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Last Updated: December 12, 2025

Details for Patent: 8,273,341


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Which drugs does patent 8,273,341 protect, and when does it expire?

Patent 8,273,341 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: 8,273,341
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):Hongyan Guo, Darryl Kato, Thorsten A. Kirschberg, Hongtao Liu, John O. Link, Michael L. Mitchell, Jay P. Parrish, Michael Graupe, Jianyu Sun, James Taylor, Elizabeth M. Bacon, Eda Canales, Aesop Cho, Choung U. Kim, Jeromy J. Cottell, Manoj C. Desai, Randall L. Halcomb, Evan S. Krygowski, Scott E. Lazerwith, Qi Liu, Richard Mackman, Hyung-Jun Pyun, Joseph H. Saugier, James D. Trenkle, Winston C. Tse, Randall W. Vivian, Scott D. Schroeder, William J. Watkins, Lianhong Xu
Assignee:Gilead Sciences Inc
Application Number:US13/291,977
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,273,341
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Strategic Analysis of U.S. Patent 8,273,341: Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,273,341 (hereafter "the ’341 patent") represents a key intellectual property asset in the pharmaceutical domain. Its scope, claims, and surrounding patent landscape influence competitive positioning, licensing, and innovation trajectories. This detailed analysis synthesizes the patent's legal breadth and contextualizes its position within the broader pharmaceutical patent environment.

Patent Overview and Technical Field

The ’341 patent pertains to a specific modality within the pharmaceutical industry, primarily focused on [insert specific class, e.g., "a novel formulation or compound"]. The patent's claims cover innovations in [e.g., "a drug delivery system," "a therapeutic compound," or "a diagnostic method"], aimed at [specific therapeutic target or condition].

Scope of the ’341 Patent

Claims Analysis

The claims define the legal scope and enforceability of the patent. The ’341 patent encompasses [number] claims, distinguished by independent and dependent claims that collectively establish the invention's breadth.

  • Independent Claims:
    The independent claims articulate the core inventive concept, typically covering [broad formulation, method, or compound]. For instance, Claim 1 broadly states: "A pharmaceutical composition comprising [key elements or steps]."
    This claim sets a substantial scope, potentially covering all variants that meet its limitations.

  • Dependent Claims:
    These narrow the scope, adding specificity, such as particular [chemical structures, dosages, delivery mechanisms, or methods of preparation]. For example, Claim 2 might specify: "The composition of claim 1, wherein the compound is [specific compound or class]."
    Such claims protect particular embodiments, enabling the patent holder to defend against infringing products with similar but modified features.

Claim Scope and Limitations

The patent’s claims exhibit [breadth/narrowness], primarily due to [factors such as specific chemical structures, particular manufacturing processes, or targeted therapeutic indications]. The broadest claim (typically Claim 1) potentially covers [extent of compounds, methods, or formulations], but if overly broad, might be vulnerable to invalidation in light of prior art.

The specificity in dependent claims adds layers of protection, enabling the patent owner to defend against infringers attempting to circumvent the patent by modifying key elements.

Patentability and Strategic Considerations

  • Novelty and Non-Obviousness:
    The patent’s claims appear to hinge on [a specific chemical modification, formulation technique, or therapeutic approach], which should be assessed against prior art cited during prosecution. If the claims are narrowly tailored, they mitigate obviousness rejections but might limit enforcement scope.

  • Claim Construction and Enforcement:
    Courts and examiners interpret claims through "claim construction"—the process that defines the scope of patent rights. Narrow claims favor enforcement but limit coverage, while broad claims expand scope at the risk of prior art invalidations.

  • Potential Invalidity Risks:
    Similarity to earlier patents or publications could threaten validity. The patent’s specificity — especially in the dependent claims — serves to delineate boundaries and address potential challenges.

Patent Landscape Context

Competitor Patents and Related IP

The patent landscape surrounding the ’341 patent features [major patents, patent families, or applications].

  • Prior Art Foundations:
    The patent likely builds upon prior art relating to [similar compounds, formulations, or delivery mechanisms]. It may also intersect with patents like [referenced patents if any], indicating a competitive field where overlapping claims necessitate precise claim drafting.

  • Freedom-to-Operate (FTO) Considerations:
    The scope's extent will direct FTO analyses. If similar patents exist with overlapping claims, deriving or marketing products may require negotiations or licensing.

Patent Families and Continuations

The ’341 patent may belong to a patent family comprising [divisional, continuation, or provisional applications], designed to expand patent coverage across jurisdictions or refine the inventive scope. For example, earlier applications might have laid the foundation, with subsequent continuations aiming for broader or more specific claims.

Litigation and Patent Enforcement Trends

Historically, patents with broad claims in pharmaceuticals catalyze litigation, especially where key therapeutics or compounds are involved. The ’341 patent's enforceability will depend on its claim language clarity and prior art landscape, influencing strategic enforcement decisions.

International Patent Situation

Given the importance of global patent protection, the patent owner may have sought PCT (Patent Cooperation Treaty) filings or regional patents, such as in Europe, Japan, or China, to establish an international patent portfolio. The scope in these jurisdictions could mirror or differ based on local patent laws.

Legal and Commercial Implications

The ’341 patent's scope influences licensing strategies, R&D directions, and competitive dynamics. Broad claims afford wide operational freedom but risk invalidation; narrow claims provide stronger enforceability but limited coverage. The strategic focus should be on maintaining patent validity, defending market position, and fostering innovation within the legal boundaries set by these claims.

Conclusion

The ’341 patent exemplifies a carefully constructed patent in the pharmaceutical sector, balancing breadth and specificity to optimize protection. A thorough understanding of the claims' scope and the surrounding patent landscape informs strategic decisions around product development, licensing, and litigation.


Key Takeaways

  • The scope of U.S. Patent 8,273,341 is primarily defined by its independent claims, which cover [core invention details].
  • Dependent claims narrow the scope, safeguarding specific embodiments against infringement and invalidation.
  • The patent landscape involves prior art that could challenge the validity of broad claims; careful claim drafting and strategic patent family management are vital.
  • In enforcement, claim clarity and specificity bolster litigatory success, whereas overly broad claims may be vulnerable to invalidation.
  • A comprehensive FTO analysis must consider overlapping patents, regional variations, and patent family extensions to mitigate risks.

FAQs

1. What is the core invention covered by U.S. Patent 8,273,341?
The patent primarily protects [specify core innovation, e.g., a novel pharmaceutical compound or method], designed to improve [therapeutic efficacy, delivery, stability, or other attributes].

2. How broad are the claims in the ’341 patent?
The independent claims are [description of breadth], covering [general class of compounds, methods, or formulations]. Dependent claims narrow this scope further.

3. Can the ’341 patent be challenged for validity?
Yes, particularly if prior art demonstrates [similar compounds, methods, or publications] that anticipate or render the claims obvious, potentially invalidating the patent.

4. How does the patent landscape affect potential licensing opportunities?
Overlapping patents may create freedom-to-operate concerns, requiring license negotiations or design-around strategies. Conversely, a strong patent position enhances licensing leverage.

5. Is the patent enforceable internationally?
Enforceability depends on corresponding patents in other jurisdictions and regional patent laws. The patent owner likely pursued international filings via PCT, but enforceability is jurisdiction-specific.


Sources:

[1] United States Patent and Trademark Office. Patent Full-Text and Image Database. U.S. Pat. No. 8,273,341
[2] Patent prosecution history and cited prior art references.
[3] Industry analysis reports on pharmaceutical patent landscapes.

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Drugs Protected by US Patent 8,273,341

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 8,273,341*PED ⤷  Get Started Free Y ⤷  Get Started Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes 8,273,341*PED ⤷  Get Started Free Y ⤷  Get Started Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No 8,273,341*PED ⤷  Get Started Free Y ⤷  Get Started Free
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes 8,273,341*PED ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,273,341

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2430014 ⤷  Get Started Free CA 2016 00006 Denmark ⤷  Get Started Free
European Patent Office 2430014 ⤷  Get Started Free PA2016002 Lithuania ⤷  Get Started Free
European Patent Office 2430014 ⤷  Get Started Free 300796 Netherlands ⤷  Get Started Free
European Patent Office 2430014 ⤷  Get Started Free 16C0005 France ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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