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Patent policy and entry: Evidence from pharmaceutical patent challenges.
- Format:
- Book
- Thesis/Dissertation
- Author/Creator:
- Mulcahy, Andrew.
- Language:
- English
- Subjects (All):
- Health services administration.
- Political planning.
- Sociological jursiprudence.
- Economics.
- 0501.
- 0553.
- 0630.
- 0769.
- Penn dissertations--Health care management and economics.
- Health care management and economics--Penn dissertations.
- Penn dissertations--Managerial science and applied economics.
- Managerial science and applied economics--Penn dissertations.
- Local Subjects:
- Penn dissertations--Health care management and economics.
- Health care management and economics--Penn dissertations.
- Penn dissertations--Managerial science and applied economics.
- Managerial science and applied economics--Penn dissertations.
- 0501.
- 0553.
- 0630.
- 0769.
- Physical Description:
- 150 pages
- Contained In:
- Dissertation Abstracts International 72-09A.
- System Details:
- Mode of access: World Wide Web.
- text file
- Summary:
- The onset of generic competition in pharmaceutical markets is increasingly determined by patent challenge rather than patent expiration. I exploit features of the pharmaceutical industry's "Paragraph IV" patent challenge process and comprehensive 2004-2009 data to study why and which generic entrants challenge innovator patents and estimate the impact of such challenges on industry and consumers. I model generic firms' entry decisions as a function of patent portfolio characteristics, market size, and other factors affecting entrants' expected costs and payoffs. Patent challenges are more likely in markets with greater on-patent innovator sales and more related presentations. While this may be partly attributed to a 180-day generic exclusivity "prize" granted to the first challenger, other early mover advantages seem to exist. Larger originator patent portfolios and portfolios with higher average citation rates raise entry costs and decrease the probability and intensity of challenge. The effect of patents on challenge varies by patent type. In particular, certain relatively weak patent types are more likely to be used strategically by innovators to deter or delay challenge. Limitations introduced in the 2003 Medicare Modernization Act to limit the strategic use of patents did decrease challenge costs. Overall, patent challenges subject significant innovator sales and on-patent years to generic competition. Under various assumptions, early generic entry due to patent challenges generated between $4.3 and $8.5 billion in savings to consumers from 2004 to 2009. The net welfare effect of patent challenges is difficult to characterize and must consider litigation costs and other factors. Regulatory exclusivity alternatives to the current patent-based systems may yield similar outcomes at lower societal cost.
- Notes:
- Thesis (Ph.D. in Health Care Management and Economics) -- University of Pennsylvania, 2011.
- Source: Dissertation Abstracts International, Volume: 72-09, Section: A, page: 3412.
- Adviser: Patricia M. Danzon.
- Local Notes:
- School code: 0175.
- ISBN:
- 9781124731377
- Access Restriction:
- Restricted for use by site license.
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