United States Patent 9,278,901: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,278,901, titled "Compounds and methods for delivery of prostacyclin analogs," is a significant patent in the field of pharmaceuticals, particularly for the treatment of conditions such as pulmonary hypertension. This patent, issued on March 8, 2016, is part of a broader portfolio of patents related to prostacyclin analogs and their delivery methods.
Background
Prostacyclin analogs, such as treprostinil, are crucial for promoting vasodilation and inhibiting platelet aggregation. These compounds are used to treat various cardiovascular diseases, including pulmonary hypertension, which is characterized by high blood pressure in the pulmonary arteries, leading to strain on the heart and potential heart failure[2].
Inventors and Assignees
The patent was invented by Ken Phares, David Mottola, and Hitesh Batra. The lawful owner of the patent is United Therapeutics Corporation (UTC), which holds the right to sue for infringement[2].
Scope of the Patent
The patent encompasses a range of compounds and methods for delivering prostacyclin analogs. Here are some key aspects of its scope:
Compounds
The patent covers various prostacyclin analogs, including treprostinil, and their formulations. These compounds are designed to be administered through different routes, such as oral, injectable, and inhalable forms[1].
Methods of Delivery
The patent describes several methods for delivering these compounds, including solutions, suspensions, and solid formulations. It also details the use of excipients and stabilizers to enhance the stability and efficacy of the prostacyclin analogs[1].
Therapeutic Uses
The primary therapeutic use of these compounds is in the treatment of pulmonary hypertension. However, the patent also suggests potential applications in other cardiovascular diseases where vasodilation and anti-platelet aggregation are beneficial[2].
Claims
The patent includes several claims that define the scope of protection:
Independent Claims
- Claim 1: A method for treating pulmonary hypertension, comprising administering a prostacyclin analog in a specific formulation.
- Claim 5: A composition comprising a prostacyclin analog and a stabilizer.
- Claim 10: A method for preparing a solution of a prostacyclin analog for injection[2].
Dependent Claims
The patent also includes several dependent claims that further specify the formulations, dosages, and administration routes of the prostacyclin analogs. These claims build upon the independent claims to provide a detailed description of the inventions[2].
Patent Landscape
The patent landscape surrounding US 9,278,901 is complex and involves multiple related patents:
Related Patents
- The patent is part of a series of patents filed by the same inventors and assigned to UTC, including patents such as US 8,252,839, US 8,349,892, and US 9,050,311. These patents collectively cover various aspects of prostacyclin analogs and their delivery methods[2].
- Other patents, such as US 9,393,203 and US 9,422,223, also relate to similar compounds and methods, indicating a robust intellectual property strategy by UTC in this therapeutic area[2].
Litigation and Enforcement
The patent has been involved in litigation, with UTC asserting its rights against potential infringers. For example, UTC has sued companies like ANI Pharmaceuticals for alleged infringement of this and other related patents[2].
Expiry and Exclusivity
The patent is set to expire on its statutory term, which is typically 20 years from the earliest filing date of the patent application. However, the exact expiry date can be influenced by various factors, including any patent term adjustments or extensions that may have been granted[5].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry, particularly in the development and marketing of treatments for pulmonary hypertension. Companies seeking to develop similar products must navigate the intellectual property landscape carefully to avoid infringement.
"Prostacyclin analogs, such as treprostinil, are crucial for promoting vasodilation and inhibiting platelet aggregation, which are key therapeutic benefits in treating pulmonary hypertension"[2].
Challenges and Opportunities
The patent presents both challenges and opportunities for other pharmaceutical companies:
Challenges
- The broad scope of the patent and its related family of patents create a significant barrier to entry for new competitors.
- Any new product development in this area must ensure that it does not infringe on the claims of this patent or its related patents[2].
Opportunities
- The patent's focus on specific formulations and delivery methods leaves room for innovation in other areas, such as new prostacyclin analogs or alternative delivery systems.
- Collaboration or licensing agreements with UTC could provide opportunities for other companies to enter the market while respecting the existing intellectual property rights[2].
Key Takeaways
- Scope and Claims: The patent covers a range of prostacyclin analogs and their delivery methods, with specific claims detailing formulations, therapeutic uses, and administration routes.
- Patent Landscape: The patent is part of a larger portfolio of related patents, indicating a strong intellectual property strategy by UTC.
- Expiry and Exclusivity: The patent's expiry date is critical for understanding the timeline for potential generic or biosimilar entries into the market.
- Impact on Industry: The patent significantly influences the development and marketing of treatments for pulmonary hypertension, requiring careful navigation of intellectual property rights.
FAQs
Q: What is the primary therapeutic use of the compounds covered by US 9,278,901?
A: The primary therapeutic use is in the treatment of pulmonary hypertension.
Q: Who are the inventors of US 9,278,901?
A: The inventors are Ken Phares, David Mottola, and Hitesh Batra.
Q: What company owns the rights to US 9,278,901?
A: United Therapeutics Corporation (UTC) owns the rights to this patent.
Q: What are some of the related patents to US 9,278,901?
A: Related patents include US 8,252,839, US 8,349,892, and US 9,050,311, among others.
Q: How does this patent impact the pharmaceutical industry?
A: It creates a significant barrier to entry for new competitors while leaving room for innovation in other areas and potential collaboration or licensing agreements.
Sources
- US9278901B2 - Compounds and methods for delivery of prostacyclin analogs - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXCorp
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO - USPTO
- US Patents | Expiry | Expiration | Dates - PharmaCompass.com
