China's latest patent law draft signals introduction of patent linkage

An update to China's patent law could be on the horizon as the government recently published a revised draft of the document with changes that offer better protection to innovative drug developers. The changes are not yet final, as the document is open for public comments until Aug. 16.

Two revisions in the draft policy are noteworthy for pharmaceutical companies making new drugs:

In one revision, patent holders of a new drug approved by the National Medical Products Administration can request a patent term extension of up to five years to compensate for delays to commercialization due to time lost in the process of regulatory review and approval. The total patent term, however, cannot exceed 14 years.

The other revision would give new drug developers the basis for legally challenging a generic drug application. The originator company could file a complaint with the Chinese IP administration over a generic drug manufacturer's submission to the National Medical Products Administration of a market authorization application. The revision also gives companies the right to appeal the IP authority's decision within 15 days of its ruling.