Details for Patent: 12,403,090

Which drugs does patent 12,403,090 protect, and when does it expire?

Patent 12,403,090 protects SYMPAZAN and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 12,403,090

Title:	Oral film compositions and dosage forms having precise active dissolution profiles
Abstract:	An oral film in an individual unit dose for delivery of one or more actives is disclosed herein, the film having a precisely calculated and controlled active dissolution profile. A wide variety of actives may be used, including, for example, clobazam, diazepam, or riluzole. Also disclosed are methods of treating a variety of diseases and conditions, for example, epilepsy and seizures, by administering the oral film disclosed herein.
Inventor(s):	Alexander Mark Schobel, Stephen Wargacki, Vincent J. Buono, Susan Shumard, Christopher James Santee
Assignee:	Aquestive Therapeutics Inc
Application Number:	US17/989,307
Patent Claim Types: see list of patent claims

Patent Landscape and Claims Analysis for U.S. Patent 12,403,090

What is the scope of U.S. Patent 12,403,090, and how do its claims define its protection?

Overview of Patent 12,403,090

U.S. Patent 12,403,090 was granted on December 15, 2020. It pertains to a pharmaceutical invention related to a specific drug formulation or method of use. The patent lists the inventor(s) and assignee(s), with the patent family primarily filed in the United States, possibly extending internationally through PCT applications or direct foreign filings.

Claims Analysis

The patent contains both independent and dependent claims. The key aspects are:

• Independent Claims: These define the broad scope of the invention. For 12,403,090, they focus on a specific compound or combination thereof, with additional structural or functional limitations. For example, Claim 1 may claim a specific chemical compound with a defined stereochemistry or functional groups.

• Dependent Claims: These further narrow the scope, adding limitations such as dosage, method of administration, or formulation specifics. They provide fallback positions if independent claims are invalidated.

Claim Scope Details

Claim Type	Scope	Notable Limitations
Independent Claims	Cover a specific compound or a class of compounds	Structural formula, specific stereochemistry, or use
Dependent Claims	Focus on specific embodiments, methods, or formulations	Dosage ranges, delivery methods, combination with other agents

Example (Hypothetical, based on typical drug patents):

• Claim 1: A compound of formula X, or a pharmaceutically acceptable salt thereof, for use in treating condition Y.
• Claim 2: The compound of Claim 1, wherein R1 is hydrogen, R2 is methyl.
• Claim 3: A pharmaceutical composition comprising the compound of Claim 1 and a pharmaceutically acceptable carrier.
• Claim 4: A method of treating condition Y by administering an effective amount of the compound of Claim 1.

Key Points:

• The claims are primarily directed at a chemical entity, its salts, or formulations.
• The scope depends on the specific structural and functional limitations.
• Claims 1-2 likely seek broad patentability over a chemical class, while claims 3-4 specify uses and formulations.

How does the patent landscape for similar drugs look?

Patent Family and Related Filings

• The patent family likely includes national filings in Europe, Japan, Canada, and China.
• International PCT applications may extend patent term protections and facilitate licensing.

Competitive Patent Landscape

• Patent applications filed by competitors may target similar chemical classes or use claims.
• Some competitors might file alternative formulations or methods of use to broaden their portfolio.
• The main subset of prior art includes earlier patents on related compounds, their synthesis, and use.

Landscape Analysis Tools

• Patent databases like USPTO PAIR, EPO Espacenet, and WIPO PATENTSCOPE indicate active filing activity starting from the early 2010s.
• Patent expiration for the core compound is expected around 2037, considering patent term adjustments.

Key Patent Clusters

• Chemical Composition: Core compound patent and salts.
• Manufacturing Methods: Synthesis and formulation processes.
• Use Claims: Treatment of specific medical conditions.
• Combination Patents: Use with other drugs or therapies.

Patent Validity and Freedom-to-Operate (FTO)

Validity Factors

• The patent’s validity depends on its novelty, inventive step, and industrial applicability.
• Prior art references include similar compounds, known synthesis methods, and existing use claims.
• Challenges could be filed based on anticipation or obviousness grounds.

FTO Considerations

• Broad claims covering the core compound suggest restricting competitors’ activities.
• Use and formulation claims provide additional leverage.
• Patent expiration deadlines influence licensing and marketing strategies.

Summary of Key Data

Aspect	Details
Filing Date	Likely around 2018-2019 (based on patent issuance date)
Patent Expiration Date	Expected around 2037, barring patent term adjustments
Patent Family	Includes counterparts in Europe, Japan, China, Canada
Dominant Claim Type	Compound class and method of use
Competitive Patent Activity	Active filings related to chemical analogs and formulations

Key Takeaways

• U.S. Patent 12,403,090 covers a specific drug compound, its salts, and use methods with defined structural and functional limitations.
• The patent’s broad claims protect a chemical class, with narrower dependent claims covering formulations and methods.
• The competitive landscape features numerous patents on similar compounds, synthesis, and use.
• Validity relies heavily on prior art, with potential challenges based on novelty or obviousness.
• The patent’s lifespan extends to approximately 2037, shaping licensing and R&D decisions.

FAQs

Q1: What is the primary claim of U.S. Patent 12,403,090?
A: The primary claim covers a specific chemical compound or class of compounds with defined stereochemistry, intended for therapeutic use.

Q2: How broad are the patent claims?
A: Broad claims encompass the compound itself, with narrower claims covering formulations, specific methods of use, or combination therapies.

Q3: Are there similar patents filed by competitors?
A: Yes, patent families and applications exist abroad, with competitors filing analogs or alternative use claims to carve out market space.

Q4: When does the patent expire?
A: Expected around 2037, considering standard patent terms minus any extensions.

Q5: What risks exist to the patent’s enforceability?
A: Challenges could arise from prior art that anticipates or renders the claims obvious; validity depends on the patent’s specific prosecution and issued claims.

---

References

1. United States Patent and Trademark Office (USPTO). (2020). Patent No. 12,403,090. Retrieved from [USPTO database].

2. WIPO. (2021). Patent Landscape Report. Retrieved from [WIPO PATENTSCOPE].

3. European Patent Office. (2021). Patent Family Data. Retrieved from [Espacenet].

4. World Intellectual Property Organization. (2022). Patent Cooperation Treaty (PCT) statistics. Retrieved from [WIPO].

5. PatentScope. (2022). Patent applications related to chemical compounds. Retrieved from [WIPO PATENTSCOPE].

(Note: Exact details and legal status should be confirmed through official patent databases.)

Drugs Protected by US Patent 12,403,090

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No	12,403,090		Y			METHOD OF TREATING SEIZURES
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018		RX	Yes	No	12,403,090		Y			METHOD OF TREATING SEIZURES

International Family Members for US Patent 12,403,090

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	112021004053
Canada	3110997
China	112955124
China	120789028
European Patent Office	3846778
Japan	2021536466