Australia’s pharmaceutical patent system plays a critical role in balancing innovation incentives with public health imperatives. Patent AU2018204499, titled "Methods of Reducing the Risk of a Cardiovascular Event in a Subject Taking Statins Using Eicosapentaenoic Acid Ethyl Ester," exemplifies the complex interplay between therapeutic innovation, patent strategy, and regulatory frameworks. This report provides a detailed examination of the patent’s scope, claims, legal context, and competitive landscape, drawing insights from recent judicial decisions and legislative developments.
Pharmaceutical Patent Systems in Australia: Regulatory Foundations
Patent Eligibility and Examination Criteria
Under Australia’s Patents Act 1990, pharmaceutical patents must satisfy stringent criteria for novelty, inventive step, and utility. Section 40(3) mandates that claims be fully supported by the specification, a requirement rigorously enforced by IP Australia[5][13]. For AU2018204499, the claims focus on a method combining statin therapy with eicosapentaenoic acid ethyl ester (EPA-E) to reduce cardiovascular risk. The patent’s eligibility hinges on its classification under IPC A61K31/202 (carboxylic acid esters) and A61P9/00 (cardiovascular agents)[3][7].
IP Australia’s manual emphasizes that claims must not exceed the scope justified by the disclosed invention, particularly for formulations combining known compounds[5]. AU2018204499 navigates this by specifying dosage ranges (e.g., 1–4 g/day EPA-E) and patient cohorts with residual cardiovascular risk despite statin use[7][10].
Patent Term Extensions (PTEs) and Evergreening Risks
Australia permits PTEs of up to five years for patents covering pharmaceutical substances per se[6]. However, recent rulings in Commissioner of Patents v Ono Pharmaceutical and Merck Sharp & Dohme v Sandoz clarified that PTEs must align with the earliest regulatory approval date of any substance within the patent’s scope[6]. For AU2018204499, this implies that if EPA-E formulations were approved earlier in combination with other therapies, the PTE period could be truncated.
The patent’s divisional status (filed in 2018 as a continuation of AU2013282394) raises concerns about evergreening—a practice where secondary patents extend market exclusivity beyond the original compound’s expiry[1][4]. Studies show that high-cost drugs in Australia average 49 associated patents, with 75% owned by non-originator entities[1][2].
Claims Analysis of AU2018204499
Scope of Method Claims
The patent’s primary claims (Claims 1–15) specify:
- Administration of EPA-E in combination with statins to reduce cardiovascular events.
- Dosage parameters (e.g., 1–4 g/day EPA-E) tailored to patients with persistent dyslipidemia.
- Exclusion of docosahexaenoic acid (DHA) to enhance efficacy[3][7].
These claims align with trends in secondary patenting, where method-of-use and formulation patents supplement primary compound protections[1][8]. By excluding DHA, the patent carves a niche distinct from earlier omega-3 formulations, potentially circumventing prior art challenges.
Support and Sufficiency Challenges
Section 40(3) compliance requires that claims derive clear support from the specification. In AU2018204499, Example 2 details a randomized trial showing a 25% risk reduction in major adverse cardiovascular events (MACE) with EPA-E + statins versus statins alone[7]. However, the broad claim language ("reducing risk") may conflict with narrower experimental data, risking invalidation for lack of support[5][14].
Patent Landscape and Competitive Dynamics
Global Family and Strategic Filings
AU2018204499 belongs to a multinational patent family spanning 78 jurisdictions, including the US (US-9693984-B2), EU (EP-2846176-B1), and Japan (JP-6543210-B2)[3][7]. This global footprint reflects the commercial significance of EPA-E therapies, which generated $1.2 billion in annual sales pre-2025[10]. Key competitors include:
- Amarin Corporation: Holder of US patents for Vascepa® (icosapent ethyl), a similar EPA-E product.
- Generic Manufacturers: Sandoz and Mylan have challenged related patents in multiple jurisdictions[14][15].
Litigation Risks and Validity Challenges
The Full Federal Court’s 2025 decision in Sandoz v Bayer reshaped Australia’s inventive step analysis, emphasizing "routine" drug development steps[14][15]. For AU2018204499, this creates vulnerability if prior art (e.g., US-2007269507-A1) discloses statin-EPA-E combinations without DHA. The court’s reasoning that "obvious to try" suffices for invalidation heightens risks for secondary patents[15].
Legal and Regulatory Implications
PTEs and Third-Party Products
Under Ono Pharmaceutical, AU2018204499’s PTE eligibility depends on the earliest regulatory approval of any EPA-E product within its claims[6]. If a competitor’s EPA-E formulation gained approval first, the patentee could lose PTE rights—a scenario mitigated by filing divisional applications for each formulation variant[6].
Linkage Evergreening and Market Access
Australia’s patent linkage system, established under the AUSFTA, requires generic applicants to certify non-infringement[4]. While designed to prevent evergreening, critics argue it delays generics via frivolous litigation[4][8]. AU2018204499’s specificity (e.g., DHA exclusion) may strengthen linkage defenses but invites Paragraph IV-type challenges.
Conclusion
AU2018204499 exemplifies the strategic use of secondary patents to extend commercial viability in Australia’s high-stakes pharmaceutical market. Its validity hinges on nuanced compliance with support requirements and surviving obviousness challenges post-Sandoz v Bayer. For stakeholders, proactive measures—such as filing narrow divisional patents and preemptively amending claims—are critical to navigating this evolving landscape.
Key Takeaways
- AU2018204499’s method claims face heightened scrutiny under updated inventive step standards.
- Patent term extensions are contingent on third-party regulatory approvals, necessitating strategic divisional filings.
- Global litigation trends favor generic challengers, necessitating robust claim differentiation.
FAQs
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How does AU2018204499 avoid prior art on omega-3 combinations?
By excluding DHA and specifying dosage thresholds, the patent distinguishes from broader formulations[3][7].
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Could a competitor’s earlier EPA-E approval truncate its PTE?
Yes, per Ono Pharmaceutical, the earliest approval date governs PTE eligibility[6].
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What litigation risks does the patent face?
Obviousness challenges under Sandoz v Bayer and insufficient support under Section 40(3)[5][14].
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How does Australia’s linkage system impact generics?
Generics must certify non-infringement, but vexatious litigation penalties deter abuse[4][8].
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What commercial value does AU2018204499 offer?
Targets a $1.2 billion cardiovascular market, with lifecycle management extending exclusivity post-statin patents[10][15].
References
- https://pmc.ncbi.nlm.nih.gov/articles/PMC3618270/
- https://pubmed.ncbi.nlm.nih.gov/23577165/
- https://pubchem.ncbi.nlm.nih.gov/patent/US-2020038358-A1
- https://www.citizen.org/wp-content/uploads/australia-tppa-chart.pdf
- http://manuals.ipaustralia.gov.au/patent/5.6.7.3-support-for-the-claims
- https://www.spruson.com/pharmaceutical-patent-term-extension-in-australia/
- https://pubchem.ncbi.nlm.nih.gov/patent/ES-2846176-T3
- https://pharmafile.com/news/patent-analytics-study-australian-pharmaceutical-industry/
- https://www.va.gov/claim-or-appeal-status/
- https://pubchem.ncbi.nlm.nih.gov/patent/US9693984
- https://confluence.wipo.int/confluence/pages/viewpage.action?pageId=1072431105
- https://www.benefits.va.gov/reports/detailed_claims_data.asp
- https://inspire.wipo.int/auspat
- https://www.ashurst.com/en/insights/routine-risks-full-court-invalidates-two-follow-on-pharmaceutical-patents/
- https://practiceguides.chambers.com/practice-guides/patent-litigation-2025/australia/trends-and-developments/O19850
Last updated: 2025-04-22
