Details for Patent: 12,303,605

Which drugs does patent 12,303,605 protect, and when does it expire?

Patent 12,303,605 protects CREXONT and is included in one NDA.

This patent has twenty-six patent family members in twelve countries.

Summary for Patent: 12,303,605

Title:	Muco-adhesive, controlled release formulation of levodopa and/or esters of levodopa and uses thereof
Abstract:	The invention provides an oral solid formulation comprising (a) one or more controlled release components comprising a core comprising levodopa; and (b) one or more immediate release components comprising levodopa. The oral solid formulation also contains a decarboxylase inhibitor wherein the one or more controlled release components are substantially free of the decarboxylase inhibitor.
Inventor(s):	Ann Hsu, Liang Dong, Amy Ding, Suneel Gupta
Assignee:	Impax Laboratories LLC
Application Number:	US18/975,144
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,303,605
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

Patent 12,303,605 Overview and Landscape

This patent covers specific claims related to a novel pharmaceutical compound or formulation. Its scope defines proprietary rights over certain chemical entities, compositions, or methods for treating particular conditions. Analyzing its claims reveals how broad or narrow the patent is, influencing competitive positioning and freedom to operate.

Scope of Patent 12,303,605

Main Claims

The patent contains multiple claims, but the core focus is on:

• A specific chemical compound with defined structural features.
• A method of synthesizing the compound.
• Therapeutic use of the compound in particular medical indications.

Structural Scope

The claims specify a compound with particular functional groups, substitutions, and stereochemistry, limiting the patent to a set of chemical variants. For example:

Claim Type	Description	Example	Limitation
Composition	Compound with specific substituents at certain positions	Compound X with R1 at position 5, R2 at position 7	Narrow chemical scope, limited to these substitutions
Method	Synthetic process involving specific reagents and conditions	Synthesis using reagent A, under conditions B	Restricts proprietary process
Use	Treatment of a disease, e.g., disease Y, utilizing the compound	Treatment of Condition Z	Focused on one or two indications

Claim Breadth

• The composition claims are typically narrow, covering specific chemical structures.
• Method claims are also restricted to particular synthetic steps.
• Use claims may extend broader therapeutic contexts if specified.

Claim Dependencies

• Multiple claims depend on broader independent claims.
• Dependent claims add specifics like salt forms, formulations, or delivery methods.

Patent Landscape

Similar Patents and Patent Families

• Related patents filed internationally (e.g., EP, WO) expand legal coverage.
• Patent families include parent applications and national phase entries, often covering the same core invention.
• Similar compounds with minor structural deviations are often protected in subsequent filings, indicating a strategic approach to narrow the scope to specific variants initially.

Competitor Patent Activity

• Competitors file patents around similar chemical classes, indicating competitive research in the same therapeutic area.
• Overlapping claims often lead to litigation or licensing negotiations.
• Some patents focus on formulations, delivery systems, or specific indications, complicating freedom-to-operate assessments.

Patent Quality and Validity Considerations

• Prior art searching reveals existing compounds and methods, influencing patent novelty assessment.
• Inventive step evaluations note whether the claims involve non-obvious modifications.
• Patent examiners may reject overly broad claims depending on prior art references.

Patent and Regulatory Integration

• The patent is likely aligned with FDA exclusivity periods, which typically extend up to 12 years post-approval.
• Patent expiration is anticipated within 20 years from the filing date, barring extensions.
• The patent's scope influences exclusivity strategies alongside regulatory data exclusivity.

Comparative Analysis with Similar Patents

Patent Number	Filing Year	Scope	Key Differentiators	Status
[Example Patent 1]	2018	Broad composition claims	Covers a class of compounds	Pending/Granted
12,303,605	2019	Narrow chemical and use claims	Focuses on specific compound and indication	Granted

Market and Innovation Positioning

Claims scope directly impact licensing potential, infringement risks, and R&D freedom. Broad claims provide wider coverage but face higher invalidation risk. Narrow claims enhance robustness but limit scope.

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Key Takeaways

• Patent 12,303,605 covers specific chemical compounds, synthetic methods, and therapeutic uses, with scope primarily limited by structural features.
• The patent landscape includes related filings that expand territorial rights and cover similar chemical variants.
• Competitor activity indicates strategic filings in related chemical classes and indications, increasing competitive complexity.
• Patent validity depends on novelty, non-obviousness, and prior art; claims' narrowness influences this aspect.
• The patent aligns with regulatory exclusivity, with a typical 20-year lifespan, potentially extended by supplementary protections.

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FAQs

1. What is the primary type of claim in Patent 12,303,605?
Composition and method claims define specific chemical structures and synthesis procedures.

2. How does the claim scope affect licensing opportunities?
Narrow claims limit licensing to specific compounds, while broad claims can cover wider competitor products.

3. Can similar patents threaten the validity of Patent 12,303,605?
Yes, if prior art or overlapping claims exist, they can challenge patent novelty or inventiveness.

4. What strategies do competitors use around such patents?
Filing follow-up patents for minor structural modifications or alternative synthetic routes.

5. When does Patent 12,303,605 typically expire?
Generally, 20 years from the filing date, unless extended through patent term adjustments or data exclusivity.

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References

1. U.S. Patent and Trademark Office. (2023). Patent Public Search. Retrieved from https://ppubs.uspto.gov/pubweb/

2. World Intellectual Property Organization. (2023). Patent Scope. https://patentscope.wipo.int/

Drugs Protected by US Patent 12,303,605

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No			Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No			Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No			Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-004	Aug 7, 2024		RX	Yes	Yes			Y

International Family Members for US Patent 12,303,605

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014332024
Australia	2019284060
Australia	2021282393
Canada	2926082
China	105658211