life sciences technologies; gene editing, induced pluripotent stem cells, and 3D bioprinting. Each represents a domain of growing patenting activity. This analysis illustrates how the practical application of the tests for patentability by national patent offices facilitates fragmentation of complex biotechnological processes into multiple, distinct legal claims. The resulting proliferation of IPR gives a particular value to patents as rent-generating devices, as bargaining tools to negotiate market access, reassure investors, and as tools for shaping the configuration of emerging technology fields.
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Michael Morrison
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Tecnoscienza – Italian Journal of Science & Technology Studies
innovation
The Role of Patenting in the Valuation of Biomedical Innovation
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2024-01-16
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Michael Morrison
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innovation
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The Role of Patenting in the Valuation of Biomedical Innovation
https://tecnoscienza.unibo.it/article/download/18105/17358
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T/S                                                                                                                ESSAY



The Role of Patenting in the Valuation of Biomedical
Innovation

Michael Morrison
University of Oxford



Corresponding author                     Abstract
Michael Morrison                         Intellectual property rights (IPR), and patents in particular, play a central
HeLEX - Centre for Health, Law           role the commercialisation of new knowledge and techniques in the life
and Emerging Technologies                sciences. In this paper I examine the shaping effect of patents and patent-
Faculty of Law, University of Oxford     ing on the innovation trajectories of three emerging biotechnologies: gene
Room 201, St Cross Building, St          editing, induced pluripotent stem cells, and 3D bioprinting. All three are
Cross Road, Oxford OX1 3UL, UK           examples of “biomodifying technologies”, that is, tools and techniques that
   michael.morrison@law.ox.ac.uk         permit human intervention in, and modification of, fundamental biologi-
                                         cal processes, and each has been subject to varying degrees of patenting
Submitted: March 21, 2023                activity. The analysis draws on the sociology of valuation to position pat-
Accepted: November 18, 2023              ents as both the outcome of particular practices of valuation and as entities
                                         that are themselves folded into other practices for calculating value in the
                                         life sciences economy. Drawing on qualitative interviews with a range of
                                         stakeholders including academic and clinical scientists, representatives of
                                         companies whose commercial activity incorporates one or more of these
                                         technologies, and actors involved in other ways with the governance of
                                         these technologies such as intellectual property experts and employees of
                                         university Technology Transfer Offices (TTOs), I show how “upstream” mar-
                                         ket considerations inform strategic assessments of what is worth patenting
                                         and how patent claims should be drafted.

                                         Keywords
                                         patents; value; valuation; biotechnology; innovation.




1. Introduction

  The concept of “biomodifying technologies” was developed to account for particular type of
technique, developed through life sciences research, that enables scientists to modify living bi-
ological tissue in a directed fashion (Morrison et al. 2019). Historical examples include cell cul-
ture, recombinant DNA (rDNA), the polymerase chain reaction (PCR), hybridoma technolo-
gy for creating monoclonal antibodies, and somatic cell nuclear transfer (“cloning”). Biomodi-
fying technologies typically arise from molecular and developmental biology; fields dedicated to
exploring the “plasticity of biological life” (Landecker 2010). They are at once “transformative”
in that they extend and enhance scientists’ capacity to manipulate and alter living biological

TECNOSCIENZA. Italian Journal of Science & Technology Studies                     © The Author(s) 2023
14(2) pp. 2    -7 6 ISSN 2038-3460                                                 Attribution 4.0 International C
                                                                                                                 ( C BY 4.0)
DOI: 10.6092/issn.2038-3460/18105                                                  www.tecnoscienza.net
Morrison                                                                                             8

material, and simultaneously “domesticated” in that they belong to a familiar “genre of tech-
nique” (ibid.) within the life sciences (c.f. Martin et al. 2020). Unlike the early caution attending
biomodifying technologies like rDNA, contemporary biomodifying technologies are subject
to rapid commercialisation and efforts to “translate” them into new products and services, as is
now common for life sciences research (Maienschein et al. 2008; Morrison and Bartlett 2022).
   The project “Biomodifying technologies and experimental space: Organisational and reg-
ulatory implications for the translation and valuation of health research” examined three
contemporary biomodifying technologies: induced pluripotent stem cells (iPSC), gene ed-
iting, and 3D printing of biological material. “IPSC technology” refers both to the method
of producing the cells by chemically “reprogramming” adult somatic cells to an embryo-like,
pluripotent state, and to the iPS cells themselves, which can be chemically induced to be-
come many different types of body cell (lung cell, nerve cell, heart muscle cell et cetera). Gene
editing tools, of which CRISPR/cas91 is currently the most prominent example, contain a
programmable “targeting” domain that can be designed by scientists to find and attach itself
to a particular sequence of genetic material in a living cell, and an enzyme that can cut out
that particular piece of the DNA, replace it, or change its content (for example, changing an
“A” to a “T” in the genetic code). 3D bioprinting is a manufacturing technique which can
be applied to many different cell types, including iPSCs. It is a form of additive manufacture
where complex three-dimensional constructs are produced via deposition of fine layers of ma-
terial one on top of the other (Mironov et al. 2008). Bioprinting adapts additive manufacture
techniques by replacing plastic or metal as the material to be 3D printed with gel-like suspen-
sions containing living cells, known as “bioinks”. The goal is to “[…] transfer the precision,
flexibility, speed and agility offered by 3D printers to clinical applications in order to recreate
highly complex and heterogeneous structures” (Lafontaine et al. 2021, 557).
   To keep the project manageable and coherent over the three case study technologies, the
project team (see Acknowledgements) opted to focus exclusively on attempts to develop these
technologies for human biomedical application. The project, and this paper, do not consider
the various plant or animal related applications of gene editing, bioprinting or iPSC. Our
investigation of biomodifying technologies was structured around three questions:
   • RQ1) How can the “experimental space” which these technologies currently occupy
        be characterised and what does this mean for translational health research and its likely
        trajectories?
   • RQ 2) What are the challenges and risks posed by these technologies for existing, legal,
        regulatory and governance regimes?
   • RQ3) What is defined as their benefit or value and how is benefit and/or value assessed?
   My focus here is the project’s first and third research questions2, which are connected. The
“experimental space” for each of the three case study biomodifying technologies maps, to a
greater or lesser extent, onto the existing socio-technical system (Geels 2002) or techno-eco-
nomic network (Callon 1990) of (medical) biotechnology. It is within this space that technol-
ogy development occurs and innovation trajectories are shaped:

     Research is conducted by public laboratories, universities, private firms (small, medium
     and multinational), non-profit organizations and health-care facilities (public and private).
9                                                                            Tecnoscienza. 2023. 14(2)

     It is funded by taxpayers, philanthropic foundations, private investors, companies and pa-
     tients. And it is shaped by public policies and agencies, such as those for intellectual prop-
     erty (IP), regulatory standards, procurement, treatment guidelines and reimbursement.
     (Swaminathan et al. 2022, 207).

   The connection between this understanding of the experimental space for biomodifying
technologies, and the issue of how they are given value (and for and by whom) lies in the
contention that the shaping of the innovation trajectories of biomodifying technologies, by
the institutions, markets regulations, laws et cetera described above, can be understood and
analysed through the lens of valuation.
   Specifically, this strand of the project (RQ3) draws on work in Valuation Studies which
treats value not as an inherent property of things, nor as a mere signifier of, e.g., social class,
but as the outcome of practices of valuation (Muniesa 2011; Dussauge, Helgesson and Lee
2015). “Value” here is also understood in the sense of “worth”: what is worth doing, having,
being, knowing, et cetera. This encompasses multiple forms of merit (moral, cultural, epis-
temic and so on) and is not limited to economic value or cost. Contemporary biomedical
innovation is subject to a plethora of assessments and valuations, including, but not limited
to, those listed by Swaminathan et al. (2022) above. Many, though not all of these nodes use
institutionally-embedded, formal tools and methods for calculating value or worth, which
Valuation Studies describes as “devices”. Translational research with biomodifying technolo-
gies may be animated by promise (Borup et al. 2006), but I argue that its trajectories and out-
comes are steered by the cumulative (inter)actions of these disparate, but durable, practices
and devices for valuing innovation.
   Considering the “experimental space” in its entirety and all the forms of valuation it con-
tains cannot be reasonably set out within the confines of a single paper. Elsewhere, project
members have analysed how academic and commercial researchers working with biomodify-
ing technologies identify what makes a “good target” for translational life sciences research
(Morrison and Bartlett 2022). That analysis concluded that “translational’’ scientists antic-
ipate the ways in which the value of their proposed work will be assessed by a variety of au-
diences (peers, funders, managers, journal editors, regulators, clinicians etc.), each deploying
their own criteria and metrics of worth. Scientists’ choices of which research is worth pursu-
ing results from attempts steer a course that is likely to demonstrate at least adequate merit to
each of these different groups. In other words, embedded practices for valuing translational
science shape what comes to count as “good” or worthwhile research. In this paper, I extend
this frame of analysis by examining patenting as another node within the experimental space
for biomodifying technologies where they are subject to a particular form of assessment or
valuation (the patent application) and where the outcome of that valuation in turn shapes
the innovation trajectories of each technology. None of this is meant to imply that patenting
is the only, or even the most important, site at which such technologies are valued. A grant-
ed patent cannot be taken as a measure of economic value or indeed of societal need for an
invention. For example, Lehoux et al. (2014, 1026) report that in the medical devices sector
almost half of all patent filings do not lead to any marketed product. Nonetheless, each of the
three biomodifying technologies studied here has been subject of considerable patent activity
Morrison                                                                                          10

(Bicudo et al. 2022; Bicudo et al. 2021a) and it remains an important part of the story of how
biomodifying technologies are valued and how their development is steered.


2. Patent examination as valuation

   What does it mean to view patents and patenting through a lens of valuation, and can such
an approach be justified? Valuation refers to “any social practice where the value or values of
something are established, assessed, negotiated, provoked, maintained, constructed and/or
contested” (Doganova et al. 2014, 87). This encompasses all forms of examination, testing and
assessment as well as judgements and calculations. Importantly, “value” in Valuation Studies
is not limited to economic value or price. Focusing on how people calculate and justify what
is worth doing, having, being, knowing and so on, provides a way to consider economic value
(usually considered quantitatively) alongside cultural and moral etc. values (usually consid-
ered qualitatively). This is not to imply that economic value in some way “is” cultural or vice
versa. Rather, both “value” and “values” “denote the desirability of certain acts over others,
and both refer to the collective production of that desirability and its governing effect on in-
dividual actions” (Dussauge et al. 2015, 9). This approach allows “valuation”-based analyses
to consider multiple registers or grammars of worth, which can intersect, combine or oppose
one another, without reducing one kind of value to another.
   From this perspective, even an uncritical “face value” account of patent filing and exami-
nation shows that it clearly entails valuation. National patent offices form an obligatory pas-
sage point for anyone seeking a patent, and constitute an institutional site of valuation. The
United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO)
are the most globally significant patent offices (Parthasarathy 2017)3. In order to transform
a piece of scientific knowledge or know-how, it must first be parcelled out and transformed
into a set of one or more claimed “inventions”. This is the task of patent attorneys who write
patent applications, known as filings. The key criteria for assessment are: novelty (is the “in-
vention” in some way distinct from what is already known), non-obviousness (did it require
an “inventive step” to produce), and that it has utility or “industrial application”. Patent offic-
es also operate on the principle of “priority”; that is the first party to file a claim has the right
to intellectual property rights on that invention, even if they were not necessarily the first to
identify or produce what is being claimed. In addition, many types of “invention” are exclud-
ed from patentability such as varieties of animals and plants, computer software, the human
body, and any elements of the human body derived from “simple discoveries”. The EPC also
contains prohibitions on granting patents in inventions whose exploitation is deemed to be
contrary to morality or “ordre public”4.
   Lamont (2012) identifies several sub-practices that can go into making a valuation includ-
ing classification, comparison and ranking of entities. In the process of examination, patent
filings are ranked (who filed first and thus has priority?) classified (do the claims made fall
into the acceptable or prohibited categories of invention?) and compared (is the claimed in-
vention suitably distinct from what has gone before?), and therefore evaluated. This kind of
institutionally embedded, standardised rules for what should (and should not) count and
11                                                                       Tecnoscienza. 2023. 14(2)

be counted, how worth should be calculated or judgements reached, and often what format
outcomes should follow can be considered as a “mode of valuation”: “a particular manner of
assessing and attributing the value of something” that is both adaptable and situated in con-
crete practices, metrics, categories and reference points (Hauge 2016, 127).
   Scholars in STS and elsewhere have produced more detailed, more critical accounts of pat-
enting, which recognise that patenting a piece of scientific knowledge or know-how is an act
of translation, in the sense envisioned by Callon (1984). It is an attempt to impose a particu-
lar order and meaning on events (usually experimental findings and artefacts) by enrolling
disparate human and non-human actors into a particular set of roles. In this case, this order-
ing partly takes place via the construction of texts in the form of patent filings which:

     [G]ive internalist and Whig accounts of the development of the process or apparatus that
     they describe, and as legal instruments they attempt to impose that interpretation on the
     material world. (Bowker 1992, 53)

  As with any attempt at translation, a patent filing can fail, and even “success” is only a tem-
porary stabilisation that can be undone by subsequent litigation. Bowker’s (1992) account
of patent litigation makes clear that criteria such as “priority” and “novelty” are produced
by considerable behind-the-scenes work that is rendered invisible in formal patent filings or
court battles, and that their validity is not inherent, but a local and contingent achievement.
However, while these critical accounts add further layers of nuance and complexity to our un-
derstanding of the processes involved, they do not invalidate the fundamental idea of patent
assessment as a series of formalised, institutionally-embedded valuations.


3. Folded valuations and the many uses of patents

   Patents may be the outcomes of a process of valuation, but once granted they are them-
selves valued, and of value, in a number of different ways. This recursiveness is a repeated
motif of valuation; for example, Helgesson and Lee note that “[a]ll experimental designs can
be seen as both the outcome of valuations and as devices for performing valuations” (2017,
9). The idea that different valuation practices can be interrelated, and that what counts in one
case can impinge on or drive what is counted, or how value is calculated in another setting
is known as “folding” (Helgesson 2016). Patents confer a monopoly right, granted by the
state, to exclude others from using an invention or to set the terms, via a licence, on which
that invention may be used. Many arguments have been put forward about the justification
and purpose of patents; that is about why such a monopoly right is worth permitting. These
include the idea that they are “natural rights” resulting from the labour of an inventor, that
they facilitate a right to self-development through creativity, that they act as a “just reward”
and thereby a stimulus for innovation, that they provide a method of maximising utility of
inventions, or that patents minimise wasteful duplication of effort by assigning control of
the future development of a technology to a single party (Papaioannou 2006; Panagopoulos
and Sideri 2021). STS scholars have also considered the value of patents as rent generating
Morrison                                                                                        12

assets (Birch 2020), as tools that facilitate their holders to secure entry to markets and send
positive signals to capital investors (Lehoux et al. 2016), and as a means to shape the wider
socio-technical systems through which new technologies develop (Hilgartner 2009). These
are all examples of folded valuation practices; what is of analytical interest is not merely that
they happen but their effects and consequences. For example, in the case of patents, we can
ask whether anticipation of market valuations folds into decisions about what gets patented
in the first place or how the claims in patent filings are drafted, and if so with what effects?
   This understanding of patents as both the outcome of valuation practices and as entities
folded into other practices of valuation within the experimental space, provides a conceptual
framework for interrogating the shaping effect of patents and patenting on the innovation
trajectories of biomodifying technologies, which is the overarching aim of this paper.


4. Methodology

   The Biomodifying technologies project (“BioMOD”) ran from 2017-2021 and employed
a range of methods: review of academic and grey literature (government reports, company
websites etc.), legal and regulatory analysis, quantitative data collection and qualitative inter-
views. The legal and regulatory analysis was partly supported by a separate grant from the
Leverhulme Trust and has been presented elsewhere (Mahalatchimy et al. 2021; Mourby et al.
2022; Lim and Li 2022). This second project, “Governing biomodification in the life sciences”
(“BioGOV”) ran from 2018 to 2022. Both projects were collaborations between the universi-
ties of Oxford, Sussex and York in the UK and both examined the same three “biomodifying
technologies”. Mapping the experimental space was an iterative process of identifying key ac-
tors from the literature, conducting qualitative interviews, and often identifying further doc-
uments, events and actors from information provided by interviewees. Based on the project
team’s prior knowledge of biotechnology, it was recognised at the outset that this would in-
clude actors such as university Technology Transfer Offices (TTOs) and patent attorneys. It is
important to note that a comparative analysis of the overall patent landscape of patenting for
the three case study biomodifying technologies, which presented both qualitative and quan-
titative data, has already been published elsewhere (Bicudo et al. 2022), as has a more detailed
look at the specific case of IP in bioprinting (Bicudo et al. 2021a). Equally, this was not a pro-
ject exclusively, or even mainly, about intellectual property per se, so interviewees were selected
to cover a range of stakeholders including academic and clinical scientists working on transla-
tional research with one or more case study technologies, representatives of companies whose
commercial activity incorporates one or more of these technologies, representatives of UK
regulatory agencies, and intellectual property experts and representatives of university. This
reflects our framing of the experimental space, and while most interviewees were asked about
their activity in relation to patents, questions about patents were only a limited part of a larger
set of interview questions designed to get interviewees discussing the ways they evaluate their
work and the ways in which they, and their work, is in turn evaluated, justified and measured.
   Interview questions were tailored to different types of interviewees and patent profession-
als were included as part of the subset of interviews with questions designed for regulatory
13                                                                                  Tecnoscienza. 2023. 14(2)

and regulatory-adjacent actors. The number of interviewees of different types is summarised
in Table 1 below. The full set of question schedules for BioMOD interviewees is available
from the UK Data Service (study number 855143). The DOI is linked at the end of the man-
uscript. Patent attorneys, like most other regulatory interviewees were reluctant to discuss
specific instances of regulating particular biomodifying technologies, usually because such
details are confidential. As a result they tended to respond to questions with illustrative gener-
alisations or examples from other well-known technology fields taken. However, this does not
necessarily limit the validity of the data presented here because most systems for regulating bi-
omedical innovation are themselves technologies of commensuration that act to make a wide
range of technology-based products amenable to valuation through a single set of devices.
Medicinal products regulation is a partial exemption as special regulatory categories already
exist for cell or gene based therapeutics, but Health Technology Assessment and Intellectual
Property Rights both aspire to fit biomodifying technologies into the remit of their existing
categories, standards, and methods of assessment and valuation. Rather than regarding this
as a limitation, it arguably increases the legitimacy of treating the analysis of biomodifying
technologies a window into wider processes of patenting in biotechnology.
   The majority of interviews were conducted in the UK by members of both project teams.
The full list of project members who contributed interviews is given in the Acknowledgements.


 Interview type                                              Number of interviews         Source Project

 Academic or clinical scientists working with gene editing   9                            BioMod
 Companies involved with gene editing                        7                            BioMod
 Academic or clinical scientists working with iPSC           9                            BioMod
 Companies involved with iPSC                                7                            BioMod
 Academic or clinical scientists working with 3D             16                           BioMod
 bioprinting                                                                              BioGov
 Companies involved with 3D bioprinting                      9                            BioMod
                                                                                          BioGov
 Representatives of regulatory bodies                        13                           BioMod
                                                                                          BioGov
 Other governance actors including intellectual property     14                           BioMod
 experts and representatives of university TTOs                                           BioGov

 TOTAL                                                       84


                                                     Table 1.
Table 1.0 Number of interviews per of
                           Number  category
                                      interviews per category.


Research ethics approval for the UK interviews on both projects was obtained from the Uni-
versity of Oxford Social Sciences and Humanities InterDivisional Research Ethics Commit-
tee. For BioMod, additional approval was obtained from the University of York ELMPS Ethics
Committee. For BioGOV, a preliminary set of interviews with 3 academic and 3 commercial
Morrison                                                                                      14

3D bioprinting developers was conducted in Brazil as a way to supplement the limited num-
ber of bioprinting interviewees identified in the UK. Research ethics approval for these six in-
terviews was obtained from the Research Ethics Committee of King’s College London, as this
was the institutional location of the project member conducting these interviews at the time.
  Written informed consent was obtained from all participants prior to the interviews. Inter-
views were a mixture of in-person, online and telephone interviews and typically lasted be-
tween 40 minutes and 1 hour although a few were longer. All interviews were audio recorded
except in a small number of cases (n = 3) where interviewees declined permission to be record-
ed and in one instance the digital recording function failed. These interviews produced only
notes made during and immediately after the interview. Audio recordings were transcribed
using a professional transcription service operating under a confidentiality agreement. Text
from each interview transcript was assigned to broad codes based on pre-determined areas of
interest defined by the projects’ aims such as commercialisation of each case study technology,
business models, patenting practices, and experiences of securing investment et cetera. Within
these broad codes, data was inductively analysed to identify themes and patterns in interview-
ees’ responses, in particular those relating to justifications for particular choices and courses
of action, and accounts of which activities or entities were worth pursuing, owning, doing,
having et cetera. The results reported below mainly derive from material at the intersections
of the codes “patents and patenting” and “value and valuation” as assembled by the author.


5. Results
  5.1 Characteristics of patenting in the experimental space for biomodifying
  technologies

   Induced pluripotent stem cells, and gene editing, which in our study included tools such as
Zinc Finger Proteins (ZFN), TALENS, and CRISPR/cas9, hew most closely to the established
socio-technical system of biotechnology innovation. In each case there is a “foundational”
new technical capacity – either a method of modifying DNA like CRISPR or the method for
chemically “reprograming” isolated skin or hair cells to an embryo-like pluripotent state which
is patented. Each initial patent was followed by a rapid growth in the number of filings and
the number of applicants. Of the three biomodifying technologies, gene editing has by far the
largest total number of patent filings and the fastest growth in number of filings (Bicudo et al.
2022). This is largely propelled by the vast popularity of CRISPR compared to other methods
such as ZFN or TALENS (Bicudo et al. 2022; Zhou et al. 2021)5. IPSC exhibit a more modest
patent estate and the slowest rate of new filings of the three technologies. This, Bicudo et al.
suggest “is arguably signalling greater anticipated difficulty in commercialising applications of
iPSC technology beyond its current use as a tool in preclinical drug screening” (2022, 6). 3D
bioprinting is the most unique of the three biomodifying technologies. Bioprinting necessarily
involves a range of elements: a bioprinter, bioinks, Computer Aided Design (CAD) software,
Computer-aided manufacture (CAM) software (which translates CAD design files into print-
er instructions), and biomaterials to provide structural and chemical support for printed con-
15                                                                            Tecnoscienza. 2023. 14(2)

structs (Bicudo et al. 2021b). There is no obvious “foundational” patent since the techniques
of additive manufacturing originated in other sectors, initially for use with plastic or metal. Bi-
oprinting has the fewest filed patents of the three biomodifying technologies but the number
of filings is growing faster than that for iPSC suggesting a growing market (Bicudo et al. 2022).
   Regardless of whether “foundational” patents derived from public or private sector re-
search, as the number of patents in each field of biomodifying technology R&D increases so
does the predominance of private sector patent holders:

       In the three domains, companies hold over 50% of the patents, a proportion that reaches
       around 65% for bioprinting. (Bicudo et al. 2022)

  Despite being heavily commercialised, bioprinting also has a greater geographic diversity of
small start-up bioprinting companies compared to the gene editing which tends to be dom-
inated by US and European firms including many large incumbent companies holding large
patent estates (Bicudo et al. 2022; Bicudo et al. 2021b) The situation with iPSC is similar but
with a higher proportion of patents held by Japanese universities and firms, as iPS has been
the subject of considerable national investment in Japan (Mikami 2015). While provision of
gene editing and iPSC tools, equipment and reagents has been largely the province of incum-
bent life sciences supply firms, there is also a flourishing academic community using “open
source” software for bioprinting and in many cases also building or modifying “in-house”
bioprinters rather than buying “off the shelf” commercial products (Bicudo et al. 2021b).
This however, is something of an exception.

     5.2 The mode of valuation in patent assessment and its effects

   The key to understanding this pattern of patenting is to recognise biomodifying technol-
ogies as platform technologies. While the promise around biomodifying technologies tends
to emphasise the potential for new therapies, the first and largest market is as tools to be used
in further research and development. To develop clinical applications of each biomodify-
ing technology requires significant additional technological development, refinement, and
advances in supporting technologies (e.g., cell culture media with no animal by-products,
bioreactors etc). This in turn creates significant scope for patenting each of these subsequent
steps and developments, as both novel and having their own, additive “technical effects”. One
IP expert explained the relevance of how the “utility” requirement is interpreted by patent
examiners in the following way:

       The way the European Patent Office has evolved its law and its practice over the years is to
       interpret that as requiring some form of technical effect that can, at least in principle, be
       translated into something useful. The US law uses the concept of usefulness a little bit more
       but I think it comes to the same sort of thing. (Intellectual property expert interview 3#)

   This “technical effect” approach to utility constitutes part of a particular “mode of valua-
tion” practiced by examiners in patent offices. The traditional scientific metric of evidence,
Morrison                                                                                                 16

here experimental evidence for what is being claimed, is translated into a legal one, in this case
the “reasonable expectation” of a future application. The particular configurations of valua-
tion practices matter because they have consequences. The ways in which the “novelty” and
“technical effect” criteria are defined and assessed facilitate, and arguably help to incentivise,
the fragmentation of a particular piece of research into multiple separate claims and patents.
Specifically, the idea of “technical effect” frames the “patentable matter” as any functional ele-
ment, rather than as a fully-operational device or process. What is patented is not for example
“an iPS-derived neuronal cell therapy for Parkinson’s disease” but the design for the func-
tioning of a particular component within one of these devices. This allows complex devices
and procedures to be broken down into multiple patentable elements, even if the utility of
the device in the everyday world derives from the whole product not its isolated components:

     You’ve got a mobile phone sitting there or your recorder that’s sitting there and you’ve prob-
     ably got dozens of patents, if not sometimes hundreds of patents, that are involved in…
     […] you can’t make a mobile phone out of just one of those patents […]. You’ve got lots of
     different aspects of it, each one of which could be separately patented, I suppose, as long as it
     fulfils that requirement of having something about it that’s technical and not just abstract.
     (Intellectual property expert interview 2#)

   With platform technologies like iPSC gene editing and bioprinting all being enrolled into
translational endeavours to develop them as components of future complex products and
services, this fragmentation has the twin effects of giving “upstream” patents with broad
product claims such as those the main gene editing tools or on induced pluripotent stem
cells significant value, whilst leaving considerable space for further innovation, which in turn
leaves room for new patent applications and thereby new actors to enter the market for devel-
oping these technologies. The multiple ways in which patents are valued, and the way these
practices fold back into decisions about what to patent are explored in the next section.

  5.3 How patent valuation criteria drive strategic behaviour in patent filing

   As the total number of patents relating to each biomodifying technology, and subject mat-
ter for each they cover, accumulates in a particular technology field, new prospective patent
applicants and market entrants must also take care not only to identify and protect what is
novel to their own attempt to commercialise some aspect of the technology, but also to check
whether, and to what extent what they want to do is covered by intellectual property rights
already held by other parties. In patent practice, securing a proposed area of activity that
does not fall under the remit of one or more existing patent holders is known as “freedom to
operate” (FTO). This is a direct consequence of the fragmentation of complex products into
many patent claims facilitated by the mode of valuation of patent offices, but it also fosters a
range of modes of valuation treat patent filing as an instrument for strategic gain (rather than,
for example, a “just reward” for innovation or a mode of personal expression6).
   Consider the practices of patent attorneys in writing filings; construction of these texts is
part of the attempted translation of experimental data and artefacts into a particular order
17                                                                            Tecnoscienza. 2023. 14(2)

and meaning (Callon 1984) but they are also actions in a particular mode of valuation (Hauge
2016). Patent attorneys make choices and write patent claims in a particular way in response to,
and as a way of enacting, particular value imperatives that are part of their professional role. Im-
portantly, the judgements they are making are less about a “naïve” consideration of whether or
not the scientific subject matter meets the criteria of novelty, non-obviousness or utility and in-
stead revolve around calculations of future markets and strategic advantage over competitors.

     [I]n general, the job of the patent attorney is to get as many different types of claim as pos-
     sible so that one way or another you are going to be able to trap an infringer or encourage
     people to stay off the market. (Intellectual property expert interview 1#)

  Some of the “value maximising” techniques are discussed in the following quotes from
current or former patent attorneys:

     If we get somebody in who say “I’ve done this, ‘A’, and I think we could do ‘B’ as well but
     we’re not sure, we haven’t done it yet”, what you can do is file twice, “A”, one specification
     with what you know is right and another specification on the same day which has some extra
     information that you’re not sure about. Then at 12 months you can say which one shall I
     take. I’ll take “B”. You can do the same if you’re not sure about… you can file two […]”.
     (PAT02- patent attorney from European law firm with UK offices)

     [T]here are going to bells and whistles that you add later. You can do that either in the
     same patent or in a different patent. You’ve got something that is a development of it that’s
     incorporating other aspects which are separately patentable, probably best putting that on a
     separate patent. (Intellectual property expert interview 3#)

   These quotes capture the “inside” manoeuvring and negotiation that goes into construct-
ing an “outside” official account of scientific discovery presented in a patent document
(Bowker 1992). In the first quote, the patent attorney explains how patent filings can accom-
modate, and even leverage, scientific uncertainty by allowing a particular piece of research to
be translated into multiple claims, some more expansive than others. Because patent applica-
tions take time to review and examine, the applicants can conduct further scientific work to
support – or refute – their more expansive suite of claims, before deciding which version to
proceed with. In the interim, both filings will count as “prior art” for anyone else trying to
file a claim on an overlapping area, even if the first set of claimants are still waiting to see if
their wider set of claims can be supported. In the second quote, the interviewee explains how
a set of research findings can be converted into multiple claims and even multiple patents by
considering the “bells and whistles” of extra or additional claims about, for example, different
areas of (potential) application.
   Patents give the holders what Hilgartner (2018, 64) terms “configurational power”: the “ca-
pacity to influence the specific arrangements of technical components, humans and organisa-
tions, and social roles and relationships that make up socio-technical systems”. Legal scholars
have similarly noted the suite of “private governance” functions conferred on patent holders:
Morrison                                                                                               18

     [P]atent holders can place conditions on use, such as clauses prohibiting use of the invention
     for particular contexts. They can also limit use by charging high costs for access to the tech-
     nology, or as noted, they can refuse to license the invention thereby becoming the sole pro-
     vider. Furthermore, how the patent is licensed can impact other technologies because some
     technologies require the use of existing patented technologies to operate. Thus, patent holder
     decisions have the potential to have significant knock-on effects for uses of other technolo-
     gies, and for research and development within a field of technologies (McMahon 2021, 143).

   These strategic ways in which patents are considered useful, or valuable in the context of
competitive markets for innovations, including biomedical innovations has in turn a shaping
effect on what is considered worth patenting and why.
   Patents on “upstream” aspects of complex technology development that cannot be invent-
ed around are especially valuable because they create obligatory passage points for anyone
wanting to work on a certain area of application. This is true for “foundational” patents such
as those on iPSC (held by iPS Academia Japan a private entity spun out from University of
Kyoto) and on CRISPR, but new “blocking patents” also emerge from subsequent R&D:

     So, the way you make dopamine cells is you have to use a particular thing called dual SMAD
     and that is currently patented only in the States by Sloan Kettering. But, that is a… no-one
     has got round that yet. So, there’s going to be that plus the patent here on how you make
     dopamine cells. So, this, I think, is going to prove to be quite a thorny issue going forward,
     will be these critical IPs. (Academic stem cell scientist 2#)

  This example concerns attempts to develop dopamine-producing neurons from iPSC as
a possible therapy for Parkinson’s disease. Anyone wanting to make this particular type of
neurons from iPSC needs specific pieces of technology that is covered by patents in the US
and UK, and which appear essential to the process.
  For universities, the value of “critical IP” of this kind lies mainly in the potential of the
patent to generate income, especially through exclusive licensing of the right to exploit the
patented technology:

     [U]niversity tech transfer offices need to earn money to commercialise the technology and
     most of the large companies coming to them want exclusive licences. So, it’s easier to do a
     deal where you give an exclusive licence. If they refuse to give an exclusive licence, then the
     licence fee will generally be much smaller. (Intellectual property expert interview 1#)

  This valuation of patents based on anticipated future markets and revenue streams echoes
the findings of Miller et al. (2009) in their study of Canadian TTOs, where they observed
that TTO staff conduct their own valuations of scientific knowledge by anticipating the in-
dustries and applications that might be prepared to pay for licencing a piece of knowledge:

     For TTOs, the immediate user of early health innovations is a commercial partner. End
     users are imagined relative to this immediate user, with the nature, size and salience of the
19                                                                           Tecnoscienza. 2023. 14(2)

     imagined needs of end users informing predictions about the likely interest of commercial
     partners. (2009, 1484)

   Companies prefer exclusive licences, especially of “foundational” patents because this grants
them a monopoly on an entire segment of a future market. For example, The Broad Institute
has licenced its CRISPR patents exclusively to Editas medicine with the proviso that Editas can
decide which targets it wishes to pursue and which to out-licence to other developers (Feeney
et al. 2018). This means, for example, that Editas can retain exclusivity over applications it
prefers, such as gene editing therapeutics for sickle cell disease or cancer, while also generating
revenue from granting other firms a licence to develop CRISPR for other medical domains
such as heart disease. In this way what matters to companies, becomes valuable to TTOs who
make their decisions about which patents to support and which types of licencing to negotiate
based on the value preferences and valuation practices of (biotechnology) firms. The revenue
generating potential of the foundational patents on CRISPR/cas9, which in turn derives from
the anticipated future markets for gene editing based therapies, is such that it has resulted in
a protracted and expensive patent dispute between rival claimants at The Broad Institute and
the University of California, Berkley (Panagopoulos and Sideri 2021; Feeney et al. 2018).
   There are also other reasons why TTOs file patents: numbers of successful patent filings
can increase their own reputation and status, and can also signal to other players in the inno-
vation space that there may be gaps in their own knowledge represented by the claimed inven-
tion7. This illustrates the ways in which multiple different valuations (of anticipated revenue
and future markets, of reputations and standing etc) are folded into TTOs’ calculation of
what science is worth patenting.
   For companies, the picture is more complex. Start-up or small biotechnology firms are
typically dependent on attracting investment from Venture Capital firms and other inves-
tors. One of the (multiple) metrics that investors use to assess firms as an investment oppor-
tunity is the size and extent of their patent holdings One UK academic who was involved
in two stem-cell related university spin-out firms, explained: “you need to protect that IP
so you can get interest from investors.” (Academic stem cell scientist 6#). When patents
become a metric, the internal content of each patent becomes less relevant. An intellectual
property expert explained:

     [T]here is a bit of tension between patent filings and venture capital. Where venture capital
     people don’t understand IP, they just look at numbers, so some [Senior company personnel]
     are very worried about giving up some of their portfolio, losing some patents. A lot of compa-
     nies just want numbers for their venture capital people and they’re no good to them. (PAT02)

  When a number of filed or granted patents becomes a metric for assessing value (whether
the value of a firm as an investment as here or a way of measuring the performance of a re-
searcher or a TTO), the value of patent holdings is quantified and abstracted. In simple terms,
the number of patents is more valuable than the content of those patents. This can explain
how the current valuation practices in innovation systems incentivise and give value to pat-
ents that may never give rise to a practical product or service.
Morrison                                                                                            20

  Equally, anticipating the need to get the licences in order to secure FTO in a complex tech-
nology field with proliferating numbers of patents can also inform a company’s calculations
about which patents are worth filing and how best to translate experimental data and arte-
facts into suites of patent claims. This situation is not unique to biotechnology. One IP ex-
pert explained the point of using an account of a former client that wanted to use a particular
industrial catalyst, only to find there were fully 800 already-granted patents relating to its use.
With no way to pay so many royalties or litigate against so many patents, only one further
solution presented itself:

     Eventually, we got a licence, basically by developing technology that the various different
     patentees would, themselves, want to take a licence on. Otherwise, no access. (Intellectual
     property expert interview 1#)

  They went on to explain:

     It’s always important to advise the small companies, and large companies, don’t just develop
     and patent the technology you want to use, develop and patent technology that your com-
     petitors may want to use so that you have a bargaining point.” (ibid.)

   This quote explains how companies can use the patents they hold to negotiate with other
IP holders for mutual access, where both, or all, parties have rights over some steps or com-
ponents needed to develop a complex product such as a cell or gene therapy. Thus, it can
also be strategically valuable for a company to file patent claims on things they think their
competitors’ might want to access in future, even if these are not of core interest to the
firm’s own product(s).
   These examples of TTOs and companies both illustrate Helgesson and Lee’s claim that “ex-
amining the configuration of valuation practices is a useful tactic for examining the complex
links between the scientific, technical, and market poles” (2017, 3). In that study, Helges-
son and Lee demonstrated how “ideas about markets for pharmaceuticals can be folded onto
ideas about how to design trials and how to select candidates to introduce in said markets”
(2017, 2) showing how, in contrast to “linear” models of innovation, markets and market
assumptions do not only appear at the “downstream” end of the R&D process but are folded
in to earlier “upstream” valuations of what is worth doing in product development. Here we
have seen a similar folding in of different anticipatory calculations of valuations about “up-
stream” markets and competitive advantage in innovation trajectories for biomodifying tech-
nologies. Assessments of the size of patent estate as a means to attract and impress investors,
the licencing and revenue generating potential for key patents, the potential utility of patents
as tools to leverage negotiation with competitors and secure market segments (also reassuring
to investors and shareholders) and so on have all been shown to be folded into, and informing,
judgements about what is worth patenting and about how patents should be constructed as
sets of claims in the domains of gene editing, iPSC and bioprinting.
21                                                                       Tecnoscienza. 2023. 14(2)

6. Conclusions

   As previous work from the project team has demonstrated (Bicudo et al. 2022; Bicudo et al.
2021a; Bicudo et al. 2021b), the development of biomodifying technologies into biomedical
products and services involves a progressive transfer of control of each technology and its trajec-
tories from public sector institutions to private ones. This is not to imply that all biomodifying
technologies arise directly from public sector research. Zinc Finger Nucleases for gene editing,
for example, are owned, patented and out licenced by Sangamo Therapeutics a California-based
biotechnology firm. However, CRISPR/cas9 and cellular reprograming to make iPSC did orig-
inate from academic work, and a lot of bioprinting techniques developed in a similar fashion.
Moreover, as most biomodifying technologies are commercialised as tools and reagents sold
(back) to public sector laboratories for the purposes of conducting further research, which then
generates more patentable knowledge that in turn is often transferred to university spin-outs
and small biotech start-ups there are repeating cycles of privatisation not merely a single event.
   Publicly funded research may be conceived of as a “public good”. However, contemporary
governments often view the public good as being best (or even exclusively) served by eco-
nomic growth through commercial innovation. Innovation policy, especially in High Income
Countries, is often guided by the belief that private control of innovation will ultimately be
guided to serve (this version of) the public interest by the “invisible hand” of market forces.
Patents prove an important practical mechanism for effecting this transfer of control due to
the “private governance” functions (McMahon 2021) they confer and the “configurational
power” (Hilgartner 2009) this enables. This power is further amplified when powerful play-
ers consolidate extensive patent suites and claims on multiple aspects of a technology field.
   The limits of this model, and the impact of patents on biomedical innovation, are well doc-
umented. Both the proliferation of patents and the extensive private governance functions
conveyed by intellectual property rights have been associated with high prices and uneven
and unequal access to medicines within countries and between High Income Countries and
Low and Middle Income Countries. These problems are not novel, but were made stark-
ly visible during the Covid-19 pandemic (McMahon 2021; Walsh et al. 2021) and have led
to calls to change global systems of biomedical innovation to ensure greater public benefit
(Swaminathan et al. 2022; Torreele et al. 2021). Biomodifying technologies are not vaccines,
but there are important similarities. Like vaccines, cell and gene based therapeutics, which
includes those based on biomodifying technologies, are very hard to reverse engineer or mim-
ic without detailed knowledge of specific manufacturing processes (McMahon 2021). The
small number of cell and gene therapies that have reached the market have very high market
prices and have raised concerns about health systems can pay for them (Jørgensen and Kefalas
2017; Devlin 2022). What the above analysis adds is to show that these outcomes are neither
inevitable nor purely the result of individual choices or some notion of “the market” as an
ineffable force acting on the world at large.
   Instead, as with our previous study of translational scientists, durable institutional prac-
tices of valuation act to shape and incentivise behaviours in relation to patents and patenting
even before any formal period of assessment is encountered. This illustrates performative
nature of valuation:
Morrison                                                                                            22

     The act of measuring, ranking or rating not only affects how the value of something is es-
     tablished but also affects what is considered valuable – or what “counts”. (Hauge 2016, 126,
     emphasis added)

   The formalised criteria of patent examination and the particular mode of valuation through
which examiners enact their assessments create the possibility of fragmentation of complex
inventions into multiple different patents held by different parties. The stable, embedded
nature of these valuations means their operation can be anticipated and responded to in a
strategic manner. In the context of a competitive, commercial global market for innovation,
anticipatory valuations of this “downstream” market become folded into assessments of what
is worth patenting and how patent claims should be drafted, augmented (the “bells and whis-
tles”) and multiplied to secure future advantage. This creates a chain of value, where what
matters to investors and shareholders influences what matters to companies, which in turn in-
forms the decisions of university TTOs, all of which must be considered by patent attorneys
and their clients. It is important to stress here that this is neither a deterministic nor a linear
relationship. At every stage multiple valuations must be considered – scientists and TTO staff
must consider how any decision about patenting in light of the various different ways their
own performance is metricised and evaluated by employers, by peers, and indeed in terms
of their own career and personal priorities. Companies must consider the cost of filing and
maintaining patents and which of the hundreds of national patent offices to file with, against
the potential strategic value of each patent, how their patent portfolio will look to investors,
what rival companies are doing, potential future revenue streams from licensing versus ex-
cluding competitors from key market segments and so on. Nonetheless, the general pattern
of bringing market considerations into supposedly “pre-market” phases of R&D is evident.
   This analysis shows that rather than constituting a malfunction of the system, the outcomes
here are fostered by the valuation practices embedded in the patent system as they encounter
the nature of life sciences innovation. Valuation is an analytic approach, not a legal remedy to
IP problems, but it does provide a new way of understanding and mapping the way innova-
tion is steered. In light of proposals to reconfigure global biomedical innovation to give great-
er weight to the public good (Swaminathan et al. 2022), I argue that in order to change what
is valued, it is necessary to change how value is understood, measured and calculated. Chang-
ing investor proprieties may be difficult to achieve without significant regulatory reform, but
universities have a clearer mandate to serve the public good, and for example TTOs could be
encouraged to rethink the priority of patenting in their mission. Some technologies may be
worth patenting (for example CRISPR “gene drive” technology was patented by academics
as a way to try and ensure more responsible oversight of its use [Scheinerman and Sherkow
2021]) but others might deliver greater public benefit if they were more open and accessible.
Both open source software and open hardware movements provide evidence of alternative in-
novation models that rely less on private governance and monopoly rights. The international
open-source movement in bioprinting, which aims to develop and share projects for afforda-
ble bioprinters to be used in various laboratories, including those lacking resources to buy the
most sophisticated scientific equipment demonstrates that this is possible. This movement
has been underpinned by the initiative of individual academic researchers, but there is noth-
23                                                                           Tecnoscienza. 2023. 14(2)

ing to suggest that it cannot gain, at some point, some form of institutional recognition and
support. Alternatively, if bioprinting products and services get closer to clinical application,
incumbent commercial interests could use patents and configurational power to squeeze out
open source developers and create a centralised market dominated by a few big firms.
   Understanding patents as (part of) the ecosystem that shapes emerging technologies also
illuminates the wider web of folded, nested valuations that feeds into the whole system, from
institutional incentives for university TTOs to the norms and duties of a patent attorney to
their client. Any potential remedies for the deleterious effects of the patent system must look
beyond the formal description of patents to consider their impact on this wider domain.


Acknowledgements

   Andrew Bartlett, Edison Bicudo, Alex Faulkner, Phoebe Li and Andrew Webster all contributed
to the generation of the qualitative interview data analysed here and to the development of a coding
scheme for the interview data as described in the methods section of this paper. All of these project
members, with further input from Jane Kaye, Miranda Mourby and Jessica Bell, contributed to our
analysis of the governance frameworks for biomodifying technologies.
   On behalf of the whole team I would particularly like to acknowledge the contribution of the late
Professor Andrew Webster (SATSU, University of York), who had significant intellectual input into the
entire project. Andrew sadly passed away before this paper was finished and will be deeply missed by all
his colleagues on the “Biomodifying technologies” project.


Data Availability

  Morrison, Michael, Bartlett, Andrew, Faulkner, Alex and Li, Phoebe (2022) Qualitative Interviews
From the Biomodifying Technologies Project, 2017-2020 [data collection]. UK Data Service. SN:
855143, DOI: 10.5255/UKDA-SN-855143.



Funding

  This work was supported by the UK Economic and Social Research Council through grant number
ES/P002943/1 and the Leverhulme Trust through grant number RPG-2017-330.



Declaration of competing interests
  I declare that I have no competing interests, whether financial, personal, or otherwise relevant to the
content or choice of journal for this manuscript.
Morrison                                                                                                  24

Notes
  1
     CRISPR stands for “Clustered Regularly Interspaced Short Palindromic Repeats” in reference to
the characteristic sequence of the RNA “targeting domain”.
   2 For a publication dealing with RQ2 in detail see Mourby et al 2022.
   3 The EPO is not a national office per se but acts as a central examining body capable of awarding a “bun-
dle” of patent rights valid in all countries that have signed up to the European Patent Convention (EPC).
   4 Specific prohibitions include examples include, cloning human beings, modifying the germ line ge-
netic identity of human beings, commercial uses of human embryos, or modifying the genetic identity
of animals and causing them suffering without substantial benefit to man or animals.
   5 For a discussion of why CRISPR has proven so widely adopted compared to other gene editing tools
see Martin et al. 2020.
   6 For a review and critique of a broader range of philosophical justifications of patent right see Papa-
ioannou 2006.
   7 My thanks to an anonymous reviewer for bringing this point to my attention.



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