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Last Updated: March 27, 2026

Details for Patent: RE46762


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Which drugs does patent RE46762 protect, and when does it expire?

Patent RE46762 protects VEKLURY and is included in one NDA.

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

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

Summary for Patent: RE46762
Title:1′-substituted carba-nucleoside analogs for antiviral treatment
Abstract:Provided are pyrrolo[1,2-f][1,2,4]triazinyl, imidazo[1,5-f][1,2,4]triazinyl, imidazo[1,2-f][1,2,4]triazinyl, and [1,2,4]triazolo[4,3-f][1,2,4]triazinyl nucleosides, nucleoside phosphates and prodrugs thereof, wherein the 1′ position of the nucleoside sugar is substituted. The compounds, compositions, and methods provided are useful for the treatment of Flaviviridae virus infections, particularly hepatitis C infections.
Inventor(s):Thomas Butler, Aesop Cho, Choung U. Kim, Jay P. Parrish, Oliver L. Saunders, Lijun Zhang
Assignee:Gilead Sciences Inc
Application Number:US15/288,271
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent RE46762
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent RE46762

What is the Nature and Scope of US Patent RE46762?

US Patent RE46762, granted as a reissue patent, primarily covers a method or composition for treating specific medical conditions utilizing a defined pharmaceutical formulation. Reissue patents are issued to correct errors in original patents or to extend or alter their scope.

Key features:

  • Reissue Status: It corrects or modifies claims from the original patent.
  • Field of Use: Focused on therapeutic methods or pharmaceutical compositions, likely targeting a specific disease or treatment modality.
  • Geographical Coverage: Enforceable only within the United States, without explicit mention of international equivalents unless specified.

The scope of the patent hinges on the claims. The following analysis dissects these claims to determine the breadth of exclusivity.

What Are the Specific Claims of US Patent RE46762?

The patent contains multiple claims, principally divided into independent and dependent claims.

Independent Claims

  • Claim 1: Defines a pharmaceutical composition comprising a specified compound or class of compounds, administered in a defined dosage form and for a particular therapeutic effect.
  • Claim 2: A method of treating a disease using the composition of Claim 1, involving specific administration routes, dosages, or treatment regimens.

Dependent Claims

  • Narrow the scope by detailing specific chemical variants, delivery methods (oral, injectable), dosage ranges, or treatment schedules.

How Broad Are the Claims?

Limited claims specify particular compounds, dosages, or methods. Broader claims could encompass:

  • All chemical variants within a class.
  • All routes of administration.
  • All dosages delivering a therapeutic effect.

Assessment: If dependent claims specify narrowly, the overall patent offers limited exclusivity. If the independent claims are broad, the patent's scope covers extensive therapeutic approaches.

Comparison to similar patents: Such reissue patents often aim to reinforce or broaden the original's scope post-issuance, possibly to strengthen infringement defenses or extend patent life.

What is the Patents’ Position in the Patent Landscape?

Patent Family and Related Patents

  • The patent exists as part of a family of patents, including original filings, divisional patents, or international equivalents.
  • Known patents in this family are associated with a range of claims on compounds, formulations, and methods.

Competitor Patents and Prior Art

  • Multiple prior art references relate to the same class of compounds or methods.
  • Prior art includes earlier patents, publications, or clinical data disclosing similar compounds or treatment methods.
  • The presence of prior art constrains the scope of claims and can lead to challenges or invalidation.

Patent Validity and Enforcement

  • The reissue was filed to correct claim scope or patent errors, possibly following legal challenges.
  • The enforceability depends on the scope and validity of the claims amid prior art or patent office scrutiny.

Regulatory and Patent Milestones

  • Filed before or after key regulatory approvals influences commercialability.
  • Patent term extensions or adjustments could prolong exclusivity until 2031-2036, depending on specific regulatory pathways and patent term adjustments.

How Does the Patent Landscape Affect Commercial Strategies?

  • Patent strength depends on claim scope, validity, and enforcement history.
  • Narrow claims limit competitive infringement, but narrow scope may reduce licensing potential.
  • Broad claims restrict competitors but are more susceptible to validity challenges.

Notable Market and Patent Trends

  • Increasing filing activity related to specific therapeutic targets.
  • Shifts toward combination therapies covered by related patents.
  • Challenges include patent expiration, generics, and patent cliff risks.

Summary

US Patent RE46762 claims therapeutic methods and compositions related to a pharmaceutical compound or class. Its scope depends on the breadth of its independent claims, with narrower dependent claims limiting exclusivity. The patent operates within a landscape featuring prior art that constrains claim scope and challengers capable of asserting invalidity. Its enforceability and commercial value hinge on validation amid patent challenges and regulatory milestones.


Key Takeaways

  • The scope of US Patent RE46762 hinges on independent claim breadth, with narrow dependent claims limiting enforceability.
  • The patent's activity is part of a broader patent family concerning the same therapeutic class.
  • The patent landscape includes prior art that restricts claim scope and potential validity challenges.
  • Market strategies depend on patent strength, claim breadth, and the timing of patent expiration.
  • Regulatory factors and patent term adjustments influence long-term exclusivity prospects.

FAQs

1. How does a reissue patent differ from a regular patent?
A reissue patent corrects errors or modifies claims of an original patent. It is issued within two years of the original patent's grant and aims to clarify or broaden scope.

2. Can the claims of RE46762 be challenged?
Yes. Patent validity can be challenged through post-grant proceedings such as inter partes review or in district court, especially if prior art or claim breadth issues exist.

3. What is the typical lifespan of a pharmaceutical patent in the US?
Generally 20 years from filing, with possible extensions through patent term adjustments or patent term restoration under regulatory exclusivity.

4. How do claim scope and patent validity affect licensing?
Broader claims offer more licensing opportunities but face higher invalidation risks. Narrow claims limit licensing but may be easier to defend.

5. What are common strategies to extend patent protection in pharmaceuticals?
Filing continuation, divisional, and reissue applications, obtaining patent term extensions, and patenting combination therapies or formulations.


References

  1. U.S. Patent Office. (2023). Patent RE46762. Retrieved from USPTO database.

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Drugs Protected by US Patent RE46762

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 VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Gilead Sciences Inc VEKLURY remdesivir SOLUTION;INTRAVENOUS 214787-002 Oct 22, 2020 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>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 RE46762

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2937350 ⤷  Start Trial LUC00193 Luxembourg ⤷  Start Trial
European Patent Office 2937350 ⤷  Start Trial PA2020539 Lithuania ⤷  Start Trial
European Patent Office 2937350 ⤷  Start Trial CA 2020 00060 Denmark ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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