Biotechnology scientists must be aware of the broad patent  landscape and push for new patent and licensing guidelines,  according to a new paper from Rice University's Baker Institute  for Public Policy.
    Published in the current issue of the journal Regenerative    Medicine, the paper is based on the June 2013 U.S. Supreme    Court ruling in the case Association for Molecular Pathology    (AMP) v. Myriad Genetics that naturally occurring genes are    unpatentable. The court case and rulings garnered discussion in    the public about patenting biological materials.  
    "The AMP v. Myriad Genetics case raises questions about the    patent system," said Kirstin Matthews, the Baker Institute    fellow in science and technology policy and an expert on    ethical and policy issues related to biomedical research and    development. She co-authored the paper with Maude Rowland    Cuchiara, the Baker Institute scholar for science and    technology policy. The paper has timely significance in light    of President Barack Obama's recent announcements on reforming    the nation's patent process, including an initiative announced    in February to "crowdsource" the review of patents.  
    "There are not many opportunities to challenge patents once    they have been granted, and the options that are available are    costly and mostly limited to lawsuits," Matthews said. Judges    typically do not have the scientific knowledge to understand    some of the technical arguments that are made in their courts,    she said. "It may be better, as President Obama has proposed,    to revise patenting guidelines at the U.S. Patent and Trademark    Office based on feedback from scientists, engineers, ethicists    and policy scholars as opposed to leaving it up to the courts."  
    Until the Supreme Court's decision, Myriad Genetics was the    only company in the U.S. that could legally conduct diagnostic    testing for BRCA 1 and 2, genes that are linked to familial    breast and ovarian cancer. The company was granted the patents    in 1998 and 2000, respectively. Myriad chose not to license the    patents and harshly pursued anyone who infringed on them.  
    "The patenting of the BRCA genes launched a raucous debate    about the ability to patent life: How do we distinguish between    what is simply discovered and what is truly 'made by man'?" the    authors asked.  
    Biotechnological inventions have been patented for several    decades, though the criteria for patent eligibility have been    refined through numerous court decisions, according to the    authors. One of the most influential was Diamond v.    Chakrabarty, which determined that "anything under the sun made    by man" could be patented, leading to the diverse biotechnology    patent landscape seen today, the authors said. However,    biotechnological patents must meet the same requirements as all    other patents, and they cannot be laws of nature, physical    phenomena or abstract ideas.  
    The authors said the ruling could affect the patentability of    other biotechnologies, like stem cells, depending on how the    ruling is interpreted. Stem cells, like genes, are also    isolated from the body although they do require some    manipulation after isolation. But it is likely that if stem    cell patents include detailed procedures for the manipulations    beyond isolation, they will be upheld. "However these types of    patents could also be challenged for failing to meet other    patenting requirements like non-obviousness -- meaning that    they were not really unique or original after all," the authors    said.  
    Overall, it remains to be seen what impact the ruling in the    AMP v. Myriad Genetics case will have on the biotech industry    or if any patenting requirements will be changed in response to    this or other court rulings, the authors said. So far, the    patentability of biotechnological inventions appears to remain    unaffected. "However, as more and more biotechnological    inventions are patented, the line between what is and is not a    'product of nature' becomes blurred and will most likely    continue to be decided in a courtroom," the authors said.  
    The authors suggest initial steps to address the current    situation, including an outside review of patents before they    are granted, reforming the rules of patent licensing to    minimize restrictive practices and requiring detailed patent    descriptions to prevent expensive and disruptive lawsuits.  
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New patenting guidelines needed for biotechnology, experts argue