First to do clinical trials, Then to increase production capacity. Daniel O’Day, global CEO of Gilead Sciences, responded to the “patent battle” at a company meeting on February 5th after the Wuhan Virus Institute publicly declared the patent for the antiviral drug Remdesivir. Asked what Gilead would do with the Remdesivir patent filed by the Wuhan virus, Daniel O’Day said:
“I think one of the things you’re doing is that it’s not going to affect our health around the world. I want to emphasize that our responsibility is to patients. Our priority is to find the right clinical trial program and demonstrate scientifically and proven that the drugs available to patients are effective. At the same time, increase capacity to meet the needs of patients worldwide.
“Patents are not our primary concern right now. I’ve asked my patent colleagues, just like gilead’s other drugs, that we’ve applied for compounds for Remdesivir in all regions of the world, using patents, including coronaviruses. We’re not going to get involved in this patent, we’re going to find ways to help patients, and of course we’re going to protect our intellectual property in another way, but patients come first. ”
Currently, Remdesivir has started clinical trials in China.
On February 4, Wuhan Virus Said, “For the drug Ridsiwe, which has not yet been listed in China and has intellectual property barriers, we have declared the patent of Chinese invention on January 21st from the point of view of protecting the national interest, in accordance with international practice and from the point of view of protecting the national interest(the use of the new coronavirus against 2019), It will also enter major countries around the world through the PCT (Patent Cooperation Agreement). ”
Gilead China has previously said that Remdesivir, a broad-spectrum antiviral drug under development, has not yet been approved in any country around the world. Remdesivir has demonstrated the activity of MERS and SARS virus pathogens in in vitro and in vitro animal models, and they are also coronaviruses, structurally similar to 2019-nCoV. Limited preclinical data for MERS and SARS indicate that Remdesivir may have potential lyno activity for 2019-nCoV.
Gilead has reached an agreement with the Chinese health authorities to support two clinical trials of people infected with 2019-nCoV to determine the safety and efficacy of Remdesivir as a potential treatment for coronaviruses. One study assessed the therapeutic effectiveness of Remdesivir for patients who were diagnosed with infection 2019-nCoV and were hospitalized but did not exhibit significant clinical symptoms (e.g., additional oxygen absorption), while another assessed Remdesivir’s use for more severe clinical symptoms (e.g., the efficacy of the diagnosed patient siphoning).
Both clinical trials, led by Chinese researchers, are conducted in Wuhan. Gilead provides the drugs needed for the research free of charge and supports the design and development of the research.
Lead research units for clinical trials are expected to release more details in the near future.
It is important to note that Remdesivir is an experimental drug that has so far been used by only a very small number of patients infected with 2019-nCov, so we do not know enough about its efficacy and are not currently sufficient to ensure that the drug is widely used. If the results of the preliminary study show the potential safety and efficacy of Remdesivir’s treatment of 2019-nCoV infections, we will endeavour to develop programmes to make Remdesivir, an experimental drug, available to more patients through appropriate channels. We are also in discussions with a number of agencies about the possibility of future clinical trials.
With regard to capacity, in response to the Ebola outbreak in West Africa in recent years, Gilead expanded Remdesivir’s production, established a stock of products to cope with future disease epidemics, and increased the stock of raw materials used to manufacture Remdesivir. We are using this inventory to meet the demand for “compassionate medication” and the need for two clinical trials currently planned for China.
While it has not yet been determined whether the drug can safely and effectively treat 2019-nCoV infections, given the urgency of the current situation, we are taking a number of measures to accelerate production progress and increase supply, including expanding the network of external pharmaceutical partners to accelerate the procurement of raw materials, API and pharmaceutical production; We started manufacturing Remdesivir in-house to complement the capacity of our external production network.
Gilead is actively working with the Chinese government and medical institutions to support clinical trials for people infected with 2019-nCoV. We also maintain regular communication with government agencies to update us on our progress in expanding production.
Zhang Xi, a lawyer at Shangbao Law Firm in Shanghai, told the 21st Century Economic Report that the actions of Wuhan Virus Institute were legal. The application for new use of the patented product for the drug, in accordance with the patent law and other relevant laws and regulations of the provisions (reference to the Patent Law, Article 2 and the 2010 edition of the Examination Guide, Chapter 10, Chapter 6.2, the application of chemical products invention creativity (2), is equivalent to the method proposed new technical proposals. As long as the patent for this use is significantly different from the previous use can be applied for, but whether the patent for this use can be granted, or depends on the substantive examination of its three characteristics (novelty, practicality and creativity) requirements.