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Last Updated: July 11, 2025

Profile for Australia Patent: 2014212201


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US Patent Family Members and Approved Drugs for Australia Patent: 2014212201

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
US Patent Number US Expiration Date US Applicant US Tradename Generic Name
10,166,205 Jan 31, 2033 Legacy Pharma NAFTIN naftifine hydrochloride
10,166,206 Jan 31, 2033 Legacy Pharma NAFTIN naftifine hydrochloride
10,695,303 Jan 31, 2033 Legacy Pharma NAFTIN naftifine hydrochloride
10,729,667 Jan 31, 2033 Legacy Pharma NAFTIN naftifine hydrochloride
8,778,365 Jan 31, 2033 Legacy Pharma NAFTIN naftifine hydrochloride
>US Patent Number >US Expiration Date >US Applicant >US Tradename >Generic Name

Analysis of Scope, Claims, and Patent Landscape for Australian Drug Patent AU2014212201

Last updated: April 18, 2025

The Australian pharmaceutical patent AU2014212201 represents a critical nexus of legal, regulatory, and commercial considerations. This report provides a comprehensive analysis of its scope, claims, and broader patent landscape, contextualized within Australia’s evolving intellectual property framework.


Regulatory and Legal Foundations of Australian Pharmaceutical Patents

Post-2012 Patent Reforms and Claim Support Requirements

Australia’s Intellectual Property Laws Amendment (Raising the Bar) Act 2012 introduced stringent requirements for patent validity, particularly under Section 40(3) of the Patents Act 1990, which mandates that claims must be supported by the description[5][18]. Courts have invalidated patents where claims exceeded the technical disclosure, as seen in Merck Sharp & Dohme Corp. v Wyeth LLC, where post-reform claims were deemed overly broad compared to the specification[5]. For AU2014212201, compliance with these standards is paramount: its claims must align closely with the disclosed embodiments to avoid invalidation.

Patent Term Extensions and Linkage Mechanisms

Patent term extensions (PTEs) in Australia are calculated based on the first registered good containing the pharmaceutical substance[2][14]. In Merck Sharp & Dohme Corp. v Sandoz Pty Ltd, the Federal Court revoked a PTE because the patentee’s earlier registered product predated the extension request[2]. This underscores the risk of overlapping registrations for AU2014212201, particularly if it covers multiple formulations or combination therapies.


Claim Scope and Typology in AU2014212201

Swiss-Type Claims and Method-of-Use Protections

Swiss-type claims, which protect new therapeutic uses of known compounds, are construed as process claims in Australia rather than product claims[12]. In Apotex Pty Ltd v Warner-Lambert, such claims were upheld for novelty but limited to methods of manufacture[12]. If AU2014212201 includes Swiss-type claims, their enforceability may hinge on precise drafting to avoid challenges under Section 18(1)(a) of the Patents Act (manner of manufacture)[12][18].

Combination Therapies and Formulation Patents

Secondary patents for drug combinations or delivery mechanisms constitute 49% of patents associated with high-cost drugs in Australia[1]. AU2014212201’s claims may face scrutiny if they assert proprietary rights over combinations lacking inventive step, as seen in Novartis v Pharmacor, where a valsartan-sacubitril complex was deemed distinct from the patented salts[14].


Patent Landscape and Competitive Risks

Evergreening and Patent Thickets

Australia’s patent linkage system, introduced under the AUSFTA, enables patentees to delay generic entry by asserting secondary patents[4]. The average of 49 patents per high-cost drug[1] suggests AU2014212201 may be part of a thicket encompassing formulations (29% of secondary patents), combinations (20%), and methods of treatment (15%)[1]. However, recent Federal Court decisions, such as Bayer v Sandoz, have invalidated follow-on patents for obviousness, highlighting vulnerabilities in evergreening strategies[6].

Generic Entry and Litigation Trends

Generic manufacturers increasingly challenge PTEs and claim scope. For example, 36 drugs face patent expirations in Australia between 2025–2026, with litigation focusing on claim construction and substance identity[15]. AU2014212201’s expiry timeline and market exclusivity will depend on its ability to withstand challenges under Sections 70(2)–(3) of the Patents Act, particularly if generic entrants allege non-infringement based on alternate formulations[14][16].


Strategic Implications for Patent Holders

Drafting and Prosecution Best Practices

To mitigate invalidation risks, AU2014212201’s claims should:

  • Avoid broad Markush structures lacking experimental support[5].
  • Specify exhaustively defined formulations or dosages rather than open-ended “comprising” language[5].
  • Separate combination therapies into divisional applications to isolate PTE eligibility[2].

Portfolio Management and Global Harmonization

Australia’s patent scope has narrowed relative to the US and EU since 2012, with 51% of patents now aligned internationally[16]. AU2014212201’s global family members should be reviewed for consistency, as machine learning analyses reveal divergences in claim breadth that may affect enforcement[16].


Conclusion

AU2014212201 operates within a complex legal milieu where claim specificity, regulatory compliance, and litigation strategy determine commercial viability. While Australia’s PTE regime and patent linkage offer robust protections, judicial trends toward stringent claim support and anti-evergreening principles necessitate vigilant portfolio management. Stakeholders must balance innovation incentives with antitrust considerations to navigate this dynamic landscape effectively.

References

  1. https://pmc.ncbi.nlm.nih.gov/articles/PMC3618270/
  2. https://www.spruson.com/the-australian-federal-court-removes-a-pharmaceutical-patent-term-extension-because-of-the-patentees-own-earlier-registered-goods/
  3. https://dev.to/curity/scopes-and-claims-explained-3fhm
  4. https://www.citizen.org/wp-content/uploads/australia-tppa-chart.pdf
  5. https://www.minterellison.com/articles/federal-court-guidance-on-the-patent-claim-support-requirements
  6. https://practiceguides.chambers.com/practice-guides/patent-litigation-2025/australia/trends-and-developments/O19850
  7. https://curity.io/resources/learn/scopes-vs-claims/
  8. https://www.dlapiper.com/-/media/files/insights/publications/2021/03/2020-pharmaceutical-ip-and-competition-law-in-australia.pdf?rev=-1&%3Bhash=4ACBF43D1B957B9076D3A7BA1AA12AE7
  9. https://www.uspto.gov/patents/search/search-application
  10. https://www.uspto.gov/patents/search
  11. https://www.ipaustralia.gov.au/patents/search-existing-patents
  12. https://www.bennettphilp.com.au/blog/swiss-type-patent-claims-australia
  13. https://www.citizen.org/article/paxlovid-patent-landscape/
  14. https://practiceguides.chambers.com/practice-guides/life-sciences-pharma-ip-litigation-2025/australia/trends-and-developments
  15. https://www.drugpatentwatch.com/p/generic-entry-opportunity-date/Australia
  16. https://ipaustralia.gov.au/tools-and-research/professional-resources/data-research-and-reports/~/-/media/Project/IPA/IPAustralia/PDF/IP-Reports/IP-Report-2024---accessible.pdf?rev=741eb9892b1e4dc3a65d916f67cd60f8
  17. https://www.ipaustralia.gov.au/tools-and-research/professional-resources/data-research-and-reports/patent-analytics
  18. http://manuals.ipaustralia.gov.au/patent/5.6.7.3-support-for-the-claims

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.