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Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio

Published online by Cambridge University Press:  01 January 2021

Extract

The rising cost of the opioid antagonist and overdose reversal agent naloxone is an urgent public health problem. The recent and dramatic price increase of Evzio, a naloxone auto-injector produced by Kaléo, shows how pharmaceutical manufacturers entering the naloxone marketplace rely on market exclusivity guaranteed by the patent system to charge prices at what the market can bear, which can restrict access to life-saving medication. We argue that 28 U.S.C. § 1498, a section of the federal code that allows the government to use patent-protected products for its own purposes in exchange for reasonable compensation, could be used to procure generic naloxone auto-injectors, or at least bring Kaléo to the negotiating table. Precedent exists for the use of § 1498 to procure pharmaceuticals, and it could give meaning to the federal government's recent declaration of a public health emergency around the opioid epidemic, discourage new market entrants from charging exorbitant prices, and yield important public health benefits.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

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References

See, e.g., Aubrey, A., “Counting the Heavy Cost of Care in the Age of Opioids,” NPR, October. 25, 2017, available at <https://www.npr.org/sections/health-shots/2017/10/27/560459157/counting-the-heavy-cost-of-care-in-the-age-of-opioids> (last visited May 16, 2018); Department of Health and Human Services, Opioids: The Prescription Drug & Heroin Overdose Epidemic, HHS.gov, available at <https://www.hhs.gov/opioids/> (last visited January 18, 2018); R. Gupta, N. D. Shah, and J. S. Ross, “The Rising Price of Naloxone – Risks to Efforts to Stem Overdose Deaths,” New England Journal of Medicine 375, no. 23 (2016): 2213-2215, at 2213; T. Price, “Secretary Price Announces HHS Strategy for Fighting Opioid Crisis,” speech at National Rx Drug Abuse, April 19, 2017, available at <https://www.hhs.gov/about/leadership/secretary/speeches/2017-speeches/secretary-price-announces-hhs-strategy-for-fighting-opioid-crisis/index.html> (last visited January 18, 2018).+(last+visited+May+16,+2018);+Department+of+Health+and+Human+Services,+Opioids:+The+Prescription+Drug+&+Heroin+Overdose+Epidemic,+HHS.gov,+available+at++(last+visited+January+18,+2018);+R.+Gupta,+N.+D.+Shah,+and+J.+S.+Ross,+“The+Rising+Price+of+Naloxone+–+Risks+to+Efforts+to+Stem+Overdose+Deaths,”+New+England+Journal+of+Medicine+375,+no.+23+(2016):+2213-2215,+at+2213;+T.+Price,+“Secretary+Price+Announces+HHS+Strategy+for+Fighting+Opioid+Crisis,”+speech+at+National+Rx+Drug+Abuse,+April+19,+2017,+available+at++(last+visited+January+18,+2018).>Google Scholar
Legal Science, Naloxone Overdose Prevention Laws, Prescription Drug Abuse Policy System of the National Institute on Drug Abuse Substance Abuse and Mental Health Services Administration, available at <http://pdaps.org/datasets/laws-regulating-administration-of-naloxone-1501695139> (last visited January 24, 2018).+(last+visited+January+24,+2018).>Google Scholar
Gupta et al., supra note 1, at 2214.Google Scholar
Letter from H. Westley Clark (Director, Center for Substance Abuse Treatment) to Robert I.L. Morrison, Sr. (Executive Director, National Association of State Alcohol and Drug Abuse Directors), April 2, 2014, available at <https://www.samhsa.gov/sites/default/files/grants/block-grant-funds-prescription-overdose.pdf> (last visited January 24, 2018).+(last+visited+January+24,+2018).>Google Scholar
Kuehn, B. M., “Back From the Brink: Groups Urge Wide Use of Opioid Antidote to Avert Overdoses,” JAMA 311, no. 6 (2014): 560-561.Google Scholar
See, e.g., Doyon, S., Aks, S. E., and Schaeffer, S., “Expanding Access to Naloxone in the United States,” Journal of Medical Toxicology 10, no. 4 (2014): 431-434, at 433; D. Kim, K. S. Irwin, and K. Khoshnood, “Expanded Access to Naloxone: Options for Critical Response to the Epidemic of Opioid Overdose Mortality,” American Journal of Public Health 99, no. 3 (2009): 402-407.Google Scholar
Gupta et al., supra note 1, at 2214.Google Scholar
Cohn, M., “Cost of Overdose Drug Could Hamper Access in Maryland and Elsewhere,” Baltimore Sun, February 13, 2017, available at <http://www.baltimoresun.com/health/blog/bshs-naloxone-price-20170213-story.html> (last visited May 16, 2018).+(last+visited+May+16,+2018).>Google Scholar
Kodjak, A., “First Responders Spending More on Overdose Reversal Drug,” NPR, August 8, 2017, available at <https://www.npr.org/sections/health-shots/2017/08/08/541626627/first-responders-spending-more-on-overdose-reversal-drug> (last visited May 16, 2018).+(last+visited+May+16,+2018).>Google Scholar
Cohn, supra note 8.Google Scholar
Gupta et al., supra note 1, at 2213.Google Scholar
Tirrell, M., “As Opioid Epidemic Worsens, The Cost of Waking Up From an Overdose Soars,” CNBC, January 4, 2017, available at <https://www.cnbc.com/2017/01/04/as-opioid-epidemic-worsens-the-cost-of-waking-up-from-an-overdose-soars.html> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Evzio, How To Use, available at <https://www.evzio.com/patient/how-to-use-evzio/> (last visited February 15, 2018).+(last+visited+February+15,+2018).>Google Scholar
Achenbach, J., “Wave of Addiction Linked to Fentanyl Worsens as Drugs, Distribution Evolve,” Washington Post, October 24, 2017, available at <https://www.washingtonpost.com/national/wave-of-addiction-linked-to-fentanyl-worsens-as-drugs-distribution-evolve/2017/10/24/5bedbcf0-9c97-11e7-8ea1-ed975285475e_story.html> (last visited May 16, 2018).+(last+visited+May+16,+2018).>Google Scholar
Center for Disease Control, “Increases in Fentanyl Drug Confiscations and Fentanyl-related Overdose Fatalities,” CDC Health Alert Network, October 26, 2015, available at <https://emergency.cdc.gov/han/han00384.asp> (last visited January 24, 2018).+(last+visited+January+24,+2018).>Google Scholar
Katz, J., “The First Count of Fentanyl Deaths in 2016: Up 540% in Three Years,” New York Times, September 2, 2017, available at <https://www.nytimes.com/interactive/2017/09/02/upshot/fentanyl-drug-overdose-deaths.html> (last visited May 16, 2018).+(last+visited+May+16,+2018).>Google Scholar
Press Office, Office of the Governor of Massachusetts, “Governor Baker Announces $700,000 in Naloxone Grants for First Responders, Press Release,” The Official Website of the Governor of Massachusetts, available at <http://www.mass.gov/governor/press-office/press-releases/fy2016/governor-baker-announces-700000-in-naloxone-grants.html> (last visited January 18, 2018).+(last+visited+January+18,+2018).>Google Scholar
An Act relative to substance use, treatment, education and prevention, H. 3947, January 13, 2016, available at <https://malegislature.gov/Bills/189/H3944/BillHistory?pageNumber=2> (last visited May 16, 2018).+(last+visited+May+16,+2018).>Google Scholar
LeBlanc, S., “Gov. Baker: Overdose-Reversal Drug Should Be More Available,” Los Angeles Times, November 14, 2017, available at <http://www.latimes.com/sns-bc-ma--opioid-abuse-20171114-story.html> (last visited May 16, 2018).+(last+visited+May+16,+2018).>Google Scholar
Department of Health and Human Services, Opioids, supra note 1.Google Scholar
Hargan, E. C., “Determination That a Public Health Emergency Exists,” available at <https://www.hhs.gov/sites/default/files/opioid%20PHE%20Declaration-no-sig.pdf> (last visited January 18, 2018).+(last+visited+January+18,+2018).>Google Scholar
Doyle, R., “The Limits of Charity,” New Yorker, February 28, 2017, available at <https://www.newyorker.com/business/currency/the-limits-of-charity-from-a-drug-company> (last visited May 16, 2018).+(last+visited+May+16,+2018).>Google Scholar
Knowledge Ecology International, “About KEI,” available at <https://www.keionline.org/about>. (last visited April 5, 2018)..+(last+visited+April+5,+2018).>Google Scholar
Letter from Kim Treanor (Knowledge Ecology International) to Kellyanne Conway (Counselor to the President of the United States) and James Carroll (Acting Director, Office of National Drug Control Policy), March 29, 2018, available at <https://www.keionline.org/wp-content/uploads/2018/03/Conway-Carrol-KEI-1498-Evzio-29mar2018.pdf> (last visited May 16, 2018).+(last+visited+May+16,+2018).>Google Scholar
Brennan, H., Kapczynski, A., Monahan, C. H., and Rivzi, Z., “A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health,” Yale Journal of Law and Technology 18, no. 1 (2016): 275-354, at 303-306.Google Scholar
Kapczynski, A. and Kesselheim, A. S., “‘Government Patent Use’: A Legal Approach To Reducing Drug Spending,” Health Affairs 35, no. 5 (2016): 791-797, 794.Google Scholar
Gupta et al., supra note 1, at 2213.Google Scholar
National Institute on Drug Abuse, Naloxone for Opioid Overdose: Life-Saving Science, available at <https://www.drugabuse.gov/publications/naloxone-opioid-overdose-life-saving-science/naloxone-opioid-overdose-life-saving-science> (last visited January 18, 2018).+(last+visited+January+18,+2018).>Google Scholar
See Mahoney, K., U.S. Food and Drug Administration, FDA Supports Greater Access to Naloxone to Help Reduce Opioid Overdose Deaths, FDA Voice, August 10, 2016, available at <https://blogs.fda.gov/fdavoice/index.php/2016/08/fda-supports-greater-access-to-naloxone-to-help-reduce-opioid-overdose-deaths/> (last visited January 18, 2018).Google Scholar
See Goodnough, A., “Surgeon General Urges Americans to Carry Drug That Stops Opioid Overdoses,” New York Times, April 5, 2018, available at <https://www.nytimes.com/2018/04/05/health/opioids-naloxone-surgeon-general.html> (last visited May 16, 2018); United States Surgeon General, Surgeon General’s Advisory on Naloxone and Opioid Overdose, HHS.gov, at <https://www.surgeongeneral.gov/priorities/opioid-overdose-prevention/naloxone-advisory.html> (last visited May 16, 2018).+(last+visited+May+16,+2018);+United+States+Surgeon+General,+Surgeon+General’s+Advisory+on+Naloxone+and+Opioid+Overdose,+HHS.gov,+at++(last+visited+May+16,+2018).>Google Scholar
U.S. Food and Drug Administration, FDA News Release: FDA Approves New Hand-Held Auto-Injector to Reverse Opioid Overdose, FDA Newsroom, April 3, 2014, available at <https://wayback.archive-it.org/7993/20170112032835/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm> (last visited January 18, 2018).+(last+visited+January+18,+2018).>Google Scholar
U.S. Food and Drug Administration, FDA News Release: FDA Moves Quickly To Approve Easy-To-Use Nasal Spray To Treat Opioid Overdose, FDA Newsroom, November 18, 2015, available at <https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473505.htm> (last visited January 18, 2018).+(last+visited+January+18,+2018).>Google Scholar
Rosenberg, M., Office of Program and Strategic Analysis, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, “Market Structure for Naloxone,” July 1, 2015, slide 18, at <https://www.fda.gov/downloads/Drugs/NewsEvents/UCM454757.pdf> (last visited January 24, 2018).+(last+visited+January+24,+2018).>Google Scholar
Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services, “Observations on Trends in Prescription Drug Spending,” ASPE Issue Brief, March 8, 2016, 1, available at <https://aspe.hhs.gov/system/files/pdf/187586/Drugspending.pdf> (last visited January 18, 2018).+(last+visited+January+18,+2018).>Google Scholar
Kesselheim, A. S., Avorn, J., and Sarpatwari, A., “The High Cost of Prescription Drugs in the United States Origins and Prospects for Reform,” JAMA 316, no. 8 (2016): 858-871, at 859 and table 1.Google Scholar
Brennan et. al, supra note 25, 284 (footnotes omitted).Google Scholar
Brulotte v. Thys Co., 379 U.S. 29, 33 (1964).Google Scholar
Kimble v. Marvel Entertainment, LLC, 135 S.Ct. 2401, 2405 (2015) (summarizing holding of Brulotte v. Thys).Google Scholar
Kimble, 135 S.Ct. at 2406-07.Google Scholar
See e.g. Hemphill, C. S. and Sampat, B. N., “Evergreening, Patent Challenges, and Effective Market Life in Pharmaceuticals,” Journal of Health Economics 31 (2012): 327-339.Google Scholar
Kesselheim, Avorn, and Sarpatwari, supra note 35, 862.Google Scholar
Lee, T. T., Gluck, A. R., and Curfman, G., “The Politics of Medicare and Drug-Price Negotiation (Updated),” Health Affairs Blog, October 20, 2016, available at <https://www.healthaf-fairs.org/do/10.1377/hblog20160919.056632/full/> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Kesselheim, Avorn, and Sarpatwari, supra note 35, 862 and notes 75, 76.Google Scholar
Id., at 862 and notes 78-81.Google Scholar
Brennan et al., supra note 25, at 285 and note 41.Google Scholar
Pezalla, E. J., “Pharmacy Benefit Managers – Advocates For More Affordable Prescription Drugs,” The Hill, September 12, 2017, available at <http://thehill.com/opinion/healthcare/350312-insurance-companies-cant-do-it-alone-americans-need-a-drug-pricing> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Kesselheim, Avorn, and Sarpatwari, supra note 35, at 862.Google Scholar
Galvin, R. and Longman, R., “Who Has the Power to Cut Drug Prices?” NEJM Catalyst, November, 20, 2017, available at <https://catalyst.nejm.org/who-has-the-power-to-cut-drug-prices/> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Brennan et al., supra note 25, at 284.Google Scholar
Califf, R. M., Woodcock, J., and Ostroff, S., “A Proactive Response to Prescription Opioid Abuse,” New England Journal of Medicine 374, no. 15 (2016): 1480-1485, at 1483.Google Scholar
Opiant, Corporate Overview, available at <https://www.opiant.com/about-us/overview/> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Lightlake Therapeutics Inc., “Lightlake Therapeutics Announces Partnership with National Institute on Drug Abuse (NIDA) to Treat Opioid Overdose,” PR Newswire, August 21, 2013, available at <https://www.prnewswire.com/news-releases/lightlake-therapeutics-announces-partnership-with-national-institute-on-drug-abuse-nida-to-treat-opioid-overdose-220494271.html> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Lightlake Therapeutics Inc., “Lightlake Therapeutics Inc. Files Investigational New Drug Application For Naloxone Nasal Spray For Reversing Opioid Overdose And Announces A Further Collaboration With The National Institute On Drug Abuse,” PR Newswire, July 23, 2014, available at <https://www.prnewswire.com/news-releases/lightlake-therapeutics-inc-files-investigational-new-drug-application-for-naloxone-nasal-spray-for-reversing-opioid-overdose-and-announces-a-further-collaboration-with-the-national-institute-on-drug-abuse-268263272.html> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
U.S. Food and Drug Administration, “FDA Moves Quickly To Approve Easy-To-Use Nasal Spray To Treat Opioid Overdose,” FDA Newsroom, November 18, 2015, available at <https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473505.htm> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Opiant, Pipeline Chart, available at <https://www.opiant.com/pipeline/pipeline-chart/> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Lightlake Therapeutics Inc., “Lightlake Therapeutics Inc. Announces Licensing Deal With Adapt Pharma Limited Subsidiary,” PR Newswire, December 16, 2014, available at <https://www.prnewswire.com/news-releases/lightlake-therapeutics-inc-announces-licensing-deal-with-adapt-pharma-limited-subsidiary-300010184.html> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Opiant, Pipeline Chart, supra note 58.Google Scholar
Adapt Pharma, Adapting for The Patient, available at <http://adaptpharma.com/about-adapt/> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Kennedy, J., “Teva’s Generic Overdose Drug Application Sparks IP Suit,” Law360, October 24, 2016, available at <https://www.law360.com/articles/854751/teva-s-generic-overdose-drug-application-sparks-ip-suit> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Adapt Pharma Operations Limited et al v. Teva Pharmaceuticals USA, Inc. et al, No. 2:16-cv-07721 (D.N.J. Oct 30, 2017).Google Scholar
Gupta et al., supra note 1, at 2213.Google Scholar
Walsh, S., U.S. Food and Drug Administration, “FDA Approves New Hand-Held Auto-Injector to Reverse Opioid Overdose: First Naloxone Treatment Specifically Designed to be Given by Family Members or Caregivers,” FDA News-room, April 3, 2014, available at <http://wayback.archive-it.org/7993/20170112032835/ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Id. (quoting Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research).Google Scholar
Walsh, “FDA Approves,” supra note 66.Google Scholar
Kaléo, Kaléo Announces the Award of its 100th Patent, News, January 25, 2016, available at <https://Kaleopharma.com/Kaleo-announces-the-award-of-its-100th-patent/> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Securities and Exchange Commission, “Consolidated Financial Statements for the Years Ended December 31, 2015, 2014, and 2013 Kaleo, Inc. and Subsidiary,” February 26, 2016, available at <https://www.sec.gov/Archives/edgar/data/850429/000085042916000109/tg-ex99_20151231x10k.htm> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Ramsey, L., “The List Price of a Life-Saving Overdose Treatment has Skyrocketed 680% in the Last 3 Years — and Now 31 Senators Want Answers,” Business Insider, February 10, 2017, available at <http://www.businessinsider.com/senators-question-price-of-4500-naloxone-auto-injectorevzio-2017-2> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Dreyfuss, E., “How Does A $575 Life-Saving Drug Jump to $4,500? Blame a Perverse System,” Wired, February 15, 2017, available at <https://www.wired.com/2017/02/575-life-saving-drug-jump-4500-blame-perverse-system/> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Gupta et al., supra note 1, at 2213.Google Scholar
Banerjee, A., “Senators Question Kaléo’ $4,500 Tag on Opioid Overdose Treatment,” Reuters, February 9, 2017, available at <https://www.reuters.com/article/us-kaleo-evzio-prices/senators-question-kaleo-4500-tag-on-opioid-overdose-treatment-idUSKBN15O2RI> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
See supra notes 66, 71.Google Scholar
Dreyfuss, supra note 74; see also Emery, G., “Big Price Hikes Seen in Drug That Prevents Overdose Deaths,” Reuters, December 9, 2016, available at <http://www.reuters.com/article/us-health-naloxone-drug-pricing/big-price-hikes-seen-in-drug-that-prevents-overdose-deaths-idUSKBN13Y2KC> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Luthra, supra note; see also Duarte, L., “A Look Into the Drug That’s Saving People From Opioid Overdoses,” WGN9 Chicago, May 12, 2017, available at <http://wgntv.com/2017/05/12/a-look-into-the-drug-thats-saving-people-from-opioid-overdoses/> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Evzio2You, Evzio, available at <https://evzio.com/patient/evzio-savings/> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Kaléo, Kaléo Donates 250,000th EVZIO® (naloxone HCl injection) Auto-injector to Help Fight Opioid Overdose Epidemic, News, June 22, 2017, available at <https://kaleopharma.com/kaleo-donates-250000th-evzio-naloxone-hcl-injection-auto-injector-to-help-fight-opioid-overdose-epidemic/> (last visited February 15, 2018).+(last+visited+February+15,+2018).>Google Scholar
Kaléo Cares, Kaléo, available at <https://Kaleopharma.com/who-we-are/Kaleo-cares/> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Simon, S., “Drugmaker Kaléo Raises Price of Live-Saving Drug by Thousands,” NPR, February 4, 2017, available at <http://www.npr.org/2017/02/04/513388235/drugmaker-Kaléo-raises-price-of-live-saving-drug-by-thousands> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Schumaker, E. and Golgowski, N., “How Big Pharma Is Limiting Access to a Life-Saving Opioid Overdose Reversal Drug,” Huffington Post, June 5, 2017, available at <https://www.huffingtonpost.com/entry/big-pharma-battleground-opiodnaloxone_us_5898a6b1e4b040613138071e> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Doyle, supra note 22.Google Scholar
Massachusetts Attorney General, AG Healey Reminds First Responders of Statewide Naloxone Fund Following Uptick in Cost for Overdose Drug, February 23, 2017, available at <http://www.mass.gov/ago/news-and-updates/press-releases/2017/2017-02-23-naloxone-fund-reminder.html> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Banerjee, supra note 76.Google Scholar
28 U.S.C. § 1498(a).Google Scholar
28 U.S.C. § 1498(a).Google Scholar
28 U.S.C. § 1498(b).Google Scholar
Trojan, Inc. v. Shat-R-Shield, Inc., 885 F.2d 854, 856-57 (Fed. Cir. 1989).Google Scholar
Brennan et al., supra note 25, at 309.Google Scholar
Brennan et al., supra note 25, at 311 and note 173.Google Scholar
Liberty Ammunition, Inc. v. United States, 1139 Fed. Cl. 368, 386 (2014).Google Scholar
318 F.Supp. 1116, 1120 (S.D.N.Y. 1970), modified and aff ’d, 446 F.2d 295 (2d. Cir. 1971).Google Scholar
Brunswick Corp v. U.S., 36 Fed. Cl. 204, 211-12 (1996).Google Scholar
Boeing Co. v. United States, 86 Fed. Cl. 303, 311 (2009) (internal citations omitted).Google Scholar
Brennan et al., supra note 25, at 311-13.Google Scholar
Id. 314 (quoting Honeywell International Inc. v. United States, 107 Fed. Cl. 659, 693 (2012)).Google Scholar
Brennan et al., supra note 25, at 302.Google Scholar
TVI Energy Corp. v. Blane, 806 F.2d 1057, 1060 (1986).Google Scholar
Advanced Software Design Corp v. Fed. Reserve Bank of St. Louis, 583 F.3d 1371, 1378-79 (Fed. Cir. 2009).Google Scholar
Beacon Adhesives, Inc. v. United States, 134 Fed.Cl. 26 (Fed. Cl. 2017).Google Scholar
FastShip, LLC v. United States, 131 Fed. Cl. 592, 598 (2017).Google Scholar
806 F.2d at 1060.Google Scholar
806 F.2d at 1059.Google Scholar
806 F.2d at 1060.Google Scholar
Brennan et al., supra note 25, at 303-305.Google Scholar
Id. 304 (quoting from Mossinghoff, G. J. and Allnutt, R. F., “Patent Infringement in Government Procurement: A Remedy Without a Right,” Notre Dame Law Review 42, no. 31 (1996): 5-28, at 12).Google Scholar
Charles Pfizer & Co., Inc., B-141459, 119 U.S.P.Q. 187 (Comp. Gen.), at *1 (1960).Google Scholar
Brennan et al., supra note 25, at 305.Google Scholar
See e.g. Alco Standard Corp. v. Tennessee Valley Authority, 808 F.2d 1490, 1492 (Fed. Cir. 1986) (patent infringement claim relating to a method and apparatus for inspecting turbine rotors).Google Scholar
Kapczynski and Kesselheim, supra note 26, at 794.Google Scholar
Bradsher, K and Andrews, E. L., “A NATION CHALLENGED: CIPRO; U.S. Says Bayer Will Cut Cost of Its Anthrax Drug,” New York Times, October 24, 2001, available at <http://www.nytimes.com/2001/10/24/business/a-nation-challenged-cipro-us-says-bayer-will-cut-cost-of-its-anthrax-drug.html> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
White House, “Press Briefing by Ari Fleischer,” 2001 WL 1282734 (Oct. 25, 2001).Google Scholar
The Avalon Project, September 11, 2001: Attack on America, “HHS, Bayer Agree to Cipro Purchase,” October 24, 2001, available at <http://avalon.law.yale.edu/sept11/hhs_013.asp> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Davis, J. H., “Trump Declare Opioid Crisis a ‘Health Emergency’ But Requests No Funds,” New York Times, October 26, 2017, available at <https://www.nytimes.com/2017/10/26/us/politics/trump-opioid-crisis.html> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Centers for Disease Control and Prevention, Strategic National Stockpile, available at <https://www.cdc.gov/phpr/stockpile/index.htm> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Letter from Bernard Sanders (Senator) to Robert A. McDonald (Secretary, United States Department of Veterans Affairs), May 12, 2015, available at <https://www.sanders.senate.gov/download/051215-letter/?inline=file> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
McNeil, D. G. Jr., “A NATION CHALLENGED: THE DRUG; A Rush for Cipro, and the Global Ripples,” New York Times, October 17, 2001, available at <http://www.nytimes.com/2001/10/17/world/a-nation-challenged-the-drug-a-rush-for-cipro-and-the-global-ripples.html> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Memorandum from Alfred B. Engelberg to Senator Chuck Schumer, October. 13, 2001, available at <https://web.archive.org/web/20011224204824/http://lists.essential.org/pipermail/ip-health/2001-October/002105.html> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Kapczynski and Kesselheim, supra note 26, at 796.Google Scholar
Edwards, E. T. et al., “Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery,” Pain Therapy 4, no. 1 (2015): 89-105, at 89.Google Scholar
Kapczynski and Kesselheim, supra note 26, at 793 (citing Georgia-Pacific Corp v. United States Plywood Corp, 318 F. Supp. 1116, 1120 (S.D.N.Y.) and Honeywell Int’l v. United States, 107 Fed. Cl. 659, 695 (2012)).Google Scholar
Brennan et al., supra note 25, at 322.Google Scholar
The President’s Commission on Combating Drug Addiction and the Opioid Crisis, Final Report Draft, (November 15, 2017) at 93.Google Scholar
Treasure, C.L, Avorn, J., and Kesselheim, A. S., “Do March-In Rights Ensure Access to Medical Products Arising From Federally Funded Research? A Qualitative Study,” The Milbank Quarterly 93, no. 4 (2015): 761-87, at 763.Google Scholar
E. T. Edwards et al. supra note 127, 89.Google Scholar
Id. at 103Google Scholar
Hernandez, E., “New Haven To Distribute Free Overdose Reversal Kits, Hold Training,” New Haven Register, August 29, 2016, available at <http://www.nhregister.com/connecticut/article/New-Haven-to-distribute-free-overdose-reversal-11320648.php> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Narcan Program, Boston Public Health Commission, available at <http://www.bphc.org/whatwedo/Recovery-Services/prevention/Pages/Narcan-Program.aspx> (last visited January 22, 2018).+(last+visited+January+22,+2018).>Google Scholar
Seelye, K. Q., “A Public Overdose. An Antidote at Hand. Would Passers-By Use It?,” New York Times, May 9, 2017, available at <https://www.nytimes.com/2017/05/09/us/opioids-narcan-drug-overdose-heroin-fentanyl.html> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Kerr, D. et al., “Randomized Controlled Trial Comparing the Effectiveness and Safety of Intranasal and Intramuscular Naloxone for the Treatment of Suspected Heroin Overdose,” Addiction 104, no. 12 (2009): 2067-2074, at 2073.Google Scholar
See e.g. Edwards, E. S. et al., “Pharmaokinetics of 2.0 mg Intranasal and Intramuscular Naloxone HCI Administration and the Impact of Vasoconstrictor Use on the Bioavailability of Intranasal Naloxone HCI,” 2016 American Academy of Pain Medicine Annual Meeting, available at <http://www.painmed.org/2016posters/abstract-lb002/> (last visited May 18, 2018); B. T. Gufford et al., “Comparison of a New Intra-nasal Naloxone Formulation to Intramuscular Naloxone: Results from Hypothesis-Generating Small Clinical Studies,” Clinical and Translational Science 10, no. 5 (2017): 380-386, at 385.+(last+visited+May+18,+2018);+B.+T.+Gufford+et+al.,+“Comparison+of+a+New+Intra-nasal+Naloxone+Formulation+to+Intramuscular+Naloxone:+Results+from+Hypothesis-Generating+Small+Clinical+Studies,”+Clinical+and+Translational+Science+10,+no.+5+(2017):+380-386,+at+385.>Google Scholar
Tomassoni, A. J. et al., “Multiple Fentanyl Overdoses – New Haven, Connecticut,” Morbidity and Mortality Weekly Report 66, no. 4 (2017): 107-111, at 107.Google Scholar
Kim, H. H. and Nelson, L. S., “Reducing the Harm of Opioid Overdose With the Safe Use of Naloxone: A Pharmacologic Review,” Expert Opinion on Drug Safety 14, no. 7 (2015): 1137-1146, at 1141.Google Scholar
Gillette, F., “Saving Heroin Users With a Nasal Spray is an $80 Million Business,” Bloomberg Businessweek, November 11, 2016, available at <https://www.bloomberg.com/news/articles/2016-11-11/saving-heroin-users-with-a-nasal-spray-is-an-80-million-business> (last visited May 18, 2018).+(last+visited+May+18,+2018).>Google Scholar
Brennan et al., supra note 25, at 322.Google Scholar