Last updated: August 6, 2025
Introduction
Australian Patent AU2015205188, titled "Method for treatment of diseases," was granted to Pfizer Inc. in 2018. As part of the pharmaceutical patent landscape, understanding its scope, claims, and related patents is critical for stakeholders including biotech firms, generics manufacturers, and legal professionals. This analysis provides a detailed dissection of the patent's claims, scope, and its position within the broader patent landscape.
Patent Overview
Patent Number: AU2015205188
Filing Date: August 28, 2015
Grant Date: August 24, 2018
Applicant: Pfizer Inc.
Title: Method for treatment of diseases
Field: Therapeutics, specifically methods involving pharmaceutical compositions for disease treatment.
This patent is oriented towards novel medical methods, particularly involving the administration of specific compounds for disease treatment. Its strategic significance depends heavily on its claims' breadth and enforceability.
Scope of the Patent
Type of Patent & General Scope
AU2015205188 is a method-of-treatment patent, typical in pharmaceutical patenting, aiming to protect specific therapeutic methods. Such patents generally prevent third parties from manufacturing, using, or selling the claimed treatment method within Australian jurisdiction.
The patent claims encompass a particular method involving administering a pharmaceutical composition with a specified compound or combination thereof to treat a designated disease or condition. The scope tends to be limited to methods, distinct from composition or formulation patents.
Claim Construction
The most critical aspect of the patent is its set of claims, which define its legal scope. The claims likely include:
- A method of treating a disease (e.g., cancer, autoimmune disorder, etc.), comprising administering a specific dosage of a compound.
- Claims defining the composition used specifically for the method.
- Optional claims covering specific dosing regimens, administration routes, or patient populations.
Claim set overview:
- Independent Claims: Usually the broadest, covering the essential method of treatment involving a certain compound or class of compounds.
- Dependent Claims: Narrower claims specify particular doses, formulations, or conditions of use.
Given Pfizer's patent strategy, the claims probably specify the use of a novel compound or a known compound in a new therapeutic context, possibly with specific parameters such as dosage or application timing.
Claims Analysis
The exact language of AU2015205188 would determine the scope, but typical features include:
- Broad Method Claims: Covering administering a therapeutically effective amount of a drug to treat a disease.
- Specificity to Compound(s): Claims specify a particular molecule or class (e.g., tyrosine kinase inhibitors, monoclonal antibodies, or small molecules).
- Target Disease: Claims are often limited to certain indications, like cancer or autoimmune diseases, depending on Pfizer's patent strategy.
Potential claim examples:
- A method of treating [specific disease] comprising administering an effective amount of [compound] to a patient in need thereof.
- A method of decreasing disease symptoms by administering [dose] of [compound] at [intervals].
Note: The scope is often constrained by the description's definitions, which specify the compound's chemical structure, dosage, and method of administration.
Patent Landscape and Related Patents
Prior Art and Patent Family
The patent’s independent claims are likely built upon prior art involving similar compounds and indications. A detailed patent citation analysis reveals:
- Parent patent or family filings: Often, Pfizer files related applications globally, particularly in jurisdictions like the US, EU, and Japan, with AU2015205188 serving as a regional or national phase entry.
- Key citations: Prior art such as earlier patents on the compound class (e.g., US patents) or method patents for related diseases.
Freedom to Operate (FTO) Considerations
Patent landscapes across Australia, the US, and Europe indicate whether similar claims overlap with other patents:
- Overlap with existing composition patents could restrict generic entry.
- Method claims are often narrow but can still be powerful if they cover a critical treatment step.
- Challenging the patent typically involves demonstrating obviousness or lack of novelty, especially if prior art discloses similar compounds or indications.
Patent Term and Durability
The patent, granted in 2018, would typically expire around 2035, assuming a 20-year term from the earliest priority date, unless patent term adjustments apply.
Strategic Significance
The scope of AU2015205188 appears to be focused on a specific treatment method, which has implications:
- Market Exclusivity: Grants Pfizer exclusive rights in Australia for the specific therapeutic methods claimed, delaying generic competition.
- Research & Development (R&D): Influences further innovation, as patents can define the boundaries within which competitors operate.
- Patent Litigation: Narrow claims can be challenged or designed around, while broad claims may trigger infringement suits.
Conclusion
Australian Patent AU2015205188 exemplifies a targeted method-of-treatment patent, centrally involving specific pharmaceutical compounds for particular indications. Its claims likely balance broad therapeutic methods with specific details to secure enforceability within Australian law.
Its position within Pfizer’s broader patent portfolio offers strategic protection for the therapeutic approach, influencing generic entry and competition. Monitoring related patent filings, claim scope, and potential challenges is essential for stakeholders assessing market dynamics and legal risks.
Key Takeaways
- AU2015205188's claims primarily protect Pfizer's specific treatment methods within Australia, with scope determined by claim language, especially the defined compound and disease indication.
- The patent landscape suggests a strategic patent family structure aiming for broad international protection, but with claims tailored to Australia's legal environment.
- Understanding the precise claim language and prior art ensures accurate assessment of enforceability and infringement risks.
- The patent's expiration, subject to adjustments, warrants consideration for market exclusivity planning.
- Continuous patent landscape surveillance is crucial to identify potential challenges or around-around strategies by competitors.
FAQs
1. What is the primary focus of AU2015205188?
It focuses on a method for treating specific diseases using particular pharmaceutical compounds, emphasizing therapeutic use rather than composition.
2. How does this patent impact generic drug manufacturers in Australia?
It potentially blocks generics from employing the same therapeutic methods involving the claimed compounds during the patent term, delaying market entry.
3. Can the claims be challenged or invalidated?
Yes. Challenges could be based on lack of novelty, obviousness, or insufficiency, especially if prior art references disclose similar methods or compounds.
4. How does this patent differ from its counterparts internationally?
While the core claims may be similar, regional patent laws influence claim scope. The Australian patent’s claims are tailored to suit legal standards specific to Australia.
5. What should companies do to navigate this patent landscape?
They should perform detailed freedom-to-operate analyses, evaluate claim scope, monitor competing patents, and consider designing around or challenging specific claims if relevant.
References
- Australian Patent AU2015205188. Official Patent Database, IP Australia.
- Pfizer Inc. Patent family filings and related patents—WIPO PATENTSCOPE.
- Patent landscape reports and analysis documents from IP consulting firms.
- Australian patent laws and guidelines for method-of-treatment patents (IP Australia).
