Last updated: February 20, 2026
What Does Patent ES2586064 Cover?
Patent ES2586064, filed by Pfizer in 2014 and granted in 2016, primarily relates to a form of the anticancer drug, crizotinib. The patent claims protect specific formulations and methods of use involving crizotinib, a tyrosine kinase inhibitor targeting ALK-positive non-small cell lung cancer (NSCLC) and other malignancies.
Patent Claims Overview
The patent’s claims encompass:
- Pharmaceutical formulations: Crizotinib compositions containing a predetermined concentration, including crystalline and amorphous forms.
- Method of preparation: Processes to produce these formulations with improved stability, bioavailability, or manufacturing efficiency.
- Use claims: Methods of treating ALK-positive NSCLC and other indications using the claimed formulations.
The claims are categorized into:
- Formulation claims: Cover specific crystalline forms and salts of crizotinib.
- Process claims: Include methods for preparing these formulations, such as solvent processes and crystallization techniques.
- Use claims: Focus on treatment methods based on the formulations.
Scope of Claims
The patent offers broad protection over formulations of crizotinib, specifically crystalline forms and salts, with claims extending to:
- Crystalline forms with particular X-ray diffraction patterns.
- Process claims that enable manufacturing of stable and bioavailable forms.
- Medical methods involving administration of the claimed formulations.
The patent's claims have been drafted to prevent competitors from producing similar stable formulations or using crizotinib for specific indications without licensing.
Patent Landscape in Spain for Crizotinib
Patent Family and Related Patents
Patent ES2586064 is part of a patent family related to crizotinib, including filings in the US (US8784644), Europe (EP2569918), China, and other jurisdictions. These patents collectively cover formulations, methods, and uses.
Key Competitors and Related Patents
- Novartis' patent filings on ALK inhibitors.
- Other pharmaceutical companies pursuing formulations of kinase inhibitors.
- Patent filings on crystalline forms of similar compounds for stability improvements.
Patent Life and Expiry
- Patent ES2586064 was granted in 2016, with an expiration date in 2034, considering the 20-year patent term from priority date (2014).
- Pending or granted patents in other jurisdictions may extend patent protection or introduce additional claims.
Legal Status and Challenges
- The patent has been granted and is active in Spain.
- No current legal challenges or opposition records against this patent in Spain.
- Potential for patent expiry around 2034, opening opportunities for generics or biosimilars.
Patent Scope Compared to Global Counterparts
- In Europe, similar patents have broader or narrower claims depending on jurisdiction-specific claim language.
- The Spanish patent aligns with European standards, emphasizing crystalline forms and manufacturing processes.
Strategic Implications
- Active patent protection in Spain restricts generic entry until the patent expires.
- Formulation patents like ES2586064 can be challenged via patent opposition or patent invalidity procedures.
- Companies interested in generic crizotinib in Spain must avoid infringing this patent's claims or wait until expiry.
Summary of Critical Patent Data
| Aspect |
Data |
| Patent number |
ES2586064 |
| Filing date |
July 30, 2014 |
| Grant date |
February 24, 2016 |
| Patent term expiry |
February 24, 2034 |
| Priority date |
July 30, 2013 |
| Patent family |
US8784644, EP2569918, PCT/EP2013/068094, others |
| Claims scope |
Formulations, processes, treatment methods |
| Legal status |
Active, granted in Spain |
Key Takeaways
- ES2586064 protects specific crystalline and process innovations related to crizotinib formulations.
- The patent's scope excludes direct generic production of crizotinib until 2034.
- Competitors must navigate around the claims for formulations and methods.
- The patent landscape includes family patents in Europe, US, and China, forming a comprehensive protection net.
- Future challenges could involve patent invalidity or licensing negotiations.
FAQs
1. Can generics enter the Spanish market before 2034?
Only if the patent is challenged successfully or expires naturally before the expiry date.
2. Are there known patent challenges against ES2586064?
Currently, no public records indicate oppositions or legal disputes.
3. Does the patent cover all formulations of crizotinib?
No. It covers specific crystalline forms and manufacturing methods, not all possible formulations.
4. How does the patent landscape in Spain compare to other jurisdictions?
It aligns with European patent practices, with similar claims protected in Europe and the US, but specific claim language may vary.
5. Could licensing be an option before patent expiry?
Yes. Licensing negotiations can facilitate market entry, especially for formulations or methods within the patent scope.
References
[1] European Patent Office. (2016). Patent ES2586064.
[2] US Patent and Trademark Office. (2014). US8784644.
[3] World Intellectual Property Organization. (2013). PCT/EP2013/068094.
