As a Special Administration Region (SAR) of China, Hong Kong still retains much of the basic common law and legal system that was established under the United Kingdom. The information below provides a brief snapshot of some of the current differences between the systems in Hong Kong and China as it relates to topics of interest for the pharmaceutical industry.

Drug Registration

Hong Kong pharmaceutical products are required to be registered by the Pharmacy and Poisons Board (PPB) before sale. Under the Pharmacy and Poisons Ordinance (PPO) (Cap 138), the PPB considers drug registration by investigating scientific data criteria in relation to safety, efficacy and quality. An applicant with a new chemical or biological entity in Hong Kong is required to provide official evidence of registration approval of the product in two or more of the following 32 countries: Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Holland, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, UK and USA.

It has only been since last year that mainland China has also been included due to the acknowledgement by the HK Department of Health of China's substantial implementation of the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Brazil, Korea and Singapore have also recently joined the above list of 32.

Yet none of the new four countries are recognised as a Stringent Regulatory Authority (SRA) as designated by the World Health Organization (WHO) and as such the reliance on data from one of these four will also require data from one of the original 32 countries. Accordingly, a drug compound made and approved in China will not automatically be allowed to be registered and sold in Hong Kong unless the above stringent measures have been satisfied.

Data Exclusivity

In HK there is a an eight-year data exclusivity period during which time a generic applicant cannot rely on an originator product's clinical data in its marketing authorisation application. In China this period is 6 years for new chemical entities commencing on the date of marketing approval in China.

Patent Linkage

Unlike some other countries which possess a patent linkage scheme, the PPB does not consider patent status as one of the criteria in vetting drug registration applications. Accordingly, as the existence of enforceable third party patent rights does not affect the PPB's consideration of registration, a third party patent owner may not become aware of the registration and/or any subsequent infringement. In contrast, in July 2021, China introduced a patent linkage scheme. The Chinese Supreme Court has already ruled under this new scheme (see Chugai Pharmaceutical Co.,Ltd (the "Chugai") v Wenzhou Haihe Pharmaceutical Co., Ltd. (the "Haihe") [(2022) Zui Gao Fa Zhi Min Zhong No.905]).

In HK information regarding the registration of pharmaceutical products can be located through the "Compendium of Pharmaceutical Products", which is regularly updated and maintained by the HK Drug Office (division of the Department of Health).

Bolar like provisions

Section 75(b) of the HK Patents Ordinance states that the "rights conferred by a patent shall not extend to: acts done for experimental purposes related to the subject matter of the relevant patented invention". This however does not extend to the use of patented products and/or patented processes for the purpose of conducting clinical trials and/or for supporting drug marketing or registration at the HK Drug Office. In their April 2017 Legislative Sub-Committee Meeting, the HKIPD (Intellectual Property Department) confirmed that no US type Bolar exemptions existed for activities undertaken solely for obtaining regulatory approval. As such, tests or experiments conducted solely for obtaining marketing approval of generic drugs can only be initiated or conducted after expiry of the patent for the originator drug. In June 2018 the HK Legislative Council discussed the potential benefits for introducing a Bolar type provision but only suggested that the Administration "would review the patent law from time to time". Again, this should be contrasted to China which introduced a Bolar type exemption in 2008 for producing, using, or importing patented drugs or patented medical apparatus and instruments, for the purpose of providing the information required for regulatory examination and approval.

Patent term extension

Since 2021 PTE provisions have been available for Chinese patents covering active pharmaceutical ingredients that have been approved for marketing in China. The extension cannot exceed 5 years, and the resulting total effective patent term cannot exceed 14 years from the approval for marketing of the new drug. Extension of term provisions are not currently available in HK. Accordingly, even if a HK patent is registered based on a corresponding Chinese patent application, the HK patent cannot be extended even if the corresponding patent in China has been extended.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.