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Abstract:
Patents on biomedical research tools - technological inputs to experimentation - may inhibit scientific inquiry and the development of life-enhancing therapies. Various "public law" approaches to address this challenge, such as a common law experimental use exception to patent infringement, have achieved limited success. In the wake of these shortcomings, this Article argues that institutions that fund and support biomedical research are resorting to an underappreciated model of private ordering to resolve research holdup. Increasingly, federal and state agencies, universities, non-profits, and disease advocacy groups are conditioning vital research support on requirements that recipients of this support make resulting patented inventions widely available for noncommercial research purposes. In essence, these institutions are contractually constructing a biomedical research commons.

These efforts represent a significant shift towards "privatizing" patent regulation. Through a new model of "consideration-based patent regulation," public institutions are embedding policy objectives in contractual quid pro quos with individual recipients of research support. This model provides public institutions with considerable freedom to effectuate norms favoring wide dissemination of research technologies. This Article greets this development with cautious optimism, providing prescriptions for how public institutions may effectively manage the contractual construction of a biomedical research commons. It concludes by exploring the significant ramifications of this development for patent law, institutions, and theory.

private ordering, norms, biomedical research, research tools, patent law, commons

Abstract:
This Article explores the concept of intellectual infrastructure in intellectual property law. It makes three principal contributions. First, it builds upon prior work to elaborate an infrastructure-based theory of productivity that encompasses trademark, copyright, and patent law. It is well-recognized that intellectual property law promotes productivity through allowing exclusive rights on refined intellectual creations such as source-identifying marks, particularized expressions, and specific inventions. Somewhat less appreciated, these bodies of law also promote productivity through ensuring wide access to productivity-enabling intellectual infrastructure, such as generic words, ideas, and natural principles, by making these assets ineligible for exclusive rights. This Article argues that this distinction between refined applications, which are eligible for exclusive rights, and foundational infrastructure, which remains subject to liberal access, is critical to promoting commercial, creative, and inventive activity throughout intellectual property law.

Second, this Article offers a social account of the definition and evolution of intellectual infrastructure. Infrastructure is a dynamic entity, and intellectual creations subject to exclusive rights can evolve into infrastructure through widespread social appropriation. For example, trademarks can evolve into generic words, particularized expressions can develop into stock literary devices, and inventions can become standard platforms for technological development. This Article argues that trademark and copyright law employ social feedback mechanisms to relax exclusive rights on assets that become intellectual infrastructure and further contends that the absence of such mechanisms in patent law may inhibit technological progress. Trademark and copyright doctrines such as genericide, the idea-expression dichotomy, and the scenes a faire doctrine dynamically relegate refined intellectual creations to the public domain as they achieve infrastructural status. Patent law lacks an analogous mechanism for liberalizing access to patented inventions that achieve this status, such as isolated, purified human embryonic stem cells and information technology standards. While patent law's relatively short term of protection mitigates the harshness of exclusive rights on foundational technologies, this one-size-fits-all approach ignores the reality that certain inventions can become infrastructure well before expiration of the patent term, particularly in rapidly advancing industries such as biotechnology and information technology.

Third, this Article draws on the Supreme Court's recent decision in eBay Inc. v. MercExchange, L.L.C. to propose a social feedback mechanism for liberalizing access to patented infrastructure. Specifically, it argues that courts in patent infringement cases should deny injunctions and allow liability rule protection for patented inventions used as infrastructure. Rather than simply relegating these foundational technologies to the public domain, this approach enhances access to patented infrastructure while maintaining incentives to invent.

trademark, copyright, patent, infrastructure, ebay, remedies, liability rule, property rule

Abstract:
Patents both promote the development of health technologies as well as constrain access to them. Access constraints on patented medicines, diagnostics, and agricultural innovations can severely compromise human health, particularly for low-income populations. To help address this challenge, this Article explores mechanisms for integrating distributive safeguards in the patent system in a manner consistent with strong property rights and private ordering. Finding existing patent doctrine inadequate, this Article examines solutions arising from the developmental histories of particular health technologies. In particular, this Article argues that public institutions, which contribute enormous amounts of "scientific capital" - money, labor, and bodily materials - to life sciences research and development, can effectively leverage these contributions to enhance access to downstream patented technologies.

By providing vital capital, government, academic, and nonprofit entities both weaken the economic need for exclusive rights as well as obtain limited co-ownership stakes in resulting inventions. By exercising this leverage, public institutions are helping to create a "distributive commons" that enhances access to patented health technologies for low-income populations. This Article surveys existing practices, providing prescriptions to address the chilling effects and technical competence concerns that undermine distributive efforts. It concludes by challenging prevailing theoretical preferences for individual rather than communal ownership of property, highlighting the advantages of public-private co-ownership of nonrival resources.

patents, biomedical, research, life sciences, pharmaceuticals, diagnostics, agriculture, biotechnology, distributive justice, commons, public institutions, NIH, CIRM, nonprofits, universities, disease advocacy, biobanks, technology transfer, licensing

Abstract:
This Article addresses a problem that has attracted significant attention from patent scholars: the potential for patents on research tools - technological products and processes that are critical inputs of scientific experimentation - to inhibit basic scientific research. The Article first argues that a fundamental distinction between "upstream" intellectual assets and "downstream" particularized technologies is central to the structure of patent law and its contribution to scientific progress. In this system, patent law specifically prohibits the patenting of upstream assets such as natural laws, natural phenomena, and abstract principles on a "fundamentality" rationale; these assets enable wide varieties of derivative applications and are better suited for common ownership in the public domain where all persons can freely draw upon them in their innovative endeavors. Rather, patent law reserves proprietary rights - and the monopoly profits they confer - for downstream, particularized technologies such as end-user goods. Drawing from studies in the sociology of science concerning the "material culture" of scientific exploration, this Article shows how some patented technologies may be even more foundational than knowledge itself. For example, human embryonic stem cells, which are patentable technologies when isolated and purified outside of the human organism, hold the key to revealing basic biological knowledge. Patents over this resource effectively create exclusive individual rights over an area of immense scientific importance and wide downstream applicability. This Article argues that the common law prohibition against patenting natural laws, natural phenomena, and abstract principles provides a legal and prudential basis for constraining patents on human embryonic stem cells and other similarly-situated biotechnology research tools. Just as knowledge itself is not patentable, courts should constrain patents on the necessary technological fountains from which it springs.

patents, research tools, biotechnology, intellectual property, common law, natural law, natural phenomena, abstract principles, patentable subject matter, stem cells

Abstract:
This Note applies the concept of "paradigm shifts" from the history and philosophy of science to describe how patents on biomedical research tools - inputs to basic research - can create conditions conducive to fundamental advances in scientific theory. Patents on research tools can prevent widespread access to these technologies and thus inhibit downstream experimentation. The decreased availability of patented research tools provides an added incentive for scientists to fundamentally reconceptualize natural phenomena in ways that do not depend on patented inputs for their exploration. This encourages scientists to "theorize around" dominant paradigms, thereby engaging in the alternative theory generation that drives profound scientific progress. Drawing on these observations, this Note argues for a time-limited experimental use exception at the beginning of the patent term in order to best balance the normal scientific processes and alternate hypothesis generation that jointly enable paradigm shifts.

patents, paradigm shifts, science, biomedical science, Kuhn, stem cells

Abstract:
Patents, and the profits they enable, exert a tangible "pull" on university research. Influenced by commercial interests, universities may favor research pathways that generate appropriable (i.e., patentable) results, thus diverting resources away from basic research. Indeed, empirical evidence suggests that revenue maximization constitutes the overriding goal of most university technology transfer offices. Commercial interests are also influencing university research in a different way, as the rush to patent biomedical research tools may inhibit academic science. Amidst these legitimate concerns, this essay explores an underappreciated, salutary facet of university patenting. While such patenting may accelerate the commercialization of academic science, it also creates opportunities for academic institutions to project their unique normative commitments into the marketplace. In this sense, patents function as interfaces that mediate two-way normative exchange between academics and industry. Increasingly, universities are utilizing patents to "push" a number of nonmarket goals into the private sector, such as ensuring wide access to patented resources for research and public health purposes. Among other effects, these efforts are increasing the availability of patented research tools for noncommercial investigations as well as expanding access to essential medicines in low-income countries. The essay concludes by exploring the normative implications of the push and pull of patents. Eschewing once-size-fits-all prescriptions, it suggests that the unique histories, constituencies, and aspirations of particular institutions should inform their approach to technology transfer.

patents, research tools, universities, technology transfer, licensing, equitable access, commercialization

Abstract:
A half century ago, author and physicist C.P. Snow warned of a “gulf of mutual incomprehension” between the liberal arts and sciences. Snow’s “Two Cultures” thesis is particularly relevant to patent law, a realm where law and science intersect. Drawing on Snow’s framework, this Article addresses challenges that arise when lay judges must engage, understand, and ultimately pass judgment on complex technologies. It first argues that technological subject matter imposes significant cognitive burdens on generalist judges. It then explores the “cognitive miser” model whereby lay persons adopt heuristics and defer to expertise to limit their engagement with technology. Drawing from this psychological model, this Article then explores the unique role of formalism in patent doctrine. Advancing an information cost theory of Federal Circuit jurisprudence, this Article argues that formalistic patent doctrine mitigates the degree to which judges must engage technological subject matter. Formalism truncates difficult technical inquiries, thus helping to mediate the intersection of law and science.

The Article then identifies a countervailing trend in recent Supreme Court patent decisions. It is well-established that the Court has substantively narrowed patent rights. Less appreciated, however, is the Court’s systematic preference for contextually-sensitive, holistic standards over inquiry-truncating, formalistic rules. This so-called “holistic turn” promises to increase the degree to which lay judges must engage technologically complex subject matter. To address resulting cognitive burdens, this Article offers prescriptions for blending the economizing virtues of rules with the flexibility and contextual sensitivity of standards. It concludes by exploring the cultural differences of the Federal Circuit and the Supreme Court as well as their implications for patent doctrine.

patents, culture, Two Cultures, STS, psychology, Federal Circuit, Supreme Court, formalism, holism, deference, expertise, judges

Abstract:
Drawing on Professor Samuelson’s article, “Are Interface Patents Impeding Interoperability,” this Response identifies situations where interface patents warrant regulatory intervention. It first notes that interfaces define “technological paradigms”: integrated systems of interoperability. It then argues that interface patents can provide incentives to invent valuable interfaces and encourage healthy competition between emerging technological paradigms. However, once an industry has coalesced around a single paradigm, the costs of strictly asserting interface patents likely outweigh their benefits. This Response argues that by considering industrial and informational developments over time, government and industry actors can calibrate policy interventions to maximize innovation both between and within technological paradigms.

patents, interfaces, interoperability, paradigms, formats, platforms, software, information technology