2:01 PM
Jan 10, 2019
 |  BC Extra  |  Politics & Policy

Patent reform back on agenda in China

China’s 13th National People’s Congress (NPC) is moving forward with a revised draft of patent law amendments that includes increased patent protection for innovative drugs. Consideration by the NPC is the final step before enacting the amendments.

The fate of IP reforms spearheaded by Jingquan Bi came into question after Bi resigned in August as secretary of China's State Administration of Market and Supervision amid a vaccines manufacturing scandal. From 2015 until March 2018, Bi had been head of China’s State Drug Administration (SDA, now National Medical Products Administration), where he led the government’s march to bring innovative new drugs to China via a slew of regulatory reforms (see "Thinking Beyond Bi").

But patent law revisions are now back on the table and NPC is accepting public comments on the draft amendments through Feb. 3.

Tony Chen, a partner at Jones Day, told BioCentury that while he expects the amended patent law will eventually be approved, the "tug of war" between the interests of innovators and generic drug companies may yet lead to changes to the current version. He said there will be two or three more additional rounds of public consultation and expects the approval process could take 6-10 months.

The draft was created in 2015 by China's National Intellectual Property Administration, formerly known as the State Intellectual Property Office. Since then, the draft has been revised by multiple departments including the Ministry of Justice and approved by the State Council (see “China’s SIPO Aims to Strengthen IP Protection”).

Under current law, the total term for invention patents is 20 years from the filing date. To compensate for patent term loss due to regulatory review and approval, the draft would grant China's State Council authority to extend the patent term by up to five years for innovative drugs when sponsors apply simultaneously for market approval in China and abroad. However, the total patent term after market approval of an innovative drug would be limited to 14 years.

The draft would also increase the maximum amount of damage compensation for patent infringement to RMB5 million ($732,139) from RMB1 million, and outlined methods to determine the level of compensation.

Xin Tao, a senior associate at law firm Hogan Lovells, told BioCentury the provisions on patent restoration and higher infringement damages would apply to both new and existing patents. He added that clinical data exclusivity is not part of the draft patent law. He expects the National Medical Products Administration (NMPA) to finalize its draft guidance on data exclusivity this year.

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