Gilead: Focus on remdesivir’s 2019-nCoV efficacy, permission talks too early

Gilead Sciences Inc said on Thursday that its focus is now on rapidly determining remdesivir’s potential as a treatment for the 2019 novel coronavirus, rather than discussing compulsory licensing or any other kind of permissions for drug manufacturing.

The comments came after the Wuhan Institute of Virology said on Wednesday that it had filed a patent application to use remdesivir to treat the novel coronavirus on January 21, which has sparked debate on China’s social media about intellectual property issues.

In response, Gilead Sciences said in an email sent to the Global Times on Thursday that the company has no right to intervene in approvals from China’s patent agency, regardless of the Wuhan Institute of Virology’s application.

The company said it had filed patent applications for the drug’s use on coronaviruses in China and some other countries and regions in 2016, but it has not yet received approval in China.

Gilead Sciences developed remdesivir and owns patents for the experimental drug in China and other countries.

“The Wuhan Institute of Virology filed the patent application three years after Gilead’s move, and thus the authorities will assess what has been known about the drug and patent applications in process,” the company said.

A manager of a domestic pharmaceutical company, which was once involved in an intellectual property (IP) dispute with a foreign company, told the Global Times that the Wuhan Institute of Virology had not violated IP rules as it had applied to use the drug’s established functions to treat a new disease – the 2019 novel coronavirus.

The manager said the institute’s move should not be criticized as it will be beneficial for the common people amid the epidemic. Given that compulsory licensing practices are allowed under special conditions, filing for a patent to benefit the people during this coronavirus outbreak is acceptable, the manager said.

After the SARS outbreak in 2003, China’s Patent Law began to allow compulsory licensing practices – allowing others to produce patented products without the consent of the patent owner – when there is a key emergency in the country or for public interest. However, China has not done so over the past 16 years.

“It’s too early to discuss compulsory licensing or any other kind of permissions at this time,” Gilead Sciences said, noting that it has not discussed manufacturing costs or financial returns with Chinese authorities.

The company said its focus is now on rapidly determining remdesivir’s potential as a treatment for the 2019 novel coronavirus and accelerating manufacturing in anticipation of potential future supply needs.

Remdesivir is not yet licensed or approved anywhere globally and it has not been demonstrated to be safe or effective for illness treatment.

Clinical trials on the safety and efficacy of remdesivir for the treatment of patients infected with the coronavirus in Wuhan, Central China’s Hubei Province, are being conducted from Thursday, the Xinhua News Agency reported.

A worker weighs drugs at the workshop of a pharmaceutical company in Haikou, South China’s Hainan Province, Feb. 3, 2020.

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