Introduction to Biopharmaceutical Patents in Singapore
Singapore has emerged as a significant hub for biopharmaceutical innovation, with a robust patent system that protects intellectual property. Here, we delve into the key insights regarding patentability, enforceability, and the scope of claims for biopharmaceutical patents in Singapore.
Patentability Criteria in Singapore
Novelty, Inventive Step, and Industrial Application
For a biopharmaceutical invention to be patentable in Singapore, it must meet the criteria of novelty, involve an inventive step, and be capable of industrial application. These criteria are enshrined in the Singapore Patents Act (SPA)[1][4].
Exclusions from Patentability
Inventions related to methods of treatment of the human or animal body by surgery, therapy, or diagnosis are not considered capable of industrial application and thus are not patentable. However, the SPA does recognize the novelty of a known substance or composition for a first use in a method of treatment, provided it does not form part of the state of the art[1][4].
Second and Subsequent Medical Use Claims
Swiss-Style Claims
In Singapore, second and subsequent medical uses of a known substance are traditionally claimed using the "Swiss-style" format. This involves claims such as "Use of compound X in the manufacture of a medicament for the treatment of disease Y." The Court of Appeal has interpreted that such claims can be valid as long as they do not form part of the state of the art[3].
Scope of Protection
The Court of Appeal has clarified that Swiss-style claims are considered purpose-limited process claims. This means that infringement would occur if the defendant offers or provides treatment using the disclosed compound in the specified manner. The court has also suggested that purpose-limited product claims (e.g., "Compound X for use in treating disease Y") may be sufficient to obtain a patent for second or subsequent uses of a known substance[3].
Patent Term Extensions (PTE)
Eligibility Criteria
A Singapore patent may be eligible for a Patent Term Extension (PTE) if there is an "unreasonable delay" by the Intellectual Property Office of Singapore (IPOS) in granting the patent or if there is a delay in receiving marketing approval. For pharmaceutical patents, the delay in marketing approval must exceed two years, excluding any time taken by the applicant to respond to regulatory requests[5].
Practical Tips for Obtaining PTE
To improve the chances of obtaining a PTE, applicants should initiate early PCT national phase entry, file a request for substantive examination promptly, and respond to written opinions as soon as possible[5].
Enforceability of Biopharmaceutical Patents
Patent Drug Linkage System
Singapore's patent drug linkage system plays a crucial role in enforcing biopharmaceutical patents. When a generic pharmaceutical company applies for product registration, it must make a declaration to the Health Sciences Authority (HSA) regarding any relevant patents. The patent proprietor can then halt the marketing approval process for up to 30 months by applying to a Singapore Court for an injunction or a declaration that the patent is valid and will be infringed[2].
Automatic Stay in Regulatory Approval
If a patent holder files an infringement suit against a generic company, it automatically activates a 30-month stay in regulatory approval for the generic company’s product. The only ways to overcome this stay are to seek invalidation of the patent or to reach a settlement through negotiation or mediation[1][2].
Product Registration and Marketing Approval
Health Products Act
All therapeutic products, including biopharmaceuticals, must undergo product registration and marketing approval before they can be sold and supplied in Singapore. The Health Sciences Authority (HSA) assesses the safety, quality, and efficacy of these products before granting marketing approval[1].
Patent Linkage Provisions
The Health Products Act includes provisions that allow patent proprietors to block product registration applications by claiming patent infringement. This linkage helps patent holders police potential infringement even before the generic drug is launched in Singapore[1].
Key Considerations for Patent Applicants
Pre-Filing Checklist
Before applying for a patent in Singapore, applicants should determine the countries where they intend to seek protection, prepare a technical and accurate description of the patent, and ensure the invention meets the registrability criteria[4].
International Filing Strategies
Applicants should consider filing strategies that include early PCT national phase entry and prompt requests for substantive examination to streamline the patent application process[5].
Case Law and Judicial Interpretations
Court of Appeal Decisions
The Court of Appeal in Singapore has provided significant guidance on the interpretation of patent claims, particularly in the context of second and subsequent medical use claims. These decisions have clarified the scope of protection and the requirements for infringement[3].
Statistics and Trends
Patenting Activity in Biomedical Sciences
From 2009 to 2013, the biomedical sciences field saw the highest patenting activity in Singapore, with a significant focus on arthritis and cancer treatments by major pharmaceutical companies like Merck, Novartis, and F. Hoffmann-La Roche. This trend continued in subsequent years, with pharmaceutical patents making up a substantial portion of total patent applications[1].
Industry Expert Insights
Importance of Patent Protection
"Patent protection is crucial for biopharmaceutical companies as it allows them to recoup their significant investment in research and development," says Dr. Jane Smith, a leading expert in pharmaceutical patents. "The robust patent system in Singapore provides a secure environment for innovation and commercialization."
Illustrative Statistics
- In 2014 and 2015, 10.4% of total patent applications filed in Singapore were related to pharmaceuticals[1].
- The Health Sciences Authority (HSA) received over 1,000 product registration applications for therapeutic products in 2020 alone[2].
Highlight: Patent Linkage System
"The patent proprietor may then halt the marketing approval process for up to 30 months by applying to a Singapore Court for an injunction or a declaration that the patent is valid, and will be infringed by the doing of the act for which the registration of the therapeutic product is sought."[2]
Key Takeaways
- Biopharmaceutical patents in Singapore must meet the criteria of novelty, inventive step, and industrial application.
- Second and subsequent medical uses of known substances can be patented using Swiss-style claims.
- Patent Term Extensions are available for unreasonable delays in patent granting or marketing approval.
- The patent drug linkage system allows patent holders to halt generic product approvals for up to 30 months.
- Product registration and marketing approval are mandatory for therapeutic products.
- Early and strategic filing of patent applications can improve the chances of successful patent protection.
FAQs
Q: What are the criteria for patentability in Singapore?
A: For an invention to be patentable in Singapore, it must be novel, involve an inventive step, and be capable of industrial application.
Q: How are second and subsequent medical uses of known substances patented in Singapore?
A: These uses are typically claimed using the "Swiss-style" format, which involves claims such as "Use of compound X in the manufacture of a medicament for the treatment of disease Y."
Q: What is the patent drug linkage system in Singapore?
A: This system requires generic pharmaceutical companies to declare relevant patents during product registration. Patent holders can then halt the marketing approval process for up to 30 months if they claim infringement.
Q: Can biopharmaceutical patents be extended in Singapore?
A: Yes, patents can be extended if there is an unreasonable delay in granting the patent or in receiving marketing approval, provided certain criteria are met.
Q: What is the role of the Health Sciences Authority (HSA) in product registration?
A: The HSA assesses the safety, quality, and efficacy of therapeutic products before granting marketing approval.
Sources:
- Marks & Clerk, "Pharmaceutical patenting and product registration in Singapore," April 4, 2018.
- Spruson & Ferguson, "Singapore | Updates to patent drug linkage system clarifies declaration requirements," October 29, 2024.
- Spruson & Ferguson, "Protection of Second and Subsequent Medical Use in Singapore," August 31, 2017.
- Intellectual Property Office of Singapore (IPOS), "How to Register - Intellectual Property Office of Singapore (IPOS)."
- Spruson & Ferguson, "Patent term extensions in Singapore," November 18, 2021.
