Understanding the Scope and Claims of United States Patent 10,752,634
Introduction
The United States Patent 10,752,634, titled "Pharmaceutical formulations of a Bruton's tyrosine kinase (BTK) inhibitor," is a significant patent in the field of oncology, particularly for the treatment of blood and bone marrow cancers. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape surrounding this innovation.
Patent Overview
Inventors and Assignee
The patent 10,752,634 was granted to inventors associated with Pharmacyclics LLC, a company known for its advancements in targeted therapies, particularly in the development of BTK inhibitors[2][5].
Patent Date and Number
The patent was granted on June 3, 2023, with the patent number 10,752,634.
Scope of the Patent
Subject Matter
The patent focuses on pharmaceutical formulations of a Bruton's tyrosine kinase (BTK) inhibitor, specifically ibrutinib. Ibrutinib is an antineoplastic agent used to treat chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenstrom's Macroglobulinemia[4].
Claims
The claims of the patent are directed towards specific formulations, methods of preparation, and uses of ibrutinib. Here are some key aspects:
- Formulations: The patent describes various pharmaceutical formulations of ibrutinib, including capsules, tablets, and other dosage forms. These formulations are designed to enhance bioavailability, stability, and patient compliance[5].
- Methods of Preparation: The claims include detailed methods for preparing these formulations, which involve specific steps and ingredients to ensure the stability and efficacy of the drug[5].
- Therapeutic Uses: The patent claims cover the use of these formulations for treating specific types of cancers, emphasizing the therapeutic benefits and safety profile of ibrutinib[4].
Claim Scope and Strategy
Broad vs. Specific Claims
The claim scope of the patent is carefully balanced between being broad enough to cover various formulations and specific enough to avoid invalidation. A common misconception is that broader claims are always better, but they can be more difficult to get granted and easier to invalidate[3].
Anchoring to Embodiments
The claims must be anchored to the specific embodiments disclosed in the patent specification. This ensures that the claims are not overly broad and do not run afoul of the abstract idea exception or fail to meet the written description requirement[3].
Patent Landscape
Related Patents
The patent landscape surrounding 10,752,634 includes numerous other patents related to ibrutinib and BTK inhibitors. These patents cover various aspects such as crystalline forms, methods of use, and other formulations. For example:
- US10,961,251 B1: Covers crystalline forms of a BTK inhibitor[1].
- US10213386B2: Describes pharmaceutical formulations of a BTK inhibitor, similar to the current patent[5].
Patent Expiration and Generic Competition
Several patents related to ibrutinib are set to expire in the coming years, which could lead to increased generic competition. For instance, key patents such as US8476284, US8703780, and US8497277 are estimated to expire in 2027[4].
Litigation and Generic Approvals
The approval of generic versions of ibrutinib, such as those by Zydus Worldwide DMCC, has been a subject of litigation. Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for ibrutinib capsules, leading to 180 days of generic drug exclusivity[2].
Industry Impact
Therapeutic Advancements
The development and patenting of ibrutinib formulations have significantly advanced the treatment of blood and bone marrow cancers. These targeted therapies have improved patient outcomes and quality of life[4].
Market Dynamics
The patent landscape influences market dynamics, with the expiration of key patents potentially leading to increased competition from generic manufacturers. This can affect pricing and accessibility of the drug[2].
Key Takeaways
- Balanced Claim Scope: The patent's claims are carefully balanced to ensure they are not overly broad, thus avoiding invalidation risks.
- Specific Formulations: The patent covers specific pharmaceutical formulations of ibrutinib, enhancing its therapeutic efficacy and patient compliance.
- Patent Expiration: Several related patents are set to expire, which may lead to increased generic competition.
- Industry Impact: The development of ibrutinib formulations has significantly advanced cancer treatment and will continue to shape market dynamics.
FAQs
Q: What is the primary use of the drug ibrutinib?
A: Ibrutinib is primarily used to treat chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenstrom's Macroglobulinemia[4].
Q: Who is the assignee of the patent 10,752,634?
A: The assignee of the patent 10,752,634 is Pharmacyclics LLC[2][5].
Q: What are the key challenges in drafting patent claims for pharmaceutical formulations?
A: Key challenges include ensuring the claims are not overly broad to avoid invalidation and are anchored to the specific embodiments disclosed in the patent specification[3].
Q: How does the patent landscape affect the availability of generic versions of ibrutinib?
A: The expiration of key patents related to ibrutinib can lead to increased generic competition, as seen with the approval of generic versions by companies like Zydus Worldwide DMCC[2].
Q: What is the significance of the patent 10,752,634 in the field of oncology?
A: The patent is significant because it covers specific formulations of ibrutinib, a crucial drug in the treatment of certain blood and bone marrow cancers, thereby enhancing therapeutic efficacy and patient compliance[4].
Sources
- United States Patent 10,961,251 B1 - Crystalline forms of a Bruton's tyrosine kinase inhibitor[1].
- FDA Approval Letter for Ibrutinib Capsules - Accessdata.fda.gov[2].
- The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law[3].
- Ibrutinib: Uses, Interactions, Mechanism of Action - DrugBank Online[4].
- Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor - Google Patents[5].
