United States Patent 9,089,471: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,089,471, titled "Formulation of indomethacin," is a significant patent in the pharmaceutical industry, particularly in the realm of drug formulation and manufacturing. This patent, granted to Dow Pharmaceutical Sciences, Inc., introduces innovative methods for producing particles of indomethacin using dry milling processes. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Indomethacin
Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) widely used for treating pain, fever, and inflammation. Its efficacy is well-established, but its formulation has presented challenges due to its poor solubility and bioavailability.
Scope of the Patent
Method of Production
The patent describes a method for producing particles of indomethacin through dry milling processes. This method involves milling a solid biologically active material (indomethacin) along with a millable grinding matrix in a mill containing multiple milling bodies. The process is designed to reduce the particle size of indomethacin to enhance its bioavailability and solubility[1].
Particle Size Reduction
A key aspect of this patent is the achievement of significantly reduced particle sizes. The process can produce particles with an average size of 2000 nm or less, often as low as 100 nm. This reduction in particle size is crucial for improving the pharmacokinetic properties of indomethacin[1].
Preservation of Crystallinity
The patent highlights that the dry milling process does not substantially alter the crystallinity of the active material. This is important because maintaining the crystalline structure ensures the stability and efficacy of the drug[1].
Claims of the Patent
Method Claims
The patent includes claims related to the method of producing the indomethacin particles. These claims specify the steps involved in the dry milling process, including the use of a millable grinding matrix and the duration of milling necessary to achieve the desired particle size[1].
Composition Claims
The patent also claims compositions comprising the milled indomethacin particles dispersed in a partially milled grinding material. These compositions can be formulated into various dosage forms such as capsules, tablets, or other pharmaceutical preparations[1].
Particle Size Claims
Specific claims are made regarding the average particle size of the indomethacin produced, with sizes ranging from 25 nm to 2000 nm. These claims are critical as they define the scope of protection for the invention[1].
Broader Patent Landscape
Venue and Jurisdiction
In the context of pharmaceutical patents, venue and jurisdiction are crucial. Recent legal developments, such as those discussed in the case of Valeant Pharmaceuticals v. Mylan, have clarified that patent infringement cases must be brought in specific judicial districts where the defendant is incorporated or has a regular and established place of business and where an act of infringement has occurred[2].
Genus Claims and Patent Scope
The pharmaceutical industry often relies on genus claims to protect broad classes of compounds. However, recent jurisprudence, particularly from the Federal Circuit, has made it challenging to obtain and maintain broad patent protection. The rigid application of Section 112(a) of the U.S. patent laws has led to a situation where innovators face difficulties in claiming the full scope of their inventions without risking invalidation[3].
Impact on Pharmaceutical Industry
The patent landscape for pharmaceuticals is complex and evolving. Innovators need robust and predictable patent protection to justify the significant investments required to bring new drugs to market. The market for therapeutic antibodies, for example, is projected to reach $300 billion by 2025, highlighting the importance of strong patent protection in this sector[3].
Applications and Extensions
Biologically Active Materials
The method described in the patent is not limited to indomethacin but can be applied to a range of biologically active materials, including therapeutic or pharmaceutical compounds, nutraceuticals, and agricultural compounds. This versatility makes the patent highly valuable across various industries[1].
Natural Products
The invention can also be applied to natural products such as seeds, cocoa, coffee, herbs, and spices that contain biologically active compounds. This broad applicability enhances the patent's significance in the field of pharmaceutical and food sciences[1].
Key Takeaways
- Innovative Production Method: The patent introduces a novel dry milling process for reducing the particle size of indomethacin, enhancing its bioavailability.
- Preservation of Crystallinity: The process maintains the crystalline structure of the drug, ensuring stability and efficacy.
- Broad Applicability: The method can be applied to various biologically active materials and natural products.
- Complex Patent Landscape: The patent operates within a complex legal framework, influenced by recent jurisprudence on genus claims and venue requirements.
FAQs
What is the primary innovation of United States Patent 9,089,471?
The primary innovation is the method of producing particles of indomethacin using dry milling processes, which reduces the particle size and enhances bioavailability.
How does the patent impact the pharmaceutical industry?
The patent provides a new method for improving the pharmacokinetic properties of indomethacin, which can be extended to other biologically active materials, thus enhancing drug efficacy and stability.
What are the implications of the patent on natural products?
The patent's method can be applied to various natural products containing biologically active compounds, such as seeds, cocoa, and herbs, making it valuable across multiple industries.
How does recent jurisprudence affect pharmaceutical patents?
Recent jurisprudence, particularly on genus claims, has made it challenging for innovators to obtain broad patent protection, affecting the commercialization strategies of pharmaceutical companies.
What is the significance of maintaining crystallinity in the dry milling process?
Maintaining the crystallinity of the drug ensures its stability and efficacy, which is crucial for pharmaceutical applications.
Sources
- US9089471B2 - Formulation of indomethacin - Google Patents
- VALEANT PHARMACEUTICALS v. MYLAN - CAFC
- Eviscerating Patent Scope - DigitalCommons@NYLS
