China has applied to patent a drug candidate being developed by Gilead Sciences as the government rushes to find the cure for the deadly coronavirus, a move that could raise questions on intellectual property and marketing rights.

The state-backed Institute of Virology in Wuhan filed the patent for using remdesivir to fight the novel coronavirus on January 21, according to a statement posted on its website two weeks later on February 4. If approved, the drug will be used to facilitate its potential global market entry, it added.Studies have been conducted outside the human bodies and found that Gilead’s remdesivir compound and the off-patent chloroquine malaria drug are both “highly effective” in the control of coronavirus infection, the Wuhan institute and the Beijing Institute of Pharmacology and Toxicology said in a research published in Cell Research Journal.

“Since these compounds have [separately] been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they should be assessed in human patients suffering from the novel coronavirus disease,” the researchers wrote.

The viral outbreak has triggered panic across the globe, forcing the nation to lock down Wuhan and other cities in central Hubei province where the deadly virus originated. It has also forced companies to shut their businesses in the mainland, forced border controls and rattled global markets.

President Xi Jinping said China must treat the fight against coronavirus as “the most important task at hand,” according to state broadcaster CCTV on February 3. So far, the virus has claimed more than 560 lives and infected at least 27,000 people, mostly in mainland China.

Remdesivir has not been approved anywhere globally and has not been showed to be safe or effective for any use, Gilead’s chief medical officer Merdad Parsey said in a statement on Friday.The firm is working with Chinese health authorities to conduct a clinical trial on patients with pneumonia symptoms to test its safety and efficacy, it said. Past clinical data on other coronaviruses give it “hope,” it added.

Medical workers transfer a suspected coronavirus patient to an ambulance from the World Dream cruise ship at Kai Tak Cruise Terminal in Hong Kong on February 3. Photo: Sam Tsang

China has applied to patent a drug candidate being developed by Gilead Sciences as the government rushes to find the cure for the deadly coronavirus, a move that could raise questions on intellectual property and marketing rights.The state-backed Institute of Virology in Wuhan filed the patent for using remdesivir to fight the novel coronavirus on January 21, according to a statement posted on its website two weeks later on February 4. If approved, the drug will be used to facilitate its potential global market entry, it added.Studies have been conducted outside the human bodies and found that Gilead’s remdesivir compound and the off-patent chloroquine malaria drug are both “highly effective” in the control of coronavirus infection, the Wuhan institute and the Beijing Institute of Pharmacology and Toxicology said in a research published in Cell Research Journal.

“Since these compounds have [separately] been used in human patients with a safety track record and shown to be effective against various ailments, we suggest that they should be assessed in human patients suffering from the novel coronavirus disease,” the researchers wrote.

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The viral outbreak has triggered panic across the globe, forcing the nation to lock down Wuhan and other cities in central Hubei province where the deadly virus originated. It has also forced companies to shut their businesses in the mainland, forced border controls and rattled global markets.

President Xi Jinping said China must treat the fight against coronavirus as “the most important task at hand,” according to state broadcaster CCTV on February 3. So far, the virus has claimed more than 560 lives and infected at least 27,000 people, mostly in mainland China.

Remdesivir has not been approved anywhere globally and has not been showed to be safe or effective for any use, Gilead’s chief medical officer Merdad Parsey said in a statement on Friday.The firm is working with Chinese health authorities to conduct a clinical trial on patients with pneumonia symptoms to test its safety and efficacy, it said. Past clinical data on other coronaviruses give it “hope,” it added.HK BUSINESS BRIEFINGGet updates direct to your inboxSUBSCRIBEBy registering, you agree to our TandC and Privacy Policy

A spokeswoman for the Foster City, California-based company said it had invented remdesivir, and had filed patent applications for the compound and its uses against coronaviruses globally, including in China, in 2016. The application in China is still pending.

“We are aware of reports of the Wuhan Institute for Virology’s patent application,” Sonia Choi, Gilead’s vice president of public affairs, said in an email reply to the South China Morning Post. “Our focus at this time is on rapidly determining the potential for remdesivir as a treatment for [the novel coronavirus] and accelerating manufacturing in anticipation of potential future supply needs.”

Asked if Gilead will contest the patent application filed by the Chinese researchers, she said China’s “application has been filed more than three years after Gilead’s filing and will be considered in view of what is already known about the compound and pending patent applications. We are unable to comment on details of [their] application because there is an 18-month delay for an application to be published.”Gilead filed a patent in 2016 for methods to treat coronavirus infections, without mentioning remdesivir. Its scientific findings on remdesivir’s effect on coronaviruses have been published in the Science Translational Medicine journal in June 2017 on how the drug, with the development code GS-5734, inhibits both epidemic and zoonotic coronaviruses.

The move by the Wuhan institute, the most advanced virology centre in Asia, evoked similar past acts elsewhere in the region. When Thailand decided in 2006 and 2007 to break patents on drugs to treat HIV and heart disease, foreign drugs makers including Abbott Laboratories responded by withdrawing their products for treating other diseases from the Southeast Asian country.

It is not know when the institute’s filing could be approved by China’s patent authority, but the unit of Chinese Academy of Sciences could provoke legal issues with its filing, according to Andrew Cobden, a patent and trademark lawyer in Hong Kong at Hogan Lovells in Hong Kong.

“One question is whether the specific combination of drugs or that specific medical use of the drug is novel, that is, the researchers who make a discovery have filed their patent application before it becomes known to the public,” Cobden said. “Another is whether they are inventive, that is, an ordinary researcher in this field would not have thought of combining those drugs, or using those drugs to treat the coronavirus.”

The Chinese researchers said the filing was based on “international practice” and for the “protection of national interest,” adding it will “temporarily not exercise any intellectual property rights if foreign pharmaceutical firms are willing to contribute towards combating the outbreak in China.”

Even if the Institute of Virology is granted the patent for the use of the drug on the novel coronavirus, it would not be able to get around any patents Gilead might have filed or obtained for the drug remdesivir, Cobden said. Gilead may as well choose to work with the institute to market the drug there.

“In theory, a patent owner may be able to use its patent to stop other companies from manufacturing, importing or selling that drug in China,” he said. “But a patent cannot stop doctors from prescribing the drug to treat a patient.”

It might take 12 to 18 months for the public to know the coverage of the patent applied for by the Wuhan institute when its application document is published, and the entire patent granting process could take several years, if its case falls within the industry norm, Cobden said.

© Pakistan Press International, source Asianet-Pakistan