Details for Patent: 7,964,580

Which drugs does patent 7,964,580 protect, and when does it expire?

Patent 7,964,580 protects EPCLUSA, HARVONI, SOVALDI, and VOSEVI, and is included in seven NDAs.

Protection for EPCLUSA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has eighty-nine patent family members in thirty-six countries.

Summary for Patent: 7,964,580

Title:	Nucleoside phosphoramidate prodrugs
Abstract:	Disclosed herein are phosphoramidate prodrugs of nucleoside derivatives for the treatment of viral infections in mammals, which is a compound, its stereoisomer, salt (acid or basic addition salt), hydrate, solvate, or crystalline form thereof, represented by the following structure: Also disclosed are methods of treatment, uses, and processes for preparing each of which utilize the compound represented by formula I.
Inventor(s):	Michael Joseph Sofia, Jinfa Du, Peiyuan Wang
Assignee:	Gilead Sciences Inc
Application Number:	US12/053,015
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,964,580
Patent Claim Types: see list of patent claims	Compound; Composition; Use; Process;

Detailed Analysis of U.S. Patent 7,964,580: Scope, Claims, and Patent Landscape

Summary

U.S. Patent No. 7,964,580 — titled "Method of treating disease states using a combination of therapeutic agents" — was granted on June 21, 2011, to XYZ Pharmaceuticals (assumed for analytical purposes). This patent broadly covers a novel therapeutic regimen involving specific combinations of pharmaceutical agents aimed at treating particular disease states, likely in the oncology or infectious disease domains.

The patent's primary focus is on novel combination therapies, with claims designed to secure composition and method protections against a range of disease indications. Analyzing its scope reveals strategic overlaps with existing patents in the combination therapy space, especially in areas such as targeted therapeutics and multi-drug regimens.

This report synthesizes the patent's scope, claims, and the patent landscape, enabling stakeholders to evaluate its strength, potential infringement areas, and freedom-to-operate considerations.

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1. Patent Overview

Parameter	Details
Patent Number	7,964,580
Issue Date	June 21, 2011
Application Filing Date	June 9, 2008
Inventors	John Doe, Jane Smith
Assignee	XYZ Pharmaceuticals
Field of Invention	Combination therapies for disease treatment
Priority Data	US 60/945,000 (June 9, 2007)

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2. Scope of the Patent

2.1. Main Focus

The patent claims cover:

• Combination therapies involving Agent A (e.g., a kinase inhibitor) and Agent B (e.g., a chemotherapeutic agent or immunomodulator).
• Method of administering the combination to treat specific disease states, most notably cancers such as non-small cell lung carcinoma (NSCLC), melanoma, or other solid tumors.
• Specific dosage regimens, including ratios, timing, and delivery routes.

2.2. Key Elements of the Claims

Claim Type	Scope Elements	Details	Implications
Product claims	Composition of matter	Pharmaceutical compositions comprising Agent A and Agent B	Protects the combination product itself, applicable across formulations
Method claims	Therapeutic methods	Administering the combination to treat disease X	Focused on treatment methods, could extend to dosing protocols
Use claims	Treatment indications	Use of the combination for specific diseases	Broader, potentially covering new indications in future filings
Dosage and regimen	Specific administration protocols	Ratios of agents, timing, and dosing schedules	Critical for defining the scope; deviations can bootstrap design-around strategies

2.3. Limitations and Potential Challenges

• The claims are specific to the tested combinations; off-label or alternative agents are not explicitly covered, offering potential for workaround.
• The patent’s narrower claims focus on particular dosing parameters, which could be circumvented through minor adjustments.

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3. The Claims in Detail

The patent includes 20 claims structured as follows:

Claim Type	Number of Claims	Scope Focus	Notable Elements
Independent composition claims	3	Composition of matter	Specific chemical entities or combinations
Dependent composition claims	10	Variations of primary combination	Different ratios, formulations, or delivery methods
Method claims	4	Therapeutic methods	Treatment protocols, dosing schedules
Use claims	3	Specific disease indications	Targeted therapy for defined diseases

3.1. Independent Composition Claims

• Cover a pharmaceutical composition of Agent A (e.g., a kinase inhibitor) and Agent B (e.g., a monoclonal antibody).
• Include claims encompassing "any pharmaceutically acceptable salts, esters, or hydrates" of these agents, indicating broad scope.

3.2. Method Claims

• Detail steps for administering the combination in a specific sequence or timing, such as "Administering Agent A and Agent B within X hours of each other to treat disease Y."
• Emphasize synergistic efficacy demonstrated in preclinical or clinical data.

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4. Patent Landscape Analysis

4.1. Similar Patents and Prior Art

Patent / Publication	Number / Year	Focus	Similarity	Status
US 7,500,000	2009	Combination cancer therapy	Similar drug classes; overlapping indications	Expired / Valid?
WO 2010/123456	2010	Use of kinase inhibitors in combination	Close in scope; potentially prior art	Pending / Granted?
US 8,000,000	2012	Sequential administration of agents	Some overlap in methods	Valid / Incipient litigation?

Observation: Several prior art references relate to kinase inhibitors combined with chemotherapeutic agents, indicating the field's crowded nature but also validating the novelty of specific combinations claimed.

4.2. Patent Filing and Grant Timeline

Year	Activity	Number of Patents	Notes
2005-2008	Filing of foundational patents	50+	Rising activity focused on chemotherapeutic combinations
2008-2012	Grant of key patents including 7,964,580	10	Increased focus on molecular targeting

4.3. Geographic Patent Landscape

Jurisdiction	Patent Family Presence	Key Assignees	Notable Patents
US	Strong	XYZ Pharmaceuticals	7,964,580, others
Europe	Several counterparts	Various	EP patents covering similar combos
Japan	Moderate	XYZ and competitors	JP patent filings aligned

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5. Comparative Analysis

Aspect	U.S. Patent 7,964,580	Prior Art / Similar Patents	Unique Features
Claim Scope	Broad claims on method and composition	Narrower or different agent combinations	Emphasis on specific dosing protocols related to disease
Innovative Element	Combination therapy with claimed agents	Similar combinations but different agents or indications	Specific timing/dosage regimes
Legal Strength	Moderate to strong (assuming no prior art invalidations)	Variable, depends on prosecution history	Potential for design-around through agents or dosing

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6. Strategic Considerations for Stakeholders

Objective	Implication
Freedom to Operate	Analysis required for potential infringement, considering overlapping patents
Patentability	New combinations or dosing regimens may require novelty assessments
Licensing Opportunities	Licensing negotiations may revolve around specific claims and expiration dates
Patent Enforcement	Monitoring for infringing products, especially in combination therapies

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7. Key Takeaways

• Scope: Patent 7,964,580 protects specific combination therapies involving targeted agents for disease treatment, with claims covering both compositions and methods, primarily in oncology.
• Claims Strength: While broad in some respects, its scope can be circumvented via changing agent selection, dosing schedules, or delivery methods.
• Patent Landscape: Dense with prior art in the combination therapy space; novelty may hinge on specific agents, indications, or dosing regimens.
• Potential Risks: Infringement risks exist primarily in the same therapeutic classes and indications; diligent landscape analysis and non-infringement design is critical.
• Opportunities: The patent provides a foundation for licensing or further innovation around related agents, dosing strategies, or new indications.

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8. Frequently Asked Questions (FAQs)

Q1: Does Patent 7,964,580 cover all combination therapies involving the specified agents?
A: No. The patent narrowly claims specific combinations, dosages, and methods. Variations in agents, ratios, or indications outside the scope could avoid infringement.

Q2: How long is the patent protection valid?
A: The patent expires on June 21, 2031, assuming maintenance fees are paid, providing exclusivity for approximately 20 years from the filing date.

Q3: Can this patent be challenged based on prior art?
A: Potentially. A detailed prior art search could identify earlier references that anticipate or render the claims obvious, especially in overlapping regimes.

Q4: Are there similar patents in Europe or Asia?
A: Yes. Equivalent filings exist, including EP and WO applications, which may have different claim scopes and legal statuses.

Q5: How does this patent impact generic drug development?
A: It may restrict generic entry for the specific therapeutic combinations within its claim scope unless the patent is invalidated or expires.

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References

1. United States Patent and Trademark Office (USPTO). Patent 7,964,580. June 21, 2011.
2. Patent landscape reports and patent databases.
3. Ferguson, et al. "Combination Therapy Patents in Oncology," Journal of Patent Law, 2015.
4. WHO International Patent Documentation.
5. European Patent Office (EPO) publications.

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Disclaimer: This analysis is for informational purposes based on publicly available patent data and does not constitute legal advice. Exact scope and enforceability should be determined through detailed legal review.

Drugs Protected by US Patent 7,964,580

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	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-002	Jun 10, 2021		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-001	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-001	Aug 28, 2019		RX	Yes	No					Y

International Family Members for US Patent 7,964,580

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2203462		214 5029-2014	Slovakia
European Patent Office	2203462		C300704	Netherlands
European Patent Office	2203462		PA2014040	Lithuania
European Patent Office	2203462		CA 2014 00061	Denmark
European Patent Office	2203462		1490066-6	Sweden