United States Patent 7,579,321: A Detailed Analysis of Scope and Claims
Introduction
U.S. Patent 7,579,321, issued on August 25, 2009, is a significant patent in the pharmaceutical domain, particularly related to transmucosal delivery systems. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventorship
The patent, titled "Pharmaceutical Compositions Including Low Dosages of Desmopressin," was issued to Allergan, Inc., with Seymour H. Fein listed as the sole inventor[2].
Claims and Scope
Claim Construction
The patent includes several claims, with particular focus on claims 1 and 19. These claims describe pharmaceutical compositions and methods for transmucosal delivery of desmopressin, a hormone used to treat conditions such as nocturnal enuresis and central diabetes insipidus.
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Transmucosal Delivery: A key term in the claims is "transmucosal," which refers to the delivery of the drug through a mucous membrane. The court has interpreted this term in its plain and ordinary meaning, without additional limitations[5].
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Dosage and Concentration: The claims specify a dose of desmopressin sufficient to achieve a maximum desmopressin plasma/serum concentration within certain limits. However, the court has ruled that the dose range is not a claim limitation, as it is not explicitly mentioned in the claim language itself[5].
Claim Preamble
The shared preamble of claims 1 and 19 outlines the aims of the invention, including the delivery of desmopressin in a manner that achieves specific plasma/serum concentrations. The court's interpretation of this preamble has been crucial in defining the scope of the patent[5].
Patent Landscape and Litigation
Jurisdiction and Venue
The patent has been involved in several legal disputes. For instance, Ferring International Center S.A. and Ferring Pharmaceuticals Inc. filed a civil action against Allergan, Inc., and other defendants, seeking correction of inventorship under 35 U.S.C. § 256. This action was filed in the Southern District of New York, which has original subject matter jurisdiction over patent disputes[2].
Claim Construction Opinions
In the case of Ferring B.V. v. Serenity Pharm., LLC, Judge Robert W. Sweet issued a claim construction opinion following a Markman hearing. The court sided with Serenity Pharmaceuticals, affirming that the term "transmucosal" and the dosage specifications should be interpreted in their plain and ordinary meaning without additional limitations[5].
Patent Scope and Validity
Patent Scope Metrics
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can indicate the breadth and clarity of the patent claims. In the case of U.S. Patent 7,579,321, the claims are relatively specific, focusing on the transmucosal delivery of desmopressin within defined concentration limits[3].
Examination Process
The examination process for this patent, like many others, would have involved narrowing the scope of the claims to ensure clarity and validity. Research has shown that the examination process tends to narrow the scope of patent claims, particularly in terms of claim length and count, to increase the probability of grant and reduce the examination duration[3].
Industry Impact
Innovation and Licensing
Patents like U.S. Patent 7,579,321 play a crucial role in the pharmaceutical industry by protecting innovative delivery systems. However, overly broad or unclear patents can lead to increased licensing and litigation costs, potentially diminishing incentives for further innovation[3].
Market Competition
The specific claims and scope of this patent influence market competition by defining what constitutes infringement. The clear interpretation of terms like "transmucosal" helps in distinguishing the patented invention from prior art and other competing products[5].
Key Takeaways
- Specific Claims: The patent's claims are specific to transmucosal delivery of desmopressin, with clear definitions of dosage and plasma/serum concentration limits.
- Litigation and Jurisdiction: The patent has been involved in significant legal disputes, particularly regarding claim construction and inventorship.
- Patent Scope: The scope of the patent is defined by its specific claims, which have been narrowed during the examination process to ensure clarity and validity.
- Industry Impact: The patent protects an innovative delivery system, influencing market competition and innovation incentives in the pharmaceutical industry.
FAQs
What is the main subject of U.S. Patent 7,579,321?
U.S. Patent 7,579,321 is focused on pharmaceutical compositions and methods for the transmucosal delivery of desmopressin.
Who is the inventor listed on the patent?
The sole inventor listed on the patent is Seymour H. Fein.
What is the significance of the term "transmucosal" in the patent claims?
The term "transmucosal" refers to the delivery of the drug through a mucous membrane and has been interpreted in its plain and ordinary meaning by the court.
How have legal disputes impacted the interpretation of this patent?
Legal disputes, such as Ferring B.V. v. Serenity Pharm., LLC, have led to court interpretations that define the scope and meaning of key terms in the patent claims.
What metrics can be used to measure the scope of a patent like U.S. Patent 7,579,321?
Metrics such as independent claim length and independent claim count can be used to measure the scope and clarity of the patent claims.
Sources
- Case 1:12-cv-02650-RWS Document 73 Filed 08/21/13: First Amended Complaint against Defendants Allergan, Inc., et al.
- Judge Sweet Holds “Transmucosal” Delivery Does Not Require: Claim construction opinion in Ferring B.V. v. Serenity Pharm., LLC.
- Patent Claims and Patent Scope: Metrics for measuring patent scope based on claim language.
- What Is the Probability of Receiving a US Patent?: Analysis of patent application outcomes at the USPTO.
