Comprehensive Analysis of United States Patent 10,272,083: Methods of Treating Chronic Lymphocytic Leukemia and Small Lymphocytic Leukemia
Introduction
United States Patent 10,272,083, titled "Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor," is a significant patent in the field of oncology, particularly in the treatment of hematological malignancies. This patent, owned by AstraZeneca, is part of the broader intellectual property portfolio protecting Calquence, a BTK inhibitor used in the treatment of various blood cancers.
Patent Overview
Patent Details
- Publication Number: US10272083B2
- Authority: United States
- Prior Art Date: The patent was filed on April 29, 2015, and granted on April 2, 2019[4].
Patent Claims
The patent describes therapeutic methods for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) using a combination of a Bruton's tyrosine kinase (BTK) inhibitor and an anti-CD20 antibody. The claims are specific to the methods of treatment rather than the composition of the BTK inhibitor itself, which is protected under separate patents.
Patent Landscape Analysis
Geographical Spread and Filing Jurisdictions
The patent is filed in the United States, which is a critical jurisdiction for pharmaceutical patents. Companies often file patents in their country of incorporation and in key markets where they intend to commercialize their products. In this case, AstraZeneca, a UK-based company, has filed this patent in the U.S. to protect its intellectual property in a major market[3].
Competitor Analysis
To understand the competitive landscape, it is essential to identify other companies and research institutions actively patenting in the BTK inhibitor and anti-CD20 antibody spaces. Companies like AbbVie, Janssen, and Gilead Sciences are also active in this area, with their own patents and ongoing research. A comprehensive patent landscape analysis would reveal the geographical focus areas, the saturation level of the patent space, and new entrants into this field[3].
Saturation of Patent Space
The BTK inhibitor and anti-CD20 antibody spaces are relatively saturated, with numerous patents and patent applications from various companies. This saturation indicates a high level of competition and innovation in these areas. For companies considering entry into this space, a detailed patent landscape analysis is crucial to identify potential opportunities and challenges[3].
Time-Slicing and Evolution of Technology
Time-slicing involves analyzing patent data over time to understand changes in technology focus, geographical coverage, and patent renewal strategies. For US10272083B2, tracking the evolution of BTK inhibitors and combination therapies can provide insights into how AstraZeneca and its competitors are adapting their strategies. This analysis can help in identifying shifts in technology focus and potential areas for future innovation[3].
Valuation and Strategic Importance
Valuation Methods
The value of a patent like US10272083B2 can be determined using several methods: cost, income, and market approaches. The cost approach considers the development costs, while the income approach looks at the future benefits provided by the patent. The market approach, which involves comparing sales data of similar patents, is particularly relevant here. Given the strategic importance of BTK inhibitors, patents in this area can command high prices, as seen in significant patent deals involving large pharmaceutical companies[2].
Strategic Insights
This patent is strategically important for AstraZeneca as it protects a key method of treatment for CLL and SLL. The combination therapy described in the patent enhances the efficacy of Calquence, making it a valuable asset in AstraZeneca's oncology portfolio. For competitors, understanding the scope and limitations of this patent is crucial for developing their own treatment methods without infringing on AstraZeneca's IP[3].
Legal Activities and Exclusivities
Recent Legal Activities
Recent legal activities on this patent include notifications and corrections related to the patent certificate. For instance, there were notifications and corrections recorded in February and March 2024, indicating ongoing maintenance and potential adjustments to the patent claims[1].
Exclusivities
The FDA has granted exclusivities to Calquence, which delay the launch of generic or bioequivalent versions of the drug, regardless of the patent status. These exclusivities are critical in maintaining AstraZeneca's market exclusivity for the treatment methods described in the patent[1].
Impact on Generic Launch
Patent Expiry and Generic Entry
The patent protecting the methods described in US10272083B2 is set to expire in July 2032, assuming no extensions or amendments. However, the exclusivities granted by the FDA will also play a role in determining when generic versions can enter the market. Tracking these legal activities and exclusivities is essential for predicting the timing of generic entry[1].
Conclusion
United States Patent 10,272,083 is a pivotal patent in the treatment of CLL and SLL, protecting a combination therapy that enhances the efficacy of BTK inhibitors like Calquence. Understanding the patent landscape, valuation, and legal activities surrounding this patent is crucial for both AstraZeneca and its competitors. This analysis highlights the importance of comprehensive patent landscape analysis in making strategic decisions in the pharmaceutical industry.
Key Takeaways
- Patent Protection: US10272083B2 protects methods of treating CLL and SLL using a BTK inhibitor and an anti-CD20 antibody.
- Competitive Landscape: The BTK inhibitor and anti-CD20 antibody spaces are highly competitive and saturated.
- Valuation: The patent's value can be significant, determined by cost, income, and market approaches.
- Legal Activities: Ongoing legal activities and FDA exclusivities affect the patent's expiry and generic entry.
- Strategic Importance: The patent is crucial for AstraZeneca's oncology portfolio and competitive positioning.
FAQs
What is the main claim of US10272083B2?
The main claim of US10272083B2 is the method of treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) using a combination of a Bruton's tyrosine kinase (BTK) inhibitor and an anti-CD20 antibody.
Who owns US10272083B2?
US10272083B2 is owned by AstraZeneca.
When is the patent set to expire?
The patent is set to expire in July 2032, assuming no extensions or amendments.
What are the FDA exclusivities granted to Calquence?
The FDA has granted exclusivities to Calquence, which delay the launch of generic or bioequivalent versions of the drug, regardless of the patent status.
How does the patent landscape analysis help in understanding US10272083B2?
Patent landscape analysis helps in understanding the geographical spread, saturation level, and competitive dynamics in the BTK inhibitor and anti-CD20 antibody spaces, providing strategic insights for decision-making.
Sources
- Pharsight: Calquence patent expiration - Pharsight
- Perpetual Motion Patents: The value of a patent - Perpetual Motion Patents
- AcclaimIP: Patent Landscape Analysis - Uncovering Strategic Insights
- Google Patents: US10272083B2 - Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
