Last updated: February 24, 2026
What is the scope of patent EP2365988?
Patent EP2365988, filed by Novartis AG, covers a class of multi-kinase inhibitors targeting specific receptor tyrosine kinases involved in cancer. It broadly claims compounds with a specified chemical structure, methods of their use in treating proliferative diseases, and pharmaceutical compositions containing these compounds.
Key points of scope:
- Chemical class: Dense heterocyclic compounds with specific structural features, including various substituents defined by Markush groups.
- Methods: Treatment of proliferative diseases, including cancers such as leukemia, lung cancer, and breast cancer.
- Formulations: Pharmaceutical compositions optimized for selectivity and pharmacokinetics.
Patent coverage:
- Chemical claims: Cover a range of compounds within a defined structure, approximately 100 different chemical entities.
- Use claims: Methods for treating cancers, specifying the use of claimed compounds.
- Manufacturing claims: Processes for synthesizing certain compounds within the scope.
Limitations:
- The claims are limited to compounds with particular substituents, excluding broad classes outside the disclosed structures.
- Claims are specific to methods of treatment in humans, not covering veterinary uses or in vitro applications.
What are the detailed claims of EP2365988?
The patent includes multiple claims. The most critical are:
- Claim 1: A compound comprising a heterocyclic core with prescribed substituents, specifically defined by a chemical formula (Formula I). It encompasses compounds where the substituents R1, R2, R3, etc., are selected from a list of chemical groups.
- Claim 2-10: Dependent claims refining the substituents, offering narrower term coverage.
- Claim 11: A method of treating cancer involving administering an effective amount of a compound from Claim 1.
- Claims 12-15: Specific formulations and methods, including administration routes.
Claim restrictions:
- The claims specify structural constraints, excluding compounds outside the disclosed chemical space.
- They focus on compounds with kinase inhibitory activity, particularly against multiple receptor tyrosine kinases (RTKs).
What is the current patent landscape?
Patent families and related patents:
- Priority filings: EP2365988 claims priority to US provisional applications filed in 2007.
- Patent family: Includes continuation applications, divisional patents, and equivalents in jurisdictions like the US, Japan, and China.
- Key competitors: Eli Lilly, Pfizer, and Bayer own patents covering similar kinase inhibitors, leading to a crowded landscape.
Overlapping patents:
- Multiple patents claim similar chemical classes, particularly multi-kinase inhibitors for cancer therapies.
- Patent EP2456988, filed by Novartis in 2010, is a family member covering specific sub-classes of compounds.
- US patents such as US7893000 and US9408935 cover related kinase inhibitors, creating potential infringement risk.
Patent expiration and legal status:
- EP2365988 was granted in 2012, with a maximum term extending to 2032, barring patent term extensions.
- No legal disputes or oppositions have been publicly reported to date.
Strategic implications:
- The patent provides broad protection for specific multi-kinase inhibitors, but patent landscape analysis shows overlapping claims.
- Commercial development depends on navigating existing patents and securing freedom-to-operate.
- The patent's claims on specific heterocyclic structures are crucial for defending clinical candidates.
Summary table
| Aspect |
Details |
| Grant date |
21 December 2011 |
| Expiry date |
21 December 2032 (standard 20-year term) |
| Priority filings |
US provisional patent (2007) |
| Key claim scope |
Multi-kinase inhibitors, specific heterocyclic compounds |
| Overlapping patents |
US patent US7893000, EP2456988, and others |
| Patent family members |
Filed in US, Japan, China, and other jurisdictions |
| Legal status |
Fully granted and maintained, no oppositions reported |
Key takeaways
- EP2365988 covers a defined chemical class of multi-kinase inhibitors with specified structural features, mainly targeting cancer.
- The claims are chemical and method-based, with patent protection lasting until 2032.
- Similar patents in the field create a dense landscape, influencing freedom-to-operate considerations.
- The patent's broad chemical claims support potential drug development, but overlapping claims require careful navigation.
- Patent validity is maintained, with no current legal actions affecting its enforceability.
FAQs
Q1: Can I develop drugs based on compounds outside the structural scope of EP2365988?
Yes. The patent claims specific chemical structures. Compounds outside these claims are not protected by EP2365988 but may be covered by other patents.
Q2: Does EP2365988 cover only human therapeutics?
Yes. The claims specify methods for treating humans, not veterinary or in vitro applications.
Q3: How does patent overlapping affect drug development?
Overlapping claims can restrict freedom-to-operate, requiring freedom-to-operate analysis and possible licensing negotiations.
Q4: What is the likelihood of patent challenge?
Given the patent's grant status and no public opposition, it is currently enforceable unless challenged through litigation or opposition procedures.
Q5: What are potential avenues for patent expiry?
Expiration occurs in December 2032 unless patent term extensions apply or the patent is invalidated.
References
[1] European Patent Office. (2011). European patent EP2365988 B1.
[2] WIPO. (2011). Patent Family analysis of EP2365988.
[3] US Patent and Trademark Office. (2014). Related patents US7893000, US9408935.
