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.
B. M.Kuehn, “Back From the Brink: Groups Urge Wide Use of Opioid Antidote to Avert Overdoses,”JAMA311, no. 6 (2014): 560-561.
6.
See, e.g., S.Doyon, S. E.Aks, and S.Schaeffer, “Expanding Access to Naloxone in the United States,”Journal of Medical Toxicology10, 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.
Center for Disease Control, “Increases in Fentanyl Drug Confiscations and Fentanyl-related Overdose Fatalities,”CDC Health Alert Network, October26, 2015, available at <https://emergency.cdc.gov/han/han00384.asp> (last visited January 24, 2018).
H.Brennan, A.Kapczynski, C. H.Monahan, and Z.Rivzi, “A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health,”Yale Journal of Law and Technology18, no. 1 (2016): 275-354, at 303-306.
26.
A.Kapczynski and A. S.Kesselheim, “‘Government Patent Use’: A Legal Approach To Reducing Drug Spending,”Health Affairs35, no. 5 (2016): 791-797, 794.
M.Rosenberg, Office of Program and Strategic Analysis, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, “Market Structure for Naloxone,”July1, 2015, slide 18, at <https://www.fda.gov/downloads/Drugs/NewsEvents/UCM454757.pdf> (last visited January 24, 2018).
34.
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, March8, 2016, 1, available at <https://aspe.hhs.gov/system/files/pdf/187586/Drugspending.pdf> (last visited January 18, 2018).
35.
A. S.Kesselheim, J.Avorn, and A.Sarpatwari, “The High Cost of Prescription Drugs in the United States Origins and Prospects for Reform,”JAMA316, no. 8 (2016): 858-871, at 859 and table 1.
36.
Id. 860.
37.
Brennan et. al, supra note 25, 284 (footnotes omitted).
38.
Brulotte v. Thys Co., 379 U.S. 29, 33 (1964).
39.
Kimble v. Marvel Entertainment, LLC, 135 S.Ct. 2401, 2405 (2015) (summarizing holding of Brulotte v. Thys).
40.
Kimble, 135 S.Ct. at 2406-07.
41.
See e.g. C. S.Hemphill and B. N.Sampat, “Evergreening, Patent Challenges, and Effective Market Life in Pharmaceuticals,”Journal of Health Economics31 (2012): 327-339.
42.
Kesselheim, Avorn, and Sarpatwari, supra note 35, 862.
R. M.Califf, J.Woodcock, and S.Ostroff, “A Proactive Response to Prescription Opioid Abuse,”New England Journal of Medicine374, no. 15 (2016): 1480-1485, at 1483.
Id. (quoting Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research).
Brunswick Corp v. U.S., 36 Fed. Cl. 204, 211-12 (1996).
98.
Boeing Co. v. United States, 86 Fed. Cl. 303, 311 (2009) (internal citations omitted).
99.
Brennan et al., supra note 25, at 311-13.
100.
Id. 313.
101.
Id. 314 (quoting Honeywell International Inc. v. United States, 107 Fed. Cl. 659, 693 (2012)).
102.
Brennan et al., supra note 25, at 302.
103.
TVI Energy Corp. v. Blane, 806 F.2d 1057, 1060 (1986).
104.
Advanced Software Design Corp v. Fed. Reserve Bank of St. Louis, 583 F.3d 1371, 1378-79 (Fed. Cir. 2009).
105.
Beacon Adhesives, Inc. v. United States, 134 Fed.Cl. 26 (Fed. Cl. 2017).
106.
FastShip, LLC v. United States, 131 Fed. Cl. 592, 598 (2017).
107.
806 F.2d at 1060.
108.
806 F.2d at 1059.
109.
Id.
110.
806 F.2d at 1060.
111.
Brennan et al., supra note 25, at 303-305.
112.
Id. 304 (quoting from G. J.Mossinghoff and R. F.Allnutt, “Patent Infringement in Government Procurement: A Remedy Without a Right,”Notre Dame Law Review42, no. 31 (1996): 5-28, at 12).
113.
Charles Pfizer & Co., Inc., B-141459, 119 U.S.P.Q. 187 (Comp. Gen.), at *1 (1960).
114.
Brennan et al., supra note 25, at 305.
115.
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).
White House, “Press Briefing by Ari Fleischer,” 2001 WL 1282734 (Oct. 25, 2001).
119.
The Avalon Project, September 11, 2001: Attack on America, “HHS, Bayer Agree to Cipro Purchase,”October24, 2001, available at <http://avalon.law.yale.edu/sept11/hhs_013.asp> (last visited January 22, 2018).
E. T.Edwardset al., “Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery,”Pain Therapy4, no. 1 (2015): 89-105, at 89.
128.
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)).
129.
Id. 793.
130.
Brennan et al., supra note 25, at 322.
131.
The President’s Commission on Combating Drug Addiction and the Opioid Crisis, Final Report Draft, (November 15, 2017) at 93.
132.
Id. at 8.
133.
C.LTreasure, J.Avorn, and A. S.Kesselheim, “Do March-In Rights Ensure Access to Medical Products Arising From Federally Funded Research? A Qualitative Study,”The Milbank Quarterly93, no. 4 (2015): 761-87, at 763.
D.Kerret al., “Randomized Controlled Trial Comparing the Effectiveness and Safety of Intranasal and Intramuscular Naloxone for the Treatment of Suspected Heroin Overdose,”Addiction104, no. 12 (2009): 2067-2074, at 2073.
140.
See e.g. E. S.Edwardset 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.
141.
A. J.Tomassoniet al., “Multiple Fentanyl Overdoses – New Haven, Connecticut,”Morbidity and Mortality Weekly Report66, no. 4 (2017): 107-111, at 107.
142.
H. H.Kim and L. S.Nelson, “Reducing the Harm of Opioid Overdose With the Safe Use of Naloxone: A Pharmacologic Review,”Expert Opinion on Drug Safety14, no. 7 (2015): 1137-1146, at 1141.
