Diagnostic Kits/Page for Joint Creation of Blog Post: Difference between revisions

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*Introduction
*Introduction
**The field of Biotechnology including Genomics and Proteomics is a critical US industry.  The emerging research in the genetic diagnostic kits presents unique challenges in intellectual property (IP). Changes in laboratory research due to actual or anticipated patent or license enforcement could signal the failure of intellectual property to spur the innovation these protection are intended to promote.  It is these issues that are at the centre of our research under the Industrial Cooperation Project at the Berkman Centre at Harvard University. This research is part of a broader project being led by Prof. Yochai Benkler. In the research, we are seeking to understand the approaches to innovation with genetic diagnostic kits looking specifically at the complexities that act as a barriers to use and innovation.  
**The field of Biotechnology including Genomics and Proteomics is a critical US industry.  The emerging research in the genetic diagnostic kits presents unique challenges in intellectual property (IP). Changes in laboratory research due to actual or anticipated patent or license enforcement could signal the failure of intellectual property to spur the innovation these protections are intended to promote.  It is these issues that are at the centre of our research under the Industrial Cooperation Project at the Berkman Centre at Harvard University. This research is part of a broader project being led by Prof. Yochai Benkler. In the research, we are seeking to understand the approaches to innovation with genetic diagnostic kits looking specifically at barriers to use and innovation.  




*2 paragraphs on what we are doing (Mac)
*2 paragraphs on what we are doing (Mac)
*2 paragraphs on case law (Andrew)
*2 paragraphs on case law (Andrew)
**The most important protections of genetic diagnostic kits are trade secret and patents.  While trade secret has a large role, studying it is difficult because most of the information is not public.  Patents are public information and have been the focus of our current research.  The gene-disease associations that researchers study can be developed into a genetic tests and these tests are often covered by patents. 
*Caselaw
**“key issue for patentability” is “whether a claim is drawn to a fundamental principle or an application of a fundamental principle.” Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 2008-1403, slip op. at 8 (Fed. Cir. Sept. 16, 2009). [[http://jolt.law.harvard.edu/digest/patent/prometheus-labs-inc-v-mayo-collaborative-servs]]
**“key issue for patentability” is “whether a claim is drawn to a fundamental principle or an application of a fundamental principle.” Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 2008-1403, slip op. at 8 (Fed. Cir. Sept. 16, 2009). [[http://jolt.law.harvard.edu/digest/patent/prometheus-labs-inc-v-mayo-collaborative-servs]]
**Under the Bilski test, a claimed process is directed to patentable subject matter if (1) “it is tied to a particular machine or apparatus,” or (2) “it transforms a particular article into a different state or thing.” Id. at 953. Furthermore, under the Bilski “machine or transformation” test, “the use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope to impart patent-eligibility,” and “the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity.” Id. at 961-62. [[http://jolt.law.harvard.edu/digest/patent/prometheus-labs-inc-v-mayo-collaborative-servs]]
**Under the Bilski test, a claimed process is directed to patentable subject matter if (1) “it is tied to a particular machine or apparatus,” or (2) “it transforms a particular article into a different state or thing.” Id. at 953. Furthermore, under the Bilski “machine or transformation” test, “the use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope to impart patent-eligibility,” and “the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity.” Id. at 961-62. [[http://jolt.law.harvard.edu/digest/patent/prometheus-labs-inc-v-mayo-collaborative-servs]]

Revision as of 15:55, 15 October 2009

Blog Post

  • Introduction
    • The field of Biotechnology including Genomics and Proteomics is a critical US industry. The emerging research in the genetic diagnostic kits presents unique challenges in intellectual property (IP). Changes in laboratory research due to actual or anticipated patent or license enforcement could signal the failure of intellectual property to spur the innovation these protections are intended to promote. It is these issues that are at the centre of our research under the Industrial Cooperation Project at the Berkman Centre at Harvard University. This research is part of a broader project being led by Prof. Yochai Benkler. In the research, we are seeking to understand the approaches to innovation with genetic diagnostic kits looking specifically at barriers to use and innovation.


  • 2 paragraphs on what we are doing (Mac)
  • 2 paragraphs on case law (Andrew)
    • The most important protections of genetic diagnostic kits are trade secret and patents. While trade secret has a large role, studying it is difficult because most of the information is not public. Patents are public information and have been the focus of our current research. The gene-disease associations that researchers study can be developed into a genetic tests and these tests are often covered by patents.
  • Caselaw
    • “key issue for patentability” is “whether a claim is drawn to a fundamental principle or an application of a fundamental principle.” Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 2008-1403, slip op. at 8 (Fed. Cir. Sept. 16, 2009). [[1]]
    • Under the Bilski test, a claimed process is directed to patentable subject matter if (1) “it is tied to a particular machine or apparatus,” or (2) “it transforms a particular article into a different state or thing.” Id. at 953. Furthermore, under the Bilski “machine or transformation” test, “the use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope to impart patent-eligibility,” and “the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity.” Id. at 961-62. [[2]]
    • a subsequent mental step in the process does not undermine the transformative nature of the prior steps. Id. at 20. [[3]]
  • 1 paragraph with links to Richard Nelson's work

Check https://cbr-diagnostics.etherpad.com/1 for current progress & collab editing