On behalf of the more than 220 members of the US-China Business Council (USCBC), we appreciate the opportunity to submit comments on the draft Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (hereby referred to as “the Measures”).
As part of the US-China Phase One trade deal and subsequent IP Action Plan, China committed to establishing a pharmaceutical patent linkage regime by October 2020. A properly implemented patent linkage regime will bring benefits to all pharmaceutical manufacturers in China, both generic and innovative, foreign and domestic. Such a system will allow China’s innovative biopharmaceutical sector to continue to develop into an international leader, while also promoting increased access to affordable medicine for Chinese consumers.
The Measures are a positive step towards establishing a pharmaceutical patent linkage system. We welcome the establishment of a unified platform in the Patent Information Registration Platform of Marketed Drugs in China, which is a crucial component to an effective framework. At the same time, USCBC members have concerns that other provisions in the measures may undercut this positive development. For example, the measures put forward a “9-month stay period,” for resolving patent disputes, which is too short to be effective. Instead, the stay period should align with the actual time it takes to receive a judgement; in 2017 China’s then-CFDA committed to a 24-month stay period, which would be more appropriate. In addition, the Measures treat biological drugs as a separate product from chemical drugs. We feel that treating biological and chemical drugs equally in the measures will not only support development of China’s innovative drug ecosystem but will also ensure full compliance with China’s Phase One commitments to include biologics fully into its patent linkage system.
We appreciate this opportunity to express our suggestions to the National Medical Products Administration and have included article-specific recommendations on these items and others in detail below.