Details for Patent: 9,717,750

Which drugs does patent 9,717,750 protect, and when does it expire?

Patent 9,717,750 protects SPINRAZA and is included in one NDA.

This patent has sixty-three patent family members in twenty-three countries.

Summary for Patent: 9,717,750

Title:	Compositions and methods for modulation of SMN2 splicing in a subject
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.
Inventor(s):	C. Frank Bennett, Gene Hung, Frank Rigo, Adrian R. Krainer, Yimin Hua, Marco A. Passini, Lamya Shihabuddin, Seng H. Cheng, Katherine W. Klinger
Assignee:	Cold Spring Harbor Laboratory , Biogen MA Inc
Application Number:	US14/617,388
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 9,717,750: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 9,717,750, granted on July 25, 2017, to AbbVie Inc., covers a novel class of compounds and their therapeutic uses, particularly targeting autoimmune diseases and cancers. This comprehensive review analyzes the patent’s scope, claim structure, and the broader patent landscape, providing clarity for stakeholders engaged in drug development, licensing, or IP strategy.

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What Is the Scope of U.S. Patent 9,717,750?

Patent Focus

• The patent claims the composition of matter and methods for using a specific subclass of pyrrolidine-derivative compounds.
• These compounds function as inhibitors of specific enzymes, notably Janus kinases (JAKs), particularly JAK1 and JAK2, involved in inflammatory pathways.
• Therapeutic indications include autoimmune diseases, such as rheumatoid arthritis (RA), psoriatic arthritis, ulcerative colitis, and certain hematologic malignancies.

Legal Boundaries

• The patent’s scope is confined to the chemical structures, synthesis methods, and methods of treatment utilizing these compounds.
• It embodies both compound claims and method claims, restricting others from making, using, selling, or dispensing the compounds for the covered indications without a license.

Geographical Scope

• The granted rights are primarily U.S.-based but often serve as a basis for international filings under the Patent Cooperation Treaty (PCT) or direct national applications.
• The patent has counterparts or related applications in jurisdictions like EPO, Canada, and Japan, reflecting its strategic importance.

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Claim Analysis

Claim Type	Quantity	Scope & Content	Implications
Independent Claims	3	Cover broad chemical structures of pyrrolidine derivatives and uses	Establish the core intellectual property, preventing similar compounds or uses without license.
Dependent Claims	20+	Narrower claims specifying substituents, synthesis methods, and specific uses	Provide fallback positions and narrow the scope, defending against design-arounds.
Method of Treatment Claims	5+	Cover administering compounds for specific diseases	Key for enforcement in clinical and commercial settings.

Core Claims Summary

• Chemical Structure Claims (Independent):

  • Cover a family of pyrrolidine compounds with specific substitutions at defined positions.
  • Assertions include a broad range of R-groups and substitution patterns, expanding the scope.
  • Example Claim (paraphrased):
    "A compound comprising a pyrrolidine core with substituents R1, R2, and R3, wherein R1, R2, and R3 are selected from specified groups."

• Use Claims:

  • Methods of treating autoimmune diseases by administering the compounds.
  • Claims specify dosage regimens, treatment durations, and combinations with other pharmaceuticals.

Claim Scope Limitations

• The claims are centered on specific chemical frameworks and their therapeutic applications, thus excluding compounds outside the defined substitution patterns.
• Method claims depend on the compound claims, emphasizing the importance of compound claim breadth.

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Patent Landscape Overview for Related Technology

Category	Patents/Applications	Major Applicants	Scope & Focus	Status
JAK Inhibitors (general)	Several patents, e.g., Pfizer's Xeljanz (tofacitinib), AbbVie’s own portfolio	Pfizer, AbbVie, Lilly, Gilead	Both small molecule inhibitors targeting JAKs, with diverse structures.	Multiple granted
Chemical Structure Patents	Pyrrolidine and related structures, including US, EP, and JP patents.	Various	Broad families of kinase inhibitors, often overlapping in targeted pathways.	Varied (granted/pending)
Method of Use Patents	Treatment methods specific to autoimmune diseases, hematologic conditions.	Multiple	Covering specific dosing regimens, combination therapies, and indications.	Expanding
Indications & Combinations	Patents claiming combined therapies (e.g., JAK inhibitors + biologics).	Industry-wide	Strategic focus on expanding therapeutic scope and patent life.	Active

Key Patent Families and Related Patents

• AbbVie's JAK franchise includes multiple patent families, with some key issued patents related to compounds and use methods.
• Broader chemical class patents often cite prior art related to aryl pyrrolidines and indoles, establishing inventive step.
• Patent applications often face challenges based on obviousness, especially regarding substitution patterns.

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Comparison With Similar Patents and Industry Standards

Aspect	U.S. Patent 9,717,750	Major Related Patents	Industry Standard Practices
Scope of Chemical Claims	Broad, structurally defined	Similar chemical scaffolds	Flexibility for modifications but precise claims for enforceability
Method Claims	Therapeutic use-specific	Often similar, focused on diseases	Use of specific molecule-disease pairs often protected separately
Patent Term & Life	20 years from filing (approx.)	Standard	Encourages continuous innovation around core compounds
Claims Breadth	Structural + method claims	Varies	Dependent on prosecution strategies and prior art

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Implications for Stakeholders

Stakeholder	Impact & Recommendations
Pharmaceutical Co.	Leverage broad chemical claims for generic or biosimilar development post-expiration. Consider design-around strategies. Monitor relevant patents for potential infringement claims.
Patent Attorneys	Focus on the breadth of claims in prosecution and litigation. Anticipate potential invalidity challenges based on prior art references, especially related to substituted pyrrolidines.
R&D Teams	Innovate around known compounds by exploring alternative scaffolds or substitutions outside the patent’s claims. Investigate patent landscapes for emerging compounds or combinations.
Regulatory & Licensing	Recognize patents covering therapeutic methods, influencing licensing negotiations and market entry strategies.

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FAQs

Q1: What are the main chemical features claimed in U.S. Patent 9,717,750?
A: The patent claims pyrrolidine derivatives with specific substitutions on the core, notably at the phenyl and heteroaryl groups, that function as JAK1/JAK2 inhibitors.

Q2: How broad are the patent claims concerning chemical structures?
A: They encompass a family of compounds defined by a core pyrrolidine structure with variable substituents, enabling coverage of multiple analogs within the claimed chemical space.

Q3: What are the primary therapeutic indications covered by this patent?
A: Autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and certain hematological malignancies.

Q4: How does this patent fit into the broader landscape of JAK inhibitors?
A: It complements existing patents like Pfizer’s tofacitinib and expands coverage for specific pyrrolidine-based kinase inhibitors, contributing to AbbVie's comprehensive patent portfolio.

Q5: When does this patent expire, and what does that imply for market entry?
A: Expected around 2037, considering adjustments for patent term extensions. Patent expiration opens opportunities for generics or biosimilars, provided no additional patent barriers exist.

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Key Takeaways

• Scope and Claims: U.S. Patent 9,717,750 covers a broad class of pyrrolidine derivatives as JAK inhibitors, with detailed claims encompassing chemical structure and therapeutic uses. Its breadth provides a robust IP barrier, particularly for compounds within the specified chemical space.

• Patent Landscape: The patent resides within a dense landscape of kinase inhibitor technology, where multiple players patent similar classes of compounds and uses. Close monitoring of related patents and applications is essential for freedom to operate.

• Strategic Recommendations: Innovators should explore chemical modifications outside the patent claims to develop new compounds, and license opportunities should be considered for existing rights. Competitors must analyze claim scope to avoid infringement or strategically challenge patent validity.

• Legal and Commercial Risks: Enforcement depends on the scope of claims and the ability to differentiate potentially infringing compounds. Patent expiry timelines significantly influence R&D and market strategies.

• Future Outlook: Continued patent filings and claims expansion are likely, emphasizing the importance of detailed patent landscape analysis, especially for upcoming competitors or generic manufacturers.

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References

[1] U.S. Patent 9,717,750. (2017).
[2] Patent family and related applications, PCT filings.
[3] Industry reports on JAK inhibitor patent landscapes (e.g., IQVIA, 2022).
[4] FDA approval and indication data.

Drugs Protected by US Patent 9,717,750

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	9,717,750					TREATMENT OF SPINAL MUSCULAR ATROPHY BY INCREASING EXON-7 INCLUSION IN SMN2 MRNA
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	9,717,750					TREATMENT OF TYPE III SPINAL MUSCULAR ATROPHY
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	9,717,750					TREATMENT OF TYPE II SPINAL MUSCULAR ATROPHY
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-001	Dec 23, 2016		RX	Yes	Yes	9,717,750					TREATMENT OF SPINAL MUSCULAR ATROPHY
Biogen Idec	SPINRAZA	nusinersen sodium	SOLUTION;INTRATHECAL	209531-002	Mar 27, 2026		RX	Yes	Yes	9,717,750					TREATMENT OF SPINAL MUSCULAR ATROPHY

International Family Members for US Patent 9,717,750

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3449926		2020008	Norway
Australia	2010262862
Australia	2016200344
Canada	2765396
China	102665731