China implements pharma patent reforms

It has introduced a patent term extension for drugs.

China has made its latest patent amendments effective, with reforms which aim to ensure protection against untimely and unfair generic competition. As a result, the local pharma market makes itself more competitive and conducive for innovative research companies, both regional and international, according to a GlobalData report.

Although China has made patent law revisions previously, the highlights of the latest reforms are the drug patent linkage system, introduction of patent term extension for drugs and the patent term compensation system.

Patent reforms by China, following the recent drug regulatory reforms, will be viewed as a greater opportunity to incentivize research and bolster entry into the world’s second largest pharma market, said GlobalData’s pharma analyst Sasmitha Sahu. She noted that despite being a generic market historically, the country has made reforms to drive research.

“Notwithstanding the negative perception owing to the COVID-19 pandemic, China continued to implement major drug regulatory reforms and clinical trial guidelines which ensure faster turnaround of regulatory approvals,” Sahu added.

Domestic pharma companies which have forayed into innovation of late are the most likely benefactors, although this will also benefit international innovator companies as well, Sahu said.

The latest Chinese patent laws now accommodate and compensate for the patent period lost owing to regulatory delays like US and EU patent rules, GlobalData said, noting that favorable drug regulatory reforms have already encouraged many international pharma companies to enter high-value deals with domestic Chinese innovator companies.

The pharmaceutical industry of China is expected to reach $300.9b by 2025 at a compound annual growth rate (CAGR) of 12.2%. Chinese patent authority ranked on the top with 16,983 pharmaceutical grants issued so far in H1 2021.

“Although China tops the patent filings and grants chart, much of it is driven by domestic filings. As China gains center-stage in the APAC region for many international pharmaceutical collaborations and deals based on novel therapies, it becomes imperative to have robust patent laws to protect the interests of the innovating stakeholders,” Sahu said.

Longer exclusivity is likely to attract international innovator companies, which will ensure that the country’s patient population can gain access to novel branded therapies, Sahu added.