Details for Patent: 12,011,506

Which drugs does patent 12,011,506 protect, and when does it expire?

Patent 12,011,506 protects JULUCA and is included in one NDA.

This patent has twenty-one patent family members in fifteen countries.

Summary for Patent: 12,011,506

Title:	Combination and uses and treatments thereof
Abstract:	Methods are provided for treating or preventing human immunodeficiency virus-1 (HIV-1) or human immunodeficiency virus-2 (HIV-2) in a virologically suppressed patient in need thereof comprising switching the patient from an antiretroviral treatment regimen comprising at least three antiretroviral agents to a treatment regimen comprising only two antiretroviral agents. In one aspect the two treatment regimen consists of dolutegravir, rilpivirine and at least one pharmaceutically acceptable excipient, diluent or carrier. In another aspect of the invention, there is provided a multilayer tablet comprising dolutegravir or a pharmaceutically acceptable salt thereof and rilpivirine or a pharmaceutically acceptable salt thereof.
Inventor(s):	Kenneth Churchill Campbell, Urbain Alfons C. Delaet, James M. GOODRICH, Juliette Segolène GUAQUIÈRE, Thomas LAUGHERY, Dominique J. LIMET, John C. POTTAGE, Ludovic Sylvain Marc RENOU, Trevor R. SCOTT, Christian Seiler, Mary WOODWARD
Assignee:	Janssen Pharmaceutica NV , GlaxoSmithKline Services ULC , ViiV Healthcare UK Ltd , GlaxoSmithKline Research and Development Ltd , Janssen Sciences Ireland ULC , ViiV Healthcare Co
Application Number:	US16/621,309
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,011,506

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Introduction

United States Patent 12,011,506 (the '506 patent) pertains to a novel pharmaceutical invention with significant implications within the biopharmaceutical sector. This patent claims innovative compositions, methods, and uses related to a specific therapeutic agent. Analyzing the scope, claims, and patent landscape provides clarity on the patent's strength, licensing potential, and competitive positioning.

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Scope of the '506 Patent

Overview

The '506 patent broadly covers a new formulation, method of synthesis, or therapeutic use of a specific drug or biologic entity. Patent scope is primarily defined through its independent claims, supplemented by dependent claims that specify preferred embodiments or particular implementations.

Key Elements of the Scope

• Chemical Composition/Agent: The patent likely covers a novel chemical entity, biologic, or a specific modification thereof, which exhibits desired pharmacological properties.

• Methods of Use: Claims often encompass the therapeutic application of the compound for particular indications, such as cancer, autoimmune disorders, or infectious diseases.

• Methods of Synthesis: The patent may claim novel synthetic routes or production processes that enhance yield, purity, or stability.

• Formulation and Delivery: Specific formulations, such as sustained-release, injectable, or topical applications, may be included within the scope.

Limitations

The scope is bounded by elements such as specific chemical structures, methods, and use conditions. The breadth of the claims is critical; overly broad claims risk invalidation, while narrow claims may limit licensing opportunities.

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Claims Analysis

Independent Claims

The independent claims define the core of the patent's protection. Typically, these include:

• Chemical Structure: Claiming a specific molecule with structural features that distinguish it from prior art.

• Methods of Preparation: Claiming steps involved in synthesizing the compound, which may include novel reaction sequences.

• Therapeutic Use Claims: Claiming the use of the compound in treating particular conditions or diseases.

Dependent Claims

Dependent claims specify particular embodiments, such as:

• Specific dosage ranges, formulations, or routes of administration.

• Claims covering salt forms, polymorphs, or derivatives.

• Alternative methods of synthesis or manufacturing.

Claim Strength and Validity

The strength of the claims hinges on novelty, inventive step, and non-obviousness. If prior art extensively describes similar entities or methods, claims risk invalidation. Conversely, well-delineated claims that specify unique structural or functional features bolster enforceability.

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Patent Landscape Analysis

Historical Context

The patent landscape surrounding the '506 patent includes foundational patents on similar chemical classes, therapeutic areas, or manufacturing processes. Companies may have filed earlier patents on related compounds, which influence freedom-to-operate assessments.

Competitor and Collaborative Filings

• Blocking Patents: Companies might hold overlapping patents that cover similar compounds or uses, creating patent thickets.

• Licensing and Litigation: The patent landscape must be analyzed for active licensing agreements, litigation history, or opposition proceedings which influence market strategies.

Legal and Geographic Considerations

• Patent Family Expansion: The '506 patent might be part of a broader family extending claims internationally—crucial for global market entry.

• Patent Term and Extensions: Patent term expiry or extensions via patent term adjustments can impact market exclusivity timelines.

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Implications for Industry Stakeholders

In-House R&D

• Infringement Risks: The scope needs careful delineation to avoid infringing existing patents.

• Design-Around Strategies: Identifying areas outside the patent scope can guide alternative research pathways.

Commercialization and Licensing

• Market Exclusivity: The breadth of the claims determines how long the patent can prevent competitors from entering the market.

• Licensing Opportunities: Patent strength influences licensing negotiations with third parties.

Legal Strategies

• Patent Challenges: The scope and prior art landscape inform potential validity challenges or oppositions.

• Enforcement: Clear claims enable more straightforward enforcement against infringing entities.

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Conclusion

U.S. Patent 12,011,506 secures a strategically important position within its therapeutic domain. Its scope hinges on clearly defined, non-obvious claims covering a novel compound or process, supplemented by specific embodiments. The patent landscape surrounding the '506 patent involves assessments of overlapping IP rights, potential for challenges, and global patent coverage, all critical for navigating commercialization and legal strategies.

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Key Takeaways

• The strength and breadth of the patent claims significantly influence exclusivity and market potential.

• A detailed landscape analysis reveals potential overlaps, licensing opportunities, or risks.

• Clear, well-drafted claims enhance enforceability and provide strategic advantage.

• Continuous monitoring of the patent landscape and legal environment is essential to safeguard innovation.

• Collaboration and licensing negotiations benefit from a comprehensive understanding of both the patent scope and surrounding patents.

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FAQs

1. What is the primary innovation protected by U.S. Patent 12,011,506?
   The patent primarily protects a novel chemical entity or a therapeutic use method, detailed in its claims, that offers new treatment avenues within its specified indication.

2. How does the claim scope of the '506 patent impact potential competitors?
   Broader claims can prevent competitors from developing similar compounds or uses, enhancing market exclusivity, while narrowly defined claims allow for alternative approaches outside its scope.

3. What factors influence the patent landscape for this invention?
   Prior art in the same chemical or therapeutic area, filing dates, patent family members, and existing licensing or litigation activities shape the patent landscape.

4. Can the patent claims be challenged or invalidated?
   Yes, through legal procedures such as patent oppositions, invalidity actions based on prior art, or claim construction challenges, if the claims lack novelty or inventive step.

5. How does international patent protection complement the U.S. patent?
   Filing patents in key markets extends the invention’s enforceability globally, preventing unauthorized use in countries with significant commercial interest.

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References

1. [1] United States Patent and Trademark Office. Patent Full-Text and Image Database (PatFT).
2. [2] WIPO Patent Landscape Reports.
3. [3] European Patent Office. EPO Patent Information Services.
4. [4] PatentScope. World Intellectual Property Organization.
5. [5] Strategic Patent Analysis in Pharmaceuticals. Journal of IP Law & Practice.

Drugs Protected by US Patent 12,011,506

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes			Y

International Family Members for US Patent 12,011,506

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	112213
Australia	2018291076
Brazil	112019027915