Peng Zhaohui, the father of the world's first commercialised gene therapy, Gendicine, is now fighting a legal war with the company he established
Hepeng Jia/Beijing, China
Peng Zhaohui, the father of the world’s first commercialised gene therapy, Gendicine, is now fighting a legal war with the company he established on the patent of the medication.
The ruling is expected to be made in mid October, 15 months after Shenzhen SiBiono filed the litigation asking Peng to return the patents for Gendicine, which were approved in his name.
As a major form of gene therapy, Gendicine uses a viral vector to deliver a normally functioning P53 gene, which acts as an important tumour suppressor. More than 50 per cent of human tumours are the result of a dysfunctional P53 gene. Not only can P53 activate DNA repair proteins if DNA damage is detected, it can arrest cell growth and also initiate cell death (apoptosis) if damage is irreparable.
Peng founded SiBiono with investments from government, State-owned firms and private investors in early 1998, and launched clinical trials of Gendicine later that year.
After five years’ struggle, Gendicine obtained the world’s first drug license for gene therapy in late 2003 when Peng was hailed as a national hero. The achievement was not without controversy however, mainly because the number of patients involved in the Gendicine trial was too low - just 130 subjects in the second and third stages of clinical trials combined.
Despite high hopes, Gendicine has not achieved the anticipated huge sales and SiBiono fell into financial difficulties. In November 2006, the company was acquired by US-listed Chinese pharmaceutical firm Benda for just US$15 million. In 2007, Gendicine’s sales grew to more than US$5 million, though were still far lower than the expected blockbuster revenues.
But a conflict between Peng and the majority shareholder Benda led to Peng’s resignation from SiBiono in June 2008.
The following month, SiBiono filed the patent lawsuit. The company insisted that Gendicine’s patents were filed in 2002 and its main patent - on the clinical use of the P53 gene carried with viral vector - was authorised in China in 2004, when Peng worked for SiBiono, so the patents should belong to the company.
’Part of the cost of the research and the patent application were based on SiBiono’s funding and equipment, so it is natural that the patent should belong to our company,’ says SiBiono chief executive Xu Wei, who is also an executive of Benda.
But Peng refutes the claims. ’The invention [of the p53 gene therapy] on which the patent is based had become mature even before SiBiono was established,’ he says. ’Without [this] and the manufacturing ability, the State Food and Drug Administration (SFDA) could not approve our clinical trials,’ Peng told Chemistry World.
He explains that former majority shareholders of SiBiono agreed that the patent belongs to him, and that he ’only agreed that the company could use it freely.’
However, Xu disagrees. ’The fact that Peng obtained the patent in his name rather than that of SiBiono only indicates that SiBiono’s former management was poor,’ Xu told Chemistry World.
While the debate continues, Peng is already planning ahead. He says the patents have been valued at more than 200 million yuan (US$29.4 million), higher than the total value of SiBiono. ’After I win the patent lawsuit, I will win back the company, eliminate the current majority stakeholders, introduce new investors and reshuffle the management,’ says Peng. ’This will put Gendicine on the right path, realising gene therapy’s promising future.’
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