IP/C/W/670  
 
23 November 2020  
(20-8438) Page: 1/7 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
 
EXAMPLES OF IP ISSUES AND BARRIERS IN COVID -19 PANDEMIC  
COMMUNICATION FROM SOUTH AFRICA  
Preliminary patent landscape of selected priority COVID -19 candidate therapeutics1 
1  INTRODUCTION  
1.  The current global pandemic of COVID -19, caused by infection with the novel coronavirus 
SARS -CoV-2, poses an unprecedented global health challenge. There are no proven effective cures 
or vaccines to date. A few hundreds of therapeutic candidates are in different stages of clinical trials, 
including the Wor ld Health Organization (WHO) international Solidarity Trial. Although many 
candidates are off -patent medicines, other repurposed and new therapies are either under patent 
protection or could be subject to new patent applications. Once safety and efficacy o f any of the 
candidate therapeutics are demonstrated, ensuring access to the effective therapeutics for all people 
will be an immediate challenge facing all countries.  
2.  Multiple barriers may hinder rapid and ample production and sufficient supply of effect ive and 
affordable therapeutics. At the centre is the use of intellectual property (IP) and other exclusivities 
to restrict manufacturing and supply options that would lower drug prices and increase patient 
access. These exclusivities may also enable compa nies to charge high prices and profiteer from the 
pandemic or prioritise wealthier countries over ones with less financial capacity. Governments need 
to prepare and take actions to address the anticipated IP barriers on therapeutics .  
3.  The preliminary patent landscape offers a non -exhaustive snapshot of the patent filing and 
granting status on five selected therapeutics candidates that ar e under review by the WHO Access 
to COVID -19 Tools Accelerator (ACT -A) therapeutics pillar. Out of the five candidates, four are 
repurposed medicines that were developed for treating other diseases. Due to the interval between 
the time of patent filing and  publication, which can take up to 18 months, new patent applications 
that might have been filed this year may emerge in the coming months.  
4.  The table below demonstrates that new patent has emerged on new monoclonal antibody with 
the Regeneron REGN10993+RE GN10987 was granted a patent in the US in June 2020 which only 
expires in 2040. The access strategy of Regeneron on this therapy remains unknown.  
5.  There are high levels of patent filing and granting on anti -viral therapies. Merck’s Molnupiravir 
(MK-4482) h as primary patent applications filed in at least 28 jurisdictions, including two regional 
patent officers, expiring between 2035 -2038. Atea pharmaceutical’s AT -527 has primary and 
secondary patents and applications filed or granted in nearly 60 jurisdictio ns, expiring between 
2036-2038. Incety Corp’s baricitinib has primary patent and application filed or granted in nearly 50 
jurisdictions, expiring in 2029. Roche’s monoclonal antibody therapy tocilizumab has primary and 
secondary patent and applications fi led or granted in nearly 30 jurisdictions, expiring between 
2022-2028.  
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1 Sources: https://www.medspal.org/?disease_areas%5B%5D=COVID -19+(drug+candidate)&page=1; 
https://worldwide.espacenet.com , https://patentscope.wipo.int   
  IP/C/W/670  
 
- 2 - REGN10933+REGN10987  
Company: Regeneron  
Category: monoclonal antibody therapy  
Description  PCT Publication/Application  Estimated expiry  Filed in  Granted in  
A patent application covering  REGN10933 and 
REGN10987 antibodies  
 N/A 
US patent granted as US10787501(B1)  25 June 2040  US US 
Molnupiravir (MK -4482)  
Company: Merck  
Category: anti -viral medicine  
Description  PCT 
Publication/Application  Estimated expiry  Filed in  
Molnupiravir and 
analogues (Markush 
structure) and their use as 
antivirals  
 WO/2016/106050  
PCT/US2015/066144  
 16 December  2035 Albania, Armenia, Australia, Azerbaijan, Belarus, Bosnia and Herzegovina, Brazil, 
Canada, China, Eurasian Patent Organization (EAPO),2 European Patent Office 
(EPO),3 India, Israel, Kazakhstan, Republic of Korea , Kyrgyz  Republic , Japan, 
Republic of Moldova , Montenegro, Morocco, North Macedonia, Russian Federation , 
Serbia, Singapore, South Africa, Tajikistan, Turkey, Turkmenistan  
Molnupiravir compound 
and its use as antiviral  
 WO/2019/113462  
PCT/US2018/064503  
 7 December  2038 Albania, Armenia, Australia, Azerbaijan, Belarus, China, EAPO, EPO,  Israel, 
Kazakhstan, Republic of Korea , Kyrgyz Republic , Japan, Mexico, North Macedonia, 
Russian Federation , Serbia, Singapore, Tajikistan, Turkey, Turkmenistan  
AT-527  
Company: Atea Pharmaceutical  
Category: ant -viral medicine  
Description  PCT 
Publication/Application  Estimated 
expiry  Filed in  Granted in  
AT-527 compound and 
analogues (Markush 
structure) & their use in 
HCV 
 WO/2016/144918  
PCT/US2016/021276  
 
 7 March 2036  Albania, , Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, 
Brazil, Canada, Egypt, EAPO, EPO, Georgia, India, Indonesia, 
Israel, Japan, Kazakhstan, Republic of Korea , Kyrgyz Republic , 
Malaysia, Mexico, Republic of Moldova , Montenegro, Morocco, New 
Zealand, Nigeria, North Macedonia, Philippines, Russian Australia, Botswana, 
China, Colombia, 
Eswat ini, The Gambia , 
Ghana, Kenya, Lesotho, 
Liberia, Malawi, 
 
2 Eurasian Patent Office covers 8 member states of the Eurasian Patent Organization: Armenia, Azerbaijan , Belarus, Kazakhstan , Kyrgyzstan , Russia, Tajikistan 
and Turkmenistan: https://www.eapo.org/en/members.html   
3 European Patent Office covers 38 member states of the European Patent Organization: https://www.epo.org/about -us/foundation/member -states.html    
  IP/C/W/670  
 
- 3 - Description  PCT 
Publication/Application  Estimated 
expiry  Filed in  Granted in  
Federation , Serbia, Kingdom of Saudi Arabia, Tajikistan, Thailand, 
Turkey, Turkmenistan, Ukraine, United Arab Emirates, Viet Nam  Mozambique, Namibia, 
Rwanda, Sao Tome and 
Principe, Sierra Leone, 
Singapore, South Africa, 
Sudan, Tanzania, 
Zambia, Zimbabwe4 
Use of AT -527 and 
similar compounds for 
RNA virus treatment 
(other than HCV)  
 WO/2018/048937  
PCT/US2017/050323  
 6 September , 
2037 Albania, Armenia, Australia, Azerbaijan, Belarus, Brazil, Canada, 
China, EAPO, EPO, Indonesia, Japan, Kazakhstan, Republic of 
Korea , Kyrgyz Republic , Malaysia, Republic of Moldova , Niger ia, 
North Macedonia, Russian Federation , Serbia, Singapore, South 
Africa, Tajikistan, Thailand, Turkey, Turkmenistan, Viet Nam   
AT-527 hemisulfate salt  
 WO/2018/144640  
PCT/US2018/016301  
 31 January  
2038 Albania, Argentina, Armenia, Azerbaijan, Belarus, Br azil, Canada, 
China, Egypt, EAPO, EPO, Colombia, Eswatini, The Gambia , India, 
Israel, Georgia, Ghana, Japan, Kazakhstan, Kenya, Republic of 
Korea , Kyrgyz Republic , Lesotho, Liberia, Malawi, Malaysia, 
Mexico, Mozambique, Namibia, New Zealand, Nigeria, North  
Macedonia, Russian Federation , Rwanda, Sao Tome and Principe, 
Serbia, Sierra Leone, , South Africa, Sudan, Tajikistan, Tanzania, 
Thailand, Turkey, Turkmenistan, Uganda, Ukraine, Uzbekistan, 
Viet Nam, Zambia, Zimbabwe  Australia, Colombia, 
Indonesia, Singapore  
Baricitinib  
Company: Incyte Corp  
Category: anti -viral medicine  
Description  PCT 
Publication/Application  Estimate 
expiry  Filed in  Granted in  
Arthritis, 
Rheumatoid  
COVID -19 (drug 
candidate)  
 WO/2009/114512  
PCT/US2009/036635  
 10 March 2029  Ecuador, Egypt, El Salvador, Guatemala, 
Honduras, Pakistan, Paraguay, Thailand, 
Trinidad and Tobago, Tunisia, Uruguay, 
Venezuela  Albania, Algeria, Argentina, Armenia, Australia, 
Azerbaijan, Bosnia and Herzegovina, Brazil, 
Canada, Chile, China, Colombia, Costa Rica, 
Dominican Republic, EAPO, EPO, India, Indonesia, 
Kazakhstan, Republic of Korea , Malaysia, Mexico, 
Morocco, Nigeria, North Macedonia, Panama, 
Peru, Philippines, Russian Federation  (term 
 
4 Many African countries included in  the table are member states of the African Regional Intellectual Property Organization (ARIPO). ARIPO’s member states 
include Botswana, Eswatini, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mauritius, Mozambique, Namibia, Rwanda, Sao Tome and Principe , Sierra Leone, Somalia, 
Sudan, Tanzania, Uganda, Zambia, Zimbabwe. https://www.aripo.org/member -states/      
  IP/C/W/670  
 
- 4 - Description  PCT 
Publication/Application  Estimate 
expiry  Filed in  Granted in  
extended to 2033), Serbia, South Africa, 
Tajikistan, Turkey, Ukraine, UAE, Uzbekistan, 
Viet Nam 
Tocilizumab  
Company: Roche  
Category: monoclonal antibody therapy  
Description  PCT 
Publication/Application  Estimate 
expiry  Filed in  Granted in  Rejected/Revoked/Refused 
in 
Tocilizumab or any 
IL-6 receptor 
antagonist use to 
treat infant chronic 
arthritis -relating 
diseases  
 WO/2002/080969  
PCT/JP2002/003312  
 2 April 2022  Albania, Israel, EPO, 
Republic of Korea , North 
Macedonia, Norway, 
Turkey, Ukrai ne, U nited 
States  Australia, Canada, China, Japan, 
Mexico, Poland, Russian 
Federation , New Zealand  Brazil  
Anti-IL-6R 
antibody 
compositions 
comprising 
methotrexate for 
treating IL -6 
related diseases  
 WO/2004/096273  
PCT/JP2004/006211  
 30 September  
2024 Albania, Brazil, EPO, India, 
Israel, North Macedonia, 
Norway  Australia, Canada, China, 
Indonesia, Japan, Republic of 
Korea , Malaysia, Mexico, Russian 
Federation , South Africa, 
Ukraine, New Zealand  Chile, Colombia  
Anti IL -6 receptor 
antibody -
containing solution 
(with sucrose and 
Polysorbate)  
 WO/2003/068260  
PCT/JP2003/001563  
 
 
 14 February  
2023 Croatia, Israel, Russian 
Federation , Norway, 
United States Australia, Albania, Canada, 
China, Brazil, EPO, India, Japan, 
Republic of Korea , Philippines, 
Poland, South Africa, Mexico,  
New Zealand  Colombia  
An antibody 
containing liquid 
formulation (not 
been subject to 
lyophilisation)  
 WO/2009/084659  
PCT/JP2008/073 798 
 26 December  
2028 Argentina, Brazil, Ecuador, 
Egypt, India, South Africa, 
Venezuela  Australia, Canada, Chile, China, 
Costa Rica, EPO, Indonesia, 
Japan, Republic of Korea , 
Morocco, Malaysia, Mexico, Peru, 
Philippines, Russian Federation , 
Thailand, Ukraine, UAE, U nited 
States, Viet Nam   Colombia   
  IP/C/W/670  
 
- 5 - Description  PCT 
Publication/Application  Estimate 
expiry  Filed in  Granted in  Rejected/Revoked/Refused 
in 
Anti-IL-6R 
antibody use in 
preventing or 
treating vasculitis  
 WO/2005/061000  
PCT/JP2004/019463  
 17 December  
2024 India, South Africa, 
Venezuela  Australia, Brazil, Canada, China, 
Indonesia, Japan, Republic of 
Korea , Malaysia, Mexico, New 
Zealand, Philippines, Russian 
Federation , United States Bosnia and Herzegovina, North 
Macedonia, Serbia, UAE, 
Colombia   
Patent la ndscapes and databases of COVID -19 medical products  
a. MedsPal database captured patent data on some selected COVID -19 candidates for therapeutics under the review of the ACT -A (antiviral 
medicines and monoclonal antibody therapies):  
Product  Jurisdictions Gra nted Expiry  
 
AT-527 
 primary patents and applications filed or granted in 
nearly 60 jurisdictions  expiring between 2036 -2038 
Baricitinib  
 primary patents and applications filed or granted in 
nearly 50 jurisdictions  expiring in 2029  
Molnupiravir (MK -4482)  
 primary patent filed in at least 28 jurisd ictions  expiring between 2035 -2038 
Tocilizuma b 
 primary and secondary patents filed or granted in at 
least 30 jurisdictions  expiring between 2022 -2028 
 
b. Preliminary patent landscapes of mRNA vaccine technology:  
 
- Pfizer/BioNTech:  https://www.citizen.org/article/biontech -and-pfizers -bnt162 -vaccine -patent -landscape/#_ftn6   
- NIH-Moderna: https://www.citizen.org/article/modernas -mrna-1273-vaccine -patent -landscape/   
 
c. Nature: Preliminary patent landscape of mRNA technologies identified 113 patent families:  
- https://www.nature.com/articles/d41573 -020-00119 -8  
Examples of IP barriers hindering development, production and supply  
a. Therapeutics:  
Gilead:  
- Gilead signed restrictive voluntary license on Remdesivir, excluding half of the world population: https://www.citizen.o rg/news/remdesivir -
should -be-in-the-public -domain -gileads -licensing -deal-picks-winners -and-losers/   
- Shortage of remdevisir in UK and EU countries: https://www.biospace.com/article/eu -faces-remdesivir -shortages -amidst -sharp -spikes -in-new-
covid-19-cases/    
  IP/C/W/670  
 
- 6 - b. Vaccines:  
 
i. Trade secrets and  know -how: 
 
- BioNTech claims to rely on know -how and trade secrets in COVID -19 vaccine production: 
https://www.sec.gov/Archives/edgar/data/1776985/000119312520 195911/d939702df1.htm   
 
ii. Disputes over COVID -19 vaccine patents:  
 
- Pfizer -BioNTech, Regeneron sued for patent infringement with COVID -19 products  
https://www.fiercepharma.com/pharma/pfizer -biontech -regeneron -sued-for-infringement -allele-s-patent -their-covid-19-products ; 
- Lawsuit reveals intellectual property is holding back production of CEPI - and Gates Foundation -funded COVID -19 vaccine candidate: 
https://twn.my/title2/briefing_papers/twn/Hammond.pdf ; 
- Inovio sued by subcontract over COVID19 vaccine technology: https://www.bizjournals.com/philadelphia/news/2020/07/09/inovio -plymouth -
meeting -covid-19-vgxi-vaccine.html   
- Moderna lost key patent challenge on its mRNA vaccine candidate for  COVID -19: https://www.nature.com/articles/s41587 -020-0674-
1#:~:text=A%20dispute%20over%20a%20key,claim%20by%20th e%20vaccine%20maker   
- Moderna failed to disclose US federal government grant in patents on its COVID -19 vaccine candidate  
https://www.statnews.c om/pharmalot/2020/08/28/moderna -covid19 -vaccine -coronavirus -patents -darpa/    
 
iii. Past experience with vaccines:  
 
- Pfizer patents on PCV13 hindering independent vaccine developer in South Republic of Korea : http://www. Republic of 
Korea biomed.com/news/articleView.html?idxno=1979   
- Report disclose excessive patenting on vaccine technologies and method of use:  
https://msfaccess.org/sites/default/files/2018 -06/VAC_report_A%20Fair%20Shot%20for%20Vaccine%20Affordability_ENG_2017.pdf   
 
c. Other technologies:  
 
- Governor of Kentucky asks 3M to release patents on N95 respirators: https://eu.courier -journal.com/story/news/20 20/04/03/beshear -calls-3-
m-release -patent -n-95-respirator -amid-pandemic/5112729002/   
- Northern Italy producers threatened by originator for using 3D printed ventilator valve: 
https://www.techtimes.com/articles/248121/20200317/maker -ventilator -valves -threatens -sue-volunteers -using -3d-printed -coronavirus.htm    
- Bloomberg reported that Bloomberg has found that “[t]h ere are hundreds of patents on things related to N95 respirators, the gold standard 
used to protect health -care workers from transmission”:  https://www.bloomberg.com/news/articles/2020 -03-20/world -war-ii-style-production -
may-carry-legal-risks-for-patriots   
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- 7 - Voluntary license and technology transfer issues  
- Gilead signed restrictive voluntary license on remdesivir, excluding half of the world population: https://www.citizen.org/news/remdesivir -
should -be-in-the-public -domain -gileads -licensing -deal-picks-winners -and-losers/   
 
- Vaccine developers: Pfizer/BioNTech: no steps taken on licensing and technology transfer   
 
- C-TAP rejected by IFPMA: https://www.ifpma.org/resource -centre/ifpma -stateme nt-on-the-solidarity -call-to-action -to-realize -equitable -global -
access -to-covid-19-health -technologies -through -pooling -of-knowledge -intellectual -property -and-data/   
 
- Overall issues of voluntary licenses: https://msfaccess.org/sites/default/files/2020 -10/IP_VoluntaryLicenses_full -brief_Oct2020_ENG.pdf   
Examples of political pressures on developing countries on the use of compulsory license and ot her flexibilities.  
- Timeline of US pressure on India IP law (2015):  https://msfaccess.org/sites/default/files/2018 -
10/IP_Timeline_US%2 0pressure%20on%20India_Sep%202014_0.pdf   
- Novartis letter to Colombia on compulsory license:  https://www.publiceye.ch/en/news/detail/glivec -in-colombia -new-leaked -letter -from-
novartis -attests -to-pressure -at-highest -level  
- Switzerland pressured Colombia over compulsory 
license:  https://www.keionline.org/22864#:~:text=However%2C%20in%20a%20letter%20of,a%20compulsory%20license%5Bii%5D.&text=
By%20sending%20this%20letter%2C%20the,needs%20of%20the%20Colombian%20population   
- USTR pressure on Colombia over the use of compulsory license and other regulatory measures   https://www.keionline.org/27256   
- https://www.keionline.org/wp -content/uploads/2018/03/Lighthizer -letter -to-Colombia -Feb-14-2018-re-OECD.pdf   
- Pressure on Malaysia over the use of compulsory license   https://www.ip -watch.org/2019/02/13/malaysia -still-pressure -make -hepatitis -c-
medicine -expensive/   
 
 
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