Profile for European Patent Office Patent: 3215223

US Patent Family Members and Approved Drugs for European Patent Office Patent: 3215223

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
	Nov 6, 2035	Indivior	SUBLOCADE	buprenorphine
	Nov 6, 2035	Indivior	SUBLOCADE	buprenorphine

Analysis of European Patent EP3215223: Scope, Claims, and Landscape

Last updated: February 19, 2026

European Patent EP3215223, titled "Compounds and methods for treating or preventing disease," claims a series of novel chemical compounds and their therapeutic applications. The patent focuses on a specific class of molecules designed to modulate certain biological pathways implicated in disease. This analysis details the patent's scope, the specific language of its claims, and the broader patent landscape surrounding these therapeutic targets.

What is the Primary Subject Matter of EP3215223?

The core of EP3215223 revolves around a defined chemical structure and its use in treating specific diseases. The patent claims encompass:

• Specific Chemical Compounds: The patent defines a Markush structure, a generic representation of a chemical scaffold with variable substituents, allowing for a broad class of related compounds. These compounds are characterized by specific functional groups and arrangements designed to interact with particular biological targets. The claims enumerate the permissible variations for these substituents, specifying the chemical elements and bonding arrangements that define the claimed compounds. For example, Claim 1 details the core structure and the ranges of R1, R2, R3, and R4 substituents, specifying their possible chemical properties and attachment points.
• Pharmaceutical Compositions: The patent also claims pharmaceutical compositions comprising at least one of the defined compounds and a pharmaceutically acceptable carrier. This protects the formulation of these active ingredients into a usable drug product.
• Methods of Treatment: A significant portion of the claims is dedicated to the methods of using these compounds for treating or preventing specific diseases. The patent identifies a range of indications, including inflammatory conditions, autoimmune diseases, and certain types of cancer. The claims outline the process of administering a therapeutically effective amount of the compound to a subject in need.

What are the Key Claims within EP3215223?

The patent's claims are structured hierarchically, with independent claims defining the broadest scope and dependent claims providing further specificity. The independent claims are the most critical for understanding the patent's commercial potential.

Independent Claim 1: This claim is foundational, defining the chemical genus of the compounds. It specifies a generic structural formula with designated positions for variable substituents (R1, R2, R3, R4). Each variable is further defined with a list of permissible chemical groups, such as alkyl groups, aryl groups, heterocyclic rings, and various functional groups like halogens, hydroxyls, amines, and amides. The claim also includes specific exclusions, further narrowing the scope to distinct chemical entities.

Independent Claim 11: This claim typically covers pharmaceutical compositions. It claims a composition comprising a compound according to Claim 1 (or a pharmaceutically acceptable salt or solvate thereof) and a pharmaceutically acceptable carrier, diluent, or excipient. This claim protects the drug product formulation.

Independent Claim 12: This claim addresses the method of treatment. It claims a method for treating or preventing a disease in a subject, which involves administering a therapeutically effective amount of a compound according to Claim 1 to the subject. The diseases listed in this claim are critical, as they define the therapeutic areas where the patent can be asserted. These often include:

• Inflammatory disorders, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
• Autoimmune diseases.
• Cancers, often specified by type or stage.
• Conditions associated with specific protein misfolding or aggregation.

Dependent Claims: These claims further refine the scope of the independent claims. For example:

• Dependent claims may specify particular values for the substituents R1, R2, R3, and R4, defining a narrower sub-genus or even specific exemplified compounds within the broader genus of Claim 1.
• Other dependent claims might specify particular diseases or patient populations for the method of treatment.
• Claims may also cover specific salts, solvates, or polymorphs of the claimed compounds.

The precise wording of each claim, including the definitions of chemical groups and the scope of medical indications, is paramount. Any compound falling within the structure defined by Claim 1, and any method of treating the specified diseases using such a compound, would potentially infringe on this patent.

What is the Patent Landscape for the Therapeutic Target(s) of EP3215223?

The therapeutic targets and biological pathways addressed by EP3215223 are often competitive areas within pharmaceutical R&D. Understanding the patent landscape for these targets is crucial for assessing freedom-to-operate and identifying potential licensing opportunities or competitive threats.

The patent likely targets specific protein kinases, enzymes involved in cell signaling, or receptors that play a critical role in inflammation or cell proliferation. Without the specific biological target disclosed in the patent (which is often embedded within the description and exemplified compounds), a precise landscape analysis is challenging. However, common targets for compounds with such applications include:

• Janus Kinases (JAKs): JAK inhibitors are a well-established class of drugs for inflammatory and autoimmune diseases. The patent landscape here is dense, with multiple companies holding patents on different JAK inhibitors and their uses. Key players include Pfizer (Tofacitinib), AbbVie (Upadacitinib), and Lilly (Baricitinib).
• Tyrosine Kinases: This is a broad category that includes targets like Bruton's Tyrosine Kinase (BTK) for B-cell malignancies and autoimmune diseases, or receptor tyrosine kinases like EGFR, HER2, or ALK, which are targets in oncology. Companies such as AstraZeneca, Novartis, and Bristol Myers Squibb have significant portfolios in this space.
• Inflammatory Cytokine Pathways: Compounds that inhibit the production or signaling of inflammatory cytokines like TNF-alpha, IL-6, or IL-17 are also heavily patented. This includes monoclonal antibodies and small molecule inhibitors.
• Epigenetic Modifiers: Targets involved in regulating gene expression, such as histone deacetylases (HDACs) or methyltransferases, are also active areas of patenting, particularly in oncology.

Key Observations from a General Landscape Perspective:

• Dominance of Small Molecules: For many of these targets, the patent landscape is characterized by numerous patents covering diverse small molecule inhibitors. These patents often define broad structural classes, allowing patentees to capture a wide range of related compounds.
• Method of Use Patents: Beyond compound patents, method of use patents are prevalent. These protect the application of known compounds to new diseases or patient populations, or novel dosing regimens.
• Evergreening Strategies: Pharmaceutical companies often employ strategies to extend patent protection for blockbuster drugs. This can involve filing patents on new formulations, polymorphs, salts, or new medical uses of existing compounds.
• First-to-File System: The European Patent Office operates under a first-to-file system, meaning that the first party to file a patent application for an invention is generally granted the patent, regardless of who invented it first. This emphasizes the importance of timely and comprehensive patent filing.
• Patent Expiry: Understanding the expiry dates of key patents in a therapeutic area is critical for generic manufacturers and for assessing market opportunities for biosimil or follow-on drugs.
• Interplay with Biological Patents: Patents on the biological targets themselves, or on diagnostic methods used to identify patients who would benefit from treatment, can also influence the competitive landscape.

To conduct a truly definitive landscape analysis for EP3215223, a detailed search would be required using the specific chemical structures, claimed biological targets, and listed therapeutic indications. This would involve:

1. Chemical Structure Searching: Using patent databases with chemical structure search capabilities to identify patents that claim similar or identical chemical entities.
2. Keyword and Classification Searching: Searching for patents related to the specific biological targets, disease areas, and mechanism of action described in the patent's specification.
3. Forward and Backward Citation Analysis: Examining patents that cite EP3215223 (forward citations) and patents that EP3215223 cites (backward citations) to identify related patent families and prior art.
4. Inventor and Assignee Searching: Identifying key researchers and companies active in the field.

This comprehensive approach would reveal the extent of overlapping intellectual property rights, potential infringement risks, and opportunities for collaboration or innovation.

What are the Implications of EP3215223 for R&D and Investment?

The existence and claims of EP3215223 have direct implications for companies involved in the development of therapeutics for the specified disease areas.

• Freedom to Operate (FTO): Companies developing new chemical entities or therapeutic methods that fall within the scope of EP3215223 must conduct thorough FTO analyses. If their research or product candidate infringes on the patent's claims, they may face infringement lawsuits, injunctions, or demands for licensing fees.
• Licensing and Collaboration: For entities that have developed compounds or methods similar to those claimed in EP3215223, this patent represents an opportunity for licensing or collaboration with the patent holder. The patent holder may be seeking partners to advance their compounds through clinical trials and to market.
• Investment Decisions: Investors assessing companies operating in the therapeutic areas covered by EP3215223 should consider the strength and breadth of this patent. A strong, broad patent can be a significant asset for a company, providing market exclusivity and a competitive advantage. Conversely, the existence of such a patent held by a competitor can be a risk factor.
• Pipeline Diversification: Companies may need to diversify their R&D pipelines to avoid direct competition with patented technologies. This could involve targeting different biological pathways or therapeutic indications.
• Generic Competition: Once EP3215223 expires, it may open opportunities for generic manufacturers to produce and market these compounds, provided no other patents remain in force. The specific expiry date, typically 20 years from the filing date (subject to extensions in some jurisdictions), is a critical piece of data.

The detailed analysis of the claims and the competitive patent landscape surrounding the underlying biological targets are essential steps for any strategic decision-making related to R&D investments or commercialization efforts in the affected therapeutic fields.

---

Key Takeaways

• European Patent EP3215223 protects a defined class of chemical compounds and their therapeutic uses in treating inflammatory, autoimmune, and oncological diseases.
• The patent's independent claims cover specific compound structures, pharmaceutical compositions, and methods of treatment, with dependent claims providing further specificity.
• The patent landscape for the likely therapeutic targets is highly competitive, featuring numerous small molecule inhibitors and method of use patents from major pharmaceutical companies.
• Companies must conduct rigorous Freedom to Operate (FTO) analyses to avoid infringement and assess potential licensing or collaboration opportunities.
• The patent's strength, breadth, and expiry date are critical factors for investment decisions and competitive strategy.

---

FAQs

1. What is the earliest possible expiry date for EP3215223? European patents generally have a term of 20 years from the filing date. The filing date for EP3215223 is December 19, 2014. Therefore, the patent's term extends to December 19, 2034, excluding any potential patent term extensions (PTEs) which are not accounted for in this general calculation.

2. Does EP3215223 cover only novel compounds, or can it cover existing compounds used in new ways? While Claim 1 primarily defines a novel class of chemical compounds, the patent's scope can extend to methods of use for these compounds. If a compound falling within the defined structure was previously known but its therapeutic utility for the specific diseases listed in the patent was not, then a method of use claim could be granted and potentially infringed.

3. How can a company determine if their compound infringes on EP3215223? Infringement occurs if a product or process falls within the scope of at least one of the patent's claims. A company must carefully compare its compound's chemical structure and its proposed therapeutic use against each claim in EP3215223. This typically involves expert legal and technical analysis.

4. What is a Markush structure, and why is it used in patent claims like those in EP3215223? A Markush structure is a graphical representation in patent claims that allows for the definition of a generic chemical compound with a variable core structure and interchangeable substituents. It is used to cover a broad range of related chemical entities and their derivatives, increasing the scope of protection beyond a single specific molecule.

5. Beyond EP3215223, are there other related European patents or patent applications filed by the same entity covering similar subject matter? Patent holders often file related applications in different jurisdictions (e.g., PCT applications that designate multiple countries including European Patent Convention members) or file divisional applications from a parent application to cover different aspects of their invention. It is advisable to investigate the patent family of EP3215223 to identify all related granted patents and pending applications.

---

Citations

[1] European Patent EP3215223. (2014). Compounds and methods for treating or preventing disease. European Patent Office.