Understanding the Scope and Claims of United States Patent 7,060,250
Introduction
United States Patent 7,060,250, titled "Diagnostic imaging contrast agents with extended blood retention," is a crucial patent in the field of medical imaging, particularly for MRI (Magnetic Resonance Imaging) contrast agents. This patent, owned by Lantheus Medical Imaging Inc., is one of several protecting the drug Ablavar.
Patent Overview
The patent 7,060,250 was granted to protect specific aspects of diagnostic imaging contrast agents, particularly those with extended blood retention. Here are the key details:
Patent Number and Title
- Patent Number: US 7,060,250
- Patent Title: Diagnostic imaging contrast agents with extended blood retention[1].
Patent Expiry
The patent expired on May 2015, marking the end of its exclusive protection period[1].
Claims and Scope
The patent claims focus on the composition and properties of the contrast agents designed to enhance the visibility of mammalian tissues during MRI.
Independent Claims
The independent claims typically define the broadest scope of the invention. For this patent, the claims revolve around the chemical composition and the method of preparation of the contrast agents. Here are some key aspects:
- Chemical Composition: The patent describes novel compounds that include a gadolinium-based complex, which is designed to have extended blood retention. This is crucial for improving the quality of MRI images[4].
- Method of Preparation: The claims also cover the methods for synthesizing these compounds, ensuring that the process yields a stable and effective contrast agent[4].
Dependent Claims
Dependent claims further specify the invention by adding additional limitations to the independent claims. These might include specific moieties, linkers, and other chemical groups that enhance the properties of the contrast agent.
- Specific Moieties: The patent details various chemical groups such as aryl, alkyl, and phosphate groups that are incorporated into the contrast agent to achieve the desired properties[4].
Patent Landscape
Understanding the broader patent landscape is essential for strategizing market entry and competition.
Family Patents
The patent 7,060,250 is part of a family of patents related to Ablavar. These patents cover various aspects of the drug, including dosage, mode of administration, and other chemical compositions.
- International Protection: While the US patent has expired, it is important to note that Ablavar is protected by patents in multiple countries. This global protection affects the timing and feasibility of generic entry in different markets[1].
Exclusivities
In addition to patent protection, Ablavar was granted exclusivities by the FDA, which further delayed the entry of generic competitors.
- New Chemical Entity Exclusivity: Ablavar held a New Chemical Entity (NCE) exclusivity that expired in December 2013. This exclusivity prevented other companies from marketing a generic or bioequivalent version of Ablavar, regardless of the patent status[1].
Legal Activities and Updates
Tracking recent legal activities on the patent is crucial for understanding any changes in its status.
- Maintenance Fees and Expiry: The patent's expiry was confirmed through various legal activities, including the payment of maintenance fees and the formal expiry notifications[1].
Impact on Generic Launch
The expiry of the patent and the exclusivities has significant implications for the generic launch of Ablavar.
- Generic Launch Date: The estimated generic launch date for Ablavar was May 2020, considering the expiry of patents and exclusivities[1].
Expert Insights
Industry experts emphasize the importance of patent scope and clarity in the pharmaceutical industry.
- Patent Scope and Quality: "Patent scope and claim clarity have been identified as significant concerns for patent quality. Even the basic approach to determining claim meaning has been called into question," notes a study on patent quality[3].
Illustrative Statistics
The impact of patent expiry on the pharmaceutical market can be significant.
- Market Entry: The expiry of key patents like US 7,060,250 can lead to a surge in generic competition, potentially reducing the market share of the original drug. For instance, the generic launch of Ablavar could lead to a significant reduction in prices, making the drug more accessible to patients.
Examples and Analogies
To understand the importance of extended blood retention in MRI contrast agents, consider the following analogy:
- Enhanced Imaging: Just as a longer exposure time in photography allows for better capture of details, extended blood retention in MRI contrast agents allows for clearer and more detailed images of the body's tissues.
Key Takeaways
- Patent Expiry: The patent US 7,060,250 expired in May 2015.
- Claims and Scope: The patent covers the composition and preparation of MRI contrast agents with extended blood retention.
- Family Patents: Part of a broader family of patents protecting Ablavar.
- Exclusivities: NCE exclusivity expired in December 2013.
- Generic Launch: Estimated generic launch date was May 2020.
- Legal Activities: Tracking legal activities is crucial for understanding patent status changes.
FAQs
Q: What is the active ingredient in Ablavar?
A: The active ingredient in Ablavar is Gadofosveset Trisodium[1].
Q: What is the primary use of Ablavar?
A: Ablavar is used for imaging mammalian tissues using MRI technology[1].
Q: When did the patent US 7,060,250 expire?
A: The patent US 7,060,250 expired in May 2015[1].
Q: What is the significance of extended blood retention in MRI contrast agents?
A: Extended blood retention allows for clearer and more detailed images of the body's tissues during MRI[4].
Q: How do exclusivities affect the generic launch of a drug?
A: Exclusivities, such as NCE exclusivity, prevent other companies from marketing a generic or bioequivalent version of the drug, delaying generic competition[1].
Cited Sources
- Pharsight: Ablavar patent expiration - Pharsight.
- PubChem: Contrast media for diagnostic imaging with increased residence time in the blood.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Diagnostic imaging contrast agents with extended blood retention.
- Unified Patents Portal: Novel compounds having use as contrast agents in magnetic resonance imaging.
