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27 February 2020Big PharmaEdward Pearcey

China approves three Gilead remdesivir patents for COVID-19 treatment

US-based Gilead Sciences has been granted three Chinese patents connected to possible COVID-19 treatment remdesivir, reported He Zhimin, the deputy director of China’s National Intellectual Property Administration (CNIPA).

“Drug development requires a huge investment in resources and time, and carries high risks, so it requires particularly strong protections on its intellectual property,” said He, speaking at a press briefing on Tuesday, February 24.

The news could put in jeopardy a Wuhan university's controversial patent application for the use of remdesivir to treat the novel coronavirus outbreak.

Gilead, the developer of experimental drug remdesivir, has applied for eight patents in total, with five still pending. Remdesivir, originally under development as a treatment for ebola, is currently undergoing clinical trials in China with results expected in late April. The CNIPA will conduct an analysis and examination of patents submitted.

According to Gilead’s website, remdesivir has not yet been approved anywhere globally for any use, but has demonstrated “in vitro and in vivo activity in animal models against the viral pathogens Middle East Respiratory Syndrome ( MERS) and Severe Acute Respiratory Syndrome ( SARS), which are also coronaviruses and are structurally similar to COVID-19”.

“The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19,” added the drugmaker.

“This is an experimental medicine that has only been used in a small number of patients with COVID-19 to date,” added the company, and the pharmaceutical giant “does not have an appropriately robust understanding of the effect of this drug to warrant broad use at this time”.

The Chinese authorities are conducting randomised clinical trials on patients in Wuhan, the centre of the viral outbreak that has infected almost 80,000 people globally, according to World Health Organization figures. However, the vast majority of cases remain in China.

Gilead is far from the only drug firm hoping to find a successful COVID-19 treatment. UK-based drugmaker GSK and Chinese biotech Clover Biopharmaceuticals recently partnered to develop a protein-based coronavirus vaccine candidate.

GSK will provide Clover with its pandemic adjuvant system (which enhances the effectiveness of vaccines) for further evaluation of Clover’s candidate, COVID-19 S-Trimer, in preclinical studies. The collaboration was announced on Monday, 24 February.

Indian drugmaker Zydus Cadila recently launched a fast track programme to develop a COVID-19 vaccine, utilising  multiple teams in Europe and India to focus on two separate approaches to developing a vaccine.

Johnson & Johnson unit Janssen has also expanded an existing R&D agreement with HHS to speed up the development of an investigational vaccine, while Regeneron announced its own expanded collaboration with HHS, focused on developing antibody treatments for the virus.

Sister publication WIPR is running a live blog where you can find all the latest news on what COVID-19 means for IP.

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More on this story

Asia
4 June 2020   IP firm Rouse will collaborate with life sciences service provider Codex to support companies looking to enter the Chinese market.
Big Pharma
10 August 2020   US biotechnology company Novavax has signed a deal with Takeda Pharmaceuticals to develop, manufacture and market a COVID-19 vaccine in Japan, it was announced on Friday, August 7.
Big Pharma
11 February 2021   China has introduced new measures to enforce a patent linkage system and proposed draft rules on how a patent owner can challenge the approval of a drug.