United States Patent 10,953,018: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,953,018, issued to Heron Therapeutics, Inc., is a significant patent in the pharmaceutical industry, particularly in the realm of emulsion formulations. This patent is part of a broader portfolio of patents held by Heron Therapeutics, which are crucial for their innovative pharmaceutical products.
Background
Heron Therapeutics is known for its advanced pharmaceutical formulations, including those for the treatment of chemotherapy-induced nausea and vomiting (CINV) and postoperative pain. The patent in question pertains to novel emulsion formulations of aprepitant, a substance used in the prevention of CINV.
Scope of the Patent
Emulsion Formulations
The patent 10,953,018 focuses on the preparation and composition of emulsion formulations containing aprepitant, which are designed for parenteral administration, including intravenous administration. These formulations are engineered to enhance the stability and efficacy of aprepitant, a key component in CINV treatment[5].
Physical Stability
A critical aspect of the patent is the definition of "physical stability" of the emulsions. According to the court's claim construction, an emulsion is considered physically stable if it meets specific criteria, including a mean droplet size not exceeding 500 nm and a PFAT5 (percent fat above 5 microns) not exceeding 0.05%. This ensures that the emulsion remains stable under appropriate storage conditions for at least one week[1].
Claims of the Patent
The patent includes several claims that define the scope of protection for the emulsion formulations.
Composition of Matter
The patent claims cover the composition of matter for the emulsions, including the specific percentages and types of ingredients used. This includes the active ingredient aprepitant, as well as other components necessary for maintaining the physical stability of the emulsion[5].
Methods of Preparation
The patent also includes claims related to the methods of preparing these emulsions. This involves detailed steps and conditions for mixing, heating, and cooling the ingredients to achieve the desired stability and efficacy[4].
Medical Uses
Claims are also made for the medical uses of these emulsion formulations, specifically in the prevention of CINV and potentially other applications where aprepitant is beneficial[3].
Patent Landscape
Related Patents
Heron Therapeutics holds a robust portfolio of patents related to pharmaceutical formulations, including several other patents that complement the 10,953,018 patent. These include patents such as U.S. Patent Nos. 9,561,229, 9,808,465, 9,974,793, and others, which collectively protect various aspects of their pharmaceutical products[2][3].
Expiration Dates
The patents covering Heron Therapeutics' products, including those related to the 10,953,018 patent, have expiration dates ranging from 2034 to 2036. This provides a significant period of exclusivity for Heron Therapeutics to commercialize and benefit from their innovative formulations[3].
International Protection
In addition to U.S. patents, Heron Therapeutics has also secured patent protection in numerous foreign countries, ensuring global coverage for their technologies and compositions. This includes countries such as Japan, Korea, and several European nations[3].
Litigation and Enforcement
Heron Therapeutics has been involved in several patent infringement cases to protect their intellectual property. For instance, they have filed lawsuits against companies like Mylan and Fresenius Kabi USA, LLC, alleging infringement of their patents, including the ones related to the emulsion formulations covered by the 10,953,018 patent[1][2].
Impact on the Pharmaceutical Industry
The 10,953,018 patent and related patents held by Heron Therapeutics have a significant impact on the pharmaceutical industry. They set a high standard for the development of stable and effective emulsion formulations, particularly for parenteral administration. This innovation can lead to better patient outcomes and expanded treatment options for conditions like CINV.
Key Takeaways
- Emulsion Formulations: The patent covers novel emulsion formulations of aprepitant for parenteral administration.
- Physical Stability: The emulsions must meet specific criteria for mean droplet size and PFAT5 to be considered physically stable.
- Composition and Preparation: Claims include the composition of matter and methods of preparation for these emulsions.
- Medical Uses: The patent covers the medical uses of these formulations, particularly in CINV prevention.
- Patent Landscape: Heron Therapeutics holds a robust portfolio of related patents with significant global coverage.
- Litigation: Heron Therapeutics actively enforces their patents through litigation to protect their intellectual property.
FAQs
Q: What is the primary focus of United States Patent 10,953,018?
A: The primary focus is on novel emulsion formulations of aprepitant for parenteral administration.
Q: What criteria define the physical stability of the emulsions in this patent?
A: The emulsions must have a mean droplet size not exceeding 500 nm and a PFAT5 not exceeding 0.05%, and remain stable for at least one week.
Q: Which company holds this patent, and what is their role in the pharmaceutical industry?
A: Heron Therapeutics, Inc. holds this patent and is a leading company in developing innovative pharmaceutical formulations.
Q: What are the expiration dates for the patents related to this technology?
A: The expiration dates range from 2034 to 2036.
Q: How does Heron Therapeutics protect its intellectual property related to this patent?
A: Heron Therapeutics actively enforces its patents through litigation against potential infringers.
