United States Patent 11,013,761: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,013,761, titled "Pharmaceutical compositions," is a significant patent in the pharmaceutical industry, particularly in the realm of oral delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Publication and Priority Date
The patent was published with the number US11013761B1, stemming from the application US17/150,529. The prior art date for this patent is crucial, as it sets the foundation for the novelty and non-obviousness of the invention[1].
Scope of the Patent
Pharmaceutical Compositions
The patent focuses on pharmaceutical compositions designed for oral administration. These compositions can be administered directly or as part of a more complex delivery system. The scope includes various formulations that enhance the efficacy and stability of the active substances[1].
Key Components
- Active Substances: The patent details the use of specific active substances, including iron hydroxide, which is a critical component in some pharmaceutical formulations.
- Excipients and Carriers: The compositions often include starch, carbohydrates, and other excipients that facilitate the delivery and stability of the active ingredients.
- Coating Agents: The patent also covers the use of coating agents to improve the palatability and shelf life of the pharmaceutical products[1].
Claims of the Patent
Method and Composition Claims
The patent includes a variety of claims that can be broadly categorized into method claims and composition claims.
- Method Claims: These claims describe the methods for preparing the pharmaceutical compositions, including the steps involved in mixing, coating, and forming the final product.
- Composition Claims: These claims define the specific compositions, including the ratios of active substances to excipients and the characteristics of the final product[1].
Specific Examples
- The patent provides detailed examples of how to prepare these compositions, including the use of granular materials and liquid components.
- It also specifies the effects of these compositions, such as the impact on food intake and the process of swallowing[1].
Patent Landscape
Related Patents and Litigation
The patent landscape surrounding US11013761B1 involves several related patents and ongoing litigation.
- Velphoro® Patent: While not directly related, the case of Vifor Fresenius Medical Care Renal Pharma (VFMCRP) vs. Teva Pharmaceuticals illustrates the importance of patent protection in the pharmaceutical industry. VFMCRP successfully defended the validity of its patent for Velphoro® (sucroferric oxyhydroxide), which is another oral delivery system used for patients with chronic kidney disease[4].
- Allergan USA, Inc. v. MSN Laboratories Private Ltd.: This case highlights the complexities of patent validity and obviousness-type double patenting. The decision in this case underscores the importance of ensuring that claims are patentably distinct to avoid invalidation[2].
Patent Expiration and Term
Patent Term Adjustments
The patent term for US11013761B1, like other patents, is generally 20 years from the priority date. However, adjustments can be made due to delays in prosecution or other factors.
- Patent Term Extensions: In some cases, patents may receive extensions due to regulatory delays, as seen in the Velphoro® patent, which includes a pediatric extension[4].
Economic and Strategic Impact
Market Protection
The patent provides significant market protection for the innovator company, allowing it to maintain exclusivity over the specific pharmaceutical compositions.
- Competitive Advantage: By defending its intellectual property, the company can prevent generic versions from entering the market, thereby maintaining a competitive advantage[4].
Innovation and R&D
The patent also encourages innovation and research and development (R&D) within the pharmaceutical industry.
- Data and Statistics: The USPTO's Patent Claims Research Dataset provides insights into the trends and scope of patent claims, highlighting the importance of detailed claim analysis in R&D strategies[3].
Industry Expert Insights
Protecting Intellectual Property
"Protecting our intellectual property is crucial for delivering innovative drugs to patients," said Florian Jehle, Chief Executive Officer of VFMCRP. This sentiment is echoed across the industry, where patent protection is a cornerstone of innovation and market strategy[4].
Illustrative Statistics
Patent Claims and Scope
The USPTO's Patent Claims Research Dataset reveals that between 1976 and 2014, there was a significant increase in the complexity and scope of patent claims. This trend continues, with patents like US11013761B1 reflecting detailed and specific claims to ensure broad protection[3].
Key Takeaways
- Pharmaceutical Compositions: The patent focuses on oral delivery systems with specific active substances and excipients.
- Method and Composition Claims: The patent includes detailed method and composition claims to ensure broad protection.
- Patent Landscape: The patent is part of a complex landscape involving related patents and ongoing litigation.
- Market Protection: The patent provides significant market protection and encourages innovation and R&D.
- Economic Impact: The patent has a substantial economic impact by maintaining exclusivity and driving R&D.
FAQs
What is the primary focus of United States Patent 11,013,761?
The primary focus of this patent is on pharmaceutical compositions designed for oral administration, including specific formulations and delivery systems.
What are the key components of the pharmaceutical compositions described in the patent?
The key components include active substances like iron hydroxide, excipients such as starch and carbohydrates, and coating agents to enhance stability and palatability.
How does the patent protect the innovator company?
The patent provides market protection by preventing generic versions from entering the market, thereby maintaining the innovator company's competitive advantage.
What is the significance of the USPTO's Patent Claims Research Dataset in this context?
The dataset provides insights into the trends and scope of patent claims, highlighting the importance of detailed claim analysis in R&D strategies and patent protection.
How does patent litigation impact the pharmaceutical industry?
Patent litigation, as seen in cases like VFMCRP vs. Teva Pharmaceuticals, underscores the importance of patent validity and the need for companies to vigorously defend their intellectual property to maintain market exclusivity.
Sources
- US11013761B1 - Pharmaceutical compositions - Google Patents
- Allergan USA, Inc. v. MSN Laboratories Private Ltd. - CAFC
- Patent Claims Research Dataset - USPTO
- VFMCRP announces U.S. Court upholds validity of Velphoro® patent - Marketscreener
