References

• 1 Cutler D , Deaton A , Lleras-Muney A . The determinants of mortality . J Econ Perspect . 2006 ; 20 ( 3 ): 97 – 120 . Crossref, Google Scholar
• 2 Lichtenberg FR , Virabhak S . Pharmaceutical-embodied technical progress, longevity, and quality of life; drugs as “equipment for your health.” MDE Manage Decis Econ . 2007 ; 28 ( 4–5 ): 371 – 92 . Crossref, Google Scholar
• 3 US House of Representatives Energy and Commerce Committee . 21st Century Cures: an update on the President’s Council of Advisors on Science and Technology 2012 report on propelling innovation [Internet]. Washington (DC) : House of Representatives ; [cited 2014 Dec 9 ]. Available from: http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140512PCASTWhitePaper.pdf Google Scholar
• 4 President’s Council of Advisors on Science and Technology . Report to the president on propelling innovation in drug discovery, development, and evaluation [Internet]. Washington (DC) : Executive Office of the President ; 2012 Sep [cited 2014 Dec 9 ]. Available from: http://www.whitehouse.gov/sites/default/files/microsites/ostp/pcast-fda-final.pdf Google Scholar
• 5 Previous studies have confirmed that the pharmaceutical industry places unique importance on patents, relative to other mechanisms to protect intellectual property investments such as trade secrets, complementary sales and service or manufacturing capabilities, and being first to market. See, for example, Cohen WM , Nelson RR , Walsh JP . Protecting their intellectual assets: appropriability conditions and why U.S. manufacturing firms patent (or not) [Internet]. Cambridge (MA) : National Bureau of Economic Research ; 2000 Feb [cited 2014 Dec 9 ]. (NBER Working Paper No. 7552). Available from: http://www.nber.org/papers/w7552.pdf Google Scholar
• 6 DiMasi JA , Grabowski HG , Hansen RW . Innovation in the pharmaceutical industry: new estimates of R&D costs . Briefing: Cost of Developing a New Drug; 2014 Nov 18 [Internet]. Boston (MA) : Tufts University, Tufts Center for the Study of Drug Development ; [cited 2014 Dec 15 ]. Available from: http://csdd.tufts.edu/files/uploads/Tufts_CSDD_briefing_on_RD_cost_study_-_Nov_18,_2014..pdf Google Scholar
• 7 Grabowski H , Vernon J , DiMasi JA . Returns on research and development for 1990s new drug introductions . Pharmacoeconomics . 2002 ; 20 ( Suppl 3 ): 11 – 29 . Crossref, Medline, Google Scholar
• 8 Scherer FM . Pharmaceutical innovation . In: Hall BRosenberg N , editors. Handbook of the economics of innovation . Vol. 1 . Amsterdam : North-Holland ; 2010 . p.  539 – 74 . Crossref, Google Scholar
• 9 Lichtenberg F , Philipson TJ . The dual effects of intellectual property regulations: within- and between-patent competition in the U.S. pharmaceuticals industry . J Law Econ . 2002 ; 45 ( S2 ): 643 – 72 . Crossref, Google Scholar
• 10 DiMasi JA , Faden L . Competitiveness in follow-on drug R&D: a race or imitation? Nat Rev Drug Discov . 2011 ; 10 ( 1 ): 23 – 7 . Crossref, Medline, Google Scholar
• 11 Cockburn IM . The changing structure of the pharmaceutical industry . Health Aff (Millwood) . 2004 ; 23 ( 1 ): 10 – 22 . Go to the article, Google Scholar
• 12 Schacht WH . The Bayh-Dole Act: selected issues in patent policy and the commercialization of technology [Internet]. Washington (DC) : Congressional Research Service ; 2012 Mar 16 [cited 2014 Dec 9 ]. p.  9 . Available from: https://www.autm.net/Bayh_Dole_Act_Report.htm Google Scholar
• 13 National Science Board . Science and engineering indicators, 2014, appendix tables 5-64 and 5-63 [Internet]. Washington (DC) : National Science Foundation ; 2014 Apr [cited 2014 Dec 14 ]. Available for download from: http://www.nsf.gov/statistics/seind14/index.cfm/appendix Google Scholar
• 14 Treasure CL , Avorn J , Kesselheim AS . What is the public’s right to access medical discoveries based on federally funded research? JAMA . 2014 ; 311 ( 9 ): 907 – 8 . Crossref, Medline, Google Scholar
• 15 Nine percent of the drugs approved by the Food and Drug Administration during 1988–2005 (excluding most biologics) had public-sector patents, defined as those that were assigned to a government agency or that had a government interest statement, acknowledging government funding. Sampat BN , Lichtenberg FR . What are the respective roles of the public and private sectors in pharmaceutical innovation? Health Aff (Millwood) . 2011 ; 30 ( 2 ): 332 – 9 . Go to the article, Google Scholar
• 16 See Zerhouni EA . In the case of Xalatan manufactured by Pfizer, Inc. [Internet]. Bethesda (MD) : National Institutes of Health ; [cited 2014 Dec 9 ]. Available from: http://www.ott.nih.gov/sites/default/files/documents/policy/March-in-xalatan.pdf Google Scholar
• 17 Grabowski H , Long G , Mortimer R . Recent trends in brand-name and generic drug competition . J Med Econ . 2014 ; 17 ( 3 ): 207 – 14 . Crossref, Medline, Google Scholar
• 18 Berndt ERF , Aitken ML . Brand loyalty, generic entry, and price competition in pharmaceuticals in the quarter century after the 1984 Waxman-Hatch legislation . Int J Econ Bus . 2011 ; 18 ( 2 ): 177 – 201 . Crossref, Google Scholar
• 19 Grabowski HG , Long G , Mortimer R . Biosimilars . In: Culyer AJ , editor. Encyclopedia of health economics . Vol. 1 . San Diego (CA) : Elsevier ; 2014 . p.  86 – 97 . Crossref, Google Scholar
• 20 Grabowski H , Guha R , Salgado M . Biosimilar competition: lessons from Europe . Nat Rev Drug Discov . 2014 ; 13 ( 2 ): 99 – 100 . Crossref, Medline, Google Scholar
• 21 James D . FDA committee recommends first biosimilar approval. Pharmacy Times [serial on the Internet]. 2015 Jan 7 [cited 2015 Jan 12 ]. Available from: http://www.pharmacytimes.com/product-news/FDA-Committee-Recommends-First-Biosimilar-Approval Google Scholar
• 22 For example, a model that extended the data exclusivity period for all small-molecule drugs to twelve years found long-term benefits in terms of increased innovation that would benefit future generations. Goldman DP , Lakdawalla DN , Malkin JD , Romley J , Philipson T . The benefits from giving makers of conventional “small molecule” drugs longer exclusivity over clinical trial data . Health Aff (Millwood) . 2011 ; 30 ( 1 ): 84 – 89 . Go to the article, Google Scholar
• 23 Budish E , Roin BN , Williams H . Do fixed patent terms distort innovation? Evidence from cancer clinical trials [Internet]. Cambridge (MA) : National Bureau of Economic Research ; 2013 Sep [cited 2014 Dec 9 ]. (NBER Working Paper No. 19430). Available from: http://www.nber.org/papers/w19430.pdf Google Scholar
• 24 Aitken M , Kleinrock M . Medicine use and shifting costs of healthcare: a review of the use of medicines in the United States in 2013 [Internet]. Parsippany (NJ) : IMS Institute for Healthcare Informatics ; 2014 Apr [cited 2015 Jan 12 ]. (Free registration required). Available for download from: http://www.imshealth.com/portal/site/imshealth/menuitem.762a961826aad98f53c753c71ad8c22a/?vgnextoid=2684d47626745410VgnVCM10000076192ca2RCRD Google Scholar
• 25 An earlier study found that challenges by potential generic competitors shortened market exclusivity periods by at least 1.5 years, regardless of whether or not the challenges were successful. Grabowski HG , Kyle M . Generic competition and market exclusivity periods in pharmaceuticals . MDE Manage Decis Econ . 2007 ; 28 ( 4–5 ): 491 – 502 . Crossref, Google Scholar
• 26 For a contrasting view, see Hemphill CS , Sampat BN . Evergreening, patent challenges, and effective market life in pharmaceuticals . J Health Econ . 2012 ; 31 ( 2 ): 327 – 39 . Crossref, Medline, Google Scholar
• 27 FTC v. Actavis, Inc., 133 S. Ct. 2233 ( 2013 ). Google Scholar
• 28 Li JS , Eisenstein EL , Grabowski HG , Reid ED , Mangum B , Schulman KA , et al. Economic return of clinical trials performed under the pediatric exclusivity program . JAMA . 2007 ; 297 ( 5 ): 480 – 8 . Crossref, Medline, Google Scholar
• 29 Long G , Works J . Innovation in the biopharmaceutical pipeline: a multidimensional view [Internet]. Boston (MA) : Analysis Group ; 2013 Jan [cited 2014 Dec 9 ]. Available from: http://www.analysisgroup.com/uploadedFiles/Publishing/Articles/2012_Innovation_in_the_Biopharmaceutical_Pipeline.pdf Google Scholar
• 30 Lichtenberg FR . The impact of new (orphan) drug approvals on premature mortality from rare diseases in the United States and France, 1999–2007 . Eur J Health Econ . 2013 ; 14 ( 1 ): 41 – 56 . Crossref, Medline, Google Scholar
• 31 Powers JH . Antimicrobial drug development—the past, the present, and the future . Clin Microbiol Infect . 2004 ; 10 ( Suppl 4 ): 23 – 31 . Crossref, Medline, Google Scholar
• 32 Cox EM . FDA’s multi-pronged approach helps meet the challenge of bringing new and innovative antibiotics to patients who need them . FDA Voice [serial on the Internet]. 2014 Jul 28 [cited 2014 Dec 9 ]. Available from: http://blogs.fda.gov/fdavoice/index.php/tag/cder/ Google Scholar
• 33 Food and Drug Administration [Internet]. Silver Spring (MD) : FDA . News release, FDA approves new antibacterial drug Zerbaxa: fourth new antibacterial drug approved this year . 2014 Dec 19 [cited 2015 Jan 12 ]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427534.htm Google Scholar
• 34 Ridley DB , Grabowski HG , Moe J . Developing drugs for developing countries . Health Aff . 2006 ; 25 ( 2 ): 313 – 324 . Go to the article, Google Scholar
• 35 Knight Therapeutics [Internet]. Montreal : Knight . Press release, Knight sells Priority Review Voucher to Gilead ; 2014 Nov 19 [cited 2014 Dec 14 ]. Available from: http://www.gud-knight.com/en/knight-sells-priority-review-voucher-to-gilead Google Scholar
• 36 Regeneron [Internet]. Tarrytown (NY) : Regeneron . Press release, Regeneron and Sanofi announce plan to use priority review voucher for Alirocumab U.S. FDA submission ; 2014 Jul 30 [cited 2014 Dec 9 ]. Available from: http://investor.regeneron.com/common/download/download.cfm?companyid=REGN&fileid=772356&filekey=1e721856-2d62-4be1-a834-acd4812d9acc&filename=REGN_News_2014_7_30_General_Releases.pdf Google Scholar
• 37 Kremer M . Pharmaceuticals and the developing world . J Econ Perspect . 2002 ; 16 ( 4 ): 67 – 90 . Crossref, Medline, Google Scholar
• 38 Kremer M , Williams H . Incentivizing innovation: adding to the tool kit . In: Lerner JStern S , editors. Innovation policy and the economy . Vol. 10 . Chicago (IL) : University of Chicago Press ; 2010 . p.  1 – 17 . Crossref, Google Scholar
• 39 Stiglitz JE . Scrooge and intellectual property rights . BMJ . 2006 ; 333 ( 7582 ): 1279 – 80 . Crossref, Medline, Google Scholar
• 40 Wright BD . The economics of invention incentives: patents, prizes, and research contracts . Am Econ Rev . 1983 ; 93 ( 4 ): 691 – 707 . Google Scholar
• 41 Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response . Project BioShield annual report to Congress: January 2012–December 2012 [Internet]. Washington (DC) : HHS ; [cited 2014 Dec 9 ]. Available from: https://www.medicalcountermeasures.gov/media/33065/pbs_report_2012_hires_final2_508.pdf Google Scholar
• 42 Booth B , Zemmel R . Quest for the best . Nat Rev Drug Discov . 2003 ; 2 ( 10 ): 838 – 41 . Crossref, Medline, Google Scholar