|
Patent landscape, scope, and claims: |
Understanding the Scope and Claims of United States Patent 10,294,232
Introduction
United States Patent 10,294,232, titled "Crystalline forms of a Bruton's tyrosine kinase inhibitor," is a significant patent in the pharmaceutical industry, particularly in the treatment of certain cancers and autoimmune diseases. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, granted to Pharmacyclics LLC (now part of AbbVie Inc.), protects the crystalline forms of ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor. Ibrutinib is marketed under the brand name IMBRUVICA and is used to treat various conditions, including mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström's macroglobulinemia[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some key aspects:
Independent Claims
- The patent claims various crystalline forms of ibrutinib, including specific polymorphs and solvates. These claims are crucial as they define the unique physical and chemical properties of the drug that distinguish it from other forms.
- For example, Claim 1 might specify a particular crystalline form of ibrutinib characterized by its X-ray powder diffraction (XRPD) pattern, which is a unique identifier for that specific polymorph[4].
Dependent Claims
- Dependent claims build upon the independent claims and provide additional details or limitations. These might include claims related to the methods of preparing these crystalline forms, their use in pharmaceutical compositions, or their application in treating specific diseases.
- For instance, a dependent claim might specify a method for preparing a particular crystalline form of ibrutinib, including the steps and conditions required to achieve that form[4].
Patent Scope and Eligibility
The scope of the patent is defined by the claims, and its eligibility is determined by the criteria set forth by the USPTO.
Subject Matter Eligibility
- The patentability of pharmaceutical inventions, including those related to crystalline forms of drugs, must comply with the subject matter eligibility criteria under 35 U.S.C. § 101. This involves ensuring that the claims do not cover mere abstract ideas or natural phenomena but instead integrate these concepts into practical applications.
- For example, the USPTO's 2024 guidance update on AI patent eligibility, while not directly applicable to pharmaceutical patents, emphasizes the importance of integrating judicial exceptions into practical applications. Similarly, in pharmaceutical patents, the claims must demonstrate a concrete technological improvement or a practical application, such as a specific method of preparation or use that enhances the drug's efficacy or stability[1].
Patent Landscape
The patent landscape surrounding IMBRUVICA and similar BTK inhibitors is complex and highly contested.
Patent Thickets
- The pharmaceutical industry, particularly in the area of biologics and small molecule drugs, often faces the issue of "patent thickets." These are dense networks of overlapping patents that can delay the entry of generic or biosimilar drugs into the market.
- For IMBRUVICA, there are multiple patents listed in the Orange Book, some of which are terminally disclaimed. This practice, where multiple patents are filed to extend the exclusivity period, can create significant barriers for generic and biosimilar manufacturers[2].
Generic and Biosimilar Entry
- The high number of patents, including those that are terminally disclaimed, can make it costly and uncertain for generic and biosimilar firms to enter the market. Empirical data shows that this can lead to delayed market entry and increased costs for challenging these patents[2].
Economic Impact
- The economic impact of such patent strategies is significant. Generic and biosimilar applicants may budget millions of dollars to challenge patents, and the ongoing litigation can continue even as new patents are added by the brand manufacturer. This environment often leads to patent settlements, which can be beneficial for both parties but also reflect the complexity and cost of navigating the patent landscape[2].
Real-World Applications and Benefits
The crystalline forms of ibrutinib protected by this patent have several real-world applications and benefits.
Enhanced Stability and Efficacy
- Specific crystalline forms of ibrutinib can offer improved stability, solubility, and bioavailability, which are critical for the drug's efficacy and patient compliance.
- For example, a particular polymorph might be more stable under various storage conditions, ensuring that the drug remains effective over its shelf life[4].
Manufacturing and Formulation
- The patented crystalline forms can also simplify the manufacturing process and improve the formulation of the drug. This can lead to more consistent and reliable production, reducing the risk of batch-to-batch variability.
- Additionally, these forms might be easier to formulate into specific dosage forms, such as tablets or capsules, which can enhance patient convenience and adherence to treatment[4].
Key Takeaways
- Patent Claims: The patent includes claims for specific crystalline forms of ibrutinib, methods of preparation, and their use in pharmaceutical compositions.
- Patent Scope: The scope is defined by these claims and must comply with subject matter eligibility criteria.
- Patent Landscape: The landscape is complex, with multiple patents and terminally disclaimed patents that can delay generic and biosimilar entry.
- Real-World Applications: The patented crystalline forms offer improved stability, efficacy, and manufacturing benefits.
FAQs
-
What is the main subject of United States Patent 10,294,232?
- The main subject is the crystalline forms of ibrutinib, a Bruton's tyrosine kinase inhibitor.
-
What are the key claims of this patent?
- The key claims include specific crystalline forms of ibrutinib, methods of preparing these forms, and their use in pharmaceutical compositions.
-
How does the patent landscape affect generic and biosimilar entry?
- The dense network of patents, including terminally disclaimed patents, can delay and complicate the entry of generic and biosimilar drugs into the market.
-
What are the real-world benefits of the patented crystalline forms of ibrutinib?
- The benefits include improved stability, solubility, bioavailability, and simplified manufacturing and formulation processes.
-
How do patent thickets impact the pharmaceutical industry?
- Patent thickets can drive up costs, reduce efficiency, and delay market entry of generic and biosimilar drugs, leading to higher costs and uncertainty for both manufacturers and consumers.
Sources
- Understanding the 2024 USPTO Guidance Update on AI Patent Eligibility - Mintz.
- Letterhead DC Office - Regulations.gov.
- Patent Claims Research Dataset - USPTO.
- Crystalline forms of a Bruton's tyrosine kinase inhibitor - PubChem.
More… ↓
⤷ Subscribe
|
