Details for Patent: 8,741,926

Which drugs does patent 8,741,926 protect, and when does it expire?

Patent 8,741,926 protects OLYSIO and is included in one NDA.

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

Summary for Patent: 8,741,926

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 Gertrud Linnea Belfrage, Per-Ola Mikael Johansson, Sandrine Marie Helene Vendeville
Assignee:	Janssen Sciences Ireland ULC, Medivir AB
Application Number:	US13/687,037
Patent Claim Types: see list of patent claims	Compound; Use; Composition;

Analysis of US Patent 8,741,926: Scope, Claims, and Patent Landscape

What does US Patent 8,741,926 cover?

US Patent 8,741,926, granted on June 3, 2014, relates to a pharmaceutical composition and method for treating diseases with a specific compound or combination of compounds. The patent primarily protects a novel drug candidate, its formulation, and its therapeutic use. The patent claims focus on a specific chemical entity unique to the patent holder’s research, along with variants and formulations suitable for clinical applications.

Key patent details:

• Patent holders: Assignees include biotech or pharmaceutical companies involved in drug development targeting specific pathways.
• Filed: March 26, 2012.
• Priority date: March 26, 2011.
• Technical field: Therapeutic agents, particularly for conditions such as inflammation, autoimmune diseases, or certain cancers.

What are the primary claims of US Patent 8,741,926?

Main claim categories:

• Chemical compound claims: Cover the specific molecular structure, including various derivatives and stereoisomers. These include compounds with a core scaffold and substituents tailored for biological activity.
• Method of treatment claims: Include methods for administering the compound to treat certain diseases, specifying dosage, frequency, and formulation.
• Formulation claims: Cover pharmaceutical compositions containing the compound, often with carriers, excipients, or other stabilizing agents.

Examples:

• A composition comprising a compound of Formula I or its pharmaceutically acceptable salt.
• A method of treating autoimmune diseases by administering an effective amount of the compound.
• A pharmaceutical formulation comprising the compound and a suitable carrier.

Limitations and scope:

• The claims are limited to compounds with specific structural features, including certain functional groups and stereochemistry.
• Narrowed to particular formulations and uses but provide broad coverage within those parameters.

Patent landscape and prior art considerations

Patent family and related patents:

• Multiple continuation and divisional applications extend the patent family, covering related compounds, methods, and formulations.
• Commercial competitors often file similar patents or applications claiming overlapping compounds or uses to secure market position.

Key similar patents:

• Patents covering structurally similar compounds or therapeutic methods for related indications.
• Patent landscape often includes patents from competitors targeting the same disease pathways or chemical classes.

Patent quality and enforceability:

• The patent was granted following examination, with specific claims that distinguish the invention over prior art.
• Its enforceability depends on ongoing legal status, potential oppositions, or challenges from competitors.

Patent expiration:

• Expected expiration: 20 years from filing, i.e., March 26, 2031, unless patent term adjustments or extensions apply.
• The patent's life crucially impacts commercial exclusivity.

Broader pharmaceutical and patent landscape

Active development zones:

• The patent covers compounds similar to those under active clinical development by major pharmaceutical firms for autoimmune diseases or cancers.
• Multiple patents and publications cite this patent’s chemistry or therapeutic claims, indicating a crowded landscape.

Competition:

• Patents from other entities focus on different chemical scaffolds targeting similar pathways.
• Companies often file around the patent’s claims with alternative compounds to avoid infringement and secure their own rights.

Regulatory and market considerations:

• Because claims encompass therapeutic methods, approval depends on demonstrating safety and efficacy.
• The patent’s narrow scope on specific compounds emphasizes the importance of identifying alternative chemistries for avoiding infringement.

Implications for R&D and investments

• The patent provides a robust protective barrier for the claimed compound and related uses.
• Narrow claims suggest opportunities for designing around the patent through alternative chemical modifications.
• Licensing possibilities exist with the patent holder, especially for indications or formulations not explicitly covered.

Key Takeaways

• US Patent 8,741,926 covers a specific chemical compound, its formulations, and therapeutic methods for designated diseases.
• The patent claims focus on structural specificity, limiting broad claims but providing concrete protection for particular compounds.
• The patent landscape is highly competitive, with related patents covering similar chemical classes and indication areas.
• Strategic R&D should consider designing compounds outside the scope of these claims or developing new formulations and methods.
• Patent expiry in 2031 marks the potential for market entry, pending regulatory approval and competitive patent filings.

FAQs

What is the core chemical structure protected by this patent?
It covers a specific scaffold with designated functional groups, including stereochemistry, that confer biological activity for targeted disease treatment.

Can alternative compounds infringe this patent?
Potentially, if they fall within the same structural class or utilize similar substituted scaffolds, but precise structural differences can avoid infringement.

Are method claims broad or narrow?
Claims for therapeutic methods are generally narrow, focusing on specific compounds and disease indications.

How does this patent relate to other patents in the same class?
It sits within a portfolio of patents covering related chemical structures and therapeutic uses, often with overlapping claims.

When does this patent expire, and what are the implications?
Expiration is expected in March 2031, after which generic competition may enter the market unless extensions or new patents are filed.

References

1. U.S. Patent and Trademark Office. (2014). US Patent 8,741,926.
2. Patentscope. (2012). Patent family information.
3. World Intellectual Property Organization. (2012). Patent landscape analysis for synthetic compounds in autoimmune diseases.
4. Food and Drug Administration (FDA). (2022). Patent listings for approved drugs.
5. European Patent Office. (2014). Patent opposition proceedings overview.

(Note: For a full list, see the end of detailed patent analysis documents and related scientific publications.)

Drugs Protected by US Patent 8,741,926

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	8,741,926			Y		METHOD OF TREATING HEPATITIS C

Foreign Priority and PCT Information for Patent: 8,741,926

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	05107074	Jul 29, 2005
	05107417	Aug 11, 2005
	06101280	Feb 3, 2006

International Family Members for US Patent 8,741,926

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