By Alison McLennan & Matthew Rimmer  
    The field of synthetic biology poses a number of    challenges for patent law.  
    With promises of improved medical treatments, greener energy    and even artificial life, the field of synthetic biology has    captured the public imagination and attracted significant    government and commercial investment.  
    This excitement reached a crescendo on 21 May 2010, when    scientists at the J Craig Venter Institute in the United States    announced that they had made a “self-replicating synthetic    bacterial cell”. This was the first living cell to have an    entirely human-made genome, which means that all of the cell’s    characteristics were controlled by a DNA sequence designed by    scientists.  
    This achievement in biological engineering was made possible by    combining molecular biotechnology, gene synthesis technology    and information technology.  
    Possibilities of synthetic biology
    In his autobiography, A Life Decoded, J. Craig Venter contends    that synthetic biology has the potential to address concerns    about energy security, climate change and sustainable    development: “My company, Synthetic Genomics Inc., is already    trying to turn an organism into a biofactory that could make    clean hydrogen fuel from sunlight and water or soak up more    carbon dioxide.”  
    He elaborated on his long-term scientific aspirations: “From    there I want to take us far from shore into unknown waters, to    a new phase of evolution, to the day when one DNA-based species    can sit down at a computer to design another.”  
    Venter maintained: “I plan to show that we understand the    software of life by creating true artificial life”.  
    Another leading researcher, Jay D. Keasling, is confident that    the field of synthetic biology can increase access to essential    medicines – particularly to provide protection against malaria.  
    However, civil society groups and technology activists have    raised concerns about the risks synthetic biology may pose to    security, public health and the environment. The ETC Group, for    instance, is concerned that organisms made with synthetic    biology (such as engineered bacteria) could be released into    the environment, with unknown effects. They’re also concerned    about potential weaponisation of synthetic biology.  
    Patentability
    There has been much controversy over the application of patent    law to emerging technologies, with large legal battles over the    patentability of information technology and business methods,    genetic testing, medical information, and stem cell research.  
    The field of synthetic biology also poses a number of    challenges for patent law and public policy. One of the most    important questions patent experts (such as Professor Graham    Dutfield) are asking is whether synthetic biology is too    different from previous biotechnologies to apply existing    objections to the patenting of living things.  
    In addition to considering patentability of synthetic biology,    patent offices and courts will have to consider the novelty,    inventiveness and utility of the claimed inventions and scope    of the claims, in light of the scientific knowledge in this    field.  
    In the United States, patent applications for synthetic biology    have fallen into two broad categories: ?1) biological tools,    methods and products.?
    2) computer programs. This includes software for design of    biological devices and programs for analysis of biochemical    activity within cells.  
    Some US patent applications have focused on the construction of    a synthetic cell. Scientists at the J Craig Venter Institute,    for example, have filed applications for patents on a minimal    bacterial genome, a synthetic genome and a method of installing    a genome into a cell.  
    Other US patent applications have involved the creation of    useful biological products from cells, such as Jay D. Keasling    and colleagues’ production of a malaria drug precursor in a    genetically modified cell.  
    There are also patent applications for various methods of    biofuel production.  
    Law reform
    US President Barack Obama’s Presidential Commission for the    Study of Bioethical Issues recommended that synthetic biology    be regulated using the principles of public beneficence,    responsible stewardship, intellectual freedom and    responsibility, democratic deliberation and justice and    fairness.  
    The Commission was, however, hopeful that synthetic biology    could “be developed in an ethically responsible manner”.  
    But intellectual property expert Arti K. Rai has concerns that,    as patent thickets have been a problem in the information    technology and biotechnology sector, this could also slow the    progress of synthetic biology research.  
    To counter this risk, some scientists and researchers have    called for the introduction of a broad defence of experimental    use, under patent law, to protect them from the threat of    patent litigation.
    The US-based group of scientists, BioBricks Foundation, already    promotes open innovation in this field and have created a space    to share their own research, right from the establishment of a    new field.  
    Sharing of information and resources in synthetic biology    research is facilitated by the Registry of Standard Biological    Parts, which is supported by a culture of sharing in the    synthetic biology community.  
    Somewhat more radically, biopunks – do-it-yourself biologists –    question the use of intellectual property rights altogether in    the field of synthetic biology. The international group of    do-it-yourself biologists, known as DIYbio, has groups in North    America, Europe and Asia, and individual members in many    countries including Australia.  
    In his book, Biopunk, Marcus Wohlsen explains that in the US    he’s observed, “An intellectual property system designed to    spur innovation by allowing inventors to profit off their    inventions has become in biopunks’ eyes a high-stakes game of    low-stakes progress.”  
    The emerging field of synthetic biology is ripe for law review    and reform, both overseas and at home in Australia. We’re    seeing a proliferation of patents in this field, with the    potential for significant impact on health, the environment and    the economy.  
    If governments are serious about the progress of biological    research, they will have to consider the implications of    patenting and licensing of synthetic biology.  
      Alison McLennan ?is a PhD candidate &      Vice-Chancellor’s Scholar at the Australian National      University, where Matthew Rimmer is an ?ARC Future Fellow and      Associate Professor in Intellectual Property. This article      was originally published at The Conversation.    
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Inventing life: patent law and synthetic biology