Diagnostic Kits/Page for Joint Creation of Blog Post

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 legal 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 they have been the focus of our current research. The gene-disease associations that researchers study can be developed into a genetic diagnostic kit and these tests are often covered by patents. Our research aims to discover the role patents play in genetic diagnostic kit development and commercialization. The Bilski case “machine-or-transformation” test provides patent protection for genetic diagnostic kits machine or transformation used in the claimed process is "not merely be insignificant extra-solution activity." In re Bilski, 545 F.3d 943, 962 (Fed. Cir. 2008) (en banc), cert. granted, 129 S. Ct. 2735 (2009).

A key issue for patentability in this area 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]]

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