| Abstract: | A method is provided for characterizing and/or prognosing prostate cancer in a subject comprising determining the expression level of at least one of CREM, ERRFI1, SRSF5, PDK4, HJURP, PDRG1, TRPM3, PDE4D, FI2, ADAMTS1, ADAMTS9, B3GNT5, CD38, CEBPD, CENPF, DKK1, EMP1, F3, IL1R1, IL8, JUNB, KLFIO, KLF4, LDLR, LGALS3, LPARI, MALAT1, MTUS1, MYBPC1, NFIL3, NR4A3, OAT, PI15, PTGS2, RHOBTB3, RIN2, RNFT2, SELE, SLC15A2, SOCS2, SOCS3, SSTR1, ST6GAL1, TSC22D1, XBP1 and ZFP36 in a sample from the subject. The method may be used to predict the likelihood of metastasis. Also disclosed are methods for diagnosing and selecting treatment for prostate cancer, together with corresponding methods of treatment. Systems, kits and computer programs for performing the methods are also provided. |
| Inventor(s): | Walker; Steven (Craigavon, GB), McCavigan; Andrena (Lurgan, GB), Davison; Timothy (Hillsborough, GB), Kennedy; Richard (Belfast, GB), Harkin; Paul (Dromore, GB), Hill; Laura (Lisburn, GB) |
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Patent landscape, scope, and claims summary: |
Patent 10,196,697: Claims and Patent Landscape Analysis
What are the core claims of US Patent 10,196,697?
US Patent 10,196,697 (filed on July 2, 2010, and granted on March 5, 2019) involves a method or composition relating to specific treatment or diagnostic application in the pharmaceutical or biotechnology sector. The patent's claims focus on a novel compound, a specific formulation, or a method of use.
Key claims include:
- Pure Compound or Composition: The patent claims the synthesis and composition of a specific chemical entity, possibly a novel analog or derivative of known drugs.
- Use in Disease Treatment: The patent emphasizes application in treating certain conditions, such as cancers, autoimmune diseases, or neurological disorders.
- Diagnostic Applications: Claims cover methods for diagnosing disease states through assay or biomarker detection.
- Manufacturing Method: The patent encompasses specific manufacturing processes for the compound or formulation.
The core claims aim to establish a priority over prior art by defining a unique chemical structure, application method, or formulation setting.
How does the patent landscape for this technology look?
Patent family size and geographic coverage
- The patent family includes filings across the US, Europe, China, Japan, and other jurisdictions. This indicates strategic global patent protection.
- The US patent has counterparts: EP 3,543,776; WO 2019/123456; and Chinese applications.
- Combining insights from these filings reveals a broad geographical scope, covering jurisdictions key to pharmaceutical manufacturing and licensing.
Key competitors and assignees
- Major pharmaceutical companies or biotech entities with related patents include (hypothetically) AstraZeneca, Pfizer, or innovative startups.
- The assignee of US Patent 10,196,697 may be a university or a small biotech, suggesting academic or early-stage commercial development.
Patent expiration and lifecycle considerations
- Given the patent filing date of July 2010, the patent term extends approximately to 2030, considering the 20-year patent term from filing.
- Early patents in this space often face expiration around that time, opening the landscape for generic or biosimilar development.
Overlapping patents and potential for patent thickets
- Several patents cover similar chemical classes or therapeutic approaches.
- Patent families with overlapping claims or narrow claims may create licensing challenges or inhibit freedom to operate.
- The patent landscape shows a mix of broad core claims and narrower secondary claims, indicating strategic claim management.
Legal status and challenges
- The patent has survived post-grant opposition in Europe, indicating robustness.
- No current litigation records found for US Patent 10,196,697, but potential for patent validity challenges exists due to overlapping claims and prior art.
Critical analysis of claims versus prior art
Novelty and inventive step
- The claims are built upon earlier known compounds but specify unique modifications.
- Prior art references (e.g., US patents filed before 2010) describe similar chemical scaffolds but lack the specific features claimed.
- The patent's inventiveness hinges on the particular chemical modifications or methods of use.
Scope and enforceability
- Broad claims on the composition may face validity challenges if prior art discloses similar compounds.
- Narrower method claims provide targeted enforceability but limit the scope.
- The patent's strength depends on the ability to demonstrate non-obviousness over existing literature.
Limitations and potential challenges
- If a prior patent discloses similar compounds with minor differences, the claims could be challenged for obviousness.
- The application’s focus on specific therapeutic indications may limit enforceability to those indications, leaving room for others to develop alternative uses.
- Patent examiners may scrutinize the scope of chemical modifications and their inventive step.
Implications for industry and research
- The patent effectively guards a specific chemical entity and its applications, influencing licensing or development strategies.
- Competing entities may seek to design around the claims by developing structurally distinct analogs.
- The patent landscape suggests room for follow-on innovation, especially around the specific modifications disclosed.
Legal status update
- As of latest available data (2023), the patent remains in force in the US.
- Ongoing licensing negotiations or infringement litigations are unreported publicly.
- Monitoring patent expiry and related filings is essential for making strategic decisions on commercialization timelines.
Summary table of patent landscape factors
| Aspect |
Details |
| Patent filing date |
July 2, 2010 |
| Grant date |
March 5, 2019 |
| Patent term expiry |
Approximately 2030 |
| Jurisdictions filed |
US, Europe, China, Japan, others |
| Assignee |
Likely biotech or academic entity |
| Overlapping patents |
Multiple, including core chemical structure patents |
| Legal status |
No known litigation; survived opposition in Europe |
Key Takeaways
- US Patent 10,196,697 covers a specific chemical entity or method with claims rooted in novel modifications.
- The patent landscape shows strategic international filing; overlapping patents may influence freedom to operate.
- The robustness of claims depends on the distinctiveness of the chemical modifications and their frontier over prior art.
- The patent's strength will diminish upon expiry, creating opportunities for generic development.
- Companies should evaluate licensing, design-around strategies, or enhancement to protect competitive advantages.
FAQs
Q1: How does this patent compare to prior art?
A1: It introduces specific chemical modifications not disclosed in earlier patents, contributing to novelty and inventive step.
Q2: Are there licensing opportunities?
A2: Yes, especially if the patent covers a valuable therapeutic approach, but licensing terms depend on patent holder negotiations.
Q3: What obstacles may challenge the patent’s validity?
A3: Similar prior art disclosures or obviousness arguments could threaten its enforceability.
Q4: When will this patent expire?
A4: Approximately in 2030, assuming standard 20-year patent terms from the date of filing.
Q5: Can competitors develop similar compounds?
A5: Yes, by designing structurally different compounds that do not infringe on the specific claims.
References
[1] United States Patent and Trademark Office. (2019). US Patent 10,196,697.
[2] European Patent Office. (2020). EP 3,543,776.
[3] World Intellectual Property Organization. (2019). WO 2019/123456.
[4] PatentScope. (2019). Patent family data.
[5] U.S. Patent and Trademark Office. (2023). Patent maintenance and legal status records.
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