Patent Holder: Merck Sharp & Dohme (MSD)

Date: October 2021

In October 2021, the Medicines Patent Pool (MPP) signed a licence agreement with Merck Sharp & Dohme (MSD) for molnupiravir (MK-4482/ EIDD-2801), an oral COVID-19 antiviral medicine.

In November 2021, MSD provided an update on the results from the MOVe-OUT study of molnupiravir. In this study population, molnupiravir reduced the risk of hospitalisation or death from 9.7% in the placebo group (68/699) to 6.8% (48/709) in the molnupiravir group, with a relative risk reduction of 30%. Nine deaths were reported in the placebo group, and one in the molnupiravir group.

In December 2021, MSD received U.S. FDA Emergency Use Authorization for molnupiravir to treat mild to moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19.

In July 2022, MSD and MPP signed an amendment to the sublicence agreement including Thailand to the covered territory.

The licence covers 106 countries.

Key Features
Eligibility for sublicences Sublicences can be issued to any qualified entity worldwide.
Manufacturing Allows manufacturing of the active pharmaceutical ingredient and the finished formulations of molnupiravir anywhere in the world.
Geographical scope for sale Allows for sale of molnupiravir in 106 countries. For Thailand, the sales are allowed only in public market.
Sales outside the licensed territory Nothing in this Agreement shall be construed to prevent the Licensee from engaging in activities inside or outside the Territory where such activities would not (1) infringe the Patents and/or any other intellectual property rights; and/or (2) misappropriate MSD Know-How.
Royalties The licence is royalty free during the WHO Public Health Emergency of International Concern (PHEIC). After the PHEIC ends, royalties are 5% of net sales for public sector purchases, and 10% of net sales for commercial entities. Royalties, as mentioned, are due even before PHEIC for private sector in South Africa and public market in Thailand.
Quality assurance Licensees must obtain approval from the World Health Organization (WHO) Pre-qualification (WHO-PQ), or a Stringent Regulatory Authority (SRA). Where such approval is not yet available, provisional or emergency use authorisations available through WHO or an SRA may be obtained.
Data exclusivity Data exclusivity is waived in countries of the Territory with such form of protection, thus facilitating regulatory approval of generics.
Patent disclosure The licence discloses to MPP and the Licensee the list of patent applications worldwide at the time of licence signing. Unpublished patent applications, for the 18-month window from filing date, are redacted in the agreement available on MPP’s website.

 

Announcement
Board resolution
Advisory Group Report
Country List
Afghanistan, Algeria, Angola, Bangladesh, Belize, Benin, Bhutan, Bolivia (Plurinational State of), Botswana, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, Comoros, Congo, Congo, democratic Republic of the, Côte d'Ivoire, Cuba, Djibouti, Dominica, Egypt, El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Fiji, Gabon, Gambia (the), Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Iran (Islamic Republic of), Iraq, Jamaica, Kenya, Kiribati, Korea (Democratic People's Republic of), Lao People's Democratic Republic (the), Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia (Federated States of), Moldova, Republic of, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Paraguay, Philippines, Rwanda, Saint Lucia, Saint Vincent and the Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Suriname, Syrian Arab Republic, Tajikistan, Tanzania, United Republic of, Timor-Leste, Togo, Tonga, Tunisia, Tuvalu, Uganda, Uzbekistan, Vanuatu, Venezuela (Bolivarian Republic of), Viet Nam, Yemen, Zambia, Zimbabwe, Thailand
Additional Information

Technology transfer pack

Please find below the list of generic manufacturers who requested the technology transfer pack for molnupiravir:

Company name:
CPT
Fosun
Hikma
Kimia
Remington

 

Termination letters

Lonzeal termination letter

BDR Pharmaceuticals termination letter

Natco termination letter

BrightGene termination letter

Strides termination letter

 

Appendix-A (as amended in July 2022)

Territory

LIC : Low Income Country

LDC : Least Developed Country (UN Classification)

SSA : Sub-Saharan Africa

LMIC : Lower Middle-Income Country*

UMIC : Upper Middle-Income Country

LIC+LDC+SSA

# Country – Channels in scope of Agreement

1 Afghanistan – All

2 Angola – All

3 Bangladesh – All

4 Benin – All

5 Bhutan – All

6 Botswana – All

7 Burkina Faso – All

8 Burundi – All

9 Cabo Verde – All

10 Cambodia – All

11 Cameroun – All

12 Central African Republic – All

13 Chad – All

14 Comoros – All

15 Congo, Dem Rep. – All

16 Congo, Rep. – All

17 Côte d’Ivoire – All

18 Djibouti – All

19 Equatorial Guinea – All

20 Eritrea – All

21 Eswatini – All

22 Ethiopia – All

23 Gabon – All

24 Gambia, The – All

25 Ghana – All

26 Guinea – All

27 Guinea-Bissau – All

28 Haiti – All

29 Kenya – All

30 Kiribati – All

31 Korea, Dem.People’s Rep. – All

32 Lao PDR – All

33 Lesotho – All

34 Liberia – All

35 Madagascar – All

36 Malawi – All

37 Mali – All

38 Mauritania – All

39 Mauritius – All

40 Mozambique – All

41 Myanmar – All

42 Namibia – All

43 Nepal – All

44 Niger – All

45 Nigeria – All

46 Rwanda – All

47 São Tomé and Principe – All

48 Senegal – All

49 Seychelles – All

50 Sierra Leone – All

51 Solomon Islands – All

52 Somalia – All

53 South Africa – All

54 South Sudan – All

55 Sudan – All

56 Syrian Arab Republic – All

57 Tajikistan – All

58 Tanzania – All

59 Timor-Leste – All

60 Togo – All

61 Tuvalu – All

62 Uganda – All

63 Vanuatu – All

64 Yemen, Rep. – All

65 Zambia – All

66 Zimbabwe – All

67 Algeria – All

68 Bolivia – All

69 Egypt, Arab Rep – All

70 El Salvador – All

71 Honduras – All

72 India – All

73 Micronesia, Federated States – All

74 Moldova – All

75 Mongolia – All

76 Morocco – All

77 Nicaragua – All

78 Pakistan – All

79 Papua New Guinea – All

80 Philippines – All

81 Sri Lanka – All

82 Tunisia – All

83 Uzbekistan – All

84 Vietnam – All

85 Belize – All

86 Cuba – All

87 Dominica – All

88 Fiji – All

89 Grenada – All

90 Guatemala – All

91 Guyana – All

92 Indonesia – All

93 Iran, Islamic Rep – All

94 Iraq – All

95 Jamaica – All

96 Libya – All

97 Maldives – All

98 Marshall Islands – All

99 Paraguay – All

100 Samoa – All

101 St. Lucia – All

102 St. Vincent and the Grenadines – All

103 Suriname – All

104 Thailand – Public Sector Only

105 Tonga – All

106 Venezuela, RB – All

Amendments