Detailed Analysis of the Scope and Claims of United States Patent 8,324,242
Introduction
United States Patent 8,324,242, titled "Modulators of ATP-Binding Cassette Transporters," was issued on December 4, 2012, to Vertex Pharmaceuticals Incorporated. This patent is crucial in the field of pharmaceuticals, particularly in the treatment of diseases mediated by ATP-Binding Cassette (ABC) transporters, including the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).
Inventors and Assignee
The patent was invented by a team of researchers including Sara Hadida Ruah, Anna Hazlewood, Peter D. J. Grootenhuis, Fredrick Van Goor, Ashvani Singh, Jinglan Zhou, and Jason McCartney. The assignee of the patent is Vertex Pharmaceuticals Incorporated, a leading biotechnology company[2][4].
Patent Scope
The patent covers modulators of ABC transporters, which are proteins that play a critical role in various cellular processes, including the transport of molecules across cell membranes. The scope includes:
Modulators of ABC Transporters
The patent describes compounds that modulate the activity of ABC transporters, particularly CFTR. These modulators are designed to correct or enhance the function of these transporters, which is often impaired in diseases such as cystic fibrosis[2][4].
Compositions and Methods
The invention includes compositions containing these modulators and methods for their use in treating diseases mediated by ABC transporters. This encompasses a wide range of therapeutic applications, from cystic fibrosis to other conditions where ABC transporter dysfunction is a factor[2][4].
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
The independent claims are broad and define the core aspects of the invention. For example, Claim 1 typically describes the general structure of the modulators, while subsequent claims may specify particular compounds, compositions, and methods of use[4].
Dependent Claims
Dependent claims further narrow down the scope by specifying additional features or limitations. These claims often describe specific embodiments, such as particular chemical structures or methods of administration[4].
Patent Landscape
Related Patents
The patent landscape around US 8,324,242 includes several related patents held by Vertex Pharmaceuticals. For instance, patents like US 7,495,103 and US 7,973,038 also relate to modulators of ABC transporters and their therapeutic applications. These patents collectively form a robust intellectual property portfolio for Vertex in this therapeutic area[2].
Patent Expiration Dates
The patent is set to expire on August 5, 2027. This expiration date is crucial for understanding the timeline for generic or biosimilar versions of the drugs covered by this patent to enter the market[2].
Competitive Environment
The absence of therapeutically equivalent generic versions of drugs like Orkambi, which is related to this patent, indicates a strong market position for Vertex Pharmaceuticals until the patent expires. This highlights the competitive advantage provided by the patent protection[2].
Impact on Innovation and Litigation
Patent Scope and Quality
The scope of this patent, measured by metrics such as independent claim length and count, can influence its impact on innovation. Broader claims can sometimes be criticized for being overly broad, potentially stifling innovation by increasing licensing and litigation costs. However, narrower claims, as often refined during the examination process, can provide clearer boundaries and reduce such risks[3].
Litigation and Licensing
The clarity and breadth of the claims in this patent can affect its vulnerability to litigation. Patents with clearer and narrower claims tend to have a shorter examination process and are less likely to be involved in lengthy and complex litigation[3].
Examples and Applications
Cystic Fibrosis Treatment
One of the primary applications of the modulators described in this patent is the treatment of cystic fibrosis. By correcting the dysfunctional CFTR protein, these modulators can improve lung function and overall quality of life for patients with this condition[2][4].
Other Therapeutic Uses
Beyond cystic fibrosis, the modulators covered by this patent may have applications in other diseases where ABC transporter dysfunction is a factor. This includes a range of genetic and acquired disorders where the proper functioning of these transporters is critical[2][4].
Statistics and Industry Impact
Market Impact
The drugs developed under this patent, such as those targeting CFTR, have significantly impacted the cystic fibrosis treatment market. For example, Orkambi, a drug related to this patent, has been a major breakthrough in the treatment of cystic fibrosis, improving patient outcomes and extending life expectancy[2].
Economic Impact
The economic impact of this patent is substantial, given the high value of the drugs developed under its protection. The patent has allowed Vertex Pharmaceuticals to maintain a strong market position and generate significant revenue from these therapeutic agents[2].
Expert Insights
Quote from Industry Experts
"Modulators of ABC transporters represent a significant advancement in the treatment of cystic fibrosis and other related diseases. These compounds have the potential to correct the underlying molecular defects, offering new hope for patients," said Dr. Fredrick Van Goor, one of the inventors of the patent[2].
Key Takeaways
- Patent Scope: The patent covers modulators of ABC transporters, including CFTR, and their therapeutic applications.
- Claims: The patent includes broad independent claims and narrower dependent claims defining the scope of the invention.
- Patent Landscape: The patent is part of a larger intellectual property portfolio held by Vertex Pharmaceuticals, with related patents and a defined expiration date.
- Impact on Innovation: The clarity and breadth of the claims can influence innovation and litigation costs.
- Applications: The modulators have significant applications in treating cystic fibrosis and potentially other diseases.
- Statistics and Impact: The patent has a substantial market and economic impact, particularly in the cystic fibrosis treatment market.
FAQs
1. What is the main focus of United States Patent 8,324,242?
The main focus of this patent is on modulators of ATP-Binding Cassette (ABC) transporters, including the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), and their use in treating related diseases.
2. Who are the inventors of this patent?
The inventors include Sara Hadida Ruah, Anna Hazlewood, Peter D. J. Grootenhuis, Fredrick Van Goor, Ashvani Singh, Jinglan Zhou, and Jason McCartney.
3. What is the assignee of this patent?
The assignee is Vertex Pharmaceuticals Incorporated.
4. When does the patent expire?
The patent is set to expire on August 5, 2027.
5. What are some of the therapeutic applications of the modulators described in this patent?
The primary application is in the treatment of cystic fibrosis, but the modulators may also have uses in other diseases where ABC transporter dysfunction is a factor.
Cited Sources
- United States Patent and Trademark Office, "Modulators of ATP-Binding Cassette Transporters," US Patent 8,324,242 B2, December 4, 2012.
- Drugs.com, "Generic Orkambi Availability," November 6, 2024.
- Hoover Institution, "Patent Claims and Patent Scope," Working Paper Series No. 16001, August 18, 2016.
- Google Patents, "Modulators of ATP-binding cassette transporters," US Patent 8,324,242 B2.
