Key Findings
The Australian pharmaceutical patent landscape is characterized by rigorous scrutiny of patentable subject matter, inventive step requirements, and compliance with disclosure obligations under §40 of the Patents Act 1990. While the specific claims of AU2022283769 are not publicly disclosed, this analysis synthesizes principles from recent case law, examination practices, and industry trends to evaluate the patent’s likely scope, enforceability challenges, and positioning within Australia’s innovation ecosystem[1][4][7].
1. Patentable Subject Matter and Scope of Claims
1.1 Manner of Manufacture Requirements
Australian courts apply a two-step test to assess patent eligibility:
- Identify the substance of the invention (distinguishing form from mere computer implementation or abstract ideas)[1].
- Determine whether the substance constitutes a "manner of manufacture" under National Research Development Corporation v Commissioner of Patents (1959)[25].
For pharmaceutical patents, claims must solve a technical problem (e.g., improving drug stability, bioavailability, or therapeutic efficacy). In Apple Inc. (2022), claims 11–12 covering biometric security features for redacted documents were upheld because they provided "technical means" to enhance security[1]. Conversely, method-of-treatment claims lacking新颖 technical effects may face rejection under §18(1A)[4][25].
1.2 Claim Drafting Strategies
- Functional vs. Structural Claims: Broad functional claims (e.g., "a compound that inhibits Protein X") risk invalidation for lack of enablement or undue breadth[24]. The Amgen v Sanofi (2023) U.S. decision, influential in Australia, rejected genus claims for antibodies defined solely by binding targets, emphasizing the need for structural specificity[21][24].
- Dependent Claims: Narrow claims specifying dosage regimes (e.g., "10–50 mg/day") or particle sizes (e.g., "D90 < 75 µm") are more likely to survive obviousness challenges[7][22].
2. Key Challenges in Prosecution and Enforcement
2.1 Written Description and Support
References
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Last updated: 2025-04-23
