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Last Updated: December 23, 2024

Details for Patent: 11,040,107

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Which drugs does patent 11,040,107 protect, and when does it expire?

Patent 11,040,107 protects EMPAVELI and is included in one NDA.

This patent has thirteen patent family members in eleven countries.

Summary for Patent: 11,040,107

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):	Grossi; Federico (Newton, MA), Deschatelets; Pascal (Lexington, MA), Francois; Cedric (Prospect, KY), Johnson; Patrick (Zurich, CH), Vega; Carolina (Berkeley, CA)
Assignee:	Apellis Pharmaceuticals, Inc. (Waltham, MA)
Application Number:	16/500,994
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Delivery; Device;
Patent landscape, scope, and claims:	United States Patent 11,040,107: A Detailed Analysis of Scope, Claims, and Patent Landscape Introduction The United States Patent 11,040,107, titled "Dosing regimens and related compositions and methods," is a significant patent issued to Apellis Pharmaceuticals, Inc. This patent is part of a broader portfolio of intellectual property related to compstatin analogs and their applications. Here, we will delve into the scope, claims, and the surrounding patent landscape of this invention. Inventors and Assignee The patent was invented by Federico Grossi, Pascal Deschatelets, Cedric Francois, Patrick Johnson, and Carolina Vega, and it is assigned to Apellis Pharmaceuticals, Inc., based in Waltham, Massachusetts[2][4]. Patent Issuance and Expiration The patent was issued on June 22, 2021, and is set to expire on November 15, 2033[2][4]. Scope of the Patent Cell-Reactive Compstatin Analogs The patent focuses on cell-reactive compstatin analogs, which are designed to interact with specific cells or cellular components. These analogs are part of a broader class of compounds known as compstatins, which have been researched for their therapeutic potential, particularly in treating conditions related to complement system dysregulation[4]. Dosing Regimens and Compositions The invention includes various dosing regimens and compositions that incorporate these cell-reactive compstatin analogs. These regimens are tailored to optimize the therapeutic efficacy and safety of the treatments. The compositions may include different formulations, such as injectables, oral forms, or topical applications, each designed to target specific diseases or conditions[4]. Claims of the Patent Independent Claims The patent includes several independent claims that define the scope of the invention. These claims cover: Specific chemical structures of the compstatin analogs. Methods of preparing these analogs. Dosing regimens for administering the analogs. Compositions containing the analogs, including pharmaceutical formulations[4]. Dependent Claims Dependent claims further specify and narrow down the scope of the independent claims. These may include specific moieties, functional groups, or other structural elements of the compstatin analogs, as well as detailed methods of administration and treatment protocols[4]. Patent Landscape Related Patents Apellis Pharmaceuticals holds a series of patents related to compstatin analogs, each contributing to a comprehensive intellectual property portfolio: Patent 10,035,822: Covers cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods. Patent 10,125,171: Focuses on cell-reactive, long-acting, or targeted compstatin analogs and their uses. Patent 11,661,441 and Patent 11,844,841: These patents also pertain to various aspects of compstatin analogs and their applications, with different expiration dates[2]. Competing Patents Other entities, such as The Trustees of the University of Pennsylvania, also hold patents related to compstatin analogs, such as Patent 9,169,307, which covers potent compstatin analogs. This indicates a competitive landscape in the research and development of these therapeutic agents[2]. Legal and Regulatory Context Patent Law Evolution The patent landscape is influenced by ongoing changes in patent law, particularly the shift from a "first to invent" to a "first inventor to file" system, aimed at harmonizing U.S. patent laws with international standards[3]. Litigation and Enforcement The enforcement of patent rights is a critical aspect of protecting intellectual property. The increased activity of the Supreme Court in patent cases, as well as the establishment of the Patent Cases Pilot Program (PCPP) in various districts, reflects the complexity and importance of patent litigation[3]. Industrial and Therapeutic Implications Therapeutic Applications Compstatin analogs have potential therapeutic applications in treating diseases related to the complement system, such as age-related macular degeneration, paroxysmal nocturnal hemoglobinuria, and other inflammatory conditions. The dosing regimens and compositions outlined in this patent are crucial for optimizing the efficacy and safety of these treatments[4]. Market Impact The issuance of this patent and others in the same series positions Apellis Pharmaceuticals as a key player in the development of compstatin analogs. This can influence market dynamics, particularly in the biopharmaceutical sector, by providing a competitive edge and protecting significant investments in research and development. Key Takeaways United States Patent 11,040,107 covers dosing regimens and related compositions and methods for cell-reactive compstatin analogs. The patent is part of a broader portfolio held by Apellis Pharmaceuticals, Inc. The scope includes specific chemical structures, methods of preparation, dosing regimens, and pharmaceutical compositions. The patent landscape is competitive, with other entities holding related patents. The legal and regulatory context is evolving, with changes in patent law and increased judicial activity in patent cases. FAQs What is the main focus of United States Patent 11,040,107? The main focus is on dosing regimens and related compositions and methods for cell-reactive compstatin analogs. Who are the inventors of this patent? The inventors are Federico Grossi, Pascal Deschatelets, Cedric Francois, Patrick Johnson, and Carolina Vega. When does the patent expire? The patent is set to expire on November 15, 2033. What are the potential therapeutic applications of compstatin analogs? Compstatin analogs have potential therapeutic applications in treating diseases related to the complement system, such as age-related macular degeneration and paroxysmal nocturnal hemoglobinuria. How does this patent fit into the broader patent landscape? This patent is part of a comprehensive intellectual property portfolio held by Apellis Pharmaceuticals, Inc., and it competes with other patents held by different entities in the field of compstatin analogs. Cited Sources: United States Patent and Trademark Office - US11040107B2. Drugs.com - Generic Empaveli Availability. Touro Law Review - Mastering Patent Claim Construction. Google Patents - US11040107B2 - Dosing regimens and related compositions and methods. More… ↓ ⤷ Subscribe

Drugs Protected by US Patent 11,040,107

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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	11,040,107	⤷ Subscribe	Y			TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN	⤷ Subscribe
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes	11,040,107	⤷ Subscribe	Y			TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS	⤷ Subscribe
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes	11,040,107	⤷ Subscribe	Y			TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Foreign Priority and PCT Information for Patent: 11,040,107

PCT Information
PCT Filed	April 09, 2018	PCT Application Number:	PCT/US2018/026753
PCT Publication Date:	October 11, 2018	PCT Publication Number:	WO2018/187813

International Family Members for US Patent 11,040,107

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018249627	⤷ Subscribe
Brazil	112019020955	⤷ Subscribe
Canada	3059304	⤷ Subscribe
China	110831544	⤷ Subscribe
China	116059313	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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