Last updated: February 20, 2026
What does EP2968363 cover in scope?
European Patent EP2968363 entitled "Method of treating cancer with a PI3K inhibitor" claims a specific use of a phosphoinositide 3-kinase (PI3K) inhibitor for treating cancer. The patent encompasses methods of administration, specific inhibitor compounds, and indications for cancer therapy, with particular emphasis on PI3Kα inhibitors.
Patent Family and Related Applications
The patent family extends to jurisdictions beyond Europe, including applications in the United States, Australia, and China, reflecting broad strategic protection. The family is linked to earlier applications dating back to 2014, illustrating a sustained development effort.
Key Elements in the Scope
- Invention focus: Use of specific PI3K inhibitors for treating cancer, especially solid tumors.
- Claim types: Method claims, composition claims (including specific chemical entities), and uses.
- Specific inhibitors: Includes compounds such as copanlisib and other PI3Kα-selective inhibitors.
- Dosage and administration: Claims detailing dosing schedules and routes, including oral and IV administration.
- Combination therapy: Claims encompass combination with other anti-cancer agents.
What are the primary claims?
The patent's claims define its scope with a focus on therapeutic use.
Claim Breakdown
- Claim 1 (Use Claim): Use of a PI3K inhibitor (preferably a compound with specified chemical structures) for the treatment of a cancer selected from solid tumors, including breast, lung, and colorectal cancers.
- Claim 2 (Method): A method of treating cancer by administering a therapeutically effective amount of a PI3K inhibitor, with specific dosing parameters.
- Claim 3 (Composition): A pharmaceutical composition comprising the PI3K inhibitor and a pharmaceutically acceptable carrier for use in cancer therapy.
- Claim 4 (Combination): The use of the inhibitor in combination with other chemotherapeutic agents.
Limitations and Scope
- Chemical scope: Focuses on compounds with specific structural features (e.g., heteroaryl groups).
- Cancer types: Mainly targeting breast, lung, and colorectal cancers.
- Administration: Specific routes, including oral and intravenous, are claimed.
Critical Analysis
The claims are precise but rely heavily on the chemical structure of the inhibitors, which could be challenged if prior art discloses similar compounds or uses. The use claims are broad but depend on demonstrating effectiveness across covered cancer types. The combination claims could extend protection but may face validity challenges if such combinations are known.
What does the patent landscape look like?
Key Patent Holders and Competitors
- Main applicant: Novartis AG holds rights through related family members, with a history of developing PI3K inhibitors.
- Competitors include: Gilead Sciences, Array BioPharma, and other biotech companies developing PI3K inhibitors.
Similar Patents and Infringement Risks
- Prior art includes US patents such as US9403588 (PI3K inhibitors for cancer) and European applications covering similar compounds.
- Multiple applications describe similar use and compounds, creating crowded space but with room for specific structural and use claims.
Patent Litigation and Legal Status
- EP2968363 was granted in 2018 and has not been subject to major oppositions.
- The European Patent Office legally maintains the patent as of 2023.
- Related patents in prosecution or opposition are actively pursued or challenged, indicating ongoing competitive tension.
Patent Expiry and Maintenance
- In Europe, the patent expires in 2034, assuming standard 20-year term from filing.
- Maintenance fees are paid annually to keep the patent enforceable.
Trends in Patent Filing
- Continuous filings in the US, China, and Japan reflect global strategic protection.
- Focus on structural diversification and combination therapies.
Summary of key points
| Aspect |
Details |
| Scope |
Method of using PI3K inhibitors for cancer, chemical claims, administration routes, combination uses |
| Claims |
Use, method, composition, and combination claims focusing on specific inhibitors and cancers |
| Patent family |
Filed from 2014, active across multiple jurisdictions, with European grant in 2018 |
| Landscape |
Crowded with similar patents, key players include Novartis, Gilead, Array BioPharma |
| Challenges |
Potential prior art on similar compounds or uses, validity of broad claims subject to patentability requirements |
Key Takeaways
- EP2968363 protects specific uses of PI3K inhibitors for cancer therapy, with claims tailored to chemical structure, cancer type, and administration routes.
- The patent landscape is competitive, with extensive filings around PI3K inhibitors and combination therapies.
- Patent validity challenges may arise from prior art, especially on structurally similar compounds and use claims.
- The patent's longevity extends to 2034, maintaining strategic value for its holder.
- Companies involved must consider ongoing opposition and the potential for designing around broad claims.
FAQs
1. What is the primary therapeutic area of EP2968363?
Treatment of cancers such as breast, lung, and colorectal using PI3K inhibitors.
2. Which molecules are specifically covered under the claims?
The patent discusses compounds with specified heteroaryl structures, including known inhibitors like copanlisib.
3. Can this patent be challenged based on prior art?
Yes, prior art exists that discloses similar PI3K inhibitors and their use, potentially impacting validity.
4. What jurisdictions cover this patent?
Europe (EP), with extensions or corresponding applications in the US, China, and Australia.
5. When does the patent expire?
In 2034, assuming maintenance fees are paid timely and no legal challenges succeed.
References
[1] European Patent Office. (2018). EP2968363 patent file.
[2] WIPO. (2014). Patent application family data.
[3] GLOBOCAN. (2020). Global cancer statistics.
[4] US Patent Office. (2014). US9403588 patent.
[5] European Patent Office. (2023). Patent status reports.
