Should a Prize System for Pharmaceuticals Require Patent Protection for Eligibility?
Citation: Talha Syed (2010/06/10) Should a Prize System for Pharmaceuticals Require Patent Protection for Eligibility?.
Internet Archive Scholar (search for fulltext): Should a Prize System for Pharmaceuticals Require Patent Protection for Eligibility?
Download: http://www.healthimpactfund.com/files/DP2 Syed.pdf
Tagged:
Summary
"Vagaries of patent protection...are less germane than (a) whether the product is sufficiently distinct from currently available treatments such that the FDA or similar regulatory agencies will require it to undergo (expensive and somewhat risky) testing for safety and efficacy in humans before general public use; and (b) whether, once it passes that threshold it provides an appreciable advance in health benefits over the existing armory of approved treatments"
Broad stages of drug development innovative activity:
- "applied research" / "search, synthesis, and screening"
- pre-clinical testing
- human testing
"types of valuable developmental activities that are at risk of being undersupplied as result of an exclusive reliance on meeting the criteria of patentability":
- new uses of existing patented compounds
- new uses of non-novel compounds
- new uses of "obvious" compounds
- new safety and efficacy info on existing drugs
Patent protection ought be neither necessary nor sufficient for prize eligibility.
Regulatory approval rather than patent should be screening mechanism for eligibility.
Further: "the case for strong patent protection for pharmaceuticals may be largely based on the combination of regulatorily-mandated clinical trials for innovators and regulatorily-enabled piggybacking for imitators. That conjecture, and its implications for patent theory and policy in general, are currently being explored by the author."
