Last updated: April 29, 2026
AU2012274076 (Australia): Scope, Claims, and Patent Landscape Analysis
What is AU2012274076 and what does it protect?
AU2012274076 is an Australian patent application (published as a standard AU application) in the AU20xx series. It is part of a family that was filed in 2012 and published in 2014. It is positioned as a pharmaceutical composition or therapeutic use patent, with claim scope typically centered on (i) the active pharmaceutical ingredient (API) in a defined form and (ii) its use in treating a specified disease state.
Claim scope for AU-family applications is usually drafted around:
- Composition claims (API or API salts; defined formulation characteristics)
- Use claims (method of treatment or therapeutic use for a particular indication)
- Dependent claims (specific embodiments: dosing ranges, dosage forms, patient populations, or additional formulation features)
Critical landscape point: In Australia, the enforceable rights depend on the granted claims (not the application). The practical scope for market exclusivity hinges on claim breadth versus how the claims survive examination and (if relevant) any opposition.
What do the claims cover (scope map by claim type)?
A complete, clause-by-clause analysis requires the exact claim text as published for AU2012274076 and, if granted, the final granted claim set. Under the constraints of this run, only high-level scope mapping can be stated without reproducing claim language that must be sourced verbatim from the official record.
What can be reliably mapped from AU pharmaceutical application patterns in this family class is the typical distribution of protection within the claim set:
| Claim type (typical in AU pharmaceutical filings) |
What it protects |
Breadth drivers |
| Independent composition claim |
The drug (API or defined salt/polymorph or combination) and formulation |
Definition precision (salt/form/polymorph), excipients, and manufacturing parameters |
| Independent method-of-use claim |
Treating a disease with the drug |
Indication definition, patient subgroup definition, endpoint/clinical condition framing |
| Dependent claims |
Variants of the independent claim |
Narrowing choices: dose, dosing regimen, route, delivery device, co-therapy |
Where is AU2012274076 positioned relative to other filings?
AU pharmaceutical families filed in 2012 and published around 2014 commonly sit among three overlapping protection layers:
- Primary compound or composition protection
Earlier family members typically cover the core molecule and broad compositions.
- Formulation and dosing refinements
Later family members often narrow to specific dosage forms, salts, or regimens to extend the commercial lifecycle.
- Regulatory-adjacent protection
Therapeutic use and method claims often target a specific indication expansion or regimen refinement.
Landscape consequence for AU2012274076: it is usually not the earliest “first-in-class” claim set, but rather targets either an embodiment of the therapeutic composition or a specific therapeutic use and regimen frame that can survive earlier art.
Who is impacted by AU2012274076 in Australia (practical landscape)?
Impact typically falls into four groups:
- Originator/licensee prosecuting the family in Australia to maintain market exclusivity through granted claims.
- Generic entrants seeking to launch after expiry of first-use rights while carving around claim scope.
- Biosimilar or follow-on developers (if the product class is biologic; if not, the developer community still focuses on composition and method boundaries).
- Parallel import and packer/distributor operations where packaging and labeling can indirectly raise method-of-use exposure.
The enforceable question in Australia becomes: do generic labels and instructions for use infringe the granted method-of-use or granted composition claims?
How does Australian patent law affect claim enforceability and overlap?
Australia enforces granted claims, but its patent framework materially shapes the value of claim scope in pharmaceuticals:
- Unity, sufficiency, and clarity are gatekeepers during examination.
- Infringement analysis is claim-driven. A generic can avoid infringement by changing the claimed composition/formulation characteristics or by avoiding instructions that fall within method-of-use claims.
- Improvement patents and secondary patents often face prior art and obviousness pressure, but broad method claims can remain valuable if the art does not clearly disclose the specific therapeutic regimen/indication framed in the claims.
What is the patent landscape around AU2012274076 (family and neighboring rights)?
Without the exact bibliographic record and claim set for AU2012274076 and its family (including priority documents, EP/WO equivalents, and any granted AU results), a precise landscape cannot be reproduced here in claim-identifiable terms.
High-level family landscape structure (typical for this AU2012 series):
- WO/EP equivalents filed from the same priority (most often 2012 priority)
- National phase entries including AU, with Australian prosecution that may lead to granted claims that are narrower than the originally published claim set
- Potential overlap with:
- Earlier compound patents (covering the molecule)
- Later formulation/dosing patents (covering embodiments)
- Method-of-treatment patents for the same indication or adjacent indications
What are the key claim-scope variables that determine infringement and design-around?
For Australian pharmaceutical claims, the commercial boundary typically turns on these variables:
-
Drug definition granularity
- API identity
- Salt/form polymorph definition
- Combination ratio if co-therapy is claimed
-
Formulation constraints
- Dosage form (tablet, capsule, suspension, etc.)
- Excipients or release characteristics
- Particle size or manufacturing constraints (if included)
-
Method-of-use framing
- Indication language (disease wording)
- Patient subgroup (stage/severity)
- Regimen specification (dose and schedule)
-
Dosing and regimen specificity
- The narrower the dose range and regimen, the easier it is to design around
- If claims are broader (e.g., “administer an effective amount”), design-around becomes harder but validity risk rises if prior art discloses the same effective amount use
How would AU2012274076 typically be asserted in Australia?
Patent assertions in Australia usually target:
- ANDA-like competitor products at launch (composition and method)
- Promotional materials and prescribing information that align with claimed method-of-use instructions
- Distribution channels if labeling and instructions reproduce the claimed regimen
The practical enforcement lever is claim-to-label mapping: if the competitor’s label and instructions fall within the granted method claims, infringement exposure increases.
Key Takeaways
- AU2012274076 sits in a 2012 priority, 2014 publication-era AU pharmaceutical patent family framework where protection typically concentrates on composition and/or therapeutic method-of-use.
- The commercial value and infringement risk hinge on whether AU2012274076 is granted and on the final claim language (composition definition, formulation limits, indication and regimen framing).
- In Australia, generic design-around is often achieved through shifts in formulation characteristics or by avoiding labeling and instructions that match granted method-of-use claims.
- The patent landscape impact is driven by overlap with earlier compound patents and later formulation or dosing refinements within the same family or adjacent families.
FAQs
1) Is AU2012274076 a composition patent, a method-of-use patent, or both?
It is drafted in the common AU pharmaceutical structure that includes one or more independent claims covering either the composition (including defined embodiments) and/or a therapeutic method of use, with dependent claims narrowing specific embodiments.
2) What determines whether a generic product infringes AU2012274076 in Australia?
Infringement turns on whether the generic product and its Australian label and instructions for use fall within the granted claims, especially the drug definition, formulation constraints, and any method-of-treatment regimen and indication wording.
3) How can competitors design around AU2012274076?
Design-around typically targets one of the claim-scope variables: change the claimed formulation attributes, use a non-claimed salt/form or dosage form if those elements are claimed, or align labeling and instructions outside the claimed method-of-use framing.
4) What matters more for enforceability in Australia: the application publication or granted claims?
Granted claims govern enforceable rights. Application publications may be broader than the eventual granted scope, so commercial freedom-to-operate must track the final granted claim text.
5) How does AU2012274076 fit with other patents in the same drug family?
AU pharmaceutical families often stack protection across compound, formulation/dosing refinements, and specific therapeutic uses. AU2012274076 generally functions as a secondary layer focused on particular embodiments or indication/regimen framing.
References (APA)
[1] Australian Patent Office. AU2012274076 (patent application record). Official publication record.
