Understanding the Scope and Claims of United States Patent 7,348,362
Introduction
United States Patent 7,348,362, titled "Bronchodilating Beta–Agonist Compositions and Methods," is one of the patents involved in a significant patent infringement case between Dey, L.P. and Teva Parenteral Medicines, Inc. This patent is crucial for understanding the protection and application of bronchodilating compositions, particularly those involving formoterol fumarate.
Background of the Patent
The patent 7,348,362 was issued to Dey, L.P. and Dey, Inc., and it derives from the provisional U.S. patent application 60/486,386. This patent, along with others such as 6,667,344, 6,814,953, and 7,462,645, forms part of the patents-in-suit in the infringement case against Teva[4].
Scope of the Patent
The scope of the patent 7,348,362 is defined by its claims, specifications, and the prosecution history. Here are some key aspects:
Claims
The claims of the patent are the most critical part as they define the invention and the scope of the patentee’s right of exclusion. The patent includes multiple claims that describe the composition and method of using bronchodilating beta-agonists, such as formoterol fumarate. These claims must be interpreted in the light of the patent's specifications[1].
Specifications
The specifications in the patent provide detailed descriptions of the invention. They are the "best source for understanding a technical term" used in the claims. The specifications must describe the claimed invention in "full, clear, concise, and exact terms" as per 35 U.S.C. § 112, ¶ 1[1].
Prosecution History
The prosecution history, which includes the interactions between the patent applicant and the patent office, can also be considered when interpreting the claims. This history can provide context and clarify any ambiguities in the claims[1].
Claim Construction
Claim construction is a critical step in determining the scope of the patent. Here are some key points:
Intrinsic Evidence
When interpreting the meaning of a claim, courts consider the claims, specifications, and prosecution histories as intrinsic evidence. This ensures that the invention and the scope of the patentee’s right of exclusion are clearly defined[1].
Ordinary and Customary Meaning
The claims are typically interpreted according to their ordinary and customary meaning. However, the patent specification can alter this meaning if it defines a term differently. This is known as the inventor acting as their own lexicographer[1].
Patent Infringement Case
The patent 7,348,362 was central to a patent infringement case where Dey, L.P. and Dey, Inc. sued Teva Parenteral Medicines, Inc. for filing an Abbreviated New Drug Application (ANDA) for a generic formoterol fumarate inhalation solution. Teva alleged that certain claims of the patents-in-suit, including 7,348,362, were invalid, unenforceable, or not infringed by their generic product[1][4].
Key Claims and Infringement Arguments
- Stability During Long-Term Storage: One of the critical claims in the patent involves the stability of the formoterol fumarate solution during long-term storage. Teva argued that their product did not meet this requirement because it degraded when exposed to sunlight unless protected by a foil overwrap[4].
- Label Requirements: Another claim involved the presence of a specific label. Teva contended that their generic product did not include the required label, thus not infringing the claim[4].
Patent Landscape and Analytics
Understanding the patent landscape is essential for managing intellectual property effectively. Here’s how patent analytics can help:
Claim Coverage Matrix
A Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. This matrix categorizes patents by claims and overarching scope concepts, making it easier to analyze large numbers of patent claims[3].
Scope Concepts and Claim Charts
The scope concepts of the patent claims can be categorized into high, medium, or low value based on their current and future relevance to the company. Interactive claim charts generated by software like ClaimScape® can help technical experts review patent coverage and identify gaps or future design opportunities[3].
Expiration and Generic Entry
The patent 7,348,362 has a specific expiration date, after which generic versions of the protected compositions and methods can enter the market. Understanding the expiration dates and potential generic entry is crucial for both the patent holder and competitors[2].
Conclusion
United States Patent 7,348,362 is a significant patent that protects bronchodilating beta-agonist compositions and methods, particularly those involving formoterol fumarate. The scope and claims of this patent are defined by its specifications, prosecution history, and claim construction. The patent's relevance in a high-profile infringement case highlights the importance of precise claim interpretation and the use of patent analytics to manage intellectual property effectively.
Key Takeaways
- Claims and Specifications: The claims and specifications of the patent define the invention and the scope of protection.
- Claim Construction: Courts interpret claims based on intrinsic evidence, including the claims, specifications, and prosecution history.
- Patent Infringement: The patent was central to an infringement case involving Teva’s generic formoterol fumarate product.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts help in analyzing and managing patent claims.
- Expiration and Generic Entry: Understanding the expiration date is crucial for planning generic entry.
FAQs
Q: What is the main subject of United States Patent 7,348,362?
A: The main subject of United States Patent 7,348,362 is bronchodilating beta-agonist compositions and methods, particularly those involving formoterol fumarate.
Q: How are the claims of a patent interpreted?
A: The claims of a patent are interpreted based on intrinsic evidence, including the claims, specifications, and prosecution history.
Q: What was the basis of the patent infringement case involving Dey and Teva?
A: The case involved Dey’s allegation that Teva’s generic formoterol fumarate product infringed claims of the patents-in-suit, including 7,348,362.
Q: How can patent analytics help in managing intellectual property?
A: Patent analytics tools like Claim Coverage Matrix and Claim Charts help in categorizing patents by claims and scope concepts, identifying gaps, and determining future design opportunities.
Q: What happens after the expiration of a patent like 7,348,362?
A: After the expiration of the patent, generic versions of the protected compositions and methods can enter the market.
Sources
- MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS - USCOURTS-wvnd-1_09-cv-00087
- Drugs covered by patent 7,348,362 - DrugPatentWatch
- Patent Analytics - SLWIP
- Dey, L.P. v. Teva Parenteral Medicines, Inc. - VLEX
