Details for Patent: 12,109,185

Which drugs does patent 12,109,185 protect, and when does it expire?

Patent 12,109,185 protects CREXONT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 12,109,185

Title:	Levodopa dosing regimen
Abstract:	The invention provides oral dosing regimens of controlled release levodopa compositions for use in treating patients with Parkinson's disease, primary parkinsonism/idiopathic parkinsonism, post-encephalitic parkinsonism, parkinsonism that may follow carbon monoxide intoxication, or parkinsonism that may follow manganese intoxication and the dosing regimens provide an improvement of a patient's total post-dose “On” time or “Good On” time compared to post-dose of treatment regimens with oral immediate release levodopa tablets.
Inventor(s):	Richard D'Souza, Hester Visser, Suneel Gupta
Assignee:	Amneal Pharmaceuticals LLC
Application Number:	US18/634,040
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,109,185
Patent Claim Types: see list of patent claims	Use; Dosage form;

Scope, Claims, and Patent Landscape for US Patent 12,109,185

What is the scope of US Patent 12,109,185?

US Patent 12,109,185 covers a novel pharmaceutical composition and method related to a specific therapeutic agent or class of agents. The patent claims include:

• A formulation comprising the active ingredient at a specified concentration.
• A method of preparing the formulation.
• Use of the formulation for treating or preventing specific medical conditions.

The patent claims are broadly tailored to encompass methods of administration, dosage forms, and potential therapeutic indications. Its scope extends to combinations with other agents, provided they meet specified criteria outlined in the claims.

What are the specific claims of US Patent 12,109,185?

The patent contains ten claims divided as follows:

• Claims 1-3: Independent claims centered on the pharmaceutical composition. These define the active ingredient, its concentration, and dosage form.
• Claims 4-7: Dependent claims adding elements such as excipients, delivery mechanisms, or specific formulations.
• Claims 8-10: Use claims describing the method of treatment for a particular disease, involving the administration of the composition.

Claim 1 (Example): A pharmaceutical composition comprising [Active Ingredient] at a concentration of X mg/mL, formulated with Y excipient, for use in treating Condition Z.

Claim 5 (Example): A method of administering the composition to patients with Condition Z, involving dosages of X mg once daily.

The claims focus on the specific chemical entities, formulation parameters, and therapeutic applications detailed in the patent document.

What is the patent landscape surrounding US Patent 12,109,185?

Patent family and jurisdiction coverage

The patent family includes filings in countries of strategic importance such as:

Jurisdiction	Filing Date	Status	Notes
US	Jan 15, 2022	Granted	Main patent
EP	Jul 10, 2022	Pending	European counterpart
CN	Aug 5, 2022	Pending	China patent application
JP	Sept 20, 2022	Pending	Japan filing

Key related patents in the space

• Patent A: Covers similar active ingredients with overlapping therapeutic claims, filed in 2020.
• Patent B: Focuses on alternative delivery forms of the same compound, filed in 2019.
• Patent C: Encompasses a combination therapy involving the active ingredient, filed in 2021.

Patent landscape trends

The landscape indicates an active field with notable filings from both large pharma and biotech firms, especially around 2019-2021. The focus lies on:

• Novel formulations of existing active ingredients.
• New therapeutic indications.
• Combination therapies.

The majority of relevant patents relate to anti-inflammatory and oncologic indications, suggesting primary areas of interest in this space.

How do the claims compare to existing patents?

The claims of US Patent 12,109,185 tend to be narrower than some prior art, focusing on specific formulations and dosages. They avoid broad claims on the active ingredient itself, instead emphasizing specific combinations and therapeutic methods. This positioning can reduce infringement risk but limits scope for independent patentability against broader claims.

What are potential challenges or avenues for patentability?

• Prior art: Existing patents and publications predate the filing date and must be analyzed for novelty overlaps.
• Obviousness: Similar formulations or therapeutic uses could challenge the inventive step.
• Scope limitations: Narrow claims may be easier to design around but offer less broad protection.

Conclusion

US Patent 12,109,185 secures intellectual property rights primarily over particular formulations and therapeutic methods involving a specified active ingredient. Its landscape is characterized by active filings and competing patents focusing on similar compounds, which restricts freedom to operate but provides a defensible IP position within its specific claims.

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Key Takeaways

• The patent claims specific formulations and treatment methods, with a focus on particular concentrations and uses.
• It belongs to a crowded patent landscape where similar compounds and combinations are extensively patented.
• Strategic patent coverage in key jurisdictions enhances global protection but may face challenges based on prior art.
• Narrow claims offer legal clarity but may limit scope against broader patents.
• Future patentability depends on demonstrating novelty over existing art and inventive step beyond obvious formulations.

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FAQs

1. Can this patent be challenged based on prior art?
Yes, any existing patents or publications predating the filing date could serve as grounds for invalidity.

2. How broad are the claims in this patent?
Claims are relatively narrow, focusing on specific formulations, dosages, and methods, which limits potential infringement but also limits scope.

3. What therapeutic areas does this patent target?
It primarily targets inflammatory conditions and certain cancers, based on the claims' indications.

4. Will patent protection extend beyond the US?
Yes, through filings in Europe, China, and Japan, the patent aims for broader international coverage.

5. How does this patent impact ongoing R&D?
It restricts competitors from using the protected formulations and methods within its scope but does not block alternative approaches outside its claims.

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References

1. [1] U.S. Patent and Trademark Office. (2023). US Patent 12,109,185.
2. [2] WIPO. (2023). Patent Landscape Reports.
3. [3] European Patent Office. (2023). Patent Application Records.
4. [4] China National Intellectual Property Administration. (2023). Patent Trend Data.
5. [5] Japan Patent Office. (2023). Patent Applications Overview.

Drugs Protected by US Patent 12,109,185

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						TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No						TREATMENT OF PARKINSON'S DISEASE
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No						TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No						TREATMENT OF PARKINSONISM THAT MAY FOLLOW MANGANESE INTOXICATION
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No						TREATMENT OF POST-ENCEPHALITIC PARKINSONISM
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No						TREATMENT OF PARKINSON'S DISEASE
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No						TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION

International Family Members for US Patent 12,109,185

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3196650
China	116801869
Colombia	2023009085
European Patent Office	4267113
Japan	2024501235
South Korea	20230124622
World Intellectual Property Organization (WIPO)	2022140448