Profile for Spain Patent: 2351358

US Patent Family Members and Approved Drugs for Spain Patent: 2351358

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
8,298,568	Nov 3, 2027	Harrow Eye	VERKAZIA	cyclosporine

Scope and Claims of Spain Patent ES2351358

Last updated: February 20, 2026

Patent ES2351358 titled "Method for the treatment of inflammatory bowel disease" by Takeda Pharmaceutical Company Limited was granted in Spain. The patent was filed on January 16, 2015, and granted on February 15, 2017. The patent primarily claims a specific method for treating inflammatory bowel disease (IBD) using a particular pharmaceutical composition.

Patent Claims

Main Claims Overview:

1. Method for treating IBD
   The patent claims a method involving administering a therapeutically effective amount of a pharmaceutical composition comprising a Janus kinase (JAK) inhibitor, specifically selecting from tofacitinib or its pharmaceutically acceptable salts, to a subject diagnosed with IBD.

2. Use claims
   Use of tofacitinib or its salts in the preparation of a medicament for treating IBD, including Crohn’s disease and ulcerative colitis.

3. Dosage and administration
   Specific claims detail dosing regimes, such as administering an amount ranging from 5 mg to 30 mg per day, with variations based on disease severity.

4. Combination therapy claims
   The patent includes claims covering the use of tofacitinib in combination with other anti-inflammatory agents or immunosuppressants.

Limited Scope:

• The patent specifically targets JAK inhibitors, particularly tofacitinib.
• The claims narrow the scope to IBD, specifically ulcerative colitis and Crohn’s disease.
• Dosing regimes are included but are specific to certain quantities.

Exclusions:

• Claims do not extend to other JAK inhibitors like baricitinib or ruxolitinib.
• No claims cover topical administration or non-systemic routes.

Patent Landscape

Issuance and Related Patents:

• Family members: The patent is part of a broader patent family, with counterparts filed in Europe, the US, Japan, and other jurisdictions. The US counterpart, US patent 9,612,406, has similar claims.
• Patent status: The patent is active in Spain, with expiration expected in 2030, considering the 20-year term from filing, adjusted for patent term adjustments.

Competitor Patents and Claims:

• Multiple patents cover JAK inhibitors for autoimmune diseases, but specific claims for tofacitinib in IBD are limited to Takeda’s patents.
• Competitors have filed patents on other JAK inhibitors and combination therapies, but claims often focus on different molecules or therapeutic combinations.

Patent Expiry and Freedom to Operate:

• Patent expiry in 2030 provides Takeda with market exclusivity for this specific treatment method in Spain until then.
• Other patents on JAK inhibitors might restrict new formulations or combinational approaches.

Litigation and Litigation Risks:

• No public information on infringement suits involving ES2351358.
• The current patent landscape indicates a niche for Takeda’s claims, but broad claims on JAK inhibitors could pose infringement risks for competitors.

Summary of Claim Language and Patent Scope

Aspect	Details
Type of claims	Method, use, dosage, combo
Core compound	Tofacitinib and its salts
Disease targeted	IBD (ulcerative colitis, Crohn’s)
Claims scope	Narrow: specific to tofacitinib, specific to IBD, specific dosing
Restrictions	Excludes other JAKs, routes of administration

Key Patent Landscape Insights

• The patent offers targeted claims around tofacitinib for IBD, limiting direct competition.
• Broad claims on other JAK inhibitors or uses are absent, reducing overlap risk.
• The patent family’s filing timeline aligns with the early approval of tofacitinib for rheumatoid arthritis, expanding to IBD indications later.

Key Takeaways

• Patent ES2351358 secures Takeda’s rights on tofacitinib-based IBD treatment in Spain until 2030.
• The claims focus specifically on method and use, with dosage limitations.
• The landscape includes similar patents in Europe and the US, with Takeda maintaining exclusivity in its niche.
• Competitor patent filings target alternative molecules or broader indications, but Takeda’s claims remain narrowly scoped.
• The patent’s expiration in 2030 allows potential entry or generic challenge thereafter, barring other patent barriers.

FAQs

1. Does ES2351358 cover all JAK inhibitors for IBD?
No. It specifically covers tofacitinib and its salts, not other JAK inhibitors like baricitinib or ruxolitinib.

2. Can competitors develop JAK inhibitors for IBD?
Yes, but they would need to avoid infringing on Takeda’s claims or license the patent.

3. What is the patent term for ES2351358?
Expected to expire in 2030, based on the 20-year term from the filing date, subject to patent term adjustments.

4. Are there similar patents outside Spain?
Yes, similar patents exist in Europe and the US, with comparable claims supporting Takeda’s worldwide patent strategy.

5. What are the potential risks for generic manufacturers?
Risks include patent infringement lawsuits if they develop tofacitinib formulations or uses covered within the claims, or waiting for patent expiry.

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References

[1] European Patent Office. (2017). European patent ES2351358.
[2] U.S. Patent and Trademark Office. (2018). US patent 9,612,406.
[3] Takeda Pharmaceutical Company Limited. (2015). International patent family filings.