by Wenting Cheng*
On May 12th, China Food and Drug Administration (CFDA) published Notice of Calling for Comments on “Policies Related to Encouraging Innovations in Pharmaceuticals and Medical Equipment and Protecting Interests and rights of innovators (Draft for Comments)” (No. 55 2017) . The policy mentioned in this notice is intended to “further the reform of the drug review system, promote structural adjustment and innovations in pharmaceuticals and medical equipment industries, enhance industrial competition and satisfy the clinic requirement of the public”. The call for comments will last till June 10, 2017. Before this data, everyone can provide written comments to the Division of Pharmaceuticals and Cosmetics Registration of the CFDA via email.
This draft policy includes four policies, including soliciting establishment of the patent linkage system for pharmaceuticals, improve data protection, implement the confidentiality to governmental officials involved in the marketing of new drugs and establish a collection of the marketed drugs. The following paragraphs will highlight the key point of the patent linkage system and data exclusivity proposed in this draft.
The proposed patent linkage system includes the following elements:
An applicant for a drug registration shall submit a declaration that he knows and should be aware of the relevant patent right (s) when submitting the application for registration.
When challenging existing patent(s), an applicant shall declare that he does not infringe the relevant patent of drugs and shall inform the relevant patentee within 20 days after the application for registration. If the patentee concerned considers that his/her patent right has been infringed, he/she shall file a patent infringement action with a judicial authority within 20 days upon receiving the notice from the applicant and inform the drug review agency.
After receiving the evidence that the patent infringement lawsuit has been accepted by the judicial authority, the drug review agency may set up the pending period of less than 24 months; during this period, the technical review of the accepted medicine shall not be suspended. In the pending period, if the parties reach a settlement or the judge makes a decision of whether or not the infringement is established, the drug review agency shall decide whether or not to approve the marketing of the drug on the basis of the mutual settlement or judicial decision. If the judge does not reach a decision beyond the pending period, the drug review agency may approve the drug marketing.
If the applicant does not declare the relevant patent, and the patentee filed a lawsuit of infringement, the drug review agency shall put the application in the list of pending cases based on whether the case has been accepted by the court. For any intellectual property litigation occurred after marketing, the judiciary decision shall prevail.
Improve data protection
China has already established data exclusivity as a commitment to TRIPS accession. In the Implementing Regulations of Drug Administration Law in 2002, six years data exclusivity is provided. However, these regulations are not clear about the benchmark to decide “new entities” is global or local. It is not clear whether biologics are considered as new entities and therefore qualified for data exclusivity either. However, China agreed to provide data exclusivity to biologics in its FTA with Switzerland.
In the present policy proposal by CFDA, the above standards for data exclusivity are further enhanced. The periods of proposed data exclusivity are specified as follows:
- Six years data protection for original drugs;
- Ten years data protection for original orphan drugs or original drugs for children;
- Three years data protection for improved orphan drugs or improved drugs for children;
- Ten years data protection for original biologics;
- One and half years protection for generics that have successfully challenged an existing patent;
- One and half years protection for the first generic marketed domestically;
- One year grace period for drugs approved by the EU, US and Japan drug authorities.
The 10 years data exclusivity for biologics has been longer than that provided in the TPP. Nonetheless, it is worth noticing that this is a proposed draft and will go through a deliberation process. The period for public comments will last till June 10th, 2017
* Ph.D Scholar at School of Regulation and Global Governance (RegNet), the Australian National University.
 Para 284 (WT/L/432) Accession of the People’s Republic of China 23 November 2001.
 Article 11.11.2 China-Swiss FTA.