27 August 2020
Chinese vaccine manufacturer CanSino Biologics announced that they’ve acquired a patent for their vaccine candidate against the novel coronavirus Covid-19 – the recombinant adenovirus vaccine Ad5-nCoV.
It is the first patent granted by the Chinese government to a vaccine against the deadly virus which has swept the world and claimed countless lives.
Ad5-nCoV, which CanSino is developing in collaboration with the Academy of Military Medical Sciences led by infectious disease expert Chen Wei, is the firm’s leading vaccine candidate. But, it has yet to complete its Phase III clinical trials. In fact, the trials have just started in Russia.
Lawyers say awarding a patent before clinical trials are completed is normal.
“The patent law in China currently requires in general for pharmaceutical inventions, such as vaccines, that qualitative or quantitative testing data is included in the description of the invention. This data should show that a notable progress has been achieved when considering the existing vaccines in the prior art,” said Oliver Lutze, principal and country manager of Spruson & Ferguson in Beijing. “In the case of COVID-19 vaccines, the hurdle should be lower as there is no vaccine at all available yet. The showing of a minimal efficacy may be sufficient if the claimed invention is novel. Therefore, no complete clinical trial data is needed that meets the standard of granting regulatory approval for the drug.”
The Covid-19 vaccine candidate will undergo a marketing approval process to determine its safety and efficiency. After it is found to be safe and effective, the vaccine is then ready for public use.
According to Yuancheng Lin, deputy director of the domestic patent department of CCPIT Patent & Trademark Law Office in Beijing, the trial data are compulsory for the approval of the vaccine by the National Medical Products Administration (NMPA).
“In other words, the patent examination procedure conducted by the CNIPA is separate from the drug approval procedure conducted by the NMPA. The former is aimed at determining whether a patent right can be granted to a patentee while the latter is aimed at determining whether a new drug, in this case a new vaccine, could be allowed to enter the market,” said Lin.
CanSino has said that the patent is proof of the Covid-19 vaccine’s safety and efficacy, first reported in the Global Times.
“The patent has provided experimental evidence to support the safety and efficacy of Ad5-nCoV in animal models, which could preliminarily support that this new vaccine would be safe and effective in humans,” said Lin. “Nevertheless, clinical trials are still needed to fully confirm its safety and efficacy in humans.”
For Lutze however, the patent does not confirm safety and efficacy of AD5-nCoV.
“The regulatory approval process has a completely different scope and purpose from the patent law. Any notable progress by a novel vaccine rewards a patent right but does not confirm that the vaccine meets all standards of being a drug that meets safety and commercialization standards. The patent can be stable and enforceable while giving no indication at all on the potential outcome of the Phase III trial. The patent grant and regulatory approval process are in fact unrelated in this regard,” Lutze explained.
That said, it does not mean that the patent has little significance. It remains very important as it gives the patentee the exclusive right to use the invention and therefore recover the financial investment poured into its creation.
“The patent grant will, however, not allow to make any predictions on the development of Ad5-nCoV as a new vaccine for COVID-19,” said Lutze. “This will only be told by the final clinical trial results.”
On the other hand, Lin views the patent as a reflection of how China’s government and scientists are putting a lot of effort into the prevention and treatment of Covid-19.
“[They] have achieved significant progress,” Lin said.
CanSino applied for the patent with the National Intellectual Property Administration in March. Phase I clinical trials commenced three days earlier. Phase I and II trials showed positive results.
Espie Angelica A. de Leon
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