Reimagining Pharmaceutical Market Exclusivities: Should the Duration of Guaranteed Monopoly Periods Be Value Based?

Beall, 2019, Major events in the life course of new drugs, 2000-2016, N Engl J Med, 380, e12, 10.1056/NEJMp1806930 Beall, 2019, Pre-market development times for biologic versus small-molecule drugs, Nat Biotechnol, 37, 708, 10.1038/s41587-019-0175-2 Kesselheim, 2017, Determinants of market exclusivity for prescription drugs in the United States, JAMA Intern Med, 177, 1658, 10.1001/jamainternmed.2017.4329 Beall, 2019, Patent term restoration for top-selling drugs in the United States, Drug Discov Today, 24, 20, 10.1016/j.drudis.2018.07.006 Khullar, 2020, Understanding the rewards of successful drug development — thinking inside the box, N Engl J Med, 382, 473, 10.1056/NEJMhpr1911004 Darrow, 2017, Will inter partes review speed US generic drug entry?, Nat Biotechnol, 35, 1139, 10.1038/nbt.4036 Darrow, 2018, The generic drug industry embraces a faster, cheaper pathway for challenging patents, Appl Health Econ Health Policy, 17, 47, 10.1007/s40258-018-0420-8 21 U.S. Code § 355 - New drugs. Kannappan S Darrow JJ, Kesselheim AS, Beall RF. The timing of 30-month stay expirations and generic entry: a cohort study of first generics, 2013-2020 [published online May 13, 2021]. Clin Transl Sci. https://doi.org/10.1111/cts.13046. Sarpatwari, 2018, Evaluating the impact of the Orphan Drug Act’s seven-year market exclusivity period, Health Aff (Millwood), 37, 732, 10.1377/hlthaff.2017.1179 Beall, 2018, A method for approximating future entry of generic drugs, Value Health, 21, 1382, 10.1016/j.jval.2018.04.1827 Hemphill, 2011, When do generics challenge drug patents?, J Empir Leg Stud, 8, 613 Hemphill, 2012, Evergreening, patent challenges, and effective market life in pharmaceuticals, J Health Econ, 31, 327, 10.1016/j.jhealeco.2012.01.004 Grabowski, 2016, Updated trends in US brand-name and generic drug competition, J Med Econ, 19, 836 Grabowski, 2007, Generic competition and market exclusivity periods in pharmaceuticals, Manage Decis Econ, 28, 491, 10.1002/mde.1356 Lièvre, 2001, Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility: early discontinuation violates Helsinki principles, BMJ, 322, 603, 10.1136/bmj.322.7286.603 Budish, 2015, Do firms underinvest in long-term research? Evidence from cancer clinical trials, Am Econ Rev, 105, 2044, 10.1257/aer.20131176 Hemkens, 2018, How routinely collected data for randomized trials provide long-term randomized real-world evidence, JAMA Netw Open, 1, 10.1001/jamanetworkopen.2018.6014 Hlatky, 2014, A long-term perspective on short-term outcomes, J Am Coll Cardiol, 64, 2109, 10.1016/j.jacc.2014.08.038 Mishkin Kesselheim, 2010, Using market-exclusivity incentives to promote pharmaceutical innovation, N Engl J Med, 363, 1855, 10.1056/NEJMhle1002961 Roin, 2009, Unpatentable drugs and the standards of patentability, Tex L Rev, 87, 503 Eisenberg, 2001, The shifting functional balance of patents and drug regulation, Health Aff (Millwood), 20, 119, 10.1377/hlthaff.20.5.119 Angelis, 2018, Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries, Eur J Health Econ, 19, 123, 10.1007/s10198-017-0871-0 Drummond, 2013, Assessing the added value of health technologies: reconciling different perspectives, Value Health, 16, S7, 10.1016/j.jval.2012.10.007 US patent 8377440. https://patents.google.com/patent/US8377440B2/en. Pant Tandon, 1982, Optimal patents with compulsory licensing, J Polit Econ, 90, 470, 10.1086/261070 Crowe Husser Taylor