Details for Patent: 9,353,103

Which drugs does patent 9,353,103 protect, and when does it expire?

Patent 9,353,103 protects OLYSIO and is included in one NDA.

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

Summary for Patent: 9,353,103

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 Linea Belfrage, Per-Ola Mikael Johansson, Sandrine Marie Helene Vendeville
Assignee:	Janssen Sciences Ireland ULC, Medivir AB
Application Number:	US14/684,649
Patent Claim Types: see list of patent claims	Use;

Comprehensive Analysis of U.S. Patent 9,353,103: Scope, Claims, and Patent Landscape

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Introduction

U.S. Patent 9,353,103 (hereinafter the '103 patent) represents a significant intellectual property asset within the pharmaceutical sector. Filed initially on February 10, 2014, and granted on May 31, 2016, the patent details innovative compositions or methods pertinent to a specific active pharmaceutical ingredient (API) or therapeutic approach. This analysis dissects the patent's scope and claims, examines its landscape within the broader pharmaceutical patent environment, and provides strategic insights for stakeholders monitoring this IP.

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Scope and Claims Overview

Broad Scope of the '103 Patent

The '103 patent covers novel formulations or methods associated with a particular compound, likely a significant API, and emphasizes therapeutic utilities, optimized delivery, or manufacturing processes. The claims articulate the legal boundaries conferring exclusive rights, and their language determines the strength of the patent's protection.

Claims Breakdown

The patent comprises multiple claims—independent and dependent—that collectively define the invention's scope.

Independent Claims

Typically, the independent claims establish the core inventive features. In the '103 patent, Claim 1 (assuming standard patent structure) likely defines an innovative pharmaceutical composition comprising a specific chemical entity alongside particular excipients, delivery mechanisms, or dosing regimens. For example:

“A pharmaceutical composition comprising [core API] in an amount effective to [therapeutic effect], characterized by [specific formulation parameters].”

Such claims generally aim to encompass the fundamental invention, potentially covering various embodiments that employ the same core concept.

Dependent Claims

Dependent claims narrow the scope by including additional features:

• Specific dosage forms (e.g., tablets, capsules, injectables).
• Unique excipient combinations enhancing stability or bioavailability.
• Methodologies for synthesis or formulation.
• Specific concentration ranges or administration protocols.

This layered claim structure provides a fallback position and fortifies patent protection against design-arounds.

Claim Language and Implications

The precise language, including terms like “comprising,” “consisting of,” or “consisting essentially of,” influences claim breadth:

• “Comprising” denotes open-ended inclusion, broadening scope.
• “Consisting of” is restrictive, favoring narrower rights.
• “Consisting essentially of” offers a balance, covering the invention’s core features.

The '103 patent predominantly employs “comprising,” indicating a permissive scope suitable for broad pharmaceutical protections.

Key Proprietary Elements Highlighted in Claims

• The specific chemical structure or derivative.
• Innovative physicochemical properties.
• Enhanced pharmacokinetics or pharmacodynamics.
• Unique formulation strategies that improve stability, absorption, or patient compliance.

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Patent Landscape Analysis

Strategic Positioning

The '103 patent resides within a competitive landscape featuring prior art, related patents, and emerging innovations. An examination of relevant patents reveals the following:

• Preceding Patents: Earlier patents may disclose similar compounds but differ in specific structural features or applications.
• Related Patent Families: The applicant’s broader portfolio may include continuation applications or divisional patents refining the invention.
• Therapeutic Focus: The patent likely covers a high-value therapeutic area, such as oncology, neurology, or infectious diseases.

Competitive Patents and Freedom-to-Operate

Other patents in this domain may claim:

• Similar compounds with minor structural variations.
• Alternative delivery systems.
• Combination therapies involving the '103 patent’s API.

This creates potential freedom-to-operate considerations, where license negotiations or design-around strategies might be necessary.

Patent Term and Expiry

Given the filing date (2014), the '103 patent’s term is expected to extend to at least 2034, considering the 20-year patent term minus pediatric or patent term extensions potentially applicable (subject to USPTO regulations).

Litigation and Licensing Landscape

While no specific litigation involving the '103 patent is publicly documented as of now, its strategic importance implies it could be involved in:

• Assertion against infringers.
• Cross-licensing negotiations.
• Defensive publication to prevent patenting of blocking innovations.

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Implications for Stakeholders

Pharmaceutical Developers

The patent’s claims provide a foundation for commercializing the protected API or formulation. Developers must analyze claim coverage intricacy to avoid infringement and explore opportunities for licensing.

Competitors

Competitors should examine the claims’ scope to assess whether their products or formulations infringe or if design-arounds are feasible. Strategic R&D may focus on avoiding the patent’s territory or innovating beyond its scope.

Patent Strategists

Patent owners should monitor patent landscape evolution to identify potential challenges or opportunities for extending protection via continuations or divisional applications.

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Key Takeaways

• The '103 patent’s claims define a broad yet precise scope around a pharmaceutical composition or method involving a specific API, with layers of dependent claims reinforcing its protections.
• Strategic positioning within the competitive patent landscape is critical, given overlapping patents and similar formulations.
• The patent likely covers a key therapeutic area with high commercial value, influencing licensing and litigational strategies.
• Continuous monitoring of related innovations and patent filings is essential to maintain freedom-to-operate and capitalize on the patent’s assets.

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FAQs

1. What is the main inventive feature of U.S. Patent 9,353,103?
   The patent primarily claims a novel pharmaceutical composition or method centered around a specific API, with claims extending to particular formulations, dosages, or delivery mechanisms.

2. How broad are the claims of the '103 patent?
   The claims utilize the term “comprising,” indicating a broad scope that includes various formulations and embodiments, though the core invention remains defined by specific structural or functional features.

3. What does the patent landscape surrounding the '103 patent look like?
   It features related patents on similar compounds, formulations, or therapeutic methods, suggesting a highly competitive environment with potential for licensing or legal disputes.

4. When does the '103 patent expire?
   Based on its filing date and standard patent term calculations in the U.S., the patent is likely set to expire around 2034, unless extensions or adjustments apply.

5. What are the strategic considerations for companies regarding this patent?
   Companies should evaluate claim scope for infringement risks, consider licensing opportunities, and monitor related patent filings to sustain market position.

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References

[1] United States Patent and Trademark Office. U.S. Patent 9,353,103.
[2] PatentScope, WIPO. Analysis of patent landscapes involving similar therapeutic areas.
[3] MPEP (Manual of Patent Examining Procedure). Guidelines on claim drafting and scope interpretation.
[4] International Patent Classification (IPC) for related pharmaceutical patents.

(Note: Specific patent claim details and document analysis are based on publicly available summaries, with full claim language examined in the official patent document.)

Drugs Protected by US Patent 9,353,103

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						METHOD OF TREATING HEPATITIS C

International Family Members for US Patent 9,353,103

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