New Laws/Regulations/Implementing Measures

China promulgated an electronic commerce law on August 31, 2018, effective, January 1, 2019.  Of interest to intellectual property rights (IPR) holders, the law makes e-commerce platform operators potentially jointly and severally liable with IP infringers and enables the relevant administrative department (e.g., the China National Intellectual Property Agency (CNIPA)) to fine platform operators up to 2 million RMB (~$291,000) for failure to protect IPR. The law also formalizes a mechanism for IPR disputes on e-commerce platforms. Continue Reading China Promulgates Electronic Commerce Law

On April 25 this year the China National Drug Administration (CNDA) published a proposed draft on Implementing Measures for Pharmaceutical Trial Data Protection.  The measures prevent other drug manufacturers from relying on earlier trial data to receive sales approval without permission from the owner of the earlier trial data.  The proposed draft extends the trial data protection term to up to 12 years compared with that of up to 6 years previously.  During the protection term, the CNDA will not approve marketing of the same drug[i] from a third party without permission of the owner whose drug gets a trial data exclusivity, except if the third party independently runs a trial and collects trial data. Continue Reading China plans to increase market exclusivity term for pharmaceuticals based on improved pharmaceutical trial data protection

On March 29, 2018, the State Council issued Measures for transferring Intellectual Property rights (IPR) to foreign parties (Pilot) (hereinafter called “Measures”). The Measures are effective immediately and apply to all technical IPR (i.e., patents, registered integrated circuit layout designs, computer software copyrights and new plant varieties rights). According to the Measures, in IPR export and M&A approval process, a relevant IP department under the State Council (e.g., the State Intellectual Property Office) must conduct additional review before IPR transfer to a foreign entity or before foreign investors acquire Chinese companies that include IPR transfer.  Previously, in IPR export approval process, only non-IP departments reviewed IPR transfer. In M&A approval process, no government departments reviewed IPR transfer. Continue Reading China tightens scrutiny on Intellectual Property transfers to foreign parties

On May 7th this year, China National Drug Administration (CNDA) released a proposed draft of special review and approval procedure for innovative medical devices. The procedure intends to expedite approval for medical devices if the Applicant has patents or patent applications pending in China. This draft contains several major revisions compared with the previous version issued in 2014. Continue Reading China plans to revise the Special Review and Approval Procedure for Innovative Medical Devices

The State Council of China announced in April this year a plan to extend patent protection for up to five years for innovative drugs due to regulatory delay.  However, the State Council has not disclosed specific rules nor timetable for same.  Meanwhile, in May this year, China and the United States issued a joint statement in the economic and trade consultations, which clearly indicated that China would advance revisions on Patent Law, and it is speculated that revisions related to the above-mentioned patent term extension for drugs will be potentially reflected in the revised Patent Law[i].

It is likely that the patent term extension will only apply to patent applications filed after the revised Patent Law is in force.  Revisions in the Patent Law will probably complete late this year, and the implementation of the patent term extension will probably begin in early next year.  In addition, if a patentee of a patented drug product only applies for regulatory approval in China or if it only receives regulatory approval overseas but not in China, the patent term extension may not be available. The maximum term extension is 5 years, not to extend total remaining patent term beyond 14 years[ii].

Patent term extension will presumably apply to both foreign and domestic pharmaceutical companies.  Drugs developed in China or overseas will also probably entitled to patent term extension.  Also, yet to be determined, whether each drug patent is entitled to a single patent term extension (e.g., if a patent is relevant to two different drugs that underwent regulatory approval, is only one extension allowable?), and if only one patent per drug is entitled to the extension.

We can expect opposition from Chinese generic drug manufacturers as this will delay their ability to supply new generic drugs.  However, foreign drug companies with new drugs should benefit with longer patent monopolies.

[i] https://www.chinalawinsight.com/2018/05/articles/intellectual-property/金杜知识产权主题月-药品知识产权法律行业%EF%BC%9A新/

[ii] http://news.pharmnet.com.cn/news/2018/01/25/489761.html