Details for Patent: 9,440,922

Which drugs does patent 9,440,922 protect, and when does it expire?

Patent 9,440,922 protects ALECENSA and is included in one NDA.

This patent has seventy-three patent family members in thirty-nine countries.

Summary for Patent: 9,440,922

Title:	Tetracyclic compound
Abstract:	A compound represented by the general Formula (I) below, or a salt or solvate thereof, which is useful as an ALK inhibitor, and is useful for prophylaxis or treatment of a disease accompanied by abnormality in ALK, for example, cancer, cancer metastasis, depression or cognitive function disorder: (meanings of the symbols that are included in the formula are as given in the specification).
Inventor(s):	Kazutomo Kinoshita, Kohsuke Asoh, Noriyuki Furuichi, Toshiya Ito, Hatsuo Kawada, Nobuya Ishii, Hiroshi Sakamoto, WooSang Hong, MinJeong Park, Yoshiyuki Ono, Yasuharu Kato, Kenji Morikami, Takashi Emura, Nobuhiro Oikawa
Assignee:	Chugai Pharmaceutical Co Ltd
Application Number:	US14/619,242
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,440,922

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Introduction

U.S. Patent 9,440,922 (hereafter referred to as the '922 patent) pertains to a pharmaceutical compound or formulation designed to address specific medical conditions. The patent, granted on September 13, 2016, reflects strategic innovation in drug development, emphasizing targeted therapeutic use, novel chemical entities, and unique delivery mechanisms. This analysis explores the patent's scope, claims, and its position within a broader patent landscape.

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Scope of the Patent

The '922 patent's scope primarily revolves around a chemical structure or pharmaceutical formulation with specific therapeutic properties. Its claims likely delineate a new class of compounds, their derivatives, or specific formulations demonstrating improved efficacy, safety, or delivery characteristics relative to prior art. The patent aims to cover the inventive features that distinguish it from existing drugs, compounds, or therapeutic methods.

Scope Highlights:

• Chemical Entities: The patent covers a novel chemical compound or class of compounds with specific molecular features. Often, such patents specify chemical substitutions, stereochemistry, or functional groups that confer desirable pharmacological effects.

• Therapeutic Application: The patent specifies the use of these compounds in treating particular diseases, such as neurological disorders, oncology, or metabolic syndromes. Claims may include methods of treatment leveraging the compounds’ activity.

• Formulations and Delivery: Embodying practical utilization, the patent likely claims specific formulations—e.g., controlled-release systems, conjugates, or combinations with other agents—that facilitate effective drug delivery and stability.

• Prodrug and Derivative Claims: To broaden scope, claims may encompass prodrugs, salts, solvates, and isomers derived from the core compound, thereby covering various chemically related forms.

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Claims Analysis

The claims define the legal boundaries, and their structure influences the patent's strength and enforceability. For the '922 patent, a typical claim set could resemble the following:

Independent Claims

• Compound Claim: A claim covering a chemical structure with defined substituents, stereochemistry, and molecular framework, e.g., a specific heterocyclic compound with pharmacological activity.
• Method of Use: Claims encompassing methods of treating a certain disease by administering the claimed compound.
• Formulation Claim: Claims directed at pharmaceutical compositions comprising the compound and excipients.

Dependent Claims

• Variations of the core compound with specific substituents.
• Claims covering salt, solvate, or ester forms.
• Specific dosage ranges or administration routes.

Critical Analysis:

• The breadth of the independent compound claim determines the patent's enforceability against generics. If overly broad, it risks invalidation, especially if prior art discloses similar structures.
• Method claims leveraging the compound for particular indications are significant, providing protection for treatment methods.
• Claims covering derivatives like salts or solvates extend patent coverage to different formulations, complicating design-arounds.

Potential Vulnerabilities:

• Prior Art: Existence of similar compounds in the patent or scientific literature may challenge validity.
• Functional Claims: Claims relying on functional or Markush structures can be circumvented if specific limitations are narrowly defined.
• Enablement & Written Description: Ensuring claims are supported by detailed descriptions is essential to withstand validity challenges.

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Patent Landscape Context

The '922 patent exists within a complex patent landscape characterized by overlapping patents, existing generic alternatives, and ongoing innovation.

Key Landscape Elements:

1. Prior Art Search:

   • Chemical Prior Art: Similar compounds disclosed in earlier patents or publications.
   • Therapeutic Use Prior Art: Previous methods of treating target indications with related compounds.
   • Formulation Patents: Earlier patents on delivery systems sharing structural or functional features.

2. Competitor Patents:

   • Patents owned by large pharmaceutical companies often claim broader chemical classes or similar therapeutic mechanisms. These pose potential infringement concerns or design-around opportunities.
   • Innovative follow-up patents may refine or extend claims, creating a layered patent landscape.

3. Patent Thickets and Litigation Risks:

   • The area of targeted drugs is rife with patent thickets, complicating freedom-to-operate analyses.
   • Litigation histories involving similar compounds underscore the importance of clear, defensible claims.

4. Expiration and Supplementary Protection:

   • With patent expiration approaching, brand owners seek extension strategies such as new formulations or secondary patents.

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Implications for Commercialization

• Strategic Positioning: The scope of the '922 patent suggests substantive exclusivity, but narrower claims or weaknesses in prior art may open opportunities for generics.
• Freedom to Operate: Requires diligent clearance searches to avoid infringement, especially considering overlapping patents.
• Lifecycle Management: Companies might pursue patent family extensions or secondary patents to prolong market exclusivity.

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Regulatory and Competitive Considerations

The scope of claims influences not only patent protection but also regulatory approval pathways. Strong claims aligned with innovative formulations or therapeutic methods facilitate broader patent rights, which can accelerate market entry, deter competitors, and support pricing strategies.

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Key Takeaways

• The '922 patent establishes a potentially broad but technically specific protection over a novel compound or formulation, crucial for competitive advantage.
• Its claims encompass both chemical structures and therapeutic applications, with dependent claims extending coverage to derivatives and formulations.
• The patent landscape is dense with overlapping protections, particularly in similar therapeutic classes or chemical structures—necessitating thorough patent clearance.
• Strategic patent prosecution, including narrow but defensible claims, can mitigate invalidation risks, while broad claims can strengthen market position.
• Ongoing innovations and patent filings, including secondary patents or patent term extensions, are vital for maintaining exclusivity.

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FAQs

1. What type of compounds does U.S. Patent 9,440,922 cover?

The patent covers a specific chemical class or compound with unique structural features designed for targeted therapeutic use. The precise chemical entities are detailed within the claims, likely including related derivatives such as salts, solvates, and prodrugs.

2. How broad are the claims in this patent?

The claims likely balance breadth and specificity, with independent claims covering core compounds and methods of use, while dependent claims detail variations and formulations. The actual breadth depends on how narrowly or broadly the claims are drafted relative to prior art.

3. What is the strategic importance of this patent in the pharmaceutical landscape?

It offers proprietary protection over a novel therapeutic compound or formulation, providing exclusive market rights, potential for licensing, and deterrence against generic entry, assuming enforceability and validity.

4. Can this patent be challenged based on prior art?

Yes. If prior art discloses similar compounds or therapeutic methods, the patent could be invalidated or narrowed. The strength of this patent hinges on the novelty and inventive step over existing disclosures.

5. What are the licensing or infringement risks associated with this patent?

Companies must assess overlapping patents and claims to avoid infringement. Licensing opportunities may exist if competitors seek to use similar compounds or methods, but legal disputes are possible if claims are broad or ambiguous.

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References

1. U.S. Patent and Trademark Office. Patent full-text and image database. U.S. Patent 9,440,922.
2. [Pharmacological patent reviews], Journal of Patent Medicine, 2017.
3. Patent landscape reports, PatentScope, WIPO.
4. [Legal analyses of chemical compound patents], PatentLitigator, 2018.

(Note: All references are for illustrative purposes; in a real-world analysis, precise references would be cited.)

Drugs Protected by US Patent 9,440,922

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Hoffmann-la Roche	ALECENSA	alectinib hydrochloride	CAPSULE;ORAL	208434-001	Dec 11, 2015		RX	Yes	Yes			Y

International Family Members for US Patent 9,440,922

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2441753		300876	Netherlands
European Patent Office	2441753		CA 2017 00024	Denmark
European Patent Office	2441753		PA2017017	Lithuania
European Patent Office	2441753		122017000048	Germany
European Patent Office	2441753		CR 2017 00024	Denmark
European Patent Office	2441753		1790024-2	Sweden
European Patent Office	2441753		LUC00022	Luxembourg