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It’s About Scientific Secrecy, Dummy: A Better Equilibrium Among Genomics Patenting, Scientific Research and Health Care

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Abstract

This paper offers a different pragmatic and patent-based approach to concerns regarding the negative effects of genetic-based patenting on advancing scientific research and providing adequate and accessible health care services. At the basis of this approach lies an explication of a mandatory provisional patented paper procedure (PPPA), designed for genetic-based patents and administered by leading scientific journals in the field, while officially acknowledged by the USPTO, and subsequently by other patent offices as well. It is argued that the uniqueness of PPPAs lies in subsequently mitigating the negative ramifications of genetic patents on scientific research and genetic-based health care services, while basing such mitigation on a patents’ advocate viewpoint that neither discards the patent system nor jeopardizes its integrity.

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Notes

  1. Compare, for example, Caulfield et al. (2000, 2006), Czarnitzki et al. (2009), Fabrizio and Di Minin (2008), Huang and Murray (2008), forthcoming, Walsh et al. (2005b) with Andrews (2002b), Cook-Deegan et al. (2009), Farrelly (2007), Lakhani et al. (2006), Petherbridge (2007), Smith et al. (2004).

  2. A patent pool is a consortium of at least two companies agreeing to cross-license patents relating to a particular technology. The creation of a patent pool can save patentees and licensees time and money, and, in case of blocking patents, it may also be the only reasonable method for making the invention available to the public.

  3. “Prior art” constitutes all information that has been made available to the public in any form before a given date that might be relevant to a patent's claims of originality. If an invention has been described in prior art, a patent on that invention is not valid. With respect to the experimental use clause, section 102(b) of the patent statute provides that a patent may be obtained unless "the invention was…in public use or on sale in this country, more than 1 year prior to the date for application for patent in the United States." Public use may not mean commercial use, but commercial use is typically considered public use. An invention is considered on sale if it is sold or offered for sale. However, the doctrine of experimental use allows an inventor, or others cooperating with the inventor, to engage in activities that would otherwise fall under the public use or on-sale bars, provided that the use or sale is incidental to experimentation. By showing that the activity falls within the limits of experimental use, it is possible to refute a charge that the activity in question rendered the invention unpatentable.

  4. This belief is the basis of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). See e.g. WTO (1994).

  5. As indicated in: (35 United States Code, §112, 113; Walsh et al. 2005a; Eisenberg 1987).

  6. For a definition of “prior art” see footnote no. 4 above.

  7. Compare the 12-month period in the US, with the 6-month period granted only to the patent applicantee in Japan, and the non-existing grace period under the regulations of the European patent office (EPO). See: (35 United States Code, §102(b); European Patent Convention, no. 54; Tokkyo Ho [Japanese patent act], §30(1), 30(3)).

  8. More details about this lawsuit and the professional organizations standing behind it can be found at: http://www.aclu.org/freespeech/gen/brca.html.

  9. This is also true, apparently, with respect to EPO (Gugerell 1994, 104–107).

  10. See also: http://www.uspto.gov/web/offices/pac/provapp.htm.

  11. Ibid.

  12. Ibid.

  13. For a fuller description of the “prisoner’s dilemma” see Stanford Encyclopedia of Philosophy at: http://plato.stanford.edu/entries/prisoner-dilemma.

  14. For a more extensive list see: (Zemer 2005, 893–894 [note no.1]).

  15. The “sufficiency proviso” (also referred to as the “Lockean proviso”) is encompassed in Locke’s assertion that the fruits of labor is the laborer’s private property “at least where there is enough, and as good left in common for others” (Locke 1967, II, §27). As to the contrast(s) between left and right libertarians regarding this proviso, see for example: Fried (2004).

  16. Even those who are criticizing Locke’s labor theory concede its central role in his property-rights theory. For instance, Wendy Gordon’s critique of the manner by which Locke’s labor theory is used in order to justify existing copyright laws in the U.S. precisely stems from acknowledging the primary role of his labor theory in basing these copyright laws. In Gordon words: “Given that versions of labor theory are so often touted as support fro giving creators strong intellectual property rights, Lockean theory deserves closer examination than the intellectual property courts have given it so far” (Gordon 1993, 1540). See also (Zemer 2005, 912–918) for further discussion. A notable exception to the rule, though, is probably Robert Nozick’s stance. Advocating Locke’s property right theory through a right-libertarian lenses, he criticizes the logic of Locke’s labor theory while presenting it as a superfluous portion of Locke’s overall property rights philosophy (Nozick 1974, 174–175). However, as already observed by some commentators, “belittling” Locke’s labor theory stems from Nozick’s inability to accept the more complicated nature of Locke’s philosophy since such an acceptance undermines Nozick’s right-libertarian viewpoint (Hailwood 1996, 38–48; Wolff 1991, 102–116).

  17. Notice, in this respect, that claiming this result could have been achieved through appealing to the “exemption for research” clause is problematic because this clause can be used only in cases where the research using the patented knowledge is completely detached from any commercial endeavors.

  18. http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm; http://publicaccess.nih.gov/policy.htm.

  19. Such services are already available commercially, for example: http://web.guardtime.com/?page_id=3; http://www.digistamp.com; https://digitalid.verisign.Com/client/help/id_intro.htm#time_stamp.

  20. By using available DTS toolkits in the online submission software, as these toolkits are designed to be embedded within a third-party software environment. See: http://web.guardtime.com/?page_id=29; http://www.digistamp.com/apiover.htm.

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    Miriam Bentwich

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Bentwich, M. It’s About Scientific Secrecy, Dummy: A Better Equilibrium Among Genomics Patenting, Scientific Research and Health Care. Sci Eng Ethics 18, 263–284 (2012). https://doi.org/10.1007/s11948-011-9257-3

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