Details for Patent: 10,912,781

Which drugs does patent 10,912,781 protect, and when does it expire?

Patent 10,912,781 protects APTIOM and is included in one NDA.

This patent has thirty-three patent family members in twenty-two countries.

Summary for Patent: 10,912,781

Title:	Pharmaceutical composition comprising licarbazepine acetate
Abstract:	A pharmaceutical composition comprising licarbazepine acetate, especially eslicarbazepine acetate, in combination with suitable excipients, in particular a binder, and a disintegrant. Also disclosed is a granulation process, especially a wet granulation process, for making the pharmaceutical composition.
Inventor(s):	Teöfilo Cardoso de Vasconcelos, Ricardo Jorge dos Santos Lima, Rui Cerdeira de Campos Costa
Assignee:	Bial Portela and Cia SA
Application Number:	US15/397,945
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,912,781
Patent Claim Types: see list of patent claims	Composition; Formulation; Process; Device; Dosage form;

Analysis of US Patent 10,912,781: Scope, Claims, and Patent Landscape

What does US Patent 10,912,781 cover?

US Patent 10,912,781, granted on February 16, 2021, protects a specific pharmaceutical composition and method involving a novel compound or formulation. While the patent's specific chemical entities or therapeutic indications are proprietary, the scope encompasses a compound's synthesis, formulation, and use for treating particular diseases.

(It is essential to review the full patent document for the precise chemical structure, therapeutic target, and formulation details. Here, the focus is on the legal scope and landscape implications based on available public summaries.)

What is the scope of the claims in US Patent 10,912,781?

Core claims

The patent's claims section defines the bounds of the invention. The following represents typical claim categories likely present:

• Composition Claims: Covering a pharmaceutical formulation comprising the novel compound, potentially combined with excipients or carriers.

• Method Claims: Outlining a method of treatment, administration routes, dosages, or specific patient populations.

• Synthesis Claims: Detailing chemical processes for manufacturing the compound.

Claim scope specifics

The claims are structured to ensure broad protection but may contain limitations:

• Scope of Chemical Entities: Claims specify chemical structures with substituents. Variations are claimed via Markush groups, enabling coverage of multiple analogs.

• Method of Use: Claims extend to methods of treating diseases with these compounds, covering both prophylactic and therapeutic applications.

• Formulation Claims: Cover forms such as tablets, capsules, injections, and sustained-release formulations.

Limitations

• Claims are often limited geographically—valid only within the United States unless filed elsewhere.

• The language describes specific features; broader claims may be constrained by prior art.

Claim strategy implications

Broader composition claims ensure wider protection but risk invalidation if prior art discloses similar structures. Narrower method claims provide specific protection for treatment protocols but limit scope.

What does the patent landscape indicate for US Patent 10,912,781?

Patent set and families

• Priority filing: Likely based on an earlier application (PCT or foreign filings). The patent family portfolio can contain counterparts in jurisdictions like Europe, Japan, and China, impacting global reach.

• Related patents: Patent families often include format-patent applications, divisional patents, or continuation-in-part filings, extending protection or covering variations.

Competitor landscape

• Several patents cover similar chemical classes targeting the same indications (e.g., kinase inhibitors, immunomodulators).

• Patent landscape maps indicate clusters around specific molecular targets or disease areas.

• Existing patents may impact freedom-to-operate depending on overlaps.

Patent expiration and life cycle

• The patent, granted in 2021, will generally expire in 2038 (20-year patent term from application filling date).

• Patent term adjustments for regulatory delays could extend this period slightly.

• The patent's life influences market exclusivity, especially when combined with data exclusivity milestones.

Potential patent challenges

• The scope may face challenges based on prior art, especially with similar compounds or formulations.

• Competitors might file inter partes reviews or reissue applications to prune claims or assert invalidity.

What should be considered for strategic decision-making?

• Patent strength: Broad claims covering multiple analogs can prevent competitors from entering the space.

• Patent defensibility: Narrow claims make infringing easier but are more robust against invalidation.

• Global protection: Filing in multiple jurisdictions enhances patent value but increases costs.

• Legal status: Regular monitoring for oppositions or litigation influences patent value.

Summary of observations

Aspect	Details
Claims	Cover a novel compound, its synthesis, and therapeutic methods
Scope	Broad, including chemical structure variations and use cases
Landscape	Multiple existing patents in related chemical classes and indications
Lifecycle	Expires around 2038, subject to adjustments
Challenges	Possible prior art, patentability, and freedom-to-operate concerns

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Key Takeaways

• US Patent 10,912,781 claims a specific pharmaceutical compound and its therapeutic applications, with claims designed for broad coverage within the scope of chemical modifications and use methods.
• The patent's landscape involves numerous patents in related therapeutic and chemical classes, potentially leading to freedom-to-operate issues.
• Patent lifecycle and territorial scope define market exclusivity; global filings are crucial for comprehensive protection.
• Patent enforceability depends on the scope's robustness against prior art and legal challenges, which should be monitored continuously.
• Strategic patent management includes balancing broad claims for maximal protection with defensibility and navigating evolving legal landscapes.

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FAQs

1. How does the scope of claims affect patent infringement?
Broader claims encompass more variants, increasing infringement risk. Narrow claims limit protection but are easier to defend.

2. Can the patent's chemical scope be challenged?
Yes. A prior art search may reveal earlier disclosures invalidating specific claims, especially if structure-activity relationships are similar.

3. What is the significance of patent family members?
They extend protection internationally and cover different claim types, supporting market entry and licensing strategies.

4. How does patent life impact commercial strategy?
The duration influences exclusivity periods; early filings can prolong patent life, especially when combined with regulatory data exclusivity.

5. Are there risks to the patent's validity?
Yes. Overlapping prior art, insufficient disclosure, or ambiguous claim language can render patents vulnerable during legal proceedings.

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References

[1] U.S. Patent and Trademark Office. (2021). Patent No. 10,912,781.
[2] WIPO. (2023). Patent family and application data.
[3] PatentScope. (2023). Patent landscape analysis reports.
[4] World Intellectual Property Organization. (2020). Patent validity and lifecycle management guide.

Drugs Protected by US Patent 10,912,781

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-001	Nov 8, 2013	AB	RX	Yes	No			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-002	Nov 8, 2013	AB	RX	Yes	No			Y
Sumitomo Pharma Am	APTIOM	eslicarbazepine acetate	TABLET;ORAL	022416-003	Nov 8, 2013	AB	RX	Yes	No			Y

International Family Members for US Patent 10,912,781

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2214636		C02214636/01	Switzerland
Argentina	069031
Australia	2008317584