United States Patent 7,439,393: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,439,393, granted on October 21, 2008, is a significant patent in the pharmaceutical industry, particularly for the treatment of respiratory diseases. This patent is associated with the drug product BREO™ ELLIPTA™, developed by Glaxo Group Limited. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Description
The patent 7,439,393 pertains to phenylethanolamine derivatives, specifically compounds used in the treatment of respiratory diseases. The invention includes inhalation devices comprising these compounds, formulations, and combinations thereof, as well as methods for treating clinical conditions in mammals using these inhalation devices[4].
Patent Claims
The patent contains nine claims that define the scope of the invention. These claims include:
- The chemical structure of the phenylethanolamine derivatives.
- Inhalation devices containing these compounds.
- Formulations and combinations of the compounds.
- Methods for the treatment or prophylaxis of clinical conditions using these inhalation devices.
The claims are designed to capture a specific class of compounds and their applications, ensuring broad yet precise protection for the invention[4].
Patent Expiration Dates
The patent 7,439,393 has multiple expiration dates due to various extensions and related patents:
- The primary patent is set to expire on May 21, 2025.
- A patent term extension (PED) is set to expire on November 21, 2025[2].
Regulatory and Patent Term Extensions
The patent term for U.S. Patent 7,439,393 has been subject to extension under 35 U.S.C. § 156. This section allows for the extension of a patent term to compensate for the time spent in regulatory review. The application for this extension was submitted by Glaxo Group Limited, and it was justified based on the significant time spent in obtaining FDA approval for BREO™ ELLIPTA™[1][5].
Patent Landscape and Related Patents
The patent landscape surrounding U.S. Patent 7,439,393 includes several related patents, many of which are also assigned to Glaxo Group Limited. These patents cover various aspects of the drug and its delivery system:
- Medicament Dispensers: Patents such as 8,161,968, 8,183,257, and 8,746,242 cover the design and functionality of medicament dispensers used with BREO™ ELLIPTA™[2].
- Muscarinic Acetylcholine Receptor Antagonists: Patents like 8,309,572 and 8,511,304 relate to other compounds and methods used in the treatment of respiratory diseases[2].
- Other Related Patents: Patents such as 7,488,827 and 7,498,440 also expire around the same time frame, indicating a comprehensive protection strategy for the entire product line[2].
Challenges in Pharmaceutical Patent Protection
The pharmaceutical industry, including patents like 7,439,393, faces significant challenges in maintaining robust patent protection. The Federal Circuit’s rigid application of Section 112(a) of the U.S. patent laws has made it difficult for innovators to claim the full scope of their inventions without risking invalidation. This has led to a situation where broad claims are often deemed invalid, while narrow claims can be easily designed around by competitors[3].
Impact on Commercialization Strategies
The patent protection landscape significantly influences commercialization strategies in the pharmaceutical industry. Innovators need to balance the breadth of their patent claims to ensure meaningful protection without violating the written description and enablement requirements. This balance is crucial for justifying the billions of dollars invested in bringing new drugs to market[3].
Industry Trends and Market Impact
The market for pharmaceuticals and biologics is expanding rapidly, with estimates suggesting the therapeutic antibody market alone could reach $300 billion by 2025. Robust and predictable patent protection is essential for supporting the commercialization of these products. However, the current jurisprudence on patent disclosure laws is causing havoc in the industry, making it challenging for innovators to secure valuable patent protection[3].
Key Takeaways
- Patent Scope and Claims: U.S. Patent 7,439,393 covers specific phenylethanolamine derivatives and their use in inhalation devices for treating respiratory diseases.
- Patent Expiration and Extensions: The patent has multiple expiration dates, with the primary patent expiring on May 21, 2025, and a PED expiring on November 21, 2025.
- Regulatory Extensions: The patent term was extended under 35 U.S.C. § 156 to compensate for regulatory review time.
- Related Patents: Several related patents cover medicament dispensers, muscarinic acetylcholine receptor antagonists, and other aspects of the drug.
- Challenges in Patent Protection: The pharmaceutical industry faces challenges due to the Federal Circuit’s application of Section 112(a), making broad claims risky and narrow claims vulnerable to design-around strategies.
- Commercialization and Market Impact: Robust patent protection is crucial for commercialization strategies, but current laws make it challenging to achieve meaningful protection.
FAQs
What is the primary compound covered by U.S. Patent 7,439,393?
The primary compound covered is a phenylethanolamine derivative, specifically 4-(1R)-2-(6-2-(2,6-dichlorobenzyl)oxy ethoxy-hexyl)amino-1-hydroxyethyl-2-(hydroxymethyl) phenol, or its salt or solvate[4].
What is the expiration date of U.S. Patent 7,439,393?
The primary patent is set to expire on May 21, 2025, with a patent term extension (PED) expiring on November 21, 2025[2].
Why was the patent term extended for U.S. Patent 7,439,393?
The patent term was extended under 35 U.S.C. § 156 to compensate for the time spent in regulatory review for FDA approval of BREO™ ELLIPTA™[1][5].
What are the challenges faced by pharmaceutical patents like 7,439,393?
Pharmaceutical patents face challenges due to the Federal Circuit’s rigid application of Section 112(a), making it difficult to claim the full scope of the invention without risking invalidation[3].
How does the current patent landscape affect commercialization strategies in the pharmaceutical industry?
The current patent landscape makes it challenging for innovators to secure meaningful patent protection, affecting their ability to justify the significant investments required to bring new drugs to market[3].
What is the impact of the expanding market for pharmaceuticals and biologics on patent protection?
The expanding market highlights the need for robust and predictable patent protection, but current laws and jurisprudence make it difficult for innovators to achieve this, potentially hindering innovation and investment in the industry[3].
Sources
- IN THE UNITED STATES PATENT AND TRADEMARK OFFICE In re: IN THE UNITED STATES PATENT AND TRADEMARK OFFICE In re.
- Generic Anoro Ellipta Availability - Drugs.com: Generic Anoro Ellipta Availability.
- Eviscerating Patent Scope - DigitalCommons@NYLS: Eviscerating Patent Scope.
- United States Patent - googleapis.com: United States Patent.
- Determination of Regulatory Review Period for Purposes of Patent Extension - Federal Register: Determination of Regulatory Review Period for Purposes of Patent Extension.
