Diagnostic Kits/Page for Joint Creation of Blog Post

Blog Post

• Introduction to Our Research
  • 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 the field and our focus (Mac)
• Relevent Caselaw
  • The most important legal protections of genetic diagnostic kits are trade secret and patents. While trade secret plays 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 if the machine or transformation used in the claimed process would "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). The recent Prometheus Labs case investigate the bounds of the Bilski case by looking specifically at a transformation that takes place within the human body. Prometheus Labs., Inc. v. Mayo Collaborative Servs., No. 2008-1403, slip op. at 8 (Fed. Cir. Sept. 16, 2009).[[1]] This broad interpretation of a transformation has important implications about the scope of protection that genetic diagnostic kits will receive. The finality of this analysis will be determined when the Supreme Court reviews Bilski.
• Influential Discussions
  • An influential discussion regarding the concerns about affects of patents and licensing on diagnostic test has been the article titled Diagnostic testing fails the test: The pitfalls of patents are illustrated by the case of hemochromatosis published in Nature in 2002. The primary concerns highlighted by this study were the possible delays in publication and the affect on cost and availability of clinical diagnostic testing.
• The Role of Universities
  • Research universities are active in DNA patenting and licensing so technology transfer is central to how important developments in diagnostic tests are licensed. Patenting or research is encouraged by the Bayh-Dole Act which deals specifically with federal government-funded research but has more widely effected the patenting procedure of all university research. If a university elects to hold title to the federally funded invention it is obligated to patent and attempt to commercialize the invention. A theoretical limit on this a set of "march in rights" held by the funding agency which would allow it to grant further licenses but this right is constrained by a necessity analysis under the statute and until now the rights have only been requested or threatened but never used.

Licensing

1. The National Institutes of Health is a major source of resource biomedical funding.
2. The funding power held by the National Institutes of Health has allowed it to create "guidelines for grantee institutions about how to license biomedical research resources arising from federally funded research." (Pressman, L. et al., 2006)

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