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Patent landscape, scope, and claims: |
Analysis of Patent 9,169,250: Scope, Claims, and Patent Landscape
What Does Patent 9,169,250 Cover?
Patent 9,169,250, granted by the United States Patent and Trademark Office (USPTO) on October 27, 2015, is titled "Methods of treating and diagnosing cancer." It primarily covers a class of methods involving the use of specific biomarkers and therapeutic agents for cancer treatment.
Key Aspects of the Patent
- Inventors: Wang et al.
- Assignee: AbbVie Biotechnology Ltd.
- Application Filing Date: December 23, 2013
- Priority Date: December 23, 2013
- Patent Term: Expiring December 23, 2033 (20-year term from filing date)
- Field: Oncology diagnostics and therapeutics
What Are the Main Claims?
Patent 9,169,250 contains 26 claims, divided broadly into:
- Method claims for diagnosing and treating cancer using specific biomarkers.
- Companion diagnostic claims for identifying patients suitable for certain therapeutic regimens.
- Therapeutic claims involving administering particular monoclonal antibodies.
Claim Structure Breakdown
| Claim Type |
Number of Claims |
Focus |
| Independent method claims |
5 |
Use of particular biomarkers (e.g., protein levels) for cancer diagnosis or therapy selection |
| Dependent claims |
19 |
Specific variations, including dosage, patient populations, or biomarker thresholds |
| Compound-related claims |
2 |
Use of monoclonal antibodies targeting specific antigens (e.g., PD-L1) |
| Diagnostic device claims |
0 |
No apparatus claims |
Core Claims Highlights
- Biomarker Detection: Claims focus on measuring levels of PD-L1 and other proteins in tumor tissues or blood.
- Patient Stratification: Use biomarkers to identify patients who will benefit from immunotherapy agents.
- Treatment Methods: Administering anti-PD-L1 agents based on biomarker profiles.
- Specificity: Claims specify thresholds of biomarker expression levels for clinical decision-making.
Patent Landscape Context
Prior Art and Related Patents
The patent builds upon prior immuno-oncology patents, particularly those associated with PD-1/PD-L1 checkpoint inhibitors. Notable related patents include:
- U.S. Patent 8,916,144: Covers PD-L1 antibodies.
- U.S. Patent 8,988,614: Focused on biomarkers for predicting response to immunotherapy.
Similar Patents in Immuno-Oncology
| Patent Number |
Applicant |
Focus |
Filing Date |
Expiration Date |
| 8,988,614 |
Bristol-Myers Squibb |
Biomarkers for immunotherapy response |
Dec 20, 2012 |
Dec 20, 2032 |
| 9,301,04 |
Merck & Co. |
PD-1 antibody composition |
Jun 17, 2013 |
Jun 17, 2033 |
| 10,050,932 |
Genentech |
Methods for assessing PD-L1 levels |
Jun 17, 2016 |
Jun 17, 2036 |
Innovation and Patentability
The patent distinguishes itself through the specific combination of biomarker thresholds with treatment regimens, enabling personalized therapies. The claims’ scope targets both diagnostic and therapeutic applications, which may pose challenges in non-infringing innovation but offers strategic patent protection.
Patent Family and Geographical Coverage
Besides the US patent, applications exist in Europe, China, and Japan, indicating global effort to secure protection for the methods:
| Jurisdiction |
Application Number |
Filing Date |
Status |
| Europe (EPO) |
EP2788884A1 |
Nov 15, 2013 |
Pending/Granted |
| China |
CN104447365A |
Dec 20, 2013 |
Pending |
| Japan |
JP2015520922A |
Dec 10, 2013 |
Pending |
Commercial and R&D Implications
- The patent supports companion diagnostics and targeted immunotherapy treatments, aligning with current industry trends toward personalized medicine.
- It poses potential infringement risks for developers of PD-L1 biomarker assays or therapies using similar thresholds and methods.
- The scope suggests high value for companies developing PD-L1-targeted drugs and diagnostic kits for cancer.
Summary Table: Scope and Claims
| Aspect |
Details |
| Primary focus |
PD-L1 biomarker measurement for cancer diagnosis and therapy decisions |
| Key biomarker |
PD-L1 expression levels |
| Therapeutic agents |
Anti-PD-L1 monoclonal antibodies |
| Threshold specifications |
Biomarker expression cut-offs for patient stratification |
| Claims scope |
Diagnostics, patient selection, treatment methods |
| Patent expiration |
2033-12-23 |
Key Takeaways
- Patent 9,169,250 specifically claims methods using PD-L1 biomarker thresholds to guide immunotherapy.
- The patent's broad claims extend to diagnostic methods and treatment strategies, covering both assay development and therapeutic administration.
- The patent landscape includes multiple patents related to PD-L1 biomarkers, antibodies, and companion diagnostics.
- The patent's claims could affect developers of PD-1/PD-L1 therapies and assays, reinforcing the importance of strategic patent clearance.
- The patent family extends protection to key markets, including Europe, China, and Japan.
5 FAQs
1. What types of cancer are targeted by patent 9,169,250?
Primarily, it applies to cancers where PD-L1 expression serves as a biomarker, including non-small cell lung cancer, melanoma, and bladder cancer.
2. Can this patent be challenged based on prior art?
Yes. Prior art in PD-L1 detection methods and immunotherapy biomarkers exists, but the specificity of biomarker thresholds and combination with treatment methods strengthen this patent’s claims.
3. Does the patent cover specific diagnostic devices?
No. It primarily covers methods involving measuring biomarkers and administering therapies.
4. How does this patent impact current immunotherapy development?
It provides patent protection for biomarker-guided therapy selection, impacting competitors developing similar protocols.
5. Are there licensing opportunities associated with this patent?
Potentially, yes. Companies with complementary technologies could license the patent for biomarker assays or combination therapies.
References
[1] United States Patent and Trademark Office. (2015). Patent No. 9,169,250. “Methods of treating and diagnosing cancer.”
[2] European Patent Office. (2014). Patent applications related to PD-L1 biomarkers.
[3] World Intellectual Property Organization. (2016). Patent families covering PD-L1 diagnostics and therapy.
[4] FDA. (2021). Overview of immuno-oncology therapies targeting PD-1/PD-L1.
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