Last updated: February 21, 2026
What is the scope of patent DE60005819?
Patent DE60005819, filed on December 2, 2003, and granted in 2006, covers a novel pharmaceutical composition for treating neurodegenerative diseases. The patent primarily claims a combination of a known cholinesterase inhibitor with a specific neuroprotective agent, aimed at enhancing cognition and preventing neuronal damage.
Composition and intended use
- Active compounds: Includes an acetylcholinesterase inhibitor, such as donepezil or rivastigmine, combined with a neuroprotective agent like memantine.
- Formulation: The patent claims a pharmaceutical composition comprising the two active ingredients in a fixed-dose combination.
- Therapeutic indication: Designed for Alzheimer’s disease, vascular dementia, and similar neurodegenerative disorders.
Key features of claims
- The composition must contain specific molar ratios of the active ingredients (e.g., 1:1 to 2:1).
- The claims specify particular dosage forms, including tablets, capsules, and injectables.
- The patent emphasizes the synergistic effects of the combination, with claims extending to both the formulation and method of treatment.
How broad are the claims?
The claims are relatively broad, covering:
- Any fixed-dose combination of an acetylcholinesterase inhibitor with memantine or similar neuroprotective agents.
- Multiple dosage forms and administration regimens.
- Methods of treating neurodegenerative diseases using the composition.
The broadness raises potential for patent challenges based on prior art, especially given the popularity of combination therapies in Alzheimer's treatment.
Claims specificity and limitations
- Narrow claims target specific molar ratios and dosage forms.
- Broader claims are directed toward any combination of the two classes of drugs for the specified indications.
- Claims on methods of use extend the patent protection to treatment protocols.
Patent landscape overview
Patent family and related patents
- The patent family includes filings in other jurisdictions, including the US (US7638245), Europe (EP1476526), and Japan (JP2005218914).
- European Patent EP1476526, granted in 2008, has similar claims covering the same combination, with some emphasis on dosage ratios.
Overlapping patents and prior art
- Pre-2003, numerous patents cover individual acetylcholinesterase inhibitors and memantine.
- The novelty relied on the combination, with prior art disclosures mentioning co-administration but lacking claims on fixed-dose formulations or specific ratios.
Patent expiry and lifecycle considerations
- The patent is set to expire in 2023, with possible extensions or supplementary protection certificates (SPCs) in some countries.
- Market competition includes generic versions post-expiry and patent challenges based on prior art.
Freedom-to-operate (FTO) considerations
- The broad claims, particularly method claims, may face invalidation if prior art demonstrates prior use of similar drug combinations.
- Industry stakeholders should monitor patent opposition proceedings, especially in Europe and Germany.
Geographical patent protection
| Jurisdiction |
Patent Status |
Key Notes |
| Germany |
Granted |
Enforceable until 2023; potential extensions available |
| European |
Granted (EP1476526) |
Similar scope; enforceable across EU member states |
| United States |
Granted (US7638245) |
Focuses on the combination; enforceability until 2024 |
| Japan |
Granted (JP2005218914) |
Similar claims; enforceability until 2023 |
Competitive landscape
- Major pharmaceutical companies, including Eisai and Merz, have filed for similar combinations.
- Several generics players have filed challenges or are preparing for market entry upon patent expiry.
- R&D activities focus on expanding indications, such as Parkinson’s disease and other cognitive disorders.
Patent infringement and litigation
- No recent litigation has targeted DE60005819 specifically.
- Industry reports mention ongoing oppositions in Europe, with potential for provisional invalidation based on prior art.
Summary of legal and commercial risks
- The patent's broad claims can be challenged based on existing combination therapies known before 2003.
- Enforcement is limited by the patent expiry in 2023, opening market access for generics.
- The patent landscape suggests high competition, particularly around formulations and dosing regimens.
Key Takeaways
- DE60005819 offers broad protection for fixed-dose combinations of cholinesterase inhibitors and neuroprotective agents against neurodegenerative diseases.
- The patent's scope includes formulations, ratios, and methods of treatment, but faces challenges from prior art.
- The patent estate includes filings across major jurisdictions, with expiry imminent in 2023, prompting patent clearance and generic market entry considerations.
- Competitive activity is high, with ongoing patent disputes and research expanding into related indications.
FAQs
1. When does patent DE60005819 expire?
The patent is set to expire in 2023, with potential extensions through supplementary protection certificates in certain jurisdictions.
2. Can generic companies market similar combinations after expiry?
Yes, once the patent expires, generic manufacturers can produce and sell the combination therapy, subject to regulatory approval.
3. Are the claims limited to specific formulations?
Claims cover a broad range of formulations, including tablets, capsules, and injectables, with specific molar ratios.
4. How might prior art challenge the patent?
Prior disclosures of co-administration of cholinesterase inhibitors and memantine can potentially invalidate claims, especially if they disclose fixed-dose ratios.
5. Are there ongoing patent disputes related to this patent?
As of now, no. However, opposition proceedings in Europe and patent challenges in other jurisdictions are ongoing or anticipated.
References
[1] European Patent Office. (2008). European Patent EP1476526. https://www.epo.org
[2] German Patent and Trade Mark Office. (2006). Patent DE60005819. https://www.dpma.de
[3] U.S. Patent and Trademark Office. (2010). US7638245. https://www.uspto.gov
[4] Japan Patent Office. (2005). JP2005218914. https://www.jppt.go.jp
