United States Patent 7,094,781: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,094,781, titled "Sulfamides and their use as endothelin receptor antagonists," is a significant patent in the pharmaceutical industry, particularly in the field of cardiovascular diseases. This patent, assigned to Actelion Pharmaceuticals Ltd., covers novel sulfamides and their application as active ingredients in pharmaceutical compositions. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Publication and Filing Dates
The patent was filed on December 4, 2001, and granted on August 22, 2006. It is part of the international patent application PCT/EP01/14182, with priority dates back to December 18, 2000[5].
Inventors and Assignee
The inventors listed are Martin Bolli, Christoph Boss, Walter Fischli, Martine Clozel, and Thomas Weller, all associated with Actelion Pharmaceuticals Ltd. in Switzerland and France[5].
Scope of the Patent
Chemical Compounds
The patent focuses on novel pyrimidine-sulfamides, which are chemically defined by specific structural formulas. These compounds are designed to act as endothelin receptor antagonists, which are crucial in treating conditions such as pulmonary arterial hypertension (PAH) and other cardiovascular diseases[4][5].
Therapeutic Use
The primary therapeutic use of these sulfamides is as endothelin receptor antagonists. Endothelin is a potent vasoconstrictor, and its receptors play a significant role in vascular tone regulation. By antagonizing these receptors, the compounds can help in dilating blood vessels and reducing blood pressure, which is beneficial in treating PAH and other related conditions[5].
Claims of the Patent
Independent and Dependent Claims
The patent includes multiple claims, both independent and dependent. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific features or limitations.
- Independent Claims: These claims define the novel sulfamides and their use as endothelin receptor antagonists. For example, Claim 1 describes the general formula of the sulfamides and their application in pharmaceutical compositions[5].
- Dependent Claims: These claims specify various aspects such as the chemical structure, synthesis methods, and pharmaceutical formulations of the sulfamides. They also include claims related to the therapeutic uses and dosages of these compounds[5].
Claim Language and Scope
The claim language is precise and detailed, ensuring that the scope of the patent is well-defined. The use of specific chemical formulas and structural descriptions helps in distinguishing the patented compounds from prior art. This precision is crucial in maintaining the validity of the patent and preventing infringement[3][5].
Patent Landscape
Related Patents
Several related patents exist, which are also assigned to Actelion Pharmaceuticals Ltd. or its successors. These include:
- Patent 10,946,015: This patent, issued on March 16, 2021, relates to stable pharmaceutical compositions comprising pyrimidine-sulfamides, similar to those described in US7094781B2. It has a patent expiration date of September 11, 2026[2].
- Patent 8,367,685: Issued on February 5, 2013, this patent also covers stable pharmaceutical compositions of pyrimidine-sulfamides and expires on October 4, 2028[2].
- Patent 9,265,762: Issued on February 23, 2016, this patent is another example of stable pharmaceutical compositions of pyrimidine-sulfamides, with an expiration date of May 29, 2027[2].
Patent Expiration Dates
The patent US7094781B2 is set to expire on December 5, 2025. This expiration date is significant as it marks the end of the exclusive rights granted to the patent holder, potentially allowing for the development of generic versions of the drug[2].
Generic Availability
As of the current date, there is no generic version of the drug (e.g., Opsumit, which is based on similar technology) available in the United States. The lack of generic alternatives is due to the ongoing patent protection and exclusivity periods granted by regulatory bodies[2].
Impact on Pharmaceutical Industry
Innovation and Competition
The patent has driven innovation in the field of endothelin receptor antagonists, leading to the development of drugs like Opsumit (macitentan). These drugs have significantly improved treatment options for patients with PAH and other cardiovascular conditions. However, the patent protection also limits competition, allowing the patent holder to maintain market exclusivity until the patent expires[2].
Economic Considerations
The economic impact of this patent is substantial. The exclusive rights granted to Actelion Pharmaceuticals Ltd. have allowed the company to recoup its investment in research and development. However, the expiration of the patent will open the market to generic competition, potentially reducing drug prices and increasing accessibility for patients[2].
Key Takeaways
- Novel Sulfamides: The patent covers novel pyrimidine-sulfamides used as endothelin receptor antagonists.
- Therapeutic Use: These compounds are primarily used in treating PAH and other cardiovascular diseases.
- Claims and Scope: The patent includes detailed claims defining the chemical structure and therapeutic use of the sulfamides.
- Related Patents: Several related patents exist, covering stable pharmaceutical compositions of similar compounds.
- Patent Expiration: The patent expires on December 5, 2025, which will impact the availability of generic versions.
- Industry Impact: The patent has driven innovation and maintained market exclusivity but will soon face generic competition.
FAQs
What is the primary therapeutic use of the sulfamides described in US7094781B2?
The primary therapeutic use of these sulfamides is as endothelin receptor antagonists, particularly in treating conditions such as pulmonary arterial hypertension (PAH) and other cardiovascular diseases.
Who are the inventors of US7094781B2?
The inventors are Martin Bolli, Christoph Boss, Walter Fischli, Martine Clozel, and Thomas Weller, all associated with Actelion Pharmaceuticals Ltd.
What is the expiration date of US7094781B2?
The patent is set to expire on December 5, 2025.
Are there any related patents to US7094781B2?
Yes, there are several related patents, including Patent 10,946,015, Patent 8,367,685, and Patent 9,265,762, all covering stable pharmaceutical compositions of pyrimidine-sulfamides.
Is a generic version of the drug based on this patent available?
As of the current date, there is no generic version of the drug available in the United States due to ongoing patent protection and exclusivity periods.
How does the patent impact the pharmaceutical industry?
The patent has driven innovation in endothelin receptor antagonists, maintained market exclusivity for the patent holder, but will soon face generic competition upon its expiration.
Sources
- US7094781B2 - Sulfamides and their use as endothelin receptor antagonists - Google Patents
- Generic Opsumit Availability - Drugs.com
- Patent Claims and Patent Scope - SSRN
- US7094781B2 - Sulfamides and their use as endothelin receptor antagonists - Google Patents
- United States Patent 7,094,781 - Google Patent Images
