Understanding the Scope and Claims of United States Patent 7,247,316
Introduction
United States Patent 7,247,316, titled "Compositions and methods for treating lymphoma," is a significant patent in the pharmaceutical sector, particularly in the treatment of lymphoma. This patent, owned by Acrotech Biopharma LLC, is part of the Marqibo Kit's patent portfolio. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Patent Overview
The patent 7,247,316 was granted to cover specific compositions and methods for treating lymphoma. Here are the key aspects:
Invention Description
The patent describes compositions that include sphingosomes, which are liposomes composed of sphingolipids, for the delivery of chemotherapeutic agents. These compositions are designed to enhance the delivery and efficacy of the drugs in treating lymphoma[2].
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key claim categories:
- Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe the composition of sphingosomes containing a chemotherapeutic agent.
- Dependent Claims: These claims build upon the independent claims and add specific limitations. For instance, a dependent claim might specify the type of chemotherapeutic agent or the method of administration[2].
Scope of the Patent
The scope of the patent is determined by the claims, which outline what is protected by the patent.
Composition Claims
These claims cover the specific formulations of sphingosomes and the chemotherapeutic agents they contain. The patent ensures that any similar composition that uses sphingosomes for drug delivery in lymphoma treatment would infringe on these claims.
Method Claims
These claims cover the methods of preparing and administering the sphingosome compositions. This includes the process of encapsulating the chemotherapeutic agent within the sphingosomes and the protocols for administering these compositions to patients[2].
Patent Landscape
Understanding the broader patent landscape is crucial for strategizing market entry and avoiding infringement.
Family Patents
The Marqibo Kit has a family of patents that cover various aspects of the drug, including dosage, mode of administration, and specific compositions. For example, other patents like US5543152, US5814335, and US5741516 also cover sphingosomes for enhanced drug delivery[2].
Exclusivities and Patent Expiry
The Marqibo Kit is protected not only by patents but also by FDA-granted exclusivities such as New Product Exclusivity and Orphan Drug Exclusivity. These exclusivities can delay the generic launch of the drug even after the patents have expired. The patent 7,247,316 itself expired in September 2020, but the exclusivities remained in effect until August 2019[2].
Patent Analytics and Claim Coverage
To fully understand the protection offered by this patent, patent analytics tools can be employed.
Claim Coverage Matrix
A Claim Coverage Matrix helps in identifying which patents and claims are actively protecting the intellectual property. This tool categorizes patents by claims and scope concepts, making it easier to filter, search, and analyze large numbers of patent claims[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can help technical experts determine whether a particular scope concept is applicable to a target product or method. These charts highlight gaps in current coverage and future design opportunities[3].
Legal Activities and Patent Life
The life of a patent can be affected by various legal activities.
Maintenance Fees and Amendments
Activities such as payment of maintenance fees, late payments, and amendments to claims can extend or shorten the life of a patent. For example, the payment of maintenance fees for US7247316 in 2019 ensured its continued validity until its expiry in 2020[2].
Restriction Requirements
If the PTO had entered a restriction requirement during the filing process, it could have affected the double patenting analysis. However, in this case, the various claims were not filed together nor restricted by the PTO, which did not impact the double patenting determination[1].
Key Takeaways
- Patent Scope: The patent 7,247,316 covers specific compositions and methods for treating lymphoma using sphingosomes.
- Claims: The patent includes independent and dependent claims that define the scope of the invention.
- Patent Landscape: The Marqibo Kit has a family of patents and is protected by FDA-granted exclusivities.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for understanding the patent landscape and identifying gaps in coverage.
- Legal Activities: Maintenance fees, amendments, and other legal activities can affect the life and validity of the patent.
FAQs
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What is the main subject of United States Patent 7,247,316?
- The main subject is compositions and methods for treating lymphoma using sphingosomes.
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What are sphingosomes, and how are they used in this patent?
- Sphingosomes are liposomes composed of sphingolipids used for enhanced drug delivery in treating lymphoma.
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What types of claims are included in this patent?
- The patent includes independent claims defining the broad scope and dependent claims adding specific limitations.
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How do FDA-granted exclusivities affect the generic launch of Marqibo Kit?
- FDA-granted exclusivities such as New Product Exclusivity and Orphan Drug Exclusivity delay the generic launch even after patent expiry.
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What tools can be used to analyze the patent landscape of this patent?
- Tools like Claim Coverage Matrix and Claim Charts can be used to analyze the patent landscape and identify gaps in coverage.
Sources
- United States Court of Appeals for the Federal Circuit - Perricone v. Medicis Pharmaceutical Corp.[1]
- Pharsight - Marqibo Kit patent expiration[2]
- SLWIP - Patent Analytics[3]