Diagnostic Kits/The dangers of diagnostic monopolies

Cook-Deegan, R., Chandrasekharan, S. & Angrist, M., 2009. The dangers of diagnostic monopolies. Nature, 458(7237), 405-406.

• "few empirical studies to help form an accurate picture of how patents affect clinical genetic testing"
• eight case studies
  • on access to genetic tests for ten conditions (prepared for Secretary’s Advisory Committee on Genetics, Health and Society)
• Effect of patents generally
  • not a great harm
  • not a great help
• Effect of patents on price
  • tests without a monopoly are priced similarly to tests with a monopoly
  • other pricing factors
    • economy of scale
    • health plan reimbursement
• Effect of patents as an incentive for test development
  • Patents do not appear to be a necessary motivation, academic labs often offer testing soon after publication
  • The restriction on the market is exclusive licenses
• Effect of patents on standards of care
  • Monopoly rights holders can often set the standard of care (because they are the only tester)
• Effect of exclusive licensing
  • ‘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
• There is a growing discussion about whether non-exclusively license should be required for diagnostic patents
• When technologies arise form public funding, the government has the power to "decide coverage and reimbursement for tests" which has been a largely unused power under the 1980 Bayh-Dole Act.