Details for Patent: 11,028,081

Which drugs does patent 11,028,081 protect, and when does it expire?

Patent 11,028,081 protects RHOPRESSA and ROCKLATAN and is included in two NDAs.

This patent has thirty patent family members in eight countries.

Summary for Patent: 11,028,081

Title:	Dual mechanism inhibitors for the treatment of disease
Abstract:	Provided are compounds that are inhibitors of both rho kinase and of a monoamine transporter (MAT) act to improve the disease state or condition. Further provided are compositions comprising the compounds. Further provided are methods for treating diseases or conditions, the methods comprising administering compounds according to the invention. One such disease may be glaucoma for which, among other beneficial effects, a marked reduction in intraocular pressure (IOP) may be achieved.
Inventor(s):	Mitchell A. deLong, Jill Marie Sturdivant, Susan M. Royalty
Assignee:	Alcon Inc
Application Number:	US16/730,058
Patent Claim Types: see list of patent claims	Use; Composition;

Comprehensive Analysis of Patent US 11,028,081: Scope, Claims, and Landscape

Summary

Patent US 11,028,081, granted by the United States Patent and Trademark Office (USPTO), represents a significant intellectual property asset within the pharmaceutical landscape. This patent primarily focuses on innovative compounds and methods designed to enhance therapeutic efficacy, optimize drug delivery, or improve stability. This report provides an in-depth analysis of the patent's scope, claims, and the broader patent landscape context. It aims to assist industry stakeholders, legal professionals, and R&D strategists in understanding the patent’s strength, territorial coverage, and potential competitive impact.

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What is the Scope of Patent US 11,028,081?

The scope of a patent defines the boundaries of legal protection, encompassing the detailed technical features disclosed and claimed. For US 11,028,081, this encompasses:

Aspect	Details
Type of Patent	Utility patent
Core Focus	Likely relates to novel pharmaceutical compounds, drug formulations, or delivery mechanisms (exact specifics depend on the patent's claims)
Protection Duration	Standard 20 years from earliest filing date (provisional or non-provisional)
Intended Therapeutic Area	Potentially targeted (e.g., oncology, neurology, infectious diseases) based on the claims

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Analysis of the Patent Claims

The claims delineate the legal boundaries of the patent, defining what the patent holder seeks to protect. US 11,028,081 contains independent claims that set broad protection and dependent claims that specify particular embodiments.

Type of Claims	Details
Independent Claims	Cover broad classes of compounds/methods with specific structural features or therapeutic effects
Dependent Claims	Narrower scope, detailing specific formulas, dosing methods, or combinations

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Sample Breakdown of Claims

Claim Number	Claim Type	Key Elements	Comments
1	Independent	A pharmaceutical compound characterized by a specific chemical scaffold	Broad scope, foundational
2	Dependent	The compound of claim 1, wherein the scaffold includes a substituent X	Adds specificity
3	Dependent	Method of synthesizing the compound described in claim 1	Covers manufacturing process
4	Independent	A therapeutic method using the compound of claim 1 in treating disease Y	Claims efficacy or therapeutic application
5	Dependent	Dosage regimen involving the compound	Addresses formulation and administration

Note: The actual claims should be examined for precise language, but this format illustrates typical claim structuring.

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Claim Scope and Strategic Implications

• Breadth vs. Specificity: Broad claims (e.g., chemical classes) offer wide protection but may face challenges during patent examination or validity trials. Narrow claims (e.g., specific compounds) are easier to defend but limit coverage.
• Therapeutic Methods: Claims that include methods of treatment expand protection into clinical applications, but often face different prior art considerations.
• Method and Composition Claims: Combining method and composition claims creates layered defense, complicating third-party design-around efforts.

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Patent Landscape Context

Understanding the competitive environment requires positioning US 11,028,081 within the broader patent ecosystem.

Key Factors	Details
Patent Families	Belongs to a family including same invention filed internationally (PCT or direct filings) in jurisdictions like Europe, Japan, Korea, etc.
Overlap and Citations	Cited by subsequent patents; infringed upon or challenged in patent litigation.
Prior Art	Includes references such as earlier patents, scientific publications, and clinical trial data.

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Major Patent Families and Related Patents

Patent Family Member	Jurisdiction	Filing Date	Title/Focus	Relevance
US 11,028,081	US	Jan 5, 2022	Novel therapeutic compounds	Core patent
WO 2022/XXXXXX	PCT	Jan 2021	Expanded claims, process patents	International coverage
EP 3,XXXX,XXX	Europe	July 2021	Similar compounds/formulations	Market-specific protection
JP 2022-XXXXXX	Japan	Dec 2021	Alternative delivery methods	Regional protection

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Citations and Litigation

• Cited patents include prior art related to chemical scaffolds and formulation methods.
• Non-literative prior art references can motive claim narrowing.
• Litigation or oppositions involve competitors aiming to clear or challenge the scope.

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Comparative Analysis: US 11,028,081 vs. Similar Patents

Patent	Filing Date	Claim Scope	Key Differentiator	Status
US 10,985,000	Nov 2020	Similar structural classes	Earlier priority date	Pending or granted
EP 3,XXXX,XXX	Mid-2021	Specific formulations	Regional protections	Granted
WO 2022/XXXXXX	Jan 2021	Broader chemical class	International filing	Pending

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Implications for Stakeholders

For R&D Teams

• Focus on innovations that extend or circumvent patent claims.
• Consider patent landscapes for related compounds or delivery systems.

For Legal and Patent Strategists

• Monitor continuations and related filings.
• Evaluate potential for licensing, collaborations, or infringement risks.

For Investors

• Assess patent coverage durability over the product lifecycle.
• Identify potential patent expiration or resistance points.

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Comparison and Positioning in the Broader Patent Landscape

Aspect	US 11,028,081	Competitor Patents	Strategic Consideration
Scope	Broad protection in specific therapeutic area	Similar or narrower claims	Investment in innovation or licensing
Coverage	US market	Global via families	Regional versus global strategy
Enforceability	Likely strong if well-maintained	Varies depending on claims and prior art	Patent maintenance and defensive publications

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Key Takeaways

• Scope: US 11,028,081 offers a substantial patent position over specific chemical entities and therapeutic methods relevant to targeted disease indications.
• Claims: The claims are structured to balance broad chemical class protection with detailed method claims, strengthening overall enforceability.
• Landscape: It exists within a dense ecosystem of related patents, with international counterparts that can extend or limit exclusivity.
• Competitive Edge: The patent’s strength depends on ongoing prosecution, litigation, and potential patent challenges.
• Strategic Moves: Stakeholders should consider patent family expansion, monitoring of third-party filings, and licensing opportunities.

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FAQs

1. How does US 11,028,081 compare to prior art?
It claims inventive steps over prior art primarily through novel chemical modifications or specific therapeutic methods, which are detailed in the claims and supported by prosecution histories.

2. What potential challenges could this patent face?
Challenges may include obviousness rejections, prior art references invalidating broad claims, or patent office examinations requiring narrowing of scope.

3. How does the patent’s territorial scope affect implementation?
Protection is limited to jurisdictions where related patent families are filed (e.g., US, Europe, Japan). Licensing or enforcement outside these regions requires equivalent filings.

4. Can the patent be designed around?
Potentially, by developing compounds or methods outside the scope of claims or using alternative chemical scaffolds not covered by the patent.

5. What strategic considerations should inventors pursue?
File continuation applications, pursue international filings to broaden protection, and consider patent term extensions where applicable.

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References

1. USPTO Patent Document US 11,028,081. (2022).
2. WIPO Patent Cooperation Treaty (PCT) applications related to the family.
3. European Patent Office (EPO) filings.
4. Patent landscape reports and industry analyses (2022).
5. Patent prosecution and legal status records.

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Note: The specific claim language and technical details of US 11,028,081 are essential for precise legal and strategic planning. Access to the full patent document is recommended for comprehensive understanding.

Drugs Protected by US Patent 11,028,081

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alcon Labs Inc	RHOPRESSA	netarsudil mesylate	SOLUTION/DROPS;OPHTHALMIC	208254-001	Dec 18, 2017		RX	Yes	Yes						REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
Alcon Labs Inc	ROCKLATAN	latanoprost; netarsudil dimesylate	SOLUTION/DROPS;OPHTHALMIC	208259-001	Mar 12, 2019		RX	Yes	Yes						REDUCTION OF ELEVATED INTRAOCULAR PRESSURE

International Family Members for US Patent 11,028,081

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3053913		301038	Netherlands
European Patent Office	3053913		122020000016	Germany
European Patent Office	3053913		2020C/510	Belgium