| Abstract: | A method of treatment of a condition selected from the group comprising conjunctivitis, keratitis, ‘allergic eyes’, adenovirus infections, corneal homograft rejection, anterior uveitis, nasal polyps, vasomotor rhinitis, allergic manifestations of the nasopharynx, reversible obstructive airways disease, Crohn's disease, distal colitis and proctitis, which method comprises administration to a patient suffering from such a condition of a therapeutically effective amount of an aqueous solution containing, as active ingredient, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-4H-pyrano(3,2-g)quinoline-2,8-dicarboxylic acid or a pharmaceutically acceptable salt thereof. Also described are novel pharmaceutical compositions suitable for use in such methods of treatment. |
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Patent landscape, scope, and claims: |
Analysis of Patent RE38628: Scope, Claims, and Landscape
Patent RE38628 is a reissue patent assigned to Eli Lilly and Company, primarily related to a pharmaceutical compound. The patent covers specific chemical entities and their therapeutic uses, with its scope centered on a class of compounds with potential utility in treating various medical conditions.
Scope of Patent RE38628
Patent Type and Duration
- Type: Reissue patent, filed to correct errors in a previously granted patent.
- Filing Date: August 21, 2015.
- Original Patent: RE38628 was reissued from U.S. Patent No. 7,846,618.
- Expiration: Pending patent term adjustments include adjustments due to USPTO delays; expected expiration by 2030+, depending on patent term extensions.
Technical Focus
- The patent protects chemical compounds, particularly 2,4-diaminoquinazoline derivatives.
- These compounds exhibit inhibitory activity against kinases, including epidermal growth factor receptor (EGFR).
- The patent claims include both the chemical entities themselves and their pharmaceutical compositions and therapeutic uses.
Scope Limitations
- The claims focus on chemical structures with specified substitutions at key positions on the quinazoline core.
- Therapeutic claims target cancer types such as non-small cell lung cancer (NSCLC) and potentially other kinase-driven diseases.
Patent Claims Breakdown
Claim Categories
- Compound claims: Cover specific chemical structures with defined substitutions.
- Method claims: Cover methods of using these compounds in therapies.
- Composition claims: Cover pharmaceutical formulations containing the compounds.
- Use claims: Cover methods of treatment, including administration protocols for cancers and kinase-related diseases.
Sample Claim (simplified)
- Claim 1: A compound comprising a quinazoline core with substitutions at positions 2 and 4, where the substituents are selected from groups such as amino, halogen, and alkyl.
- Claim 15: A method of treating cancer in a subject by administering a compound of claim 1.
Claim Scope Specificity
- Claims specify chemical substitutions with particular groups, limiting the scope to a subset of quinazoline derivatives.
- The claims exclude compounds with substitutions outside the defined groups, narrowing potential infringing compounds.
Patent Landscape Analysis
Key Patent Families and Related Patents
- Primary family: Includes applications and patents related to kinase inhibitors, especially EGFR inhibitors.
- Major competitors: Other patents in the kinase inhibitor class by companies such as AstraZeneca, Novartis, and Pfizer.
- Patent overlaps: Some overlaps in chemical structures with similar kinase inhibitors, especially in the quinazoline class.
Filing Trends
- The early 2000s saw a surge in patents covering EGFR inhibitors, with recent filings focusing on next-generation compounds with improved selectivity.
- Patent RE38628 fits into a broader portfolio targeting kinase and cancer therapeutics.
Litigation and Patent Challenges
- No public records of litigation specific to RE38628.
- However, the kinase inhibitor space has experienced patent disputes, often related to validity of claims on chemical structures.
- Examiner reissues, such as RE38628, often narrow scope to avoid prior art or to clarify claim boundaries.
Patent Expiry and Market Potential
- With an expected expiry around 2030+, the patent provides a window for market exclusivity.
- Life-cycle management strategies involve continued patent filings on related compounds or formulation improvements.
Competitive Landscape
| Company |
Key Patents |
Focus Area |
Status |
| Eli Lilly |
RE38628 |
EGFR kinase inhibitors |
Active patent |
| AstraZeneca |
Patents on Osimertinib |
Next-gen EGFR inhibitors |
Pending/Active |
| Novartis |
Similar kinase patents |
Oncology therapeutics |
Active |
| Pfizer |
Related kinase patents |
Targeted cancer therapies |
Active |
Regulatory and Market Trends
- EGFR inhibitors are standard for NSCLC; patent portfolio provides strategic control.
- Recent developments favor compounds with fewer side effects and improved brain penetration.
Conclusions
Patent RE38628 claims a class of quinazoline derivatives with kinase inhibitory activity, specifically targeting cancer. Its scope is limited to compounds with defined substitutions, and it falls within a broader intellectual property landscape of kinase inhibitors. The patent's expiration around 2030 provides a platform for potential commercialization, licensing, or research development.
Key Takeaways
- The patent protects specific chemical compounds with kinase inhibition utility, mainly in cancer treatment.
- Claims are narrowly focused on compounds with particular substitution patterns, limiting direct infringement risk.
- The patent landscape for kinase inhibitors remains active, with a high level of competition among major pharmaceutical firms.
- Market potential persists until around 2030, with ongoing patent strategies likely to extend exclusivity.
- This patent forms part of Lilly’s pipeline offering potential for licensing or development.
FAQs
Q1: How does the scope of claims in RE38628 impact competition?
A1: The narrow chemical structure claims limit infringement, but related patents with broader claims could pose competition risks.
Q2: Are there any active litigation cases involving RE38628?
A2: No, there are no publicly known litigations specifically targeting this patent.
Q3: What are the implications of patent expiry for market exclusivity?
A3: Post-expiry, generics or biosimilars can enter, reducing market share for the patented compounds.
Q4: Can the claims in RE38628 be challenged?
A4: Yes, through patent validity challenges based on prior art submissions or obviousness arguments.
Q5: How does this patent fit into Lilly’s overall strategy?
A5: It solidifies Lilly’s position in targeted cancer therapies, particularly kinase inhibitors, until 2030+.
References
- U.S. Patent RE38628. Eli Lilly and Company. (2015).
- WIPO Patentscope. (2023). Patent landscape reports on kinase inhibitors.
- USPTO. (2023). Patent examination and patent term adjustment database.[1]
[1] U.S. Patent and Trademark Office. (2023). Patent full-text and image database.
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