Last updated: February 19, 2026
This report details the scope, claims, and patent landscape surrounding European Patent EP2861072, a patent held by Celgene Corporation (now a subsidiary of Bristol Myers Squibb). The patent covers pharmaceutical compositions containing lenalidomide, a key active pharmaceutical ingredient in several oncology treatments. The analysis includes an examination of the patent's granted claims, their geographic coverage, and potential implications for generic competition and ongoing litigation.
What is the Core Innovation Protected by EP2861072?
EP2861072 protects specific pharmaceutical compositions of lenalidomide. The core innovation lies in the formulation of lenalidomide into dosage forms that offer improved stability or pharmacokinetic properties compared to earlier formulations. The patent's claims define the precise composition of these pharmaceutical forms, often specifying excipients and their quantities.
Key Claim Features
The granted claims of EP2861072 are central to understanding its protective scope. These claims define the exact parameters of the protected compositions.
- Claim 1 (Original): The primary claim typically defines a specific pharmaceutical composition comprising lenalidomide and one or more pharmaceutically acceptable excipients. The exact excipients and their percentages are critical. For instance, a common feature in lenalidomide patents relates to specific diluents, binders, disintegrants, or lubricants used in tablet manufacturing.
- Dependent Claims: Subsequent claims often narrow the scope of the first claim, adding further limitations. These might specify particular types of fillers (e.g., lactose monohydrate), disintegrants (e.g., croscarmellose sodium), or coatings. They can also define specific dosage strengths or manufacturing processes.
The precise wording of these claims dictates what constitutes infringement. Broadly worded claims offer wider protection, while narrowly defined claims may be more susceptible to circumvention by alternative formulations.
What is the Geographic Coverage of EP2861072?
European patents are validated on a country-by-country basis after grant. EP2861072 has been validated in numerous European Union member states and other European Patent Convention (EPC) contracting states.
Validated States
As of the most recent available data, EP2861072 has been validated in the following key European countries:
- Germany
- France
- United Kingdom
- Italy
- Spain
- Netherlands
- Switzerland
- Austria
- Belgium
- Denmark
- Finland
- Ireland
- Luxembourg
- Portugal
- Sweden
- Norway
- Poland
- Greece
- Cyprus
- Czech Republic
- Estonia
- Hungary
- Latvia
- Lithuania
- Malta
- Slovakia
- Slovenia
- Bulgaria
- Romania
- Croatia
This broad validation provides Celgene (and subsequently Bristol Myers Squibb) with extensive market exclusivity across major European pharmaceutical markets. The expiry date of the patent in these jurisdictions will be critical for forecasting generic market entry.
Patent Term
The term of a European patent is 20 years from the filing date, subject to the payment of annual renewal fees. Supplementary Protection Certificates (SPCs) can extend the term of protection for medicinal products for up to five years beyond the patent expiry, compensating for regulatory delays. The effective market exclusivity for the drug product protected by EP2861072 is thus determined by the later of the patent expiry date or the SPC expiry date.
For lenalidomide-based products like Revlimid®, the patent and SPC landscape has been complex and subject to extensive legal challenges.
What is the Competitive Landscape and Patent Litigation Surrounding EP2861072?
The patent landscape for lenalidomide is characterized by a layered strategy of patent filings, including patents on the active substance itself, specific polymorphs, crystalline forms, formulations, and methods of use. EP2861072 is part of this broader portfolio.
Overlapping Patent Protection
Celgene has historically relied on a portfolio of patents to protect lenalidomide products. EP2861072 is one of several key patents that, in conjunction with others, has formed the basis of its market exclusivity. Understanding its scope requires considering its relationship with other patents covering lenalidomide.
- Active Substance Patents: Patents covering the lenalidomide molecule itself are fundamental.
- Formulation Patents: EP2861072 falls into this category, protecting specific ways lenalidomide is formulated into a usable drug product.
- Method of Use Patents: These protect specific therapeutic indications for lenalidomide.
Generic Challenges and Litigation
The immense commercial success of lenalidomide-based products has made them prime targets for generic manufacturers. Legal challenges to Celgene's patents, including EP2861072, have been frequent and often complex.
- Invalidity Challenges: Generic companies typically seek to invalidate the patent by arguing it lacks novelty, inventiveness, or sufficient disclosure, or that it claims subject matter not originally filed.
- Non-Infringement Arguments: Alternatively, generic manufacturers may argue that their proposed product does not fall within the scope of the patent's claims, often by designing around the specific limitations of the claims.
- Outcome of Litigation: The outcome of litigation can vary significantly by jurisdiction. Successful challenges to key formulation or process patents can open the door for earlier generic entry.
Example of Litigation Impact: While specific details of ongoing or concluded litigation directly targeting EP2861072 are proprietary and subject to jurisdictional variations, it is widely known that the broader lenalidomide patent portfolio has been litigated extensively. Courts have examined the validity and infringement of various formulation and process patents, with outcomes impacting the timeline for generic market entry in different regions. For instance, challenges to formulation patents have historically focused on whether generic formulations contain the same specific excipients or exhibit equivalent stability profiles as claimed in the patent.
Key Competitors and Generic Entry Timelines
The primary focus of competition is from generic drug manufacturers seeking to launch their versions of lenalidomide products. The timeline for generic entry is directly dictated by the expiry of the patent and any applicable SPCs, as well as the success of any patent litigation.
| Company Type |
Primary Objective |
Role in Landscape |
| Celgene/BMS |
Defend patent exclusivity, maximize product lifecycle. |
Patent holder, active litigant, market incumbent. |
| Generic Manufacturers |
Launch off-patent lenalidomide products. |
Challengers to patents, potential infringers, future market entrants. |
| Regulatory Bodies |
Ensure drug safety, efficacy, and quality. |
Gatekeepers for generic drug approval, indirectly influencing market entry timelines. |
The market for lenalidomide has seen significant competition emerge in regions where patent and SPC protection has weakened or expired. The launch of generic lenalidomide products has demonstrably impacted pricing and market share for the originator product.
What are the Implications of EP2861072 for Future Market Entry and Investment?
The existence and scope of EP2861072, along with other relevant patents and regulatory exclusivity periods, directly influence the commercial viability and investment attractiveness of lenalidomide-related assets.
Impact on Generic Market Entry
EP2861072, if still in force and relevant to current marketed lenalidomide formulations, acts as a barrier to entry for generic manufacturers whose products might fall within its claims.
- Formulation Differentiation: Generic companies must ensure their formulations do not infringe. This often involves developing alternative excipient combinations or manufacturing processes that fall outside the patent's claims.
- Patent Expiry and Litigation: The definitive pathway for generic entry hinges on the patent's expiry date and the outcomes of any legal challenges. A patent that is successfully invalidated or expires without strong follow-on protection allows for unimpeded generic competition.
Investment Considerations
For investors, understanding the strength and remaining life of patents like EP2861072 is paramount.
- Risk Assessment: The presence of strong, unexpired patents reduces the risk of early generic competition, thereby preserving the revenue stream for the originator. Conversely, weak or expiring patents increase the risk.
- Valuation: The projected market share and profitability of both originator and generic products are heavily influenced by patent cliffs. Accurate forecasting requires meticulous analysis of the patent portfolio and its legal challenges.
- Licensing Opportunities: For companies holding such patents, they represent valuable assets that can be licensed to generate revenue. For generic companies, they represent hurdles to overcome or assets to challenge.
Strategic Importance of Formulation Patents
Formulation patents, such as EP2861072, are critical tools for extending product exclusivity beyond the life of the primary active ingredient patent. They protect a specific way of delivering the drug, which can be difficult for competitors to replicate without infringing.
- Second-Generation Products: Companies often develop new formulations with improved properties (e.g., bioavailability, stability, ease of administration) and patent these. This allows them to transition the market to their newer, protected product as the original patent nears expiry.
- Deterrent to Litigation: A strong portfolio of formulation patents can deter potential litigants by presenting multiple layers of potential infringement claims, increasing the cost and complexity of legal challenges.
The specific claims of EP2861072 define the precise boundaries of this protection. Analysis of these claims against proposed generic formulations is a critical step for any company looking to enter the lenalidomide market or for investors assessing the value of incumbent products.
Key Takeaways
- European Patent EP2861072 protects specific pharmaceutical compositions of lenalidomide, a component of key oncology drugs.
- The patent has been validated in numerous European countries, offering broad geographic market protection.
- Its claims define the precise excipient combinations and formulation characteristics that are protected.
- EP2861072 is part of a larger patent portfolio used by Celgene/Bristol Myers Squibb to defend lenalidomide exclusivity.
- The patent landscape for lenalidomide has been subject to extensive litigation, with generic manufacturers actively challenging patent validity and seeking to design around existing claims.
- The remaining term of EP2861072 and any associated Supplementary Protection Certificates, alongside the outcomes of legal challenges, directly influences the timeline for generic market entry and the investment outlook for lenalidomide-related products.
Frequently Asked Questions
- What is the exact filing date of EP2861072?
The filing date for EP2861072 is October 24, 2013.
- When does EP2861072 expire?
The patent term is 20 years from the filing date, making its nominal expiry October 24, 2033. However, effective market exclusivity may be extended by Supplementary Protection Certificates (SPCs) and is subject to annual renewal fee payments.
- Who is the current owner of EP2861072?
The current owner is Celgene Corporation, a subsidiary of Bristol Myers Squibb.
- Can a generic company launch a lenalidomide product if it doesn't use the exact composition claimed in EP2861072?
Yes, if a generic company can demonstrate that its formulation does not fall within the scope of the granted claims of EP2861072 and does not infringe any other valid and in-force patents or regulatory exclusivities. This often involves developing a formulation with different excipients or properties.
- Has EP2861072 been successfully challenged in court?
Information regarding specific successful invalidation challenges solely against EP2861072 is not publicly detailed in broad analyses, but the broader lenalidomide patent portfolio has faced numerous legal challenges across jurisdictions, with varying outcomes impacting market exclusivity.
Citations
[1] European Patent Office. (n.d.). EP2861072 B1 - Pharmaceutical composition. Retrieved from European Patent Register. (Specific details regarding renewal fees and validated states are available via the EPO Register search).
[2] Bristol Myers Squibb. (2024). Annual Report on Form 10-K for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission. (Company reports often contain details on key intellectual property and litigation).
