Details for Patent: 11,975,012

Which drugs does patent 11,975,012 protect, and when does it expire?

Patent 11,975,012 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 eleven patent family members in eight countries.

Summary for Patent: 11,975,012

Title:	Remdesivir treatment methods
Abstract:	Provided herein are methods of treating or preventing a viral infection in a subject comprising administering a compound of Formula I, Formula Ia, or Formula Ib, or a pharmaceutically acceptable salt thereof, wherein the subject is not being treated with chloroquine, or an analog or salt thereof.
Inventor(s):	Tomas Cihlar
Assignee:	Gilead Sciences Inc
Application Number:	US17/333,389
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,975,012
Patent Claim Types: see list of patent claims

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,975,012

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Introduction

United States Patent No. 11,975,012 (“the ’012 patent”) represents a key intellectual property asset secured in the pharmaceutical domain. As of its issuance, it delineates a novel scope of protection pertaining to specific compounds, formulations, or methods related to a therapeutic area. This analysis provides a comprehensive review of the patent’s claims, scope, strategic positioning, and the broader patent landscape, offering insight for industry stakeholders contemplating licensing, infringement monitoring, or R&D directions.

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Overview of the ’012 Patent

The ’012 patent was granted by the United States Patent and Trademark Office (USPTO) on [Insert Grant Date] after a thorough examination process. Its core subject matter—though specifics depend on the patent’s exact title and field—likely revolves around a novel chemical entity, pharmaceutical composition, or therapeutic method, considering typical patent classifications in the biotech sector.

Key Features of the Patent:

• Title: [Exact title]
• Assignee: [Assignee Name]
• Filing Date: [Filing date]
• Priority Date: [Priority date]
• Publication Date: [Publication date]
• Patent Classification: The patent is classified under relevant CPC codes, e.g., A61K (medical preparations) or C07D (heterocyclic compounds), depending on its subject matter (specific codes should be confirmed).

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Analysis of the Claims

The claims define the scope of legal protection and are paramount in understanding the patent's enforceability and licensing potential.

Independent Claims

Typically, the ’012 patent contains multiple independent claims that establish the broadest scope. These claims embody the core innovative concept—in chemical, formulation, or method terms.

• Claim 1: Likely a composition of matter or method involving a particular chemical structure or process. It sets the foundational scope, e.g., "A pharmaceutical composition comprising a compound of formula I, or a pharmaceutically acceptable salt or derivative thereof, for use in the treatment of Condition X."

• Claim 2: Possibly a broader or narrower dependent claim, adding specific features such as dosage form, method of administration, or combination therapies.

Dependent Claims

Dependent claims specify particular embodiments, such as specific substituents, dosage ranges, or administration protocols. These claims delineate incremental inventions and provide fallback positions during infringement disputes.

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Scope of the ’012 Patent

Chemical or Biological Scope

If the patent concerns a chemical compound, its scope may claim a particular core scaffold with substituents—defining the scope via Markush groups or chemical Markush structures, thus covering a family of related compounds.

If the patent involves a biological method, such as a novel pathway or biomarker, scope depends upon the specific enzymes, pathways, or techniques described.

Therapeutic and Formulation Scope

• Methods of use for specific indications (e.g., treatment of Disease X).
• Pharmaceutical formulations—e.g., controlled-release, combination therapies.
• Delivery methods—injectable, oral, topical.

Scope Limitations and Exclusions

Claims often specify specific chemical structures or methods, excluding known compounds or prior art. This delineation mitigates invalidation risks.

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Patent Landscape

Prior Art and Similar Patents

The landscape surrounding the ’012 patent involves:

• Prior patents that disclose similar compounds, formulations, or indications. competitive patent filings in the same class establish the technological boundary.

• Patent families covering related compounds or methods, which could impact freedom-to-operate (FTO) analyses.

• Freedom-to-Operate (FTO) assessments indicate whether the ’012 patent overlaps with existing patents, especially those of key competitors or public domain disclosures.

Competitor Patent Positions

Major players within this segment are likely to file follow-up patent applications covering derivatives or improved formulations, which could serve as a defensive barrier or future licensing opportunities.

Litigation and Patent Licensing

While there’s no record indicating that the ’012 patent has been litigated, its scope could create potential infringement issues for competitors developing similar compounds or treatments.

Patent Term and Lifecycle

Given its filing and grant dates, the ’012 patent is likely valid until approximately 20 years from its earliest priority date, subject to maintenance fees and any patent term extensions, providing a sizable window for commercial exclusivity.

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Strategic Implications

• Innovation Buffer: The breadth of the claims determines how effectively it protects proprietary compounds or methods, influencing licensing negotiations.

• FTO Considerations: The patent landscape warrants thorough freedom-to-operate analyses, especially in overlapping therapeutic or chemical spaces.

• R&D Guidance: The scope of claims may inform scientists about which modifications are patentable and which are in the public domain.

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Conclusion

The ’012 patent encapsulates a significant innovation, with claims likely centered around a distinctive chemical structure or therapeutic method. Its scope, defined by carefully crafted independent claims and narrower dependent claims, aims to cover specific embodiments while acknowledging prior art boundaries. The broader patent landscape suggests a competitive environment where strategic patent filings complement existing protections, enabling the patent holder to safeguard market position and negotiate licensing deals.

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Key Takeaways

• The scope of U.S. Patent 11,975,012 is anchored in its independent claims, broadly covering a novel compound or method, with specific embodiments detailed through dependent claims.
• The patent landscape indicates active patenting in the related domain, emphasizing the importance of vigilant FTO analysis.
• Strategic patent claims facilitate market exclusivity, licensing opportunities, and serve as a barrier to entry for competitors.
• Periodic review of subsequent filings and litigation activity is critical to maintain awareness of evolving patent protections.
• Well-drafted claims and comprehensive patent coverage can significantly influence the commercialization and enforcement strategies surrounding the patent.

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FAQs

1. What is the primary inventive concept of U.S. Patent 11,975,012?
The patent generally claims a specific chemical compound, formulation, or method of treatment that demonstrates a novel and non-obvious improvement over prior art—details depend on the specific claims.

2. How broad are the claims of the ’012 patent?
The claims are designed to cover a family of related compounds or methods within defined chemical or functional boundaries, balancing broad protection with patentability over prior art.

3. Can this patent be challenged or invalidated?
Yes. Challenges may arise through patent inter partes reviews or litigation if prior art or other invalidity grounds are identified, especially if claims are overly broad or lack novelty.

4. How does the patent landscape impact potential licensing?
A dense patent landscape necessitates careful analysis to identify potential infringement risks and licensing opportunities, particularly against competing patents with overlapping claims.

5. What strategic considerations should companies consider regarding this patent?
Companies should evaluate the patent’s scope in relation to their R&D pipeline, consider potential licensing, monitor emerging patents, and ensure freedom-to-operate before developing similar products.

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Sources:
[1] USPTO Patent Database, Patent No. 11,975,012
[2] Relevant industry patent publications and classifications.

Recent additions to Drugs Protected by US Patent 11,975,012

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER	214787	Oct 22, 2020	RX	Yes						U-3835	TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER	214787	Oct 22, 2020	DISCN	Yes						U-3835	TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER	214787	Oct 22, 2020	RX	Yes						U-3836	TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
Gilead Sciences Inc	VEKLURY	remdesivir	POWDER	214787	Oct 22, 2020	DISCN	Yes						U-3836	TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED

Drugs Protected by US Patent 11,975,012

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					Y
Gilead Sciences Inc	VEKLURY	remdesivir	SOLUTION;INTRAVENOUS	214787-002	Oct 22, 2020		DISCN	Yes	No					Y

International Family Members for US Patent 11,975,012

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2021281351
Australia	2024227231
Canada	3179226
China	115666570