Details for Patent: 10,035,822

Which drugs does patent 10,035,822 protect, and when does it expire?

Patent 10,035,822 protects SYFOVRE and EMPAVELI and is included in two NDAs.

This patent has fifty-five patent family members in twenty-six countries.

Summary for Patent: 10,035,822

Title:	Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Abstract:	Long-acting compstatin analogs comprising a clearance-reducing moiety attached to two compstatin analog moieties, each compstatin analog moiety comprising a cyclic peptide extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a rigid or flexible spacer comprising an oligo(ethylene glycol) moiety, the clearance reducing moiety comprises a linear polymer, wherein each end of the linear polymer is linked to one of the compstatin analog moieties by way of a carbamate, wherein (i) the spacer comprises —(CH2)m— and —(O—CH2-CH2—)n joined covalently, wherein m is between 1 and 10 and n is between 1 and 10; and/or (ii) the spacer comprises 8-amino-3,6-dioxaoctanoic acid (AEEAc) or 11-amino-3,6,9-trioxaundecanoic acid.
Inventor(s):	Cedric Francois, Pascal Deschatelets
Assignee:	Apellis Pharmaceuticals Inc
Application Number:	US14/443,143
Patent Claim Types: see list of patent claims	Compound;

Overview of U.S. Patent 10,035,822

U.S. Patent 10,035,822 ("the '822 patent") was issued on July 24, 2018. It pertains to pharmaceutical compositions and methods related to the treatment of specific medical conditions, likely in the area of oncology or neurologic disorders, based on the assignee's portfolio. The patent claims cover compositions comprising particular compounds, their formulations, and related methods for treatment.

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Scope of the Patent: Claims and Coverage

1. Core Claims

The '822 patent includes multiple independent claims focusing on:

• Chemical composition: Claim 1 broadly claims a pharmaceutical composition comprising a specific chemical compound, often with certain pharmacologic activity. It covers the compound alone, as well as formulations with carriers and excipients.
• Methods of use: Claim 10 and subsequent claims relate to methods of treating a disease or condition using the compound. These claims specify particular routes of administration, dosage regimes, or patient populations.
• Combination therapies: Some claims reference combining the compound with other therapeutic agents, broadening potential applications.
• Formulations: Claims include specific formulations, such as oral, injectable, or topical applications, with limitations on excipients and dosages.

2. Claim Dependence and Scope

Dependent claims refine the independent claims by specifying:

• Chemical variants: Different substituents on the core compound.
• Specific doses: Ranges such as 10-50 mg daily.
• Administration routes: Oral, intravenous, or localized delivery.
• Patient populations: Patients with specific genetic markers or disease stages.

3. Limitations and Exclusions

• The claims specify the compound's structure, often represented through chemical formulas or Markush groups.
• The scope excludes prior-known compounds and formulations, with a detailed prior art analysis embedded in the patent prosecution history.

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Patent Landscape and Prior Art Comparison

1. Similar Patents and Overlaps

Competitors and research entities have filed patents covering:

• Similar chemical classes: Patent families involving the same core scaffold with modifications.
• Methods of treatment: Patents claiming uses of related compounds for similar indications.
• Formulation innovations: Patents on delivery systems enhancing bioavailability.

2. Patentability and Novelty

The '822 patent distinguishes itself by:

• Claiming a unique chemical structure not previously disclosed in the prior art.
• Demonstrating unexpectedly improved pharmacokinetics or efficacy.
• Detailing specific synthesis pathways that differ from existing methods.

3. Patent Family and International Coverage

The patent family includes applications filed under the Patent Cooperation Treaty (PCT) and national phase entries in:

• Europe (EP application)
• China (CN application)
• Japan (JP application)
• Canada (CA application)

These extend protection and facilitate global commercialization.

4. Litigation and Patent Challenges

No public records indicate litigation or invalidity challenges as of 2023. However, competitors may contest claims through post-grant review or inter partes review (IPR).

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Implications for R&D and Commercialization

• The '822 patent clarifies a broad scope for the claimed compound and uses, enabling infringement opportunities for similar compounds outside the exact structure but within the claimed genus.
• The patent’s coverage over formulations and methods enhances enforceability.
• Strategic licensing or patenting of specific derivatives could be pivotal for competitors.

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Key Takeaways

• The '822 patent primarily protects a specific class of pharmaceutical compounds and their use in treating certain conditions.
• Its claims are structured to cover both chemical compositions and therapeutic methods, including some formulations.
• The patent landscape features related filings that may impact freedom to operate.
• The patent has broad jurisdictional protection, with extensions in key markets.
• No significant legal disputes or invalidity filings are publicly recorded yet.

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FAQs

Q1. What specific chemical structure does U.S. Patent 10,035,822 claim?
It claims a chemical compound with a defined core scaffold, including specific substituents detailed via chemical formulas and Markush groups. The structure is designed for specific therapeutic activities, with claims covering various derivatives.

Q2. What indications does the patent target?
The patent generally claims treatment methods for conditions such as cancer or neurological disorders, based on the pharmacological profile of the compound. Specific indications are detailed in the application but are broad enough to include multiple disease states.

Q3. How does the patent landscape look for similar compounds?
Existing patents overlap mainly regarding similar chemical classes and treatment methods. The '822 patent’s novelty hinges on unique structural features and demonstrated efficacy improvements.

Q4. Are there any notable challenges to this patent?
There are no public indications of challenges. However, competitors could potentially contest its validity through post-grant procedures if prior art is identified.

Q5. How strong is the patent coverage internationally?
The patent family extends to multiple jurisdictions, including Europe, Canada, China, and Japan, providing broad protection for the claimed inventions.

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Citations

[1] U.S. Patent and Trademark Office. "Patent Full-Text and Image Database," USPTO.gov.
[2] World Intellectual Property Organization. "Patent Cooperation Treaty (PCT) Applications," WIPO.int.

Drugs Protected by US Patent 10,035,822

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	10,035,822			Y
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes	10,035,822			Y

Foreign Priority and PCT Information for Patent: 10,035,822

PCT Information
PCT Filed	November 15, 2013	PCT Application Number:	PCT/US2013/070417
PCT Publication Date:	May 22, 2014	PCT Publication Number:	WO2014/078731

International Family Members for US Patent 10,035,822

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3660033		301178	Netherlands
European Patent Office	3660033		PA2022010	Lithuania
European Patent Office	3660033		2022C/522	Belgium
European Patent Office	3660033		CA 2022 00023	Denmark
European Patent Office	3660033		LUC00265	Luxembourg