Diagnostic Kits/Competitive advantages in Kits

Answer the questions:

(ADDED TO PAPER)

1. Define the competitive advantages in the field and the barriers of entry

penumbra effect

• tests with genes in common lead to one lab having a functional monopoly over the group of diseases that require the common gene or mutation Cook-Deegan et. al., 2009.

The Myriad Story

• Patent-Mediated Standards in Genetic Testing
  • "2006, Dr. Mary-Claire King and her colleagues published a study in the Journal of the American Medical Association" (page 16)
    • patented materials where licensed by the lab at a high licensing fee
    • the labs use of multiplex ligation probe amplification (MLPA) was a dramatic improvement over the current Myriad test
  • "Despite the fact that the work of King and her colleagues did not duplicate any clinical service offered by Myriad, the company’s response indicated that its patents would likely be infringed by any clinical testing based on the results from the King study" (page 17)
  • Myriad has strong commercial control over genetic testing options due to its patent holdings

• Access to Bio-Knowledge: From Gene Patents to Biomedical Materials
  • "Myriad Genetics owns patents on the BRCA1 and BRCA2 genes, which are important in 5-10% of breast cancer cases." (page 22-23)
  • Myriad has enforced these patents against:
    • OncorMed
    • University of Pennsylvania
  • "Letters from Myriad also led other commercial testing centers to exit the market rather than face potential litigation." (page 23)

• European Opposition to Exclusive Control Over Predictive Breast Cancer Testing and the Inherent Implications for United States Patent Law and Public Policy: A Case Study of the Myriad Genetics' BRCA Patent Controversy
  • "the most recent opposition challenges the patent as not fulfilling relevant provisions in the European patent law, as well as impeding heath care and scientific discovery." (quoting the abstract)

• Molecules and Conflict: Cancer, Patents, and Women's Health

• "In addition, we should not conflate the issues. The Myriad controversy, which has been the dominant gene patent cautionary tale, is not really an anti-commons/patent thicket story. The Myriad case is more about patient access to tests and the development of downstream technologies. These are tremendously important issues, for sure, but not evidence of a breakdown of the upstream research environment." (Caulfield, Timothy, 2009)
  • This contrary view seems to assert that down stream access issues are not patent related but due to commercial pressures. This lack of causation between patent protection and commecial pressures is unjustified.

Patent Scope

• The Discovery of Invention: Gene Patents and the Question of Patentability
  • "This paper considers the problematic scope of so-called gene patents and identifies factors, both within the legal framework and in terms of the socio-economic policies underpinning intellectual property, that support a restricted purpose-bound approach to patent protection of gene sequences." (Quoting Abstract)

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