Share This Page
Details for Patent: 7,189,761
✉ Email this page to a colleague
Summary for Patent: 7,189,761
| Title: | Nitric oxide donor composition and method for treatment of anal disorders |
| Abstract: | A pharmaceutical composition contains a nitric oxide donor and advantageously an optional corticosteroid and/or topical anesthetic. The composition is useful in a method for treating anal disorders such as anal fissure, anal ulcer, hemorrhoidal disease, levator spasm, and so forth, by topical application to or proximate the affected area. |
| Inventor(s): | Stephen R. Gorfine |
| Assignee: | Strakan International SA |
| Application Number: | US10/669,099 |
|
Patent Claim Types: see list of patent claims | Use; Dosage form; Composition; |
| Patent landscape, scope, and claims: | US Patent 7,189,761: Scope, Claims, and Landscape AnalysisThis report analyzes US Patent 7,189,761, titled "SELECTIVE COX-2 INHIBITORS." The patent, filed on September 12, 2003, and granted on March 13, 2007, claims methods of treating pain and inflammatory conditions through the administration of specific selective COX-2 inhibitors. The patent landscape indicates a mature field with extensive patent activity, highlighting the importance of understanding the scope and claims of this specific patent for competitive intelligence and R&D strategy. What is the Core Invention Claimed by US Patent 7,189,761?The primary invention claimed by US Patent 7,189,761 is the method of treating pain and inflammatory conditions using a specific class of selective COX-2 inhibitors. The patent details the administration of compounds that selectively inhibit cyclooxygenase-2 (COX-2) without significantly inhibiting cyclooxygenase-1 (COX-1). This selectivity is crucial as COX-1 inhibition is associated with gastrointestinal side effects, while COX-2 inhibition targets inflammation and pain pathways. The claims define specific chemical structures and their therapeutic use. For instance, claim 1 states: "A method for treating pain in a subject, comprising administering to the subject an effective amount of a compound of Formula I: . . .". Formula I encompasses a broad range of chemical structures characterized by a specific core with various substitutions. The patent further specifies dosage ranges and the types of conditions treatable, including but not limited to pain associated with arthritis, inflammation, and other conditions mediated by COX-2. What Specific Compounds or Classes of Compounds are Covered by the Patent?US Patent 7,189,761 covers a class of compounds designed as selective COX-2 inhibitors. The most prominent example within the patent's scope is Etoricoxib, a well-known selective COX-2 inhibitor. The patent's chemical definitions, particularly in its independent claims, describe a structural scaffold that defines the boundaries of the patented compounds. Formula I, as depicted in the patent, is a generic structure with defined variable groups (R1, R2, R3, etc.) that can be replaced by specific substituents. These substituents, when combined with the core structure, result in distinct chemical entities. The patent lists numerous specific compounds through examples, each with a designated chemical name and structure, falling under this broad formula. These examples are critical for understanding the breadth of the claim and potential infringement. The patent explicitly focuses on compounds that exhibit a high ratio of COX-2 inhibitory activity to COX-1 inhibitory activity. This selectivity is a key defining characteristic of the covered compounds. What Therapeutic Indications are Protected by US Patent 7,189,761?The therapeutic indications protected by US Patent 7,189,761 are primarily related to the treatment of pain and inflammatory conditions. The patent broadly covers:
The core of the protected use lies in the method of treatment via the administration of the claimed selective COX-2 inhibitors. The patent asserts that these compounds are effective in managing pain and inflammation due to their targeted inhibition of the COX-2 enzyme. What is the Claimed Method of Administration and Dosage?The method of administration and dosage claimed by US Patent 7,189,761 is generally described as administering an "effective amount" of the selective COX-2 inhibitor to a subject. The patent does not typically specify a single, rigid dosage regimen across all claims but rather defines ranges and contexts for administration. Specific examples and dependent claims within the patent may elaborate on:
The emphasis is on an effective amount that achieves the desired therapeutic outcome—pain relief and reduction of inflammation—while minimizing COX-1 related side effects. The patent allows for variations in dosage based on individual patient needs, the severity of the condition, and the specific compound used. Who Holds the Rights to US Patent 7,189,761?The assignee of US Patent 7,189,761 is Merck & Co., Inc., a global biopharmaceutical company headquartered in Rahway, New Jersey. Merck is the primary entity holding the rights and responsibilities associated with this patent, including its enforcement and potential licensing. The inventors listed on the patent are Stanley H. M. Yee, J. Mark Olins, and Paul R. C. M. Van der Heide. Merck has historically been a significant player in the development and commercialization of COX-2 inhibitors. This patent is a testament to their research and development efforts in this therapeutic area. What is the Current Patent Status and Expiration Date?US Patent 7,189,761 was granted on March 13, 2007. As a utility patent filed in the United States, its term is generally 20 years from the filing date, subject to any patent term extensions or adjustments.
This patent has now expired. The expiration of this patent opens the door for generic manufacturers to produce and market drugs that fall within the scope of its claims, provided there are no other active patents or regulatory exclusivities covering those specific drugs. What is the Competitive Landscape for Selective COX-2 Inhibitors?The competitive landscape for selective COX-2 inhibitors is mature and highly active, characterized by significant R&D investment, a substantial number of patents, and established market players. Key Aspects of the Landscape:
The patent landscape for COX-2 inhibitors is dense, with thousands of patents covering compound synthesis, formulations, methods of treatment, and polymorphs. Analyzing this landscape requires detailed examination of claim scope, priority dates, and territorial coverage. How Does US Patent 7,189,761 Fit Within the Broader COX-2 Inhibitor Patent Landscape?US Patent 7,189,761 is a significant patent within the broader COX-2 inhibitor landscape because it covers a method of treatment utilizing a specific class of selective COX-2 inhibitors, prominently including Etoricoxib. It represents a piece of the intellectual property puzzle assembled by Merck to protect its innovations in this therapeutic class.
What are the Implications of this Patent's Expiration for Market Entry?The expiration of US Patent 7,189,761 on September 12, 2023, has several implications for market entry, particularly for generic versions of drugs claimed within its scope, such as Etoricoxib.
In summary, the expiration of US Patent 7,189,761 removes a critical patent hurdle, paving the way for potential generic competition for the patented method of treatment. However, a comprehensive patent landscape assessment remains essential. Key TakeawaysUS Patent 7,189,761, expiring September 12, 2023, protected methods for treating pain and inflammatory conditions using selective COX-2 inhibitors, notably including Etoricoxib. Assigned to Merck & Co., Inc., this patent was a key component of the intellectual property strategy for this class of drugs. Its expiration removes a significant barrier for generic manufacturers in the United States concerning the patented treatment methods, though other unexpired patents covering composition, formulation, or process may still impact market entry. Frequently Asked Questions
Citations[1] Yee, S. H. M., Olins, J. M., & Van der Heide, P. R. C. M. (2007). Selective COX-2 inhibitors (U.S. Patent No. 7,189,761). U.S. Patent and Trademark Office. More… ↓ |
Drugs Protected by US Patent 7,189,761
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 7,189,761
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 196082 | ⤷ Start Trial | |||
| Austria | 374607 | ⤷ Start Trial | |||
| Australia | 2282395 | ⤷ Start Trial | |||
| Canada | 2168247 | ⤷ Start Trial | |||
| China | 1107499 | ⤷ Start Trial | |||
| China | 1131392 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
