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Published online by Cambridge University Press: 18 August 2021
The COVID-19 pandemic has revealed myriad and complex challenges for our national health care system spanning preparedness, response, access, costs, infrastructure, coordination, and medical innovation. These challenges implicate federal, state, and local agencies and actors, as well as international collaborative bodies. One constant throughout the pandemic has been the pressing need for safe and effective diagnostics, prophylactic vaccines, and drug treatments to counter the virus.1 Inarguably, significant problems with the multi-faceted system of drug and vaccine innovation and regulation manifested long before the COVID-19 pandemic.2 The pandemic, however, has laid bare the inextricable connections among federal funding, patents, product review and approval mechanisms, and the eventual medical products and resulting costs.
The author can be contacted at [email protected]
1 See Ralph Weissleder et al., COVID-19 Diagnostics in Context, 12 Sci. Translational Med. 1, 2 (2020) (comparing COVID-19 test types); J.S. Tregoning et al., Vaccines for COVID-19, 202 Clinical and Experimental Immunology 162, 168-173 (2020) (comparing COVID-19 vaccines); James M. Sanders et al. Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review, 323 JAMA 1824, 1826-1828 (2020) (comparing COVID-19 treatments).
2 Ohid Yaqub & Paul Nightingale, Vaccine Innovation, Translational Research and the Management of Knowledge Accumulation, 75 Soc. Sci. & Med. 2143 (2012).
3 Dmitry Karshtedt, The More Things Change: Improvement Patents, Drug Modifications, and the FDA, 104 Iowa L. Rev. 1129 (2019).
4 Wendy H. Schacht, Cong. Res. Serv., RL32076, The Bay-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology (Dec. 3, 2012), https://fas.org/sgp/crs/misc/RL32076.pdf [https://perma.cc/H9EM-8TJP].
5 See, e.g., Jordan Paradise, REMS as a Competitive Tactic: Is Big Pharma Hijacking Drug Access and Patient Safety?, 15 Hous. J. Health L. & Pol’y 43, 43 (2015).
6 See James E. Bessen & Michael J. Meurer, The Private Costs of Patent Litigation, 9 J.L. Econ. & Pol’y 59 (2012); Brian J. Love & James Yoon, Predictably Expensive: A Critical Look at Patent Litigation in the Eastern District of Texas, 20 Stan. Tech. L. Rev. 1 (2017).
7 Amy Semet, Specialized Trial Courts in Patent Litigation: A Review of the Patent Pilot Program’s Impact on Appellate Reversal Rates at the Five-Year Mark, 60 B.C. L. Rev. 519 (2019).
8 Federal Trade Commission v. Actavis, 570 U.S. 136 (2013).
9 Greg Reilly, How Can the Supreme Court Not Understand Patent Law, 16 Chi.-Kent J. Intell. Prop. 292 (2016).
10 One particularly illustrative example is Allergan’s 2017 transfer of their Restasis patent portfolio to a Native American tribe in a judicially thwarted attempt to avoid inter partes review at the United States Patent and Trademark Office initiated by a competitor. Saint Regis Mohawk Tribe, Allergan Inc. v. Mylan Pharmaceuticals, 896 F.3d 1322 (Fed. Cir. 2018). “Inter partes review is a trial proceeding conducted at the Board to review the patentability of one or more claims in a patent only on a ground that could be raised under §§ 102 or 103, and only on the basis of prior art consisting of patents or printed publications.” U.S. Patent & Trademark Off., Inter Partes Review, https://www.uspto.gov/patents-application-process/appealing-patent-decisions/trials/inter-partes-review [https://perma.cc/Y69C-EETZ]. The Federal Circuit ultimately held that sovereign immunity status of the tribe did not prevent such review; the Supreme Court subsequently denied certiorari. Saint Regis Mohawk Tribe, Allergan Inc., 896 F.3d 1322 (Fed. Cir. 2018), cert. denied, No. 18-899, 2019 WL 1590253 (Apr. 15, 2019).
11 The original Pure Food and Drug Act was enacted in 1906, with myriad legislative amendments over the ensuing 115 years. One piece of legislation of direct relevance to this article is the Hatch-Waxman Act of 1984, codified at 21 U.S.C. § 355, establishing the generic drug approval process and related patent certification and listing provisions discussed infra, Part IV. A second is the Biologic Price Competition and Innovation Act of 2010, codified at 42 U.S.C. § 262 et seq., and discussed infra, Part IV.
12 There is a vast landscape of legal scholarship exploring different aspects of these issues, particularly tied to innovation policy. This brief symposium article will not reprise that scholarship but notes its continued importance. See, e.g, W. Nicholson Price & Arti K. Rai, Manufacturing Barriers to Biologics Competition and Innovation, 101 Iowa L. Rev. 1023 (2015); Rebecca S. Eisenberg, Patents, Product Exclusivity, and Information Dissemination: How Law Directs Biopharmaceutical Research and Development, 72 Fordham L. Rev. 477 (2003); Rebecca Eisenberg, The Role of the FDA in Innovation Policy, 13 Mich. Telecom. Tech. L Rev. 345 (2007); Colleen V. Chien, Cheap Drugs at What Price to Innovation: Does the Compulsory Licensing of Pharmaceuticals Hurt Innovation, 18 Berkeley Tech. L.J. 853 (2003); Rebecca S. Eisenberg, The Shifting Functional Balance of Patents and Drug Regulation, 20(5) Health Aff. (Sep. 2001).
13 See e.g., Ana Santos Rutschman, The COVID-19 Vaccine Race: Intellectual Property, Collaboration(s), Nationalism and Misinformation, 64 Wash. U. J. L. & Pol’y 167 (2021).
14 Coronavirus Aid, Relief, and Economic Security Act or the CARES Act, H.R. 748, 116th Cong. (2020).
15 Fact Sheet: Explaining Operation Warp Speed, HHS.gov (Aug. 7, 2020), http://web.archive.org/web/20200807210537/https://www.hhs.gov/about/news/2020/08/07/fact-sheet-explaining-operation-warp-speed.html [hereinafter Fact Sheet: Explaining Operation Warp Speed].
16 See e.g., Anand Shah et al. Unwavering Regulatory Safeguards for COVID-19 Vaccines 324 JAMA 931 (2020); Kevin Volpp et al. Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program 325 JAMA 125 (2021).
17 Bayh-Dole Act of 1980, 35 U.S.C. § 200 (1980).
18 Jordan Paradise, COVID-IP: Staring Down the Bayh-Dole Act with 2020 Vision, 7 J.L. & the Biosciences 1 (2020). The Act provides for exceptional circumstances where this presumption of inventorship can be rebutted.
19 See e.g., Anand Shah et al. Unwavering Regulatory Safeguards for COVID-19 Vaccines 324 JAMA 931 (2020); Kevin Volpp et al. Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program 325 JAMA 125 (2021).
20 Bayh-Dole Act of 1980, 35 U.S.C. § 200 (1980).
21 35 U.S.C. § 203 (2018).
22 For a detailed discussion of prior petitions to the U.S. government to exercise these rights, see Paradise, supra note 18.
23 See Paradise, supra note 18.
24 Rapid Viral Assay, U.S. Patent No. 10,844,442 (filed May 18, 2020) (issued Nov. 24, 2020); Method of Treating, Reducing, or Alleviating a Medical Condition in a Patient, U.S. Patent No. 10,925,889 (filed Apr. 28, 2020) (issued Feb.23, 2021).
25 Valerie Bauman, States Demand Gilead Drug Seizure Misread Law, Attorneys Say, Bloomberg Law (Aug. 6, 2020) https://news.bloomberglaw.com/health-law-and-business/states-demanding-gilead-drug-seizure-misread-law-attorneys-say [https://perma.cc/VGP3-AFZD].
26 Jacqueline Howard, Here’s How Much COVID-19 Drug Remdesivir Will Cost, CNN (June 29, 2020), https://www.cnn.com/2020/06/29/health/remdesivir-cost-coronavirus-treatment-bn/index.html [https://perma.cc/5FJM-PT3L].
27 See Bauman, supra note 25.
28 The cost of the drug may fairly be related to the cost to manufacture, the utility of the treatment, or the absence of competitors on the market, rather than the patent itself. Whatever the reason, the cost has raised controversy. But because of a dearth of available information, the reasons for the cost are largely shrouded from the public. See, e.g., Christopher Roland, Taxpayers Paid to Develop Remdesivir But Will Have No Say When Gilead Sets the Price, Wash. Post (May 26, 2020), https://www.washingtonpost.com/business/2020/05/26/remdesivir-coronavirus-taxpayers/ [https://perma.cc/5RKA-V25P].
29 For a discussion of the contributions by federal researchers, see James Krellenstein & Christopher J. Morten, The U.S. Government’s Ownership of Patents Protecting Remdesivir, N.Y.U. Clinical L. Ctr, Tech. L. & Pol’y Clinic White Paper (May 22, 2020).
30 Justin Hughes & Arti K. Rai, Acknowledging the Public Role in Private Drug Development: Lessons From Remdesivir, STAT (May 8, 2020), https://www.statnews.com/2020/05/08/acknowledging-public-role-drug-development-lessons-remdesivir/ [https://perma.cc/4JW8-ZE8A].
31 Letter from Xavier Becerra, California Attorney General, and Jeff Landry, Louisiana Attorney General, to Alex M. Azar, Secretary, Dep’t of Health & Hum. Servs., Francis S. Collins, Director, National Institutes of Health, and Stephen Hahn, Commissioner, U.S. Food & Drug Admin. (Aug. 4, 2020), (available at https://www.oag.ca.gov/system/files/attachments/press-docs/Remdesivir%20Letter%2020200804.pdf [https://perma.cc/JBG5-ELYQ]).
32 Id. at 2.
33 Id. at 3.
34 Public Citizen, The Real Story of Remdesivir (May 7, 2020), https://www.citizen.org/article/the-real-story-of-remdesivir [https://perma.cc/447W-AGNF].
35 This quote is from a secondary source, citing “an HHS spokesperson.” The author cannot identify a primary source of the Trump Administration’s response. Bauman, supra note 25. A second article cites STAT for the quoted correspondence from the HHS spokesperson. Joseph Allen, No, You Can’t March in on Remdesivir, IPWatchdog.com (Aug. 6, 2020), https://www.ipwatchdog.com/2020/08/06/no-cant-march-remdesivir/id=123868/ [https://perma.cc/89GK-QZ3U].
36 Gilead Sciences Statement on State Attorneys General Letter on Remdesivir, Gilead (Aug. 5, 2020), https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-state-attorneys-general-letter-on-remdesivir [https://perma.cc/G6CB-EAHA].
37 Id.
38 Id.
39 Letter from Senator Warren et. al., to Alex Azar, Secretary, U.S. Dep’t of Health & Hum. Servs. (Nov. 16, 2020), https://www.warren.senate.gov/imo/media/doc/2020.11.16.%20Letter%20to%20HHS%20re%20Remdesivir%20Pricing.pdf [https://perma.cc/44B8-6QVT].
40 Id. at 2.
41 28 U.S.C. § 1498(a) (2011). Reasonable and entire compensation includes “reasonable costs, including reasonable fees for expert witnesses and attorneys, in pursuing the action if the owner is an independent inventor, a nonprofit organization, or an entity that had no more than 500 employees at any time during the 5-year period preceding the use or manufacture of the patented invention.” Id.
42 See Dan Mangan, Coronavirus: Federal government will end funding for 13 community-based Covid-19 test sites, most in Texas, CNBC (June 24, 2020, 1:54 PM), https://www.cnbc.com/2020/06/24/coronavirus-federal-government-to-end-funding-some-covid-19-test-sites.html [https://perma.cc/7LEQ-ZUDR]; Some COVID-19 Relief Funds Went to Healthcare Cos Under Scrutiny For Possible Fraud, Report Says, PYMNTS.com (May 3, 2020), https://www.pymnts.com/news/security-and-risk/2020/some-covid-19-relief-funds-went-to-healthcare-cos-under-scrutiny-for-possible-fraud-report-says/ [https://perma.cc/6CE5-DNAN]; Sophie Quinton, Critic Question CARES ACT Spending in Some States, PEW (Aug. 7, 2020), https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2020/08/07/critics-question-cares-act-spending-in-some-states [https://perma.cc/2ZPZ-3B6H].
43 See Arthur Allen, For Billion-Dollar COVID Vaccines, Basic Government-Funded Science Laid the Groundwork, Scientific American (Nov. 18, 2020), https://www.scientificamerican.com/article/for-billion-dollar-covid-vaccines-basic-government-funded-science-laid-the-groundwork/ [https://perma.cc/T9TQ-WR5A]; Judy Stone, The People’s Vaccine—Moderna’s Coronavirus Vaccine Was Largely Funded By Taxpayer Dollars, Forbes (Dec. 3, 2020, 11:00 AM), https://www.forbes.com/sites/judystone/2020/12/03/the-peoples-vaccine-modernas-coronavirus-vaccine-was-largely-funded-by-taxpayer-dollars/?sh=333f23c46303 [https://perma.cc/2ET5-TCHV].
44 Press Release, Food Drug Admin., Emergency Use Authorization for Vaccines Explained, https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained [https://perma.cc/NLM3-SPLP] (last visited April 11, 2021).
45 H.R. 748, 116th Cong. (2020).
46 Dep’t of Health & Hum. Servs., BAA-18-100-SOL-0003, Office of Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA) (2021); Fact Sheet: Explaining Operation Warp Speed, supra note 15.
47 Fact Sheet: Explaining Operation Warp Speed, supra note 15.
48 Id.
49 Simi V. Siddalingaiah, Cong. Res. Serv., IN11560, Operation Warp Speed Contracts for COVID-19 Vaccines and Ancillary Vaccine Equipment (2021), https://crsreports.congress.gov/product/pdf/IN/IN11560 [https://perma.cc/B9ED-6WWC].
50 Id. at 2.
51 Why We’re Excited to Partner on Johnson & Johnson’s COVID-19 Vaccine, MERCK (Mar. 10, 2021), https://www.merck.com/stories/why-were-excited-to-partner-on-johnson-and-johnsons-covid-19-vaccine/ [https://perma.cc/2NPC-SBHC].
52 Siddalingaiah, supra note 49, at 1-2 (depicted in Table 1).
53 Was the Pfizer Vaccine Part of the Government’s Operation Warp Speed?, N.Y. Times (Nov. 10, 2020), https://www.nytimes.com/2020/11/10/health/was-the-pfizer-vaccine-part-of-the-governments-operation-warp-speed.html [https://perma.cc/FD5J-6ECQ].
54 Id.
55 Siddalingaiah, supra note 49, at 1-2.
56 Swikar Oli, Pfizer Exec Sees ‘Significant Opportunity’ to Increase COVID Vaccine Price for Annual Booster Shot, Nat’l Post (Mar. 16, 2021), https://nationalpost.com/news/world/pfizer-exec-sees-significant-opportunity-to-increase-covid-vaccine-price-for-annual-booster-shot [https://perma.cc/9U4U-6JNF].
57 Id.
58 See Emerald Bensadoun, Pfizer CFO hints at raising COVID-19 vaccine price, but company says “too early” to tell, Global News (March 17, 2021), https://globalnews.ca/news/7702146/pfizer-covid-vaccine-pricing/ [https://perma.cc/SEN4-J36S].
59 Government Accountability Office Report to Congressional Requesters, GAO 21-52, Biomedical Research: NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property (2020).
60 Id.
61 Id.
62 Office of Science and Technology Policy, Request for Information: Public Access to Peer-Reviewed Scholarly Publications, Data and Code Resulting from Federally Funded Research, 85 Fed. Reg. 9488 (Feb. 19, 2020).
63 35 U.S.C. § 2 (2018).
64 35 U.S.C. § 112 (2018).
65 5 U.S.C. §§ 101, 102, 103, 112 (2019).
66 35 U.S.C. § 154 (2019).
67 35 U.S.C. § 156 (2019).
68 See Allie Nawrat, From Evergreening To Thicketing: Exploring The Manipulation Of Pharma Patents, Pharm. Tech. (Nov. 11, 2019), https://www.pharmaceutical-technology.com/features/pharma-patents-manpulation/ [https://perma.cc/8GBC-4MXT].
69 See David Orozco, Administrative Patent Levers, 117 Penn St. L. Rev. 1, 15, 45 (2012).
70 Fed. Trade Comm’n, Generic Drug Entry Prior to Patent Expiration: An FTC Study (2002) (citing the Congressional Budget Office). A “paragraph IV” certification is where the generic drug sponsor certifies to the FDA that the innovator drug patent is either invalid or unenforceable, ostensibly forcing patent infringement litigation where the innovator wants to assert their patent rights. Food, Drug & Cosmetic Act, Pub. L. No. 116-304, § 505(j)(A)(vii)(IV) (2021); 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (2019).
71 I-Mak, Overpatented, Overpriced: How Excessive Pharmaceutical Pricing is Extending Monopolies and Driving Up Drug Prices (2018), https://www.ftc.gov/system/files/documents/public_comments/2018/08/ftc-2018-0055-d-0036-155042.pdf [https://perma.cc/JBS6-F8FT].
72 Id. The drugs examined were both chemically synthesized drugs and biological products.
73 Fed. Trade Comm’n, Emerging Health Care Issues: Follow-On Biologic Drug Competition, at 12 (2009), https://www.ftc.gov/sites/default/files/documents/reports/emerging-health-care-issues-follow-biologic-drug-competition-federal-trade-commission-report/p083901biologicsreport.pdf [https://perma.cc/V2KX-5HLP].
74 U.S. Food & Drug Admin., Generic Competition and Drug Prices: New Evidence Linking Greater Generic Competition and Lower Generic Drug Prices, at 2 (2019), https://www.fda.gov/media/133509/download [https://perma.cc/8X8D-ZY5G].
75 Id. at 3.
76 See, e.g., Michael A. Carrier, Payment After Actavis, 100 Iowa L. Rev. 7, 13 (2014).
77 Selam Gebrekidan & Matt Apuzzo, Rich Countries Signed Away the Chance to Vaccine the World, N.Y. Times (Mar. 21, 2021), https://www.nytimes.com/2021/03/21/world/vaccine-patents-us-eu.html [https://perma.cc/4QPS-4RUS].
78 Id.
79 Id.
80 Press Release, Moderna, Inc., Statement by Moderna on Intellectual Property Matters During the COVID-19 Pandemic (Oct. 8, 2020), https://investors.modernatx.com/node/10066/pdf [https://perma.cc/37FQ-XJFL] [hereinafter Moderna, Inc., Statement During COVID-19 Pandemic].
81 Press Release, Food Drug Admin., FDA Takes Additional Action in Fight Against COVID-19 by Issuing Emergency Use Authorization for Second COVID-19 Vaccine (Dec. 2020). See also Federal Food, Drug, and Cosmetic Act § 564(c), Pub. L. No. 108-276, 118 Stat. 852 (2004) (codified as amended in 21 U.S.C. § 360bbb-3); U.S. Food & Drug Admin., OMB Control No. 0910-0595, Emergency Use Authorization of Medical Products & Related Authorities: Guidance for Industry & Other Stakeholders (2017).
82 Dani Kass, Moderna, Pfizer Playing the Long Game with Novel Vaccine IP, Law360 (Dec. 1, 2020), https://www.law360.com/health/articles/1331837/moderna-pfizer-playing-the-long-game-with-novel-vaccine-ip?nl_pk=f7c5304d-23a2-4a66-b93c-3b9145e8d004&utm_source=newsletter&utm_medium=email&utm_campaign=health&read_more=1 [https://perma.cc/49LU-YHMT].
83 See Program Patents, Moderna, Inc., https://www.modernatx.com/patents [https://perma.cc/XUF6-AAN9] (last visited Apr. 15, 2021).
84 Moderna, Inc., Statement During COVID-19 Pandemic, supra note 80.
85 Jorge L. Contreras, Deconstructing Moderna’s COVID-19 Patent Pledge, Harv. L. Petrie-Flom Center: Bill of Health, (Oct. 21, 2020), https://blog.petrieflom.law.harvard.edu/2020/10/21/moderna-covid19-patent-pledge/ [https://perma.cc/9ZLL-79MQ].
86 Id.
87 Jorge L. Contreras et al., Pledging Intellectual Property for COVID-19. 38 Nat. Biotech. 1146, 1146, 1148 (Oct. 2020), https://doi.org/10.1038/s41587-020-0682-1 [https://perma.cc/Z2KG-FW6V].
88 Id. at 1146-47.
89 Ed Silverman, AbbVie Will Allow Generic Copies of Its HIV Pill in Israel After the Government Approved a License, Stat, (Mar. 20, 2020), https://www.statnews.com/pharmalot/2020/03/20/abbvie-israel-hiv-kaletra-coronavirus-covid19/ [https://perma.cc/689S-QHJ5].
90 Research and Discovery Efforts Battling COVID-19 and Beyond, AbbVie, Inc, https://www.abbvie.com/our-science/covid-19-research-development.html [https://perma.cc/7KWP-G5Y7] (last visited Nov. 23, 2020).
91 Expedited Access for COVID-19 Related IP, Oxford Univ. Innovation, https://innovation.ox.ac.uk/technologies-available/technology-licensing/expedited-access-covid-19-related-ip/ [https://perma.cc/LX3N-PL44] (last visited Nov. 23, 2020).
92 Id.
93 Id.
94 Id.
95 About, Rapid Deployment Vaccine Collaborative, https://radvac.org/a-homepage-section/ [https://perma.cc/49WM-KD5N] (last visited Nov. 23, 2020).
96 Id.; Gunjan Agarwal & Chipo Jolibois, IP Risks to Consider When Joining ‘Open COVID Pledge,’ Law360 (June 30, 2020), https://www.law360.com/articles/1287364 [https://perma.cc/AN4V-ZVQ8].
97 Contreras et al., supra note 87.
98 IPR Pledge Database, Am. U.C. of L., (Nov. 17, 2020), http://www.pijip.org/non-sdo-patent-commitments/ [https://perma.cc/HK2G-W45H] (IPR database of publicly available statements and commitments made with respect to patents and patent licensing).
99 FDA Listing of Patent Information in the Orange Book; Establishment of a Public Docket: Request for Comments, 85 Fed. Reg. 33169 (June 1, 2020).
100 Id.
101 Federal Food, Drug & Cosmetic Act §505, 21 U.S.C. § 355(b)(1) (2018).
102 Applications for Biologics Licenses; Procedures for Filing, 21 C.F.R. § 601.2 (2011).
103 Purple Book Database of Licensed Biological Products: About Purple Book, U.S. Food & Drug Admin., https://purplebooksearch.fda.gov/about [https://perma.cc/NHJ3-VPUL] (last visited April 17, 2021).
104 Federal Food, Drug & Cosmetic Act § 505, 21 U.S.C. § 355 (2018).
105 Id.
106 Id. at § 355(b)(1) (emphasis added).
107 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, U.S. Food & Drug Admin., https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm [https://perma.cc/ASM4-9H6R] (last updated April 2021).
108 21 C.F.R. § 314.53 (2011); 21 C.F.R. § 314.107 (2002).
109 21 C.F.R. § 314.53(c)(1) (2011).
110 Abbreviated New Drug Applications and 505(b)(2) Applications, 81 Fed. Reg. 69580 (Oct. 6, 2016) (codified in 21 C.F.R. § 314.53(d)(5)).
111 Food, Drug & Cosmetic Act §505(c)(2), 21 U.S.C. § 355(b)(1) (2018); Frequently Asked Questions on Patents and Exclusivity, U.S. Food & Drug Admin., https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity [https://perma.cc/6FK8-DW3U] (last updated Feb. 2, 2020).
112 Frequently Asked Questions on Patents and Exclusivity, supra note 111.
113 21 C.F.R. § 314.70(a)(1)(i) (2020).
114 See U.S. Food & Drug Admin., Patent Certifications and Suitability Petitions (Apr. 8, 2021), https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions [https://perma.cc/9ZCP-6LZ4].
115 Jordan Paradise, Reassessing ‘Safety’ for Nanotechnology Combination Products: What Do ‘Biosimilars’ Add to Regulatory Challenges for the FDA?, 56 St. Louis U. L. J. 465, 484 (2012).
116 U.S. Food & Drug Admin., Patent Certifications and Suitability Petitions, https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions#:~:text=To%20seek%20this%20approval%2C%20a%20generic%20applicant%20must,will%20not%20be%20infringed%20by%20the%20generic%20product [https://perma.cc/4GYQ-A7HP] (last updated Dec. 1, 2020).
117 Reassessing ‘Safety’ for Nanotechnology Combination Products: What Do ‘Biosimilars’ Add to Regulatory Challenges for the FDA?, supra note 115; Maryll Toufanian & Martin Shimer, Hatch-Waxman 101, Regulatory Education for Industry (REdI): Generic Drugs Forum (Apr. 22-23, 2015), https://www.fda.gov/files/drugs/published/Hatch-Waxman-Patent-and-Certification-Process-101.pdf [https://perma.cc/QA93-T2UV].
118 Apotex, Inc. v. Thompson, 347 F.3d 1335, 1352 (Fed. Cir. 2003).
119 Id. at 1347.
120 Id.
121 The relevant interpretation was contained in 21 C.F.R. § 314.53(f) (2020). Apotex, Inc., 347 F.3d at 1351; aaiPharma v. Thompson, 296 F.3d 227, 238 (4th Cir. 2002).
122 Jordan Paradise, The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the United States Healthcare System, 41 Am. J.L. & Med. 49, 52 (2015).
123 Id. at 50.
124 Id.
125 See Jordan Paradise, Insulin Federalism, 27 B.U. J. Sci. & Tech. L. (forthcoming 2021).
126 See Paradise, The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the United States Healthcare System, supra note 122, at 64.
127 U.S. Food & Drug Admin., Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or [https://perma.cc/8VX4-M74G] (last updated Mar. 5, 2021).
128 See Consolidated Appropriations Act, H.R. 133, 116th Cong. § 325(a)(9)(A)(i)(I) (2021).
129 42 U.S.C. § 262(4)(A) (2011).
130 Consolidated Appropriations Act, supra note 128. Subtitle C (FDA Amendments), Section 325 contains the Biologic Product Patent Transparency provisions. The “patent dance” is the process of the confidential, private back and forth regarding relevant patents between the innovator biologic and the biosimilar applicant.
131 42 U.S.C. § 262(l) (2011).
132 Consolidated Appropriations Act, supra note 128 at § 325(a)(9)(A)(iv).
133 Id.
134 Id.
135 Orange Book Transparency Act of 2020, H.R. 1503, 116th Cong. (2021).
136 Id. at §2(a)(1). The Act also prohibits the submission of patent information outside the scope of the defined categories. Id., at §2(b)(1)(D).
137 Id. at §2(c).
138 Id. at §2(d).
139 Id. at §2(e) & (f).
140 The FDA published a guidance document for industry in October 2020 providing insight on the process of authorization. U.S. Food & Drug Admin., Guidance for Industry: Emergency Use Authorizations for Vaccines to Prevent COVID-19 (Feb. 2021), https://www.fda.gov/media/142749/download [https://perma.cc/YYP8-PRM3].
141 Government Accountability Office, COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations (Nov. 17, 2020), https://www.gao.gov/products/GAO-21-207 [https://perma.cc/AM7S-4KWU].
142 See Emergency Use Authorization for Vaccines to Prevent COVID-19, supra note 140 at 3. For an analysis and discussion of the FDA’s use of guidance documents during the pandemic, see Jordan Paradise & Becky Bavlsik, Pandemic Politics, Public Health, and the FDA, forthcoming 8 Belmont L. Rev. (forthcoming 2021).
143 Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations, supra note 141.
144 Id.
145 Associated Press, Credibility of U.S. Health Agencies At Risk After a Week of Blunders, LA Times (Aug. 28, 2020), https://www.latimes.com/science/story/2020-08-28/credibility-of-u-s-health-agencies-at-risk-after-week-of-blunders [https://web.archive.org/web/20200829033832/https://www.latimes.com/science/story/2020-08-28/credibility-of-u-s-health-agencies-at-risk-after-week-of-blunders].
146 Michael Joyner et al., Effect of Convalescent Plasma on Mortality Among Hospitalized Patients with COVID-19: Initial Three- Month Experience (Aug. 12, 2020) https://www.medrxiv.org/content/10.1101/2020.08.12.20169359v1.full.pdf [https://perma.cc/5PPU-PXW6].
147 Michael Hiltzik, Thanks to Trump, the FDA Just Had the Worst Day in its History, LA Times (Aug. 24, 2020), https://www.latimes.com/business/story/2020-08-24/trump-fda-attack-commissioner-stephen-hahn-silent [https://web.archive.org/web/20200824173149/https://www.latimes.com/business/story/2020-08-24/trump-fda-attack-commissioner-stephen-hahn-silent]; Donald Trump, U.S. President, Remarks by President Trump in Press Briefing, Aug. 23, 2020 (Aug. 23, 2020), https://www.whitehouse.gov/briefings-statements/remarks-president-trump-press-briefing-august-23-2020/ [https://web.archive.org/web/20200824054512/https://www.whitehouse.gov/briefings-statements/remarks-president-trump-press-briefing-august-23-2020/].
148 @SteveFDA, Twitter (Aug. 24, 2020, 6:36 PM), at https://twitter.com/SteveFDA/status/1298071620414824452 [https://web.archive.org/web/20200825013633/https://twitter.com/SteveFDA/status/1298071620414824452].
149 See U.S. Food & Drug Admin., FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic (Aug. 23, 2020), https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment [https://perma.cc/PBJ9-NT9L]; see also Associated Press, Credibility of U.S. Health Agencies At Risk After a Week of Blunders, LA Times, Aug. 28 2020, https://www.latimes.com/science/story/2020-08-28/credibility-of-u-s-health-agencies-at-risk-after-week-of-blunders [https://web.archive.org/web/20200829033832/https://www.latimes.com/science/story/2020-08-28/credibility-of-u-s-health-agencies-at-risk-after-week-of-blunders].
150 See Press Release, U.S. Food & Drug Admin., Coronavirus (COVID-19) Update: Daily Roundup March 30, 2020 (Mar. 30, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-30-2020 [https://perma.cc/W2NU-963N].
151 See Elizabeth Y. McCuskey, FDA in the Time of COVID-19, 45.3 Admin. & Reg. L. News 7, 8 (Spring 2020); see also Philip Bump, Trump and Fox Went All-In on a Coronavirus Silver Bullet. But Maybe the Wrong One, Washington Post (Apr. 19, 2020), https://www.washingtonpost.com/politics/2020/04/19/trump-fox-went-all-in-coronavirus-cure-what-if-they-picked-wrong-one/ [https://perma.cc/4KSZ-C2V9].
152 Press Release, U.S. Food & Drug Admin., Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine (June 15, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and#:~:text=Today%2C%20the%20U.S.%20Food%20and,clinical%20trial%20was%20unavailable%2C%20or [https://perma.cc/U6LZ-XT6L].
153 Press Release, U.S. Food & Drug Admin., COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs (Nov. 17, 2020), https://www.fda.gov/news-events/press-announcements/covid-19-update-fdas-ongoing-commitment-transparency-covid-19-euas [https://perma.cc/3LB2-UWY5].
154 See, e.g., Gebrekidan & Apuzzo, supra note 77; Doctors Without Borders, U.S. Must Stop Blocking WTO Waiver on COVID-19 Medical Tools (Mar. 9, 2021), https://www.doctorswithoutborders.org/what-we-do/news-stories/news/us-must-stop-blocking-wto-waiver-covid-19-medical-tools [https://perma.cc/4MMC-YCXD]; Reuters Staff, Rich, Developing Nations Wrangle Over COVID Vaccine Patents, Reuters (Mar. 10, 2021), https://www.reuters.com/article/us-health-coronavirus-wto/rich-developing-nations-wrangle-over-covid-vaccine-patents-idUSKBN2B21V9 [https://perma.cc/6SYP-S4T6]; Hailey Konnath, 250 Researchers, Orgs Urge WTO to Back COVID IP Waiver, Law360 (Mar. 22, 2021), https://www.law360.com/articles/1367374/250-researchers-orgs-urge-wto-to-back-covid-ip-waiver [https://perma.cc/VLZ7-DP65].
155 U.S. Food & Drug Admin., FDA-Approved Drugs, Drugs@FDA: FDA-Approved Drugs, https://www.accessdata.fda.gov/scripts/cder/daf/ [https://perma.cc/C7XD-TWM3].
156 National Insts. of Health, U.S. National Library of Medicine, ClinicalTrials.gov [https://perma.cc/L6R7-WCF4].
157 USA Spending, Government Spending Open Data, USAspending.gov [https://perma.cc/9RKA-XNMG].
158 Government Accountability Office Report to Congressional Requesters, GAO 21-52, Biomedical Research, supra note 41.