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)
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	Use; Composition;

Scope and Claims Analysis of U.S. Patent 8,741,926

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Patented Invention Overview

U.S. Patent 8,741,926 pertains to combination therapies involving a certain class of compounds and additional anti-HCV agents. The patent emphasizes therapeutic combinations and methods targeting hepatitis C virus (HCV) replication, mainly through co-administration of a compound with a specified chemical structure and another anti-HCV agent.

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Claims Summary

The patent contains 19 claims segregated into:

• Compound combinations (Claims 1–7, 14–17),
• Methods of inhibiting HCV (Claims 8–13),
• Pharmaceutical compositions (Claims 14–17),
• And specific embodiments involving HCV polymerase inhibitors, protease inhibitors, and other agents (Claims 4–6, 10–13, 15–19).

Claims can be grouped into:

• Independent claims:
  • Claim 1: Combination of a compound (with a specific structure or its N-oxide/salt/stereoisomer) with another anti-HCV compound.
  • Claim 8: Method involving administering the above combination.
  • Claim 14: Pharmaceutical composition comprising the combination.
• Dependent claims: Narrow variations or specific embodiments of the independent claims.

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Scope of the Patent Based on Claims

• Compound Scope:

  • The core compound is defined broadly as having a particular formula or N-oxide, salt, or stereoisomer derivatives (Claim 1, 14). The specific chemical structure is not provided in the excerpt but is central to the patent. The claims cover not only the base compound but also its N-oxide, salts, and stereoisomers, expanding the scope substantially.

• Combination Scope:

  • The patent claims combinations with a broad range of anti-HCV agents:
  • HCV polymerase inhibitors
  • HCV protease inhibitors
  • Inhibitors of other targets in the HCV lifecycle
  • Immunomodulatory agents
  • Broad inclusion allows for multiple classes of anti-HCV agents.

• Methodology Scope:

  • The methods specify administering the combination to inhibit HCV replication, emphasizing simultaneous, sequential, or separate administration.

• Formulation Scope:

  • The patent covers pharmaceutical compositions with carriers and the active combination, ensuring commercial viability across different dosage forms.

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Patent Landscape and Related Patents

• Prior Art Context:

  • The landscape for HCV therapies involves multiple classes of inhibitors (polymerase, protease, NS5A inhibitors). Numerous patents exist covering combinations of these agents.
  • Key patents in the field typically claim specific drug combinations or methods of use for combinations of direct-acting antivirals (DAAs).

• Novelty and Non-Obviousness:

  • The patent's broad definitions of the compound class and the multi-class anti-HCV agents provide wide coverage.
  • The inclusion of salts, stereoisomers, and N-oxides broadens patent scope.
  • Lack of specific chemical details limits precise landscape positioning but suggests the patent aims to preempt claims across a broad chemical scope and combination strategies.

• Patent Family and Related Patents:

  • Related patents could involve specific compounds encompassed by the generic formula, their N-oxides, salts, or particular combination regimens.
  • Patents from prominent players like Gilead, AbbVie, or Merck might address similar combination strategies, but the broad claim language indicates an intent to cover wide therapeutic combinations involving the core compound class.

• Potential Overlaps:

  • The claims overlap with existing combination patents on HCV polymerase and protease inhibitors but emphasize structural variations and combination flexibility.
  • Patent landscape analysis should focus on prior art involving compounds with similar structural features and combination use with known DAAs.

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Strategic Implications

• Patent Coverage:

  • The patent offers broad protection over a class of compounds with versatile anti-HCV agents. -, their salts, stereochemistry, and N-oxides expand the protection.
  • The claims include methods and compositions, covering commercial development from drug combinations to formulations.

• Potential Challenges:

  • Prior art claiming specific combinations of HCV DAAs could limit enforceability.
  • The broad structural claims could be challenged on grounds of obviousness if similar compounds or combinations exist.

• Litigation/Patent Challenges:

  • Note the broad scope could face scrutiny unless the core compound structure is sufficiently novel and non-obvious.
  • Patent examiners or third-party challengers may target specific claims, especially those encompassing known agents.

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Key Takeaways

• Patent 8,741,926 covers a broad class of compounds and their combinations with various anti-HCV agents, including methods and formulations.
• Its scope extends to salts, stereoisomers, N-oxide derivatives, and multiple classes of anti-HCV agents used alone or in combination.
• Positioned in a crowded HCV patent landscape, it offers extensive coverage but may face assertions or invalidation challenges based on prior art.
• The patent’s broad claims suggest an intention to cover comprehensive combination therapies involving the subject compound class.

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FAQs

1. Does this patent cover specific chemical compounds or classes?
The patent broadly covers compounds with a specified formula, including salts, stereoisomers, and N-oxides, but the exact chemical structure is not detailed here.

2. Which anti-HCV agents are included in the patent claims?
HCV polymerase inhibitors, protease inhibitors, inhibitors of other viral lifecycle targets, immunomodulatory agents, and antiviral agents.

3. Are method claims limited to concurrent administration?
No, claims encompass simultaneous, sequential, or separate administration.

4. Does the patent include formulations?
Yes, it claims pharmaceutical compositions comprising the compounds with carriers.

5. What is the strategic significance of this patent?
It provides a broad shield covering a wide array of combination therapies involving the core compound, potentially blocking competitors from developing similar combination treatments.

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References

1. U.S. Patent and Trademark Office. (2014). Patent No. 8,741,926.

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
European Patent Office	1912999		1490062-5	Sweden