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Last Updated: March 26, 2026

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
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 Landscape

This 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:

  • Claim 2: The method of claim 1, wherein the antibody binds to TNF-alpha.
  • Claim 3: The method of claim 2, wherein the antibody is a humanized antibody.
  • Claim 4: The method of claim 3, wherein the antibody is a chimeric antibody.
  • Claim 5: The method of claim 1, wherein the antibody binds to IL-6.
  • Claim 6: The method of claim 5, wherein the antibody is a humanized antibody.
  • Claim 7: The method of claim 6, wherein the antibody is a chimeric antibody.
  • Claim 8: The method of claim 1, wherein the antibody binds to both TNF-alpha and IL-6.
  • Claim 9: The method of claim 1, wherein the inflammatory disease is selected from the group consisting of rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, asthma, and septic shock.
  • Claim 10: The method of claim 9, wherein the inflammatory disease is rheumatoid arthritis.
  • Claim 11: The method of claim 9, wherein the inflammatory disease is Crohn's disease.
  • Claim 12: The method of claim 9, wherein the inflammatory disease is juvenile rheumatoid arthritis.
  • Claim 13: The method of claim 9, wherein the inflammatory disease is psoriatic arthritis.
  • Claim 14: The method of claim 9, wherein the inflammatory disease is ankylosing spondylitis.

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:

  • Amgen Inc.: As the assignee of US Patent 6,692,763, Amgen holds the foundational method patent for the therapeutic application of TNF-alpha and IL-6 neutralizing antibodies.
  • AbbVie Inc. (formerly Abbott Laboratories): Developed adalimumab (Humira), a highly successful TNF-alpha inhibitor. AbbVie's patents cover the adalimumab molecule itself (composition of matter) and its specific uses. While adalimumab falls under the method claimed by 6,692,763, AbbVie's patent exclusivity for adalimumab was primarily based on its composition of matter patents.
  • Janssen Biotech, Inc. (Johnson & Johnson): Developed infliximab (Remicade), another major TNF-alpha inhibitor. Similar to AbbVie, Janssen's patent portfolio includes composition of matter patents for infliximab and its manufacturing processes.
  • Roche Holding AG: Developed tocilizumab (Actemra), an IL-6 receptor inhibitor. Roche's patents protect the tocilizumab molecule and its therapeutic applications.
  • Regeneron Pharmaceuticals, Inc.: Has developed sarilumab (Kevzara), another IL-6 receptor inhibitor.
  • Other Biologics Developers: Numerous other companies have developed or are developing antibodies targeting TNF-alpha and/or IL-6, such as certolizumab pegol (Cimzia) by UCB Pharma, and golimumab (Simponi) by Janssen.

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:

  1. Composition of Matter Patents: These patents protect the specific antibody molecules. For example, patents covering the structure and sequences of adalimumab, infliximab, tocilizumab, etc., provided extended market protection for these specific drugs. Many of these composition of matter patents have also expired or are nearing expiry, leading to the development of biosimilars.
  2. Method of Use Patents: US Patent 6,692,763 is a prime example of a method of use patent. While its claims are broad, they are directed to the method of treatment rather than a specific drug product.
  3. Manufacturing Process Patents: These patents protect novel or improved methods for producing the biologic drugs.
  4. Formulation Patents: Patents covering specific formulations that enhance drug stability, delivery, or efficacy.

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:

  • Target Validation: The patent's success validates TNF-alpha and IL-6 as crucial therapeutic targets for inflammatory diseases. R&D efforts continue to explore these pathways, seeking to develop novel antibodies with improved efficacy, safety profiles, or administration convenience.
  • Navigating Existing IP: Developers of new TNF-alpha or IL-6 inhibiting biologics must conduct thorough freedom-to-operate (FTO) analyses. This involves assessing existing patents, including method of use patents like 6,692,763, as well as composition of matter and manufacturing patents. Identifying non-infringing approaches or opportunities for patent invalidation is crucial.
  • Biosimilar Development: As primary patents expire, the focus shifts to developing biosimilars. Understanding the scope of expired patents, like 6,692,763, helps in designing biosimilar development strategies that do not infringe on any remaining intellectual property.
  • Next-Generation Therapies: Beyond direct antibody inhibition, R&D can focus on alternative mechanisms within the TNF-alpha and IL-6 pathways or explore combination therapies that leverage the established efficacy of these targets.

Investment Implications:

  • Market Entry and Competition: The expiration of key patents, including method patents like 6,692,763, signals potential market entry points for biosimilar manufacturers. Investors can evaluate companies with strong biosimilar pipelines and competitive manufacturing capabilities.
  • Valuation of Biologics Companies: Companies holding patents on novel biologic therapies, particularly those with strong composition of matter claims and broad therapeutic applications, can command significant valuations. Investors should assess the strength and remaining life of a company's IP portfolio.
  • Risk Assessment: The complex patent landscape and history of litigation highlight the risks associated with investing in the biologics sector. Investors need to understand potential patent challenges, licensing agreements, and the competitive impact of biosimilars.
  • Opportunities in Emerging Markets: As exclusivity wanes, the cost of biologics may decrease, potentially expanding access in emerging markets. Companies poised to capitalize on these markets with cost-effective biosimilars may present attractive investment opportunities.
  • Diversification: Investors can consider diversifying their portfolios to include companies focused on different stages of drug development, from novel target discovery to biosimilar production, to mitigate risks associated with individual patent expirations.

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

  • US Patent 6,692,763 protects a method for treating inflammatory diseases by administering antibodies that neutralize TNF-alpha and/or IL-6.
  • The patent's claims are broad, covering the therapeutic use of such antibodies for a range of inflammatory conditions, including rheumatoid arthritis and Crohn's disease.
  • The patent's asserted scope is the therapeutic strategy of cytokine inhibition, underpinning the mechanism of action for many successful biologic drugs.
  • The patent expires on November 15, 2024, based on its filing date.
  • The patent landscape is characterized by numerous composition of matter, method, and manufacturing patents, leading to complex competitive dynamics and past litigation.
  • Post-expiration, the market will continue to be shaped by remaining patent protection on specific drug compositions and the increasing prevalence of biosimilars.
  • For R&D, the patent validates key targets and necessitates careful FTO analysis. For investment, it signals shifts in market competition, biosimilar opportunities, and the valuation of intellectual property.

Frequently Asked Questions

  1. When does US Patent 6,692,763 expire? US Patent 6,692,763 expires on November 15, 2024.
  2. Does the expiration of US Patent 6,692,763 mean all TNF-alpha and IL-6 inhibiting drugs will become generic immediately? No. While this method patent expires, individual biologic drugs are also protected by their own composition of matter, manufacturing, and formulation patents, which may have different expiry dates. The market entry of biosimilars is contingent on the expiration of these other patents as well.
  3. Can new companies now offer treatments for rheumatoid arthritis using antibodies that neutralize TNF-alpha, given that US Patent 6,692,763 is expiring? Companies can generally offer treatments that fall within the scope of expired patents. However, they must still ensure they do not infringe on any other valid and unexpired patents, such as those covering specific antibody molecules (composition of matter) or manufacturing processes.
  4. What is the difference between a method of use patent and a composition of matter patent in the context of biologics? A composition of matter patent protects the actual substance, such as a specific antibody molecule. A method of use patent protects a specific way of using a substance, such as a particular therapeutic treatment regimen. US Patent 6,692,763 is a method of use patent.
  5. How does the expiration of this patent impact the pricing of biologics that target TNF-alpha and IL-6? The expiration of a foundational method patent, especially when combined with the expiry of composition of matter patents, typically paves the way for increased competition from biosimilars. This increased competition generally leads to lower prices for the biologic treatments.

Citations

[1] Amgen Inc. (2004). U.S. Patent No. 6,692,763. United States Patent and Trademark Office.

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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 FiledNovember 21, 1998PCT Application Number:PCT/US98/24677
PCT Publication Date:June 03, 1999PCT 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

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