Introduction
Hong Kong, a hub of commerce, trade, and innovation, boasts a robust and transparent intellectual property regime. For biopharmaceutical companies, understanding the nuances of patent law is crucial for protecting their inventions. Here, we delve into the key insights regarding patentability, enforceability, and the scope of claims for biopharmaceutical patents in Hong Kong.
Patentability in Hong Kong
Governing Laws
Patents in Hong Kong are governed by the Patents Ordinance and the Patents (General) Rules. These laws provide the framework for what can be patented and the procedures for patent applications[1][5].
Types of Patents
In Hong Kong, there are two main types of patents: standard patents and short-term patents. Standard patents offer a maximum protection term of 20 years, while short-term patents provide protection for up to 8 years[5].
Patentable Subject Matter
Methods for the treatment of the human or animal body by surgery or therapy, and diagnostic methods practiced on the human or animal body, are not regarded as inventions susceptible of industrial application and thus are not patentable. This exclusion aims to prevent patent law from interfering directly with medical practices[3].
Medical or Diagnostic Use Claims
Claims related to medical or diagnostic uses can be formulated in specific ways to be patentable. For instance, direct purpose-limited product claims (e.g., "substance X for use in the treatment of disease Y") and Swiss-type claims (e.g., "use of a compound/composition Y in the manufacture of a medicament for the treatment of disease X") are accepted. However, the scope of protection conferred by these claim formats can differ[3].
Enforceability of Biopharmaceutical Patents
Compulsory Licenses
Hong Kong has provisions for import and export compulsory licenses for patented pharmaceuticals, particularly in situations of national emergency or to allow manufacturers to export pharmaceutical products to other WTO members facing similar situations[1].
Patent Linkage and Patent Term Extension
Although Hong Kong does not have a patent linkage system similar to China's, the concept of patent term extension (PTE) is relevant. In China, for example, PTE applications must be filed within three months of the drug’s marketing approval date, and the protection is limited to one patent per drug. This mechanism can be a point of consideration for biopharmaceutical companies operating in the region[2].
Scope of Claims
Claim Formats
In Hong Kong, claims for second or further medical uses can be made using either the direct purpose-limited product claim format or the Swiss-type claim format. The direct purpose-limited product claim format is generally considered to offer broader protection than the Swiss-type claim format[3].
Novelty and Industrial Application
For a claim to be patentable, it must be novel and have an industrial application. Claims must clearly specify the use to which the substance or composition is intended, and the absence of the term "for use" in a claim can render it unacceptable[3].
Amendments and Post-Grant Changes
Applicants can seek post-grant amendments to their claims, including changing from a Swiss-type claim to a purpose-limited product claim. However, such amendments must comply with the relevant sections of the Patents Ordinance and prevailing case law[3].
Application Process
Filing Routes
Biopharmaceutical companies can file standard patent (O) applications directly with the Registrar of Patents in Hong Kong. Alternatively, they can opt for the re-registration route for standard patent (R) applications or file short-term patent applications[5].
Examination Guidelines
The Patents Registry in Hong Kong provides detailed examination guidelines that outline the general principles and specific requirements for patent applications, including those related to medical or diagnostic use claims[3][5].
Recent Developments
New Original Grant Patent System
Hong Kong has introduced a new original grant patent system, allowing for a direct local original grant patent route for filing standard patent applications. This system aims to streamline the patent application process and enhance the protection of inventions[1].
Key Takeaways
- Patentability: Methods for treatment or diagnostic practices are not patentable, but specific claim formats like direct purpose-limited product claims and Swiss-type claims can be used to protect medical uses.
- Enforceability: Compulsory licenses can be granted in emergency situations, and while Hong Kong does not have a patent linkage system, understanding similar mechanisms in neighboring regions is important.
- Scope of Claims: Claims must be novel, have an industrial application, and specify the intended use. Different claim formats offer varying scopes of protection.
- Application Process: Multiple filing routes are available, including direct filing for standard patents and re-registration routes.
- Recent Developments: The new original grant patent system simplifies the application process for standard patents.
FAQs
What types of patents are available in Hong Kong?
In Hong Kong, there are two main types of patents: standard patents with a maximum protection term of 20 years and short-term patents with a maximum protection term of 8 years[5].
Can methods for the treatment of the human body be patented in Hong Kong?
No, methods for the treatment of the human or animal body by surgery or therapy are not regarded as inventions susceptible of industrial application and thus are not patentable[3].
What are the accepted claim formats for medical uses in Hong Kong?
Direct purpose-limited product claims and Swiss-type claims are accepted formats for protecting medical uses in Hong Kong[3].
How does the new original grant patent system in Hong Kong benefit biopharmaceutical companies?
The new original grant patent system allows for a direct local original grant patent route, streamlining the patent application process and enhancing the protection of inventions[1].
Can compulsory licenses be granted for patented pharmaceuticals in Hong Kong?
Yes, Hong Kong has provisions for import and export compulsory licenses for patented pharmaceuticals, particularly in situations of national emergency or to allow manufacturers to export pharmaceutical products to other WTO members facing similar situations[1].
Sources
- Axiom Law: Intellectual Property Regime and the Patents System in Hong Kong.
- Hogan Lovells: What China's new patent linkage and patent term extension systems mean for foreign pharma.
- Intellectual Property Department, Hong Kong SAR Government: Section 5: Medical or Diagnostic Use Claims.
- IP Watchdog: A Comparative Look at Patent Subject Matter Eligibility Standards.
- Intellectual Property Department, Hong Kong SAR Government: Section 13: Patent Applications.
