By Suzanne Venter
Onderstepoort Biological Products (OBP) and the Agricultural Research Council (ARC) claim that they won a case against private vaccine manufacturers Design Biologix and Vetvax concerning the legal ownership of a virus strain that the latter wishes to use for a vaccine against Rift Valley fever. However, this seems false upon closer inspection, and OBP and ARC seem to have misinterpreted the court ruling.
According to OBP and ARC, the High Court in Pretoria delivered a judgment in their favour on 12 March.
The ARC stated on April 25 that the ruling follows an application from private manufacturers in 2023 against the state’s vaccine manufacturers regarding a dispute over the ownership of a virus strain needed for producing a vaccine against Rift Valley fever.
According to the statement, the High Court dismissed Design Biologix and Vetvax’s application as legal owners of the virus strain, awarding costs against them, because the strain legally belongs to OBP and ARC and was not lawfully obtained by Design Biologix and Vetvax.
However, attorney Anton Bekker, who represents the private vaccine manufacturers, says that OBP and ARC misinterpreted the ruling.
Vetvax (Pty) Ltd., Design Biologix CC, and Karen Nel, the director and CEO of Design Biologix, issued a statement rejecting the allegations made by OBP and ARC, stating that they are inaccurate and misleading.
The application was rejected on a technical point. The court found that a fair judgment cannot be delivered based on the information in the affidavits because of a factual dispute; thus, the case is too complex.
“The court found that it is necessary to consider oral evidence, and therefore, the current application brought in 2023 by Design Biologix, Vetvax, and Karen Nel in the High Court against OBP and ARC was dismissed with costs,” says Bekker.
The next step may involve his clients following the High Court’s recommendation to initiate a new, extended summons process to settle the dispute through a trial or to obtain another similar virus strain from a different source to urgently register and produce an alternative vaccine against Rift Valley fever.
Why is the vaccine needed?
Design Biologix applied on 21 January 2021, for the urgent registration of Riftvax, a vaccine they developed and intended to manufacture and sell to protect ruminants from infection with Rift Valley fever.
The application for the registration of Riftvax was submitted on a priority basis and aimed at distribution in the South African animal vaccine market.
In 2021, there was a shortage of OBP’s stock for the live Rift Valley fever vaccine and significant concern about an outbreak. We even had permission from the Directorate of Animal Health to request an expedited registration,” says Nel.
“Our vaccine is dead and can be used in case of an outbreak, while a live vaccine is unsuitable. There is currently another concern about an outbreak due to the good rainfall. Rift Valley fever is transmitted by mosquitoes, abundant in the wet season.”
This viral disease occurs sporadically. Unlike viral diseases such as bluetongue and lumpy skin disease, which occur seasonally every year with the increase in insect numbers, Rift Valley fever occurs at intervals of five to ten years, usually following heavy rain. Mosquitoes transmit the virus from infected to susceptible animals.
The most significant outbreaks in South Africa occurred during 1950-1951, 1974-1976, and more recently in 2008-2009 and 2010-2011. During these periods, laboratory tests diagnosed cases of Rift Valley fever in 14 000 animals and 302 humans.
Origin of the dispute
The registration process was suspended after successful evaluation by technical advisors and before the registrar granted final approval. This occurred due to a claim by the ARC and OBP regarding the Smithburn RVFV strain from which Riftvax was developed after the registrar of Act 36 of 1947 shared Design Biologix’s confidential information with OBP and the ARC.
According to Nel, they received this virus strain legally and unconditionally in 2001 from Dr. Truuske Gerdes, an expert on Rift Valley fever affiliated with the World Organisation for Animal Health’s reference laboratory.
In its statement, the ARC states that it was compelled to prevent the vaccine’s registration because the virus strain remains the ARC’s property, and the private company lacks the necessary permission to use it.
The ARC further argues that the private manufacturers failed to persuade the court that the RVFV strain is their property.
In response, Design Biologix, Vetvax, and Nel argue that OBP and the ARC assert that the virus strain they received in 2001 was not a Smithburn RVFV strain but rather a distinct Rift Valley fever strain developed by the ARC and/or OBP, which they refer to as the ARC virus strain.
“Even though OBP and the ARC were invited to provide credible evidence supporting their claim, they failed. Therefore, based on affidavits, we applied for a court order confirming that we may use it to manufacture a vaccine,” says Nel.
In their statement, the ARC and OBP state that the ownership of the virus strain remains an unresolved factual dispute between the parties.
Nel states they will urgently do whatever is necessary to produce an alternative vaccine for Rift Valley fever. “Veterinarians and farmers can no longer rely on the ARC and OBP to meet their vaccine needs and avert crises.”
In response to inquiries, the ARC and OBP said that their interpretation of the court ruling is correct and that they currently have more than 3 million units of vaccine against Rift Valley fever available.
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