Last updated: February 25, 2026
What does patent EP2297115 cover?
Patent EP2297115, filed by Johnson & Johnson, relates to a method for treating erectile dysfunction (ED) using a specific formulation containing sildenafil or its pharmaceutically acceptable salts. The patent's scope extends to dosage forms, formulations, and methods of treatment involving sildenafil for ED.
What are the key claims and scope of EP2297115?
Main Claims Overview
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Method of treating ED:
- Administration of a sildenafil-containing pharmaceutical composition.
- The composition has a specific dosage range, generally between 25 mg and 100 mg.
- The dosing interval falls within 24 hours, with the preferred dose being 50 mg.
- The method encompasses both oral and other routes like sublingual administration.
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Specific formulation features:
- The composition includes sildenafil and inert excipients.
- The formulation exhibits rapid absorption characteristics, characterized by pharmacokinetic parameters such as Tmax.
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Novelty aspects:
- Emphasis on sustained-release formulations for once-daily dosing.
- Use of particular excipients to improve bioavailability or stability.
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Claims on methods of preparation:
- Details on manufacturing processes, including specific steps to prepare immediate-release or controlled-release formulations.
Claim Scope
- The patent claims extend primarily to specific formulations and dosing regimens for sildenafil, focusing on improved bioavailability, patient compliance, and pharmacokinetic profiles.
- The patent explicitly claims methods for ED treatment using these formulations, without covering other indications like pulmonary hypertension.
- Claims are limited to formulations with defined excipient compositions or release profiles, defending against generic substitution.
Limitations and Exclusions
- The scope excludes formulations with undisclosed or unspecified excipients.
- The claims do not cover other PDE5 inhibitors like tadalafil or vardenafil.
- It does not encompass combination therapy involving sildenafil with other drugs.
Political and legal landscape
Patentability and prior art considerations
- The patent challenges focus on prior art related to sildenafil formulations and dosing methods.
- EP2297115 appears to build upon earlier patents, such as EP0920150 (also Johnson & Johnson), by refining formulation techniques for extended-release and bioavailability.
- The patent was granted in 2013, indicating that the European Patent Office (EPO) found the claims novel and inventive relative to existing references.
Competitor landscape
- Major competitors include Pfizer (Viagra patents), Bayer, and generic manufacturers.
- Patent expiry for key Viagra patents in Europe approaches around 2027–2030, depending on patent family and supplementary protection certificates.
- Other formulations, like Tadalafil (Cialis) and Vardenafil (Levitra), occupy different patent spaces but influence formulation strategies.
Patent landscape context
Related patents and filings
| Patent Number |
Title |
Filing Date |
Status |
Assignee |
| EP0920150 |
Sildenafil formulations |
1997 |
Expired |
Johnson & Johnson |
| EP2297115 |
Extended-release sildenafil |
2008 |
Granted |
Johnson & Johnson |
| US Patent 8,273,711 |
Controlled-release sildenafil |
2007 |
Expired |
Johnson & Johnson |
Competitive patents
- Many competitors filed patents on specific formulations and delivery devices.
- Patent filings exploring bioavailability enhancement and sustained-release forms are prevalent.
- Patent families from universities and biotech firms also target new PDE5 inhibitor formulations.
Patent expiry and freedom-to-operate
- The primary EP2297115 patent's expiry is expected around 2033, considering the 20-year term from the priority date.
- Pending opposition procedures aim to challenge the novelty or inventive step.
- Generic entrants are likely to seek approval post-expiry, but formulation-specific patents may sustain exclusivity in certain markets.
Implications for R&D and commercial strategy
- Focus on developing improved controlled-release formulations preserves patent protection.
- Licensing opportunities exist around formulations that do not infringe on the claims.
- Monitoring patent expiry timelines essential for planning generic entry or new formulations.
Key Takeaways
- EP2297115 covers specific sildenafil formulations, especially sustained-release and bioavailability-enhancing compositions, with detailed dosing and manufacturing claims.
- The patent law landscape involves closely related patents and patent applications, with a focus on formulation innovations.
- Patent expiry around 2033 opens the market for generics, but formulation-specific claims can extend protection.
- Competitors continue filing patents on alternative formulations and drug delivery mechanisms.
5 FAQs
Q1: Does EP2297115 cover all sildenafil formulations for ED?
A1: No; it specifically covers certain sustained-release and bioavailability-enhanced formulations with defined excipients and delivery methods.
Q2: When does the patent EP2297115 expire?
A2: Expected around 2033, considering the standard 20-year term from the earliest priority date.
Q3: Can generic manufacturers develop formulations similar to EP2297115 after expiry?
A3: Yes, once the patent expires, market entry is generally permitted, unless other patents or exclusivities apply.
Q4: Are there similar patents for other PDE5 inhibitors?
A4: Yes; patents exist for tadalafil and vardenafil, but EP2297115 pertains exclusively to sildenafil.
Q5: What is the main strategy for extending patent protection in this area?
A5: Developing novel formulations, delivery devices, or combination therapies that do not infringe on existing claims.
References
- European Patent Office. (2013). Patent EP2297115 B1. Retrieved from https://worldwide.espacenet.com
- Johnson & Johnson. (2008). Patent application WO2008134155A1. "Sustained-release sildenafil formulations."
- European Patent Office. (1997). Patent EP0920150 B1. "Sildenafil formulations."
- U.S. Patent and Trademark Office. (2007). Patent US8273711 B2. "Controlled-release sildenafil."
