[Ip-health] MPP-AbbVie License on Glecaprevir and Pibrentasvir

Baker, Brook b.baker at northeastern.edu
Tue Nov 13 15:36:06 PST 2018

MPP-AbbVie License on Glecaprevir and Pibrentasvir (G/P):  Backtracking on Geographic Coverage but with Options for Oppositions, Compulsory Licenses, and Negotiated Territorial Expansion
Professor Brook K. Baker
Nov. 13, 2018

AbbVie and the Medicines Patent Pool have negotiated a roylty-free licensing and sublicensing agreement on a priority hepatitis C direct acting antiviral, glecaprevir and pibrentasvir (G/P).  This G/P combo is recommended by the WHO as a pan-genotypic adult first-line regimen with ongoing Phase 3 trials for adolescents and children.  G/P has a high resistance barrier and the shortest treatment duration of any HCV regimen to date.

The main drawback of the MPP-AbbVie license is its relatively limited geographic scope – particularly its exclusion of India, a high burden country with a significant population of people living with HCV.  Not only are there fewer countries and territories included in the license (95 and 4 respectively) than in previous DAA licenses (Table 1), but the percentage of the global population living with HCV covered –  47.5% - is lower than Gilead’s bilateral license for sofosbuvir (62.3%) and BMS’s license for daclatasvir (54.3%).  Consistent with previous licenses, AbbVie prioritizes exclusion of so-called pharmerging markets and upper-middle-income markets, presumably reserving those markets for higher margin brand sales in both private and public sector markets.  The exclusion of countries with more capacity to finance reasonably priced HCV elimination strategies shrinks the overall market for generic G/P, reduces economies-of-scale for generic producers, and thus undermines treatment and elimination strategies in licensed territories as well.  As another negative, the license restricts production to companies located within the territory plus India (a manufacturing country only).

The patent situation in India and excluded territories is important.  There are five relevant patents filed on G, P, and G/P in India, one of which involving pibrentasvir is being opposed by I-MAK and Third World Network.  A first examination report on that application, since amended, detailed multiple grounds for denying a patent. If oppositions are expanded to the other four applications, if they are all successful, and if AbbVie does not unduly extend evaluation of its patent applications via substitutions, selection, amended or protracted appeals, then Indian generic companies would eventually be permitted to supply India and other non-territories where no granted patent is in force.  Thus, the MPP licenses accomplishes some “wholesale” work in facilitating generic entry and competition in 99 countries and territories while complementary oppositions open up opportunities some excluded territories as well since the license allows supply to countries and territories if no granted patent will be infringed.  Unfortunately, G/P appears to be very widely patented in LMICs, with 30 out of 32 extra-territorial LMICs in the MedsPAL database reporting granted and pending patents (Table 2). http://www.medspal.org/?product_standardized_name=Glecaprevir/Pibrentasvir%20100/40%20mg. On the plus side, there is some possibility that the MPP will be able to convince AbbVie to expand the licensed territory, including in India, while generic licensee develop and registered the licensed product.  Even if AbbVie does not expand the licensed territory, countries where patents are in effect still have the option to issue compulsory licenses and to be lawfully supplied by generic sublicensees.

Table 1:  Countries and Territories Included in the License

Afghanistan, Angola, Antigua and Barbuda, Bangladesh, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Cook Island, Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, Dominica, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guadeloupe, Guinea, Guinea-Bissau, Guyana, Haiti, Indonesia, Jordan, Kenya, Kiribati, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Niger, Nigeria, Niue, Pakistan, Palau, Papua New Guinea, Philippines, Rep., Reunion Islands, Rwanda, Saba, Saint Eustatius, Saint Kitts and Nevis, Saint Lucia, Saint Vincent & the Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Suriname, Swaziland, Tanzania, Timor-Leste, Togo, Tunisia, Turkmenistan, Tuvalu, Uganda, Vanuatu, Vietnam, West Bank & Gaza, Yemen, Zambia, Zimbabwe
            Countries in bold have filed or granted patents

Table 2:  LMICs with Granted or Pending Patents Excluded from the License
(MedsPAL Nov. 13, 2018)

Albania, Armenia, Azerbaijan, Belarus, Bosnia & Herzegovina, Brazil, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Kazakhstan, Kyrgyz Republic, Macedonia, Malaysia, Mexico, Moldova, Mongolia, Montenegro, Paraguay, Peru, Russia, Serbia, Tajikistan, Thailand, Turkey, Ukraine, Venezuela
*Nicaragua and El Salvador listed at having no relevant patent filed

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