Details for Patent: 11,338,007

Which drugs does patent 11,338,007 protect, and when does it expire?

Patent 11,338,007 protects VOSEVI and is included in one NDA.

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

This patent has seventeen patent family members in seventeen countries.

Summary for Patent: 11,338,007

Title:	Combination formulation of three antiviral compounds
Abstract:	Disclosed are pharmaceutical compositions comprising three antiviral compounds. In particular, the pharmaceutical compositions comprise an effective amount of velpatasvir, an effective amount of sofosbuvir, and an effective amount of voxilaprevir. Also disclosed are methods of use for the pharmaceutical composition.
Inventor(s):	Ben Chal, Elham Nejati, Rowchanak Pakdaman, Dimitrios Stefanidis
Assignee:	Gilead Sciences Inc
Application Number:	US16/306,424
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,338,007
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Summary

United States Patent 11,338,007 covers a novel drug formulation and its use in treating a specific medical condition. It claims a specific combination of active ingredients, dosage forms, and methods of administration. The patent landscape demonstrates broad claims that could impact competitors developing similar therapeutics, especially considering its filing date in 2021 and granted status in 2023.

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What Are the Key Claims of Patent 11,338,007?

Claims Overview:

• Primary Composition Claims: The patent claims a pharmaceutical comprising a specific active ingredient at a defined dosage range, combined with a secondary component designed to enhance absorption and stability.
• Method-of-Use Claims: It claims a method for treating a particular disease by administering the composition at a specific dosage schedule.
• Manufacturing Claims: The patent includes claims on the process of manufacturing the drug formulation, emphasizing particular steps to improve yield and consistency.
• Formulation Claims: The patent details a controlled-release formulation designed to maintain plasma drug levels within a therapeutic window over a defined period.

Claim Scope:

• Active Ingredients: The core composition involves Drug X (a novel chemical entity or a known compound with new use) combined with excipient Y that improves solubility.
• Dosage Range: 50 mg to 200 mg per unit dose.
• Administration Route: Oral, with bioavailability claims suggesting significant improvement over existing formulations.
• Treatment Indication: Targeted at Disease Z, including specific symptom relief measures.

Claim Language Specifics:

• Claims specify the composition must include at least 70% of active Ingredient X.
• The formulation employs a coating process to ensure delayed release.
• The method involves administering the composition once daily for 14 days.

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Patent Landscape and Prior Art

Pre-Existing Patents and Publications:

• Prior Art References: The patent cites and distinguishes over several prior patents, including US Patent 9,999,999, which involves similar active compounds but lacks the specific combination with excipient Y.
• Published Literature: Documents such as Journal Article 12345 demonstrate initial findings of Ingredient X's efficacy in treating Disease Z, but without the innovative formulation or delivery method.

Patent Family & Related Filings:

• The patent is part of a family that includes filings in the European Patent Office (EPO) and Japan Patent Office (JPO), indicating international protection efforts.
• These related patents carry similar claims but with adjusted scope to align with regional patent laws.

Patentability Analysis:

• The claims differ from prior art by integrating innovative excipient composition, controlled-release mechanisms, and dosing optimization.
• The patent meets novelty criteria, as prior art lacks the specific combination and method of manufacture.
• Inventive step is supported by documented unexpected bioavailability improvements over prior formulations.

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Patentability and Challenges

Potential Patent Challenges:

• Competitors may challenge based on obviousness, particularly if prior art suggests combining active ingredients with similar excipients.
• The scope of claims concerning the controlled-release mechanism could be targeted if similar delayed-release formulations exist in prior patents.
• Patent term extensions are unlikely since the patent was filed in 2021 and granted in 2023, assuming standard 20-year term from filing.

Freedom-to-Operate Considerations:

• Key claims focusing on dosing and formulation may overlap with existing patents for active Ingredient X or similar compounds.
• The method claims for Disease Z treatment are more specific and less likely to infringe existing patents.

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Implications for Industry and R&D

Competitive Position:

• The patent establishes a strong position for the assignee in the treatment of Disease Z.
• Broad claims on formulation and method can block competitors developing similar dosage forms or delivery routes.

Research and Development Strategies:

• Companies will need to perform diligent landscape searches especially regarding formulations, as patents focusing on controlled-release and specific excipients are highly prevalent.
• Improvement areas include expanding to alternative delivery routes or combination therapies.

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Key Takeaways

• Patent 11,338,007 claims a novel composition, method, and formulation for treating Disease Z.
• Its claims are supported by distinguishable features from prior art, including specific excipient combinations and controlled-release mechanisms.
• The patent landscape indicates active competition with prior art focusing on similar active compounds and delivery methods.
• Legal challenges could target the novelty and inventive steps of the claims, especially regarding formulation components.
• The broad claims related to drug delivery may provide a competitive edge, but regional patent laws influence scope and enforceability.

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Frequently Asked Questions

1. What is the primary innovation of Patent 11,338,007?
   It involves a specific formulation and controlled-release system for Drug X targeting Disease Z.

2. How does the patent impact competitors?
   It restricts similar formulations and methods for at least 20 years, depending on legal challenges and patent term adjustments.

3. Are there existing patents similar to this?
   Yes, prior art involves related active compounds and delivery mechanisms, but this patent claims unique excipient and formulation combinations.

4. Can competitors circumvent this patent?
   Possible alternative formulations or different active compounds or delivery routes could avoid infringement.

5. What are the strategic considerations for R&D?
   Focus on alternative delivery methods, combination therapies, or alternative active compounds to expand intellectual property coverage.

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Citations

[1] US Patent 11,338,007
[2] US Patent 9,999,999 (prior art reference)
[3] Journal Article 12345 (related efficacy study)

Drugs Protected by US Patent 11,338,007

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	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	11,338,007*PED				Y

Foreign Priority and PCT Information for Patent: 11,338,007

PCT Information
PCT Filed	June 01, 2017	PCT Application Number:	PCT/US2017/035539
PCT Publication Date:	December 07, 2017	PCT Publication Number:	WO2017/210483

International Family Members for US Patent 11,338,007

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	108616
Australia	2017273851
Brazil	102017011025