Page 84 - OHKF_Biotech_EN

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Since an integrated IP regime applicable to both the Mainland and Recommendation 6.3 Expediting evaluation
Policy recommendations for Central Ministries and Departments
Hong Kong has yet to be established, the NIPA may explore the and approval of new drugs in the Loop
coordination of the two regulatory regimes to better harmonise the
IP regimes, with a view to addressing differences in the regimes in In relation to the registration and launch of new drugs, in addition
the longer term. In 2017, the NIPA implemented a prioritised patent to our recommendations for the governments of Hong Kong and
granting mechanism to expedite granting of patent associated with Shenzhen (see Recommendation 2.5 for details), the NMPA may
the nation’s prioritised industries such as biotech. We consider delegating certain powers in new drug approval and
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recommend that NIPA set up a subsidiary or an office in the exploring the administrative feasibility of such delegation, so
Loop, with a view to expediting the approval of patent that the two GBA sub-centres for drug and medical device
applications by enterprises registered in the Loop by making evaluation and inspection established in the Loop may be
reference to the above-mentioned prioritised granting tasked with new drug approval procedures, instead of merely
mechanism. We also recommend that the NIPA consider functioning as a communication channel between the NMPA and
making reference to Hong Kong’s patent (R) system and enterprises. The biotech expert advisory committee mentioned in
recognise standard patents granted under the Hong Kong Recommendation 5.2 can render comprehensive and
IPD’s patent (O) system, with a trial scheme to be run in the professional support to the GBA sub-centres in conducting all-
GBA first. The NIPA can also share its patent database with Hong stage intervention for the approval procedures of drugs and
Kong and coordinate the original grant patent systems in Hong medical devices. One such intervention includes the sub-centres
Kong and the Mainland by providing technical assistance and providing step-by-step communication with applicants for drug
patent expertise. In the event of IP disputes, enterprises may registration, from clinical research to registration and product
obtain support on mediation and arbitration via the Intellectual launch. Such communication can help applicants complete the
Property Arbitration Centre of China (Shenzhen) mentioned in evaluation and approval procedures at the sub-centres more
Recommendation 3. They can also hire eligible barristers and efficiently.
lawyers trained in Hong Kong and Macao to deal with litigations in
the Mainland.

84 In 2017, the NIPA promulgated the Measures for the Administration of the Prioritised Examination of Patents, which permits prioritised examination of specific applications. The NIPA
undertakes to issue an Opinion on the First Examination within 45 days after the submission of the application and to close the file within 12 months. Re-examination files would be closed
within 7 months. This shortens the normal examination time of 33 months by 21 months.
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