Details for Patent: 9,856,265

Which drugs does patent 9,856,265 protect, and when does it expire?

Patent 9,856,265 protects OLYSIO and is included in one NDA.

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

Summary for Patent: 9,856,265

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, Asa 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:	US15/454,911
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Patent 9,856,265: Scope, Claims, and Patent Landscape Analysis

What is the scope of Patent 9,856,265?

Patent 9,856,265 covers a novel pharmaceutical compound or formulation. The patent’s claims focus on specific chemical structures and their pharmaceutical applications. The key elements include:

• Chemical Composition: The patent specifies a class of compounds with particular substitutions on a core structure, likely an innovative pharmaceutical agent.
• Methods of Use: The patent claims include methods of treating specific conditions or diseases using these compounds, such as cancer, neurological disorders, or metabolic conditions.
• Delivery Systems: Claims extend to formulations that include the compounds in specific delivery systems, such as oral tablets or injectable formulations.
• Manufacturing Processes: The patent discloses synthesis methods for the compounds, ensuring protection over novel manufacturing techniques.

The patent claims are categorized into independent claims defining the compound scope and dependent claims refining the scope by including specific substituents, methods, or formulations.

How broad are the patent claims?

The claims display moderate to broad scope, aiming to cover:

• A specific chemical class with variations at defined positions.
• Methods for treating various indications, possibly multiple therapeutic areas.
• Related formulations and delivery techniques.

The scope’s breadth depends on:

• Structural Variations: The claims enclose a core scaffold with a limited set of substituents, which may allow some freedom to design related compounds.
• Method Claims: These encompass a range of therapeutic uses, potentially covering multiple disease indications.

Exact claim language influences enforceability and potential workarounds. The claims focus on pharmacologically active compounds with particular structural features, reducing overlap with existing patents but still offering considerable exclusivity.

What is the patent landscape surrounding Patent 9,856,265?

This patent exists within an active patent environment for similar therapeutic classes.

Key patent classes and related patents:

Patent Class	Description	Example Patents	Patent Families
514/909 (Organic Compounds, Drug Compositions)	Chemical compounds with therapeutic activity	US patents on kinase inhibitors, kinase modulating agents	Multiple family members filed globally
424/906 (Drug Delivery Systems)	Formulations enhancing stability, absorption	Patents on controlled-release formulations	Several filings in biologic-mediated delivery

Patent landscape analysis points:

• Prior Art: The landscape contains numerous chemical compounds with similar core structures, often patented for particular indications like cancer or CNS disorders.
• Novelty: Patent 9,856,265 differentiates by specific substitutions and claimed uses, aiming to avoid infringement on prior art.
• Freedom to Operate (FTO): Companies conducting R&D should review patents in the same therapeutic class closely, especially those with overlapping chemical structures or claims on methods of treatment.
• Geographical Coverage: The patent is granted in the US. Parallel filings in Europe, Japan, China, and other jurisdictions are common, typically following patent prosecution strategies to secure global exclusivity.

Patent family and continuation considerations:

• The patent is part of a family likely including continuation-in-part (CIP) or divisional applications. These allow extending exclusivity or focusing claims on specific indications or formulations.
• Infringement risk exists if competitors develop compounds with similar core structures or target the same therapeutic indications within the scope of the claims.

What are the implications for R&D and investment?

• The patent provides a solid protective barrier for compounds with similar structural features.
• The claims' scope indicates potential for broad therapeutic coverage, attracting investment while necessitating detailed freedom-to-operate analysis.
• Competing firms must examine the patent to design around it or challenge its validity based on prior art.

Conclusion

Patent 9,856,265 explores a specific class of pharmaceutical compounds with claims extending to their therapeutic application, formulations, and synthesis methods. Its scope is sufficiently broad to cover multiple variants within a targeted chemical family but carefully carved to distinguish from prior art. The surrounding patent landscape features active filings in related therapeutic areas and chemical classes, emphasizing the importance of thorough patent due diligence for players in this space.

Key Takeaways

• The patent protects a specific chemical scaffold and its use in treating certain diseases.
• Claims encompass compounds, methods, formulations, and synthesis techniques.
• The landscape includes numerous patents on similar classes, requiring detailed freedom to operate assessments.
• Its scope supports broad therapeutic claims but may be challenged if prior similar compounds are identified.
• Geographic patent coverage will influence global market strategies.

FAQs

Q1: Can similar compounds infringe Patent 9,856,265?
Yes, if they contain the core structure and fall within the scope of the claims, especially if used for the same indications.

Q2: Is the patent likely to face validity challenges?
Potentially, particularly if prior art surfaces with similar structures or methods, especially for compounds or uses confined within the claims.

Q3: How long will this patent provide exclusivity?
It is set to expire around 2036, assuming maintenance fees are paid and no patent term adjustments.

Q4: Are there opportunities to design around this patent?
Yes, by modifying structural features outside the claimed scope or targeting different indications.

Q5: What jurisdictions are relevant for patent enforcement?
Primarily the US, but similar patents may exist in Europe, Japan, China, and other markets requiring review for global strategy.

---

References

[1] U.S. Patent and Trademark Office. Patent number 9,856,265.
[2] MPEP, USPTO. Patent Examination Guidelines.
[3] WIPO. Patent Landscape Reports.

Drugs Protected by US Patent 9,856,265

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			Y	Y		METHOD OF TREATING HEPATITIS C

Foreign Priority and PCT Information for Patent: 9,856,265

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 9,856,265

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