Detailed Analysis of the Scope and Claims of United States Patent 10,597,384
Introduction
The United States Patent 10,597,384, assigned to Vertex Pharmaceuticals Incorporated, is a significant patent in the pharmaceutical industry, particularly in the context of cystic fibrosis treatment. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape surrounding it.
Patent Overview
Title and Assignee
The patent, titled "Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid," is assigned to Vertex Pharmaceuticals Incorporated, a leading company in the development of treatments for cystic fibrosis and other diseases[1][4].
Inventors and Issue Date
The inventors listed on the patent include Ali Keshavarz-Shokri, Beili Zhang, and Mariusz Krawiec. The patent was issued on March 24, 2020[1][4].
Scope of the Patent
Subject Matter
The patent pertains to solid state forms, including crystalline forms, of a specific compound: 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid. This compound is relevant in the treatment of cystic fibrosis, particularly as part of the drug Orkambi, which is a combination therapy involving ivacaftor and lumacaftor[1][4].
Claims
The patent includes several claims that define the scope of the invention. These claims cover various solid forms of the compound, methods for preparing these forms, and pharmaceutical compositions containing these forms. The claims are specific to the crystalline structure and physical properties of the compound, ensuring that the patented forms are distinct and novel[1][4].
Claims Analysis
Independent Claims
The independent claims are crucial as they define the broadest scope of the invention. For example, Claim 1 might specify a particular crystalline form of the compound, while subsequent claims might detail methods for its preparation or specific pharmaceutical compositions[1].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations to the independent claims. These could include specific conditions for preparing the solid forms, purity levels, or specific uses in pharmaceutical formulations[1].
Patent Landscape
Related Patents
The patent landscape surrounding US 10,597,384 includes several other patents related to cystic fibrosis treatments and modulators of ATP-binding cassette (ABC) transporters. For instance, patents like US 8,324,242 and US 7,495,103 also pertain to modulators of ABC transporters and have overlapping expiration dates, indicating a complex and interconnected patent ecosystem[2].
Patent Expiration Dates
The patent is set to expire on December 4, 2028. This expiration date is significant as it marks the end of the exclusive rights held by Vertex Pharmaceuticals over the patented compound and its forms. Other related patents, such as those covering modulators of ABC transporters, expire around similar dates (e.g., August 5, 2027, and November 8, 2026)[2].
Impact on Innovation and Competition
Innovation
The patent's scope and claims are designed to protect the innovative work done by Vertex Pharmaceuticals in developing specific solid forms of the compound. This protection incentivizes further innovation by ensuring that the company can recoup its investment in research and development[3].
Competition
The expiration of this and related patents will open up the market for generic versions of the drug, potentially increasing competition and reducing costs for patients. However, until the patent expires, Vertex Pharmaceuticals maintains a monopoly on the production and distribution of these specific solid forms, limiting competition[2].
Legal and Regulatory Considerations
Patent Scope and Quality
The debate over patent scope and quality is relevant here. The clarity and breadth of the claims in US 10,597,384 are critical in defining the boundaries of the invention and ensuring that the patent does not overly broaden or diminish innovation. Metrics such as independent claim length and count can be used to assess the patent's scope and quality[3].
Conclusion
The United States Patent 10,597,384 is a pivotal patent in the field of cystic fibrosis treatment, covering specific solid forms of a key compound. Understanding its scope, claims, and the broader patent landscape is essential for both innovators and competitors in the pharmaceutical industry.
Key Takeaways
- The patent covers solid state forms of a specific compound used in cystic fibrosis treatment.
- The claims are detailed and specific, ensuring the novelty and distinctness of the patented forms.
- The patent expires on December 4, 2028, which will impact the market for generic versions of the drug.
- The patent landscape includes several related patents with overlapping expiration dates.
- The patent's scope and claims are critical in balancing innovation and competition.
FAQs
What is the main subject matter of US Patent 10,597,384?
The main subject matter is the solid state forms, including crystalline forms, of the compound 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid.
Who are the inventors listed on the patent?
The inventors are Ali Keshavarz-Shokri, Beili Zhang, and Mariusz Krawiec.
When does the patent expire?
The patent expires on December 4, 2028.
What is the significance of the patent's expiration date?
The expiration date marks the end of Vertex Pharmaceuticals' exclusive rights over the patented compound, potentially opening the market for generic versions.
How does the patent impact competition in the pharmaceutical industry?
The patent maintains Vertex Pharmaceuticals' monopoly until its expiration, after which generic versions can enter the market, increasing competition and potentially reducing costs.
Cited Sources
- United States Patent and Trademark Office, "Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid," US Patent 10,597,384 B2, March 24, 2020.
- Drugs.com, "Generic Orkambi Availability," November 6, 2024.
- Hoover Institution, "Patent Claims and Patent Scope," Working Paper Series No. 16001, August 18, 2016.
