On July 6, China’s National People’s Congress (NPC) released additional amendments to the Chinese Patent Law following the Jan 2019 draft version.  As reported previously by this blog when the 2019 version first came out, the proposed Chinese Patent Law complement ongoing efforts to establish and strengthen incentives to develop new, innovative drug products, consistent with the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, issued by the General Office of the State Council in October 2017.  The most significant change that’s targeted to drug products would be the possibility of extending the 20-year term of invention patents for new drugs.  Among the many significant changes in the current version, we would like to highlight two provisions that (once adopted) would serve the statutory legal framework for China’s “Hatch-Waxman” system that would significantly impact the considerations for drug developers when seeking new drug approvals in China.

• Article 42, in the 2019 version, the proposed patent term extension would appear to be limited to products that are first submitted for marketing approval to China and another country.  As we reported in the past, the highlighted language would limit the usefulness of the provision.  The current version has removed that limitation.
• Article 75, the current version adds new provisions to allow patent litigation to be initiated while the new drug application is still pending review at NMPA.  Patent holder can launch the legal challenge within 30 days of the publication of a new drug application by a competitor.  There is a nine-month timeline for the dispute to be resolved with a court or the patent office.

The proposed patent law changes could be significant, and the public comment period, which runs through August 16, offers companies an opportunity to voice support and/or suggest revisions to enhance the proposal.