According to Singapore’s Regulation 23, when a drug company wants to register a new drug, the Health Sciences Authority (HSA) needs to determine if there is a patent in force. According to the Singapore’s Patent Act 1994, the HSA requires the drug applicant to determine whether a patent declaration should be made for their drug registration. However, the drug industry believes that the current regulation is too vague on patent declarations, and this could lead to confusion on when to or if a patent needs to be declared.
In an effort to clarify this regulation, the HSA is proposing to fine-tune their patent stance to only require patent declarations for an API, formulation of the drug, or the use of an API in the manufacture of a drug for specific diagnostic, preventative, or therapeutic use. In short, patents not included in these three areas under a revised Regulation 23 would not be required to make a declaration. The HSA believes that such changes to Regulation 23 will eliminate the haphazard use of the patent declaration mechanism and lead to drugs getting on the market quicker and via a streamlined process. The HSA is interested in industry’s feedback on this change and will study the feedback and update stakeholders accordingly.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.twobirds.com/en/insights/2020/singapore/patent-linkage-scheme-in-singapore