KEI Blogs and Reseach notes on COVID-19/Coronavirus

The following are links to KEI’s work on the coronavirus pandemic.

• March 5, 2020. Unreasonable pricing and the “Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020”
• March 14, 2020. Three areas in Section 202 of the Bayh-Dole Act that require action to ensure sufficient rights in patents on coronavirus relevant inventions.
• March 16, 2020. Patent Troll Files Lawsuit to Block Possible Coronavirus Diagnostic.
• March 17, 2020. Chilean Chamber of Deputies approves resolution for compulsory licenses for patents relating to the coronavirus virus.
• March 20, 2020. Legislative Committee in Ecuador approves resolution on compulsory licensing of patents relating to the coronavirus.
• March 20, 2020. Kathryn Ardizzone, Role of the U.S. Federal Government in the Development of GS-5734/Remdesivir, KEI Briefing Note 2020:1.
• March 23, 2020. Israel issues compulsory license to allow government to import generic versions of Kaletra.
• March 23, 2020. KEI Letter to Speaker Pelosi Regarding Use of “Other Transaction Authority” (OTA) in Coronavirus Bill to Escape Bayh-Dole Public Interest Safeguards.
• March 23, 2020. FDA gives Gilead a seven year regulatory monopoly for remdesivir to treat COVID-19, on grounds it is an “Orphan” treating a rare disease.
• March 23, 2020. President and Minister of Health of Costa Rica ask WHO to create global pool for rights in COVID-19 related technologies.
• March 24, 2020. House Coronavirus Bill Provision Could be Used for COVID-19/Coronavirus-Related R&D without Public-Interest Safeguards.
• March 25, 2020. FDA States Submission Date of Gilead’s Coronavirus Treatment Orphan Status Application is ‘Confidential’.
• March 27, 2020. Open letter to the World Health Organization (WHO) and its Member States on the proposal by Costa Rica to create a global pool for rights in the data, knowledge and technologies useful in the prevention, detection and treatment of the coronavirus/COVID-19 pandemic
• March 31, 2020. KEI and Public Citizen letter to Congress regarding Costa Rica proposal for WHO COVID-19 pool of rights in technology and data.
• April 1, 2020. Canadian Policy option that can permit the government to exercise rights in patents arising under procurement contracts in Canada, if “prior obligations” exist, and how that relates to WHO COVID-19 pooling proposal.
• April 6, 2020. NIH Response to KEI Letter to Secretary Azar on Bayh-Dole Options for COVID-19-related Inventions.
• April 6, 2020. WHO Director-General Remarks in support of Proposal by Costa Rica for Global Rights Pool on COVID-19 Technologies.
• April 7, 2020. Open letter asking 37 WTO Members to declare themselves eligible to import medicines manufactured under compulsory license in another country, under 31bis of TRIPS Agreement.
• April 10, 2020. KEI letter to Brazil Congress, regarding compulsory licensing bill.
• April 15, 2020. European Union Draft Resolution on COVID-19 for WHA73.
• April 22, 2020. Luis Gil Abinader. Government funding related to the cobas Liat Analyzer PCR testing device. KEI Research Note 2020:1.
• April 26, 2020. Canada notifies WTO on Bill C-13 to Facilitate Compulsory Licensing in the COVID-19 Response.
• April 28, 2020. KEI comments on the resolution WHA73: “Covid-19 Response” proposed by the European Union.
• May 1, 2020. Kathryn Ardizzone. The Federal Government’s Authority to Restrict or Eliminate Contractors’ Rights to Federally-Funded Inventions in “Exceptional Circumstances”. KEI Briefing Note 2020:2.
• May 4, 2020. Unitaid calls on world leaders and the global community to support the Covid-19 Technology Pool.
• May 11, 2020. 14 May 2020 – The WHO Covid-19 Technology Pool: The solution to ensure global access to Covid-19 health technologies.
• May 13, 2020. Patents related to PX-UV, an R2-D2 look-alike robot that may disinfect public spaces from SARS-CoV-2.
• May 13, 2020. WHO member states poised to adopt weaker than needed COVID-19 resolution after tortuous negotiations.
• May 28, 2020. Luis Gil Abinader. Role of Private Sector, Governments and Charities in Funding Research and Development Related to Tocilizumab. KEI Research Note 2020:2.
• May 29, 2020. AstraZeneca, Pfizer, IFPMA on the WHO COVID-19 Pool at May 28, 2020 IFPMA Press Briefing.
• June 3, 2020. EU Trade Commissioner Phil Hogan issues statement on European Union compulsory licensing in context of COVID-19, makes important statement about TRIPS Article 31bis.
• June 18, 2020. All aboard Gavi’s COVAX express? First class tickets for fully self-financed countries: second class tickets for funded countries (supported by ODA).
• June 21, 2020. WTO TRIPS Council (informal): South Africa’s interventions on COVID-19, TRIPS flexibilities, and domestic manufacturing capacity.
• June 24, 2020. Senate Foreign Relations Committee questions State Department, USAID, and HHS on COVID-19 and U.S. International Pandemic Preparedness, Prevention, and Response.
• June 24, 2020 (Updated June 29, 2020). Kathryn Ardizzone and James Love. Other Transaction Agreements: Government Contracts that May Eliminate Protections for the Public on Pricing, Access and Competition, Including in Connection with COVID-19. KEI Briefing Note 2020:3.
• July 1, 2020. KEI receives seven new contracts for COVID 19 research from BARDA and DOD, including five using “Other Transactions Authority” that weaken or eliminate Bayh-Dole and FAR Safeguards.

KEI is also taking a daily snapshot of COVID-19 confirmed cases in countries reported by JHU, here.

KEI has filed multiple Freedom of Information Act requests on issues related to the coronavirus pandemic, including on government funding of candidates for potential treatment of COVID-19. A list of all related FOIA requests and their current statuses is available here.

Press Links

• 2 July 2020. Sarah Owermohle. “Senators concerned about Covid-19 vaccine price controls.” Politico. https://www.politico.com/news/2020/07/02/senators-express-concern-over-covid-19-vaccine-price-controls-348192
• 2 July 2020. Jake Johnson. “‘A Scandal’: Contracts Show Trump Giving Big Pharma Free Rein to Price Gouge Taxpayer-Funded Coronavirus Drugs.” Common Dreams. https://www.commondreams.org/news/2020/07/02/scandal-contracts-show-trump-giving-big-pharma-free-rein-price-gouge-taxpayer-funded
• 1 July 2020. Christopher Rowland. “Trump administration makes it easier for drugmakers to profit from publicly funded coronavirus drugs, advocates say.” Washington Post. https://www.washingtonpost.com/business/2020/07/01/vaccine-coronavirus-barda-trump/
• 1 July 2020. Jonathon Gardner. “Federal coronavirus contracts dodge pricing oversight, advocacy group says.” BioPharma Dive. https://www.biopharmadive.com/news/coronavirus-contracts-dodge-pricing-oversight/580896/
• 1 July 2020. Bob Herman. “Federal government weakened its march-in rights for coronavirus drugs.” Axios. https://www.axios.com/federal-government-barda-contracts-moderna-regeneron-aaf9fde2-2ee1-46fb-8465-0d573e6af1ed.html
• 1 July 2020. Sharon Lerner. “The Trump Administration is waiving the public’s right to affordable coronavirus treatments.” The Intercept. https://theintercept.com/2020/07/01/coronavirus-treatment-drug-contracts-trump/
• 1 July 2020. Ed Silverman and Nicholas Florko. “Some U.S. government contracts for Covid-19 research could skirt affordable pricing laws.” STAT. https://www.statnews.com/pharmalot/2020/07/01/covid19-coronavirus-vaccines-drug-prices/
• 30 May 2020. Samuel Lovett. “Coronavirus: Company behind leading vaccine candidate criticised for ‘appalling’ lack of transparency”. Independent. https://www.independent.co.uk/news/health/coronavirus-vaccine-trial-results-us-symptoms-covid-19-moderna-a9524401.html
• 29 May 2020. Donato Paolo Mancini and Michael Peel. “Poorer countries join WHO call for virus patents to be shared.” Financial Times. https://www.ft.com/content/b964cfb2-5f2e-4cb7-b9ad-535481495eaa
• 26 May 2020. Christopher Rowland. “Taxpayers paid to develop remdesivir but will have no say when Gilead sets the price.” Washington Post. https://www.washingtonpost.com/business/2020/05/26/remdesivir-coronavirus-taxpayers/
• 20 May 2020. Alan Story. “Covid-19 vaccine patent pooling enters uncertain waters.” Green World. https://greenworld.org.uk/article/covid-19-vaccine-patent-pooling-enters-uncertain-waters
• 17 May 2020. Sarah Boseley. “US and UK ‘lead push against global patent pool for Covid-19 drugs’.” The Guardian. https://www.theguardian.com/world/2020/may/17/us-and-uk-lead-push-against-global-patent-pool-for-covid-19-drugs
• 13 May 2020. Ed Silverman. “World Health Assembly draft resolution boosts access to Covid-19 medicines.” STAT. https://www.statnews.com/pharmalot/2020/05/13/covid19-coronavirus-resolution-access-medicines-who/
• 13 May 2020. Jacob Bell. “Gilead licenses COVID-19 drug to 5 generics companies.” BioPharma Dive. https://www.biopharmadive.com/news/gilead-license-remdesivir-generic-makers/577876/
• 8 May 2020. Justin Hughes and Arti Rai. “Acknowledging the public role in private drug development: lessons from remdesivir.” STAT. https://www.statnews.com/2020/05/08/acknowledging-public-role-drug-development-lessons-remdesivir/
• 8 May 2020. Ed Silverman. “The U.S. government contributed research to a Gilead remdesivir patent — but didn’t get credit.” STAT. https://www.statnews.com/pharmalot/2020/05/08/gilead-remdesivir-covid19-coronavirus-patents/
• 7 May 2020. Niklas Schenck. “Medizin ist ein öffentliches Gut, jeder muss sich das ­leisten können.” Suddeutsche Zeitung Magazin. https://sz-magazin.sueddeutsche.de/gesundheit/jamie-love-manon-ress-interview-corona-covid-19-88769?reduced=true
• 6 May 2020. Matthew Bultman. “Pooling Patents to Speed Virus Treatments More Logical Than Easy.” Bloomberg Law. https://news.bloomberglaw.com/ip-law/pooling-patents-to-speed-virus-treatments-more-logical-than-easy
• 6 May 2020. Samuel Lovett. “‘The vaccine is only half the story’: If a cure is found, the world must be ready for the challenges that follow.” Independent. https://www.independent.co.uk/independentpremium/long-reads/coronavirus-vaccine-latest-cure-covid-19-oxford-university-trump-who-america-a9493966.html
• 22 April 2020. Valerie Bauman and Susan Decker. “Covid Seen as Tipping Point to Lower Drug Prices, Patent Sharing.” Bloomberg Law. https://news.bloomberglaw.com/pharma-and-life-sciences/covid-seen-as-tipping-point-to-lower-drug-prices-patent-sharing
• 22 April 2020. Robert Mackey and Sharon Lerner. “As Trump Urges Doctors to Lie on Live TV, Federal Official Says He Was Fired for Limiting Hydrochloroquine Use.” The Intercept. https://theintercept.com/2020/04/22/trump-urges-doctors-lie-live-tv-federal-official-says-fired-limiting-use-hydroxychloroquine/
• 17 April 2020. Emily Kopp. NIH announces strategy for developing COVID-19 drugs, vaccines. Roll Call. https://www.rollcall.com/2020/04/17/nih-announces-strategy-for-developing-covid-19-drugs-vaccines/
• 16 April 2020. Ed Silverman. “European Union urges the World Health Assembly to pursue a voluntary pool for Covid-19 products.” STAT. https://www.statnews.com/pharmalot/2020/04/16/european-union-who-voluntary-pool-covid19-coronavirus/
• 8 April 2020. Editorial Team. “The Netherlands Joins COVID-19 IP Pool Initiative; Kentucky Governor Requests 3M Release N95 Patent.” Health Policy Watch. https://www.healthpolicy-watch.org/the-netherlands-joins-covid-19-ip-pool-initiative-kentucky-governor-requests-3m-release-n95-patent/
• 7 April 2020. Ed Silverman. “Wealthy nations urged to embrace WTO deal and import meds made under compulsory licenses.” STAT. https://www.statnews.com/pharmalot/2020/04/07/wto-compulsory-licensing-covid19-coronavirus-patents/
• 3 April 2020. Alicia Mundy. “How Big Pharma Is Getting Ready To Blackmail Americans”. DCReport. https://www.dcreport.org/2020/04/03/how-big-pharma-plans-to-blackmail-americans/
• 31 March 2020. Donato Paolo Mancini. “Big drugmakers under pressure to share patents against coronavirus“. Financial Times. https://www.ft.com/content/b69afd98-a8af-40d9-b520-4231d9cac68f
• 28 March 2020. Steven Ross Johnson. “Race for COVID-19 treatments reignites debate over role of public funding”. Modern Healthcare. https://www.modernhealthcare.com/supply-chain/race-covid-19-treatments-reignites-debate-over-role-public-funding
• 25 March 2020. Sydney Lupkin. “Gilead Declines ‘Rare Disease’ Status For Experimental Coronavirus Drug”. NPR. https://www.npr.org/sections/health-shots/2020/03/25/821534016/drugmaker-asks-fda-to-rescind-rare-disease-status-perks-for-covid-19-drug
• 25 March 2020. Donato Paolo Mancini, Hannah Kuchler, and Kiran Stacey. “Gilead asks to rescind special status for potential coronavirus drug”. Financial Times.  https://www.ft.com/content/107706c0-6ec0-11ea-89df-41bea055720b
• 25 March 2020. Carlos Salazar F. “Medio especializado en medicina resalta petición de Costa Rica a la OMS para liberar información especializada sobre Covid 19.” El Pais.CR https://www.elpais.cr/2020/03/25/medio-especializado-en-medicina-resalta-peticion-de-costa-rica-a-la-oms-para-liberar-informacion-especializada-sobre-covid-19/
• 24 March 2020. Donato Paolo Mancini. Gilead criticised over ‘orphan status’ for potential virus treatment – Activists slam US drugmaker for seeking exclusivity ‘despite calls for solidarity’ to tackle pandemic. https://www.ft.com/content/9fea4f1c-6dba-11ea-89df-41bea055720b
• 24 March 2020. Ed Silverman. “WHO is asked to create a voluntary intellectual property pool to develop Covid-19 products”. STAT. https://www.statnews.com/pharmalot/2020/03/24/covid19-coronavirus-costa-rica-intellectual-property/
• 24 March 2020. Elaine Ruth Fletcher and Svet Lustig. “Costa Rica Urges WHO To Lead Global Initiative For Pooled Rights To COVID-19 Diagnostics, Drugs & Vaccines.” Health Policy Watch. https://www.healthpolicy-watch.org/costa-rica-urges-who-to-lead-global-initiative-for-pooled-rights-to-covid-19-diagnostics-drugs-vaccines/
• 23 March 2020. Lee Fang, Sharon Lerner. “Coronavirus Treatment Developed by Gilead Sciences Granted ‘Rare Disease’ Status, Potentially Limiting Affordability”. The Intercept. https://theintercept.com/2020/03/23/gilead-sciences-coronavirus-treatment-orphan-drug-status/
• 23 March 2020. Ed Silverman. “Ecuador becomes the latest country to eye compulsory licensing for Covid-19 products”. STAT. https://www.statnews.com/pharmalot/2020/03/23/ecuador-compulsory-licensing-covid19-coronavirus/
• 18 March 2020. Ed Silverman. “Chilean lawmakers support compulsory licensing for coronavirus medicines and vaccines”. STAT. https://www.statnews.com/pharmalot/2020/03/18/chile-compulsory-licensing-coronavirus-covid19-vaccines/
• 5 March 2020. Sarah Karlin-Smith. “How the drug industry got its way on the coronavirus“. Politico. https://www.politico.com/news/2020/03/05/coronavirus-drug-industry-prices-122412