Sacrificing the Patentability Standard of Novelty and Industrial Application on the Altar of Incremental Biotech Innovation in Hong Kong
BIOTECHNOLOGY IN HONG KONG, Volume III, Albert Wai-Kit Chan, ed. (Whitestone: U.S.-China IP Institute 2018) 291-307.
13 Pages Posted: 29 Apr 2017 Last revised: 4 Jan 2021
Date Written: February 1, 2017
Despite non-novelty and the non-susceptibility of industrial application for a diagnostic, therapeutic or surgical treatment, most jurisdictions, including Hong Kong, have chosen to allow first and further medical use claims. Hong Kong’s new patent system includes for the first time in its history the possibility of applying for an Original Grant Patent. It is expected that the Patent (Amendment) Bill 2015 will come into effect in 2018. This article first focuses on the patentability requirements for medical use claims, their failure and solution. Like an alchemist who is forging gold out of lead, the new Hong Kong patent ordinance purifies the failures of these patentability requirements by using two fictions (Sections 9(B)(5) and 93(4) Patents Ordinance). After this doctrinal hurdle is overcome, the Hong Kong patent system pragmatically allows for straightforward purpose-limited claims, but also for Swiss-type claims. Even though Hong Kong followed the UK and EPO in accepting the Swiss-type claim, it does not follow them in their rejection of this convoluted claim, because Hong Kong’s patent system wants to continue to be able to re-register Chinese innovation patents that are phrased as Swiss-type claims.
The advantages and disadvantages of first and further medical use, methods of delivery and patient groups are explored. In case of a slew of ever more obscure uses, it seems, at least prima facie, the scales are tipped towards protection of extending originators’ patent rights which is not conducive for generics and the access to reasonably priced medicines, but might be positive for efficacy studies.
The article will pose the age old question as well: will a patent-friendly but potentially access-unfriendly approach harness or harm innovation in biotech? Here a distinction will be made between the different kinds of innovation, such as claims for polymorphs, enantiomers (optical isomers), salts, ethers, esters, compositions, doses, prodrugs, metabolites, analogy processes, and Markush and selection claims. The article will explore the possibility of reconciling the granting of patents for second and further medical use claims with an enhanced efficacy and utility regime conform the respective Canadian and Indian legal innovations, so that at least these medical uses will demonstrate incremental but observable improvements for patients.
Keywords: novelty, non-obviousness, inventiveness, patent law, intellectual property law, pharmaceuticals, secondary medical use, further medical use, Swiss-type claims, alchemy, polymorphs, enantiomers, salts, ethers, esters, compositions, doses, prodrugs, metabolites, industrial application
JEL Classification: Q30, Q31, Q39
Suggested Citation: Suggested Citation