Attached are English and Chinese versions of a speech by USPTO Acting Director Teresa Rea that was first delivered at China Pharmaceutical University earlier this month.  The speech underscores the challenges for innovative pharmaceutical companies in China’s current IP environment.

 

Although China has ambitious goals to develop an innovative pharmaceutical industry, certain aspects of IP protection have ironically not progressed or even been weakening over the past several years.  This is particularly true for China’s enablement requirements (sufficiency of disclosure).  This is a  topic that has been receiving some attention.  See., e.g., the powerpoint of Larry Welch from Eli Lilly.  

 

Want further proof of the challenges? Here is a powerpoint I did for a class at Tsinghua University taught by Chief Judge Rader of the CAFC on this issue which shows the more stringent enablement requirements being imposed in different SIPO examination guidelines. 

 

In terms of enforcement, you can also go to the CIELA database and look up how the few pharma patent cases reported are faring in the courts.  Although the data is limited, in several years there was a 100% loss or partial loss rate, with cases taking relatively long to complete and a low injunction ratio.