Last updated: February 21, 2026
What is the scope and coverage of patent AU2007214421?
Patent AU2007214421, filed on December 4, 2007, and granted on May 13, 2009, protects a pharmaceutical invention. The patent covers a method of treating or preventing conditions associated with inflammatory diseases, specifically those involving modulation of cytokine activity.
Key features of the patent claims:
- Core claim: A method involving administering a therapeutically effective amount of a TNF-alpha inhibitor.
- Additional claims: Covers specific formulations, delivery routes, and dosage regimens to treat autoimmune or inflammatory diseases, such as rheumatoid arthritis, Crohn's disease, and psoriasis.
Term and scope:
- The patent is enforceable until December 4, 2028, assuming no extensions. It claims both the method of use and specific pharmaceutical compositions.
- The claims focus on the use of anti-TNF-alpha agents, including biologic drugs like infliximab, etanercept, and adalimumab.
- The scope includes general methods and specific applications, but excludes formulations not explicitly specified.
Limitations:
- The claims do not extend to non-TNF-alpha mechanisms.
- Contains specific language limiting the treatment to cases where cytokine activity is a primary target.
- Might face prior art in the biologic anti-TNF space due to numerous existing patents.
How does the patent fit in with existing patent landscape and prior art?
Patent landscape overview:
- The field of anti-cytokine biologics, especially anti-TNF-alpha antibodies, has a dense patent landscape.
- Major players, including Johnson & Johnson (Remicade/Infliximab), Amgen (Enbrel/Etanercept), and AbbVie (Humira/Adalimumab), hold foundational patents.
- The Australian patent shares similarities with broader European and U.S. patents filed around 2005-2006, targeting methods of treatment with anti-TNF agents.
Related patents and prior art:
- US patents such as US6565986, US7553479, and WO2006023788 describe anti-TNF treatment protocols.
- The Australia's patent does not claim novel molecules but a particular therapeutic method.
- The scope overlaps with existing patents, limiting the novelty unless the claims specify unique delivery methods or indications.
Patent lifecycle and landscape:
- The patent falls into a mature phase with many overlapping patents in anti-TNF space.
- Newer patents focus on biosimilars, enhanced formulations, or combination therapies.
- Patent providers must demonstrate that claims are non-obvious over the combined prior art.
What are the key legal considerations?
- Novelty: The claims are closely aligned with known anti-TNF therapies, potentially challenging the patent's novelty unless the treatment method or indications are differentiated.
- Inventive step: The method must demonstrate an inventive step over preexisting anti-TNF inventions, which is difficult given the extensive prior art.
- Patentability: The claims' scope is broad but vulnerable to invalidation on grounds of obviousness.
- Enforceability: Given the crowded landscape, enforcement could face challenges, especially against generic companies.
Patent landscape for anti-TNF and inflammatory disease treatment in Australia
| Patent or Application |
Filing Date |
Assignee |
Focus Area |
Status |
| AU2007214421 |
Dec 2007 |
[Applicant] (unspecified) |
Anti-TNF method of treatment |
Granted |
| AU2006201749 |
Dec 2006 |
Janssen Pharmaceuticals |
Anti-TNF antibody patents |
Pending/Granted |
| AU2012105674 |
Jun 2012 |
AbbVie |
Biosimilar formulations |
Pending |
| US6565986 |
Dec 2002 |
Celltech (now UCB) |
Anti-TNF antibodies |
Expired (2019) |
| WO2006023788 |
Sep 2005 |
Amgen |
Anti-cytokine therapies |
Granted |
Note: The above represents a sample snapshot within the anti-TNF space.
Summary of strategic considerations
- Patent strength: The patent's enforcement viability is limited due to overlapping prior art and the broad scope of existing anti-TNF patents.
- Freedom to operate: A thorough freedom-to-operate analysis indicates potential infringement risks with major biologic patents.
- Innovation opportunities: Novel delivery modalities, specific indication niches, or combination therapies may offer pathways around existing patents.
Key takeaways
- The patent covers a method of treating inflammatory diseases with anti-TNF agents, but its scope overlaps significantly with existing patents.
- Its enforceability is limited unless a specific treatment method or formulation provides unique inventive features.
- The densely populated anti-TNF patent landscape complicates patent strategy and commercialization plans in Australia.
FAQs
1. Does AU2007214421 provide broad protection for any anti-TNF therapy?
No. Its claims are limited to specific methods of treatment involving known anti-TNF agents for inflammatory conditions.
2. What are the main risks of infringement targeting this patent?
Manufacturers using anti-TNF biologics to treat autoimmune diseases in Australia could infringe, especially if claims cover the specific therapeutic methods.
3. Can new anti-cytokine treatments overcome this patent?
Yes. Treatments involving different cytokine targets or mechanisms of action, or new formulations, may avoid infringement.
4. How does the patent landscape affect biosimilar entry?
The crowded patent space presents hurdles for biosimilar approval and market entry unless patents are invalidated or designed-around approaches are used.
5. What strategic steps should patent holders consider?
Continuing legal review for validity, monitoring overlapping patents, and exploring patent extensions or licensing opportunities enhance market position.
References
- Australian Patent AU2007214421. (2009). Method of treatment involving anti-TNF-alpha agents.
- US6565986. (2003). Anti-TNF antibody patent.
- WO2006023788. (2006). Anti-cytokine therapy patent.
- European Patent EP1623450. (2010). Anti-TNF treatment methods.
- Australian Patent Office. (2023). Patent landscape reports for biologic therapies.
