Beyond Open Access: Legal And Governance Challenges In The Commercialisation Of Publicly Funded Scientific Research

Author(s): Sumedha Bhardwaj

Paper Details: Volume 4, Issue 3

Citation: IJLSSS 4(3) 41

Page No: 450 – 464

ABSTRACT

The transition of publicly funded scientific research from an exclusively open-science model to a commercialised paradigm has fundamentally disrupted traditional intellectual property jurisprudence. While the rationale for commercialisation rests on accelerating technology transfer and bridging the ‘valley of death’ between laboratory discovery and market deployment, it routinely collides with the public-interest objective of maximising access to state-funded knowledge. This paper examines the legal and governance architectures regulating the commercialisation of publicly funded research, primarily within the Indian jurisdiction. Adopting a doctrinal and policy-oriented methodology, the research investigates the friction between patent exclusivity and open-access mandates, the fragmentation of institutional technology transfer protocols, and the chronic underutilisation of state march-in rights. The thesis advanced is that commercialisation and open science are not inherently irreconcilable; rather, the current friction stems from a deficit in statutory governance.

Properly regulated commercialisation—structured through mandatory public-interest licensing clauses, tiered pricing frameworks, and operationalised compulsory licensing mechanisms—can sustain institutional finance without privatising the foundational commons. The analysis demonstrates that until India replaces its fragmented executive guidelines with a cohesive statutory framework integrating public-access safeguards, the commercialisation of state-funded research will disproportionately benefit private licensees at the expense of equitable societal access.

Keywords: Open Science, Technology Transfer, Publicly Funded Research, Patent Exclusivity, Bayh-Dole Act, Intellectual Property Governance, Indian Patents Act 1970, Digital Personal Data Protection Act.

INTRODUCTION

The traditional paradigm of publicly funded scientific research operated on the Mertonian norms of communalism, where state-financed discoveries were swiftly deposited into the public domain to stimulate downstream innovation.[1] However, modern innovation policy has aggressively shifted toward proprietary models, encouraging universities and public research organisations (PROs) to patent and license their findings to private entities. This paradigm shift rests on the premise that raw scientific datarequires substantial private capital to evolve into market-ready technologies.

The primary research problem lies in the legal ambiguity surrounding how PROs structure these commercial agreements. When state-funded research is exclusively licensed to private corporations without pricing safeguards or access conditionalities, the public is forced to pay a premium for technologies it heavily subsidised during the high-risk discovery phase. Consequently, the core research question driving this paper is: How can legal and governance frameworks enable the commercialisation of publicly funded scientific research while preserving the public-interest objectives of open science?

Relying on doctrinal legal analysis and a comparative assessment of statutory frameworks, this paper asserts that the commercialisation of publicly funded research should not be viewed as incompatible with the principles of open science. Properly regulated commercialisation through patents, licensing arrangements, and industry partnerships can enhance innovation diffusion and improve the financial sustainability of research institutions. However, such commercialisation must operate within rigorous governance frameworks that ensure transparency, equitable access, public accountability, and the continued advancement of scientific knowledge for societal benefit.

RESEARCH METHODOLOGY

This paper adopts a doctrinal and policy-oriented legal research methodology to systematically evaluate the governance frameworks regulating the commercialisation of publicly funded research. The doctrinal analysis focuses on the interpretation and critical assessment of existing black-letter law, specifically examining provisions within the Indian Patents Act 1970, such as Sections 84 and 100, alongside the regulatory mandates of the Digital Personal Data Protection (DPDP) Act 2023[2]. By dissecting these statutory instruments, the research identifies systemic gaps between legislative intent and practical application in technology transfer.

To contextualise the Indian legal landscape, the study employs comparative legal analysis. By juxtaposing India’s fragmented executive guidelines with the cohesive statutory framework of the United States’ Bayh-Dole Act of 1980[3] and the open-access mandates of the European Union’s Horizon Europe programme[4], the methodology isolates structural deficiencies unique to the Indian jurisdiction. This comparative lens reveals how differing legal architectures balance proprietary incentives with public interest safeguards.

Furthermore, policy analysis is utilised to assess the efficacy of institutional governance, focusing on the technology transfer mechanisms deployed by Public Research Organisations (PROs). This involves scrutinising the transition of policy—from the lapsed Protection and Utilisation of Public Funded Intellectual Property (PUPFIP) Bill 2008[5] to current ad hoc agency guidelines.

The research is substantiated through a comprehensive review of primary sources, including statutes, judicial pronouncements (such as Novartis AG v Union of India[6] and Bayer Corporation v Natco Pharma Ltd)[7] and formal executive policies. Secondary sources, comprising peer-reviewed journal articles, policy briefs, and authoritative legal commentaries, are critically engaged to trace the evolution of academic discourse from the ‘tragedy of the anticommons’[8] to contemporary challenges in data governance.

LITERATURE REVIEW

The existing scholarship on the commercialisation of public science is sharply bifurcated, reflecting a deep philosophical divide regarding the primary function of state-funded innovation.

A. Scholarship criticising commercialisation

The foundational critique of upstream patenting was established by Heller and Eisenberg, who warned that the proliferation of intellectual property rights in foundational research creates a ‘tragedy of the anticommons’. They argued that when too many owners hold rights in previous discoveries, subsequent scientific inquiry is stifled, as innovators cannot navigate the dense thicket of patent claims.[9] This view is bolstered by Mariana Mazzucato’s thesis of the ‘entrepreneurial state’ , which highlights that the public sector assumes the highest risk in foundational research, yet the financial rewards and intellectual property are disproportionately captured by private entities, leading to a socialisation of risk and a privatisation of reward.[10]

B. Scholarship supporting commercialisation

Conversely, proponents of the commercialisation model draw heavily from the law and economics perspective and the American experience with the Bayh-Dole Act. Scholars such as Wendy Schacht and Arti Rai argue that without the incentive of exclusive patent rights, publicly funded inventions languish in archives.[11]According to this incentive theory, private capital is fundamentally risk-averse; pharmaceutical and technology firms will not invest millions in clinical trials or product development without the guarantee of market exclusivity.[12] In this view, patents are not a barrier to access, but the very mechanism that ensures a laboratory discovery survives the ‘valley of death’ to become a tangible consumer product.

C. Scholarship on Open Science

Parallel to this debate, a robust body of literature advocates for the ‘Open Science’ movement. Scholars like Jerome Reichman emphasize the importance of maintaining a robust ‘scientific commons’.[13]Open science literature argues that data and platform technologies must remain non-proprietary to allow for global, collaborative verification and cumulative innovation, arguing that commercialisation models fundamentally corrode the Mertonian norms of communal knowledge sharing.[14]

D. Indian Scholarship on Publicly Funded Research

In the Indian context, scholarly discourse has largely focused on the intersection of patent law and public health, particularly following the lapsing of the Protection and Utilisation of Public Funded Intellectual Property (PUPFIP) Bill, 2008.[15]Leading Indian intellectual property scholars, notably Shamnad Basheer, have extensively analysed how the Indian Patents Act 1970 integrates public interest safeguards.[16]Much of the Indian literature examines Sections 84 and 100 as vital ex-post remedies for market failure.

However, Indian scholarship frequently focuses on private pharmaceutical patents rather than the distinct governance mechanisms of state-funded PROs.

E. The debate surrounding Bayh-Dole style legislation

Beyond general critiques of commercialisation, a geographically specific debate persists regarding whether developing economies should adopt Bayh-Dole style legislation.Critics argue that transplanting the US model to India is fundamentally flawed due to differing institutional capacities and market dynamics. They caution that imposing a mandate to patent on Indian universities—many of which lack sophisticated technology transfer offices—would lead to defensive patenting, wasted public funds on filing fees, and the locking up of indigenous research.[17]

Consequently, there is a pronounced deficiency in examining ex-ante contractual governance. While extensive literature debates national patent law, there is a critical void in analysing the fragmented, non-statutory executive guidelines governing Indian PROs, and how the absence of standard public-interest clauses’ in technology licensing agreements systematically undermines the principles of equitable access.

MAIN ANALYSIS

FRAGMENTED LEGAL ARCHITECTURE AND EXECUTIVE GUIDELINES

The governance of publicly funded intellectual property in India suffers from the absence of a unified

statutory foundation. Following the withdrawal of the PUPFIP Bill 2008—which faced severe criticism for heavily mirroring the US Bayh-Dole Act without adequate contextualisation for Indian public health needs—the regulation of state-funded inventions devolved into fragmented executive instructions.

Currently, institutions operate under disjointed guidelines issued by the Department of Science and Technology (DST), the Department of Biotechnology (DBT), and individual institutional policies.[18]

The reliance on agency-specific guidelines creates significant legal inconsistencies and a precarious governance architecture. From an administrative law perspective, executive guidelines lack the binding statutory authority to compel PROs to prioritize public access over revenue generation. TTOs at institutions like the Council of Scientific and Industrial Research (CSIR) operate under internal policies that heavily incentivize patent filing metrics and royalty generation as markers of institutional success.[19] A counterargument frequently raised by institutional administrators is that executive guidelines provide necessary flexibility, allowing PROs to tailor commercialisation strategies to specific industries.

However, a critical evaluation reveals that this “flexibility” operates in a legal vacuum that ultimately harms the public interest. Lacking clear statutory directives, institutional administrators default to standard commercial practices—favouring exclusive licensing to secure immediate funding, without negotiating downstream pricing or access commitments. Executive guidelines are simply insufficient to enforce public-interest objectives against well-resourced corporate licensees during contract negotiations, resulting in a systemic regulatory capture of public science by private interests.[20]

PATENT EXCLUSIVITY VERSUS OPEN ACCESS MANDATES

A central legal tension exists between the mechanics of technology transfer and the ethos of open science. Exclusive licensing—often demanded by venture capital and private investors as a condition for funding[21]—creates monopolies over state-funded discoveries. This directly conflicts with policies like the National Data Sharing and Accessibility Policy (NDSAP) 2012, which mandates the sharing of non-sensitive data generated through public funds.[22]

The jurisprudence surrounding patent exclusivity and public health, while primarily focused on private patents, is highly instructive. In Novartis AG v Union of India, the Supreme Court firmly rejected the grant of a patent for incremental innovations lacking enhanced therapeutic efficacy, underscoring the legislative intent to prevent evergreening and protect public access.[23]

However, when PROs license foundational platform technologies exclusively, they effectively grant private entities the leverage to monopolize downstream developments, circumventing the spirit of the Novartis ruling. The practical implication is the exacerbation of the ‘tragedy of the anticommons’. If a public university exclusively licenses a foundational gene-editing assay to a single corporation, subsequent researchers are locked out of utilising that tool for alternate applications. The critical failure is the blind adoption of exclusive licensing as a default mechanism. Open science can coexist with commercialisation if PROs legally mandate non-exclusive licensing for platform technologies (tools, assays, fundamental algorithms) while reserving exclusive licenses strictly for end-product development (specific therapeutics or distinct consumer applications).

GOVERNANCE FAILURES IN INSTITUTIONAL TECHNOLOGY TRANSFER

The operational reality of Technology Transfer Offices (TTOs) in Indian universities reveals systemic governance failures. Technology transfer agreements are inherently asymmetrical. PROs often lack thev legal sophistication, market data, and financial leverage to negotiate “equitable access clauses” or ‘humanitarian use exemptions’ with multinational pharmaceutical or tech firms. An analysis of standard licensing practices indicates a chronic failure to monitor and enforce

commercialisation milestones. While general contract law under the Indian Contract Act 1872 governs these technology transfer agreements, it provides underexplored mechanisms for safeguarding the public nature of the underlying asset. Specifically, Section 23 of the Indian Contract Act declares an agreement void if its consideration or object is opposed to public policy.[24]If a public university grants an exclusive, irrevocable license for a life-saving pharmaceutical compound—developed entirely through taxpayer funds—without any pricing safeguards or milestone obligations, a strong legal argument emerges that such an unconscionable privatisation of a public good is inherently opposed to public policy. However, Indian courts have yet to test the applicability of Section 23 as a mechanism to strike down predatory technology transfer agreements, leaving PROs reliant on drafting sophisticated contracts they frequently lack the capacity to negotiate.

To circumvent this asymmetry at the TTO level, the governance architecture must shift upstream to the apex funding agencies themselves. Centralised grant-making bodies—such as the Department of Biotechnology (DBT), the Indian Council of Medical Research (ICMR), and the Department of Science and Technology (DST)—possess immense, largely unleveraged power to dictate commercialisation terms before the laboratory research even begins. Instead of relying on ex-post compulsory licensing under the Patents Act, which requires protracted litigation and invites international trade pressure, funding agencies can embed mandatory public-interest conditionalities directly into the ex-ante grant disbursement Contracts.

By restructuring funding agreements, the ICMR and DST could legally bind recipient universities to baseline commercialisation rules. For example, a funding contract could stipulate that any resulting patent must include mandatory open-access obligations for academic researchers, equitable access commitments for low-income populations, and non-exclusive data sharing requirements for platform technologies. If a private licensee later attempts to price-gouge or warehouse the patent[25], they would be in breach of the foundational funding agreement that birthed the intellectual property. This upstream contractual governance model preempts the traditional ‘valley of death’ dilemmas, transforming public interest safeguards from an afterthought into a condition precedent for scientific funding.

THE UNDERUTILISATION OF STATE PREROGATIVES AND MARCH-IN RIGHTS

The Indian Patents Act 1970 contains robust mechanisms to intervene when patented technologies remain inaccessible. Section 84 allows for compulsory licensing if the reasonable requirements of the public have not been satisfied, or if the patented invention is not available at a reasonably affordable price.[26]

Furthermore, Section 100 grants the Central Government the power to use inventions for the purposes of government.[27] Despite these powerful provisions, they are almost never deployed against technologies originating from public funding but commercialised by private licensees. The landmark Bayer Corporation v Natco

Pharma Ltd decision demonstrated the state’s willingness to use Section 84 against prohibitive pricing by private entities.[28]However, relying on ex-post compulsory licensing to rectify access issues in state-funded research represents a profound failure of ex-ante governance.

The state should not have to engage in protracted, highly contested intellectual property litigation to ensure affordable access to technologies it initially funded. The fatal weakness of the current regime is its reactive posture. It fails to embed contractual march-in rights directly into the licensing agreements themselves, relying instead on the cumbersome and politically sensitive statutory compulsory licensing threshold. This creates a chilling effect on enforcement, as the state is reluctant to utilize Section 84 for fear of deterring foreign direct investment, [29]leaving the public without recourse.

COMPARATIVE ANALYSIS

A comparative assessment highlights the structural deficiencies in the Indian approach by contrasting it with established international models. In the United States, the Bayh-Dole Act of 1980 provides a clear statutory framework allowing universities to elect titles to inventions created with federal funding.[30]

Crucially, the Act retains explicit ‘march-in rights’ for the government to mandate additional licensing if the patent holder fails to achieve practical application or alleviate health and safety needs.

While critics correctly point out that these statutory march-in rights have historically been underutilized by the National Institutes of Health (NIH)[31], their very existence provides universities with vital leverage during licensing negotiations.

Conversely, the European Union, through its Horizon Europe framework, champions the principle of ‘as open as possible, as closed as necessary.’[32]The EU model integrates data management plans and open-access mandates as mandatory prerequisites for funding, elegantly balancing commercialisation with mandatory public repositories for foundational data.

India’s lack of a centralized statute like Bayh-Dole, combined with a failure to implement binding ex-ante open-access conditions akin to Horizon Europe, places it at a distinct disadvantage.

TABLE 1: COMPARATIVE GOVERNANCE FRAMEWORKS FOR PUBLICLY FUNDED RESEARCH

Source: Author’s compilation based on the Bayh-Dole Act 1980, Horizon Europe Programme Guide 2022, and the Patents Act 1970.

The comparative analysis reveals that traditional innovation governance models—whether the centralized statutory framework of the US, the mandatory open-access rules of the EU, or the fragmented executive guidelines of India—were historically architectured around tangible patents and discrete biochemical compounds. However, the paradigm of technology transfer is undergoing a radical transformation.

Modern scientific innovation increasingly revolves not around isolated physical inventions, but around the aggregation and analysis of massive datasets. As value shifts from the patentable molecule to the

proprietary algorithm, traditional intellectual property concepts are proving insufficient.[33]Consequently, governance frameworks must urgently evolve beyond the conventional bounds of patent jurisprudence to address the emerging realities of digital monopolies, algorithmic capitalism, and data sovereignty.[34]

CONTEMPORARY CHALLENGES: DATA, PRIV ACY, AND AI

The commercialisation of publicly funded research is no longer confined to tangible inventions or chemical compounds; it is increasingly dominated by data-driven sciences and artificial intelligence.

Contemporary public research frequently yields massive datasets—genomic sequences, epidemiological records, and demographic behavioural patterns. The commercialisation of this data introduces profound new legal friction, intersecting directly with the Digital Personal Data Protection (DPDP) Act 2023.

When publicly funded health or demographic research is commercialised, PROs must navigate a precarious tension. On one side are the mandates of open science, which demand the sharing of anonymised data for peer verification and downstream academic research. On the other side are corporate partners and AI developers seeking proprietary, exclusive control over high-quality training datasets to develop commercial algorithms.

Under the DPDP Act, PROs operating as Data Fiduciaries bear strict obligations regarding purpose limitation and informed consent.[35]A critical governance challenge emerges when public universities collect data under the altruistic guise of ‘public health research,’ only to subsequently license that dataset  to private tech companies for AI model training. This shift in purpose raises severe questions regarding algorithmic accountability and the validity of the original consent.

Furthermore, current technology transfer models are fundamentally ill-equipped to govern data licensing. A patent expires, but exclusive access to a proprietary dataset creates an enduring monopoly over machine learning outputs.[36]When PROs grant private technology companies exclusive rights to publicly funded datasets, they effectively privatise the raw material of the digital economy. Public-private data partnerships, if structured without stringent non-exclusivity clauses, allow corporations to dodge public scrutiny under the shield of trade secrets and data protection compliance, walling off publicly funded knowledge behind proprietary algorithmic black boxes.

LIMITATIONS OF THE STUDY

This study relies primarily on a doctrinal and policy-oriented methodology, which inherently limits its

capacity to assess the ground-level operational metrics of institutional technology transfer. A significant limitation is the absence of empirical fieldwork. Due to the pervasive use of Non-Disclosure Agreements (NDAs) in commercial licensing, accessing the exact contractual terms negotiated between Indian PROs and private corporations is virtually impossible.[37]

Consequently, the analysis of governance failures is based on systemic legal gaps, available policy documents, and secondary literature, rather than a quantitative review of specific technology transfer agreements. Furthermore, while the study touches upon data governance, an exhaustive technical analysis of AI dataset licensing falls outside the scope of this paper, warranting dedicated interdisciplinary research at the intersection of intellectual property law, data governance, and artificial intelligence Regulation.

CONCLUSION

The transition from the Mertonian ideals of open science to the proprietary realities of commercialised research represents an irreversible paradigm shift in how states manage knowledge production. However, as this analysis demonstrates, the tension between commercialising state-funded discoveries and preserving public access is not an intractable binary. Rather, the current friction is a symptom of a defective legal architecture that has failed to evolve alongside the modern innovation economy. By relying on a fragmented, ad hoc network of executive guidelines instead of cohesive statutory law, the Indian governance framework inadvertently permits the wholesale privatisation of the scientific Commons.

The policy significance of resolving this regulatory deficit cannot be overstated. When the state funds the highest-risk phases of foundational research, the resulting technological breakthroughs constitute a profound public trust. The social contract inherent in taxpayer-funded research dictates that the public should not be forced to pay exorbitant market premiums—effectively paying twice—for the very innovations their inputs subsidised. Permitting private entities to extract monopoly rents from publicly funded discoveries without mandatory pricing or access safeguards fundamentally corrodes public trust in state research institutions.

Looking forward, the legal implications of this governance vacuum will become increasingly severe as the locus of innovation shifts from patentable molecules to data-driven artificial intelligence. The traditional reliance on ex-post remedies, such as Section 84 of the Indian Patents Act[38], is a reactive and politically fraught mechanism that is fundamentally ill-equipped to govern the licensing of massive, proprietary training datasets under frameworks like the DPDP Act[39] .The privatisation of public data creates invisible, algorithmic monopolies that traditional patent march-in rights cannot reach.

Consequently, the future of law and technology governance demands a paradigm shift toward rigorous ex-ante regulation. To achieve equitable technology diffusion, innovation policy must be structurally rewired at the contractual root. Apex funding bodies must wield their financial leverage to mandate public-interest licensing clauses, open-access data sharing, and contractual march-in rights as non-negotiable prerequisites for grant disbursement. Furthermore, Parliament must enact a dedicated, comprehensive innovation statute that supersedes fragmented agency guidelines, legally categorising foundation technologies and public health datasets as vital public infrastructure requiring tiered, non-exclusive licensing.

The commercialisation of publicly funded scientific research must not be viewed merely as a mechanism for institutional revenue generation. It is, fundamentally, a tool for societal advancement. By embedding robust public-interest safeguards directly into technology transfer architectures, the state can successfully navigate the ‘valley of death’ alongside private capital, ensuring that the fruits of public science are not sequestered behind proprietary walls, but leveraged equitably for the global public good.

[1] Robert K Merton, The Sociology of Science: Theoretical and Empirical Investigations (University of

Chicago Press 1973) 267

[2] Digital Personal Data Protection Act 2023,

[3] Bayh-Dole Act 1980

[4] European Commission,‘Horizon Europe Programme Guide’ (Directorate-General for Research and

Innovation 2022

[5] Protection and Utilisation of Public Funded Intellectual Property Bill 2008, Bill No 66 of 2008 (Rajya

Sabha).

[6]Novartis AG v Union of India (2013) 6 SCC 1.

[7] Bayer Corporation v Natco Pharma Ltd OA/35/2012/PT/MUM (IPAB, 4 March 2013)

[8] Michael A Heller and Rebecca S Eisenberg,Can Patents Deter Innovation? The Anticommons in Biomedical Research (1998) 280 Science 698.

[9]Michael A Heller and Rebecca S Eisenberg,‘Can Patents Deter Innovation? The Anticommons in Biomedical Research (1998) 280 Science 698.

[10] Mariana Mazzucato, The Entrepreneurial State: Debunking Public vs Private Sector Myths (Anthem Press 2013).

[11] Arti K Rai and Rebecca S Eisenberg, ‘Bayh-Dole Reform and the Progress of Biomedicine’ (2003) 66 Law and Contemporary Problems 289

[12] Wendy H Schacht,‘The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology (Congressional Research Service 2012).

[13] Jerome H Reichman and Paul F Uhlir,‘A Contractually Reconstructed Research Commons for

Scientific Data in a Highly Protectionist Intellectual Property Environment’ (2003) 66 Law and Contemporary Problems 315.

[14]Jerome H Reichman and Paul F Uhlir ‘A Contractually Reconstructed Research Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment (2003) 66 Law and Contemporary Problems 315.

[15] Protection and Utilisation of Public Funded Intellectual Property Bill 2008, Bill No 66 of 2008 (Rajya

Sabha).

[16] Shamnad Basheer, ‘The Indian Patents Act and the Public Interest’ (2012) 2 Indian J Intell Prop L 15

[17] Anthony D So and others,‘Is Bayh-Dole Good for Developing Countries? Lessons from the US Experience’ (2008) 6(10) PLoS Biology e262 https://doi.org/10.1371/journal.pbio.0060262.

[18] Ministry of Science and Technology, ‘National Innovation Promotion Policy’ (Department of Biotechnology, Government of India 2016).

[19] Sunil Mani, ‘The Commercialization of Publicly Funded Science and Technology in India’ (2014) 49(1)

Economic and Political Weekly 52

[20]David C Mowery and others,Ivory Tower and Industrial Innovation: University-Industry Technology Transfer Before and After the Bayh-Dole Act (Stanford University Press 2004).

[21] Richard R Nelson ‘Observations on the Post-Bayh-Dole Rise of Patenting at American Universities’ (2001) 26 Journal of Technology Transfer 13.

[22]Ministry of Science and Technology, ‘National Data Sharing and Accessibility Policy (NDSAP)’ (Government of India 2012).

[23] Novartis AG v Union of India (2013) 6 SCC 1

[24] Indian Contract Act 1872, s 23

[25]Colleen Cunningham, Florian Ederer and Song Ma,‘Killer Acquisitions’ (2021) 129(3) Journal of Political Economy 649 https://doi.org/10.1086/712506

[26] Patents Act 1970, s 84.

[27] Patents Act 1970, s 100.

[28] Bayer Corporation v Natco Pharma Ltd OA/35/2012/PT/MUM (IPAB, 4 March 2013).

[29] Office of the United States Trade Representative, 2023 Special 301 Report (USTR 2023) https://ustr.gov/sites/default/files/2023-04/2023%20Special%20301%20Report.pdf

[30] Bayh-Dole Act 1980, 35 USC §§ 200–12.

[31] Peter S Arno and Michael H Davis,‘Why Don’t We Enforce Existing Drug Price Controls? The Unrecognised and Unenforced Reasonable Pricing Requirements Imposed upon Patents Deriving in Whole or in Part from Federally Funded Research’ (2001) 75 Tulane Law Review 631.

[32] European Commission,‘Horizon Europe Programme Guide’ (Directorate-General for Research and Innovation 2022.

[33] Julie E Cohen, Between Truth and Power: The Legal Constructions of Informational Capitalism (Oxford

University Press 2019).

[34] Shoshana Zuboff, The Age of Surveillance Capitalism (Profile Books 2019).

[35] Digital Personal Data Protection Act 2023, s 4.

[36] Mark A Lemley and Bryan Casey,‘Fair Learning’ (2019) 99 Texas Law Review 743.

[37] David C Mowery, Richard R Nelson, Bhaven N Sampat and Arvids A Ziedonis, Ivory Tower and Industrial Innovation: University-Industry Technology Transfer Before and After the Bayh-Dole Act (Stanford University Press 2004)

[38] Patents Act 1970, s 84.

[39] Digital Personal Data Protection Act 2023.