Intellectual Property & Contemporary Issues of Biotechnology Law Supreme Court Bar Association Presentation Kathmandu, Nepal December 23, 2016 Ramesh Karky, SJD, LL M

Photo: Breakthrough Breast Cancer Image of the BRCA gene (above) Photo: Breakthrough Breast Cancer Image of the BRCA gene (above). In the case involving Association for Molecular Pathology v Myriad Genetics the US Supreme Court addressed the issue of whether isolated human genes are patentable. In a unanimous decision, the nine presiding justices ruled that naturally isolated DNA is not patentable but that synthetic DNA, such as cDNA, is patentable. See www.wipo.org

Future areas of importance: 1. Internet 2. Outer space 3. Biotechnology

General Introduction to Biotechnology Law Definition of biotechnology: “Invention which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.” (Implementing Regulation rule 23c + art. 32 of the EU Dir.) What is biotechnology law? - Different jurisdictions have been using patent law, seed law, plant protection law, pesticide law, food and safety law, environment law and other as biotechnological law. - Gene is the central part of biotechnology law.

Biotechnology Law in Different Jurisdictions In the US The Coordinated Framework for Regulation of Biotechnology (CFR) of 1986: - No need of new specific biotechnology law - Existing laws had adequate bases. In Canada The Federal Regulatory Framework for Biotechnology (1993) - Use existing laws and regulations

Biotechnology Law in Different Jurisdictions In the EU EU Biotech legislation: - EU legislation has been in place since the early 1990’s. - Genetic modification technology is strictly regulated. In Japan - No specific law In Australia - Specific biotechnology law

Biological Sequences - Until 1950s, biotechnological inventions were not covered by patent. - Now patenting of living organisms is one of the major components. - No uniformity of regulations on patenting of living organisms.

Patentability of Biological Sequences in the US - Invention: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.” (US Patent Act s. 101) - Diamond v. Chakrabarty case (1980) - USPTO (the United States Patent and Trademark Office) has been granting patents over microorganisms such as DNA sequences for almost 30 yrs. - Myriad case (2013) Isolated DNA as such is a discovery, not a patentable subject mater.

Patentability of Biological Sequences in Canada - Invention: “Any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.” (Canadian Patent Act s. 2) - Harvard College v. Canada (Commissioner of Patents) (2002) Higher life-forms were not patentable while cells and genes were patentable.

Patentability of Biological Sequences in the EU - EPC (European Patent Convention) (1973): No provision of biotechnology at first. - The Directive on the Legal Protection of Biotechnological Inventions (1998). - The Directive excludes human genetic material and plant varieties from patentability.

Patentability of Biological Sequences in the EU European patents shall not be granted to the following subject matters: (a)  processes for cloning human beings; (b)  processes for modifying the germ line genetic identity of human beings; (c)  uses of human embryos for industrial or commercial purposes; (d)  processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. Exclusion and exception from patentability: Contrary to “ordre public” or morality; and plant or animal varieties or essential biological processes (except microbiological process or products).

Patentability of Biological Sequences in Japan Invention: “Invention in this law means a highly advanced creation of technical ideas utilizing a law of nature.” (Article 2(1) of the Japanese Patent Law) Exclusion - Methods of treating the human body by surgery, therapy or diagnostic methods practiced on the human body - Provision of public order and moral Has been granting patent to DNA and biotechnological inventions.  

Patentability of Biological Sequences in Australia Patents Act 1990 (Cth), definition of invention: “Any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention.” - Genes are patentable. – Exclusion of inventions involving “human beings, and the biological processes for their generation.” Invention the “use of which would be contrary to law.

Application of Bioinformatics Bioinformatics can be used in various fields, i. e., molecular medicine, personalized medicine, preventive medicine, gene therapy, drug development, crop improvement, insect resistance, improve nutritional quality, and many other. (Bioinformatics – Applications Areas, Bioinformatics Resource Portal Available at http://bioinformaticstools.webs.com/application.htm)   “Every disease has a genetic component. … we can search for the genes directly associated with different diseases and begin to understand the molecular basis of these diseases more clearly. This …will enable better treatments, cures and even preventative tests to be developed.” (Bioinformatics – Applications Areas, Bioinformatics Resource Portal Available at http://bioinformaticstools.webs.com/application.htm)

Application of Bioinformatics, continue “The potential for using genes themselves to treat disease may become a reality. Gene therapy is the approach used to treat, cure or even prevent disease by changing the expression of a persons’ genes.” (Bioinformatics – Applications Areas, Bioinformatics Resource Portal Available at http://bioinformaticstools.webs.com/application.htm)   “The arrival of the complete genome sequences and their potential to provide a greater insight into the microbial world and its capacities could have broad and far reaching implications for environment, health, energy and industrial applications.” Available at http://bioinformaticstools.webs.com/application.htm Jan. 16, 2014)

The National Institute of Genetics Supercomputer system The ten petaFLOP K machine This is actually Riken’s supercompter --- from CNN in 2012 “The machine, installed at the RIKEN Advanced Institute for Computational Science, in Kobe, Japan, currently operates at over 10 petaFLOPS. It is more than four times faster than its nearest rival, China's NUDT YH MPP computer (2.57 petaflops).” “… Supercomputing System Services comprising leading-edge, large-scale cluster-type computers, large-scale memory-sharing computers, and high-capacity, high-speed disk devices.” High performance and distributed computing, will revolutionise genetics in the coming years

Biological Sequences -Issue of patenting Sequence Database -Lack of Law? Software -Issue of Open Source

QUESTIONS? ……………………………… Thank you Ramesh Karky, SJD, LL M