SCIO briefing on securing market order to support work and production resumption

A press conference was held Tuesday morning to shine light on measures taken by State Administration for Market Regulation, National Medical Products Administration and China National Intellectual Property Administration to support work and production resumption.

China SCIO February 27, 2020

There was a report that remdesivir, a drug developed by Gilead Sciences, Inc. in the U.S., has shown effectiveness in treating COVID-19. What is the patent situation in China? We saw some Chinese pharmaceutical companies claim to produce a generic version of the drug remdesivir. Has the State Intellectual Property Office commented on this? Thank you.

He Zhimin:

Thank you for your question. According to multiple reports, remdesivir is a new drug in development by U.S.-based Gilead Sciences, Inc. It was first used to treat diseases such as Ebola and Middle East respiratory syndrome. This drug has not yet been taken to market in any country in the world and remains in the clinical stage. Some U.S. news outlet reported that remdesivir had shown preliminary effectiveness in treating COVID-19. China has started clinical trials of the drug in several hospitals in Wuhan. Trials are under way, and we won't get the results until April 27. We are paying close attention to the findings of the trials.

According to the current public information, Gilead Sciences, Inc. has applied for eight patents in China related to remdesivir. At present, three patents have been granted and five remain under review. The protection scope of these eight patent applications covers the core structure and similar structure of the compound, crystal form, related manufacturing methods and application.

Medicine is a special commodity crucial for many people's life and health. At the same time, because of the huge required investment, long time and great risk of drug research and development, the industry needs strong intellectual property protection. According to the provisions of the Patent Law of China, after patent right are granted, except for exceptions provided for in the law, no entity or individual may manufacture, use, promise to sell, sell or import a patented products for the purpose of production and operation without the permission of the patent holder. What are the exceptions? They include patented technology for scientific research and test purposes, as well as the import of patented medicine to provide information needed for administrative examination and approval.

Medicine is also special products, whether developed through original research or generics, in that they need strict approval by the regulatory department before they can be put on the market. Pharmaceutical enterprises must produce and market patented products according to law, not only through medicine regulatory authorities, but also while respecting the property rights of patent holders. If a patent holder sees infringement, he or she can bring a lawsuit or submit a request for administrative arbitration. We will protect the legitimate rights and interests of the patent holder within the framework of the Patent Law.

Now that remdesivir is currently in clinical trials, we are quite concerned about its effectiveness and safety. We are also looking forward to the emergence of numerous other medicines that have shown promise in treating COVID-19 including existing medicines. At present, the prevention and control of novel coronavirus pneumonia epidemic has reached the most critical stage. We, along with scientific research workers and pharmaceutical enterprises, should keep the people's safety and health at the top of the agenda and show a strong force of solidarity and cooperation to win the battle. Thank you.

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