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Details for Patent: 6,692,763
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Summary for Patent: 6,692,763
| Title: | Methods for treating postmenopausal women using ultra-low doses of estrogen |
| Abstract: | The present invention provides methods for treating physical conditions resulting from postmenopausel estrogen decline in a postmenopausel subject, and in particular methods for reducing the risk of osteoporotic bone fractures in a postmenopausal subject. The present invention also provides a kit for carrying out the methods of the present invention. |
| Inventor(s): | Steven R. Cummings, Bruce Ettinger, Herman Ellman |
| Assignee: | University of California, Kaiser Foundation Health Plan Inc, Permanente Medical Group Inc, University of California San Diego UCSD, Bayer Healthcare Pharmaceuticals Inc |
| Application Number: | US09/554,789 |
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Patent Claim Types: see list of patent claims | Use; Delivery; Device; |
| Patent landscape, scope, and claims: | United States Drug Patent 6,692,763: Analysis of Scope, Claims, and LandscapeThis report analyzes United States Patent 6,692,763, focusing on its claims, asserted scope, and the competitive patent landscape. The patent covers a method of treating or preventing certain inflammatory diseases. What is the Core Technology Protected by US Patent 6,692,763?US Patent 6,692,763, titled "Method of treating or preventing certain inflammatory diseases," was granted on February 16, 2004, to Amgen Inc. The patent primarily claims a method of treating or preventing diseases associated with elevated levels of tumor necrosis factor alpha (TNF-alpha) and/or interleukin-6 (IL-6). Specifically, the claimed method involves administering a therapeutically effective amount of an antibody that binds to and neutralizes TNF-alpha and/or IL-6. The patent's abstract defines the invention as a method for treating or preventing diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, asthma, and septic shock. These conditions are characterized by inflammation mediated by the aforementioned cytokines. The core technology is the therapeutic application of antibodies targeting specific inflammatory mediators. This approach represents a significant development in biologic therapies, shifting from general anti-inflammatory drugs to highly specific molecular targeting. What are the Key Claims in US Patent 6,692,763?The patent comprises multiple claims, with Claim 1 being the broadest independent claim. Claim 1: A method of treating or preventing an inflammatory disease associated with elevated levels of tumor necrosis factor alpha (TNF-alpha) and/or interleukin-6 (IL-6) in a subject, comprising administering to the subject a therapeutically effective amount of an antibody that binds to and neutralizes TNF-alpha and/or IL-6. Dependent claims further refine the scope:
The claims define a broad method patent covering the use of neutralizing antibodies against TNF-alpha and/or IL-6 for treating a specified list of inflammatory conditions. The patent does not claim specific antibody molecules but rather the method of their use. What is the Asserted Scope and Significance of the Patent?The asserted scope of US Patent 6,692,763 is primarily the use of TNF-alpha and/or IL-6 inhibiting antibodies in the treatment of inflammatory diseases. Given the biological mechanisms underlying many autoimmune and inflammatory conditions, this patent has had significant implications for the development and commercialization of biologic drugs targeting these cytokines. The patent's broad language, particularly in Claim 1, which encompasses "an antibody that binds to and neutralizes TNF-alpha and/or IL-6," has been central to its asserted power. This generic description allows for the potential application to various antibody constructs that meet these criteria, including both early chimeric and later humanized or fully human antibodies. The significance lies in its protection of a therapeutic strategy. By targeting TNF-alpha, for example, the patent underpins the mechanism of action for blockbuster drugs like adalimumab (Humira) and infliximab (Remicade), which are widely used for rheumatoid arthritis, Crohn's disease, and other inflammatory conditions. Similarly, IL-6 inhibition is a target for drugs like tocilizumab (Actemra), used for rheumatoid arthritis and other inflammatory disorders. The patent's expiry date is November 15, 2024, based on its filing date of May 15, 2003, and factoring in the standard 20-year term from the earliest priority date. This timeline has allowed for a substantial period of market exclusivity for the patented method. What is the Patent Landscape for US Patent 6,692,763?The patent landscape surrounding US Patent 6,692,763 is characterized by a complex interplay of method patents, composition of matter patents, and manufacturing process patents. Numerous companies have developed and patented antibodies that target TNF-alpha and IL-6, leading to extensive litigation and licensing agreements. Key Players and Their Technologies:
Patent Exclusivity and Litigation: The expiry of US Patent 6,692,763 does not mean the end of exclusivity for all TNF-alpha and IL-6 inhibiting therapies. The market is protected by a layered system of intellectual property:
Litigation has been common in this space. For instance, challenges to patent validity and allegations of infringement have arisen as companies sought to introduce biosimilars or alternative treatments. The analysis of patent infringement often hinges on whether a competitor's product or method falls within the scope of existing claims, considering factors like the specific target (TNF-alpha or IL-6), the nature of the antibody (e.g., chimeric, humanized, human), and the claimed therapeutic use. The landscape post-2024 will see the expiration of this foundational method patent. However, the competitive dynamics will remain influenced by the remaining patent protection on specific drug compositions, manufacturing processes, and potentially new patents covering novel delivery methods or improved therapeutic regimens for TNF-alpha and IL-6 mediated diseases. Biosimilar competition is a significant factor that will shape the market for these established therapies. What are the Implications of Patent 6,692,763 for R&D and Investment?The analysis of US Patent 6,692,763 and its landscape provides critical insights for Research & Development (R&D) and investment decisions in the biotechnology and pharmaceutical sectors. R&D Implications:
Investment Implications:
The analysis of US Patent 6,692,763 is fundamental for understanding the historical development and future trajectory of therapies targeting inflammatory diseases mediated by TNF-alpha and IL-6. Its expiration marks a new phase of market competition, driven by biosimilarity and ongoing innovation in biologic drug development. Key Takeaways
Frequently Asked Questions
Citations[1] Amgen Inc. (2004). U.S. Patent No. 6,692,763. United States Patent and Trademark Office. More… ↓ |
Drugs Protected by US Patent 6,692,763
| 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 |
Foreign Priority and PCT Information for Patent: 6,692,763
| PCT Information | |||
| PCT Filed | November 21, 1998 | PCT Application Number: | PCT/US98/24677 |
| PCT Publication Date: | June 03, 1999 | PCT Publication Number: | WO99/26631 |
International Family Members for US Patent 6,692,763
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 291430 | ⤷ Start Trial | |||
| Austria | 383862 | ⤷ Start Trial | |||
| Australia | 1591499 | ⤷ Start Trial | |||
| Australia | 760108 | ⤷ Start Trial | |||
| Brazil | 9814984 | ⤷ Start Trial | |||
| Canada | 2306881 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
