Patent Barriers to Local Health Technology Access in South Africa
Health technologies such as COVID-19 vaccines and diagnostic tests face patent barriers in South Africa, hindering local manufacturing and access. Moderna's mRNA vaccine patents are being challenged for delayed technology transfer, impacting vaccine development and commercialization.
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Patent barriers to COVID- 19 health technology access and local manufacturing in South Africa
Health technologies reviewed in the analysis: Moderna s mRNA COVID-19 vaccine Pfizer s mRNA COVID-19 vaccine Cepheid s COVID-19 PCR diagnostic test cartridges Merck s (MSD s) antiviral medicine molnupiravir Pfizer s antiviral medicine ritonavir-boosted nirmatrelvir (Paxlovid) Eli Lilly JAK inhibitor baricitinib
Modernas mRNA vaccine: Moderna has pledged not to assert its patents during the pandemic but retains discretion of determining when it ends . Has filed patents in South Africa with broad protection Has refused to cooperate with and transfer technology to the WHO mRNA Hub
Moderna has filed eight patents related to its COVID- 19 mRNA vaccine in South Africa to date: four of which have been granted, three of which remain pending, and one of which has been withdrawn. *Table exported from VaxPal on 25/02/2022 Expected Expiry Date Product Name Patent Description Patent Status Patent Application Number mRNA-1273 (pINN Elastomeran) 0.5 ml Compositions and methods for delivering modified mRNA into cells to modulate protein expression (production of immunoglobulins) Granted ZA201403666 10/3/2031 Compositions and methods for delivering modified mRNA into cells to modulate protein expression (production of immunoglobulins) Granted ZA201303161 10/3/2031 Compositions and methods for delivering modified mRNA into cells to modulate protein expression (production of immunoglobulins) Filed ZA201403119 10/3/2031 Method of expressing a polypeptide by administering an isolated mRNA Granted ZA201402547 10/3/2032 Method of producing a polypeptide in a mammalian cell or tissue with a formulation comprising a modified mRNA encoding the polypeptide; Pharmaceutical compositions comprising modified mRNA formulated in LNPs Filed ZA201503621 12/14/2032 Impact of patents and failure to transfer tech: - Delayed development of vaccine through WHO mRNA Hub - Significant uncertainty regarding the prospects of commercializing a vaccine developed by the Hub Method of producing a polypeptide in a mammalian cell or tissue with a formulation comprising a modified mRNA encoding the polypeptide; Pharmaceutical compositions comprising modified mRNA formulated in LNPs Filed ZA201503620 12/14/2032 Method of producing a polypeptide in a mammalian cell or tissue with a formulation comprising a modified mRNA encoding the polypeptide; Pharmaceutical compositions comprising modified mRNA formulated in LNPs Granted ZA201403783 12/14/2032 Method of expressing a polypeptide by administering an isolated mRNA Withdrawn ZA201703921
Civil society recommendations: - Ramp up pressure on Moderna to license its intellectual property and transfer its technology to the WHO mRNA Tech Transfer Hub. - Develop an advocacy and legal strategy to challenge patents granted to Moderna in South Africa. - Continue to advocate for urgent reform of South Africa s patent laws to ease the process of compulsory licensing to protect public interest in the country.
Pfizer has filed multiple patents on its vaccine that impede the development of competitor products globally, but has not yet filed patents in South Africa Pfizer s mRNA vaccine Two patents recently filed for through the WIPO PCT may be filed in SA up to 22 October 2022 Pfizer has opposed waiver and refused to cooperate with/ transfer tech to the WHO mRNA Hub Has granted a fill finish license to Biovac, but does not allow for local manufacture of active drug substance
PATENT DESCRIPTION Process for producing a lipid vesicle encapsulating a nucleic acid within the lipid vesicle Method of producing a lipid vesicle encapsulating a therapeutic product which includes nucleic acid PATENT STATUS National Phase entered PATENT APPLICATION NUMBER PCT/CA0300941 EXPIRY DATE 6/30/2023 National Phase entered PCT/CA2006001239 7/27/2026 Method for inducing a mammalian cell to produce protein using in-vitro synthesized mRNA that comprises or m<1> (1-methylpseudouridine) National Phase entered PCT/US2006032372 8/21/2026 Nucleic acid molecule comprising promoter, transcribable nucleic acid sequence and nucleic acid sequence with at least two copies of a 3 - untranslated region of a human beta-globin gene National Phase entered PCT/EP2006009448 9/28/2026 Lipid nano-particle composition National Phase entered PCT/CA2009000496 4/15/2029 Lipid nano-particle composition (non-lamellar) National Phase entered PCT/CA2011000778 6/30/2031 Purified preparation of messenger RNA comprising a 1-methyl-pseudouridine residue Withdrawn PCT/US2014026140 Nucleic acid molecule comprising promoter, transcribable nucleic acid sequence which codes for modified polyadenyl sequence (containing nucleotides other than A nucleotides), the RNA obtainable well as RNA obtainable by transcription and use of said RNA for vaccination Withdrawn PCT/EP2014064924 Lipids and lipid nanoparticle formulations for delivery of nucleic acids (ALC-0159 lipid and analogues) National Phase entered PCT/US2015034496 6/5/2035 Nucleic acid molecule comprising promoter, transcribable nucleic acid sequence which codes for modified polyadenyl sequence (containing nucleotides other than A nucleotides), the RNA obtainable well as RNA obtainable by transcription and use of said RNA for vaccination National Phase entered PCT/EP2015065357 7/6/2035 Method of decreasing immunogenicity of RNA by modifying the nucleotide sequence of the RNA by reducing the uridine (U) content National Phase entered PCT/EP2016070012 8/24/2036 ALC-0315 lipid and analogues and lipid nanoparticle formulations for delivery of nucleic acids National Phase entered PCT/US2016059575 10/28/2036 Patents filed through WIPO PCT Lipid nanoparticle comprising cationic lipid, nucleic acid, lamellar outer layer and preparation methods Withdrawn PCT/US2018058555 Method for delivering a nucleic acid to a primate (Human) by administering a lipid nanoparticle with specific mean particle diameter comprising nucleic acid encapsulated within the LNP, cationic lipid, neutral lipid, steroid and polymer-conjugated lipid Filed PCT/US2020046407 8/14/2040 Source: VaxPal and email communication with the MPP Covers mRNA composition Filed WO2021213924 A1 2041 Relates to packaging and storing Filed WO 2021/213945 A1 2041
Civil society recommendations: - Ramp up pressure on Pfizer to license its intellectual property and transfer its technology to the WHO mRNA Hub, and/or through the Medicines Patent Pool or the COVID-19 Technology Access Pool (CTAP). - Engage relevant officials and departments within the South African government (CIPC, DTI, DSI) on the critical need to monitor new patent applications related to Pfizer s vaccine and to ensure that patents that do not meet the country s patentability criteria or harm public health/interest are not granted. - Continue to advocate for urgent reform of South Africa s patent laws to strengthen the country s patentability criteria, protect public interest, and enable opposition of patent applications by third parties.
Cepheids COVID-19 PCR test cartridge: During early stages of the pandemic, shortages of Cepheid s COVID-19 test cartridges severely hampered South Africa s ability to rapidly scale-up COVID-19 diagnosis. While failing to deliver adequate supply of test cartridges, Cepheid ignored requests from South Africa for technology transfer to enable local manufacturing of its test cartridges. Cepheid has used a variety of tactics to build its monopoly position in the diagnostic space and undermine the entry/growth of competitor companies, including: designing closed systems that prevent the use of test materials made by other companies, hoarding knowledge and refusing to license IP and transfer technology, and filing patents.
Cepheid applied for 16 patents related to its diagnostic technologies and processes in SA between 2014 and 2021. The five patents applied for before January 2017 have all been granted, while the remainder are pending. PATENT APPLICATION NUMBERS: 2014/07770, ZA2015/00467, 2015/02463, 2015/06532, 2017/00502, 2017/06683, 2018/01048, 2018/01049, 2018/01050, 2019/03750, 2019/03892, 2020/06485, 2021/01476, 2021/01477, 2021/01478, 2021/02464 Challenges in identifying relevant patents: - Lack of transparency regarding patents on health technologies - Broad range of technology types that may be patented: diagnostic assays, processes, consumable parts, and machinery - Granting without examination creates complexity for competitors in determining the validity of patents granted.
Civil society recommendations: - Push Cepheid to license its intellectual property and transfer technology to diagnostic manufacturers in developing countries. - Engage global stakeholders and conduct further research on the need for and feasibility of financing and developing open-diagnostic systems that provide ease of use (automated), can rapidly conduct diagnosis of multiple specimens, and can be used at or near point-of-care. - Engage national stakeholders on what is needed to develop national diagnostic manufacturing capacity and ensure that capacity developed is sustainable.
Therapeutics ritonavir- boosted nirmatrelvir molnupiravir baricitinib
Molnupiravir Patent Status Patent Number Application Expected Date Expiry Patent Description Molnupiravir analogues structure) and their use as antivirals and Filed ZA201704291 12/16/2035 (Markush Molnupiravir compound and its use as antiviral Filed ZA202002849 12/7/2038 Nirmatrelvir (PF-07321332)+Ritonavir Patent Application Number Expected Date Expiry Patent Description Patent Status PF-07321332 compound Filed ZA- PCT/IB2021/057281 8/6/2041 Baricitinib Patent Application Number Patent Description Patent Status Expected Expiry Date Baricitinib compound Granted ZA201006000 3/10/2029
MPP licenses allow for sale of generic molnupiravir and Paxlovid in South Africa s public sector 27 generic companies have been licensed to produce generics under the deal, including Aspen Pharmacare and CPT Pharma. Yet, still no legal pathway for generic sale in private sector, and LMICs excluded from MPP licensing deals
Civil society recommendations: - Push for licensing deals to allow for sale of generic products in South Africa s private sector esp. by Aspen Pharmacare and CPT Pharma. - Push for generic use licensing deals in developing countries excluded from the MPP licensing deal. - Support compulsory licensing efforts in developing countries excluded from the MPP deal.
