United States Patent 10,130,592 B2: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,130,592 B2, titled "Epinephrine Formulations," is a significant patent in the pharmaceutical industry, particularly in the realm of emergency medical treatments. This patent, issued on November 20, 2018, is part of a series of patents related to epinephrine formulations and is held by Endo Operations Limited.
Background of the Patent
The patent is a continuation of several earlier patent applications, including U.S. patent application Ser. No. 14/863,112, filed on September 23, 2015, and is related to other patents such as U.S. Pat. No. 9,119,876 and U.S. Pat. No. 9,295,657[4].
Scope of the Patent
Pharmaceutical Compositions
The patent covers pharmaceutical compositions that include epinephrine, a crucial medication used in emergency situations such as anaphylaxis and cardiac arrest. These compositions may include various additives to enhance stability, shelf life, and efficacy[1][4][5].
Methods of Administration
The patent details different methods of administering epinephrine, which can be critical in emergency settings. This includes formulations suitable for injection, ensuring rapid and effective delivery of the medication[4].
Methods of Making the Compositions
The patent also describes methods for preparing these epinephrine formulations. This includes processes for maintaining the stability of epinephrine, such as controlling pH levels and using antioxidants to prevent degradation[1][4].
Key Claims of the Patent
Composition Claims
- The patent claims cover compositions that include epinephrine along with other components such as pH raising agents, antioxidants, and preservatives. These components help in maintaining the stability and efficacy of the epinephrine over its shelf life[1][4].
- Specific claims include compositions with low levels of total impurities, which is crucial for ensuring the safety and effectiveness of the medication[4].
Method Claims
- The patent includes claims related to the methods of making these compositions. This involves detailed processes for formulating epinephrine with various additives to achieve desired properties such as resistance to significant pH changes over shelf life[1][4].
Use Claims
- The patent also claims methods of treating medical conditions by administering these epinephrine compositions. This encompasses the use of these formulations in emergency medical situations[4].
Patent Landscape and Litigation
Related Patents
The patent is part of a broader landscape of epinephrine formulation patents held by Endo Operations Limited. Other related patents include U.S. Pat. No. 9,119,876 and U.S. Pat. No. 9,295,657, which also cover various aspects of epinephrine formulations[2][4].
Litigation
The patent has been involved in litigation, particularly in a case where Endo Operations Limited alleged patent infringement by Fresenius Kabi USA, LLC. The complaint alleged that Fresenius Kabi's proposed product would infringe on at least one claim of the ’876, ’657, and ’592 patents upon FDA approval[2].
Importance of Patent Claims
Breadth and Specificity
The scope of the patent claims is critical in defining the boundaries of the patent owner’s rights. Broad claims can capture a wider range of inventions but risk being invalidated if they are not commensurate with what is taught in the patent application. Narrow claims, while safer, can be easily designed around by competitors[3].
Impact on Innovation
The patent claims in U.S. Patent 10,130,592 B2 are designed to balance breadth and specificity, ensuring that Endo Operations Limited can protect its intellectual property while allowing for innovation within the pharmaceutical industry. The inclusion of specific components and methods helps in maintaining the integrity of the patent while preventing easy circumvention by competitors[3].
Technical Aspects
Stability and Shelf Life
One of the key technical aspects covered by the patent is the stability of epinephrine formulations over their shelf life. The use of antioxidants, pH raising agents, and preservatives ensures that the epinephrine remains effective and safe for use even after prolonged storage[1][4].
pH Control
The patent emphasizes the importance of maintaining a stable pH level in the formulations. This is achieved through the use of buffer solutions and other pH controlling agents, which are crucial for the stability and efficacy of epinephrine[1][4].
Industry Impact
Emergency Medical Treatments
The epinephrine formulations covered by this patent are vital in emergency medical treatments. The stability and efficacy ensured by the patent claims are critical in saving lives during anaphylactic reactions and other emergency situations[4].
Market Competition
The patent landscape around epinephrine formulations is highly competitive, with several companies vying for market share. The strong patent claims in U.S. Patent 10,130,592 B2 help Endo Operations Limited maintain a competitive edge in this market[2].
Key Takeaways
- Comprehensive Coverage: The patent covers a wide range of aspects including compositions, methods of administration, and methods of making epinephrine formulations.
- Stability and Efficacy: The use of antioxidants, pH raising agents, and preservatives ensures the stability and efficacy of the epinephrine formulations.
- Litigation and Patent Landscape: The patent is part of ongoing litigation and is closely related to other patents in the same field.
- Industry Impact: The patent is crucial for emergency medical treatments and maintains a competitive edge for Endo Operations Limited in the market.
FAQs
What is the main focus of U.S. Patent 10,130,592 B2?
The main focus of U.S. Patent 10,130,592 B2 is on pharmaceutical compositions comprising epinephrine, methods of administration, and methods of making these compositions.
Who holds the U.S. Patent 10,130,592 B2?
The U.S. Patent 10,130,592 B2 is held by Endo Operations Limited.
What are the key components of the epinephrine formulations covered by the patent?
The key components include epinephrine, pH raising agents, antioxidants, and preservatives to ensure stability and efficacy.
Why is pH control important in these formulations?
pH control is crucial for maintaining the stability and efficacy of epinephrine over its shelf life.
Is the patent involved in any litigation?
Yes, the patent is involved in litigation, particularly in a case against Fresenius Kabi USA, LLC, alleging patent infringement.
Sources
- US10130592B2 - Epinephrine formulations - Google Patents
- Case 1:24-cv-01065-UNA Document 1 Filed 09/24/24 Page 1 of 21
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Epinephrine formulations - Justia Patents
- US-10130592-B2 - Epinephrine Formulations | Unified Patents
