Introduction

1. Introduction The Patentability of Human Genes • Is patenting human genes moral? • Should it be legal? • Should there be international intervention?

2. DNA: The Molecule Of Life

3. Patents Arguments For: Arguments Against: Impedes cumulative innovation Administering patent system results in social costs Foregone consumer surplus • Investment Protection • Innovator would be unable to recover costs • Free Rider problem • Social welfare increase

4. U.S. Patents • U.S. Law: Patents must be novel, useful, and either a process, machine, manufacture, or composition of matter • Diamond v. Chakrabarty [1980] • “anything under the sun made by man” • Patentable - Genetically altered life • Unpatentable - Laws of nature, Physical Phenomena, Abstract Ideas

5. Isolated DNA: Invention or Discovery? Invention Discovery Isolating DNA from its natural environment makes it an invention The extraction process results in changes to its molecular structure • Isolated DNA is a product of nature • Isolating DNA from the thousands of nucleotides does not give it a new utility

6. Gene Patenting over the past 30 years • Over 2,600 patents for isolated DNA have been awarded from the U.S. Patent and Trademark Office • Opponents: Societal harm has resulted from monopolistic patents that exclude research on the genome • Supporters: Patent protection induces biotech innovations

7. Myriad Genetics Case • Association for Molecular Pathology v. United States PTO [2010, 2011] • In 1997, Myriad was awarded patents covering the isolated DNA sequences BRCA 1 and 2 and associated diagnostic methods • Preempted anyone else from working with BRCA genes without permission

8. Myriad Genetics Case (cont’d) • Lawsuit by genetic researchers arguing that BRCA genes are products of nature • The District Court rejected all product and process patents in 2010 • The Federal Appeals Court reversed the decision in 2011 • Case will now be heard by Supreme Court

9. Legal Analysis • Why has the issue of utility been ignored by courts? • In the case of human genes, too much protection impedes innovation • Strive for a more legally nuanced outcome

10. Moral Analysis According to Locke, human labor gives rise to property rights only when: …it transforms or adapts something from the state of nature …there remains enough resources of the same quality for others to appropriate (strong) or …others are not made worse off by the appropriation of resources (weak)

11. Moral Analysis (cont’d) Lockean analysis would determine that isolated DNA cannot be claimed as someone’s property, since: …isolated DNA is discovered not invented …isolated DNA, when patented, does not provide others with an “equal opportunity” to utilize valuable genetic resources …isolated DNA, when patented, makes others worse off

12. International Controversy According to TRIPS: …patents apply to any invention, product and/or process that is novel, inventive and applicable to the relevant industry (Art. 27.1) …three types of inventions that can be excluded from patentability, 1. inventions contrary to morality, 2. diagnostic, therapeutic, and surgical methods for the treatment of humans or animals, and 3. plants and animals other than microorganisms (Art. 27.2, Art. 27.3a, Art 27.3b) …compulsory licensing and government use without the authorization of the patent holder are allowed under certain conditions (Art. 31)

13. 2002 TRIPS Survey • Article 27.3(b) is ambiguous, such that member nations can: …exclude gene patenting …allow gene patenting …allow for the protection of the specific use of the gene disclosed in the patent but not the gene, itself • Countries in which it is possible to patent biological material isolated from its natural environment: Bulgaria, Canada, Australia, Switzerland, Czech Republic, European Communities, Estonia, Hong Kong, Iceland, Japan, Norway, Poland, and the United States

14. Amending TRIPS to Exclude Human Genes from Patentability Arguments For: Arguments Against: Patents stimulate investment in the advancement of medical science Patents generate benefits to mankind If the patentability requirements were respected in full, human genes would be patent-ineligible • Patent holders and applicants are from developed countries • Patents prevent those in developing countries from using patented material • The patenting of human genes is unethical; it privatizes and commercializes life itself

15. Representative Nations Divided • No amendment: Reps. from Switzerland, the United States, the European Union, Japan, and Australia, and Canada • Possible amendment: Reps. from Brazil, Venezuela, Ecuador, Pakistan, Zimbabwe, Nigeria (on behalf of the African Group), and Angola (on behalf of the Least-Developed Countries Group)

16. Conclusions • Gene patents are unwarranted • Patents for genetic tests derived from working with genes such as BRCA are valid, if they meet the requirements for process patents • An amendment to TRIPS is unnecessary, since isolated DNA should be excluded from patentability based on the current TRIPS patent criteria • TRIPS council should offer specific recommendations encouraging member nations to view isolated DNA patent-ineligible