Key Findings
The Australian pharmaceutical patent landscape demonstrates increasing judicial scrutiny of claim scope, formulation patents, and inventive step requirements. While AU2020201919's specific claims are not publicly disclosed, analysis of analogous cases and regulatory trends reveals critical considerations for drug patents in Australia regarding claim drafting strategies, patent term extension (PTE) eligibility, and validity challenges.
Patent Scope and Claim Strategy Considerations
Claim Breadth vs. Validity Risks
Australian courts have emphasized that excessively broad claims face heightened invalidation risks under multiple grounds:
- Written description requirement: Claims must find "anchorage" in disclosed embodiments[2]. For example, in Yu v. Apple, broad software claims divorced from technical implementations were invalidated[2].
- Abstract idea exception: Functional claims lacking technical implementation details risk invalidation under Section 18(1A) of the Patents Act[2][35].
- Inventive step: Recent decisions like Bayer v. Sandoz (2024) invalidated follow-on patents where claims covered routine formulation steps or dosage optimizations[17][27].
Empirical studies show patents with shorter independent claims (avg. 139 words) and fewer independent claims (avg. 2.7) have higher grant rates and faster examination[1].
Patent Landscape and Competitive Dynamics
Evergreening and Secondary Patents
| Australia sees intensive "evergreening" activity, with high-cost drugs averaging 49 associated patents per product[4]. Common strategies include: |
Patent Type |
% of Associated Patents |
Example Invalidations |
| Formulation |
29% |
Bayer v. Sandoz (2024)[27] |
| Combination therapy |
20% |
Novartis v. Generic Health (2024)[42] |
| Delivery mechanism |
15% |
Cipla v. Novo Nordisk (2024)[6] |
Non-originator entities hold 75% of secondary patents, primarily pursuing formulation and method-of-use claims[4][12].
Critical Legal Developments Impacting AU2020201919
Patent Term Extensions (PTEs)
The Federal Court confirmed formulation patents remain PTE-eligible if they disclose a "pharmaceutical substance per se"[6][41]. Key considerations:
- Excipients don't negate eligibility unless purely functional (e.g., stabilizers without therapeutic effect)[41].
- Mixture claims must demonstrate chemical interaction with physiological systems[6][35].
Inventive Step Standards
The Bayer Full Court recalibrated obviousness analysis for pre-Raising the Bar patents[27][34]:
- "Directly led" test: Skilled teams must be directly motivated to pursue claimed solutions without unpredictable hurdles.
- Routine steps: Optimization of dosage forms (e.g., tablet hardness, excipient ratios) now face stricter scrutiny[17][23].
- Prior art thresholds: Abstracts referencing drug candidates by code names (e.g., "BAY 59-7939") may now qualify as ascertainable prior art[34][40].
Strategic Recommendations for Patentees
- Claim drafting:
- Anchor broad claims to ≥3 specific embodiments with experimental data[2][35].
- Avoid purely result-based limitations (e.g., "improved bioavailability") without structural features[35][37].
- Portfolio management:
- File divisional applications within 12 months to preserve priority dates for narrower claims[35].
- Use the new Australian Patent Search (APS) tool to identify blocking prior art early[11][21].
- PTE strategy:
- Submit ARTG registration certificates within 6 months of grant[6][26].
- For combination therapies, emphasize synergistic effects in specification[4][42].
Conclusion
AU2020201919 likely faces heightened validity challenges given Australia's shifting patent jurisprudence. Patentees must balance claim breadth with detailed technical disclosures, particularly for formulation and dosage regimen patents. Proactive use of patent analytics and monitoring of Federal Court decisions will be critical to maintaining enforceable protection in Australia's competitive pharmaceutical market.
<blockquote>
"While a broad claim scope is desirable, claims of different scopes, including claims directed to specific means or methods, are crucial to the success of the application process and the strength of the granted patent."
– Federal Court of Australia in *Cipla Australia Pty Ltd v Novo Nordisk A/S* [2024][6]
</blockquote>
Key Citations
[1] Patent scope metrics (2016)
[2] Claim broadening pitfalls (2021)
[4] Evergreening patterns (2013)
[6] PTE eligibility (2024)
[27] Obviousness standards (2024)
[35] Patent examination guidelines (2025)
[41] Formulation patent validity (2025)
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Last updated: 2025-04-23
