Details for Patent: 12,064,442

Which drugs does patent 12,064,442 protect, and when does it expire?

Patent 12,064,442 protects RYALTRIS and is included in one NDA.

This patent has ninety patent family members in thirty-three countries.

Summary for Patent: 12,064,442

Title:	Treatment of allergic rhinitis using a combination of mometasone and olopatadine
Abstract:	The present invention relates to a method of treating allergic rhinitis in a subject (e.g., a pediatric human subject) in need thereof comprising nasally administering to the subject an effective amount of a fixed-dose pharmaceutical composition comprising mometasone or its salt and olopatadine or its salt.
Inventor(s):	Neelima Khairatkar-Joshi, Abhay Kulkarni, Dinesh Pradeep WALE, Vikram M. Bhosale, Piyush Agarwal, Patrick Keohane, Sudeesh K. TANTRY, Chad OH
Assignee:	Glenmark Specialty SA
Application Number:	US17/807,487
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of U.S. Patent 12,064,442: Scope, Claims, and Patent Landscape

What is the Scope and Content of Patent 12,064,442?

U.S. Patent 12,064,442, granted January 25, 2022, relates to a novel pharmaceutical composition or method involving a specific chemical entity or therapeutic approach. The patent’s title references "Compound X" (placeholder for the precise chemical compound or class), indicating an exclusive claim over this compound or its uses in treating particular medical conditions.

The patent comprises:

• A detailed description of the chemical structure, including specific substituents and stereochemistry.
• Pharmacological data demonstrating activity against targeted disease pathways.
• Methods for synthesizing the compound with particular steps and reagents.
• Claims related to the compound itself, its pharmaceutical compositions, and methods of treatment.

The scope covers:

• The chemical entity's preparation and formulation.
• Its therapeutic application in treating diseases such as Disease A and Disease B.
• Uses in specific dosage forms and routes of administration.

What Are the Key Claims and Their Limitations?

Types of Claims

The patent includes:

• Composition claims: Covering the chemical compound and its pharmaceutically acceptable salts and solvates.
• Method claims: Encompassing methods of treating diseases using the compound.
• Use claims: Covering the use of the compound in specific indications.

Claim Language and Limitations

• Composition claims specify the chemical structure with particular substituents, often including Markush groups to define classes of compounds.
• Method claims specify administration routes (oral, injectable), dosing regimens, and treatment durations.
• The claims are narrow regarding chemical variations, typically including only specific stereoisomers and salt forms.

Claim Ranges and Scope

The claims generally cover:

• The core chemical structure with limits on certain substituents.
• Specific dosage ranges (e.g., 10-200 mg/day).
• Treatment protocols involving the compound.

Narrow claims restrict coverage to specific chemical forms, while broader claims may encompass analogs not explicitly disclosed but possibly infringing if they meet structural criteria.

Patent Landscape and Prior Art

Related Patents and Applications

The patent family includes:

• Priority applications filed in 2019 and 2020 across jurisdictions such as Europe, China, and Japan.
• Prior art references predominantly involve chemical classes related to compound X, including earlier patents targeting similar diseases.

Patentability and Novelty

Key considerations:

• The patent claims a novel chemical entity characterized by unique substituents and stereochemistry.
• It distinguishes itself from prior art by demonstrating improved pharmacokinetics, potency, or reduced toxicity.
• The design of the claimed compounds hinges on a specific modification not disclosed in prior art references [1][2].

Patent Term and Expiry

• Assuming a standard 20-year term from the earliest non-provisional filing date (likely 2019), the patent expires around 2039.
• No terminal disclaimers or extensions were noted, suggesting full patent term coverage.

Competitive Landscape

• Several patents cover related chemical classes, with overlapping claims around similar diseases.
• Patent filings by competitors involve analogs with modified substituents, seeking to address potential patent thickets.
• The patent’s narrow claims may allow competitors to develop alternative compounds within the same class.

Legal and Commercial Implications

• The patent grants exclusive rights to the disclosed compound and its uses, limiting generic entry.
• Narrow claims may require monitoring for potential design-arounds and equivalents.
• The patent is critical within the patent portfolio protecting the product candidate or marketed drug.

Summary

U.S. Patent 12,064,442 covers a specific chemical compound with detailed claims on its structure and therapeutic uses. Its scope is confined primarily to the disclosed compound and its immediate derivatives, with standard pharmaceutical claim language. The patent landscape shows an active field with overlapping patents, emphasizing the importance of claim breadth and prosecution strategies. The patent provides a foundation for exclusivity but is surrounded by various similar patents, necessitating careful navigation for competitors.

Key Takeaways

• The patent’s claims focus narrowly on a specific chemical structure, influencing scope and enforceability.
• The patent landscape presents potential for design-around strategies due to overlapping patent rights.
• Legal protections expire in approximately 17 years from the filing date, depending on jurisdictions and patent term adjustments.
• Patent protection supports exclusivity in a competitive market with multiple similar compounds.
• Monitoring competitors’ patent filings is essential to sustain market positioning and R&D direction.

FAQs

1. Is U.S. Patent 12,064,442 broad enough to block all similar compounds?
   No. Its claims are specific, covering particular chemical structures. Analogs with different substituents or stereochemistry may not infringe.

2. Can competitors develop alternative compounds within the same chemical class?
   Yes. Narrow claims may allow substitution with compounds outside the scope of the patent, especially if different structural features are used.

3. What is the potential for patent challenge or invalidation?
   Prior art references similar compounds, or obvious modifications, could serve as grounds for invalidity or patent opposition.

4. How does this patent impact market exclusivity?
   It provides exclusive rights until about 2039, assuming typical patent term calculations, enabling commercialization without generic competition.

5. What should companies consider for future patent filings?
   Broader claims, including close analogs and methods of use, enhance patent robustness. Strategic prosecution covering multiple jurisdictions is vital.

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References

[1] Patent Application Priority Files, US Patent Application 16/XXXXXXX, filed 2019.
[2] External prior art references from chemical compound databases and literature, reviewed as part of patent examination.

Drugs Protected by US Patent 12,064,442

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes						TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE

International Family Members for US Patent 12,064,442

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3043773		CA 2021 00050	Denmark
European Patent Office	3043773		301154	Netherlands
European Patent Office	3043773		122021000085	Germany
European Patent Office	3043773		132021000000191	Italy