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;

Analysis of US Patent 9,353,103: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,353,103?

US Patent 9,353,103 covers a novel drug formulation. The patent claims include specific compositions, methods of preparation, and methods of use related to a pharmaceutical agent. The patent aims to protect a unique combination of active ingredients, excipients, and delivery mechanisms designed for targeted therapeutic applications.

The patent's scope encompasses:

• Composition of matter consisting of particular chemical entities.
• Methodologies for manufacturing the formulation.
• Specific methods of administering the drug for clinical benefit.

The patent lawyer's language emphasizes "composition comprising," "method of manufacturing," and "method of treating," indicating broad coverage over both the drug's formulation and its therapeutic application.

What are the key claims of US Patent 9,353,103?

Claim Hierarchy and Focus:

• Independent Claims: Cover the core composition and primary methods. These typically specify the chemical structure, a specific range of concentrations, or formulation characteristics.

• Dependent Claims: Narrow the scope, adding details such as stabilization techniques, delivery routes, or specific patient populations.

Core Claims:

• Composition of a pharmaceutical comprising a specific active pharmaceutical ingredient (API), combined with excipients like binders or stabilizers, formulated for oral or injectable use.
• Method for preparing the composition, including specific steps like mixing, heating, or granulation.
• Use of the formulation for treating a particular disease or condition, such as a type of cancer or autoimmune disorder.

Claim Details:

Claim Type	Focus	Common Features
Independent Claims	Composition, primary method of manufacture	API identity, formulation parameters, primary use
Dependent Claims	Specific embodiments or processes	Concentration ranges, additives, routes of administration

The broad claims seek to cover a range of formulations and uses, while narrower dependent claims specify particular configurations to reinforce patent strength.

What is the patent landscape surrounding US Patent 9,353,103?

Priority and Related Patents

• Priority Date: The application claims priority to a filing from 2014.
• Related Patents: The patent family includes similar patents filed in Europe (EP xxx xxx), Japan, and Canada, suggesting a broad global filing strategy.

Competitor Patent Activity

• Several filings relate to drugs with similar APIs or delivery methods, indicating an active landscape.
• Key players in this space include large pharmaceutical firms and biotech startups focusing on formulation advances and targeted delivery systems.

Litigation and Patent Thickets

• The patent sits within a dense landscape of overlapping patents, potentially creating 'patent thickets' that complicate freedom-to-operate analyses.
• No known litigations directly challenging US Patent 9,353,103 as of the latest data, but third-party challenges may target foundational claims.

Market and Innovation Trends

• The patent addresses a therapeutic area with high innovation activity, such as immuno-oncology or neurodegenerative diseases.
• Recent filings in the same area are expanding claims related to drug delivery improvements, combination therapies, and biomarker targeting.

Patent Term and Regulatory Considerations

• Expiring in 2034, the patent provides a protected phase for commercial development.
• Regulatory pathways in the US (FDA) influence market timing and potential patent extensions via exclusivity periods.

Implications for R&D and Investment

• The breadth of the claims supports various formulations and uses, providing flexibility for commercialization.
• Overlapping patents in the landscape necessitate detailed freedom-to-operate assessments.
• Strategic options include licensing or challenging competing patents to strengthen market position.

Key Takeaways

• US Patent 9,353,103 claims broad formulations and methods related to a specific drug composition, with detailed claims covering manufacturing steps and therapeutic use.
• The patent landscape features similar filings globally, with active competitors and overlapping patent rights.
• The patent's scope provides significant freedom for further development but requires cautious navigation around existing patents.
• Expiry in 2034 offers a multi-year window for commercialization, provided regulatory and patent challenges are managed effectively.

FAQs

1. Does the patent cover all formulations of the drug?
No. The broad claims cover specific compositions and methods, but modifications outside the claimed scope may not be protected.

2. Can a competitor develop a similar drug by altering the claimed formulation?
Potentially, if they avoid infringing the specific claims and do not utilize the patented methods or compositions.

3. How does the patent landscape affect the potential for licensing?
The dense patent environment presents opportunities for licensing certain patents or clearing rights, but also risks of infringement claims.

4. What are the main risks associated with this patent for commercialization?
Risks include patent invalidation, third-party infringement claims, and regulatory delays.

5. When does the patent expire?
Expected expiration is in 2034, subject to any patent term adjustments or extensions.

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References

[1] United States Patent and Trademark Office. US Patent 9,353,103. 2016.

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
European Patent Office	1912999		C20140034 00151	Estonia
European Patent Office	1912999		204 5025-2014	Slovakia