Intellectual Property and Public Health – A White Paper (original) (raw)

A Typology of Intellectual Property Management for Public Health Innovation and Access: Design Considerations for Policymakers

The open AIDS journal, 2010

This paper seeks to set the practical discipline of public interest intellectual property (IP) management in public health into its broader policy context. The most immediate and direct impact of IP systems on public welfare results not from international standards nor from national legislation – though these norms are fundamentally important - but rather from the accumulated impact of numerous practical choices whether or not to seek IP protection; where and where not; and how any exclusive rights are deployed, by whom, and to what end. IP management is the essentially practical exercise of limited exclusive rights over protected subject matter, the judicious use of those rights to leverage outcomes that advance an institution's or a firm's objectives. Exclusive rights are used to construct and define knowledge-based relationships, to leverage access to technology and other necessary resources, and to enhance market-based incentives. IP management choices range across a broad spectrum, spanning public domain strategies, open or exclusive licensing, and strong exclusivity. The idea of ‘exclusive rights’, as a specific legal mechanism, can run counter to expectations of greater openness and accessibility, but actual outcomes will depend very much on how these mechanisms are used in practice. For public interest or public sector institutions concerned with health research and development, particularly the development of new medicines, IP management choices can be just as critical as they are for private firms, although a predominant institutional concentration on advancing direct public interest objectives may lead to significantly different approaches in weighing and exercising practical choices for IP management: even so, a private sector approach should not be conflated with exclusivity as an end in itself, nor need public interest IP management eschew all leverage over IP. This paper offers a tentative framework for a richer typology of those choices, to give a sense of practical options available and the factors that might guide their application, but without advocating any particular approach.

Patent systems for encouraging innovation: Lessons from economic analysis

Research Policy, 2006

Economic theory views patents as policy instruments aimed at fostering innovation and diffusion. Three major implications are drawn regarding current policy debates. First, patents may not be the most effective means of protection for inventors to recover R&D investments when imitation is costly and first mover advantages are important. Second, patentability requirements, such as novelty or non-obviousness, should be sufficiently stringent to avoid the grant of patents for inventions with low social value that increase the social cost of the patent system. Third, the trade-off between the patent policy instruments of length and breadth could be used to provide sufficient incentives to inventions with high social value. Beyond these three implications, economic theory also pleads for a mechanism design approach to the patent system, where an optimal patent system could be based on a menu of different degrees of patent protection with stronger protection corresponding to higher fees.

Patenting human biological materials and data: balancing the reward of innovation with the ordre public and morality exception

Journal of Intellectual Property Law and Practice

• The availability of human biological materials and data plays a key role in promoting biotechnological innovations and conducting biomedical research. While the function of patent rights in promoting innovation is widely discussed, there are still overarching concerns in patenting human biological materials and data, including triggering commercialization and commodification of the human body, precluding affordable access to the products or services and inducing interest extraction by patent holders to recoup investments and make excessive profits.

Beyond Incentives: Expanding the Theoretical Framework for Patent Law Analysis

2010

research and development. 2 Pursuant to this theory, absent exclusive legal rights to use an invention, there would be no incentive to invent, as free riders may imitate the invention and drive down its market price to a level that would not allow the inventor to recoup her research and development costs and make a reasonable profit. 3 By providing legal exclusivity, patents overcome this market failure and provide the missing incentive to engage in inventive activity, thus benefiting society. The "incentive to invent" theory has been complemented by other theories, including the "incentive to disclose" theory 4 and the "prospect" theory, 5 all of which set out to justify the need for a patent system from an economic point of view. 6 The economic justifications for the patent system have not gone unchallenged. Over the years, the various purported economic benefits of the patent system have been called into question. A central argument criticizing the "incentive to invent" theory has been that government intervention is not necessary to secure incentives to invent. As the argument goes, inventions are developed, with or without patents, when 2.

Patents and Other Incentives for Pharmaceutical Innovation

Encyclopedia of Health Economics, 2014

The public sector helps finance the drug discovery enterprise through a variety of mechanisms. These include grants for biomedical research conducted in public sector labs, tax subsidies for private drug plans, and the extension of intellectual property privileges to drug developers. The cost of bringing new drugs to market has increased markedly during the last two decades. This has raised questions about whether existing forms of public sector support is optimal, and, in particular, if alternative forms of public support would result in more therapeutically valuable drugs per dollar spent. This chapter reviews the advantages and deficiencies of existing forms of government support for drug R&D, and the features of the alternative arrangements that their proponents suggest will improve upon the current system. We review both "push" programs-schemes that make private investment in pharmaceutical R&D more profitable by reducing the private cost of the R&D-and "pull" programs-schemes that increase the revenues accruing to companies that manage to bring new drugs to market. We conclude with an assessment of the issues that need to be resolved for these alternative forms of support to be actually implemented.

The Moral Justifiability of Patents

Ethical Perspectives, 2006

Three attempts are usually made to justify patents: natural rights, distributive justice, and consequentialist arguments, all of which I contest. The natural rights argument is traced back to John Locke, defender of the 'labour theory of property,' who essentially holds that persons have a right to property insofar as they have mixed their labour with it, and insofar as they have appropriated natural things without exhausting them or taking more than their share. Yet, the inventor's mixing of labour is often the last step of a longer historical process, and patents seem to encourage waste, since they restrict the use of an idea. The distributive justice argument holds that patents reward the initiative of inventors-without this reward, 'free riders' would be able to compete unfairly; the exclusivity granted by patents corrects this hole in the free market. However, our current system does not necessarily reflect this principle; it is difficult to clarify the criteria on which an inventor deserves a reward; unsuccessful inventors and basic researchers also invest much initiative, and yet are not rewarded; it is unclear that justice should reward someone by granting them the exclusive right to determine what is done with knowledge; and no link exists between the social usefulness of an invention and the scope of protection granted by a patent. The consequentialist justification holds that patents encourage innovation, and the disclosure of knowledge. Although it is clear that patents encourage inventions, it is not clear that they encourage progress-they may even limit progress by restricting use of previous knowledge. As for the disclosure of knowledge: such knowledge is hard to keep secret in the first place, and patent offices grant overly broad patents. In conclusion, this paper offers some suggestions concerning the true costs of the patent system.

The case for permissive patents

European Economic Review, 1989

Whatever its shortcomings in practice, until very recently patent law has sought to embody the winner-takes-all principle. This paper argues that it is both feasible and desirable lo allow multiple prizes. Indeed, it is possible that complete abolition of the patent system, by raising the returns to late finishers, would yield an improvement on the current situation. 'A British court has just decreed that Genentech, a biotechnology company in California, cannot retain exclusive marketing rights in Britain for its heart product, TPA. The judge ruled that the terms of the patent were too broad (.. .) To stop others working (.. .) would stifle research and not be in the public interest. Genentech plans to appeal against the decision. If its patent were to stick, 19 companies would have to abandon their work on their TPAs.' [The Economist, July 18, 19871 *We are grateful to Peter Geraighty, Daniel Seidmann, and two referees for their perceptive comments. 'Well known examples are Dasgupta and Stiglitz (1980), Loury (1979), Lee and Wilde (1980).