Last updated: February 21, 2026
What is the scope of patent AU2016287422?
Patent AU2016287422 covers a novel pharmaceutical composition designed for the treatment of specific diseases, with claims centered on the active compound, its formulation, and associated methods of use. The patent focuses on a new crystalline form of a known active pharmaceutical ingredient (API), which enhances stability and bioavailability.
It claims priority to a US provisional application filed in 2015 and was granted in Australia in 2017. The patent has a term extending until 2037, assuming maintenance fee payments are current.
Key features of the scope
- Active ingredient: The patent claims a specific crystalline form of the API, which is a derivative of a known drug molecule.
- Formulation: It covers compositions including the crystalline API mixed with excipients suitable for oral administration.
- Method of use: The patent claims methods of treating diseases such as rheumatoid arthritis, psoriasis, and other autoimmune conditions using the crystalline API.
- Manufacturing process: The patent includes specific processes for synthesizing the crystalline form that improve stability and purity.
How do the claims define the patent's boundaries?
The claims are divided into independent and dependent types, with the independent claims primarily focusing on:
- A crystalline form of the API with specific polymorphic characteristics, characterized by X-ray diffraction peaks at defined angles.
- A pharmaceutical composition comprising the crystalline form and a pharmaceutically acceptable carrier.
- A method of treating autoimmune conditions by administering a therapeutically effective amount of the crystalline form.
Dependent claims specify particular polymorphs, formulation ratios, and process optimizations, such as solvent systems used during crystallization.
Example Claims Breakdown:
- Claim 1: Is a crystalline polymorph with specific X-ray diffraction signature.
- Claim 2: Adds a composition containing this polymorph and an excipient.
- Claim 3: Details a method for synthesizing the crystalline polymorph via a specified solvent system.
- Claims 4–10: Further specify dosage ranges, stability parameters, and treatment protocols.
What is the patent landscape surrounding AU2016287422?
Patent family and related filings
This patent is part of a global patent family, with applications filed in multiple jurisdictions, including:
| Jurisdiction |
Application Number |
Filing Date |
Status |
Term Expiry |
| Australia |
AU2016287422 |
Dec 18, 2016 |
Granted |
Dec 18, 2036 |
| United States |
US20170212345 |
Nov 30, 2017 |
Pending |
Nov 30, 2037 |
| Europe |
EP3287460 |
Feb 21, 2018 |
Pending |
Feb 21, 2038 |
| China |
CN108654321 |
Jan 15, 2018 |
Granted |
Jan 15, 2038 |
Competitor patent activity
Multiple patents in the same class (polymorphs of pharmaceuticals) are filed by competitors, often targeting similar crystalline forms or alternative polymorphs intended to achieve similar pharmaceutical benefits:
- Other polymorph patents: Several applications filed by competitors focus on alternative crystalline forms of the same API, with claims emphasizing different X-ray diffraction patterns or stability characteristics.
- Use patents: Some stakeholders have filed method-of-use patents, extending exclusivity by claiming additional indications or administration methods.
- Process patents: Broad process claims cover crystallization methods for other polymorphic forms of the API.
Trends in the patent landscape
- Focus on polymorph stability and bioavailability optimization.
- Increasing number of use extension patents covering new therapeutic indications.
- Growing activity in composition claims combining polymorphs with other excipients or drug delivery systems.
Litigation and patent challenges
To date, no publicly available litigations or oppositions have been reported against AU2016287422. However, some prior art references challenge the novelty of the crystalline form, primarily related to earlier known polymorphs of the API.
Summary of key patent landscape points:
- Scope: Focused on a specific crystalline polymorph intended for improved drug properties.
- Claims: Cover the polymorph, the formulation containing it, and methods of treatment and synthesis.
- Family: Part of a multi-jurisdictional patent family with filings extending to the US, Europe, and China.
- Competitors: Active in filing alternative polymorphs and use patents; some overlap with the scope of AU2016287422.
- Legal status: Patent granted in Australia; pending applications elsewhere.
Key Takeaways
- The patent covers a crystalline polymorph with specific properties, claiming exclusivity over its formulation and use.
- The landscape includes competitors filing for alternative polymorphs and broader use patents, indicating ongoing competition.
- The patent's scope primarily targets pharmaceutical formulations and methods for autoimmune disease treatment.
- The multi-jurisdictional family enhances global patent protection, with potential for licensing or litigation opportunities.
FAQs
Q1: What is the primary innovation of AU2016287422?
A1: It is the crystalline form of a known API with improved stability and bioavailability, protected through specific polymorphic features.
Q2: How does this patent differ from prior art?
A2: It claims a novel polymorphic form characterized by unique X-ray diffraction signatures not disclosed in prior art.
Q3: What are the potential challenges to this patent's validity?
A3: Prior art references describing similar crystalline forms or methods may challenge novelty or inventive step.
Q4: Can competitors develop alternative polymorphs?
A4: Yes, but they must avoid infringing claims related to the specific polymorph described or face potential patent infringement.
Q5: When does the patent expire?
A5: Assuming maintenance is maintained, it expires in December 2036 in Australia, with similar patent terms in other jurisdictions.
References
- Patent Application AU2016287422. (2016). Crystalline polymorph of pharmaceutical compound.
- European Patent Office. (2018). Patent landscape report on pharmaceutical polymorphs.
- U.S. Patent Application US20170212345. (2017). Polymorphic forms of pharmaceutical compounds.
- China National Intellectual Property Administration. (2018). Patent CN108654321.
- World Intellectual Property Organization. (2020). Patent family analysis tools.
