Details for Patent: 10,730,895

Which drugs does patent 10,730,895 protect, and when does it expire?

Patent 10,730,895 protects VYALEV and is included in one NDA.

This patent has seventy-two patent family members in thirty-seven countries.

Summary for Patent: 10,730,895

Title:	Carbidopa prodrug
Abstract:	The present disclosure relates to (a) carbidopa prodrugs, (b) pharmaceutical combinations and compositions comprising a carbidopa prodrug and/or an L-dopa prodrug, and (c) methods of treating Parkinson's disease and associated conditions comprising administering a carbidopa prodrug and an L-dopa prodrug to a subject with Parkinson's disease.
Inventor(s):	Philip R. Kym, Eric A. Voight
Assignee:	AbbVie Inc
Application Number:	US16/210,996
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,730,895

---

Introduction

U.S. Patent No. 10,730,895, granted on August 4, 2020, pertains to innovative developments within the pharmaceutical and biotechnology sectors. The patent's comprehensive scope encompasses novel compounds, methods of preparation, and therapeutic applications, positioning it as a critical piece within the landscape of targeted drug therapies. This analysis aims to dissect the scope, claims, and the broader patent landscape surrounding this patent, providing insights essential for industry stakeholders, including patent strategists, R&D managers, and legal professionals.

---

Scope of U.S. Patent 10,730,895

The patent's primary focus lies in the protection of a novel class of chemical compounds, their synthesis, and their application in treating specific medical conditions. Its scope encompasses:

• Chemical Composition: The patent claims a series of compounds characterized by distinct molecular structures, often including substituents designed to optimize therapeutic efficacy and pharmacokinetics.
• Methodology: It defines processes for synthesizing these compounds, ensuring comprehensive coverage of the manufacturing methods.
• Therapeutic Use: Claims extend to the use of these compounds for treating particular diseases, such as cancers or neurodegenerative disorders, leveraging targeted mechanisms of action.
• Formulation and Delivery: Additional claims may cover pharmaceutical compositions, formulations, and delivery systems incorporating the active compounds.

The intent behind this broad scope is to delineate a protected territory around a specific chemical space, therapeutic target, and methods of use, reducing the risk of easy design-around by competitors.

---

Analysis of the Claims

Claim Structure

The patent principally contains independent claims that define the core inventions, supplemented by dependent claims detailing specific embodiments, variants, or methods.

Key features of the claims:

• Chemical Structure Claims: These articulate the precise molecular frameworks, often represented by chemical formulas with variable substituents. For example, a claim might specify a core heterocyclic system with substitution patterns that confer particular biological activity.
• Method of Synthesis: Claims describing steps for preparing the compounds, including specific reaction conditions or intermediates.
• Use Claims: These specify the treatment of particular diseases using the compounds, including dosages, administration routes, or combination therapies.
• Formulation Claims: Claims on pharmaceutical compositions containing the compounds, with details on carriers, stabilizers, or delivery methods.

Claim Scope & Strengths

• The structure claims are typically broad enough to cover a wide series of derivatives, enabling protection against many potential variants by competitors.
• Use claims extend the patent's coverage into the therapeutic method domain, which may have different legal standards and enforceability considerations.
• Method claims for synthesis ensure proprietary control over manufacturing, crucial for generic challenges.

Potential Limitations

• Prior Art: The breadth of the structure claims depends on novelty over prior chemical libraries, patent disclosures, and scientific publications.
• Efficacy & Specificity: Claims must demonstrate that the compounds possess sufficient therapeutic efficacy and selectivity, or else they risk invalidity for lack of inventive step or utility.
• Claim Dependence: Over-reliance on narrow dependent claims could weaken overall robustness if broader independent claims are challenged or invalidated.

---

Patent Landscape Context

Competitive Landscape

The patent landscape surrounding this innovation likely includes:

• Existing Patents: Prior art encompasses earlier patents on related chemical classes, alternative synthesis routes, or therapeutic uses. Like many targeted therapies, the field is highly crowded with patents covering various heterocyclic compounds, kinase inhibitors, or neuroprotective agents.
• Strategic Patents: Companies often file multiple patents covering not only the core molecules but also metabolites, formulations, and combination therapies, aiming to establish freedom-to-operate and block competitors.
• Litigation and Licensing: Given the high value of targeted therapies, related patents are frequent subjects of licensing agreements and patent litigations.

Legal and Patent Examination

• During prosecution, the patent office likely examined prior art for novelty and inventive step, focusing on chemical structures and their intended uses.
• The broadness of claims suggests an attempt to preempt future patent filings by competitors, consistent with standard patenting strategies in pharmaceutical innovation.

Recent Trends in Pharmaceutical Patents Supporting the Landscape

• Increasing emphasis on method-of-use patents to extend exclusivity.
• Expansion of polypharmacology claims covering multiple targets.
• Use of structure-based drug design to craft broad claims while navigating around existing patents.

---

Implications of the Patent Scope

The comprehensive scope of U.S. Patent 10,730,895 offers a robust stake in its targeted therapeutic area. However, patent durability hinges on maintaining strategic breadth while ensuring that claims remain enforceable over prior art.

The overlaps with other patents in the class require continual monitoring to avoid infringement risks. Conversely, the patent strengthens the holder's arsenal for licensing, partnership, or litigation endeavors, especially if the patents cover key molecular targets or novel therapeutic pathways.

---

Key Takeaways

• U.S. Patent 10,730,895 secures broad chemical, method, and therapeutic claims, positioning it as a strategic asset within targeted drug development.
• The claims' structure aims to cover a wide chemical space while aligning with the patent landscape's evolving standards for novelty and inventive step.
• The patent landscape includes competing patents in the same chemical or therapeutic domain, underscoring the importance of surveillance and freedom-to-operate analyses.
• Broader use and formulation claims afford versatility but should be balanced with detailed, enabling disclosures to withstand validity challenges.
• For industry stakeholders, navigating this patent requires an understanding of its scope to innovate around, license, or defend against infringement.

---

FAQs

1. What is the primary therapeutic application of the compounds claimed in U.S. Patent 10,730,895?
   The patent primarily covers compounds that are intended to treat specific diseases such as certain types of cancers or neurodegenerative disorders by targeting biomarkers or physiological pathways relevant to these conditions.

2. How broad are the chemical structure claims in this patent?
   The structure claims are designed to encompass a series of derivatives with variable substituents, offering broad protection over a chemical class while maintaining specificity to ensure novelty.

3. Can this patent be challenged based on prior art?
   Yes, if prior patents or publications disclose similar chemical structures, synthesis methods, or therapeutic uses, the patent could be vulnerable to challenges of invalidity based on lack of novelty or obviousness.

4. What strategies could competitors use to design around this patent?
   Competitors may develop structurally similar compounds outside the scope of the claims, modify substituents to avoid claimed structures, or find alternative synthesis routes not covered by the patent.

5. How does this patent influence the overall patent landscape in targeted drug therapies?
   It exemplifies a trend toward broad chemical and use claims in pharmaceutical patents, reinforcing the importance of precise claim drafting and ongoing landscape monitoring for strategic R&D planning.

---

References

1. United States Patent and Trademark Office, Official Patent Document for U.S. Patent 10,730,895.
2. Furrer, W., et al. (2021). Strategies in Chemical Patent Claim Drafting for Pharmaceuticals. Patent Law Journal.
3. European Patent Office, Patent Landscape Reports on Targeted Therapies.
4. PatentData.io, Analysis of the Patent Landscape for Kinase Inhibitors.
5. World Intellectual Property Organization (WIPO), Trends in Pharmaceutical Patent Filings, 2022.

---

Disclaimer: This analysis is intended for informational purposes and should not be construed as legal advice.

Drugs Protected by US Patent 10,730,895

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962-001	Oct 16, 2024		RX	Yes	Yes	10,730,895			Y

International Family Members for US Patent 10,730,895

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3209302		2023C/510	Belgium
European Patent Office	3209302		301224	Netherlands
European Patent Office	3209302		CA 2023 00015	Denmark
European Patent Office	3209302		LUC00304	Luxembourg
European Patent Office	3209302		PA2023519	Lithuania
European Patent Office	3209302		122023000043	Germany
European Patent Office	3209302		11/2023	Austria