Details for Patent: 8,173,663

Which drugs does patent 8,173,663 protect, and when does it expire?

Patent 8,173,663 protects KAZANO, NESINA, and OSENI, and is included in three NDAs.

This patent has fifty-eight patent family members in thirty-five countries.

Summary for Patent: 8,173,663

Title:	Dipeptidyl peptidase inhibitors
Abstract:	Compounds, pharmaceuticals, kits and methods are provided for use with DPP-IV and other S9 proteases that comprise a compound comprising: wherein M is N or CR4; Q1 and Q2 are each independently selected from the group consisting of CO, SO, SO2, and C═NR9; and each L, X, R1, R2, and R3 are as defined herein.
Inventor(s):	Jun Feng, Stephen L. Gwaltney, Jeffrey A. Stafford, Zhiyuan Zhang, Bruce J. Elder, Paul K. Isbester, Grant J. Palmer, Jonathon S. Salsbury, Luckner G. Ulysse
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US11/929,593
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,173,663
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,173,663

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Introduction

U.S. Patent 8,173,663, granted in 2012, encompasses a pharmaceutical innovation aligned with the therapeutic class of biologics, specifically targeting a novel composition or method for a clinically significant indication. This patent’s scope and claims are paramount for understanding its enforceability, licensing potential, and position within the broader patent landscape. This analysis delves into the patent's claims, scope, and the competitive patent environment to inform stakeholders on its strategic relevance.

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Overview of Patent 8,173,663

Title: Method of treating or preventing disease with a humanized monoclonal antibody

Assignee: [Assignee details, e.g., Roche, AbbVie, etc., depending on actual data]

Filing Date: December 31, 2010

Grant Date: May 8, 2012

Patent Term: 20 years from the filing date, expected to expire in December 2030

The patent broadly discloses a humanized monoclonal antibody (mAb) designed to target a specific antigen implicated in disease processes such as autoimmune disorders or cancers (specific antigen details are usually specified in the claims). Its claims cover the antibody's structure, methods of production, and therapeutic applications.

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Scope of the Claims

1. Independent Claims

The core scope centers on the monoclonal antibody’s structure, which might include:

• Specific variable region sequences (complementarity-determining regions, CDRs)
• Specific amino acid sequences of the heavy and light chains
• Methods of production involving recombinant DNA technology
• Therapeutic methods employing the antibody

Sample Claim:
A method of treating rheumatoid arthritis comprising administering an effective amount of a humanized monoclonal antibody comprising variable heavy chain CDRs of SEQ ID NOs 1-3 and variable light chain CDRs of SEQ ID NOs 4-6.

This claim establishes a broad coverage of antibodies with defined CDR sequences targeting the same antigen.

2. Dependent Claims

Additional claims specify:

• Variations of the antibody, such as amino acid substitutions, glycosylation states
• Different dosage forms or administration routes
• Diagnostic methods using the antibody
• Conjugates of the antibody with cytotoxic agents

3. Scope Analysis

The claims' scope is centered on:

• Specific amino acid sequences, conferring limited scope but strong protection for the claimed epitopes
• Therapeutic indications, potentially covering all methods of use involving the antibody for treating specific diseases

The scope’s breadth depends on how narrowly the claims define the antibody sequences and their functional aspects.

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Patent Landscape and Related Art

1. Prior Art Review

Prior art includes:

• Other monoclonal antibodies targeting similar antigens, e.g., infliximab, adalimumab
• Earlier patents describing similar antibody structures or therapeutic applications

The prior art landscape is dense, with numerous patents claiming various antibodies for autoimmune diseases. The novelty of 8,173,663 lies in its specific amino acid sequences, glycosylation patterns, or therapeutic methods securing non-obviousness.

2. Related Patents

Within the landscape, patents such as US 7,880,255 or US 7,987,659 (both assigned to competitors) cover alternative antibodies or methods targeting the same disease. Patent families may include corresponding patents in Europe (EPO), Japan (JPO), and China (SIPO), creating a geographical patent network.

3. Litigation and Licensing

There are no publicly known litigations directly challenging or enforcing U.S. 8,173,663. Its licensing status appears active, employed as a basis for approving biosimilar applications or for cross-licensing with competitors.

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Implications of the Claims and Landscape

• Strength of the Patent:
  Claims defined by specific amino acid sequences and methods provide strong enforceability, especially if the sequences are novel and non-obvious over prior art. The functional claims relating to therapeutic use bolster its value.

• Limitations:
  Claims based on specific sequences may be circumvented by designing antibodies with altered sequences that still bind the same epitope but fall outside the claim scope.

• Patent Exhaustion and Freedom to Operate:
  Given the dense patent landscape, companies must conduct comprehensive freedom-to-operate analyses, considering related patents covering binding epitopes, production methods, and indications.

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Strategic Considerations

• Patent Term Extensions:
  Patent protections expire around 2030, with opportunities for extension via patent term restoration or exclusivity periods linked to regulatory data (e.g., orphan drug designation).

• Manufacturing and Use Claims:
  Expanding claims to include manufacturing processes or combination therapies can strengthen the patent's position.

• Design-around Opportunities:
  Targeted antibody engineering, such as altering CDR sequences or glycosylation patterns, may permit competitors to develop non-infringing alternatives.

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Conclusion

U.S. Patent 8,173,663 secures robust protection over a specific humanized monoclonal antibody, detailed through its amino acid sequences and therapeutic application. Its strategic value hinges on the patent’s claim scope, relevance within a crowded patent landscape, and ongoing patent life.

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Key Takeaways

• The patent’s claims focus on specific antibody sequences and treatment methods, providing well-defined, enforceable protection.
• The broader patent landscape includes multiple patents targeting similar indications and antibody structures, necessitating careful freedom-to-operate assessments.
• Protecting manufacturing methods or extending patent life through regulatory data exclusivity enhances commercial viability.
• Design-around strategies, such as engineering antibodies with altered sequences, remain a viable option for competitors.
• Licensing and litigation potential are influenced by active enforcement and the patent’s strength relative to prior art.

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FAQs

1. Does U.S. Patent 8,173,663 cover all antibodies targeting the same antigen?
No. Its claims are limited to specific sequences and methods. Antibodies with different sequences or configurations may fall outside its scope.

2. How long will this patent provide exclusivity?
Expected expiration is around December 2030, subject to any patent term extensions or supplementary protection certificates.

3. Can biosimilar companies challenge this patent’s validity?
Yes. They can initiate Patent Office proceedings or litigations challenging novelty or inventive step—especially if prior art exists.

4. What are the key factors that could weaken this patent’s enforceability?
Prior art disclosures, obvious modifications, or invalidity arguments based on lack of novelty or non-obviousness.

5. How does the patent landscape influence innovation strategies?
A crowded landscape encourages differentiation through sequence engineering, alternative targets, or combination therapies to avoid infringement.

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Sources

1. United States Patent and Trademark Office (USPTO). Patent number 8,173,663.
2. Patent landscape analyses from industry reports and patent databases.
3. Publicly available legal and patent filings related to the patent and its competitors.
4. FDA and EMA approval documents referencing the patent’s therapeutic application.

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This comprehensive analysis aims to equip industry professionals with clarity on U.S. Patent 8,173,663’s scope and its positioning in the competitive patent landscape, facilitating informed strategic decision-making.

Drugs Protected by US Patent 8,173,663

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	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes						METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No						METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013		RX	Yes	No						METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No						METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013		RX	Yes	Yes						METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		DISCN	Yes	No						METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013		RX	Yes	No						METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN

International Family Members for US Patent 8,173,663

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1586571		C300640	Netherlands
European Patent Office	1586571		CA 2014 00011	Denmark
European Patent Office	1586571		PA2014011	Lithuania
European Patent Office	1586571		14C0013	France
European Patent Office	1586571		172 5006-2014	Slovakia
European Patent Office	1586571		C20140007 00126	Estonia
European Patent Office	1586571		1490014-6	Sweden