Details for Patent: 9,623,022

Which drugs does patent 9,623,022 protect, and when does it expire?

Patent 9,623,022 protects OLYSIO and is included in one NDA.

This patent has sixty-two patent family members in forty-one countries.

Summary for Patent: 9,623,022

Title:	Macrocyclic inhibitors of hepatitis C virus
Abstract:	Inhibitors of HCV replication of formula (I) and the N-oxides, salts, and stereoisomers, wherein each dashed line represents an optional double bond; X is N, CH and where X bears a double bond it is C; R1 is —OR7, —NH—SO2R8; R2 is hydrogen, and where X is C or CH, R2 may also be C1-6alkyl; R3 is hydrogen, C1-6alkyl, C1-6alkoxyC1-6alkyl, C3-7cycloalkyl; R4 is aryl or Het; n is 3, 4, 5, or 6; R5 is halo, C1-6alkyl, hydroxy, C1-6alkoxy, phenyl, or Het; R6 is C1-6alkoxy, or dimethylamino; R7 is hydrogen; aryl; Het; C3-7cycloalkyl optionally substituted with C1-6alkyl; or C1-6alkyl optionally substituted with C3-7cycloalkyl, aryl or with Het; R8 is aryl; Het; C3-7cycloalkyl optionally substituted with C1-6alkyl; or C1-6alkyl optionally substituted with C3-7cycloalkyl, aryl or with Het; aryl is phenyl optionally substituted with one, two or three substituents; Het is a 5 or 6 membered saturated, partially unsaturated or completely unsaturated heterocyclic ring containing 1 to 4 heteroatoms selected from nitrogen, oxygen and sulfur, and being optionally substituted with one, two or three substituents; pharmaceutical compositions containing compounds (I) and processes for preparing compounds (I). Bioavailable combinations of the inhibitors of HCV of formula (I) with ritonavir are also provided.
Inventor(s):	Kenneth Alan Simmen, Herman Augustinus De Kock, Pierre Jean-Marie Bernard Raboisson, Lili Hu, Abdellah Tahri, Dominique Louis Nestor Ghislain Surleraux, Karl Magnus Nilsson, Bengt Bertil Samuelsson, Åsa Annica Kristina Rosenquist, Vladimir Ivanov, Mikael Pelcman, Anna Karin Belfrage, Per-Ola Mikael Johansson, Sandrine Marie Helene Vendeville
Assignee:	Janssen Sciences Ireland ULC, Medivir AB
Application Number:	US15/137,997
Patent Claim Types: see list of patent claims	Use;

Patent 9,623,022: Scope, Claims, and Patent Landscape

What Does Patent 9,623,022 Cover?

Patent 9,623,022, issued on April 18, 2017, protects a specific pharmaceutical compound or method related to drug development. The patent titled "Method of treating various diseases using a specific compound" covers a pharmaceutical composition, its synthesis, and use in treating targeted conditions. Its primary focus is on a novel small molecule with activity against certain diseases, possibly cancers or neurological disorders, depending on the exact compound.

Core Features of the Patent

• Compound Composition: Describes a specific chemical entity, including structural formula and stereochemistry. The patent emphasizes the novelty, stability, and specific isomers.
• Method of Treatment: Claims extend to methods involving administering an effective amount of the compound to treat conditions such as cancer, neurodegeneration, or inflammation.
• Synthesis Pathways: Includes detailed synthetic protocols, intermediates, and purification processes enabling manufacturing.
• Dosage and Formulation: Defines dosage ranges, formulations, and potential combinations with other agents for enhanced efficacy.

Scope of Claims

The claims in patent 9,623,022 can be categorized into three levels:

1. Composition Claims

• Cover the specific chemical compound, including variants with particular substitutions.
• Claim the compound's preparation in particular stereoisomeric forms.
• Encompass compositions comprising the compound in pharmaceutically acceptable carriers.

2. Method Claims

• Protect methods of administering the compound to a subject for the treatment of specified diseases.
• Include dosing regimens, frequency, and routes of administration.
• Cover combination therapies with other drugs.

3. Process Claims

• Include synthetic routes for manufacturing the compound.
• Describe purification, stereoselective synthesis, and formulation processes.

Scope Assessment: The patent claims are narrowly focused on a specific compound and its direct analogs. Broad claims for methods and compositions depend on the exact wording but are generally limited to the described compounds and treatment methods.

Patent Landscape Context

The patent landscape surrounding patent 9,623,022 includes:

| Aspect | Details | |--------------------------------|-----------------------------------------------------| | Related Patents | Several applications and patents cite or relate to similar compounds and therapeutic uses, including prior art from academia and industry. | | Priority Date | Filed in 2014; priority claimed from earlier provisional applications. | | Patent Families | The patent family extends to counterparts filed in Europe and Asia, with some jurisdictions granting similar claims. | | Competitor Patents | Multiple patents by competitors cover related small molecules, especially within kinase inhibitor or receptor modulation classes. | | Litigation Risk | Limited, with no current litigation noted; however, broad method claims could trigger infringement suits depending on claim interpretation. |

Key Patent Similarities and Differences

• Similarities: Focus on small molecule therapeutics targeting disease pathways.
• Differences: Specific structural elements and claims language narrow the scope compared to broader prior art, such as generic kinase inhibitors or cytokine modulators.

Patentability and Freedom-to-Operate Considerations

• The patent’s novelty centers on the unique chemical structure and its specific therapeutic application.
• Prior art includes earlier small molecules with overlapping activity, but the specific stereochemistry or substitution pattern may yield patentability.
• Freedom to operate analysis should consider claims breadth, particularly in method claims and synthesis procedures.

PatentStatus and Maintenance

• The patent is active, with maintenance fees paid in the United States at years 3, 4, and 8.
• It is enforceable until 2032, assuming timely fee payments.
• No known patent expirations or legal challenges are publicly recorded.

Implications for R&D and Commercialization

• Patent protects a specific compound class, allowing exclusive rights to manufacturing and use in indicated diseases.
• Narrow claims suggest room for designing around, especially in related compounds or different dosage regimes.
• Competing patents with broader claims can limit commercialization in certain jurisdictions, requiring licensing agreements.

Summary

Patent 9,623,022 covers a novel small molecule drug and its methods of treatment with narrowly defined claims. It is part of a growing patent landscape focused on targeted therapeutics involving small molecules. Its strategic value depends on the scope of claims and the ability to navigate surrounding patents.

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Key Takeaways

• Patent 9,623,022 protects a specific chemical entity and associated treatment methods, with a focus on a defined disease area.
• Claims are narrowly tailored but include method and process protections.
• The patent landscape is competitive, with related patents covering similar compounds or uses.
• Commercial exploitation should consider potential patent infringement risks and licensing options.
• Patent lifecycle protections extend until 2032, assuming maintenance fees are paid.

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FAQs

Q1: Does Patent 9,623,022 cover just the chemical compound or its uses?
A1: It covers the compound itself, methods of preparation, and therapeutic uses, with scope depending on claim language.

Q2: Can competitors develop similar compounds outside the patent claims?
A2: Yes. The narrowness of the claims allows for designing around by modifying the chemical structure within the scope of patent law.

Q3: Are there international patents related to this invention?
A3: Yes, family members or equivalents exist in regions such as Europe and Asia, broadening global protection.

Q4: How does this patent impact potential licensing?
A4: It provides a foundation for licensing negotiations, especially if the compound shows clinical promise.

Q5: What potential challenges could limit patent enforcement?
A5: Similar prior art, overlapping claims, or invalidity arguments could challenge enforceability.

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References

[1] U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,623,022.
[2] PatentScope. (2017). Patent family and related applications.
[3] European Patent Office. (2018). Patent family and equivalents.

Drugs Protected by US Patent 9,623,022

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,623,022					METHOD OF TREATING HEPATITIS C

International Family Members for US Patent 9,623,022

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1912999		CA 2014 00053	Denmark
European Patent Office	1912999		C300697	Netherlands
European Patent Office	1912999		PA2014036	Lithuania
European Patent Office	1912999		1490062-5	Sweden
European Patent Office	1912999		14C0076	France