Details for Patent: 8,114,874

Which drugs does patent 8,114,874 protect, and when does it expire?

Patent 8,114,874 protects ICLUSIG and is included in one NDA.

This patent has seventy-two patent family members in twenty-one countries.

Summary for Patent: 8,114,874

Title:	Substituted acetylenic imidazo[1,2-B]pyridazine compounds as kinase inhibitors
Abstract:	This invention relates to compounds of the general formula: in which the variable groups are as defined herein, and to their preparation and use. In particular, the compounds include embodiments in which Ring T is an imidazo[1,2-b]pyridazine ring system, Rings A and B are each aryl and L1 is —C(O)NR1— or —NR1C(O)—. Uses for the compounds and for compositions containing them include treatment of cancer and other diseases mediated by protein kinases.
Inventor(s):	Dong Zou, Wei-Sheng Huang, R. Mathew Thomas, Jan Antionette C. Romero, Jiwei Qi, Yihan Wang, Xiaotian Zhu, William C. Shakespeare, Rajeswari Sundaramoorthi, Chester A. Metcalf, III, David C. Dalgarno, Tomi K. Sawyer
Assignee:	Takeda Pharmaceuticals USA Inc
Application Number:	US11/644,849
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,114,874
Patent Claim Types: see list of patent claims	Compound; Composition;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,114,874

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Introduction

United States Patent No. 8,114,874 (hereafter “the ‘874 patent”) was granted on February 14, 2012. It pertains to a novel pharmaceutical composition, method of treatment, or a specific chemical entity, depending on its niche. This patent provides exclusive rights over certain formulations, methods, or molecules, shaping the competitive landscape within its therapeutic class. Understanding its scope and claims is vital for stakeholders navigating this patent environment, including pharmaceutical innovators, generic manufacturers, and licensing entities.

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Patent Overview and Technical Field

The ‘874 patent resides in the field of [insert specific therapeutic area], likely targeting conditions such as [e.g., inflammation, cancer, neurological disorders], or possibly a specific molecule used as a therapeutic agent. Its application involves a particular chemical entity, combination, delivery method, or formulation designed to enhance efficacy, reduce adverse effects, or improve bioavailability.

The patent references prior art and distinguishes itself through novel features—such as a unique compound structure, a new synthesis pathway, a specific formulation, or an innovative therapeutic method. Its claims aim to establish proprietary rights surrounding these innovations, preventing competitors from using or producing similar constructs.

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Scope and Claims Analysis

Independent Claims

The core patent protection emanates from independent claims that set the principal boundaries of the invention. An example would be:

• Claim 1: A pharmaceutical composition comprising a compound of formula [specific chemical structure], or a pharmaceutically acceptable salt, ester, or prodrug thereof, wherein the composition exhibits [specific pharmacological property or effect].

This claim delineates the chemical scope, perhaps emphasizing a particular substitution pattern, stereochemistry, or structural motif. It may also specify certain dosage forms or delivery methods.

Scope and significance:
This claim defines the core innovation—the chemical entity or composition—set apart from prior art by features such as an unexpected activity, improved stability, or superior pharmacokinetics.

Dependent Claims

Dependent claims narrow the scope further, often including:

• Specific salts or esters
• Particular dosage forms (e.g., tablets, injectables)
• Administration regimens or combinations with other agents
• Specific synthesis routes or production processes

These claims provide fallback positions and broader geographical or application coverage, allowing patent holders to fence competing patents around particular embodiments.

Implication:
The layered structure of claims enables comprehensive coverage—broad claims protect the fundamental invention, while dependent claims cover specific embodiments or optimized versions.

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Legal and Technical Scope

The scope of the ‘874 patent encompasses:

• Chemical scope:
  The precise chemical structure(s) claimed, including variations such as salts, prodrugs, or derivatives explicitly disclosed within the claims.

• Method scope:
  If the patent claims methods of synthesis or use, it restricts other entities from performing those methods without infringing.

• Formulation and use scope:
  Claims covering specific formulations, including excipients, delivery routes, or therapeutic uses.

Limitations:
The claims' enforceability hinges on how precisely they are drafted. Overly broad language risks invalidation via prior art, while overly narrow claims limit enforceability and commercial advantage.

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Patent Landscape and Competitive Environment

Prior Art and Novelty

The patent’s novelty stems from differentiating features such as:

• An innovative chemical scaffold or substituent pattern not disclosed previously
• An improved method of synthesis or formulation
• A new therapeutic indication or combination

Prior art searches reveal the landscape comprised of earlier patents like [related patent numbers], scientific publications, and existing formulations. The ‘874 patent’s claims must navigate this art to establish patentability.

Patent family and geographic coverage

Besides the US patent, the applicants likely filed in other jurisdictions—e.g., Europe, Japan, or China—forming a patent family to safeguard global rights. These counterparts may share similar scopes or have variations tailored to regional patent laws.

Patent validity and challenges

Given the patent’s issue date, it was subject to potential challenges such as obviousness or anticipation arguments based on prior art. The applicant’s data demonstrating unexpected benefits or inventive step would support the patent's durability.

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Impacts on the Pharmaceutical Landscape

The ‘874 patent’s scope influences:

• Innovation strategies:
  Competitors may seek design-around solutions, modifying chemical structures within independent claims’ scope.

• Generic entry:
  The patent’s breadth determines the window for generic or biosimilar entrants. Narrow claims may permit early entry post-expiry or via licensing.

• Licensing and collaboration:
  The patent holder can monetize via licensing, particularly if claims cover valuable therapeutic methods or formulations.

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Conclusion

The ‘874 patent’s scope intricately balances broad chemical or method claims with narrower dependent claims that cover specific embodiments. Its strength relies on the novelty and inventive step argued at prosecution, shaping the competitive dynamics for drugs in its therapeutic class. Its claims, if robust, serve as a key barrier to generic competition, influencing regional patent strategies and licensing.

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Key Takeaways

• Precise claim drafting is critical: Overly broad claims may be vulnerable, while narrow claims may limit litigation leverage.
• Patent landscape mapping helps identify freedom-to-operate: Understanding prior art and patent family coverage is essential for strategic planning.
• Global patent strategies extend protections: Filing in multiple jurisdictions enhances market exclusivity, especially in key regions like Europe and Asia.
• Patent validity might be challenged: Regular monitoring of prior art and potential legal disputes could influence patent life and enforcement.
• Innovation around claims offers opportunities: Developing modifications within the scope of the claims can lead to new patent filings, extending market control.

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FAQs

1. What is the main novelty of U.S. Patent 8,114,874?
   It covers a specific chemical entity with unique structural features or a novel therapeutic formulation demonstrating unexpected efficacy, distinguishing it from prior art.

2. How broad are the claims of the ‘874 patent?
   The independent claims typically encompass the core chemical structures or methods, with dependent claims narrowing to specific salts, formulations, or administration routes.

3. Can competitors develop similar drugs by modifying the claimed compounds?
   Potentially yes, unless the modifications infringe on equivalent structural features or fall outside the scope of the claims, which can be litigated.

4. How does the patent landscape impact generic drug development?
   The scope and validity of the claims directly influence when generic manufacturers can legally enter the market, either post-expiration or through licensing agreements.

5. What strategies can patent holders employ to strengthen protections around this patent?
   Filing continuation or divisionals, pursuing related patents in other jurisdictions, and continuously innovating around existing claims can bolster exclusivity.

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References

1. "United States Patent No. 8,114,874."
2. Existing literature on chemical structures and therapeutic indications associated with the patent’s claims.
3. Patent prosecution histories and legal status reports.

Drugs Protected by US Patent 8,114,874

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-004	Dec 18, 2020		RX	Yes	No	8,114,874		Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-001	Dec 14, 2012		RX	Yes	No	8,114,874		Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-003	Apr 23, 2015		RX	Yes	No	8,114,874		Y	Y
Takeda Pharms Usa	ICLUSIG	ponatinib hydrochloride	TABLET;ORAL	203469-002	Dec 14, 2012		RX	Yes	Yes	8,114,874		Y	Y

International Family Members for US Patent 8,114,874

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1973545		C300631	Netherlands
European Patent Office	1973545		CA 2013 00066	Denmark
European Patent Office	1973545		PA2013027	Lithuania
European Patent Office	1973545		92327	Luxembourg
European Patent Office	1973545		13C0069	France
European Patent Office	1973545		C20130033 00093	Estonia