References
- Arno, P. S., & Davis, M. H. (2000). Why don't We enforce existing drug price controls–The unrecognized and unenforced reasonable pricing requirements imposed upon patents deriving in whole or in part from Federally Funded Research. Tulane Law Review, 75, 631. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=243040.
- Bajgain, K. T., Badal, S., Bajgain, B. B., & Santana, M. J. (2021). Prevalence of comorbidities among individuals with COVID-19: A rapid review of current literature. American Journal of Infection Control, 49(2), 238–246. https://doi.org/https://doi.org/10.1016/j.ajic.2020.06.213
- Barlas, S. (2019). Democratic presidential candidates lead attack on drug prices: Health insurance expansions tougher on drugs than dems’ bill in house. Pharmacy and Therapeutics, 44(9), 539–544. https://pubmed.ncbi.nlm.nih.gov/31485147.
- Brachmann, S. (2019). Examining the Truvada #BreakThePatent debate: Gilead responds. IPWatchdog. https://www.ipwatchdog.com/2019/03/03/examining-truvada-breakthepatent-debate-gilead-responds/id=106906/.
- Break the Patent Campaign. (2019). #Breakthepatent. https://breakthepatent.org/.
- Carines, G. (2016). Cost is biggest barrier to PrEP in Europe, ECDC report declares. AIDSMAP. http://www.aidsmap.com/news/jun-2016/cost-biggest-barrier-prep-europe-ecdc-report-declares.
- Chami, G., & Wasswa-Kintu, S. (2011). Compulsory licensing of generic drugs remains mired in quagmires. CMAJ: Canadian Medical Association Journal, 183(11), E705–E706. https://doi.org/https://doi.org/10.1503/cmaj.109-3898
- Conti, R. M., & Kleutghen, P. (2019, July 29). Is ‘Competitive Licensing’ proposed In HR 1046 practical for lowering drug prices? Health Affairs, https://www.healthaffairs.org/do/10.1377/hblog20190724.85223/full/.
- Correa, C. (2002). Implications of the doha declaration on the trips agreement and public health. The World Health Organization. https://apps.who.int/iris/bitstream/handle/10665/67345/WHO_EDM_PAR_2002.3.pdf.
- C-SPAN. (2019, February 5). 2019 State of the Union Address [Video]. C-SPAN. https://www.c-span.org/video/?457350-1/president-trump-appeals-unity-end-gridlock-state-union-address.
- Davis, R. (2019). Democratic candidates advocate For busting drug patents. Law360. https://www.law360.com/articles/1221027/democratic-candidates-advocate-for-busting-drug-patents.
- Dyer, O. (2020). Covid-19: Remdesivir has little or no impact on survival, WHO trial shows. BMJ, 371, m4057. https://doi.org/https://doi.org/10.1136/bmj.m4057
- Essential Inventions. (2004a). Petition to use authority under bayh-dole act to promote access to ritonavir, supported by national institute of allergy and infectious diseases contract No. AI27220. http://www.essentialinventions.org/legal/norvir/norvir-29jan04petition.pdf.
- Essential Inventions. (2004b). Ritonavir (Norvir). http://www.essentialinventions.org/drug/ritonavir.html.
- Garrison, C. (2020). Price, profit and the covid-19 health technology pool: The example of remdesivir. Medicines Law & Policy. https://medicineslawandpolicy.org/2020/05/price-profit-and-the-covid-19-health-technology-pool-the-example-of-remdesivir/.
- GHJP Joins PrEP4All in Calling on CDC To Use Its Patents for PrEP. (2019). Yale Law School. https://law.yale.edu/yls-today/news/ghjp-joins-prep4all-calling-cdc-use-its-patents-prep.
- Gilead Sciences. (2020). Voluntary Licensing Agreements for Remdesivir. https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir.
- Harvey, D. (2007). A brief history of neoliberalism. Oxford University Press.
- Hayes, R., Schmidt, A. J., Pharris, A., Azad, Y., Brown, A. E., Weatherburn, P., Hickson, F., Delpech, V., Noori, T., & Network, t. E. D. D. M. (2019). Estimating the ‘PrEP Gap’: How implementation and access to PrEP differ between countries in Europe and Central Asia in 2019. Eurosurveillance, 24(41), https://doi.org/https://doi.org/10.2807/1560-7917.ES.2019.24.41.1900598
- Hemel, D. J., & Ouellette, L. L. (2017). Bayh–Dole beyond borders. Journal of Law and the Biosciences, 4(2), 282–310. https://doi.org/https://doi.org/10.1093/jlb/lsx011
- Hill, A., van der Lugt, J., Sawyer, W., & Boffito, M. (2009). How much ritonavir is needed to boost protease inhibitors? Systematic review of 17 dose-ranging pharmacokinetic trials. AIDS, 23(17), 2237–2245. https://doi.org/https://doi.org/10.1097/QAD.0b013e328332c3a5
- Horby, P. W., Mafham, M., Bell, J. L., Linsell, L., Staplin, N., Emberson, J., Palfreeman, A., Raw, J., Elmahi, E., & Prudon, B. (2020). Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): A randomised, controlled, open-label, platform trial. The Lancet, 396(10259), 1345–1352. https://doi.org/https://doi.org/10.1016/S0140-6736(20)32013-4
- House Committee on Overight and Reform. (2019, May 16). HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments. https://oversight.house.gov/legislation/hearings/hiv-prevention-drug-billions-in-corporate-profits-after-millions-in-taxpayer.
- Kaiser, J. (2020, June 3). NIH grapples with rush to claim billions in pandemic research funds. Science Magazine. https://www.sciencemag.org/news/2020/06/nih-grapples-researchers-rush-claim-billions-pandemic-research-funds.
- Kankanala, K. C. (2012). FUN IP: Fundamentals of intellectual property. Literators Publishing.
- Keown, A. (2020). Following outcry, Gilead sciences seeks to rescind orphan drug designation for COVID-19 drug. BioSpace. https://www.biospace.com/article/following-outcry-gilead-sciences-seeks-to-rescind-orphan-drug-designation-for-covid-19-drug/.
- Knowledge Ecology International. (2017). Several march-in and royalty free rights cases, under the Bayh-Dole Act. https://www.keionline.org/cl/march-in-royalty-free.
- Knowledge Ecology International. (2020a). Resolution to require the National Government to establish compulsory licenses and other measures. https://www.keionline.org/ecuador-CL-coronavirus-resolution.
- Knowledge Ecology International. (2020b). Resolution for the granting of non-voluntary licenses referred to in article. https://www.keionline.org/chilean-covid-resolution.
- Knowledge Ecology International. (n.d.). Compulsory licensing as limitations on remedies for infringement under 28 U.S.C. §1498: Patent and copyright. https://www.keionline.org/cl/28usc1498.
- Kohler, J. C., Lexchin, J., Kuek, V., & Orbinski, J. (2010). Canada's access to medicines regime: Promise or failure of humanitarian effort? Healthcare Policy = Politiques de Sante, 5(3), 40–48. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2831732/. https://doi.org/https://doi.org/10.12927/hcpol.2013.21638
- Kolata, G. (2020, June 29). Remdesivir, the First Coronavirus Drug, Gets a Price Tag. The New York TImes. https://www.nytimes.com/2020/06/29/health/coronavirus-remdesivir-gilead.html.
- Love, J. (2016). 51 members of Congress have asked the NIH to use March-in rights to rein in high drug prices. Knowledge Ecology International. https://www.keionline.org/22983.
- Lui, L., Feldman, W. B., Avron, J., & Kesselheim, A. S. (2020, March 6). March-In Rights And Compulsory Licensing—Safety Nets For Access To A COVID-19 Vaccine. Health Affairs Blog. https://www.healthaffairs.org/do/10.1377/hblog20200501.798711/full/.
- Make Medcines Affordable (MMA). (2020). Make Medicines Affordable. https://makemedicinesaffordable.org/en/home/.
- Médecins Sans Frontières. (2012). Success story: The case of TDF in Brazil. Patent Opposition Database. https://www.patentoppositions.org/en/case_studies/4f106d0504a7f92f5b000003.
- Médecins Sans Frontières. (2020a). “If I can get this treatment, I can live longer”. Médecins Sans Frontières Access Campaign. https://msfaccess.org/patents-and-intellectual-property.
- Médecins Sans Frontières. (2020b). WTO COVID-19 TRIPS waiver proposal. Médecins Sans Frontières Access Campaign. https://msfaccess.org/sites/default/files/202012/COVID_TechBrief_MSF_AC_IP_TRIPSWaiver MythsRealities_ENG_Dec2020.pdf.
- Medicines Law & Policy. (2020). The TRIPS Flexibilities Database. http://tripsflexibilities.medicineslawandpolicy.org.
- Morten, C. (2019). Statement on CDC’s patents for PrEP. Yale Global Health Justice Partnership. https://law.yale.edu/sites/default/files/area/center/ghjp/documents/ghjpmortenstatement.pdf.
- Nandy, K., Salunke, A., Pathak, S. K., Pandey, A., Doctor, C., Puj, K., Sharma, M., Jain, A., & Warikoo, V. (2020, 2020/09/01). Coronavirus disease (COVID-19): A systematic review and meta-analysis to evaluate the impact of various comorbidities on serious events. Diabetes & Metabolic Syndrome: Clinical Research & Reviews, 14(5), 1017–1025. https://doi.org/https://doi.org/10.1016/j.dsx.2020.06.064
- National Institutes of Health. (2004a). In the Case of NORVIR® Manufactured by ABBOTT LABORATORIES, INC. National Institutes of Health, Office Of The Director. https://www.cogr.edu/sites/default/files/March-In-Norvir.pdf.
- National Institutes of Health. (2004b). NIH Public Meeting on Norvir/Ritonavir March-in Request May 25, 2004. https://www.ott.nih.gov/sites/default/files/documents/2004NorvirMtg/2004NorvirMtg.pdf.
- National Institutes of Health. (2020). Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding. https://grants.nih.gov/policy/natural-disasters/corona-virus.htm.
- New York City Council. (2019). New York City Council Speaker Corey Johnson Completes Tenure as Acting Public Advocate. https://council.nyc.gov/press/2019/03/26/1720/.
- Penman, J., & Quigley, F. (2017). Better late than never: How the US government can and should use Bayh-Dole March-in rights to respond to the medicines access crisis. Willamette Law Review, 54, 171. http://hdl.handle.net/1805/24134.
- Perez-Casas, C., Chirac, P., Berman, D., & Ford, N. (2000). Access to fluconazole in less-developed countries. The Lancet, 356(9247), 2102. https://doi.org/https://doi.org/10.1016/S0140-6736(05)74314-2
- Rabitschek, J. H., & Latker, N. J. (2005). Reasonable pricing-a new Twist for March-in Rights Under the Bayh-Dole Act. Santa Clara Computer & High Tech. Law Journal, 22, 149. https://digitalcommons.law.scu.edu/chtlj/vol22/iss1/4.
- Richards, K. T., Hickey, K. J., & Ward, E. (2020). Drug pricing and pharmaceutical patenting practices. Congressional Research Service. https://crsreports.congress.gov/product/pdf/R/R46221.
- Riva, L., Yuan, S., Yin, X., Martin-Sancho, L., Matsunaga, N., Pache, L., Burgstaller-Muehlbacher, S., De Jesus, P. D., Teriete, P., Hull, M. V., Chang, M. W., Chan, J. F.-W., Cao, J., Poon, V. K.-M., Herbert, K. M., Cheng, K., Nguyen, T.-T. H., Rubanov, A., Pu, Y., … Chanda, S. K. (2020). Discovery of SARS-CoV-2 antiviral drugs through large-scale compound repurposing. Nature, 586(7827), 113–119. https://doi.org/https://doi.org/10.1038/s41586-020-2577-1
- Roehr, B. (2007). Class action over Abbott's pricing of antiretroviral moves forward. BMJ, 334(7608), 1339–1339. https://doi.org/https://doi.org/10.1136/bmj.39257.587569.BE
- Saez, C. (2018). Truvada case shows civil society’s success with pre-grant opposition. Intellectual Property Watch. https://www.ip-watch.org/2018/05/08/truvada-case-shows-civil-societys-success-pre-grant-opposition/.
- Sagonowsky, E. (2020). Gilead loses again in PrEP patent fight with HHS, sending dispute to federal court. FiercePharma. https://www.fiercepharma.com/pharma/gilead-loses-another-prep-patent-challenge-against-hhs-sending-dispute-to-federal-court.
- Shah, A., & Gorgan, K. E. (2020). HHS HIV drug lawsuit: Setting precedent for other high priced medications or government collaborations? The National Law Review. https://www.natlawreview.com/article/hhs-hiv-drug-lawsuit-setting-precedent-other-high-priced-medications-or-government.
- Subhan, J. (2006). Scrutinized: The TRIPS agreement and public health. McGill Journal of Medicine, 9(2), 152–159. PMID: 18523624; PMCID: PMC2323529.
- t Hoen, E. (2002). TRIPS, pharmaceutical patents, and access to essential medicines: A long way from Seattle to Doha. Chicago Journal of International Law, 3(1), 27–46. PMID: 15709298.
- t Hoen, E. (2009). The global politics of pharmaceutical monopoly power: Drug patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and public health. AMB Pubishers.
- t Hoen, E., Berger, J., Calmy, A., & Moon, S. (2011). Driving a decade of change: HIV/AIDS, patents and access to medicines for all. Journal of the International AIDS Society, 14(1), 15–15. https://doi.org/https://doi.org/10.1186/1758-2652-14-15
- t Hoen, E., Veraldi, J. D., Toebes, B., & Hogerzeil, H. (2018). Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016. Bulletin of the World Health Organization, 96(3), 185–193. https://ssrn.com/abstract=3384083. https://doi.org/https://doi.org/10.2471/BLT.17.199364
- Thomas, J. R. (2016). March-In Rights Under the Bayh-Dole Act. Congressional Research Service. https://fas.org/sgp/crs/misc/R44597.pdf.
- Treasure, C. L., Avorn, J., & Kesselheim, A. S. (2015). Do March-In rights ensure access to medical products arising from Federally Funded Research? A qualitative study. The Milbank Quarterly, 93(4), 761–787. https://doi.org/https://doi.org/10.1111/1468-0009.12164
- United Nations Human Rights Office of the High Commissioner. (2020). Access to medicines - a fundamental element of the right to health. https://www.ohchr.org/EN/Issues/Development/Pages/AccessToMedicines.aspx.
- United States v. Gilead Sciences., Inc., Case No. 11-cv-00941-EMC. (N.D. Cal. Nov. 5, 2019). https://www.mintz.com/sites/default/files/media/documents/2019-12-09/19-cv-0210320Complaint20USA20v.20Gilead20Sciences20Inc.pdf.
- U.S. Patent and Trademark Office. (2008). U.S. Government Patents. U.S. Patent and Trademark Office. https://www.uspto.gov/web/offices/ac/ido/oeip/taf/govt/govt_toc.htm.
- Whalen, R. (2014). The Bayh-Dole Act & public rights in Federally Funded Inventions: Will the agencies ever go marching in. Northwestern University Law Review, 109, 1083. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3000130.
- Wilbur, T. (2019). IP Explained: Four things to know about the Bayh-Dole Act. PhRMA. https://catalyst.phrma.org/ip-explained-four-things-to-know-about-the-bayh-dole-act.
- Wong, H. (2020). The case for compulsory licensing during COVID-19. Journal of Global Health, 10(1), 010358–010358. https://doi.org/https://doi.org/10.7189/jogh.10.010358
- World Trade Organization. (2006a). Fact sheet: Obligations and exceptions. https://www.wto.org/english/tratop_e/trips_e/factsheet_pharm02_e.htm#dohadecl5d.
- World Trade Organization. (2006b). Pharmaceutical patents and the TRIPS Agreement. https://www.wto.org/english/tratop_e/trips_e/pharma_ato186_e.htm.
- World Trade Organization. (2017). WTO IP rules amended to ease poor countries’ access to affordable medicines. https://www.wto.org/english/news_e/news17_e/trip_23jan17_e.htm.
- World Trade Organization. (2020a). Overview: The TRIPS Agreement. https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm.
- World Trade Organization. (2020b). WTO legal texts. https://www.wto.org/english/docs_e/legal_e/legal_e.htm#TRIPs.