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Challenges and Opportunities at the Interface of Synthetic Biology, Microbiology, and Intellectual Property Rights

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Abstract

During the last decade, the genomics revolution has created powerful instruments for genetic manipulation of living organisms. In addition, new biotechnological tools allow modifying organisms in order to perform specific tasks. In particular, synthetic biology is a fast-developing and transdisciplinary field that uses engineering principles to design and assemble novel biological components. For example, within the area of industrial microbiology, synthetic biology has contributed to build from scratch or reengineer new microorganisms or chemical compounds. However, all these scientific and biotechnological innovations present a substantial challenge also for the law and especially for intellectual property rights. Considering this multifaceted scenario, this chapter discusses the current challenges and opportunities at the intersection of synthetic biology, microbiology, and intellectual property also reflecting on alternative forms of protection for genetically engineered works created by using synthetic biology.

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Notes

  1. 1.

    Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).

  2. 2.

    Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).

  3. 3.

    Diamond v. Chakrabarty, 447 US 303 (1980). In this landmark decision, the US Supreme Court held that a live and human-engineered microorganism can be considered a patentable subject matter under Section 1010 of the US Patent Act. According to the rule of this decision, patents can be issued on “anything under the sun that is made by man.” For a review of the case, see Eisemberg 2006.

  4. 4.

    Moore v. Regents of the University of California, 793 P.2d 479 (Cal. S. Ct) (1990).

  5. 5.

    See Amgen, Inc. v. Chugai Pharm. Co., 13 US P.Q.2d (BNA) 1737, 1759 (D. Mass. 1989).

  6. 6.

    See, e.g., judgment of the Court of Justice of the European Union in Oliver Brüstle v Greenpeace eV (C-34/10) [2012] 1 C.M.L.R. 41.

  7. 7.

    See Lab. Corp. of America Holdings v. Metabolite Labs., Inc., 548 US 124, 126, 79 US P.Q.2d (BNA) 1065, 1066 (2006) (per curiam) (Breyer, J., dissenting) (quoting US Const. art. I, § 8, cl. 8).

  8. 8.

    See Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, art. 27, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 33 I.L.M. 1125 (1994) [hereinafter TRIPS]. On this point, see also Gibson 2008: 1,3.

  9. 9.

    Council Directive 98/44/EC, art. 5(2), 1998 O.J. (L 213) 13 (EC).

  10. 10.

    Id., at art. 3(2).

  11. 11.

    Convention on the Grant of European Patents, art. 53(c), Oct. 5, 1973, 13 I.L.M. 270 [hereinafter EPC]. The EPC provides a uniform method and standard for examining a European patent application but reserves to members of the European Union the task of interpreting and enforcing a patent: “under the EPC, the EPO grants European patents for one or more of the contracting parties to the EPC. However, a European patent is not a uniform patent. Rather it consists of a bundle of parallel national patents granted as a result of a centralized grant by the EPO.”

  12. 12.

    See decision T 964/99 (OJ EPO 2002, 4), starting from the interpretation set out in decision T 385/86 and decision T 964/99.

  13. 13.

    Rule 26(1) of October 5, 1973, as adopted by decision of the Administrative Council of the European Patent Organisation of December 7, 2006, and as last amended by decision of the Administrative Council of the European Patent Organisation of October 26, 2010 [hereinafter Implementing Regulations]. The rules cited are to the earlier version. On the point, see Macchia 2011: 37.

  14. 14.

    Implementing Regulations, Rule 27(a).

  15. 15.

    See, e.g., Bement v. Nat’l Harrow Co., 186 US 70, 90–92 (1902) (“The general rule is absolute freedom in the use or sale of rights under the patent laws of the USA”).

  16. 16.

    In the USA, an intellectual property rights holder has no obligation to either use or license its property rights. On the point, see Hovenkamp et al. 2006: 13.

  17. 17.

    Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).

  18. 18.

    Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).

  19. 19.

    See Article 2 (1) of the Berne Convention for the Protection of Literary and Artistic Works, Sept. 9, 1886, as revised at Paris on July 24, 1971, and amended in 1979, S. Treaty Doc. No. 99–27 (1986) ([hereinafter “Berne Convention”).

  20. 20.

    17 US C § 101.

  21. 21.

    Here the term includes genetic materials and gene fragments, such as expressed sequence tags (ESTs) and single nucleotide polymorphisms (SNPs).

  22. 22.

    Diamond v Chakrabarty 447 US 303 (1980).

  23. 23.

    DecisionT19/90-3.3.2, 1990 O.J. Eur. Pat. Off. 476.

  24. 24.

    See Office of Technology Assessment, US Congress, Publ’n No. OTA-BA-370, New Developments in Biotechnology: Patenting Life – Special Report 43 (1989) (reporting the Copyright Office’s unofficial position that nucleic acid sequences are not copyrightable). More recently, the USPTO has explicitly rejected a copyright claim in a genetic engineering modified fish that an applicant had genetically altered so that the fish “fluoresces” when it is exposed to artificial light; see US Copyright Office, Re: GloFish Red Zebra Danio Glowing in Artificial Sunlight (5 September 2013) available at http://ipmall.law.unh.edu/sites/default/files/hosted_resources/CopyrightAppeals/2013/GloFishRedZebraDanioGlowing.pdf (cited in Samuelson, 2016).

  25. 25.

    Austl. L. Reform Comm’n (ALRC), Genes and Ingenuity: Gene Patenting, and Human Health, ALRC Report 99 (Aug. 2004), § 28, available at https://www.alrc.gov.au/publications/report-99

  26. 26.

    Id. at 28.21.

  27. 27.

    See complaint at 19, 22–25, Ass’n for Molecular Pathology v. US Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (No. 09 Civ. 4515).

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  1. Accounting & Law Department, Jönköping University International Business School, Jönköping, Sweden

    Nicola Lucchi

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  1. Department of Mycology and Plant Pathology, Institute of Agricultural Sciences Banaras Hindu University, Varanasi, Uttar Pradesh, India

    Harikesh Bahadur Singh

  2. Department of Biochemistry, Institute of Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India

    Chetan Keswani

  3. Department of Biochemistry, Institute of Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India

    Surya Pratap Singh

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Lucchi, N. (2019). Challenges and Opportunities at the Interface of Synthetic Biology, Microbiology, and Intellectual Property Rights. In: Singh, H., Keswani, C., Singh, S. (eds) Intellectual Property Issues in Microbiology. Springer, Singapore. https://doi.org/10.1007/978-981-13-7466-1_2

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