Abstract
Patents on biotech products have a scope that goes well beyond what is covered by the most widely applied ethical justifications of intellectual property. Neither natural rights theory from Locke, nor public interest theory of IP rights justifies the wide scope of legal protection. The article takes human genes as an example, focusing on the component that is not invented but persists as unaltered gene information even in the synthetically produced complementary DNA, the cDNA. It is argued that patent on cDNA holds this information captive, or illegitimately appropriates it in limiting other researchers and inventors’ opportunity to explore new functions and uses based on this non-invented information. A tighter connection between legal IP protection and the use description stated in the patent claim is suggested. By binding protection to the product’s foreseeable functions and use, instead of the product itself and all future uses of it, legitimacy of biotech product patents is restored.
Similar content being viewed by others
Notes
This is how they are stated in World Trade Organization’s Agreement on Trade Related Aspects of Intellectual Property Rights - TRIPS, Art. 27. See WTO TRIPS, Art. 27:1.
They are non-rivalrous in the sense that one person’s use of them does not negatively affect other persons’ availability of the same good.
They appear to separate between product patents and use patents, implying, misleadingly, that the inventor can choose between applying for product patent or use patent. The product patent in fact gives exclusive rights to make, sell or indeed use the invention. The use privilege is common to product patents and process patents, often therefore referred to by the common legal term utility patent. See USPTO (2013).
Reference and quote borrowed from Sagoff (2002): Monsanto Co. v. Rohm and Haas Co. 312 F.Supp.778, 790 (E.D. Pa. 1970), aff’d 456 F.2nd 592 (3rd Cir), cert. Denied 407 U.S. 934 (1972). According to Sagoff the quote expresses an attitude that is no longer prevailing after, as he notes, patents have been issued for DNA, protein, and various cell lines through a “sea change in patent policy” (p. 424).
One can question to what extent the public already possesses this content as a valid argument against allowing patents. It is probably more relevant to point to the lack of inventiveness and utility in merely isolating DNA.
German patent law is however a notable exception. I shall therefore present its purpose-bound patent protection of human DNA below.
See also Rebecca S. Eisenbergs discussion of this particular development in Eisenberg 2002.
Deutscher Bundestag 2003 from the Chapter 3. «Reichweite des Stoffschutzes und ethische Grenzen». This translation and the ones which follow from this chapter are mine unless otherwise indicated.
Translation borrowed from Kilger et al. op. cit.
Mark Sagoff, accurately I believe, observes that the right holders themselves share the utilitarian justification for the patent system: “Industry leaders [..] regard patent policy as serving an entirely utilitarian or economic purpose that has nothing to do with natural property rights”. See Sagoff (2002), p. 421. A look at IP rights intensive corporations’, like pharmaceutical companies, websites will confirm this.
This text is of course written before the Myriad case conclusion.
References
Brody, B. 2006. Intellectual property and biotechnology: the U.S. internal experience-part II. Kennedy Institute of Ethics Journal 16: 2.
Bundesministerium der Justiz und für Verbraucherschutz 2013. Patent Act. http://www.gesetze-im-internet.de/patg/. Accessed 13 Mar 2015.
Deutscher Bundestag 2003. Drucksache 15/1709. Entwurf eines Gesetzes zur Umsetzung der Richtlinie über den rechtlichen Schutz biotechnologischer Erfindungen. http://dip21.bundestag.de/dip21/btd/15/017/1501709.pdf. Accessed 5 Mar 2015.
Doll, J.J. 1998. The patenting of DNA. Science 280(5364): 689–690. http://www.sciencemag.org/content/280/5364/689.full. Accessed 6 Mar 2015.
Drahos, P. 1996. A philosophy of intellectual property. Farnham: Ashgate.
Eisenberg, R.S. 2002. How can you patent genes? In Who Owns Life? eds. D. Magnus, A. Caplan and G. McGee, 117–134. Amherst: Prometheus Books.
EU directive 98/44/EC. Directive on the legal protection of biotechnological inventions. July 6, 1998. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0044&from=EN. Accessed 16 Oct 2014.
Federal Register. 2001. Vol. 66, No. 4/Friday, January 5, Notices.
Finnie, I. and M. Liberto 2014. USPTO guidance for examiners takes expansive view of myriad and prometheus decisions. Global IP Matters. http://www.globalipmatters.com/2014/03/07/uspto-guidance-for-examiners-takes-expansive-view-of-myriad-and-prometheus-decisions. Accessed 16 Oct 2014.
Haag, T., and Kilger, C. 2013. Myriad ruling versus biotech patent eligibility in Europe. Law360, June 21. http://www.law360.com/articles/451636/myriad-ruling-vs-biotech-patent-eligibility-in-europe. Accessed 16 Oct 2014.
Kilger, C.; Feldges, J., and Jaenichen, H.R. 2005. The erosion of compound protection in Germany: implementation of the EU Directive on the legal protection of biotechnological inventions—the German way. Journal of the Patent and Trademark Office Society July 2005. http://www.fh-k.com/wp-content/uploads/2014/09/20.pdf. Accessed 16 Oct 2014.
Locke, J. 1690. Second treatise of government. Indianapolis: Hackett Publishing.
Macer, D.R.J. 2002. The Pharmacogenomics Journal 2: 361–366. http://www.nature.com/tpj/journal/v2/n6/full/6500140a.html. Accessed 13 Oct 2014.
Monsanto Co. V. Rohm and Haas Co. 1970. 312 F.Supp. 778 (1970). United States District Court, E. D. Pennsylvania.
Nozick, R. 1974. Anarchy state and utopia. New York: Basic Books.
Nuffield Council on Bioethics. 2002. The ethics of patenting DNA. A discussion paper. London: Nuffield Council of Bioethics.
Parry, B. 2005. From the corporeal to the informational: exploring the scope of benefit sharing agreements and their applicability to sequence databases. In Bioethics in a Small World, eds. F. Thiele and R.E Ashcroft, 73–91. Berlin: Springer.
Resnik, D.B. 2001. DNA patents and scientific discovery and innovation: assessing benefits and risks. Science and Engineering Ethics 7: 29–62.
Resnik, D.B. 2002. Discoveries, inventions and gene patents. In Who Owns Life? eds. D. Magnus, A. Caplan, and G. McGee, 135–159. Amherst: Prometheus Books.
Resnik, D.B. 2004. Owning the genome. A moral analysis of DNA patenting. Albany: State University of New York Press.
Ropp, A., and Taubman, T. 2006. Bioethics and patent law: the case of myriad. WIPO Magazine, Issue 4, August. http://www.wipo.int/wipo_magazine/en/2006/04/article_0003.html. Accessed 15 Oct 2014.
Sagoff, M. 2002. Are genes inventions? An ethical analysis of gene patents. In A Companion to Genethics. eds. J. Burley, and J. Harris, 420–437. Oxford: Blackwell.
Sherkow, J. 2013. A closer look at Supreme Court’s decision on gene patenting. Stanford Medicine. http://scopeblog.stanford.edu/author/jsherkow/. Accessed 27 Mar 2014.
The European Patent Convention Part II, Art. 52 (1). http://documents.epo.org/projects/babylon/eponet.nsf/0/00E0CD7FD461C0D5C1257C060050C376/$File/EPC_15th_edition_2013.pdf. Accessed 6 Jan 2014.
U.S. Code §101-3. http://www.gpo.gov/fdsys/granule/USCODE-2011-title35/USCODE-2011-title35-partII-chap10-sec101/content-detail.html. Accessed 13 Mar 2014.
US Supreme Court No. 12-398. Association for Molecular Pathology et al. Petitioners v. Myriad Genetics. Inc., et al. June 13, 2013.
USPTO. 2013. Types of patents. Alexandria, VA: US Patent and Trademark Office.
Westerlund, L. 2002. Biotech patents. Equivalence and exclusions under European and U.S. patent law. New York: Kluwer Law International.
Wilson, J. 2002. Patenting organisms. In Who Owns Life? eds. D. Magnus, A. Caplan and G. McGee, 25–58. New York: Prometheus Books.
WTO TRIPS. Agreement on trade-related aspects of intellectual property rights. http://www.wto.org/english/docs_e/legal_e/27-trips.pdf. Accessed 1 April 2014.
Acknowledgments
Ronny Selbæk Myhre and Bjørn Myskja are attendants at my abstract presentation at the 12th World Congress of Bioethics in 2014; the audience, and particularly Erik Christensen, at the 2014 conference sponsored by The Research Council of Norway. The Normative Dimensions of New Technologies was hosted by Norwegian University of Science and Technology (NTNU); the Workshop for Practical Philosopy -VERP- at NTNU, in particular Per-Erling Movik and Morten Dahlback.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Andreassen, T. Ethical reasons for narrowing the scope of biotech patents. Med Health Care and Philos 18, 463–473 (2015). https://doi.org/10.1007/s11019-015-9647-4
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11019-015-9647-4