Introduction
Patenting biopharmaceuticals in New Zealand involves a complex interplay of legal frameworks, regulatory requirements, and international agreements. Understanding the key insights into patentability, enforceability, and the scope of claims is crucial for innovators and industry stakeholders.
Patentable Subject Matter
General Principles
In New Zealand, the patentability of biopharmaceuticals is governed by the Patents Act 2013. Methods of medical treatment, diagnosis, and surgery practiced on human beings are not patentable, aligning with the majority of countries except the United States and Australia[1][5].
Swiss-Type Claims
New Zealand allows Swiss-type claims, which protect new uses of known pharmaceutical ingredients. A significant decision by the Intellectual Property Office of New Zealand (IPONZ) has expanded the scope of these claims to include novel dosage regimes. For instance, a patent application by Genentech Inc. and Washington University for intermittent treatment using insulin-like growth factor-1 (IGF-1) was approved, recognizing the novelty in the dosage regime rather than the active ingredient itself[1].
Clarity and Specificity of Claims
Guidelines for Examination
The IPONZ guidelines for examining Swiss-type claims emphasize clarity and specificity. The decision in the Taiho Pharmaceutical Co., Ltd. case highlighted the importance of clear claims, such as the use of trifluridine and tipiracil hydrochloride in a specific molar ratio for treating solid cancers[3].
Double Patenting
Recent Developments
The Taiho decision also addressed the issue of double patenting, signaling a shift away from objections to this practice. This means that applicants can now seek protection for new medical uses without facing the traditional barriers of double patenting[3].
Patent Term and Extensions
Standard Patent Term
In New Zealand, all patents, including those for biopharmaceuticals, have a non-extendible term of 20 years from the filing date. This has been the case since the Patents Amendment Act 1994, which abolished term extensions that were previously available[2][5].
Potential Extensions Under TPP
The Trans-Pacific Partnership Agreement (TPP) may introduce limited patent term extensions for pharmaceuticals, including biologics, due to regulatory delays. However, these extensions are still under consideration and not yet implemented[2][5].
Data Protection and Exclusivity
Current Provisions
New Zealand provides 5 years of data protection for data submitted to Medsafe for marketing approval of new drug molecules. However, this protection does not distinguish between small drug molecules and biologics, and it does not extend to subsequent uses of known drugs[5].
Proposed Changes Under TPP
The TPP proposes up to 12 years of data protection for biologics, which could significantly impact the protection and exclusivity period for biopharmaceuticals in New Zealand[5].
Patent Linkage
Current Status
New Zealand does not have a system of patent linkage, which prevents marketing approval of generic products while a patent is in force. This is in contrast to systems like the US 'Orange Book' or the Australian system, which require generic manufacturers to declare potential patent infringement[5].
Potential Impact
The introduction of patent linkage under the TPP could delay the marketing approval of generic pharmaceuticals, affecting the cost and availability of drugs in New Zealand[5].
Regulatory Delays and IP Office Delays
Extensions for Delays
The New Zealand government is considering introducing patent term extensions to compensate for delays in the Intellectual Property Office and regulatory approvals. These extensions would be limited and subject to specific conditions[2].
International Comparisons
Southeast Asian Markets
In comparison to Southeast Asian markets like Singapore, Malaysia, and Indonesia, New Zealand's patenting considerations for pharmaceuticals are more restrictive. However, the region's varying patentability requirements, prosecution strategies, and data exclusivity provisions highlight the need for tailored approaches in each jurisdiction[4].
Industry Impact
Innovation and Protection
The recent IPONZ decisions and potential changes under the TPP signify a positive step for pharmaceutical innovation in New Zealand. These developments allow for broader patent protection, encouraging research and development in the biopharmaceutical sector[1][3].
Economic and Public Health Implications
The extension of patent terms and data protection periods can impact the cost and availability of pharmaceuticals. While these measures protect innovation, they also raise concerns about access to affordable medicines and the broader public health implications[5].
Key Takeaways
- Patentable Subject Matter: Methods of medical treatment are not patentable, but new uses of known pharmaceuticals can be protected through Swiss-type claims.
- Clarity and Specificity: Claims must be clear and specific, as highlighted by recent IPONZ decisions.
- Double Patenting: Objections to double patenting are being relaxed, allowing for broader protection.
- Patent Term and Extensions: Standard patent term is 20 years, with potential limited extensions under the TPP.
- Data Protection: Current data protection is 5 years, with proposed extensions for biologics under the TPP.
- Patent Linkage: Currently not implemented, but proposed under the TPP.
- Regulatory Delays: Potential extensions for delays in IP Office and regulatory approvals.
FAQs
Q: Can methods of medical treatment be patented in New Zealand?
A: No, methods of medical treatment, diagnosis, and surgery practiced on human beings are not patentable in New Zealand[1][5].
Q: What are Swiss-type claims, and how are they relevant to biopharmaceuticals?
A: Swiss-type claims protect new uses of known pharmaceutical ingredients. They are relevant as they allow for patenting novel dosage regimes and other new uses of existing drugs[1].
Q: Does New Zealand provide patent term extensions for pharmaceuticals?
A: Currently, no, but the TPP may introduce limited patent term extensions for regulatory delays[2][5].
Q: How does New Zealand protect data submitted for marketing approval?
A: New Zealand provides 5 years of data protection for data submitted to Medsafe, with no distinction between small drug molecules and biologics[5].
Q: What is patent linkage, and is it implemented in New Zealand?
A: Patent linkage prevents marketing approval of generic products while a patent is in force. It is not currently implemented in New Zealand but may be introduced under the TPP[5].
Sources
- AJ Park, "New Dosage Regimes for Pharmaceuticals now Patentable in New Zealand"
- Henry Hughes, "Patent Term extensions for (pharmaceutical) regulatory delay and delay in the Intellectual Property Office of New Zealand"
- AJ Park, "IPONZ decision revisits the Swiss-type format and double patenting in New Zealand"
- Legalwise Seminars, "Patenting Pharmaceuticals in Southeast Asia - Legalwise Seminars"
- Henry Hughes, "Pharmaceuticals Patents Data protection and the TPP"
