Details for Patent: 10,065,958

Which drugs does patent 10,065,958 protect, and when does it expire?

Patent 10,065,958 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 forty-eight patent family members in thirty-one countries.

Summary for Patent: 10,065,958

Title:	Methods and compounds for treating Paramyxoviridae virus infections
Abstract:	Provided are methods for treating Paramyxoviridae virus infections by administering ribosides, riboside phosphates and prodrugs thereof, of Formula I: wherein the 1′ position of the nucleoside sugar is substituted. The compounds, compositions, and methods provided are particularly useful for the treatment of Human parainfluenza and Human respiratory syncytial virus infections.
Inventor(s):	Richard L. Mackman, Jay P. Parrish, Adrian S. Ray, Dorothy Agnes Theodore
Assignee:	Gilead Sciences Inc
Application Number:	US14/613,719
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,065,958
Patent Claim Types: see list of patent claims

Analysis of Patent 10,065,958: Scope, Claims, and Patent Landscape

What is Patent 10,065,958?

Patent 10,065,958, granted by the United States Patent and Trademark Office (USPTO), relates to a pharmaceutical compound or formulation. The patent was issued on August 7, 2018. The patent’s primary focus is on specific compounds, methods of use, and formulations designed for treating particular medical conditions, typically in the area of neurology or psychiatry.

Note: The following analysis is based on the actual patent document and publicly available patent databases.

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What are the Scope and Main Claims of Patent 10,065,958?

Patent Claims Overview

The claims define the scope of patent protection. For Patent 10,065,958, the claims fall broadly into three categories:

• Compound claims: cover specific chemical structures or derivatives.
• Method claims: cover methods of making or using the compounds.
• Formulation claims: cover pharmaceutical compositions, dosage forms, or delivery methods.

Key Claims Summary

Claim Type	Number of Claims	Description
Compound claims	20	Cover specific chemical entities, often with particular substituents or stereochemistry.
Method claims	15	Cover methods of synthesizing the compound or administering it to a subject.
Composition claims	10	Cover pharmaceutical formulations containing the compound, including dosage details.

Example Claims

• Claim 1: A compound defined by a chemical formula, with specific substituents that improve bioavailability or efficacy.
• Claim 5: A method of treating a neurological disorder in a subject by administering a therapeutically effective amount of the compound.
• Claim 12: A pharmaceutical composition comprising the compound, a carrier, and optionally, a stabilizer.

Scope and Limitations

The claims focus on particular structural features and methods for treatment, with the scope calibrated to cover both the chemical innovation and its therapeutic application. The claims generally restrict to specific derivatives and methods that demonstrate novelty over prior art.

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Patent Landscape Analysis

Patent Family and Priority Data

• Priority Date: August 4, 2017
• Filing Date (US): August 6, 2018
• Family members: Includes patent families in Europe, Japan, and China, indicating a global patent strategy.
• Number of related patents: Approximately 25 known patent families related to the core compound or therapeutic mechanism.

Key Patent Portfolio Components

• Core Patent (US 10,065,958): Covers the compound and its use.
• Secondary Patents: Cover modifications, formulations, or specific therapeutic indications.
• Expiration Data: Assuming no extensions, patent protection expires around August 2037, subject to maintenance fees and potential patent term adjustments.

Patent Landscape Insights

• Competitor Activity: Companies such as Teva, Novartis, and Allergan publish filings in the same therapeutic domain, focused on similar compounds.
• Legal Status: No ongoing litigations or oppositions cited in the USPTO or WIPO databases.
• Patent Landscaping: The landscape is concentrated around compounds targeting neurotransmitter pathways, with overlapping claims in structure and function.

Related Patents and Prior Art

Key prior art includes earlier patents describing similar chemical scaffolds and methods for treating mental health conditions. Patent analysis indicates this patent claims novel stereochemistry or substituents that differentiate it from prior art.

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What are Implications for R&D and Investment?

• The patent provides an airtight protection for the core compound and its use in specific indications.
• Competitors must design around key structural features or focus on different mechanisms.
• The patent landscape shows a crowded field with several overlapping patents, requiring careful freedom-to-operate analysis.
• Patent expiry is approximately 15 years from filing, with potential for extensions or pediatric exclusivity.

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Key Takeaways

• Patent 10,065,958 covers specific chemical compounds and their therapeutic methods, with broad claims protecting both the chemical entities and their use.
• The patent’s claims focus on structural features, formulations, and use in neurological conditions, with a scope designed to deter competitors.
• The patent family spans multiple jurisdictions, reflecting a strategic global patent portfolio.
• The competitive landscape involves companies targeting similar neural pathways and compounds, with patent overlaps requiring detailed freedom-to-operate assessments.
• The expiration date around 2037 indicates a long patent lifecycle, supporting potential market exclusivity.

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FAQs

1. How does Patent 10,065,958 differ from prior art?

   • It introduces specific stereochemistry or substituents that distinguish it from earlier compounds, providing a novel and non-obvious aspect.

2. Can the claims be challenged during patent term?

   • Yes, via post-grant review or patent infringement litigation if challenges arise.

3. What therapeutic indications does the patent cover?

   • Primarily neurological or psychiatric conditions, such as depression or anxiety, depending on the patent’s detailed description.

4. How does the patent landscape affect market entry?

   • The dense patent landscape requires innovators to develop novel compounds or formulations that do not infringe existing patents.

5. When does global patent protection expire?

   • Typically around 2037, subject to national laws, maintenance fees, and potential patent term extensions.

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References

[1] United States Patent and Trademark Office. (2018). Patent No. 10,065,958.
[2] World Intellectual Property Organization. (n.d.). Patent landscape reports for neurological therapeutics.
[3] European Patent Office. (n.d.). Patent families related to neuropharmacology compounds.

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Note: Exact claims wording, patent family specifics, and competitor patent details require consultation of the full patent document and patent database searches.

Drugs Protected by US Patent 10,065,958

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 10,065,958

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2595980		132020000000176	Italy
European Patent Office	2595980		122020000084	Germany
European Patent Office	2595980		301084	Netherlands
European Patent Office	2595980		2020C/554	Belgium
European Patent Office	2595980		53/2020	Austria
European Patent Office	2595980		C02595980/01	Switzerland
European Patent Office	2595980		C202030068	Spain