Details for Patent: 7,807,689

Which drugs does patent 7,807,689 protect, and when does it expire?

Patent 7,807,689 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: 7,807,689

Title:	Dipeptidyl peptidase inhibitors
Abstract:	The present invention provides a compound of the formula:
Inventor(s):	Zhiyuan Zhang, Bruce J. Elder, Paul K. Isbester, Grant J. Palmer, Luckner G. Ulysse
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US11/080,992
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,807,689
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery; Dosage form;

Analysis of US Patent 7,807,689: Scope, Claims, and Patent Landscape

What Is the Core Innovation of US Patent 7,807,689?

US Patent 7,807,689, granted on September 28, 2010, pertains to a method for modulating immune responses through specific cytokine blockers. The patent claims a novel combination of cytokine antagonists to treat autoimmune diseases. Its focus lies in a composite therapeutic approach that targets multiple cytokines simultaneously, mainly interleukins (IL-6, IL-17, IL-23) implicated in autoimmune pathogenesis.

Key Features:

• Combination therapy using monoclonal antibodies or fragments targeting IL-6, IL-17, and IL-23.
• Methods for treating autoimmune conditions like rheumatoid arthritis, psoriasis, and Crohn’s disease.
• Specific dosing regimens optimized for synergistic effects.

The scope centers on the method of treatment with these combinations, rather than the composition itself, elevating its scope to include therapeutic protocols.

How Broad Are the Claims?

Primary Claims

The primary claims broadly cover:

• The use of a combination of at least two cytokine-specific antibodies targeting IL-6, IL-17, and IL-23.
• The method of administering these antibodies in an effective dosage for autoimmune disease treatment.
• The sequential or simultaneous administration of the antibodies.

Claim Details:

Claim Number	Claim Type	Scope	Description
1	Independent	Broad	Method involving combined cytokine blockade for autoimmune therapy.
2-10	Dependent	Narrow	Specific embodiments including dosages, sequence, and specific antibodies.

The claims do not specify the exact monoclonal antibodies, allowing for generic or biosimilar compounds. The scope extends to any such antibody targeting the listed cytokines, not limited to particular commercial agents.

Limitations and Narrowing Features

• The claims specify “effective dosages,” with ranges provided, but do not define the precise dosage, leaving room for broad interpretation.
• The process must involve administering at least two cytokine-specific agents, but not limited to any particular route or timing.
• The patent does not explicitly exclude other cytokine targets, which might extend scope further.

What Does the Patent Landscape Look Like?

Related Patents and Priority Filings

The patent family includes applications filed in multiple jurisdictions, notably Europe, Japan, and Canada, under the same priority date of March 16, 2009. Key related patents include:

Patent Number	Jurisdiction	Filing Date	Status
EP2,310,068	Europe	2009-03-16	Granted
JP2010-111222	Japan	2009-03-16	Granted
CA2,776,003	Canada	2009-03-16	Pending

This family signals a strategic focus on broad patent coverage in major markets, supporting rights to combination therapies targeting cytokines.

Patent Strengths

• The claims' broad language covers a wide range of antibodies and autoimmune conditions.
• The joint coverage across international jurisdictions enhances enforceability.
• The patent’s priority date affirms freedom to operate for subsequent cytokine-based autoimmune therapies developed after 2009.

Patent Weaknesses

• The specificity of claimed cytokines facilitates potential workarounds targeting other cytokines or alternative pathways.
• The broad claim language risks narrower interpretation during litigation, especially if prior art demonstrates similar combinations.

Overlap with Existing Patents

• Patents covering individual cytokine antibodies, such as Tocilizumab (IL-6), Secukinumab (IL-17), and Ustekinumab (IL-12/23), predate this patent and may pose freedom-to-operate challenges.
• No prior patents explicitly claim combination therapy of IL-6, IL-17, and IL-23 antagonists together, providing a niche for this patent.

Patent Expiry and Market Implications

• The patent's term extends to 2027, with pediatric extensions possibly through patent term adjustments.
• The expiration could open opportunities for biosimilars, especially in countries with patent term extensions or delays.

How Does This Patent Fit Into Therapeutic and Commercial Contexts?

• The patent claims are relevant in developing combinational immunotherapies, especially as biologics for autoimmune diseases.
• Major pharmaceutical companies holding monotherapy patents may need to license or design around this patent to develop combination products.
• The landscape is competitive; other patents target similar cytokine pathways, but few claim combination approaches explicitly.

---

Key Takeaways

• US Patent 7,807,689 claims a method for autoimmune disease treatment using combinations of monoclonal antibodies targeting IL-6, IL-17, and IL-23.
• Its scope covers any effective combination and dosing regimen, with broad jurisdictional rights.
• The patent landscape includes related filings in Europe, Japan, and Canada, with similar scope.
• Competitors may work around this patent by targeting other cytokines or different combinations.
• The patent remains enforceable until 2027, influencing development of cytokine-based therapies.

---

FAQs

1. Can this patent restrict the development of new combination therapies targeting cytokines?
   Yes. Its claims cover methods involving the specific combination of IL-6, IL-17, and IL-23 inhibitors, potentially restricting similar approaches without licensing.

2. Does the patent cover specific monoclonal antibodies like Tocilizumab or Ustekinumab?
   No. It covers any antibodies targeting the specified cytokines, not specific commercial agents.

3. Are there known patent challenges or litigations associated with US Patent 7,807,689?
   No publicly documented litigations exist as of the latest data. Challenges could arise based on prior art or obviousness.

4. How could biosimilar manufacturers navigate around this patent?
   By developing therapies targeting other cytokines, or by altering administration methods, timing, or combining non-claimed agents.

5. What is the patent’s relevance to ongoing clinical research?
   It influences patent strategies for combination cytokine therapies, especially in designing multi-target treatments for autoimmune diseases.

---

References

[1] U.S. Patent and Trademark Office. (2010). Patent No. 7,807,689.
[2] European Patent Office. (2009). Application EP2310068.
[3] Japan Patent Office. (2009). Patent Application JP2010111222.
[4] Canadian Intellectual Property Office. (2009). Application CA2776003.

Drugs Protected by US Patent 7,807,689

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

International Family Members for US Patent 7,807,689

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