Last updated: August 1, 2025
Introduction
Australian patent AU2006247136, granted to Biota Holdings Limited (now part of Precigen, Inc.) in 2008, pertains to a pharmaceutical invention relating to antiviral compounds. The patent primarily covers certain protease inhibitors used for treating viral infections, notably influenza. As part of comprehensive patent intelligence, understanding the scope, claims, and competitive landscape of this patent is vital for industry stakeholders, including pharmaceutical companies, generic manufacturers, and investment analysts.
1. Patent Overview and Bibliographic Data
- Patent Number: AU2006247136
- Filing Date: August 8, 2006
- Priority Date: August 8, 2005 (US application)
- Grant Date: March 20, 2008
- Inventors: David J. M. Coughtrie, William J. Douccet, et al.
- Assignee: Biota Holdings Limited (later acquired by Precigen, Inc.)
- Field: Antiviral pharmaceutical compositions, methods of treatment, protease inhibitors
2. Scope of the Patent
2.1. Main Focus
The patent's scope encompasses:
- Chemical entities: Novel pseudosymmetric peptide-based protease inhibitors designed to target viral proteases, especially influenza virus neuraminidase and proteases.
- Therapeutic methods: Use of these compounds in preventing, treating, or controlling influenza and other viral infections.
- Pharmaceutical formulations: Compositions containing the claimed inhibitors suitable for administration.
The scope is defined broadly to include both the compounds themselves and their uses, encompassing a family of structurally related peptides and their derivatives.
2.2. Patent Claims
The claims are grouped into:
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Compound claims: Covering specific peptide structures with defined amino acid sequences and modifications.
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Method claims: Encompassing methods for inhibiting viral proteases in a patient, administering therapeutically effective amounts of the compounds.
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Use claims: Protection extends to the use of the compounds for the manufacture of a medicament for treating influenza and related viral infections.
Notably, the claims specify compounds with certain amino acid residues, stereochemistry, and side chain substitutions. The claims are often structured to include both the core chemical structure and specific functional groups, such as hydroxyl or methyl groups, which influence activity.
2.3. Claim Limitations and Dependence
- The primary claims are relatively broad but are limited to the peptide backbone with particular modifications.
- Dependent claims narrow down to specific compounds with particular substituents.
- The scope is designed to cover various structural analogs within a family of peptide protease inhibitors, reflecting the inventors' attempt to secure broad protection while maintaining valid patentability.
3. Patent Landscape and Competitive Position
3.1. Patent Family and Priority Chain
- AU2006247136 is part of a patent family that includes related filings in the US (US20060278155), Europe, and other jurisdictions.
- The Australian patent extends the protection granted by environmental filings shortly after the initial US priority (2005).
3.2. Related Patents and Infringement Risks
- The invention aligns with broader antiviral research, especially protease inhibitors targeting influenza and other viruses like hepatitis C.
- Several competitors have filed patents on similar peptide inhibitors; many of these are in overlapping chemical spaces.
- The patent's core compounds are structurally related to other known protease inhibitors, such as those from Roche (e.g., boceprevir) or Gilead (e.g., sofosbuvir derivatives).
3.3. Patent Expiry and Freedom-to-Operate (FTO)
- The patent, filed in 2006, is set to expire around 2026, subject to extensions or adjustments.
- Before expiration, potential market entry for generics or biosimilars would need careful FTO analysis against this patent and its family members.
3.4. Patent Validity and Litigation
- The patent survived initial examination and opposition in Australia, indicating sound patentability.
- As of today, no known litigations explicitly challenge this patent; however, its broad claims could be subject to invalidation or challenge if prior art emerges.
4. Therapeutic and Commercial Implications
4.1. Market Relevance
- Influenza antiviral drugs such as oseltamivir or zanamivir dominate the market; novel protease inhibitors could offer alternatives or combination therapies.
- The scope of claims allows for potential development of structurally similar compounds within the patent, but biological efficacy, safety, and resistance profiles will influence market adoption.
4.2. R&D Strategy
- Innovators can explore compounds outside the scope of this patent by modifying amino acid residues or creating different chemical scaffolds.
- Patent holders might enforce licensing or collaborate to expand their reach into influenza treatment or other viral diseases.
5. Regulatory Considerations
- Since the patent covers therapeutic compounds, any commercial product would require regulatory approval from the Therapeutic Goods Administration (TGA) in Australia, mirroring international regulatory pathways.
- Patent protection does not exempt the product from clinical testing, safety assessments, and regulatory scrutiny.
6. Key Challenges and Opportunities
- Challenges: Patent expiration risks, emerging resistance to peptide inhibitors, and competition from broad-spectrum antiviral agents.
- Opportunities: Broad claims covering various peptide modifications provide a platform for circular innovation; patent exclusivity can support licensing negotiations or strategic alliances.
7. Conclusion: Strategic Insights
- Patent AU2006247136 secures a broad scope of protease inhibitor compounds pertinent to influenza.
- The patent landscape emphasizes a highly competitive space involving peptide inhibitors and antiviral therapeutics.
- Stakeholders should monitor related filings and emerging prior art that could impact claim validity.
- The patent's nearing expiration underscores the importance of developing novel analogs or alternative mechanisms to maintain therapeutic dominance.
Key Takeaways
- Scope: The patent broadly covers peptide-based protease inhibitors and their therapeutic use against viral infections.
- Claims: Focused on specific chemical structures, with broader claims to therapeutic methods, creating substantial protection in the antiviral space.
- Landscape: A competitive environment with overlapping patents, underscoring the importance of clear freedom-to-operate and monitoring.
- Lifecycle: Set to expire circa 2026, providing a window for commercialization but demanding innovation for sustained market presence.
- Strategic Focus: Developing structurally novel inhibitors outside the scope or improving efficacy can circumvent patent limits and enhance commercial prospects.
FAQs
1. What are the primary chemical features protected by AU2006247136?
The patent protects peptide-based protease inhibitors with specific amino acid sequences, stereochemistry, and side-chain modifications designed to inhibit viral proteases, particularly influenza neuraminidase.
2. How does this patent influence the development of new influenza antivirals?
It grants exclusive rights to a family of peptide inhibitors, motivating competitors to design structurally distinct compounds or alternative antiviral mechanisms until patent expiry.
3. Can companies design around this patent?
Yes. By modifying amino acid sequences, side chains, or employing different chemical scaffolds not covered by the claims, companies can develop alternative therapies.
4. What is the potential impact of patent expiry in 2026?
Post-expiry, generic manufacturers can enter the market, increasing accessibility but reducing exclusivity profits for patent holders.
5. How does this patent landscape affect strategic R&D investments?
Investors should focus on innovative modifications that extend beyond current patent claims, ensuring long-term competitive advantage.
References
- Australian Patent AU2006247136 [Official Patent Database], accessed 2023.
- US Patent Application US20060278155, related to the same invention family.
- Patent family global filings and status reports, WIPO PATENTSCOPE.
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