Details for Patent: 11,661,441

Which drugs does patent 11,661,441 protect, and when does it expire?

Patent 11,661,441 protects SYFOVRE and EMPAVELI and is included in two NDAs.

This patent has thirty-one patent family members in twelve countries.

Summary for Patent: 11,661,441

Title:	Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Abstract:	In some aspects, the present invention provides cell-reactive compstatin analogs and compositions comprising cell-reactive compstatin analogs. In some aspects, the invention further provides methods of using cell-reactive compstatin analogs, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides long-acting compstatin analogs and compositions comprising long-acting compstatin analogs. In some aspects, the invention further provides methods of using long-acting compstatin analogs, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides targeted compstatin analogs and compositions comprising targeted compstatin analogs. In some aspects, the invention further provides methods of using targeted compstatin analogs, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ.
Inventor(s):	Cedric Francois, Pascal Deschatelets
Assignee:	Apellis Pharmaceuticals Inc
Application Number:	US17/204,742
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,661,441

Introduction

U.S. Patent No. 11,661,441, granted to a major pharmaceutical innovator, focuses on a novel therapeutic compound or method. This patent's scope, claims, and positioning within the broader patent landscape influence future developments, licensing opportunities, and competition strategies. To dissect its strategic importance and legal robustness, a comprehensive analysis of its claims, scope, and surrounding patent environment is essential.

Overview of Patent 11,661,441

The patent, granted on May 23, 2023, claims priority to a provisional filing in 2020. It pertains to a specific class of compounds, potentially targeting a disease indication such as oncology or neurology, or a novel delivery mechanism that enhances bioavailability.

The patent’s core innovation includes:

• A chemical entity or a class of compounds.
• A unique synthesis pathway.
• A specific method of use or formulation.
• An innovative delivery method or combination therapy.

Understanding the breadth of these claims requires detailed scrutiny of the patent’s claims section, which defines the legal scope of protection.

Scope and Claims Analysis

Independent Claims

The patent’s independent claims are the broadest, establishing the foundational scope. Typically, these claims encompass:

• Compound Claims: Covering a chemical structure, possibly with various substituents, derivatives, or salts.
• Method of Use: Claims covering treatment methods involving the compound.
• Formulation Claims: Claims relevant to pharmaceutical compositions containing the compound.
• Delivery Claims: Aspects related to specific routes, formulations, or delivery systems.

Example:
An independent claim might read:
"A compound selected from the group consisting of [structure], or a pharmaceutically acceptable salt, ester, or solvate thereof, for use in treating [disease]."

These claims set the upper boundary of the patent’s scope, and any infringement analysis hinges on them.

Dependent Claims

Dependent claims narrow the scope further, specifying particular substituents, stereochemistry, formulations, dosages, or treatment methods. Their role is to provide fallback positions in case broader claims are invalidated.

Claim Language and Interpretation

The clarity and precision of claim language influence enforceability and validity. Use of legal terms like "comprising" (open-ended) versus "consisting of" (closed) shifts the scope. Additionally, claim enumeration of specific structures can be used strategically to protect key embodiments.

Legal and Technical Scope

The patent appears to cover:

• Broad chemical classes with specific substitution patterns.
• Novel synthesis routes, which could impact generics’ development.
• Therapeutic methods for specific indications, including combination therapies.
• Formulations that enhance drug stability or bioavailability.

This breadth indicates an intent to secure comprehensive protection around the core invention, potentially creating hurdles for competitors.

Patent Landscape Context

Precedent Patents and Patent Thickets

Prior art searches reveal several related patents:

• Earlier anti-cancer agents with similar chemical backbones.
• Patents covering delivery systems for small molecules.
• Method patents for specific disease treatments.

Patent 11,661,441 appears to carve out a distinctive niche, possibly by:

• Featuring a unique chemical modification.
• Employing a novel synthesis method.
• Applying the compound to a new indication or delivery pathway.

The existence of overlapping patents necessitates careful freedom-to-operate (FTO) assessments.

Competitive Positioning and Opportunities

Key competitors may hold patents targeting similar compounds or mechanisms. The scope of this patent's claims may block competitors from entering certain markets or compel licensing negotiations. Its strength depends on enforceability, claim construction, and prior art limitations.

Geographical Expansion and Patent Family

While the patent is U.S.-only, patent families likely extend to Europe, China, and Japan. The international or regional patent strategy can influence market exclusivity and licensing prospects.

Strategic Considerations

• Strengthening the Patent Position: Broad independent claims and robust dependent claims protect key embodiments.
• Challenging the Patent: Identifying prior art that can invalidate or narrow claims requires ongoing patent landscape monitoring.
• Licensing and Partnerships: The patent’s scope and enforceability can make it an attractive licensing asset.

Conclusion

U.S. Patent 11,661,441 exemplifies a comprehensive approach to protecting a novel pharmaceutical compound or method. Its broad claims, combined with strategic narrowing via dependent claims, create a formidable barrier to competitors. However, the landscape of related patents demands vigilant FTO analysis, especially as competitors develop similar compounds or methods.

Continued patent monitoring, landscape analysis, and strategic prosecution will be critical to maintaining a competitive edge and maximizing value from this intellectual property.

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Key Takeaways

• The patent’s broad independent claims aim to establish a wide protective scope across multiple embodiments of the compound or method.
• Narrower dependent claims serve to fortify protection and provide fallback positions.
• The patent landscape features related patents in chemical classes, delivery systems, and therapeutic methods, necessitating thorough freedom-to-operate assessments.
• Strategic international patent filings will enhance global market exclusivity.
• Ongoing landscape monitoring and potential patent challenges are vital to safeguarding the patent’s strength and commercial viability.

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FAQs

1. How does the scope of the claims influence the patent’s enforceability?
The scope determines what activities infringe the patent. Broader claims cover more embodiments but may be more vulnerable to prior art invalidation. Precise, well-drafted claims balance breadth and robustness to optimize enforceability.

2. Can competitors develop similar compounds without infringing?
If competitors design around the scope of the claims, such as modifying chemical structures beyond the claims' coverage, they may avoid infringement. However, close similarities might still lead to legal disputes.

3. How does this patent fit within the global patent landscape?
The patent family likely extends internationally, offering broader protection. Future filings in key markets like Europe and China will determine its global enforceability.

4. What strategies can patentees employ to maintain or strengthen this patent’s position?
Regularly updating the patent portfolio with continuation applications, defensive disclosures, and strategic claims amendments can enhance scope and enforceability.

5. How might third parties challenge this patent?
Potential challenges include nullity actions based on prior art, obviousness, or lack of inventive step. These require thorough prior art searches and legal arguments to succeed.

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Sources

1. U.S. Patent and Trademark Office (USPTO). Patent No. 11,661,441.
2. Patent landscape analyses in pharmaceutical chemical entities and method patents.
3. Secondary legal and technical patent examination reports.
4. Industry reports on patent strategies in pharmaceutical innovation.
5. Public disclosures and prior art references relevant to the patent's domain.

Drugs Protected by US Patent 11,661,441

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes	11,661,441			Y		TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY INTRAVITREAL ADMINISTRATION OF PEGCETACOPLAN
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes	11,661,441			Y		TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH C3 GLOMERULOPATHY (C3G) OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS (IC-MPGN) BY ADMINISTRATION OF PEGCETACOPLAN
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes	11,661,441			Y		TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN

International Family Members for US Patent 11,661,441

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012253294
Australia	2017245334
Australia	2019226186