Understanding the Scope and Claims of United States Patent 10,617,668
Introduction
United States Patent 10,617,668, issued on April 14, 2020, is a significant patent in the pharmaceutical industry, particularly related to formulations of specific compounds. This patent is assigned to Janssen Pharmaceutica NV and involves the work of inventors Wang Wenhua, Outwin Todd, and Joseph Thomas C.
Patent Overview
The patent titled "Pharmaceutical formulations" focuses on formulations that include compounds of Formula (I), or their prodrugs, or pharmaceutically acceptable salts. This is crucial for the development and manufacturing of certain pharmaceutical products, especially those related to diabetes treatment, such as Canagliflozin, which is a well-known medication for type 2 diabetes[2].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are critical as they outline the specific aspects of the formulation that are protected under the patent. Here are some key points about the claims:
- Compound Formulations: The patent claims cover specific formulations of compounds of Formula (I), which are designed to enhance the stability, bioavailability, or efficacy of the drug.
- Prodrugs and Salts: The claims also extend to prodrugs and pharmaceutically acceptable salts of the compounds, which allows for a broader range of therapeutic applications[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, often narrowing down the scope to particular aspects such as the composition, method of preparation, or specific uses of the formulations.
Patent Expiration Dates
The patent is set to expire on May 11, 2031. This expiration date is significant as it determines when generic versions of the drug can be marketed without infringing on the patent rights[5].
Therapeutic Equivalence and Bioequivalence
The formulations covered under this patent have been evaluated for therapeutic equivalence and bioequivalence. For instance, Canagliflozin Tablets, 100 mg and 300 mg, have been determined to be bioequivalent and therapeutically equivalent to the reference listed drug, which is crucial for regulatory approvals[2].
Litigation and Regulatory Aspects
The patent has been involved in various legal and regulatory proceedings. Generic drug manufacturers, such as Laurus Labs Limited, have filed Abbreviated New Drug Applications (ANDAs) with paragraph IV certifications, challenging the validity or enforceability of the patent. This has led to litigation, with the FDA noting that final approval of such ANDAs may be delayed until the expiration of certain related patents[2].
Metrics for Patent Scope
The scope of the patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Impact on Innovation
The patent landscape, including patents like 10,617,668, plays a crucial role in innovation within the pharmaceutical industry. While broad patents can sometimes hinder innovation by increasing licensing and litigation costs, well-defined and narrower claims can facilitate clearer boundaries and encourage further research and development[3].
Industry Expert Insights
Industry experts often highlight the importance of patent clarity and scope in driving innovation. For example, Alan Marco and his colleagues from the U.S. Patent and Trademark Office have emphasized that clearer and narrower claims can reduce the complexity and duration of patent examinations, thereby promoting a healthier innovation environment[3].
Statistical Significance
The impact of patents on innovation can be statistically significant. Studies have shown that patents with narrower claims tend to have higher forward citations, indicating their influence on subsequent innovations. Additionally, the examination process tends to narrow the scope of patent claims, which can lead to more focused and effective innovation[3].
Real-World Applications
The formulations protected under this patent have real-world applications, particularly in the treatment of type 2 diabetes. Canagliflozin, for instance, is a medication that helps control blood sugar levels and is part of a class of drugs known as SGLT2 inhibitors.
Conclusion
United States Patent 10,617,668 is a critical patent in the pharmaceutical sector, covering specific formulations of compounds used in diabetes treatment. Understanding its claims, scope, and the surrounding patent landscape is essential for both innovators and generic drug manufacturers.
Key Takeaways
- Patent Claims: The patent includes independent and dependent claims that define the scope of the formulations.
- Expiration Date: The patent expires on May 11, 2031.
- Therapeutic Equivalence: The formulations are bioequivalent and therapeutically equivalent to reference listed drugs.
- Litigation: The patent is involved in legal proceedings related to generic drug applications.
- Innovation Impact: Clear and narrower claims can facilitate innovation by reducing complexity and litigation costs.
- Real-World Applications: The formulations are used in the treatment of type 2 diabetes.
FAQs
Q: What is the main focus of United States Patent 10,617,668?
A: The patent focuses on formulations including compounds of Formula (I), or their prodrugs, or pharmaceutically acceptable salts.
Q: Who are the inventors of this patent?
A: The inventors are Wang Wenhua, Outwin Todd, and Joseph Thomas C.
Q: When does the patent expire?
A: The patent expires on May 11, 2031.
Q: What is the significance of the patent in the pharmaceutical industry?
A: The patent is significant for the development and manufacturing of specific pharmaceutical products, such as Canagliflozin, used in treating type 2 diabetes.
Q: How does the patent affect generic drug manufacturers?
A: Generic drug manufacturers must navigate the patent landscape, including potential litigation and regulatory delays, before they can market generic versions of the drug.
Sources
- US10617668B2 - Pharmaceutical formulations - Google Patents
- 2020-09-24 We have determined your Canagliflozin Tablets,. 100 mg and 300 mg, to be bioequivalent and therapeutically equivalent to the reference listed drug - FDA
- Patent Claims and Patent Scope - Hoover Institution
- FORM 10-Q Johnson & Johnson
- Generic Invokana Availability - Drugs.com
