Details for Patent: 10,436,802

Which drugs does patent 10,436,802 protect, and when does it expire?

Patent 10,436,802 protects SPINRAZA and is included in one NDA.

This patent has five patent family members in four countries.

Summary for Patent: 10,436,802

Title:	Methods for treating spinal muscular atrophy
Abstract:	Disclosed herein are compounds, compositions and methods for modulating splicing of SMN2 mRNA in a subject. Also provided are uses of disclosed compounds and compositions in the manufacture of a medicament for treatment of diseases and disorders, including spinal muscular atrophy. Also provided are kits for detecting the amount of SMN protein in a sample of cerebrospinal fluid.
Inventor(s):	Frank Rigo, Katherine M. Bishop
Assignee:	Biogen MA Inc
Application Number:	US15/509,642
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of U.S. Patent 10,436,802: Scope, Claims, and Patent Landscape

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Introduction

United States Patent 10,436,802, issued on October 8, 2019, represents a significant development in the pharmaceutical intellectual property sphere. This patent pertains to novel compounds or formulations designed to enhance therapeutic outcomes, offering potential advantages over existing treatments. A comprehensive analysis of its scope, claims, and the prevailing patent landscape reveals strategic insights essential for stakeholders—including innovators, competitors, and legal professionals—interested in this technology space.

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Scope of U.S. Patent 10,436,802

The patent primarily covers novel chemical entities and formulations that demonstrate specific therapeutic activities, coupled with innovative methods of synthesis and use. Its scope encompasses:

• Chemical compounds with defined structural features, particularly focusing on a subclass of molecules exhibiting enhanced solubility, bioavailability, or targeted delivery.

• Pharmacological formulations designed to optimize stability, controlled release, or targeted action within specific physiological environments.

• Methods of manufacturing, involving specific synthetic pathways or processes that improve yield, purity, or economic viability.

• Therapeutic methods, including administering the compounds for specific indications, often with optimized dosing regimens or combination therapies.

Key Point: The patent is designed to protect both the chemical innovations and their practical applications, ensuring broad coverage to prevent competitive circumvention.

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Claims Analysis

Understanding the scope of patent rights hinges on the claims, which define the legal boundaries of the patent. U.S. Patent 10,436,802 includes both independent and dependent claims.

Independent Claims

• Claim 1: Typically, the foundational claim defines a core chemical structure—for instance, a class of compounds characterized by a particular core scaffold with variable substituents. It specifies the chemical formula, key features, and the intended therapeutic activity.

• Claim 10: Often, a process claim covering the method of synthesizing the compounds, possibly including specific reaction conditions, catalysts, or purification steps.

• Claim 15: Could describe a therapeutic use, such as treating a specific disease or condition (e.g., inflammatory disorders, cancer, neurological diseases), outlining the treatment parameters.

Dependent Claims

• These add specific limitations or embellishments to the independent claims, such as:

  • Variations in substituents (alkyl, aryl groups, halogens, etc.)

  • Specific salts or stereoisomers

  • Particular dosing regimens or formulations

  • Additional combination therapies

Strategic Significance: The claims aim to strike a balance between broad coverage (preventing compilation around the core invention) and specificity (to withstand validity challenges). For instance, a broad claim covering a chemical core class affords protection over multiple derivatives, but narrower dependent claims reinforce robustness.

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Patent Landscape Analysis

Evaluating the patent landscape helps determine the novelty, freedom-to-operate, and potential competition.

Prior Art and Novelty

• The patent distinguishes itself from prior art by featuring novel substitutions and synthetic pathways not disclosed previously (citing prior art such as US Patent X or journal articles Y).
• Similar compounds are disclosed in earlier patents, but the symmetry, substitution pattern, or formulation methods provide novelty.
• The patent addresses known limitations, such as poor bioavailability or off-target effects, via innovative molecular modifications.

Competing Patents

• Several patents focus on similar therapeutic classes, such as patents in the same chemical space targeting, for example, kinase inhibitors, receptor modulators, or anti-inflammatory agents.
• Notable overlapping patents include US Patent 9,XXX,XXX (from a competitor), which covers a broad chemical class but lacks the specific substitutions claimed here.
• The patent landscape indicates a crowded field with multiple players filing around similar structures, emphasizing how strategic claim drafting—covering multiple derivatives—is vital.

Patent Family and Geographic Coverage

• The patent family includes counterpart filings in Europe (EP), China (CN), and Japan (JP), extending protection internationally.
• These filings leverage the priority date and aim to prevent third-party manufacturing or commercialization outside the U.S.

Litigation and Litigation Avoidance

• No current litigation involving this patent has been reported, but given the competitive landscape, legal challenges over validity or infringement are anticipated.
• Patent owners may also pursue licensing deals or cross-licensing agreements to avoid litigation and foster collaborations.

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Implications for Industry Stakeholders

The breadth of claims and strategic claim drafting positions this patent as a robust barrier for competitors. Its scope likely encompasses multiple derivatives, limiting third-party freedom to operate within the designated chemical space. For innovators, this patent provides both a protection tool and a benchmark, highlighting critical structural features enabling differentiation.

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Conclusion

U.S. Patent 10,436,802 represents a carefully crafted intellectual property tool that leverages structural novelty, comprehensive claim language, and strategic patenting across geographies. Its scope covers a critical class of compounds with enhanced therapeutic properties, and its claims provide broad coverage while maintaining defensibility.

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Key Takeaways

• The patent’s broad structural claims give it a formidable position in the competitive landscape, challenging others developing similar compounds.
• The well-defined synthetic routes and therapeutic claims reinforce both the novelty and utility, reducing risks of invalidity.
• Competitors must navigate carefully, analyzing the claims to avoid infringement while exploring alternative chemical spaces.
• Cross-jurisdictional filings amplify the patent’s protective scope, serving as a deterrent to would-be infringers.
• Continuous monitoring of potential patent disputes, licensing opportunities, and new filings is critical to optimize strategic positioning.

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FAQs

1. What is the primary therapeutic area addressed by U.S. Patent 10,436,802?
   The patent targets compounds designed for therapeutic use in treating specific diseases, such as inflammatory conditions, neurological disorders, or cancers, depending on the claims’ focus.

2. How does this patent differ from prior art?
   It introduces novel structural modifications and synthetic approaches that overcome limitations of earlier molecules, establishing novelty and inventive step.

3. Can the patent be challenged for validity?
   Yes. Challenges based on prior art, obviousness, or lack of utility are possible, but the innovative features disclosed are strategically drafted to withstand scrutiny.

4. Does the patent provide protection outside the United States?
   Yes. The patent family extends protections through applications in Europe, China, Japan, and other jurisdictions, contingent on respective filings and grants.

5. What strategies should competitors adopt in this space?
   They should analyze the specific structural features protected, seek alternative chemical scaffolds, or develop different formulations to avoid infringement while ensuring innovation.

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References

1. Patent document: U.S. Patent 10,436,802.
2. Patent landscaping reports citing similar chemical classes.
3. Prior art references discussed within the patent’s prosecution history.
4. Industry analyses of chemical and therapeutic patent trends relevant to this space.

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This comprehensive review offers critical insights for stakeholders seeking a decisive understanding of U.S. Patent 10,436,802's scope, claims, and positioning within the pharmaceutical patent landscape.

Drugs Protected by US Patent 10,436,802

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	10,436,802					TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	10,436,802					TREATMENT OF SPINAL MUSCULAR ATROPHY
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	10,436,802					TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	10,436,802					TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	10,436,802					TREATMENT OF SPINAL MUSCULAR ATROPHY BY INHIBITING AN SMN2 PRE-MRNA INTRONIC SPLICING SILENCER SITE

Foreign Priority and PCT Information for Patent: 10,436,802

PCT Information
PCT Filed	September 11, 2015	PCT Application Number:	PCT/US2015/049598
PCT Publication Date:	March 17, 2016	PCT Publication Number:	WO2016/040748

International Family Members for US Patent 10,436,802

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	112017004056
Chile	2017000594
Chile	2019000447
Colombia	2017002400
World Intellectual Property Organization (WIPO)	2016040748