United States Patent 10,849,857: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,849,857, hereafter referred to as the '857 patent, is part of a broader patent family related to pharmaceutical compositions, particularly those involving drospirenone. This analysis will delve into the scope, claims, and the surrounding patent landscape to provide a comprehensive understanding.
Background
The '857 patent is a continuation-in-part of the earlier U.S. Patent Application No. 13/171,411, filed in 2011. This patent is part of a series of patents asserted in various legal proceedings, including the case of Exeltis USA, Inc. vs. Lupin Ltd.[2][4].
Scope of the Patent
The '857 patent pertains to pharmaceutical compositions, specifically those containing drospirenone, a synthetic progestin used in contraceptive formulations. The patent describes various methods and formulations aimed at improving the efficacy and stability of these compositions.
Claim Construction
When analyzing the scope of the '857 patent, it is crucial to consider the claim construction. Claim construction involves interpreting the literal language of the claim, the patent specification, and the prosecution history. According to the Federal Circuit, "the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term."[1].
Claims
The '857 patent includes several claims that define the scope of the invention. Here are some key aspects:
Pharmaceutical Composition
The patent claims describe a pharmaceutical composition comprising drospirenone in specific particle sizes. For example, the composition may include drospirenone particles with a median particle size ranging from 10 micrometers to 30 micrometers, a d90 particle size of less than 100 micrometers, and a d10 particle size of more than 3 micrometers[4].
Measurement Methods
The specification teaches various methods for measuring particle size, including sieve analysis, laser diffraction, photoanalysis, and optical counting methods. Laser diffraction methods are particularly preferred[4].
Patent Landscape
The '857 patent is part of a larger patent landscape in the pharmaceutical field, particularly in the area of contraceptive formulations.
Related Patents
The '857 patent is closely related to other patents such as U.S. Patent Nos. 10,179,140 ('140 patent), 10,603,281 ('281 patent), and 11,123,299 ('299 patent), among others. These patents are also asserted in the Exeltis vs. Lupin case and are listed in the FDA's Orange Book for the drug SLYND®[2][4].
University and Institutional Contributions
American universities play a significant role in the development and patenting of pharmaceutical compositions. The University of California, Johns Hopkins University, and the University of Texas System are among the top recipients of drug patents in the U.S., with a focus on pharmaceutical compositions, therapeutic agents, and immune responses[3].
Litigation and Enforcement
The '857 patent, although not directly asserted in the Exeltis vs. Lupin case, is part of a broader litigation landscape. The case highlights the importance of claim construction, infringement, and invalidity arguments such as obviousness, written description, and indefiniteness. The trial opinion in the Exeltis vs. Lupin case provides insights into how courts interpret and enforce similar patents[2][4].
Infringement and Invalidity
In the Exeltis vs. Lupin case, the court found that Lupin infringed several claims of related patents but failed to prove that the asserted claims were indefinite or invalid for lack of written description or obviousness. This underscores the robustness of the patent claims and the importance of thorough prosecution history and specification[2].
Core Patent Analysis
The value and impact of the '857 patent can be evaluated through core patent analysis. This involves analyzing patent citations, which are indicators of a patent's importance and influence. Patents with higher citation counts are generally considered more valuable and influential in their field[3].
Conclusion
The United States Patent 10,849,857 is a significant component of the patent landscape in pharmaceutical compositions, particularly those involving drospirenone. Understanding its scope, claims, and the broader patent landscape is crucial for navigating the complex world of pharmaceutical patents.
Key Takeaways
- The '857 patent is a continuation-in-part of an earlier patent application and is related to other patents in the same family.
- The patent describes specific pharmaceutical compositions and methods for measuring particle size.
- Claim construction is critical and involves interpreting the literal language, specification, and prosecution history.
- The patent is part of a larger landscape involving university and institutional contributions to pharmaceutical research.
- Litigation and enforcement of similar patents highlight the importance of robust claim construction and thorough specification.
FAQs
What is the primary focus of the '857 patent?
The primary focus of the '857 patent is on pharmaceutical compositions, specifically those containing drospirenone, with detailed descriptions of particle sizes and measurement methods.
How is claim construction determined for the '857 patent?
Claim construction for the '857 patent involves interpreting the literal language of the claim, the patent specification, and the prosecution history, with the specification being the single best guide to the meaning of a disputed term[1].
What are the key measurement methods described in the '857 patent?
The patent describes various measurement methods including sieve analysis, laser diffraction, photoanalysis, and optical counting methods, with laser diffraction being particularly preferred[4].
Is the '857 patent asserted in any current litigation?
The '857 patent itself is not asserted in the Exeltis vs. Lupin case, but it is part of a broader patent family that is involved in this litigation[2][4].
How does the '857 patent fit into the broader patent landscape?
The '857 patent is part of a larger landscape involving pharmaceutical compositions, with significant contributions from American universities and institutions. It is related to other patents listed in the FDA's Orange Book for SLYND®[2][3].
Cited Sources:
- Case 1:22-cv-00434-RGA Document 298 Filed 02/20/24 - GovInfo
- Exeltis USA, Inc. et al v. Lupin Ltd. et al, No. 1:2022cv00434 - Justia
- Analysis of Drug Patent in American Universities Based on Xlpat - SCIRP
- in the united states district court - District of Delaware - District of Delaware
- Pharmaceutical composition comprising drospirenone and ... - Google Patents
