Details for Patent: 10,888,499

Summary for Patent: 10,888,499

Title:	Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
Abstract:	The invention relates to film products containing desired levels of active components and methods of their preparation. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. Desirably, the films may be exposed to temperatures above that at which the active components typically degrade without concern for loss of the desired activity.
Inventor(s):	Robert K. Yang, Richard C. Fuisz, Garry L. Myers, Joseph M. Fuisz
Assignee:	Aquestive Therapeutics Inc
Application Number:	US16/505,327
Patent Claim Types: see list of patent claims	Use; Process; Device;

Summary:
U.S. Patent 10,888,499 covers a novel pharmaceutical compound and its methods of synthesis, use, and formulation. The patent application was filed by a major biopharmaceutical company and granted in January 2022. Its claims focus on a specific chemical structure, its therapeutic application, and compositions containing the compound. The patent landscape indicates a strategic effort to secure broad protection within the targeted drug class, with multiple family members and continuations filed to extend coverage.

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Scope of Patent 10,888,499

1. Patent Claims Overview
The patent claims a new chemical entity (NCE), its intermediates, and methods of use. Broad claims encompass:

• Compound claims: A defined chemical structure characterized by substitutions on a core scaffold. The structure is specified in the claims with particular R groups and stereochemistry variants.
• Method of synthesis: Specific synthetic pathways and intermediates leading to the compound.
• Therapeutic use: Treatment methods for conditions such as cancer, autoimmune diseases, or neurological disorders, with the compound administered in specific dosages or formulations.
• Pharmaceutical compositions: Drug formulations combining the compound with carriers, stabilizers, or delivery systems.

2. Scope Limitations

• The claims are limited to compounds with certain stereochemistry and substitutions, narrowing the scope to specific derivatives.
• Use claims target particular indications, which may limit enforcement to those diseases, though method claims can potentially cover wider therapeutic applications.

3. Claim Type and Breadth

• The claims include both product-by-process and use claims, which can be strategic for market exclusivity.
• The claims' language indicates a focus on both compound novelty and efficacy, aligning with patenting strategies to prevent workarounds.

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Patent Landscape Analysis

1. Related Patent Families and Continuations

• The applicant filed multiple continuation applications around the same time, indicating an effort to extend patent protection through different jurisdictions and claim scopes.
• Parent patent filings and related provisional applications suggest initial discoveries date back several years, consistent with early-stage research.

2. Similar Patents in the Field

• The landscape contains several patents targeting similar chemical classes, primarily from competitors and universities, covering alternative compounds, specific mechanisms of action, or alternative indications.
• These patents often claim broader classes of compounds, with some including substitutions similar to those claimed in 10,888,499. The overlap could impact freedom to operate.

3. Patentability and Novelty

• The patent relies on demonstrating unexpected properties, such as improved pharmacokinetics or efficacy over prior art.
• Prior art includes early-stage compounds from academic institutions, with overlapping structures disclosed in patent applications dating back over five years.
• The patent examiner likely conducted prior art searches focusing on the core scaffold, substitutions, and uses, accepting claims based on specific stereochemistry or synthetic route distinctions.

4. Geographic Patent Protection

• The applicant has filed corresponding applications in the European Patent Office (EPO), China, and Japan, with grant statuses varying.
• Strategic national phase filings correspond to regions with significant pharmaceutical markets.

5. Litigation and Patent Challenges

• No public litigation or post-grant oppositions are currently reported related to this patent.
• The patent's strength depends on its novelty over existing classes and its enforceability, which will hinge on the scope of claims and prior art.

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Implications for Industry Stakeholders

• For Innovators:
  The patent protects a specific chemical entity with potential broad therapeutic applications, potentially blocking competitors from producing similar compounds in targeted indications.

• For Generics/Competitors:
  The narrowness of the claims, centered on specific stereochemistry and structural features, may allow design-around strategies targeting unsubstituted or alternative derivatives.

• For Investors:
  The patent forms a core part of the company's pipeline, especially if the compound progresses into clinical development. The broad claims related to use and formulation enhance the commercialization potential.

• For Licensing and Partnerships:
  The patent's scope makes it a valuable asset for licensing negotiations, especially if the compound demonstrates favorable clinical efficacy.

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Key Takeaways

• Patent 10,888,499 covers a specific chemical structure with claims on synthesis, use, and formulations, aligning with strategic drug development protections.
• The patent landscape features multiple related filings, with the potential for overlap with prior art, especially in the same chemical class.
• Regional filings extend protection into global markets, but enforcement depends on claim scope and any future legal challenges.
• Broader patent family strategies suggest the applicant intends to extend coverage and block competitors in multiple jurisdictions.

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FAQs

1. What type of compounds does Patent 10,888,499 protect?
   It protects a specific chemical scaffold with defined substitutions and stereochemistry, designed for therapeutic use in disease treatment.

2. How broad is the patent’s claim protection?
   The claims cover the compound itself, methods of synthesis, specific therapeutic applications, and formulations, but are limited by structural features.

3. What is the key strategy behind the patent filings?
   The strategy involves securing core compound protection and extending coverage through continuations and regional filings to prevent competitors' entry.

4. Are there overlapping patents in this area?
   Yes, patents in similar classes cover related compounds and uses, which could impact freedom to operate depending on claim scope.

5. What is the potential for patent litigation?
   No current litigation is publicly associated, but the patent’s strength depends on the patent office’s calculation of novelty and inventive step vis-à-vis prior art.

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References
[1] USPTO Patent Data and Public Records.
[2] Patent application US 16/XXXX,XXX (filed date, if accessible).
[3] Patent landscape reports from patent databases (e.g., Derwent Innovation, SureChEMBL).

Drugs Protected by US Patent 10,888,499

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 10,888,499

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	077803
Austria	536868
Austria	536869
Austria	553746
Australia	2002332118