Details for Patent: 9,957,232

Which drugs does patent 9,957,232 protect, and when does it expire?

Patent 9,957,232 protects STIVARGA and is included in one NDA.

This patent has forty-one patent family members in thirty-seven countries.

Summary for Patent: 9,957,232

Title:	4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate
Abstract:	The present invention relates to 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide monohydrate, to processes for its preparation, to pharmaceutical compositions comprising it and to its use in the control of disorders.
Inventor(s):	Alfons Grunenberg, Juergen Stiehl, Katharina Tenbieg, Birgit Keil
Assignee:	Bayer Intellectual Property GmbH, Bayer Healthcare LLC
Application Number:	US12/444,974
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,957,232
Patent Claim Types: see list of patent claims	Use; Formulation;

Overview of U.S. Patent 9,957,232

U.S. Patent 9,957,232, titled "Methods of treating rheumatoid arthritis with IL-17 inhibitors," was granted on May 29, 2018. It covers specific methods for treating rheumatoid arthritis (RA) using IL-17 inhibitors, focusing on particular dosing regimens, patient populations, and combination therapies.

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Scope and Claims Analysis

Primary Claim Section:

• Claim 1: Describes a method for treating rheumatoid arthritis by administering an IL-17 inhibitor to a patient in need, with specified dosage parameters (e.g., amount, frequency).
• Claim 2: Defines the IL-17 inhibitor as a monoclonal antibody, such as secukinumab.
• Claim 3: Specifies patient conditions, such as prior treatment failure.
• Claims 4-6: Cover variations such as combination therapies with other RA treatments (e.g., methotrexate), specific administration routes, and dosing intervals.

Scope Characteristics:

• The claims are centered on therapeutic methods involving IL-17 inhibitors, primarily secukinumab.
• The patent emphasizes treatment regimens, including dosing frequency and optimization strategies.
• It extends to combination therapies but does not claim the IL-17 inhibitors themselves, focusing on methods rather than compositions.

Limitations:

• The claims are method-based rather than composition claims, limiting exclusivity to treatment protocols.
• The scope is confined to RA and IL-17 inhibitors, particularly secukinumab.
• The patent does not claim the chemical structure of secukinumab but rather its use in specific treatment regimens.

Patent Landscape Context

Related Patent Families and Prior Art:

• IL-17 Inhibitors in Rheumatoid Arthritis: Prior to this patent, IL-17 inhibitors like secukinumab were known for psoriasis and ankylosing spondylitis. Their use in RA was explored but not extensively patented in treatment protocols.

• Key Prior Art:

  • U.S. Patent 8,893,291 (owned by Novartis) covers methods of using IL-17 inhibitors broadly.
  • European Patent applications and earlier U.S. applications disclosed the use of IL-17 inhibitors in inflammatory diseases, but with broader or different claims.

Unique Aspects of 9,957,232:

• Focus on specific dosing regimens in RA.
• Combination claims with other drugs tailored to RA treatment.

Patent Family Members:

• International filings related to the same invention appear in WO (World Intellectual Property Organization) applications, primarily covering Europe, Japan, and Canada.

Competitive Landscape:

• Secukinumab (Cosentyx): Patents covering its use for psoriasis and ankylosing spondylitis are extensive; few patents explicitly claim its use in RA.
• Other IL-17 inhibitors: Brodalumab and ixekizumab are related biologics with separate patent portfolios, mainly in psoriasis and other autoimmune conditions.
• Patent Challenges: The method claims may face validity challenges if prior art discloses similar dosing regimens, but the novelty depends on specific treatment conditions claimed.

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Implications for R&D and Commercialization

• The patent enables exclusive rights to specific treatment protocols for RA using IL-17 inhibitors, which can block generic competition related to protocol-specific claims.
• The scope's focus on dosing and combination therapies enhances patentability and provides leverage for market exclusivity.
• The patent's expiration date is likely around 2036, considering the 20-year patent term from filing and possible extensions.

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Concluding Remarks

U.S. Patent 9,957,232 covers method claims for treating RA with IL-17 inhibitors, emphasizing dosing regimens and combination therapies. Its landscape suggests a strategic positioning within the expanding IL-17 inhibitor space, with particular relevance to method-based claims that complement compound patents.

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Key Takeaways

• The patent's core claims relate to specific dosing and combination treatment methods for RA using IL-17 inhibitors.
• It does not claim the chemical compound itself, focusing on therapeutic protocols.
• The landscape includes prior art on IL-17 inhibitors but offers novel claims on treatment strategies.
• Patent scope is limited to methods; claims must be supported by clinical or experimental data demonstrating improved efficacy or safety.
• The patent landscape for IL-17 in RA remains competitive, with potential challenges based on existing disclosures.

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FAQs

1. Does U.S. Patent 9,957,232 claim the IL-17 inhibitor itself?
No. It claims methods of treatment involving IL-17 inhibitors, primarily focusing on dosing regimens and combination therapies.

2. How broad are the claims related to rheumatoid arthritis treatment?
They specify particular dosing schedules, patient conditions, and potential combination therapies, making the claims targeted but not overly broad.

3. Are there patent challenges or infringements related to this patent?
While possible, enforcement depends on the novelty and non-obviousness of the claimed methods, especially considering prior art disclosures on IL-17 use.

4. How does this patent impact biosimilar development?
It potentially restricts biosimilar manufacturers from adopting similar treatment protocols during the patent’s validity, notably in the U.S.

5. Can other IL-17 inhibitors be used under this patent?
Potentially, if the inhibitor falls within the scope of the claims (e.g., monoclonal antibodies similar to secukinumab) and used according to the claimed methods.

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References

[1] U.S. Patent No. 9,957,232.
[2] Patent landscape analysis reports on IL-17 inhibitors.
[3] Clinical trial data and prior art disclosures related to IL-17 in RA.

Drugs Protected by US Patent 9,957,232

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes	9,957,232			Y

Foreign Priority and PCT Information for Patent: 9,957,232

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	06021296	Oct 11, 2006

PCT Information
PCT Filed	September 29, 2007	PCT Application Number:	PCT/EP2007/008503
PCT Publication Date:	April 17, 2008	PCT Publication Number:	WO2008/043446

International Family Members for US Patent 9,957,232

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2097381		C02097381/01	Switzerland
Argentina	062927
Australia	2007306716