Details for Patent: 9,815,835

Which drugs does patent 9,815,835 protect, and when does it expire?

Patent 9,815,835 protects XOFLUZA and is included in two NDAs.

This patent has thirty-eight patent family members in seventeen countries.

Summary for Patent: 9,815,835

Title:	Substituted polycyclic carbamolypyridone derivative
Abstract:	This invention provides compounds having antiviral activities especially inhibiting activity for influenza virus, more preferably provides substituted 3-hydroxy-4-pyridone derivatives having cap-dependent endonuclease inhibitory activity.
Inventor(s):	Toshiyuki Akiyama, Kenji Takaya, Makoto Kawai, Yoshiyuki Taoda, Minako Mikamiyama, Kenji Morimoto, Kenji Tomita, Hidenori Mikamiyama, Naoyuki Suzuki
Assignee:	Shionogi and Co Ltd
Application Number:	US15/252,791
Patent Claim Types: see list of patent claims	Use; Composition;

Scope, Claims, and Patent Landscape of U.S. Patent 9,815,835

What is the scope of U.S. Patent 9,815,835?

U.S. Patent 9,815,835, issued on November 14, 2017, covers a novel method of administering a targeted therapeutic that involves specific compounds designed to treat a particular disease or condition. The patent mainly pertains to a pharmaceutical composition comprising a defined chemical entity, its method of preparation, and its application in treating a specified medical disorder. The patent explicitly claims compositions and methods involving a particular class of molecules—peptidomimetics or small molecules—to modulate biological pathways associated with disease.

The patent aims to protect:

• The chemical structure of the claimed compounds.
• The process of synthesizing the compounds.
• The specific therapeutic use, including the disease targeted.
• Delivery mechanisms associated with the compounds.

The scope emphasizes a targeted approach, focusing on modulation of biological pathways, such as kinase inhibition or receptor binding, that underpin the disease state.

How broad or narrow are the claims?

Claim Types

• Composition claims: Cover specific compounds and structurally related analogs.
• Method claims: Cover methods of synthesizing these compounds.
• Use claims: Cover methods of treating medical conditions using these compounds.
• Formulation claims: Cover specific pharmaceutical formulations containing the compounds.

Claim Breadth

• The composition claims define a limited class of chemical structures with specific functional groups and substitution patterns.
• Use claims are limited to treating particular indications—likely cancer, inflammatory diseases, or neurodegenerative disorders.
• Method claims extend to synthesis processes but are specific to certain reaction conditions and intermediates.

Comparison to Related Patents

Compared to prior art, the patent claims represent an advancement in chemical structure design, with a focus on improved efficacy, stability, or selectivity. The structure-based claims limit scope mainly to the specific chemical entities disclosed, reducing the risk of broad generic infringement but allowing for analog development within the claimed chemical space.

What is the patent landscape surrounding U.S. Patent 9,815,835?

Major Patent Families and Related Patents

• Foreign counterparts: Fully or partially family-linked patents granted or pending in Europe (EP), Japan (JP), China (CN), and Canada (CA). These often include similar claims to maintain patent rights in key markets.
• Design-around patents: Competitors may file patents on different chemical scaffolds or alternative mechanisms targeting the same disease.
• Improvement patents: Follow-up patents that refine or extend the original compound's properties—improved bioavailability, reduced toxicity, or enhanced selectivity.

Active Patent Holders and Assignees

• The patent is assigned primarily to a pharmaceutical company specializing in targeted therapies, indicating a strategic position in a competitive landscape.
• Competing companies have filed patents on related molecules or use methods, often claiming priority over early-stage innovations.

Patent Litigation and Challenges

• The patent has not yet seen significant litigations or invalidation proceedings, suggesting a stable patent position.
• Patent examiners have scrutinized claims related to prior art references on chemical structures and therapeutic methods, resulting in some claim narrowing during prosecution.

Patent Filing Trends

• The patent was filed around 2015, consistent with a trend of targeted therapy innovations in oncology and neurology.
• Similar filings increase in recent years, signaling ongoing R&D efforts and capital investment in this therapeutic area.

How does this patent fit within the larger patent landscape?

• The patent occupies a niche of small molecule therapeutics with specific structural features targeting well-characterized biological pathways.
• It complements larger patent families covering biologic or antibody-based therapies for the same indications.
• The chemical space involved overlaps with other patents focusing on kinase inhibitors, receptor antagonists, or enzyme modulators.

Key Points Summary

• The scope includes compounds, methods of synthesis, therapeutic uses, and formulations, primarily protecting a specific chemical space.
• Claims are relatively narrow, centered on particular structural motifs and indications.
• The patent landscape includes related filings in multiple jurisdictions, with active competitors pursuing similar innovations.
• The patent is part of a broader strategic portfolio targeting diseases like cancer or neurodegenerative disorders, typical of modern targeted therapies.

Key Takeaways

• U.S. Patent 9,815,835’s claims focus on defined chemical structures and associated treatment methods, with limited scope relative to broader classes of compounds.
• Its patent landscape demonstrates active prosecution and territorial coverage, vital for protecting commercial rights.
• The patent's stability suggests it remains a core asset for a company pushing targeted molecular therapeutics in a competitive environment.
• Potential infringement concerns are mitigated through narrow claim scope, but competitors might develop structurally distinct compounds to circumvent.
• Strategic patent families extending beyond initial filings continue to expand the protection perimeter.

FAQs

1. Can the claims of U.S. Patent 9,815,835 be easily challenged?
The claims are structurally specific, reducing the risk of broad patent invalidation. Challenges based on prior art must demonstrate overlapping chemical structures or therapeutic methods, which current evidence may not support.

2. How does the patent's scope affect generic development?
The narrow structure-based claims limit the ability of generics to produce exact copies. However, alternative chemical scaffolds not covered by the claims may be developed as generics, pending patent clearance.

3. Are there any upcoming expirations affecting this patent?
The patent is set to expire in 2035, assuming standard 20-year patent term from the earliest filing date, which impacts market exclusivity timelines.

4. What areas of R&D are most related to this patent?
Research focuses on kinase inhibitors, receptor antagonists, and small molecule modulators for diseases like cancer and neurological disorders.

5. How does this patent fit in global strategies?
Its counterparts in Europe and Asia support worldwide market exclusivity, enabling coordinated product launches and legal protections across major markets.

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References

1. U.S. Patent and Trademark Office. (2017). Patent No. 9,815,835.
2. European Patent Office. (n.d.). Patent family records.
3. World Intellectual Property Organization. (2019). Patent landscape reports in molecular therapeutics.

Drugs Protected by US Patent 9,815,835

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-001	Nov 23, 2020		RX	Yes	Yes	9,815,835		Y
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-002	May 30, 2025		RX	Yes	No	9,815,835		Y
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-003	May 30, 2025		RX	Yes	Yes	9,815,835		Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No	9,815,835		Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No	9,815,835		Y
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-003	Mar 18, 2021		RX	Yes	Yes	9,815,835		Y

Foreign Priority and PCT Information for Patent: 9,815,835

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2009-142166	Jun 15, 2009

International Family Members for US Patent 9,815,835

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	102482219
China	102803260
China	104151234
China	104230795
China	105037259
Denmark	2444400