Patent Term Extensions In China: Overviews And Takeaways

China has developed rapidly in the pharmaceutical industry in the past few years and has become one of the largest and most active pharmaceutical markets in the world. To further encourage innovation in drug development, China has initiated a series of regulatory and patent reforms in the pharmaceutical industry in recent years, including the implementation of patent term extension (PTE).

Background

The pharmaceutical industry is highly dependent on patent protection due to the high cost, long cycle and high risk of researching and developing new drugs. Without patent protection, it would be difficult for innovative drug companies to recover their research and development costs and achieve reasonable profits, thereby negatively affecting their enthusiasm for research and development of new drugs. However, drug marketing requires strict approval by the drug regulatory authorities, including a series of studies like non-clinical safety evaluation and clinical