United States Patent 4,312,860: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,312,860, titled "Lung Surfactant Compositions," was granted on January 26, 1982. This patent is significant in the medical field, particularly in the area of respiratory care, and it is important to analyze its scope, claims, and the surrounding patent landscape.
Background of the Invention
The patent addresses the need for synthetic lung surfactant compositions to temporarily substitute for natural lung surfactant in mammalian lungs. Natural lung surfactant is crucial for reducing the surface tension in the lungs, facilitating easier breathing. The absence or deficiency of this surfactant can lead to respiratory distress syndrome, especially in premature infants.
Scope of the Invention
The patent describes a synthetic protein-free lung surfactant composition designed to mimic the properties of natural lung surfactant. The composition typically includes a mixture of phospholipids, such as dipalmitoylphosphatidylcholine (DPPC), and other components like fatty alcohols and cholesterol.
Key Components
- Phospholipids: Specifically, DPPC is highlighted as a critical component due to its ability to reduce surface tension.
- Fatty Alcohols: These are included to enhance the spreading properties of the surfactant.
- Cholesterol: Added to improve the stability and function of the phospholipid monolayer[4].
Claims of the Invention
The patent includes several claims that define the scope of the invention:
Claim 1
This claim describes the synthetic lung surfactant composition comprising a mixture of phospholipids, fatty alcohols, and cholesterol. It specifies the proportions and types of these components necessary to achieve the desired surfactant properties[4].
Subsequent Claims
Subsequent claims detail various aspects of the composition, including the specific types of phospholipids and fatty alcohols, the method of preparation, and the use of the composition in medical treatments.
Patent Landscape Analysis
To understand the broader context and impact of this patent, a patent landscape analysis is essential.
Technological Evolution
The development of synthetic lung surfactants marked a significant advancement in neonatal care. This technology has continued to evolve, with subsequent patents focusing on improved formulations, delivery methods, and broader applications.
Competitive Landscape
Several companies and research institutions have been active in this field, filing patents related to lung surfactants and respiratory care. For example, patents like US20140109899A1 on aerosol delivery systems indicate ongoing innovation in delivery methods, which can be seen as complementary or competitive to the original surfactant composition[5].
Global Competition
The global landscape includes major pharmaceutical companies and research institutions. The competition is driven by the need for more effective and safer treatments. Patent mapping helps in identifying key players, their strategies, and emerging trends in the field[3].
Regulatory and Legal Aspects
Patent Term Extension
Under certain conditions, patents related to medical products can be extended due to regulatory reviews. For instance, Section 156 of Title 35, United States Code, allows for patent term extensions if the product has been subject to FDA or Department of Agriculture reviews. This could potentially impact the expiration dates of related patents[2].
Opposition and Litigation
Like any patent, US 4,312,860 could face opposition or litigation. The process involves filing a written reasoned statement and paying the opposition fee, similar to the procedures outlined in the European Patent Convention[1].
Impact and Applications
The invention has had a significant impact on medical care, particularly in neonatology. Synthetic lung surfactants have reduced the incidence of respiratory distress syndrome in premature infants, improving survival rates and outcomes.
Clinical Use
The composition described in the patent is used in clinical settings to treat respiratory distress syndrome. Its effectiveness has led to widespread adoption and further research into improving surfactant formulations.
Economic Impact
The economic impact of this patent is substantial, given the critical nature of the treatment it provides. The market for lung surfactants has grown, driven by the need for effective treatments in neonatal care.
Key Takeaways
- Synthetic Lung Surfactant: The patent introduced a synthetic protein-free lung surfactant composition, a crucial innovation in respiratory care.
- Components and Claims: The composition includes phospholipids, fatty alcohols, and cholesterol, with specific claims detailing their proportions and uses.
- Patent Landscape: The technology has evolved with ongoing innovations in formulations and delivery methods, involving multiple players in the global market.
- Regulatory and Legal: The patent is subject to regulatory reviews and potential term extensions, with opposition and litigation processes applicable.
- Impact and Applications: The invention has significantly improved neonatal care outcomes and has a substantial economic impact.
FAQs
What is the main purpose of the synthetic lung surfactant composition described in US 4,312,860?
The main purpose is to temporarily substitute for natural lung surfactant in mammalian lungs, particularly to treat respiratory distress syndrome in premature infants.
What are the key components of the synthetic lung surfactant composition?
The key components include phospholipids (such as DPPC), fatty alcohols, and cholesterol.
How has the technology evolved since the granting of US 4,312,860?
The technology has evolved with improvements in formulations, delivery methods (e.g., aerosol delivery systems), and broader applications in respiratory care.
Who are the main competitors in the global market for lung surfactants?
The main competitors include major pharmaceutical companies and research institutions actively filing patents and developing new treatments in the field.
Can the patent term of US 4,312,860 be extended?
Yes, under certain conditions, the patent term can be extended due to regulatory reviews by the FDA or Department of Agriculture, as per Section 156 of Title 35, United States Code.
Sources:
- European Patent Office, "ARYLALKYL-AND ARYLOXYALKYL-SUBSTITUTED EPITHELIAL...", [EP2931711NWB1].
- United States Patent and Trademark Office, "Extension Under 35 U.S.C. 156(e)(1) - OG Date: 29 July 2003".
- InventionIP, "Patent Landscape Analysis and Search Report".
- Google Patents, "US4312860A - Lung surfactant compositions".
- Google Patents, "US20140109899A1 - Aerosol delivery systems, compositions and methods".
