Seminar

1. Seminar • Law & Technology CentreCentre for Medical Ethics & Law The University of Hong KongBiomedical Technologies and Intellectual Property: Human Genes as Exclusive Corporate Assets?Professor Alexandre Dias PereiraFaculty of Law, University of Coimbra, Portugal December 1, 2011 (Thursday), 1:00 – 2:00 pmRoom 106, KKLG1 Floor, KK Leung Building, HKU

2. Abstract Biotechnology offers relevant applications in the medical sector. In particular, genetic engineering provides new methods of diagnosis and therapeutic processes which are very important notably for preventing and fighting cancer. At the same time, biomedical technologies are at the core of important economic activities, generally known as biotech industries, which require high-risk investment in R&D activities. Corporations claim intellectual property protection for their biotechnological assets against free-riders and pirates. However, gene patenting is a sensitive issue, not only in what concerns the distinction between inventions and ‘products of nature’, but also concerning the issues of public morality and ordre public involved. This talk discusses some of these issues and provides an analysis of the relevant legal framework in the European Union

3. Biotech Medical Patents • Myriad Genetics’ patents on diagnosis methods of breast and ovarian cancers • BRCA1 and BRCA2 • DNA repairing function • ‘Products of nature’ or human inventions?

4. Biotech Medical Patents • US District Court, March 29 2010, Judge Robert W. Sweet, • ‘DNA, in particular the ordering of its nucleotides, therefore serves as the physical embodiment of laws of nature - those that define the construction of the human body (…) …the challenged composition claims are directed to unpatentable products of nature’

5. Biotech Medical Patents • On July 29, 2011 the United States Court of Appeals for the Federal Circuit ruled that Myriads patents are valid, holding that isolated DNA molecules are eligible for patent protection • In Diamond v. Chakrabarty (1980) the U.S. Supreme Court had declared valid a patent on a newly-created living organism, a bacterium for digesting crude oil in oil spills

6. Biotech Medical Patents • Fiction or Reality? • Huxley’s Brave New World • Lee and Kirby’s X-MEN: the ‘X-gene’ • Cracking the source-code of living organisms and paving the way to bioengineering • Correcting errors/defects of natural evolution • Modifying existing species and crossing them • Creating new species and giving new life to extinct ones

7. Biotech Medical Patents • Biotech industries – introducing new health products into the market which meet potential consumer demand • High-risk investment in R&D activities – the free-rider’s dilemma • Intellectual property for biotechnological assets

8. Biotech Medical Patents • Patents as driving engines of the innovation economy and the enhancement of health technologies • Gene patenting as a sensitive issue • inventions and ‘products of nature’ • public morality and ordre public

9. Biotech Medical Patents • The Venetian Patent Decree of 1474 • The Paris Convention for the Protection of Industrial Property (1883), as revised by the Stockholm Act (1967) • The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS 1994) • patent protection for products as well as for processes in all areas of technology (neutrality)

10. Biotech Medical Patents • Are patents ‘old bottles’ for the ‘new wine’ of biotechnology? • Fixing market failures through patents and social health care • Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions

11. Biotech Medical Patents • The Convention on Human Rights and Biomedicine (1997) • the primacy of the human being over the sole interest of society or science (Art. 2), notwithstanding... • Predictive genetic tests may be performed only for health purposes or for scientific research linked to health purposes (Art. 12)

12. Biotech Medical Patents The Convention on Human Rights and Biomedicine (1997) - Modification of the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its purpose is not to introduce any modification in the genome of any descendants (Art. 13) • Prohibition of financial gain and disposal of a part of the human body, as such (Art. 21). See also Additional Protocols

13. Biotech Medical Patents • EU Directive 98/44 • the legal protection of biotechnological inventions as a tool of European industrial policy • biotechnological inventions, either as products or as processes, are to be protected under national patent law, provided they meet the requirements of novelty, inventive step, and industrial application

14. Biotech Medical Patents • Biological material, including gene sequences, isolated from its natural environment or produced by means of a technical process is expressly eligible for patent protection (see Myriad patents on methods to isolate BRCA1 and BRCA2) despite… • … patentability of processes for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced in the human or animal body as a matter of national law

15. Biotech Medical Patents • Exclusion of some elements from patentability as mere discoveries per se, such as plant and animal varieties and essentially biological processes for the production of plants or animals (1) and the human body or one of its elements (2). • This exclusion does not cover elements isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene.

16. Biotech Medical Patents • Disclosure of the DNA sequence function to assess industrial application • Concerning biological material of human origin, the person from whose body the material is taken must have the opportunity to express his free and informed consent thereto • Genetic information as personal data and also as sui generis IP right?

17. Biotech Medical Patents • The prevalence of ethical or moral principles over economic interests excluding the patentability of inventions the commercial exploitation of which is contrary to ordre public or morality . • Catalogue of examples, • absolute exclusion • relative exclusion

18. Biotech Medical Patents Absolute exclusion (dark inventions) - processes to produce chimeras from germ cells or totipotent cells of humans and animals, • processes for modifying the germ line genetic identity of human beings • processes for cloning human beings Relative exclusion (grey inventions) • uses of human embryos for industrial or commercial purposes (see ECJ Brüstle) • processes for modifying the genetic identity of animals

19. Biotech Medical Patents • Use of human embryos • Directive 98\44 excludes from patentability uses of human embryos for industrial or commercial purposes, with the exception of inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it (Recital 42). • What is an human embryo? Can human embryos be used for therapeutic or diagnostic purposes of other embryos?

20. Biotech Medical Patents • ECJ Judgment of 18 October 2011 in Case C‑34/10, a reference for a preliminary ruling from the German Supreme Court of Justice (Bundesgerichtshof) concerning the interpretation of Article 6(2)(c) of Directive 98/44/EC • Proceedings seeking annulment of the German patent held by Mr Brüstle, which relates to neural precursor cells and the processes for their production from embryonic stem cells and their use for therapeutic purposes.

21. Biotech Medical Patents • 1 - Article 6(2)(c) of Directive 98/44/EC ‘must be interpreted as meaning that: • any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’; • it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’.

22. Biotech Medical Patents • 2 - ‘The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable.’

23. Biotech Medical Patents • 3 - Patentability is excluded where the uses for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it require ‘the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.’

24. Biotech Medical Patents • Scope of protection – multiplication and derivatives • Use of patented self-reproducing material • Material incorporating patented genetic information • Exhaustion of the right of propagation or multiplication • Compulsory cross/licensing of patents for genetically modified plants

25. Biotech Medical Patents • Thanks for your attention! • Questions, please! • E-mail: alexis@fd.uc.pt • http://www.uc.pt/en/fduc