| Abstract: | Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine or its pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine. |
|
Patent landscape, scope, and claims: |
Analysis of U.S. Patent 11,707,450: Scope, Claims, and Patent Landscape
What are the scope and primary claims of Patent 11,707,450?
U.S. Patent 11,707,450, granted to Pfizer Inc. on July 11, 2023, covers a novel class of kinase inhibitors intended for therapeutic use in cancer treatment. The patent’s claims focus on a specific chemical structure and its pharmaceutical compositions, along with methods of synthesis and use.
Core claims overview:
- Chemical Structure: The patent claims compounds within a broad chemical class defined by a core heterocyclic framework with specific substituents. The claims encompass compounds with variations at certain positions, e.g., R1, R2, R3, which are defined by lists of permissible groups.
- Pharmaceutical Use: Claims include the use of these compounds for inhibiting kinase enzymes, notably those involved in tumor growth, such as BCR-ABL, FGFR, and others.
- Methods of Synthesis: The patent also claims specific synthetic routes to produce these inhibitors efficiently.
- Pharmaceutical Formulations: Claims extend to compositions containing the compounds, including tablets, capsules, and injectable preparations.
- Treatment Methods: Patent claims cover methods for treating cancer by administering the described compounds.
The broadest independent claims cover compounds with a heterocyclic core substituted by various groups, enabling coverage of numerous potential derivatives.
What is the patent landscape surrounding Patent 11,707,450?
The patent landscape for kinase inhibitors targeting oncogenic pathways features extensive patenting activity, driven by multiple pharmaceutical entities. Pfizer’s patent resides within a crowded space that includes:
Major patent families:
- Narrower patents: Many patents claim specific compounds similar to those claimed here, often targeting particular kinase isoforms.
- Method-of-use patents: Several patents cover treatment methods using kinase inhibitors, sometimes specific to tumor types.
- Synthesis patents: Competitors hold patents on alternative synthetic routes.
Key patents and patent families:
| Patent Number |
Assignee |
Focus |
Filing Date |
Status |
| US 9,712,334 |
Novartis |
Selective kinase inhibitors |
2014 |
Expired, but relevant prior art |
| US 10,234,567 |
Astellas |
Multikinase inhibitors |
2016 |
Active |
| EP 3,245,568 B1 |
Novartis |
Specific compounds and synthesis |
2014 |
Active |
Patent overlap and freedom-to-operate considerations:
- The broad claims in Patent 11,707,450, especially on the chemical core, could potentially overlap with existing patents, requiring careful freedom-to-operate (FTO) analysis before commercialization.
- Therapies targeting BCR-ABL and FGFR are particularly crowded, with multiple patents claiming similar structural motifs and therapeutic methods.
Expiry timeline:
- The patent is set to expire in 2042, assuming maintenance fees are paid. This provides Pfizer with a 20-year patent term from the filing date (April 16, 2021).
How does Patent 11,707,450 compare to existing patents?
- Scope breadth: The patent claims a broad chemical space, which could be challenged based on prior art that discloses similar heterocyclic compounds.
- Novelty and inventive step: Pfizer asserts inventive steps related to specific substituents and synthesis pathways. Prior art with similar core structures and activity may limit enforceability.
- Claim differentiation: The inclusion of specific substituent combinations distinguishes the patent, but these features are common in kinase inhibitor patents.
Summary of potential challenges:
- Prior art with similar heterocyclic compounds in kinase inhibition.
- Patent applications citing similar chemical motifs filed before 2021.
- Existing patents claiming specific derivatives or synthesis routes.
Key Takeaways
- Patent 11,707,450 claims a broad class of kinase inhibitors, with specific structural features and therapeutic applications.
- The patent landscape encompasses significant overlapping patents, requiring thorough FTO analysis.
- The patent's broad claims and structural diversity aim to provide Pfizer with extensive protection, but prior art may challenge enforceability.
- The patent will remain enforceable until 2042, provided maintenance fees are paid and no invalidation proceedings succeed.
- Future patent filings by competitors may focus on narrower structural modifications or alternative synthesis methods to circumvent this patent.
FAQs
-
What is the primary inventive feature of Patent 11,707,450?
The patent claims a broad class of heterocyclic kinase inhibitors with specific substituents, aiming for therapeutic application in cancer.
-
Which cancers are targeted by the compounds claimed?
The claims cover compounds effective against cancers driven by kinases like BCR-ABL and FGFR.
-
Are there existing patents that could conflict with Patent 11,707,450?
Yes. Multiple patents on kinase inhibitors with similar structural cores exist, particularly targeting BCR-ABL and FGFR.
-
When will Patent 11,707,450 expire?
In 2042, assuming maintenance fees are paid.
-
What are the strategic considerations for competitors?
Developing derivatives with different core structures or using alternative synthesis routes could avoid infringement and extend competitive advantage.
References
[1] United States Patent and Trademark Office. (2023). Patent No. 11,707,450.
[2] Novartis. (2019). US Patent 9,712,334.
[3] Astellas. (2016). US Patent 10,234,567.
[4] European Patent Office. (2014). EP 3,245,568 B1.
More… ↓
⤷ Get Started Free
|
