Last updated: February 19, 2026
Patent ES2650611, titled "Combination therapy for the treatment of cancer," describes a novel therapeutic approach for treating various cancers. The patent's claims focus on specific pharmaceutical compositions and their use in treating patients, particularly those with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC).
What is the Core Innovation of ES2650611?
The central innovation protected by ES2650611 is the use of a specific combination of therapeutic agents to treat cancer. The patent claims a pharmaceutical composition comprising:
- Osimertinib: A third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI).
- Ramucirumab: A monoclonal antibody that inhibits vascular endothelial growth factor receptor 2 (VEGFR2).
The combination aims to address resistance mechanisms that often develop with single-agent EGFR TKI therapy, particularly T790M resistance mutations. Osimertinib targets these mutations directly, while ramucirumab targets angiogenesis, a critical process for tumor growth and metastasis.
What Specific Cancers Does ES2650611 Target?
The patent explicitly targets a range of cancers, with a primary focus on:
- Non-small cell lung cancer (NSCLC): This is the most emphasized indication. The claims are specifically directed towards treating NSCLC patients with EGFR mutations, including T790M positive NSCLC.
- Other solid tumors: While NSCLC is the primary focus, the broader claims suggest potential applicability to other solid tumors that are driven by EGFR signaling pathways or exhibit angiogenic potential.
What are the Key Claims of ES2650611?
The patent's claims define the legal boundaries of its protection. Key claims in ES2650611 include:
- Claim 1: A pharmaceutical composition comprising osimertinib and ramucirumab.
- Claim 2: The composition of Claim 1, further comprising a pharmaceutically acceptable carrier.
- Claim 3: The composition of Claim 1, for use in treating cancer.
- Claim 4: The use of the composition of Claim 1 in treating non-small cell lung cancer.
- Claim 5: The use of the composition of Claim 1 in treating non-small cell lung cancer having an EGFR T790M mutation.
- Claim 6: The use of the composition of Claim 1 in treating non-small cell lung cancer that is resistant to prior EGFR TKI therapy.
- Claim 7: A method of treating cancer, comprising administering a therapeutically effective amount of osimertinib and a therapeutically effective amount of ramucirumab to a subject in need thereof.
- Claim 8: The method of Claim 7, wherein the cancer is non-small cell lung cancer.
- Claim 9: The method of Claim 7, wherein the cancer is non-small cell lung cancer having an EGFR T790M mutation.
- Claim 10: The method of Claim 7, wherein the cancer is non-small cell lung cancer that is resistant to prior EGFR TKI therapy.
These claims establish protection for both the combined drug product and its therapeutic application in specific patient populations.
What is the Patent Status and Expiry Date for ES2650611?
ES2650611 was granted by the Spanish Patent and Trademark Office (OEPM). The patent has a standard term of 20 years from the filing date.
- Filing Date: December 15, 2016
- Publication Date: June 1, 2017
- Grant Date: November 15, 2018
- Expected Expiry Date: December 15, 2036
This expiry date indicates a significant period of market exclusivity for the patented combination in Spain.
What is the Competitive Landscape for Osimertinib and Ramucirumab Combinations?
The patent landscape for osimertinib and ramucirumab combinations is influenced by the existing patents for each individual drug, as well as potential patent filings for novel formulations, manufacturing processes, and specific therapeutic applications of their combination.
Key Competitors and Related Patents:
- Osimertinib (Tagrisso):
- Developed by AstraZeneca.
- Primary patents cover the compound itself, its polymorphs, and therapeutic uses, particularly for EGFR-mutated NSCLC.
- Key patents for osimertinib have likely been filed in numerous jurisdictions globally, including Spain.
- AstraZeneca holds significant intellectual property around osimertinib, extending its exclusivity.
- Ramucirumab (Cyramza):
- Developed by Eli Lilly and Company.
- Patents cover the antibody itself, its manufacturing, and its use in treating various cancers, including NSCLC, gastric cancer, and colorectal cancer.
- Eli Lilly also has a robust patent portfolio protecting ramucirumab.
Intersection of Patents:
ES2650611 represents a strategic patent for a combination therapy, aiming to carve out protection beyond the individual drug patents. This type of combination patent is crucial for establishing market exclusivity for a particular therapeutic regimen.
- Potential for Litigation: Given the commercial significance of both osimertinib and ramucirumab, any competitor seeking to market a similar combination therapy in Spain before the expiry of ES2650611 would face potential patent infringement litigation.
- Licensing Opportunities: Companies seeking to develop or market this specific combination therapy would likely need to secure a license from the patent holder of ES2650611.
- Generics and Biosimilars: The expiry of patents for the individual drugs may pave the way for generics and biosimilars. However, ES2650611 will continue to protect the combination until its expiry in 2036, potentially delaying the entry of generic combination products.
What is the Commercial Significance of ES2650611?
The commercial significance of ES2650611 is directly tied to the clinical and market success of the osimertinib and ramucirumab combination.
- Osimertinib (Tagrisso): Tagrisso is a blockbuster drug for AstraZeneca, generating billions in annual revenue, particularly for the treatment of EGFR-mutated NSCLC, including in the first-line setting and for T790M-positive patients who have progressed on earlier EGFR TKIs.
- Ramucirumab (Cyramza): Cyramza is also a significant product, used in combination with other agents for NSCLC, gastric cancer, and other indications.
The combination therapy protected by ES2650611 offers a potential next-generation treatment option, aiming to overcome resistance and improve outcomes for a challenging patient population. Its commercial success will depend on:
- Clinical Efficacy and Safety: Demonstrated superior outcomes compared to existing therapies in robust clinical trials.
- Regulatory Approvals: Obtaining marketing authorization from relevant health authorities.
- Market Access and Reimbursement: Securing favorable pricing and reimbursement from healthcare systems and payers in Spain.
- Competition: The emergence of other novel therapies or combinations targeting similar patient groups.
The patent provides a strong defensive position for the patent holder, securing market exclusivity for this specific therapeutic approach in Spain until 2036. This exclusivity is critical for recouping the significant R&D investment and maximizing commercial returns.
What are the Implications for R&D and Investment?
For pharmaceutical companies, contract research organizations (CROs), and investors involved in oncology R&D, ES2650611 has several implications:
- Freedom to Operate (FTO): Any entity considering developing or marketing a therapeutic combination of osimertinib and ramucirumab in Spain must conduct a thorough FTO analysis to ensure they are not infringing ES2650611 or related patents.
- In-Licensing/Out-Licensing: Companies holding the patent may seek to out-license it to other pharmaceutical companies for co-development or commercialization. Conversely, companies interested in this specific combination may need to in-license the patent.
- Diversification Strategies: For companies with portfolios in NSCLC or EGFR inhibitors, understanding this patent is crucial for strategizing future R&D, identifying potential partnerships, or avoiding areas of existing strong IP protection.
- Investment Due Diligence: Investors evaluating companies with oncology assets should scrutinize their IP portfolios, including the presence of patents like ES2650611, to assess market exclusivity and competitive positioning.
- Combination Therapy Development: The patent highlights the increasing importance of combination therapies in oncology. R&D efforts may focus on identifying synergistic drug combinations and securing intellectual property for them.
Key Takeaways
- Patent ES2650611 protects a pharmaceutical composition and method of treatment comprising osimertinib and ramucirumab for cancer therapy, primarily targeting EGFR-mutated NSCLC.
- The patent provides exclusivity in Spain until December 15, 2036.
- The claims cover both the drug composition and its therapeutic use, establishing a strong market position for the patented combination.
- The competitive landscape involves existing patents for individual drugs (osimertinib and ramucirumab) and the strategic patenting of their combination.
- The commercial significance is substantial, driven by the proven efficacy of both agents and the unmet need for advanced NSCLC treatments.
- R&D and investment decisions must account for ES2650611 to ensure freedom to operate, identify licensing opportunities, and strategize competitive positioning.
FAQs
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Can generic osimertinib and ramucirumab be combined and sold in Spain before December 15, 2036?
Generic versions of individual drugs may become available after their respective patent expiries. However, the combination therapy itself is protected by ES2650611 until December 15, 2036. Selling a product that infringes on the claims of ES2650611, even if it uses generic versions of the active ingredients, would constitute patent infringement in Spain.
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Does ES2650611 cover any other cancer types besides NSCLC?
While NSCLC is the primary and most detailed indication within the patent's claims, the broader language used in some claims may extend to "cancer" generally, implying potential applicability to other solid tumors where EGFR or VEGF pathways are relevant. However, the most robust protection and specific targeting are for NSCLC.
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What is the relationship between ES2650611 and patents held by AstraZeneca or Eli Lilly for their individual drugs?
ES2650611 is a distinct patent that specifically protects the combination of osimertinib and ramucirumab. It is likely held by an entity that has secured rights or developed this specific combination strategy, potentially distinct from the originators of the individual drugs. This combination patent complements, rather than replaces, the patents for the individual drug entities.
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What constitutes "prior EGFR TKI therapy" as mentioned in the claims of ES2650611?
"Prior EGFR TKI therapy" refers to any previous treatment regimen that included an epidermal growth factor receptor tyrosine kinase inhibitor. This can include first-generation (e.g., gefitinib, erlotinib), second-generation (e.g., afatinib, dacomitinib), or third-generation (e.g., osimertinib itself, if used sequentially in a different context) TKIs. The patent is particularly focused on overcoming resistance that arises after such treatments.
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If a company has a patent for a new formulation of osimertinib, does that grant them the right to combine it with ramucirumab under ES2650611?
No. A patent for a new formulation of osimertinib would protect that specific formulation. However, to commercialize a combination of that formulation with ramucirumab in Spain, the company would still need to address the intellectual property rights granted by ES2650611, which protects the combination itself. This may require obtaining a license from the holder of ES2650611.
Citations
[1] OEPM. (n.d.). Spanish Patent ES2650611. Retrieved from OEPM database.
