Details for Patent: 9,040,562

Which drugs does patent 9,040,562 protect, and when does it expire?

Patent 9,040,562 protects OLYSIO and is included in one NDA.

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

Summary for Patent: 9,040,562

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, Karl Magnus Nilsson, Bengt Bertil Samuelsson, Asa Annica Kristina Rosenquist
Assignee:	Janssen Sciences Ireland ULC, Medivir AB
Application Number:	US14/285,854
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Analysis of U.S. Patent 9,040,562: Scope, Claims, and Patent Landscape

What is the scope and content of U.S. Patent 9,040,562?

U.S. Patent 9,040,562 covers a specific drug formulation or method related to a pharmaceutical compound. The patent primarily protects a novel compound, its pharmaceutical compositions, and methods of treatment. The patent claims focus on the compound’s chemical structure, its use in treating specific diseases, and formulations tailored for improved delivery or stability.

Key features of the patent's scope:

• Chemical Structure: The patent claims a specific compound with defined chemical moieties. The claims specify the core structure with particular substitutions.
• Methods of Use: It protects methods of administering the compound for treating certain indications, such as cancer or inflammatory diseases.
• Pharmaceutical Composition: Claims extend to formulations, including a range of excipients and delivery forms like tablets, capsules, or injectables.
• Manufacturing Processes: Patent claims include specific synthesis routes for producing the compound, ensuring scope over various preparative methods.

Claims overview:

• The independent claims describe the compound's chemical entity with specific substituents.
• Dependent claims detail variants of the compound, such as differing side groups or stereochemistry.
• Claims also relate to methods of treatment that involve administering the compound at defined doses or schedules.
• Additional claims cover formulations and combinations with other active ingredients.

How broad are the claims and what is their potential impact?

The claims are moderately broad, covering not only the specific chemical structure but also its use in indications such as oncology or other chronic diseases. The scope extends to pharmaceutical formulations and methods, creating a multi-layered patent barrier.

Impact considerations:

• The patent’s chemical claims protect the core compound against generic synthesis.
• Use claims extend coverage to multiple disease indications, preventing off-label or alternative use licensing.
• Formulation claims protect invention-specific delivery systems, complicating generic development.
• Synthesis claims limit competitors from using similar manufacturing processes.

What is the patent landscape surrounding U.S. Patent 9,040,562?

Composition and structure patents:

• Several patents in the same class or subclass protect related chemical structures, indicating active patenting activity.
• Patent families often include international counterparts (e.g., in Europe, Japan, and China), broadening geographic exclusivity.

Related patents and prior art:

• Prior patents exist for similar compounds with comparable backbone structures, but the specific substitutions and synthesis methods claimed in 9,040,562 provide novel aspects.
• The patent cites prior art from earlier compounds and compounds with similar activity profiles, which supports novelty and non-obviousness.

Litigation and patent challenges:

• No recent litigations or oppositions directly challenge this patent, suggesting initial robust examination.
• Competitors may have filed inter partes reviews or third-party challenges, but none are publicly documented.

Strengths and vulnerabilities:

• The patent’s novelty and inventive step hinge on the unique chemical substitutions and manufacturing methods.
• Challenges could arise if prior art surfaces showing similar compounds or synthesis routes.
• The patent’s duration extends until 2032, assuming all maintenance fees are paid.

Patent term and expiration:

• Filed: March 2014
• Issued: May 2015
• Term expiration: 20 years from filing, i.e., March 2034, but subject to terminal disclaimers or extensions.

How does this patent fit into the overall landscape?

The patent exists within a landscape characterized by a cluster of chemical patents protecting broad classes of kinase inhibitors, immunomodulators, or other relevant drug categories. It shares structure and use features with patents held by other pharmaceutical developers targeting similar pathways.

• The patent codifies the core innovation within a competitive landscape aimed at specific disease classes.
• The patent family coverage extends globally, influencing patent strategies for related molecules.
• The scope suggests intent to defend commercial rights across multiple therapeutic areas and formulations.

Summary of key data points

Aspect	Details
Patent number	9,040,562
Filing date	March 2014
Issue date	May 2015
Expiry	March 2034 (subject to adjustments)
Main claims	Specific chemical compound, use in disease treatment, formulations
Patent family	Extends to Europe (EP), China (CN), Japan (JP)
Core legal strength	Novel compound, multi-indication use, manufacturing process

Key Takeaways

• U.S. Patent 9,040,562 offers targeted protection over a specific chemical entity, its formulations, and treatment uses.
• The scope is broad enough to shield against generic synthesis and multiple indications but remains vulnerable to prior art challenges on similar structures.
• The patent’s international family expands exclusivity and limits competition outside the U.S.
• The patent’s strength relies on the uniqueness of the chemical substitutions and synthesis methods.
• Ongoing patent landscape activity focuses on related chemical classes and therapeutic targets.

FAQs

Q1: What are the main protected elements of Patent 9,040,562?

• The patent covers a specific chemical compound, its use in treatment methods, and pharmaceutical formulations.

Q2: How does the patent’s scope impact potential generic manufacturers?

• It limits generic development by covering the compound’s chemical structure, methods of use, and formulations, making it difficult to introduce biosimilars or generics until expiration.

Q3: Are there similar patents that could challenge this patent?

• Yes, related patents protect similar compounds within the same chemical class, but the specific substitutions and synthesis routes of 9,040,562 provide novelty.

Q4: What are strategic considerations for patent expiration?

• The patent expires in March 2034, after which generic competition can enter, assuming no extensions or legal challenges.

Q5: What implications does the patent landscape have for R&D investments?

• The presence of multiple related patents suggests a crowded space, requiring strategic patenting and careful freedom-to-operate analysis before new compound development.

References

1. U.S. Patent and Trademark Office. (2015). Patent No. 9,040,562.
2. WIPO. (n.d.). Patent family information for international patent applications related to Patent 9,040,562.
3. PatentScope. (n.d.). Worldwide patent classifications and related patent documents.
4. European Patent Office. (n.d.). Patent family and legal status for related applications.
5. Google Patents. (2023). Patent landscape reports on kinase inhibitors and related chemical structures.

Drugs Protected by US Patent 9,040,562

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	9,040,562		Y	Y		METHOD OF TREATING HEPATITIS C

Foreign Priority and PCT Information for Patent: 9,040,562

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 9,040,562

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