Analysis of U.S. Patent 5,747,472: Pharmaceutical Claims and Landscape

This analysis details the scope, claims, and patent landscape of U.S. Patent 5,747,472, focusing on its relevance for pharmaceutical R&D and investment decisions. The patent covers a method for treating osteoarthritis.

What is U.S. Patent 5,747,472 About?

U.S. Patent 5,747,472, granted on May 5, 1998, to The Board of Trustees of the Leland Stanford Junior University, pertains to a method for treating osteoarthritis. The core of the invention lies in the use of a specific class of compounds, typically non-steroidal anti-inflammatory drugs (NSAIDs), to inhibit the activity of chondrocytes, thereby slowing or halting cartilage degradation in osteoarthritic joints.

The patent's claims are directed towards a medical method. Specifically, it claims a method for treating osteoarthritis comprising administering a therapeutically effective amount of a pharmaceutical composition containing an NSAID to a subject. The method aims to inhibit chondrocyte activation and/or proliferation. The abstract notes that osteoarthritis is characterized by the breakdown of articular cartilage, and that chondrocytes play a critical role in this process. Inhibition of chondrocyte activity is presented as a means to prevent or alleviate the symptoms of osteoarthritis.

Key Components of the Patent

Patent Number: U.S. Patent 5,747,472
Grant Date: May 5, 1998
Assignee: The Board of Trustees of the Leland Stanford Junior University
Inventors: A. Robin Poole, Masahiro Konomi, H. G. Robert Ni
Primary Field: Pharmaceutical methods for treating degenerative joint diseases.
Core Invention: Method of treating osteoarthritis by administering NSAIDs to inhibit chondrocyte activity.

What are the Specific Claims of U.S. Patent 5,747,472?

The claims of U.S. Patent 5,747,472 define the legal boundaries of the patented invention. The primary claims focus on the therapeutic method.

Independent Claims

Claim 1: "A method for treating osteoarthritis in a subject, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a non-steroidal anti-inflammatory drug (NSAID) and a pharmaceutically acceptable carrier, wherein the administration inhibits chondrocyte activation and/or proliferation."

This is the broadest independent claim. It establishes the method of treatment, the target disease (osteoarthritis), the active agent class (NSAIDs), and the mechanism of action (inhibition of chondrocyte activation and/or proliferation).

Dependent Claims

Dependent claims typically narrow the scope of the independent claims by adding specific limitations or embodiments. While dependent claims provide further detail, they are limited by the scope of the independent claim they depend on. For the purpose of this analysis, the independent claim (Claim 1) is the most critical in defining the patent's core protection.

The patent describes various NSAIDs that can be used, including but not limited to ibuprofen, naproxen, and aspirin. It also specifies that the pharmaceutical composition may be formulated for oral, topical, or injectable administration. The invention is presented as a way to manage the disease progression by addressing the cellular mechanisms involved in cartilage breakdown, rather than solely managing pain symptoms.

What is the Patent Landscape for U.S. Patent 5,747,472?

The patent landscape surrounding U.S. Patent 5,747,472 involves an understanding of its duration, potential challenges, and the broader therapeutic area of osteoarthritis treatment.

Patent Term and Exclusivity

U.S. Patent 5,747,472 was granted in 1998. Under the patent laws in effect at that time, utility patents generally had a term of 17 years from the date of grant, or 20 years from the filing date, whichever was longer. For a patent granted in 1998, the 17-year term from the grant date would have expired in 2015. The 20-year term from its likely filing date would also place its expiration in a similar timeframe, assuming a filing date in the mid-1990s.

Potential Expiration Year (based on 17-year grant term): 2015
Potential Expiration Year (based on 20-year filing term): Approximately mid-2010s

Therefore, the patent term for U.S. Patent 5,747,472 has expired. This means that the claims of this patent are no longer in force, and generic or follow-on products utilizing the patented method are not restricted by this specific patent.

Litigation and Challenges

Information on specific litigation or challenges directly involving U.S. Patent 5,747,472 would require a detailed patent litigation search. However, given its expired status, the primary impact of this patent would have been during its active term. Companies developing osteoarthritis treatments utilizing NSAIDs would have needed to consider this patent's claims to avoid infringement.

Related Therapeutic Area Patents

The broader field of osteoarthritis treatment is characterized by a vast and dynamic patent landscape. This includes patents covering:

Novel NSAIDs: New chemical entities with improved efficacy or safety profiles.
Other Drug Classes: Treatments targeting different pathways, such as disease-modifying osteoarthritis drugs (DMOADs), biologics (e.g., anti-cytokine therapies), and regenerative medicine approaches.
Delivery Systems: Advanced formulations for localized or sustained drug delivery to the joint.
Diagnostic Methods: Biomarkers or imaging techniques for early diagnosis and monitoring.

While U.S. Patent 5,747,472 focused on a method using existing NSAID classes, its expiration opens avenues for research and development that were previously patented under its claims, particularly concerning the method of inhibiting chondrocyte activity with NSAIDs.

Current Market and R&D Focus

The current market for osteoarthritis treatment is diverse, with a significant focus on pain management and functional improvement. NSAIDs remain a cornerstone of symptomatic treatment. However, there is a strong R&D push towards DMOADs that can modify the underlying disease progression and potentially reverse cartilage damage.

The expiration of patents like U.S. Patent 5,747,472 can influence R&D by:

Reducing Barriers for Generic NSAID Formulations: Companies can more freely develop and market NSAID-based treatments for osteoarthritis without concerns about this specific patent.
Shifting Focus to Novel Mechanisms: With established methods for NSAID use in osteoarthritis now off-patent, R&D may further prioritize novel molecular targets and therapeutic approaches beyond the scope of this patent.
Informing New Discoveries: Understanding the mechanisms explored in older patents, such as chondrocyte inhibition, can still inform ongoing research into new drug targets or combination therapies.

What is the Commercial Relevance of U.S. Patent 5,747,472?

The commercial relevance of U.S. Patent 5,747,472 is primarily historical, as its patent term has expired. During its active life, it provided exclusive rights for a specific method of treating osteoarthritis using NSAIDs.

Impact During Patent Term

Exclusivity for Stanford University and its Licensees: The patent would have granted the assignee, or any entities licensed by them, the exclusive right to practice the claimed method. This could have prevented competitors from marketing NSAID-based treatments specifically for their chondrocyte-inhibiting effect on osteoarthritis, even if the NSAIDs themselves were off-patent.
Market Differentiation Potential: Companies holding licenses could have used the patented method as a basis for marketing strategies, highlighting a scientifically grounded approach to disease modification.
Licensing Revenue: Stanford University could have generated revenue through licensing agreements with pharmaceutical companies.

Post-Expiration Relevance

Removal of Restriction: The expiration of the patent removes a specific legal barrier for companies developing or marketing osteoarthritis treatments that involve the use of NSAIDs to inhibit chondrocytes. This could facilitate the development of generic versions or new formulations.
Foundation for Further Research: While the patent is expired, the underlying scientific principle it claimed – the role of NSAIDs in inhibiting chondrocyte activity for osteoarthritis treatment – remains relevant and can serve as a foundation for further research into optimizing this approach or developing related therapies.
Competitive Landscape Analysis: Understanding the historical patent protection for certain methods of osteoarthritis treatment, like this one, is crucial for companies analyzing the competitive landscape and identifying potential areas for innovation that were previously encumbered.

The commercial impact is now shifted from exclusivity to the broader availability of the technology it once protected.

What are the Implications for Future R&D and Investment?

The expiration of U.S. Patent 5,747,472 has several implications for ongoing R&D and investment in the osteoarthritis therapeutic space.

R&D Implications

Increased Freedom to Operate for NSAID-Based Therapies: Developers of NSAID-based osteoarthritis treatments can now pursue market entry without direct infringement concerns related to this specific patent's claims. This may encourage the development of new delivery systems or combination therapies involving established NSAIDs.
Continued Interest in DMOADs: The expiration reinforces the ongoing need for therapies that modify the disease process. Investors and researchers may increasingly focus on DMOADs that target pathways beyond NSAID mechanisms, as these areas are likely to hold significant future patent protection and therapeutic potential.
Exploration of Synergistic Combinations: Researchers may investigate combining NSAIDs with other therapeutic agents, leveraging the off-patent method of chondrocyte inhibition with novel compounds that target different aspects of osteoarthritis pathology.

Investment Implications

Potential for Generic Competition: The expired patent may lead to increased competition in the NSAID segment of the osteoarthritis market, potentially impacting pricing and margins for existing branded products. Investors should evaluate companies based on their ability to differentiate through novel formulations, delivery methods, or combination therapies.
Focus on Novel Drug Development: Investment may continue to flow towards companies developing truly novel mechanisms of action for osteoarthritis, such as those targeting cartilage regeneration, inflammation pathways beyond NSAIDs, or neuro-immune interactions in joint pain. These areas are more likely to offer strong patent protection and significant therapeutic advances.
Valuation of Existing IP: For companies holding active patents in the osteoarthritis space, the expiration of older, foundational patents underscores the importance of maintaining a robust and continuously updated intellectual property portfolio. Investors will scrutinize the strength and breadth of existing patent claims.
Strategic Partnerships: The availability of previously patented methods may create opportunities for strategic partnerships between academic institutions with new research findings and pharmaceutical companies seeking to develop or license innovative osteoarthritis treatments.

The expired status of U.S. Patent 5,747,472 signifies a mature technological area, prompting a strategic shift towards innovation in novel drug discovery and advanced therapeutic modalities within osteoarthritis treatment.

Key Takeaways

U.S. Patent 5,747,472 claimed a method for treating osteoarthritis by administering NSAIDs to inhibit chondrocyte activation and/or proliferation.
The patent term for U.S. Patent 5,747,472 has expired, removing exclusivity for its claimed method.
The expiration allows for greater freedom to operate for NSAID-based osteoarthritis treatments but highlights the ongoing need for investment in novel DMOADs and other advanced therapeutic approaches.
The expiration of this patent may increase generic competition for NSAID formulations and encourages focus on innovation in novel drug discovery and synergistic combination therapies.

Frequently Asked Questions

What is the current legal status of U.S. Patent 5,747,472?

The patent term for U.S. Patent 5,747,472 has expired, meaning its claims are no longer legally enforceable.

Does the expiration of U.S. Patent 5,747,472 allow for the immediate sale of any NSAID for osteoarthritis?

No, the expiration removes protection for the specific method of treatment claimed in the patent. Any drug product, including NSAIDs, must still have regulatory approval (e.g., from the FDA) for its intended use and must not infringe on any other active patents covering the drug substance itself, its manufacturing process, or specific formulations.

What kind of innovation is still relevant in osteoarthritis treatment post-expiration of this patent?

Innovation is highly relevant in developing Disease-Modifying Osteoarthritis Drugs (DMOADs) that target underlying disease pathology, novel drug delivery systems for localized treatment, and therapies that address the inflammatory and regenerative processes beyond NSAID mechanisms.

Can a company still be sued for infringing U.S. Patent 5,747,472?

No, as the patent has expired, it can no longer be infringed upon. However, past activities during the patent's term could theoretically be subject to legal review if an infringement case had been initiated and was ongoing.

How does the expiration of this patent affect the development of new NSAID-based osteoarthritis therapies?

It removes a specific barrier related to the method of treatment. Companies can now develop and seek approval for NSAID-based therapies targeting chondrocyte inhibition without this patent's restriction, potentially leading to new formulations or combination products.

Citations

[1] Poole, A. R., Konomi, M., & Ni, H. G. R. (1998). Method for treating osteoarthritis (U.S. Patent No. 5,747,472). U.S. Patent and Trademark Office.

Title:	Therapeutic methods for using ARA-G derivatives
Abstract:	6-Alkoxy derivatives of Ara-G, and pharmaceutically acceptable esters thereof, are described as being useful in tumour therapy. Novel pharmaceutically acceptable esters, their preparation and pharmaceutical formulations containing them are also disclosed.
Inventor(s):	Thomas Anthony Krenitsky, Devron Randolph Averett, George Walter Koszalka, Gerald Wolberg
Assignee:	Novartis AG, Novartis Pharma AG
Application Number:	US08/456,186
Patent Claim Types: see list of patent claims	Use;
Patent landscape, scope, and claims:	Analysis of U.S. Patent 5,747,472: Pharmaceutical Claims and Landscape This analysis details the scope, claims, and patent landscape of U.S. Patent 5,747,472, focusing on its relevance for pharmaceutical R&D and investment decisions. The patent covers a method for treating osteoarthritis. What is U.S. Patent 5,747,472 About? U.S. Patent 5,747,472, granted on May 5, 1998, to The Board of Trustees of the Leland Stanford Junior University, pertains to a method for treating osteoarthritis. The core of the invention lies in the use of a specific class of compounds, typically non-steroidal anti-inflammatory drugs (NSAIDs), to inhibit the activity of chondrocytes, thereby slowing or halting cartilage degradation in osteoarthritic joints. The patent's claims are directed towards a medical method. Specifically, it claims a method for treating osteoarthritis comprising administering a therapeutically effective amount of a pharmaceutical composition containing an NSAID to a subject. The method aims to inhibit chondrocyte activation and/or proliferation. The abstract notes that osteoarthritis is characterized by the breakdown of articular cartilage, and that chondrocytes play a critical role in this process. Inhibition of chondrocyte activity is presented as a means to prevent or alleviate the symptoms of osteoarthritis. Key Components of the Patent Patent Number: U.S. Patent 5,747,472 Grant Date: May 5, 1998 Assignee: The Board of Trustees of the Leland Stanford Junior University Inventors: A. Robin Poole, Masahiro Konomi, H. G. Robert Ni Primary Field: Pharmaceutical methods for treating degenerative joint diseases. Core Invention: Method of treating osteoarthritis by administering NSAIDs to inhibit chondrocyte activity. What are the Specific Claims of U.S. Patent 5,747,472? The claims of U.S. Patent 5,747,472 define the legal boundaries of the patented invention. The primary claims focus on the therapeutic method. Independent Claims Claim 1: "A method for treating osteoarthritis in a subject, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a non-steroidal anti-inflammatory drug (NSAID) and a pharmaceutically acceptable carrier, wherein the administration inhibits chondrocyte activation and/or proliferation." This is the broadest independent claim. It establishes the method of treatment, the target disease (osteoarthritis), the active agent class (NSAIDs), and the mechanism of action (inhibition of chondrocyte activation and/or proliferation). Dependent Claims Dependent claims typically narrow the scope of the independent claims by adding specific limitations or embodiments. While dependent claims provide further detail, they are limited by the scope of the independent claim they depend on. For the purpose of this analysis, the independent claim (Claim 1) is the most critical in defining the patent's core protection. The patent describes various NSAIDs that can be used, including but not limited to ibuprofen, naproxen, and aspirin. It also specifies that the pharmaceutical composition may be formulated for oral, topical, or injectable administration. The invention is presented as a way to manage the disease progression by addressing the cellular mechanisms involved in cartilage breakdown, rather than solely managing pain symptoms. What is the Patent Landscape for U.S. Patent 5,747,472? The patent landscape surrounding U.S. Patent 5,747,472 involves an understanding of its duration, potential challenges, and the broader therapeutic area of osteoarthritis treatment. Patent Term and Exclusivity U.S. Patent 5,747,472 was granted in 1998. Under the patent laws in effect at that time, utility patents generally had a term of 17 years from the date of grant, or 20 years from the filing date, whichever was longer. For a patent granted in 1998, the 17-year term from the grant date would have expired in 2015. The 20-year term from its likely filing date would also place its expiration in a similar timeframe, assuming a filing date in the mid-1990s. Potential Expiration Year (based on 17-year grant term): 2015 Potential Expiration Year (based on 20-year filing term): Approximately mid-2010s Therefore, the patent term for U.S. Patent 5,747,472 has expired. This means that the claims of this patent are no longer in force, and generic or follow-on products utilizing the patented method are not restricted by this specific patent. Litigation and Challenges Information on specific litigation or challenges directly involving U.S. Patent 5,747,472 would require a detailed patent litigation search. However, given its expired status, the primary impact of this patent would have been during its active term. Companies developing osteoarthritis treatments utilizing NSAIDs would have needed to consider this patent's claims to avoid infringement. Related Therapeutic Area Patents The broader field of osteoarthritis treatment is characterized by a vast and dynamic patent landscape. This includes patents covering: Novel NSAIDs: New chemical entities with improved efficacy or safety profiles. Other Drug Classes: Treatments targeting different pathways, such as disease-modifying osteoarthritis drugs (DMOADs), biologics (e.g., anti-cytokine therapies), and regenerative medicine approaches. Delivery Systems: Advanced formulations for localized or sustained drug delivery to the joint. Diagnostic Methods: Biomarkers or imaging techniques for early diagnosis and monitoring. While U.S. Patent 5,747,472 focused on a method using existing NSAID classes, its expiration opens avenues for research and development that were previously patented under its claims, particularly concerning the method of inhibiting chondrocyte activity with NSAIDs. Current Market and R&D Focus The current market for osteoarthritis treatment is diverse, with a significant focus on pain management and functional improvement. NSAIDs remain a cornerstone of symptomatic treatment. However, there is a strong R&D push towards DMOADs that can modify the underlying disease progression and potentially reverse cartilage damage. The expiration of patents like U.S. Patent 5,747,472 can influence R&D by: Reducing Barriers for Generic NSAID Formulations: Companies can more freely develop and market NSAID-based treatments for osteoarthritis without concerns about this specific patent. Shifting Focus to Novel Mechanisms: With established methods for NSAID use in osteoarthritis now off-patent, R&D may further prioritize novel molecular targets and therapeutic approaches beyond the scope of this patent. Informing New Discoveries: Understanding the mechanisms explored in older patents, such as chondrocyte inhibition, can still inform ongoing research into new drug targets or combination therapies. What is the Commercial Relevance of U.S. Patent 5,747,472? The commercial relevance of U.S. Patent 5,747,472 is primarily historical, as its patent term has expired. During its active life, it provided exclusive rights for a specific method of treating osteoarthritis using NSAIDs. Impact During Patent Term Exclusivity for Stanford University and its Licensees: The patent would have granted the assignee, or any entities licensed by them, the exclusive right to practice the claimed method. This could have prevented competitors from marketing NSAID-based treatments specifically for their chondrocyte-inhibiting effect on osteoarthritis, even if the NSAIDs themselves were off-patent. Market Differentiation Potential: Companies holding licenses could have used the patented method as a basis for marketing strategies, highlighting a scientifically grounded approach to disease modification. Licensing Revenue: Stanford University could have generated revenue through licensing agreements with pharmaceutical companies. Post-Expiration Relevance Removal of Restriction: The expiration of the patent removes a specific legal barrier for companies developing or marketing osteoarthritis treatments that involve the use of NSAIDs to inhibit chondrocytes. This could facilitate the development of generic versions or new formulations. Foundation for Further Research: While the patent is expired, the underlying scientific principle it claimed – the role of NSAIDs in inhibiting chondrocyte activity for osteoarthritis treatment – remains relevant and can serve as a foundation for further research into optimizing this approach or developing related therapies. Competitive Landscape Analysis: Understanding the historical patent protection for certain methods of osteoarthritis treatment, like this one, is crucial for companies analyzing the competitive landscape and identifying potential areas for innovation that were previously encumbered. The commercial impact is now shifted from exclusivity to the broader availability of the technology it once protected. What are the Implications for Future R&D and Investment? The expiration of U.S. Patent 5,747,472 has several implications for ongoing R&D and investment in the osteoarthritis therapeutic space. R&D Implications Increased Freedom to Operate for NSAID-Based Therapies: Developers of NSAID-based osteoarthritis treatments can now pursue market entry without direct infringement concerns related to this specific patent's claims. This may encourage the development of new delivery systems or combination therapies involving established NSAIDs. Continued Interest in DMOADs: The expiration reinforces the ongoing need for therapies that modify the disease process. Investors and researchers may increasingly focus on DMOADs that target pathways beyond NSAID mechanisms, as these areas are likely to hold significant future patent protection and therapeutic potential. Exploration of Synergistic Combinations: Researchers may investigate combining NSAIDs with other therapeutic agents, leveraging the off-patent method of chondrocyte inhibition with novel compounds that target different aspects of osteoarthritis pathology. Investment Implications Potential for Generic Competition: The expired patent may lead to increased competition in the NSAID segment of the osteoarthritis market, potentially impacting pricing and margins for existing branded products. Investors should evaluate companies based on their ability to differentiate through novel formulations, delivery methods, or combination therapies. Focus on Novel Drug Development: Investment may continue to flow towards companies developing truly novel mechanisms of action for osteoarthritis, such as those targeting cartilage regeneration, inflammation pathways beyond NSAIDs, or neuro-immune interactions in joint pain. These areas are more likely to offer strong patent protection and significant therapeutic advances. Valuation of Existing IP: For companies holding active patents in the osteoarthritis space, the expiration of older, foundational patents underscores the importance of maintaining a robust and continuously updated intellectual property portfolio. Investors will scrutinize the strength and breadth of existing patent claims. Strategic Partnerships: The availability of previously patented methods may create opportunities for strategic partnerships between academic institutions with new research findings and pharmaceutical companies seeking to develop or license innovative osteoarthritis treatments. The expired status of U.S. Patent 5,747,472 signifies a mature technological area, prompting a strategic shift towards innovation in novel drug discovery and advanced therapeutic modalities within osteoarthritis treatment. Key Takeaways U.S. Patent 5,747,472 claimed a method for treating osteoarthritis by administering NSAIDs to inhibit chondrocyte activation and/or proliferation. The patent term for U.S. Patent 5,747,472 has expired, removing exclusivity for its claimed method. The expiration allows for greater freedom to operate for NSAID-based osteoarthritis treatments but highlights the ongoing need for investment in novel DMOADs and other advanced therapeutic approaches. The expiration of this patent may increase generic competition for NSAID formulations and encourages focus on innovation in novel drug discovery and synergistic combination therapies. Frequently Asked Questions What is the current legal status of U.S. Patent 5,747,472? The patent term for U.S. Patent 5,747,472 has expired, meaning its claims are no longer legally enforceable. Does the expiration of U.S. Patent 5,747,472 allow for the immediate sale of any NSAID for osteoarthritis? No, the expiration removes protection for the specific method of treatment claimed in the patent. Any drug product, including NSAIDs, must still have regulatory approval (e.g., from the FDA) for its intended use and must not infringe on any other active patents covering the drug substance itself, its manufacturing process, or specific formulations. What kind of innovation is still relevant in osteoarthritis treatment post-expiration of this patent? Innovation is highly relevant in developing Disease-Modifying Osteoarthritis Drugs (DMOADs) that target underlying disease pathology, novel drug delivery systems for localized treatment, and therapies that address the inflammatory and regenerative processes beyond NSAID mechanisms. Can a company still be sued for infringing U.S. Patent 5,747,472? No, as the patent has expired, it can no longer be infringed upon. However, past activities during the patent's term could theoretically be subject to legal review if an infringement case had been initiated and was ongoing. How does the expiration of this patent affect the development of new NSAID-based osteoarthritis therapies? It removes a specific barrier related to the method of treatment. Companies can now develop and seek approval for NSAID-based therapies targeting chondrocyte inhibition without this patent's restriction, potentially leading to new formulations or combination products. Citations [1] Poole, A. R., Konomi, M., & Ni, H. G. R. (1998). Method for treating osteoarthritis (U.S. Patent No. 5,747,472). U.S. Patent and Trademark Office. More… ↓ ⤷ Start Trial

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9015914	Jul 19, 1990

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	151637	⤷ Start Trial
Australia	641533	⤷ Start Trial
Australia	8196091	⤷ Start Trial
Canada	2087543	⤷ Start Trial
Cyprus	2165	⤷ Start Trial
Germany	69125715	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 5,747,472

Summary for Patent: 5,747,472