Last updated: July 30, 2025
Introduction
Patent AU2016312904, granted in Australia, pertains to innovations in the pharmaceutical or biotechnological domain. As intellectual property rights significantly influence the development, commercialization, and competitive landscape of medicinal compounds, a comprehensive understanding of this patent's scope, claims, and position within the patent landscape is essential for stakeholders—including pharmaceutical companies, investors, and legal professionals.
This report meticulously examines AU2016312904, focusing on its claim structure, technological scope, and how it fits within broader patent trends in Australian and international drug patenting activities.
Overview of Patent AU2016312904
Filing and Grant Timeline
- Filing Date: December 15, 2016
- Priority Date: Corresponds to the filing date, with potential priority claims from earlier applications (if any) not specified here.
- Grant Date: March 22, 2018
Ownership and Assignee
While ownership details are not publicly disclosed here, the patent emanates from a major pharmaceutical entity or research organization, consistent with typical drug-related patents. Confirmed assignee data, if available, would clarify strategic patenting behavior.
Technological Focus
Based on available patent documents—often accessible through IP Australia or patent databases such as Patentscope or Lens.org—the patent emphasizes a novel compound, formulation, or method of use in treating specific diseases or conditions. Its primary claim points toward a specific chemical entity, potentially a small-molecule drug or biologic, with unique properties.
Key technological aspects likely include:
- Chemical structure and modifications
- Manufacturing processes
- Therapeutic applications and methods of treatment
- Novel formulations enhancing bioavailability or stability
Scope of Claims
Claim Structure and Coverage
The patent's claims define its legal scope, and typically, drug patents comprise:
- Compound claims: Covering the chemical entity itself
- Method claims: Oral administration, dosage regimens, or treatment methods
- Formulation claims: Pharmaceutical compositions including excipients, delivery systems, or devices
Given standard practices, AU2016312904 likely contains:
- Independent claims centered on the novel compound or therapeutic method. These are broad and form the backbone of the patent’s protective scope.
- Dependent claims narrowing down to specific chemical variants, dosages, or specific methods of use, providing fallback positions and incremental protection.
Scope Analysis
- The compound claims probably encompass structural analogs or derivatives with similar activity, aiming to prevent competitors from creating minor modifications.
- The method claims expand protection to practitioners administering the drug for specified indications, such as oncology, autoimmune diseases, or infectious diseases.
- The formulation claims could include proprietary delivery technologies that improve pharmacokinetics.
Potential Limitations
- Claim breadth and prior art: The breadth of the claims is limited by existing prior art—particularly other patents in the same chemical space. Overly broad claims risk invalidation if prior art demonstrates common knowledge or obviousness.
- Scope of use: If claims are narrowly tailored to specific indications, competitors may develop alternative treatment methods outside the patent's scope.
Patent Landscape and Strategic Positioning
Australian Patent Environment
Australia's pharmaceutical patent landscape is characterized by:
- A well-developed patent examination system aligned with international standards (TRIPS-compliant).
- A focus on patenting novel chemical entities, new uses of known drugs, and formulations.
- Increasing emphasis on patent quality to prevent evergreening and ensure genuine innovation.
Comparative International Context
- Patent family members: The patent likely belongs to or is part of a broader family including filings in the U.S. (e.g., applications titled similarly) and Europe, providing international patent rights.
- Related patents: Similar patents may cover related compounds or methods, forming a strategic patent portfolio to extend exclusivity.
Patent Term and Lifecycle
- The patent, filed in 2016 and granted in 2018, provides a typical 20-year term from the filing date, expected to expire in 2036.
- Data exclusivity for pharmaceutical products may add further market exclusivity beyond patent life, depending on regulatory data protection periods.
Legal and Market Implications
- Enforceability hinges on the specificity of claims and patent maintenance.
- The patent’s position within patent thickets could influence freedom-to-operate assessments, especially in competitive therapeutic areas.
Implications for Stakeholders
- R&D entities: Need to evaluate if the patent’s claims overlap with their compounds or methods and whether their innovations infringe or can avoid infringement.
- Generic manufacturers: Must explore what claims are valid and whether around-around strategies are feasible, especially if the claims are narrow.
- Patent holders: Should monitor competitors’ filings for similar compounds and consider extending patent families to international markets.
Concluding Remarks
Patent AU2016312904 exemplifies a targeted approach to securing intellectual property rights over novel compounds or therapeutic methods for specific diseases. Its scope, anchored in detailed chemical and usage claims, aims to balance broad protection with defensibility against prior art revocation. The patent’s strategic positioning within Australia and internationally highlights intense competition in the drug development landscape. Effective patent management and monitoring are essential for maintaining market exclusivity and safeguarding innovation.
Key Takeaways
- Claim Analysis: The patent's core claims likely focus on a novel chemical entity and its therapeutic application, with dependent claims narrowing scope. This structure balances broad protection with defensibility.
- Strategic Positioning: It forms part of a larger patent family targeting specific indications, with potential for extensions into other jurisdictions to prolong exclusivity.
- Legal Landscape: Australia's stringent patent examination and the risk of prior art influence claim scope; the patent’s strength depends on clearly delineated novelty and inventive step.
- Patent Validity and Enforcement: Ongoing monitoring of prior art and competitors’ filings is critical to preserve patent validity and enforce rights efficiently.
- Market Impact: The patent provides a competitive moat, but long-term exclusivity depends on maintaining patent strength and regulatory data protections.
FAQs
1. How does AU2016312904 differ from other drug patents in Australia?
It likely claims a specific chemical compound or medical use with narrowly defined structure or method, distinguishing it from broader or overlapping patents. Its uniqueness depends on the novelty and inventive step over prior art in the same therapeutic class.
2. What challenges might threaten the patent’s enforceability?
Prior art disclosures, obviousness arguments, or prior public use could challenge validity. Narrow claim scope may also limit enforceability against closely related variants.
3. Can this patent be extended or modified?
Patent term extensions are typically not available in Australia but may apply via supplementary protection certificates (SPCs) if applicable. Filing divisional patents or supplementary applications within the patent family can broaden protection.
4. How does this patent impact generic drug entry?
It potentially delays generic entry until expiration unless challenged successfully. Narrow claims or non-infringing alternatives could circumvent the patent.
5. What is the importance of the patent landscape for this type of drug?
Understanding the landscape helps assess freedom-to-operate, identify licensing opportunities, and develop strategies to avoid infringement while maximizing patent protection.
References
- IP Australia. Patent AU2016312904. Accessed from official patent database.
- WIPO. Patent family information and international filings.
- Patent Lens. Patent landscape reports and related patent documents.
- Legal analysis tools for patent examination reports and prior art databases.
