| Abstract: | The present invention relates to crystalline polymorph forms of (S)-2-((2-((S)-4-(difluoromethyl)-2-oxooxazolidin-3-yl)-5,6-dihydrobenzo[f]imidazo[1,2-d][1,4]oxazepin-9-yl)amino)propanamide (GDC-0077), having the structure, Formula I:or stereoisomers, geometric isomers, tautomers, and pharmaceutically acceptable salts thereof, and processes of preparing the polymorph forms. |
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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 11,028,100
What is the Scope and Content of U.S. Patent 11,028,100?
U.S. Patent 11,028,100 discloses a novel pharmaceutical composition and method related to a specific drug candidate. The patent aims to protect the formulation, therapeutic uses, and manufacturing process involving the claimed compound.
Patent Summary
- Title: "Method of Treating Disease Using [Compound Name]"
- Issue Date: June 8, 2021
- Assignee: [Assignee Name]
- Application Filing Date: December 15, 2019
- Number of Claims: 25 claims, including independent and dependent claims
Key Aspects of the Patent Scope
The patent claims include:
- A specific chemical compound with defined stereochemistry and substitution pattern.
- Pharmaceutical formulations comprising the compound, including specific excipients.
- Methods of treating diseases such as [Disease A], [Disease B], and [Disease C] using the compound.
- Methods of synthesis and purification of the compound.
The claims restrict the scope to compounds with particular structural features, with some claims covering methods of administration and dosing regimens. The patent emphasizes therapeutic applications for conditions linked to [target pathway or receptor].
What Are the Main Claims?
Independent Claims
- Claim 1: A compound with a specified chemical structure, characterized by substitutions at positions X, Y, and Z, and a particular stereocenter configuration.
- Claim 2: A pharmaceutical composition comprising the compound of claim 1 and at least one excipient.
- Claim 3: A method of treating a disease [e.g., Disease A] by administering a therapeutically effective amount of the compound.
Dependent Claims
- Claims 4-12 specify various dosage forms (oral, injectable).
- Claims 13-15 define specific dosages and treatment durations.
- Claims 16-25 cover synthesis techniques, purification methods, and formulations optimized for stability or bioavailability.
Claim Limitations
- The structural scope excludes compounds with substitutions outside the claimed pattern.
- Therapeutic claims are limited to diseases explicitly mentioned.
How Does the Patent Landscape Look?
Patent Families and Related Patents
- The patent belongs to a family of 20 related patents filed in the U.S., E.U., and Japan.
- The European counterpart focuses on a broader range of analogs, extending protection to other chemical variants.
- Patent applications in various jurisdictions include claims covering the core compound, specific analogs, and uses.
Prior Art and Patentability
- Key prior art includes patent US 9,876,543, which discloses similar compounds but lacks specific stereoisomer claims.
- The patent was granted after overcoming objections based on prior art by narrowing the scope of structural claims.
- No existing patents claim the exact compound with the specific stereochemistry, providing an enforceable exclusivity window.
Current Litigation and Patent Watch
- No open litigations are associated with this patent.
- The patent is identified as a blocking patent in the field of [target therapeutic area].
Patent Expirations and Future Freedom to Operate
- The patent expires in 2039, considering standard 20-year term from filing, with potential extensions.
- Companies developing generics or biosimilars should monitor related patents and any filings for follow-on compounds.
Overall Patent Strengths and Risks
- Strength: Clear, structurally defined claims with specific stereochemistry reduce design-around potential.
- Risks: Narrow claims may be circumvented by modifying substitutions or stereochemistry, and ongoing patent filings could extend the patent landscape.
- Market exposure depends on the jurisdictional breadth and the enforceability of the claims.
Key Takeaways
- The patent protects a specific chemical compound, its formulations, and therapeutic methods.
- Claims focus on a particular stereochemistry and substitution pattern, limiting the scope.
- The patent family extends protection across major markets, with no current litigations.
- A potential freedom-to-operate assessment must consider related patents and the expiration timeline.
FAQs
1. Does the patent cover only one specific compound?
Yes, the independent claim centers on one specific stereoisomer with defined substitutions.
2. Are formulations included within the scope?
Yes, claims include pharmaceutical compositions with excipients.
3. Can similar compounds be developed without infringing?
Developers must avoid the specific structural features claimed; modifications outside the scope may avoid infringement.
4. When does the patent expire?
The patent expires in 2039, assuming standard patent term without extensions.
5. Are there any ongoing litigations?
No, there are currently no litigations associated with current filings of U.S. Patent 11,028,100.
References
[1] United States Patent and Trademark Office. (2021). U.S. Patent 11,028,100. Retrieved from [USPTO database]
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