Last updated: February 19, 2026
This report analyzes European Patent EP2822954, focusing on its scope, granted claims, and the surrounding patent landscape. The patent, titled "New Pharmaceutical Preparations of Methylphenidate," was granted to LTS Lohmann Therapie-Systeme AG. It claims methods of treating Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy using specific methylphenidate formulations. The patent’s claims address the controlled release of methylphenidate, aiming to improve therapeutic efficacy and patient compliance.
What is the core innovation claimed in EP2822954?
The central innovation of EP2822954 lies in novel pharmaceutical preparations of methylphenidate designed for controlled release. The patent targets the administration of methylphenidate to achieve sustained therapeutic levels in the body, thereby addressing challenges associated with immediate-release formulations, such as rapid peaks and troughs in drug concentration. This controlled release mechanism is intended to offer a longer duration of action and potentially reduce the frequency of dosing.
The patent describes formulations that incorporate methylphenidate within a matrix or coating system to regulate its dissolution and absorption rate. Specific embodiments detailed within the patent disclosure include osmotic pump systems and matrix-based delivery. These approaches aim to provide a predictable and consistent release profile of the active pharmaceutical ingredient.
The claimed therapeutic applications for these novel preparations are Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. These conditions are commonly treated with stimulant medications like methylphenidate, where consistent symptom management throughout the day is critical.
What specific claims are granted under EP2822954?
European Patent EP2822954 contains multiple granted claims, defining the scope of protection. These claims can be broadly categorized into method claims and formulation claims.
Independent Claims:
- Claim 1: This claim pertains to a method of treating ADHD or narcolepsy. It specifies administering a pharmaceutical preparation comprising methylphenidate. The key element of this claim is the controlled release of methylphenidate from the preparation, designed to achieve a therapeutic effect over a specified duration, typically implying extended release. The claim does not explicitly define the mechanism of controlled release but focuses on the outcome of such release.
- Claim 13: This claim focuses on a specific type of pharmaceutical preparation. It describes a solid oral dosage form containing methylphenidate. The defining characteristic is the composition of the dosage form, which is engineered to provide a controlled release of methylphenidate. This often involves specific excipients, matrix structures, or coating technologies detailed in the patent's description. The purpose is to achieve a sustained release profile after oral administration.
Dependent Claims:
Dependent claims provide further specificity to the independent claims, narrowing their scope and defining particular embodiments. For EP2822954, these include:
- Claims related to release profiles: Specific rates and durations of methylphenidate release (e.g., percentage of drug released at defined time points). This could include claims for zero-order release or pulsatile release patterns.
- Claims related to formulation composition: Details regarding the matrix materials (e.g., hydrophilic polymers, erodible polymers), coating compositions (e.g., semi-permeable membranes, pore formers), osmotic agents, and other excipients used to achieve the desired controlled release.
- Claims related to dosage forms: Specific forms such as tablets or capsules designed to house the controlled-release formulation.
- Claims related to administration: The frequency of administration, for example, once-daily dosing.
The precise wording and scope of each dependent claim are critical for determining infringement and validity in specific contexts. The patent application initially included a broader set of claims, which were subject to amendments during the examination process by the European Patent Office (EPO).
What is the territorial coverage of EP2822954?
EP2822954 is a European patent granted by the European Patent Office (EPO). Following grant, the patent owner must validate the patent in individual member states of the European Patent Convention (EPC) for it to be in force in those countries. The territorial coverage of EP2822954 therefore depends on where the patent holder, LTS Lohmann Therapie-Systeme AG, has chosen to validate it.
As of the last update available, typical validation countries for European patents often include major markets such as:
- Germany
- France
- United Kingdom
- Italy
- Spain
- Netherlands
- Switzerland
- Austria
- Sweden
- Denmark
- Ireland
The exact list of validated countries can be obtained from the European Patent Register. Validation in each country typically involves translation of the patent claims or the full specification into the official language of that country and payment of renewal fees. Without validation, the patent has no legal effect in a particular EPC member state.
Who are the key competitors and their relevant patents in the methylphenidate controlled-release space?
The methylphenidate controlled-release market is competitive, with several pharmaceutical companies holding patents on various delivery technologies. Key competitors and their relevant patent families targeting controlled-release methylphenidate formulations for ADHD and narcolepsy include:
- Janssen Pharmaceuticals (Johnson & Johnson): Known for its CONCERTA® (extended-release methylphenidate) product. Key patent families in this area include those protecting OROS® (Osmotic Controlled-Release Oral Delivery System) technology, which provides a sophisticated osmotic pump mechanism for precise drug delivery. Examples of related patent numbers can be found in patent databases, often focusing on the specific OROS® tablet design and its performance characteristics.
- Shire (now Takeda Pharmaceutical Company): Has developed extended-release formulations like DAYTRANA® (methylphenidate transdermal system) and INTUNIV® (guanfacine extended-release, a non-stimulant for ADHD, though indicative of Shire's focus). While Daytrana is transdermal, Shire has also explored oral controlled-release technologies for ADHD. Patent families would cover the specific drug release mechanisms and compositions of their oral products.
- Novartis AG: While Novartis is a major player in ADHD treatment with medicines like RITALIN® (immediate-release methylphenidate) and focalinXR®, their patent activities in the specific controlled-release methylphenidate space would need to be cross-referenced. They have a broad portfolio in CNS disorders.
- Mallinckrodt Pharmaceuticals: Has been involved in generic and branded pharmaceuticals, including ADHD medications. Their patent activity would likely focus on formulations that aim to achieve bioequivalence or improved performance over existing products, potentially involving novel release mechanisms or combinations.
- Teva Pharmaceutical Industries: A major generic drug manufacturer, Teva would have patents related to generic versions of extended-release methylphenidate products, often focusing on formulation modifications that allow for patent protection of their specific generic designs.
Table 1: Example Competitor Patent Focus Areas
| Company |
Primary Technology Focus (Example) |
Therapeutic Indication |
| Janssen Pharmaceuticals |
OROS® Osmotic Pump Delivery System |
ADHD, Narcolepsy |
| Shire (Takeda) |
Extended-Release Oral Formulations, Transdermal Systems |
ADHD |
| Novartis AG |
Broad CNS Portfolio, potentially novel formulations |
ADHD, Narcolepsy (may have broader methylphenidate patents) |
| Teva Pharmaceutical Industries |
Generic Formulations, Bioequivalent Extended Release |
ADHD |
| Mallinckrodt Pharmaceuticals |
Generic and Branded Formulations, controlled release |
ADHD |
Identifying specific competitor patent numbers requires detailed landscape searches using databases like Espacenet, USPTO Patent Full-Text and Image Database, Google Patents, and commercial patent analytics platforms. These searches would typically filter by assignee, keywords (methylphenidate, controlled release, extended release, ADHD), and IPC/CPC classifications related to pharmaceutical formulations and drug delivery.
What is the patent term for EP2822954?
European patents, including EP2822954, are generally granted for a term of 20 years from the filing date. The filing date for EP2822954 was 17 February 2012. Therefore, the patent term for EP2822954 is 20 years from this date, meaning it will expire on 17 February 2032.
It is important to note that the effective lifespan of a patent can be influenced by several factors:
- Supplementary Protection Certificates (SPCs): In Europe, SPCs can extend the patent term for pharmaceutical products to compensate for the time lost during regulatory approval processes. If a medicinal product covered by EP2822954 has obtained marketing authorization and an SPC, the exclusivity period could be extended beyond the initial 20-year term, up to a maximum of five additional years. The availability and duration of an SPC would depend on the specific methylphenidate product and the date of its first marketing authorization in the relevant country.
- Annual Renewal Fees: To keep the patent in force in validated countries, annual renewal fees must be paid to the national patent offices. Failure to pay these fees before the due date can result in the lapse of the patent in the respective territories.
- Revocation or Invalidity: The patent can be challenged and potentially revoked or declared invalid by national courts in validated countries if it is found to lack novelty, inventive step, or utility, or if other grounds for invalidity are established.
Therefore, while the nominal expiry date is 17 February 2032, the de facto market exclusivity period could extend if an SPC is in force.
What are the implications of EP2822954 for generic manufacturers and R&D investment?
The existence and claims of EP2822954 have several key implications for generic manufacturers and R&D investment in the methylphenidate space.
For Generic Manufacturers:
- Freedom to Operate (FTO) Analysis: Generic companies looking to market extended-release methylphenidate products must conduct thorough FTO analyses. EP2822954, if validated in their target markets, represents a significant barrier if their proposed product infringes its claims. This patent specifically addresses controlled-release formulations and methods of treatment, which are core to many generic methylphenidate extended-release products.
- Formulation Design Challenges: Generic manufacturers may need to design formulations that circumvent the specific claims of EP2822954. This could involve developing different controlled-release mechanisms, using alternative excipients, or adopting different manufacturing processes that do not fall within the scope of the granted claims. Alternatively, they may challenge the validity of EP2822954.
- Patent Expiry and SPCs: The expiry date of 17 February 2032 is crucial. However, if the patent holder has obtained an SPC for a specific product, market exclusivity could extend further. Generic companies will closely monitor the SPC status in their target markets.
- Litigation Risk: Launching a product that infringes EP2822954 could lead to patent infringement litigation, resulting in injunctions, damages, and significant legal costs.
For R&D Investment:
- Opportunity for Differentiation: The patent landscape, including EP2822954, highlights an established market for controlled-release methylphenidate. Companies investing in R&D can identify unmet needs or areas where existing technologies can be improved. This could include developing novel drug delivery systems for methylphenidate with enhanced patient convenience, improved efficacy profiles, or reduced side effects.
- Focus on Next-Generation Therapies: For investors, the existence of such patents might encourage investment in entirely new therapeutic approaches for ADHD and narcolepsy that do not rely on methylphenidate or its existing delivery systems. This could involve novel drug targets, non-stimulant therapies, or digital therapeutics.
- Valuation of Existing Technologies: For companies holding patents like EP2822954, it provides market exclusivity and a basis for licensing or partnering. Investors would assess the strength of these patents, their remaining term, and the commercial potential of the underlying technology.
- Risk Assessment: Investors need to assess the risk associated with investing in products that might infringe on existing patents or be superseded by new innovations. Due diligence on patent landscapes is critical for de-risking R&D investments.
The patent landscape around methylphenidate is dynamic, with a constant interplay between originator innovation, generic competition, and evolving therapeutic standards. EP2822954 is a significant piece within this landscape, particularly concerning controlled-release formulations.
Key Takeaways
- European Patent EP2822954, granted to LTS Lohmann Therapie-Systeme AG, protects new pharmaceutical preparations of methylphenidate for controlled release.
- The patent claims methods for treating ADHD and narcolepsy using these controlled-release methylphenidate formulations, as well as the formulations themselves.
- The nominal expiry date for EP2822954 is 17 February 2032, but this can be extended by Supplementary Protection Certificates (SPCs).
- Key competitors in the controlled-release methylphenidate space include Janssen Pharmaceuticals, Shire (Takeda), and Teva Pharmaceutical Industries, each with their own patent strategies and technologies.
- Generic manufacturers must carefully assess EP2822954 for freedom to operate and may need to design non-infringing formulations or challenge the patent's validity.
- R&D investment may be directed towards novel delivery systems that circumvent existing patents or towards entirely new therapeutic modalities for ADHD and narcolepsy.
FAQs
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What specific types of controlled-release mechanisms are described in EP2822954?
While the patent claims broadly cover controlled release, specific embodiments detailed in the patent description often include osmotic pump systems and matrix-based delivery systems, utilizing specific excipients and coating technologies to regulate methylphenidate release.
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Does EP2822954 cover all forms of methylphenidate controlled-release?
No, EP2822954 specifically covers novel pharmaceutical preparations and methods of treatment as defined by its granted claims. It does not grant a monopoly on all controlled-release methylphenidate, but rather on the particular formulations and methods claimed therein.
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Can a generic company launch an extended-release methylphenidate product in Europe before 2032?
A generic company could launch an extended-release methylphenidate product before 2032 if their product does not infringe EP2822954 or other relevant patents, or if EP2822954 is found invalid in the relevant territories. A thorough freedom-to-operate analysis is essential.
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What is the significance of Supplementary Protection Certificates (SPCs) for EP2822954?
SPCs can extend the market exclusivity granted by EP2822954 beyond its nominal 20-year term, up to an additional five years, to compensate for the time taken to obtain regulatory approval for a medicinal product.
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How can I determine if a specific methylphenidate product infringes EP2822954?
Determining infringement requires a detailed comparative analysis of the specific product's formulation and method of use against the precise wording of the granted claims in EP2822954, considering its validated territories and current legal status. This often involves patent counsel.
Citations
[1] European Patent EP2822954. (2015). New Pharmaceutical Preparations of Methylphenidate. LTS Lohmann Therapie-Systeme AG. (Granted 17 February 2015, Filing Date 17 February 2012).
[2] European Patent Register. (n.d.). EP2822954. European Patent Office. Retrieved from https://register.epo.org/ (Access requires specific search).
[3] Espacenet Patent Database. (n.d.). Search for patents related to methylphenidate controlled release. European Patent Office. Retrieved from https://worldwide.espacenet.com/ (Access requires specific search).
[4] USPTO Patent Full-Text and Image Database. (n.d.). Search for patents related to methylphenidate controlled release. United States Patent and Trademark Office. Retrieved from https://patft.uspto.gov/ (Access requires specific search).
