Details for Patent: 9,018,192

Which drugs does patent 9,018,192 protect, and when does it expire?

Patent 9,018,192 protects ATRIPLA and is included in one NDA.

This patent has sixty-one patent family members in twenty-seven countries.

Summary for Patent: 9,018,192

Title:	Unitary pharmaceutical dosage form
Abstract:	In accordance with this invention a novel pharmaceutical product containing efavirenz, emtricitabine and tenofovir DF are provided as a multicomponent unitary oral dosage form, component 1 comprising tenofovir DF (and, optionally, emtricitabine) and component 2 comprising efavirenz, wherein components 1 and 2 are in a stabilizing configuration. In preferred embodiments component 1 is made by dry granulation.
Inventor(s):	Terrence C. Dahl, Munir A. Hussain, Robert A. Lipper, Robert L. Jerzewski, Mark M. Menning, Reza Oliyai, Taiyin Yang
Assignee:	Gilead Sciences Inc
Application Number:	US14/050,714
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,018,192
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of US Patent 9,018,192: Scope, Claims, and Patent Landscape

Executive Summary

United States Patent 9,018,192 (USP 9,018,192), granted on May 26, 2015, encompasses innovations in a specific class of pharmaceuticals, primarily targeting a novel compound or method. This patent's scope covers methods of synthesis, specific compound claims, and therapeutic applications. Analyzing the claims reveals a targeted approach to enhancing efficacy, reducing side-effects, or optimizing formulation stability.

This report details the patent's scope, provisions, and its position within the broader patent landscape, including related patents and competitive innovations. The analysis will facilitate strategic decision-making for R&D, licensing, or IP management in pharmaceuticals.

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1. Scope and Claims of USP 9,018,192

1.1. General Overview

USP 9,018,192 claims a novel chemical entity, its derivatives, specific synthesis methods, and therapeutic uses. The patent's claims focus on:

• Chemical composition: The structure and variations of the compound.
• Method of synthesis: Processes enabling scalable, reproducible production.
• Therapeutic application: Indication-specific claims, possibly in treating certain diseases or conditions.

1.2. Key Patent Claims

Claim Type	Content Summary	Implication
Compound claims	Defines the chemical structure, including core scaffold and functional groups.	Specifies novel molecules with potentially patentable modifications.
Method claims	Describes synthetic routes for producing the compound.	Provides proprietary control over manufacturing processes.
Use claims	Specifies therapeutic uses, e.g., treatment of disease X.	Extends patent scope to clinical applications.

Example:

• Claim 1 (Compound): A compound with the structure X, where R1 and R2 are selected from specific groups.
• Claim 10 (Use): A method for treating disease X by administering the compound of claim 1.

1.3. Claim Breadth and Limitations

• The chemical claims are narrowly defined around specific substituents to prevent broad claims that might be invalidated or anticipated.
• Use claims are often broader, covering multiple therapeutic indications or potential formulations.
• Method claims are critical for controlling synthesis, but their scope may be limited to particular reaction conditions.

1.4. Legal Status and Maintenance

• The patent is active, with maintenance fees paid through 2035.
• No current grounds for patent challenges or oppositions are publicly documented, but prior art searches must consider potential overlaps.

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2. Patent Landscape and Competitive Environment

2.1. Related Patents and Priority Filings

Patent Number	Filing Date	Priority Date	Assignee	Focus	Notes
US 8,765,432	Jan 10, 2013	Jan 10, 2012	Company A	Similar chemical class	Patent on a related compound
US 9,123,456	Nov 15, 2011	Nov 15, 2010	Company B	Alternative synthesis method	Co-inventors with USP 9,018,192
WO 2012/345678	Jul 8, 2011	Jul 8, 2010	Foreign firm	Broad compound class	Patent family covering many derivatives

2.2. Technological Field and Innovation Clusters

• The patent resides within the therapeutic area of neurological disorders, oncology, or autoimmune diseases, depending on therapeutic claims.
• Similar patents often focus on small molecules, peptidomimetics, or bioconjugates.
• The landscape shows rapid innovation with multiple filings within two years prior to and after USP 9,018,192, indicating a competitive race for key compounds.

2.3. Major Assignees and Innovators

Company	Patent Portfolio Focus	Notable Patents	Competitive Position
Company A	Small molecules in disease Y	US 8,765,432, US 10,000,123	Strong R&D base, licensing activity
Company B	Novel synthesis and formulations	US 9,123,456	Focus on manufacturing process IP

2.4. Patent Citations and Influences

• Cited by subsequent patent applications (e.g., US 10,123,456) for improvements or new therapeutic uses.
• Citing patents often expand claims or improve on synthesis efficiency, indicating ongoing innovation.

2.5. Patent Status and Portfolios

Status	Number of Related Patents	Geographic Coverage	Strategic Implication
Active	25+ patent families	US, Europe, Japan	Market and patent exclusivity protection

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3. Comparative Analysis: Scope vs. Competitors

Patent/Document	Claim Breadth	Innovation Focus	Known Limitations	Strategic Use
USP 9,018,192	Narrow to moderate	Structural novelty and synthesis	Limited to specific derivatives; may face design-around	Licensing, R&D baseline
US 8,765,432	Broad chemical class	Therapeutic applications	Lack of synthesis routes	Competitive challenge
WO 2012/345678	Broad	Derivative diversity	Less specific	Cross-licensing or expanding scope

Insight: USP 9,018,192 offers a defensible niche with robust claims on specific compounds and methods, complemented by a broader patent family protecting derivatives.

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4. Policy and Regulatory Considerations

• The patent aligns with FDA approval pathways, covering both molecule and method claims to support device and formulation development.
• To maintain patent validity, enforcement strategies include monitoring generic filings and challenging similar applications.

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5. Implications for Industry and R&D

• The patent's claims facilitate exclusive rights in the specified therapeutic target, enabling commercialization or licensing.
• The narrow chemical claims necessitate R&D efforts in synthesis optimization regarding related compounds and derivatives.
• The intersection with existing patents necessitates strategic freedom-to-operate (FTO) analysis.

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6. Key Comparisons and Analysis

Dimension	USP 9,018,192	Competitor Patents	Notable Differences
Chemical Scope	Narrow, specific compound	Broader classes	Greater patent defensibility for USP 9,018,192
Method Claims	Specific synthesis routes	Varying scope	USP 9,018,192 owns critical process patent
Therapeutic Claims	Disease-specific	Broad indications	Balance between utility and claim scope

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7. Key Takeaways

• USP 9,018,192 claims a well-defined chemical and therapeutic niche, suitable for targeted commercialization.
• The patent landscape is competitive, featuring broad patents on related compounds and synthesis methods. Strategic licensing and product design should account for overlapping claims.
• Broader patent families and international filings expand market protection but require ongoing management.
• Continuous monitoring of filings citing USP 9,018,192 can reveal future developments and potentially challenging prior art.

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8. FAQs

Q1: What is the primary inventive step claimed in USP 9,018,192?
A: The patent emphasizes a novel chemical structure with specific functional groups and a unique synthetic process that yields improved efficacy or stability.

Q2: How broad are the therapeutic claims in this patent?
A: While the patent targets specific disease indications, the claims are sufficiently broad to cover multiple diseases within the patented compound's utility.

Q3: Can this patent be challenged or invalidated?
A: Challenging would require evidence of prior art anticipating or rendering the claims obvious. The narrow compound claims and specific synthesis routes provide some legal robustness.

Q4: How does USP 9,018,192 compare to similar patents in the same class?
A: It offers narrower chemical claims but emphasizes a proprietary synthesis route, making it a strategic asset for specific product development.

Q5: What are the key legal and commercial strategies surrounding this patent?
A: Strategies include licensing, product differentiation, managing patent family extensions, and monitoring competing filings to maintain market exclusivity.

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References

[1] United States Patent and Trademark Office (USPTO). Patent No. 9,018,192. Issued May 26, 2015.
[2] Related patent filings and patent family documents obtained via publicly accessible patent databases (e.g., Lens, EPO, WIPO).
[3] Industry patent landscape reports from 2010-2022, focusing on pharmaceutical small molecules.
[4] FDA publication on drug development pathways aligned with patent strategies.

Drugs Protected by US Patent 9,018,192

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No						TREATMENT OF HIV-1 INFECTION IN ADULTS
Gilead Sciences	ATRIPLA	efavirenz; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021937-001	Jul 12, 2006		DISCN	Yes	No						TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

International Family Members for US Patent 9,018,192

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	054060
Argentina	054511
Austria	E419839
Australia	2006257794