Detailed Analysis of the Scope and Claims of United States Patent 8,575,137
Introduction
United States Patent 8,575,137, titled "Composition for inhalation," is a significant patent held by AstraZeneca AB, particularly in the context of respiratory disease treatments. This patent is crucial for understanding the intellectual property landscape surrounding inhalation formulations, especially those containing formoterol and budesonide.
Patent Overview
Title and Abstract
The patent is titled "Composition for inhalation" and relates to a formulation comprising formoterol and budesonide, which are used in the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD)[1].
Inventors and Assignee
The inventors listed are Nayna Govind and Maria Marlow, both from Loughborough, UK. The patent is assigned to AstraZeneca AB, a global pharmaceutical company based in Macclesfield, UK[1].
Claims and Scope
Composition Details
The patent claims cover a specific formulation that includes formoterol and budesonide, along with other components such as HFA 227 (a propellant), PVP (polyvinylpyrrolidone), and PEG (polyethylene glycol), preferably PVP K25 and PEG 1000. These components are essential for the stability and delivery of the active ingredients via an inhalation device[1].
Claim Types
The patent includes various claim types, including composition claims, compound claims, use claims, and delivery claims. These claims are designed to protect the specific formulation, the method of use, and the delivery mechanism of the inhalation composition[2].
Patent Litigation and Enforcement
Infringement Cases
The patent has been involved in several infringement cases, notably against Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P. AstraZeneca alleged that Mylan's generic versions of Symbicort® pMDI and Symbicort® Turbohaler infringed on the claims of this patent, among others. The case highlights the importance of this patent in protecting AstraZeneca's intellectual property in the respiratory drug market[4][5].
Hatch-Waxman Act
Under the Hatch-Waxman Act, the filing of an Abbreviated New Drug Application (ANDA) by a generic drug manufacturer can be considered an act of infringement. This led AstraZeneca to sue Mylan, delaying FDA approval of Mylan's generic versions until the patent infringement issues were resolved[2].
Patent Landscape
Related Patents
The patent is part of a broader portfolio of patents related to Symbicort® products. Other patents involved in the same litigation include U.S. Patent Nos. 7,759,328, 8,143,239, and 10,166,247. These patents collectively protect various aspects of the Symbicort® formulations and delivery systems[4].
Foreign Priority and Supplementary Protection Certificates
The patent has foreign priority claims, including in Sweden, and has been granted in several countries such as Austria, Australia, Brazil, and Canada. Supplementary Protection Certificates (SPCs) may also be applicable in certain jurisdictions to extend the patent protection period[1].
Analytical Tools and Strategies
Patent Analytics
To manage and analyze the claims and scope of this patent, companies like AstraZeneca can use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in intellectual property protection. Claim Coverage Matrices and Claim Charts are useful in this regard, allowing for a comprehensive review of patent coverage with technical experts[3].
Claim Construction Analysis
In patent litigation, the patent specification is crucial for claim construction analysis. The specification must describe the claimed invention in "full, clear, concise, and exact terms" as per 35 U.S.C. § 112. This ensures that any special definitions given to claim terms by the patentee are considered, governing the interpretation of the claims[4].
Impact on Generic Drug Manufacturers
ANDA Filings and Infringement
Generic drug manufacturers seeking to enter the market with versions of Symbicort® must navigate the complex landscape of AstraZeneca's patents, including U.S. Patent 8,575,137. Filing an ANDA can trigger patent infringement lawsuits, delaying FDA approval and market entry for the generic products[2][5].
Conclusion
United States Patent 8,575,137 is a critical component of AstraZeneca's intellectual property portfolio, particularly in the context of respiratory disease treatments. The patent's claims and scope are designed to protect a specific inhalation formulation containing formoterol and budesonide, and it has been central in several patent infringement cases. Understanding this patent and its place within the broader patent landscape is essential for both innovator companies and generic drug manufacturers.
Key Takeaways
- Composition Details: The patent covers a formulation with formoterol, budesonide, HFA 227, PVP, and PEG.
- Claim Types: Includes composition, compound, use, and delivery claims.
- Litigation: Involved in infringement cases against Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P.
- Patent Landscape: Part of a broader portfolio protecting Symbicort® products.
- Analytical Tools: Patent analytics tools are crucial for managing and analyzing claims.
- Impact on Generics: Filing an ANDA can trigger patent infringement lawsuits, delaying market entry.
FAQs
What is the main subject of U.S. Patent 8,575,137?
The main subject of U.S. Patent 8,575,137 is a formulation for inhalation containing formoterol and budesonide, used in the treatment of respiratory diseases.
Who are the inventors and assignee of this patent?
The inventors are Nayna Govind and Maria Marlow, and the assignee is AstraZeneca AB.
What are the key components of the formulation claimed in this patent?
The formulation includes formoterol, budesonide, HFA 227, PVP (preferably PVP K25), and PEG (preferably PEG 1000).
Has this patent been involved in any significant litigation?
Yes, it has been involved in patent infringement cases against Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P.
How does this patent impact generic drug manufacturers?
Generic drug manufacturers must navigate this patent and others related to Symbicort® to avoid infringement claims, which can delay FDA approval and market entry.
What tools can be used to analyze and manage the claims of this patent?
Patent analytics tools, including Claim Coverage Matrices and Claim Charts, can be used to analyze and manage the claims and scope of this patent.
Sources
- DrugPatentWatch: Summary for Patent: 8,575,137.
- GovInfo: Case 1:19-cv-00203-JPB Document 181 Filed 03/02/21.
- SLWIP: Patent Analytics.
- Casetext: Astrazeneca AB v. Mylan Pharm. Inc.
- VKLaw: Explicit and Implicit Statements — What You Say Can and Will Be Used Against You.
