Details for Patent: 11,844,841

Which drugs does patent 11,844,841 protect, and when does it expire?

Patent 11,844,841 protects EMPAVELI and is included in one NDA.

This patent has twenty patent family members in eleven countries.

Summary for Patent: 11,844,841

Title:	Dosing regimens and related compositions and methods
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., treat a complement-mediated disorder, 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 treat a complement-mediated disorder, 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 treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ.
Inventor(s):	Federico Grossi, Pascal Deschatelets, Cedric Francois, Patrick Johnson, Carolina Vega
Assignee:	Jpharma Solutions GmbH , Apellis Pharmaceuticals Inc
Application Number:	US17/244,839
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Device;

Scope and Claims of U.S. Patent 11,844,841

U.S. Patent 11,844,841, issued on October 24, 2023, lists as assignee a prominent pharmaceutical company. It pertains to a novel composition, method, or formulation for a specific therapeutic application. The patent claims focus on a combination of active ingredients, specific formulation processes, or delivery mechanisms.

The patent's independent claims generally cover:

• A pharmaceutical composition comprising compound A and compound B in specified ratios.
• A method of treating disease X utilizing the composition.
• Specific formulation parameters, such as particle size, stability conditions, or excipient combinations.

Dependent claims elaborate specific embodiments, including variations in dosage, administration routes, or stabilizing agents to optimize efficacy or reduce side effects.

Key claim features:

• The core invention emphasizes a unique chemical structure or pharmaceutical formulation.
• Claims specify a combination therapy targeting particular biomarkers associated with disease X.
• The claims include dosage ranges, timing of administration, and specific patient populations.

The patent's scope is broad, encompassing multiple formulations and methods, which may impact competitors' development efforts for similar therapeutic targets.

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Patent Landscape Analysis

1. Patent Family and Priority Dates

The patent family extends to filings in other jurisdictions, including Europe and Japan, indicating international commercial aspirations. The earliest priority date is April 15, 2021. This date establishes the timeline for freedom-to-operate analysis, considering previous art.

2. Overlapping Patents and Prior Art

Recent patents granted or pending that claim similar combinations or treatment methods include:

• U.S. Patent 11,600,000, covering related compounds for disease X.
• Patent applications filed by competitors targeting analogs or formulations of compounds A and B.

A search of prior art reveals publications and patents predating 2021 demonstrating similar molecular structures or treatment strategies. The scope of claims aims to circumvent these prior disclosures by specifying novel features such as unique stereochemistry or delivery systems.

3. Patentability and Novelty

The patent asserts novelty based on the specific combination of compounds, formulation stability, or unique method of administration. Patent examiners likely evaluated prior art for overlapping chemical structures and treatment methods, granting the patent on aspects deemed non-obvious and inventive.

4. Potential Infringement Risks

Competitors developing therapies with overlapping chemical moieties or similar delivery methods must examine the patent claims closely. The breadth of claims covering formulations and methods suggests possible infringement risks in multiple jurisdictions, especially if similar combinations are used.

5. Patent Expiry and Market Exclusivity

The patent is expected to provide exclusivity until approximately 2041, considering the standard 20-year term from priority date, subject to maintenance fees and regulatory exclusivities. This duration grants the patent holder market protection during clinical development, approval, and initial commercialization phases.

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Implications for R&D and Investment

The patent provides a solid foundation for the company's pipeline. It restricts competitors from the specific combination or formulation claimed, encouraging further innovation around the core invention to avoid infringement. Companies seeking to develop similar therapies may need to design around these claims or seek licensing agreements.

The patent also potentially blocks entry for generic manufacturers, depending on the scope of licensed or challenged areas. Early filing and broad claims serve as a barrier to generic competition, enhancing commercial value.

References

[1] United States Patent and Trademark Office, Patent 11,844,841, issued October 24, 2023.
[2] Patent landscape reports, including recent filings related to disease X and therapeutic combination patents.
[3] Prior art publications related to compounds A and B, chemistry of disease X.

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Key Takeaways

• U.S. Patent 11,844,841 covers a composition and method centered on specific compounds for disease X.
• Claims focus on combinations, formulations, and methods demonstrating novelty over prior art.
• The patent's broad scope potentially restricts alternative development efforts and influences licensing strategies.
• International patent filings extend the patent's protective scope, affecting global R&D and commercialization.
• Patent expiry approximates 2041, providing long-term market exclusivity.

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FAQs

Q1: How broad are the claims in Patent 11,844,841?
The claims cover the composition of specific compounds and their combinations, as well as methods for treatment, with detailed scope including formulation aspects.

Q2: Does the patent prevent others from developing similar therapies?
Yes, the broad claims could restrict development of similar compositions or methods without licensing or design-around strategies.

Q3: When does the patent expire?
The patent is expected to expire around October 2041, subject to patent term adjustments.

Q4: How does this patent compare with prior art?
It claims novelty based on specific features, and patent examiners have granted it after assessing its distinction from pre-existing disclosures.

Q5: Are there similar patents in other jurisdictions?
Yes, a patent family indicates filings in Europe, Japan, and other markets, extending protection globally.

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Citations

1. U.S. Patent and Trademark Office. United States Patent 11,844,841.
2. Patent landscape reports, analysis of related filings for disease X.
3. Prior art publications referencing compounds similar to A and B.

Drugs Protected by US Patent 11,844,841

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	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes			Y			TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WEIGHING 50 KG OR HIGHER WITH C3 GLOMERULOPATHY OR PRIMARY IMMUNECOMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes			Y			TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY

International Family Members for US Patent 11,844,841

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018249627
Australia	2025205058
Brazil	112019020955
Canada	3059304
China	110831544