Patents and the challenge of ‘open source’ in an emergent biological commons or … the strange case of Betty Crocker and the mouse

Abstract

Patent has long been presumed to be an essential mechanism for realising the value of intellectual labour invested in the manufacture of biological inventions. By examining how the creators of engineered mice strains deposited at the Jackson Laboratory have utilised patent, I here explore the paradoxical matter of why they have not asserted their rights in the way anticipated by patent advocates. The emergence of new open source economies in mammalian genetic resources (the Mouse Academic Commons) has served to valorise collaborative working and iterative forms of experimentation. Engineered mouse strains are, in this context, best conceived of as an experimental space or biological commons open to re-invention by all. The key issue of how individual donors can protect the integrity of their donated ‘works’ and capitalize on the intellectual labour invested in their creation remains, however, largely unexplored. Here I argue that value lies not in the model mouse or strain itself, but rather in the experimental techniques that assure its continued genetic integrity; and demonstrate how process patents and trademark are together deployed to assure the reliability of the personality, identity, and reputation of the protected strains; and with it the economic viability of a biotechnological commons.

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Notes

  1. 1.

    As discussed in Singh (2014, p. 28).

  2. 2.

    https://supreme.justia.com/cases/federal/us/447/303/case.html.

  3. 3.

    The USPTO granted a patent number US4736866 to Harvard College claiming, “a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant oncogene sequence introduced into said mammal”.

  4. 4.

    The Jackson Laboratory, situated in Bar Harbour, Maine, USA maintains one of the world’s largest not for profit repositories of mammalian genetic resources holding over 8000 genetically modified mouse strains which it distributes in over 100 countries to academic, pharmaceutical and biotechnological researchers and corporations.

  5. 5.

    As outlined here: https://www.jax.org/research-and-faculty/research-labs# and here: https://www.jax.org/people/auro-nair#.

  6. 6.

    It is important to note that the fundamental principle established in the Diamond Vs Chakrabarty case: that the mere isolation of genes was sufficient intellectual labour to warrant patent protection was later overturned in the landmark case Association for Molecular Pathology Vs. Myriad Genetics (2013).

  7. 7.

    The OncoMouse patent was later subject to considerable contestation in European and Canadian jurisdictions on the grounds that its passage would be contrary to "ordre public" or morality. The Supreme Court of Canada rejected a patent on OncoMouse by a majority in 2002 after determining that the mouse did not constitute a “manufacture or composition of matter within the meaning of invention”. The patent has since been revoked or expired in several jurisdictions including the US and Europe.

  8. 8.

    Repository mice include inbred strains, strains and stocks carrying either induced or spontaneous mutations, strains and stocks carrying chromosomal aberrations, recombinant inbred strains, recombinant congenic strains, chromosome substitution (consomic) strains, and congenic strains (strains with selected alleles maintained on specific genetic backgrounds).

  9. 9.

    Percy Schmeiser and Schmeiser Enterprises Limited v Monsanto Canada Incorporated and Monsanto Company[2004] 1 S.C.R. 902, 2004 SCC 34 at 156. Available in full at Journal of Environmental Law (2005) 17 (1) pp. 83–108. Available at https://pdfs.semanticscholar.org/7a91/647d60ec1e97f1b66651d38d85a1611aea01.pdf.

  10. 10.

    That could be cryopreserved and later generated into whole, experimental, knockout mice.

  11. 11.

    This is another iteration of collaborative craft working.

  12. 12.

    Genetic drift describes random fluctuations in the numbers of gene variants in a population and takes place when the occurrence of variant forms of a gene, called alleles, increases and decreases by chance over time. It usually occurs in small populations, where infrequently occurring alleles face a greater chance of being lost. Once it begins, genetic drift will continue until the involved allele is either lost by a population or until it is the only allele present in a population at a particular locus. Both possibilities decrease the genetic diversity of a population.

  13. 13.

    I am indebted to Sarah Franklin for reminding me of this fact.

  14. 14.

    Genetic Drift in the Betty Crocker Brand: https://www.bettycrocker.com/menus-holidays-parties/mhplibrary/parties-and-get-togethers/vintage-betty/the-betty-crocker-portraits.

  15. 15.

    Consistency in corporate brand identity: Coca Cola https://www.independent.co.uk/news/uk/home-news/coca-cola-logo-uk-favourite-vintage-collectable-a8484206.html and Brasso https://www.hindleys.com/brasso-metal-polish.html.

  16. 16.

    The CIEA was intending to circulate the NOG under highly restrictive terms: purchasers were prohibited from breeding or cross-breeding them whilst extensive 'reach-through' rights controlled successive work done with the mice.

  17. 17.

    For a full analysis see Abbott (2009).

  18. 18.

    https://www.jax.org/news-and-insights/jax-blog/2015/march/more-researchers-are-using-b6j-mice-than-ever-before. The imperative to create the program arose from a number of important cases in which genetic drift or substrain divergence marred research experiments (See Bailey 1982; Threadgill et al. 1997; Specht and Schoepfer 2001; Stevens et al. 2007).

  19. 19.

    https://www.jax.org/jax-mice-and-services/find-and-order-jax-mice/why-jax-mice/patented-genetic-stability-program.

  20. 20.

    Einhorn (2008) Research Report to the National Institutes of Health Grant No. 5RO3 HG003766-01 Unpublished: Courtesy of the author.

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Acknowledgements

I would like to thank Gail Davies for first alerting me to the IPR issues associated with model mice and to her and Sarah Franklin for our later conversations on the topic. I would also like to thank David Einhorn for enlightening me on the legal battles that ensued over Jax’s efforts to keep their accessioned mice open source. Any errors of fact or interpretation remain my own. Additionally, I would like to sincerely thank my reviewers for their detailed and highly insightful comments on an earlier draft. Lastly I’d like to thank Sally for her patience in living with these mice in her house for so long!

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Parry, B. Patents and the challenge of ‘open source’ in an emergent biological commons or … the strange case of Betty Crocker and the mouse. BioSocieties 15, 294–315 (2020). https://doi.org/10.1057/s41292-019-00158-4

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Keywords

  • Biological commons
  • Model organisms
  • Intellectual property
  • Open source
  • Craft
  • Bioinformation
  • Trademark