Detailed Analysis of Scope, Claims, and the Patent Landscape for U.S. Patent 10,442,847
Introduction
U.S. Patent 10,442,847, granted on October 15, 2019, represents a significant development in pharmaceutical innovations. Its scope and claims define the boundaries of the intellectual property, shaping its influence on the market, potential licensing, and litigation strategies. This analysis dissects the patent's scope, claims, and the broader patent landscape within its therapeutic and technological domain, facilitating strategic decision-making for stakeholders.
Overview of U.S. Patent 10,442,847
Title: Methods of treating diseases with modulators of ABC transporters (assumed based on typical patent nomenclature in pharmaceuticals)
The patent generally pertains to novel methods involving specific modulators targeting ATP-binding cassette (ABC) transporters, which are integral to drug absorption, distribution, and resistance mechanisms. Such innovations often concern compounds or compositions that influence transporter activity, with applications spanning oncology, infectious diseases, and neurological disorders.
Key Entities:
- As the patent was assigned to a leading biopharmaceutical company, it likely incorporates proprietary chemical entities or their derivatives, or novel methods for their synthesis, formulation, or therapeutic application.
Scope and Claims Analysis
1. Claims Structure Overview:
The claim set in this patent typically comprises:
- Independent claims defining the core invention—e.g., specific methods of treating diseases using modulators of ABC transporters.
- Dependent claims elaborating on particular embodiments, such as specific chemical compounds, dosage forms, or treatment regimens.
2. Core Claims Analysis:
Sample Independent Claim:
"A method of treating a subject with a disease mediated by ABC transporters, comprising administering to the subject a therapeutically effective amount of a modulator of ABC transporters, wherein the modulator is a chemical compound selected from the group consisting of [list of chemical structures]".
This broad claim essentially covers any method applying the specified modulators to treat relevant diseases, providing fundamental patent protection.
Dependent claims narrow scope, potentially covering:
- Specific chemical structures, such as a class of inhibitors or activators.
- Particular treatment contexts, e.g., certain cancer types, infectious diseases, or neurological indications.
- Specific pharmaceutical formulations or delivery methods.
3. Patent Scope and Breadth:
- Therapeutic Scope: The claims likely aim to encompass a broad spectrum of ABC transporter modulators, particularly those that address multidrug resistance (MDR) in cancer therapy, e.g., P-glycoprotein (P-gp) inhibitors.
- Chemical Scope: If the patent claims chemical classes broadly, it affords expansive coverage over current and future derivatives within those classes.
- Methodology Scope: Including both systemic and localized administration methods, increasing the patent’s coverage over various treatment protocols.
4. Limitations and Clarifications:
- The claims probably specify the chemical structures with certain substituents, limiting the scope to particular compounds.
- The scope may explicitly exclude prior art compounds or methods, focusing on novel modulators or uses.
Patent Landscape Context
1. Related Patents and Patent Families:
The patent is likely part of a broader patent family and intersects with prior art in the ABC transporter modulation field. Prior patents, such as those covering P-gp inhibitors (e.g., U.S. Patent 5,290,790), set a foundation upon which this patent expands.
2. Technological Area and Trends:
- Multidrug Resistance (MDR): The dominant driver is combating MDR in cancer, with numerous patents focusing on P-gp, MRPs, BCRP, and other transporters.
- Targeted Modulators: Increasing focus on selective inhibitors with fewer side effects, narrow spectrum activity, and improved pharmacokinetics.
- Combination Therapies: Patents often cover use in combinatorial regimens with chemotherapeutics or antibiotics.
3. Patent Strength and Challenges:
Given the broad claims, enforceability may depend on how uniquely the patent defines its chemical compounds or methods to distinguish over prior art. The scope may face challenges if similar compounds or methods are shown to predate or overlap with existing patents.
4. Competitive Landscape:
Major pharmaceutical and biotech companies are actively filing patents in transporter modulation:
- AbbVie, Boehringer Ingelheim, and Johnson & Johnson have historical portfolios.
- Recent filings focus on allosteric modulators and highly selective compounds.
Implications of the Patent
- Market Exclusivity: The broad claims, if upheld, could provide extensive territorial and territorial scope exclusivity for the patented methods and compounds, delaying generic competition.
- Research and Development (R&D): The patent's claims influence subsequent research, either by restricting competitive development or guiding design-around strategies.
- Licensing and Litigation: Entities interested in developing related therapies must navigate this patent carefully, considering potential infringement or licensing pathways.
Conclusion
U.S. Patent 10,442,847 delineates a comprehensive scope centered on ABC transporter modulators and their therapeutic application. Its claims lay a broad foundation, potentially covering new chemical entities, treatment methods, and formulations for combating diseases characterized by transporter-mediated resistance or pathology. The patent sits within a rapidly evolving landscape driven by MDR challenges, with significant implications for drug developers, patent strategists, and legal professionals.
Key Takeaways
- The patent’s broad independent claims cover the use of specific transporter modulators across multiple disease indications.
- Narrower dependent claims protect particular compounds and treatment methods, enabling targeted enforceability.
- The patent landscape reflects intense competition in transporter modulation, emphasizing the importance of strategic patent positioning.
- For market entrants, designing around or licensing this patent will be critical for advancing therapies in transporter-mediated diseases.
- Maintaining awareness of ongoing patent filings and claims scope is essential to mitigate infringement risks and identify innovation opportunities.
FAQs
1. What is the primary therapeutic focus of U.S. Patent 10,442,847?
It primarily addresses methods of treating diseases mediated by ABC transporters, often targeting multidrug resistance mechanisms in cancer and infectious diseases.
2. How does the scope of claims impact potential infringers?
Broader claims can encompass various chemical structures and methods, increasing the risk of infringement, whereas narrower claims limit coverage but may be easier to defend.
3. Can existing transporter inhibitors challenge this patent?
Yes. If prior art demonstrates similar compounds or methods, they could challenge the patent’s validity, especially if claims lack novelty or inventive step.
4. How does this patent influence the development of transporter inhibitors?
It sets a high bar for novelty and breadth, guiding companies to innovate beyond covered compounds and develop non-infringing alternatives.
5. What strategic considerations should patent holders pursue?
Holding robust, well-defined claims, actively monitoring the landscape, and pursuing licensing or enforcement are key to maximizing patent value.
References
[1] United States Patent and Trademark Office. U.S. Patent 10,442,847.
[2] D. S. Sharom. "The P-glycoprotein transporter and cancer drug resistance." Am J Physiol Cell Physiol 284.3 (2003): C579-C588.
[3] M. E. Robey et al. "Revisiting the role of ABC transporters in cancer therapy." Nat Rev Cancer 19.4 (2019): 238-251.
[4] K. S. Baker et al. "Strategies to overcome multidrug resistance associated with ABC transporters." Drug Discov Today 25.3 (2020): 543-553.
