United States Patent 10,772,888: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,772,888, titled "Solid pharmaceutical compositions containing an integrase inhibitor," is a significant patent in the pharmaceutical industry, particularly in the realm of HIV treatment. This patent, assigned to a pharmaceutical company, outlines specific formulations and methods related to the integrase inhibitor raltegravir. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent in question involves solid pharmaceutical compositions, specifically compressed tablets, for oral administration of raltegravir. Raltegravir is an integrase inhibitor used in the treatment of HIV-1 infection. The patent describes the formulation, composition, and manufacturing process of these tablets, ensuring they meet the necessary pharmaceutical standards for efficacy and stability[1].
Scope of the Patent
Pharmaceutical Composition
The scope of the patent includes the detailed composition of the solid pharmaceutical formulations. These formulations typically consist of raltegravir in the form of a pharmaceutically acceptable salt, along with other excipients such as fillers, binders, disintegrants, and lubricants. The patent specifies the ranges and amounts of these components to ensure the tablets have the desired properties for oral administration[1].
Manufacturing Process
The patent also covers the manufacturing process, including the steps involved in preparing the active pharmaceutical ingredient (API), mixing it with excipients, and compressing the mixture into tablets. This process is crucial for maintaining the quality and consistency of the final product[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition of the tablets, the method of preparation, and the specific ratios of the active ingredient to the excipients. For example, one claim might specify the amount of raltegravir and the type of salt used, while another might detail the process of compressing the mixture into tablets[1].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These could include specific ranges for the amounts of excipients, particular methods for mixing, or specific conditions for tablet compression. These claims help to protect the invention by providing a more detailed description of the preferred embodiments[1].
Patent Landscape
Related Patents
The patent landscape for integrase inhibitors and solid pharmaceutical compositions is complex and involves numerous patents. Other patents may cover different aspects of integrase inhibitors, such as different formulations, delivery methods, or manufacturing processes. For instance, patents related to other integrase inhibitors like elvitegravir or dolutegravir might overlap in some areas but also introduce distinct innovations[2].
Litigation and Settlements
Patent litigation is common in the pharmaceutical industry, and patents like 10,772,888 are often involved in such disputes. Settlements and litigation outcomes can significantly impact the patent landscape. For example, settlements may allow generic manufacturers to enter the market earlier under specific conditions, while litigation can result in the enforcement or invalidation of patent claims[2].
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research has shown that metrics such as independent claim length and count can be useful in measuring patent scope. Patents with narrower claims, as indicated by shorter independent claim lengths and fewer independent claims, tend to have a higher probability of grant and a shorter examination process. This is relevant for understanding the strategic approach taken in drafting the claims for 10,772,888[3].
Historical Context and Searchability
Historical Patents
Understanding the historical context of pharmaceutical patents can provide insights into the evolution of drug formulations and manufacturing processes. Resources such as the NYPL Libguides and the USPTO website offer access to historical patents, allowing researchers to trace the development of similar inventions over time[4].
Online Resources
Modern patent searching can be conducted through various online resources, including the USPTO website, Google Patents, and the European Patent Office's Espacenet. These resources provide full text and images of patents, facilitating comprehensive searches and analyses of patent landscapes[4].
Impact on Generic Entry
Expiration and Generic Entry
The expiration of patent 10,772,888 will have significant implications for generic entry into the market. Generic manufacturers can file Abbreviated New Drug Applications (ANDAs) with Paragraph IV certifications, challenging the validity of the patent or seeking approval to market a generic version of the drug before the patent expires. Settlements and litigation outcomes, as mentioned earlier, can also influence when and how generic versions become available[5].
Key Takeaways
- Pharmaceutical Composition: The patent covers specific solid pharmaceutical compositions containing raltegravir, including the formulation and manufacturing process.
- Claims: The patent includes independent and dependent claims that define the scope of the invention, protecting the composition and method of preparation.
- Patent Landscape: The landscape involves numerous related patents and potential litigation, which can impact the enforcement and validity of the patent.
- Metrics for Scope: Independent claim length and count are useful metrics for understanding the scope and strategic drafting of the patent.
- Historical Context: Historical patents provide insights into the evolution of drug formulations and manufacturing processes.
- Impact on Generic Entry: The expiration of the patent and any settlements or litigation will determine when and how generic versions of the drug can enter the market.
FAQs
What is the primary focus of United States Patent 10,772,888?
The primary focus of this patent is on solid pharmaceutical compositions containing the integrase inhibitor raltegravir, specifically for oral administration.
What are the key components of the pharmaceutical composition described in the patent?
The composition includes raltegravir in the form of a pharmaceutically acceptable salt, along with excipients such as fillers, binders, disintegrants, and lubricants.
How does the patent protect the manufacturing process?
The patent includes claims that detail the steps involved in preparing the active pharmaceutical ingredient, mixing it with excipients, and compressing the mixture into tablets.
What metrics can be used to measure the scope of a patent?
Metrics such as independent claim length and count can be used to measure the scope of a patent, indicating the breadth and clarity of the claims.
What happens when the patent expires?
Upon expiration, generic manufacturers can enter the market with their versions of the drug, subject to any settlements or litigation outcomes that may have occurred.
Where can one find detailed information on historical patents?
Detailed information on historical patents can be found through resources such as the NYPL Libguides, the USPTO website, and other online patent databases.
Sources
- US10772888B2 - Solid pharmaceutical compositions containing an integrase inhibitor - Google Patents
- ANDA Litigation Settlements | Hatch-Waxman | Robins Kaplan LLP
- Patent Claims and Patent Scope - SSRN
- How to Search for an Historical U.S. Patent - NYPL Libguides
- Pharmaceutical drugs covered by patent 10,772,888 - DrugPatentWatch
