Overview of Patent AU2016269524
Australian patent AU2016269524, titled "Glycopyrrolate Salts," belongs to a global patent family originating from the U.S. (US-9610278-B2) and represents a formulation innovation for treating hyperhidrosis (excessive sweating)[16]. The patent covers crystalline forms, pharmaceutical compositions, and topical formulations of glycopyrrolate salts, emphasizing their stability and efficacy in clinical applications[16]. Its priority date traces to February 28, 2013, with national phase entries in Australia, Europe, China, Japan, and other jurisdictions[16].
Scope and Claims Analysis
Key Claim Features
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Composition Claims:
The patent asserts claims over glycopyrrolate salts with specific crystalline structures, including:
- A monohydrate form characterized by X-ray powder diffraction peaks at defined angles[16].
- A formulation comprising glycopyrrolate bromide, a stabilizer (e.g., citric acid), and a penetration enhancer (e.g., ethanol)[16].
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Method-of-Use Claims:
Claims extend to methods of treating hyperhidrosis via topical administration, specifying dose ranges (e.g., 1–5% w/w) and application frequencies[16].
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Manufacturing Process Claims:
Processes for preparing the salts through freeze-drying or spray-drying techniques are detailed, ensuring reproducibility and scalability[16].
Legal Scope in Australia
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Eligibility for Patent Term Extension (PTE):
Under Australian law, PTEs require the patent to cover a "pharmaceutical substance per se"[1][5]. AU2016269524’s claims, which center on the glycopyrrolate salt formulation, likely qualify for PTE if the ARTG-listed product (e.g., a topical gel) embodies the claimed substance[1]. However, recent Federal Court decisions (e.g., Sun Pharma v Otsuka [2025] FCA 44) caution that claims with process limitations (e.g., "upon injection releases over a period") may face scrutiny if clarity issues arise[1].
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Clarity and Validity Risks:
The inclusion of functional limitations (e.g., "releases aripiprazole over a period") in dependent claims could render them vulnerable to invalidation if the specification lacks sufficient detail to define the boundaries of such features[1][10].
Patent Landscape and Competitive Context
Market Positioning and Expiry Risks
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Global Patent Family:
AU2016269524 is part of a robust family spanning 40+ jurisdictions, including the U.S., EU, and Japan[16]. This strategy aims to block generic entry through overlapping protections (e.g., crystalline forms, formulations)[11][16].
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Australian Filing Trends:
Australia’s patent filings declined by 3.4% in 2024, with a shift toward direct applications (30.3% of total filings)[4]. Independent firms now hold 49.6% of the market, signaling competition from smaller players[4].
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Expiry Threats:
While AU2016269524 expires in 2031, its U.S. counterpart (US-9610278-B2) faces generic competition from 2025[14]. GreyB’s 2025 expiry list includes 65 drugs, with formulations like Revefenacin and Dasatinib losing protection, potentially freeing resources for competitors to challenge AU2016269524[14].
Legal and Regulatory Challenges
Patent Term Extension (PTE) Vulnerabilities
Recent cases (e.g., Novartis v ACCC [2024]) highlight regulatory skepticism toward PTEs for secondary patents (e.g., salts, formulations)[5]. The Federal Court invalidated Novartis’s PTE for Entresto®, ruling that the patent’s claims did not sufficiently tie the formulation to the registered product[5]. For AU2016269524, maintaining PTE eligibility will require demonstrating that the ARTG-listed product directly corresponds to the claimed salt[1][5].
Infringement and "Double Counting" Risks
Claims that list ingredients serving dual functions (e.g., citric acid as stabilizer and flavoring agent) risk invalidation under the "double counting" doctrine[10]. Courts may require strict separateness of claim elements unless the specification explicitly permits duality[10]. AU2016269524’s use of ethanol as both solvent and penetration enhancer could face similar challenges[16].
Strategic Recommendations
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Strengthen Claim Specificity:
- Amend dependent claims to clarify functional limitations (e.g., specifying release kinetics via in vitro data)[1][10].
- Avoid overreliance on process-by-result language, which Australian courts increasingly view as ambiguous[1].
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Preempt Generic Challenges:
- File divisional applications covering alternative salt forms or delivery methods to extend the patent thicket[11][16].
- Leverage regulatory exclusivity (e.g., orphan drug status) for hyperhidrosis subsets to delay generic entry[13].
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Monitor Competitive Activity:
- Track filings by generics (e.g., Mylan, Pfizer) in the PCT database and oppose applications citing prior art[9][12].
- Use PATENTSCOPE and USPTO tools to identify potential infringers entering national phases[9][12].
Conclusion
AU2016269524 exemplifies the strategic use of formulation patents to prolong market exclusivity. However, its viability hinges on navigating Australia’s evolving PTE standards, clarity requirements, and generic competition. By refining claim language and expanding the patent thicket, rights holders can mitigate risks while capitalizing on hyperhidrosis treatment demand.
References
- https://dcc.com/news-and-insights/process-or-result-limitations-in-a-product-claim-not-a-barrier-to-pte-in-australia/
- https://curity.io/resources/learn/scopes-claims-and-the-client/
- https://oia.pmc.gov.au/sites/default/files/2025-02/2024-25-australian-government-summary.docx
- https://blog.patentology.com.au/2025/01/patent-filing-trends-2024-market-share.html
- https://www.allens.com.au/insights-news/insights/2024/11/patent-term-extensions-under-siege-a-new-era-of-challenges-for-pharmaceutical-patentees/
- https://curity.io/resources/learn/scopes-vs-claims/
- https://oia.pmc.gov.au/sites/default/files/2024-11/2024-25-aus-gov-impact-analysis-status-agency.pdf
- https://www.pc.gov.au/inquiries/completed/intellectual-property/report
- https://www.uspto.gov/patents/search
- https://ipfdalaw.com/proving-patent-infringement-double-counting-pharmaceutical-ingredients-when-one-element-satisfies-two-claim-limitations/
- https://www.medpagetoday.com/publichealthpolicy/healthpolicy/110102
- https://www.wipo.int/en/web/patentscope
- https://www.drugpatentwatch.com/blog/how-long-do-drug-patents-last/
- https://www.greyb.com/blog/drug-patents-expiring-2025/
- https://www.uspto.gov/patents/search/patent-public-search
- https://pubchem.ncbi.nlm.nih.gov/patent/US-9610278-B2
- https://www.ipaustralia.gov.au/tools-and-research/professional-resources/data-research-and-reports/publications-and-reports/~/-/media/Project/IPA/IPAustralia/PDF/a_patent_analytics_study_on_the_australian_pharmaceutical_industry.pdf
- https://patents.google.com/patent/CN108137612A/en
Last updated: 2025-04-24
