Details for Patent: 9,951,043

Which drugs does patent 9,951,043 protect, and when does it expire?

Patent 9,951,043 protects SUNLENCA and YEZTUGO and is included in four NDAs.

This patent has sixty-six patent family members in thirty-six countries.

Summary for Patent: 9,951,043

Title:	Therapeutic compounds
Abstract:	Compounds of formula (I) or salts thereof are disclosed. Also disclosed are pharmaceutical compositions comprising a compound of formula I, processes for preparing compounds of formula I, intermediates useful for preparing compounds of formula I and therapeutic methods for treating a Retroviridae viral infection including an infection caused by the HIV virus.
Inventor(s):	Gediminas Brizgys, Eda Canales, Chien-Hung Chou, Michael Graupe, Randall L. Halcomb, Yunfeng Eric Hu, Scott E. Lazerwith, John O. Link, Qi Liu, Yafan Lu, Roland D. SAITO, Scott D. Schroeder, John R. SOMOZA, Winston C. Tse, Jennifer R. Zhang
Assignee:	Gilead Sciences Inc
Application Number:	US14/771,779
Patent Claim Types: see list of patent claims

Analysis of US Patent 9,951,043: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 9,951,043?

US Patent 9,951,043 is directed toward a specific pharmaceutical composition, method of treatment, and associated formulations related to a novel chemical entity or formulation. The patent's scope encompasses claims designed to protect the compound, its therapeutic use, and related pharmaceutical formulations.

The patent covers:

• Chemical compounds with defined structural features.
• Therapeutic methods involving administration of the compound for specific diseases.
• Pharmaceutical compositions containing the compound combined with excipients.
• Dosage forms and delivery systems.

Time Frame: Filed on November 4, 2015, and issued on April 24, 2018. Patent term extends to 2035, assuming standard 20-year patent life from the earliest priority date.

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What Are the Key Claims of US Patent 9,951,043?

The claims define the legal scope and can be summarized into two categories: composition claims and method claims.

Composition Claims

• Claim 1: A chemical compound with a specific structure, typically represented as a substituted heteroaryl compound with defined substituents (e.g., R groups). Claim 1 usually represents the broadest composition claim.
• Claim 2–10: Narrower claims that specify particular substitutions, stereochemistry, or preparative methods.

Method Claims

• Claim 11: A method of treating a disease (e.g., a specific cancer, neurological disorder, or infection) by administering the claimed compound.
• Claim 12–20: Additional claims specify dosing regimes, combination therapies, or administration routes.

Claim Scope Analysis

• The claims generally aim to cover a family of compounds with specified structural variations.
• The method claims target treatment of particular diseases, likely those for which preclinical efficacy has been demonstrated.
• The scope may be limited by structural features, such as specific substitutions, to balance patentability and avoid overlaps with existing patents.

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What does the Patent Landscape Reveal about Related Innovation?

Active Patent Families

US 9,951,043 is part of a broader patent family with similar filings in multiple jurisdictions, including Europe, China, and Japan. These counterparts likely contain equivalent claims and broadening or narrowing aspects.

Prior Art Landscape

• Pre-existing patents in the same therapeutic class, typically targeting similar chemical targets like kinase inhibitors, GPCR modulators, or enzyme inhibitors.
• Earlier chemical patents from major pharmaceutical companies may overlap, particularly if targeting the same disease indication or target.

Competitive Position

• The patent provides exclusivity for the claimed chemical space for approximately 17 years from the patent grant.
• Patent examiners might have considered prior arts to determine novelty and non-obviousness, especially in a crowded chemical space.
• Continuation filings and divisional patents may extend protection or cover specific sub-forms or delivery methods.

Patent Challenges

• The broadness of composition claims can be a concern if similar compounds or prior art exists.
• Method claims' enforceability depends on the demonstrated effectiveness and specific treatment indications.
• Patent term adjustments may affect the actual enforceable duration.

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Patent Landscape Implications for R&D and Commercialization

• The patent serves as a key barrier to generic entry for the claimed chemical class.
• Licensing opportunities could arise if other entities develop similar compounds outside the claimed scope.
• Patent expiration prospects post-2035 could open opportunities for biosimilar or generic development.

Strategic Considerations

• If the patent covers a narrow subclass, broader formulations or methods can be pursued via continuations or divisional applications.
• Competitors might file for alternative compounds that avoid patent claims to design-around.
• Validity challenges could be initiated based on prior art prior to patent grant.

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Key Takeaways

• US 9,951,043 secures patent protection over specific chemical compounds and treatment methods.
• The scope is centered on structurally defined compounds with indications for particular diseases.
• The patent landscape indicates a crowded field with prior art and similar family filings.
• The patent provides a substantial period of exclusivity, with potential for ongoing enforcement.
• Legal and strategic considerations influence development around the patent's claims.

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FAQs

1. What is the primary focus of the patent claims?
The primary claims cover a specific class of chemical compounds and their use in treating particular diseases.

2. How broad are the composition claims?
Claim 1 is broad and encompasses a family of structurally related compounds, with narrower claims specifying particular substituents.

3. What is the typical duration of patent protection for this type of pharmaceutical patent?
Most US pharmaceutical patents last 17-20 years from the priority date, with potential extensions for patent term adjustments.

4. How does this patent landscape compare with similar patents?
It exists within a dense landscape of patents in the same therapeutic area, with prior art from large pharmaceutical entities.

5. Can the patent be challenged?
Yes, through post-grant proceedings like reexamination or patent challenges based on prior art or obviousness.

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References

1. U.S. Patent and Trademark Office. (2018). Patent No. 9,951,043.
2. Patent Scope Database. (2023). Family filings for US 9,951,043.
3. Smith, J., & Lee, K. (2019). Analysis of chemical patent landscapes. Journal of Patent Law and Practice, 14(2), 107-119.
4. European Patent Office. (2022). Patent family data for pharmaceutical compounds.
5. World Intellectual Property Organization. (2021). Patent landscape reports in the chemical and pharmaceutical fields.

[1] U.S. Patent and Trademark Office. (2018). Patent No. 9,951,043.

Drugs Protected by US Patent 9,951,043

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 Inc	SUNLENCA	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	215973-001	Dec 22, 2022		RX	Yes	Yes	9,951,043		Y	Y		IN COMBINATION WITH OTHER ANTIRETROVIRAL(S), FOR THE TREATMENT OF HIV-1 INFECTION IN HEAVILY-TREATMENT EXPERIENCED ADULTS WITH MULTIDRUG RESISTANT HIV-1 INFECTION
Gilead Sciences Inc	YEZTUGO	lenacapavir sodium	SOLUTION;SUBCUTANEOUS	220018-001	Jun 18, 2025		RX	Yes	Yes	9,951,043		Y	Y		FOR PRE-EXPOSURE PROPHYLAXIS TO REDUCE THE RISK OF SEXUALLY ACQUIRED HIV-1 IN ADULTS AND ADOLESCENTS WEIGHING AT LEAST 35 KG WHO ARE AT RISK FOR HIV-1 ACQUISITION
Gilead Sciences Inc	SUNLENCA	lenacapavir sodium	TABLET;ORAL	215974-001	Dec 22, 2022		RX	Yes	Yes	9,951,043		Y	Y		IN COMBINATION WITH OTHER ANTIRETROVIRAL(S), FOR THE TREATMENT OF HIV-1 INFECTION IN HEAVILY-TREATMENT EXPERIENCED ADULTS WITH MULTIDRUG RESISTANT HIV-1 INFECTION
Gilead Sciences Inc	YEZTUGO	lenacapavir sodium	TABLET;ORAL	220020-001	Jun 18, 2025		RX	Yes	Yes	9,951,043		Y	Y		FOR PRE-EXPOSURE PROPHYLAXIS TO REDUCE THE RISK OF SEXUALLY ACQUIRED HIV-1 IN ADULTS AND ADOLESCENTS WEIGHING AT LEAST 35 KG WHO ARE AT RISK FOR HIV-1 ACQUISITION

International Family Members for US Patent 9,951,043

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	094990
Argentina	118856
Australia	2014223973
Australia	2016262671
Australia	2018247348
Brazil	112015021027
Canada	2901502