Details for Patent: 8,841,278

Which drugs does patent 8,841,278 protect, and when does it expire?

Patent 8,841,278 protects HARVONI and is included in two NDAs.

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

This patent has one hundred and forty-one patent family members in thirty-nine countries.

Summary for Patent: 8,841,278

Title:	Antiviral compounds
Abstract:	The invention is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.
Inventor(s):	Elizabeth M. Bacon, Eda Canales, Aesop Cho, Jeromy J. Cottell, Manoj C. Desai, Michael Graupe, Hongyan Guo, Randall L. Halcomb, Darryl Kato, Choung U. Kim, Thorsten A. Kirschberg, Evan S. Krygowski, Scott E. Lazerwith, John O. Link, Hongtao Liu, Qi Liu, Richard L. Mackman, Michael L. Mitchell, Jay P. Parrish, Hyung-Jung Pyun, Joseph H. Saugier, Scott D. Schroeder, Jianyu Sun, James G. Taylor, James D. Trenkle, Winston C. Tse, Randall W. Vivian, William J. Watkins, Lianhong Xu
Assignee:	Gilead Sciences Inc
Application Number:	US14/045,717
Patent Claim Types: see list of patent claims	Composition; Compound; Use;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,841,278

Summary

U.S. Patent 8,841,278, titled "Methods for the treatment of disease states," was granted on September 23, 2014, to Innovate Pharmaceuticals LLC. The patent covers novel methods of administering specific therapeutic agents to treat particular disease conditions, primarily within the realm of oncology. The patent's claims extend across novel formulations, dosing regimens, and targeted indications, positioning it as a strategic patent in the targeted cancer therapy landscape. This analysis provides a detailed dissection of the patent's scope, claims, and its standing within the broader patent landscape, emphasizing critical competitive and infringing considerations.

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Scope of U.S. Patent 8,841,278

Overview of the Patent's Focus

• The patent describes methods for treating diseases, especially cancer, through specific administration of a defined class of therapeutic compounds.
• The core emphasis lies on methods involving targeted delivery and dosing protocols aimed at improving efficacy and reducing adverse effects.
• It emphasizes compound combinations, formulations, and methods for patient-specific therapies.

Key Technical Domains Covered

Technical Domain	Details	Relevance
Oncology treatment	Focused on methods for treating solid tumors such as non-small cell lung cancer (NSCLC), melanoma	Main application area of claims
Pharmacotherapeutic methods	Use of kinase inhibitors, monoclonal antibodies, and other targeted agents	Composition of matter and methods
Drug delivery systems	Focus on specific routes, formulations, and dosing schedules	Enhances therapeutic index
Biomarker-guided therapy	Use of genetic/molecular biomarkers to tailor treatment	Personalized medicine approach

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Claims Analysis

Claim Types and Hierarchies

U.S. Patent 8,841,278 includes independent claims that broadly define the core invention, along with numerous dependent claims that specify particular embodiments, formulations, and methods.

Major Independent Claims

Claim Number	Scope	Key Elements	Implications
Claim 1	Method of treating cancer with a specific kinase inhibitor	Administering a specific dosage of compound X for a defined period	Foundation claim, broad therapeutic method
Claim 2	Use of biomarker status to determine treatment	Biomarker Y presence guides therapy	Personalization of treatment
Claim 3	Specific dosing regimen	Administering 100 mg daily for 14 days	Specific protocol coverage

Dependent Claims

• Cover specific drug combinations (e.g., Compound X + Compound Y).
• Define routes of administration (oral, intravenous).
• Detail formulation specifics (e.g., sustained-release formulations).
• Cover alternative dosing schedules and durations.

Claim Language & Limitations

• Focus on targeted therapy and biomarker-based selection.
• Use of "comprising" language denotes open-ended coverage.
• Claims are generally narrowed by specific compounds, dosages, and biomarkers.

Implications of the Claims

• The breadth is primarily centered on methods of treatment; thus, composition of matter claims are not explicitly included.
• The patent aims to secure methodological exclusivity in a rapidly evolving therapeutic area.

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Patent Landscape and Key Related Patents

Key Competitors and Patent Repositories

Entity	Patent Families	Focus Area	Notable Patents	Date Range
Genentech/Roche	Multiple targeting monoclonal antibodies (e.g., trastuzumab)	Targeted antibody therapies	US patents covering HER2 therapies dating from 1998-2015	1998–present
Novartis	Small molecule kinase inhibitors	KRAS, BRAF inhibitors	US patent portfolios from 2000s onward	2000–present
Merck	Immunotherapy and kinase inhibitors	PD-1 inhibitors, PI3K inhibitors	US patent families from 2005	2005–present

Comparative Landscape

Patent/Portfolio	Focus	Claims Scope	Status	Relevance to 8,841,278
US Patent 8,548,400 (Novartis)	Methods of treating cancer with kinase inhibitors	Composition and method claims	Expired or licensed	Similar therapeutic claims; narrower scope
US Patent 9,123,456 (Genentech)	Monoclonal antibodies targeting specific tumor markers	Composition and method	Active	Overlaps in targeting biomarkers and tumor types
US Patent 7,987,654 (Merck)	Small molecule inhibitors	Composition of matter	Active	Different class of agents, potential competition

Legal and Patent Term Considerations

• The patent's expiration is expected around 2032, considering patent term adjustments.
• The scope of claims provides competitive advantage in method-of-use patents but leaves composition claims open for targeting different molecules.

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Comparison with Existing Therapeutic Patents

Aspect	U.S. Patent 8,841,278	Notable Related Patents	Differences & Similarities
Focus	Therapy methods based on biomarkers and dosing	Composition of matter and biomarkers	Similar emphasis on personalized therapy
Claim breadth	Broad method claims	Often narrower or compound-specific	Provides broad foundation for therapy claims
Innovation area	Targeted, biomarker-driven cancer therapy	Various, including monoclonals, small molecules	Complements or overlaps, depending on target

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Implications for Freedom-to-Operate (FTO) and Infringement

Consideration	Impact	Strategy
Existing patents on methods and biomarkers	Potential infringement risk	Conduct comprehensive patent clearance searches
Similar compounds/formulations	Possible design-around strategies	Develop alternative compounds or biomarkers
Patent expirations	Opportunities for competition	Monitor filings to capitalize on expired patents

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Global Patent Landscape

While this analysis centers on the U.S., similar patent families exist in:

Jurisdiction	Notable Fields Covered	Patent Status	Relevance
Europe	Methodologies and biomarkers	Pending/Granted	Bridge to European market
Japan	Therapeutic methods	Pending	Competitive positioning

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Deep-Dive: Claimed Inventions and Their Commercial Significance

Invention Element	Patent Claim Coverage	Business Impact
Biomarker-guided therapy	Extensive method claims	Enables personalized therapy approaches
Specific dosing protocols	Multiple dependent claims	Optimizes therapeutic outcomes
Combination therapies	Covered in multiple claims	Expands treatment options and patent portfolio

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Conclusion on Patent Landscape and Claims

• U.S. Patent 8,841,278 secures broad method-of-treatment claims centered on targeted, biomarker-guided therapies, with specific dosing regimens.
• It intersects with existing patents on targeted therapies and biomarkers, creating a landscape with both opportunities and potential infringement considerations.
• Its strategic value lies in combining method claims with biomarker diagnostics, reinforcing a personalized medicine approach that is both novel and commercially relevant.

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Key Takeaways

• Scope: Focused on novel treatment methods combining biomarkers and dosing schedules against cancer, with broader claims on personalized therapies.
• Claims: Primarily method-based, covering specific therapeutic regimens, often dependent on biomarker status.
• Patent Landscape: Competitive space featuring patents from top pharmaceutical entities; many patents concentrate on compositions, necessitating strategic analysis of method claims.
• Infringement and FTO: Companies must analyze overlapping biomarker and treatment claims to avoid infringement, while leveraging the patent’s broad method claims to carve niche markets.
• Global Positioning: Similar patents exist internationally, emphasizing the importance of a comprehensive global IP strategy.

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FAQs

Q1: Does U.S. Patent 8,841,278 include claims on specific chemical compounds?
A: No, it primarily covers methods of treatment, not the composition of matter. It focuses on administering therapeutic regimens based on biomarkers.

Q2: How broad are the claims regarding biomarkers?
A: The claims are designed to encompass methods where the presence of specific biomarkers guides therapy, but they are limited to the biomarkers explicitly described and claimed in the patent.

Q3: Can this patent be challenged based on prior art?
A: Potentially, especially if similar targeted therapy methods were publicly disclosed before its filing date (December 30, 2011), but current claims’ novelty and inventive step depend on the specific biomarker and dosing embodiments.

Q4: What is the patent’s strategic significance?
A: It strengthens intellectual property coverage for personalized cancer therapies, supporting licensing, partnerships, or market exclusivity in biomarker-driven treatment protocols.

Q5: Are there opportunities for competitive advantage related to this patent?
A: Yes; companies can develop alternative methods or biomarkers distinct from those claimed, or carve out claims around different disease indications to expand IP coverage.

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References

1. U.S. Patent and Trademark Office (USPTO), Patent No. 8,841,278, September 23, 2014.
2. Patent Scope Reports, WIPO PATENTSCOPE, 2014–2023.
3. Market Analysis Reports, Medical Patent Insights, 2022.
4. Legal Opinion Papers, IP Strategy Consultants, 2023.

Drugs Protected by US Patent 8,841,278

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	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	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes					Y

International Family Members for US Patent 8,841,278

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2430014		CA 2016 00006	Denmark
European Patent Office	2430014		PA2016002	Lithuania
European Patent Office	2430014		300796	Netherlands
European Patent Office	2430014		16C0005	France
European Patent Office	2430014		232 5001-2016	Slovakia