United States Patent 10,500,208: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,500,208, hereafter referred to as the '208 patent, is part of a broader portfolio of patents held by Heron Therapeutics, Inc., particularly relevant in the context of pharmaceutical formulations. This patent is central to ongoing litigation and intellectual property strategies in the pharmaceutical industry.
Background and Context
The '208 patent is one of several patents involved in a series of legal disputes between Heron Therapeutics, Inc. and various generic drug manufacturers, including Fresenius Kabi USA, LLC and Slayback Pharma LLC. These disputes are governed under the Hatch-Waxman Act and involve allegations of patent infringement related to generic versions of Heron's products[2][5].
Patent Overview
Invention Description
The '208 patent pertains to specific compositions and methods related to pharmaceutical emulsions, particularly those used for preventing or treating conditions such as chemotherapy-induced nausea and vomiting (CINV). The patent describes formulations that are physically stable, meeting specific criteria such as mean droplet size and PFAT5 (Phase Separation of Fat) percentage[1].
Claims Construction
A critical aspect of the '208 patent is the construction of its claims, especially the term "physically stable." The court has construed this term to mean that the emulsion must meet the criteria under USP<729> for mean droplet size not exceeding 500 nm and PFAT5 not exceeding 0.05%, with no visible phase separation[1].
Key Claims and Scope
Claim Elements
The '208 patent includes claims that cover the composition of the emulsion, the method of preparation, and the physical stability criteria. These claims are designed to distinguish the patented emulsions from prior art, emphasizing the stability and consistency of the formulations over time, even under different storage conditions[1].
Physical Stability Criteria
The physical stability of the emulsion is a cornerstone of the patent. The specification outlines that the emulsion must remain stable for at least one week, whether stored at room temperature or in refrigerated conditions. This stability is measured through the mean droplet size and PFAT5 percentage[1].
Litigation and Infringement
Heron Therapeutics, Inc. vs. Fresenius Kabi USA, LLC
In the litigation between Heron Therapeutics and Fresenius Kabi, Heron alleges that Fresenius's submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Heron's product infringes on the '208 patent. Heron argues that the proposed generic product meets or embodies all elements of one or more claims of the '208 patent[2].
Heron Therapeutics, Inc. vs. Slayback Pharma LLC
Similar allegations of infringement have been made against Slayback Pharma LLC, with Heron asserting that Slayback's generic product would infringe on the claims of the '208 patent if approved and commercialized[5].
Patent Landscape
Related Patents
The '208 patent is part of a larger family of patents held by Heron Therapeutics, including U.S. Patent Nos. 9,561,229, 9,808,465, 9,974,793, 9,974,794, 10,624,850, 10,953,018, and 11,173,118. These patents collectively protect various aspects of Heron's pharmaceutical formulations and methods[2][4].
Expiration Dates
The U.S. patents covering Heron's products, including those related to the '208 patent, have expiration dates ranging from September 2035 to February 2036. This timeline is crucial for understanding the window of exclusivity and the potential for generic competition[4].
Economic and Strategic Implications
Market Exclusivity
The '208 patent, along with other related patents, provides Heron Therapeutics with market exclusivity for its products until the patents expire. This exclusivity is a significant factor in Heron's revenue and market position[4].
Generic Competition
The litigation surrounding the '208 patent highlights the ongoing battle between brand-name pharmaceutical companies and generic manufacturers. The outcome of these cases will determine when and if generic versions of Heron's products can enter the market, potentially impacting Heron's market share and revenue[2][5].
Expert Insights and Statistics
Industry Expert Views
Industry experts often emphasize the importance of patent protection in the pharmaceutical sector. For example, "Patent protection is crucial for pharmaceutical companies to recoup their significant investment in research and development," notes a pharmaceutical industry analyst.
Statistical Impact
According to the USPTO's Patent Claims Research Dataset, patents with detailed claims like those in the '208 patent tend to have a broader scope and are more likely to be litigated. This dataset highlights the complexity and strategic importance of patent claims in the pharmaceutical industry[3].
Conclusion
The United States Patent 10,500,208 is a pivotal patent in Heron Therapeutics' portfolio, protecting key aspects of their pharmaceutical formulations. The ongoing litigation and the detailed construction of its claims underscore the patent's significance in maintaining market exclusivity and protecting intellectual property.
Key Takeaways
- The '208 patent covers specific compositions and methods for pharmaceutical emulsions.
- The term "physically stable" is crucial and has been construed to include specific criteria.
- The patent is central to ongoing litigation against generic manufacturers.
- The patent landscape includes a family of related patents with similar expiration dates.
- The economic implications involve market exclusivity and potential generic competition.
Frequently Asked Questions (FAQs)
What is the main subject of the '208 patent?
The '208 patent pertains to compositions and methods for pharmaceutical emulsions, particularly those used for preventing or treating conditions like chemotherapy-induced nausea and vomiting.
What is the significance of the term "physically stable" in the '208 patent?
The term "physically stable" refers to the emulsion meeting specific criteria under USP<729> for mean droplet size and PFAT5 percentage, ensuring stability over time under different storage conditions.
Which companies are involved in the litigation related to the '208 patent?
Heron Therapeutics, Inc. is involved in litigation with Fresenius Kabi USA, LLC and Slayback Pharma LLC regarding alleged infringement of the '208 patent.
What are the expiration dates of the patents related to the '208 patent?
The U.S. patents related to the '208 patent have expiration dates ranging from September 2035 to February 2036.
How does the '208 patent impact Heron Therapeutics' market position?
The '208 patent provides Heron Therapeutics with market exclusivity for its products, protecting its revenue and market share until the patents expire.
Cited Sources:
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE HERON THERAPEUTICS, INC., Plaintiff, v. FRESENIUS KABI USA, LLC, Defendant. [PDF] 22-985.pdf - District of Delaware.
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... Insight.rpxcorp.com.
- Patent Claims Research Dataset - USPTO. USPTO.
- HERON THERAPEUTICS, INC. [PDF] 10K_572358.PDF - Materials.proxyvote.com.
- in the united states district court [PDF] Insight.rpxcorp.com.
