On 12 May, 2017 the CFDA published its intention to work on a new patent linkage and data protection system for China as part of a reform of its regulatory approval processes (2017 Policy Notice No. 55). The Notice includes a proposal for the general terms of the new regime which indicates major changes. The general public is asked to comment on the draft concept by 11 June at the latest (however a shorter response deadline of 25 May has been encouraged by CFDA).

The developments should be followed closely as many details are not finalised. Many stakeholders have asked for improvements in the CFDA’s involvement in patent matters to ensure a proper balance between innovative pharma and generic entrants. Now CFDA has shared its thoughts on the future concepts.

Here are the most important elements of the proposal which appear to be the basis for the new regime:

Patent linkage

Every applicant for a drug approval shall make a declaration on knowledge of relevant patent rights in its application for drug approval and, further, needs to make notice to any corresponding patentee that the applicant is not infringing on these patents within 20 days.

If the patentee disagrees with the declaration, the patentee shall bring a patent infringement suit and inform the CFDA within 20 days after notification. After the receipt of a notification on the patent infringement law suit, CFDA has the discretion to suspend the drug approval process for a maximum of 24 months. During the suspension period CFDA shall decide on the drug approval based on the outcome of the patent litigation, or based on any settlement among the parties. If no decision from the patent litigation or any settlement is available after 24 months, the drug application may proceed to approval and the patentee will have to rely on the outcome of the infringement suit. If the applicant for the regulatory approval has not declared a relevant patent, and a patentee brings a lawsuit against the applicant after the acceptance of the drug application, a decision on the suspension in view of the progress of the patent litigation shall be made by the CFDA.

Regulatory data protection

Every applicant for a drug approval can file a request for data protection for the submitted experimental data in the application. For innovative drugs the data protection period will be 6 years (increased to 10 years for the treatment of rare diseases or paediatric uses) while therapeutic biologics will enjoy 10 years of data protection. Existing drugs modified for the treatment of rare diseases or paediatric use will enjoy a 3-year data protection term. It is clarified that for drugs that have already been approved outside China the same data protection periods will apply, if the request for marketing approval in China is filed within one year after having obtained approval by the European Medicine Agency, or the United States or Japanese drug regulators. Shortened data protection application periods will apply, if the application in China is filed later than that one year period, but will be a minimum of 1.5 years. China therefore encourages early entry of new drugs into China by this policy reform.

Generic applicants that successfully challenge the originator’s patent will also receive a 1.5-year data protection bonus linked to their application, which adds a motivation for generics to file invalidation requests against originator patents. The data protection period is calculated from the date of the marketing approval and CFDA will not accept data from other applicants during this period, other than those created by later applicants.

New register for approved drugs

A Catalogue of Approved Drugs in China (comparable to the “Orange Book” in the United States) is further proposed. Besides scientific information on the drug’s use and the market approval holder’s information, it will also include intellectual property information such as lists of relevant patents, the data protection period and drug monitoring period.

The proposal further includes new guidelines for enforcement of confidentiality obligations for the CFDA staff.

Interested parties can comment to CFDA within the above mentioned deadlines.