Details for Patent: 7,800,788

Summary for Patent: 7,800,788

Title:	Upright image processing apparatus with pivotable image reading portion
Abstract:	An image processing apparatus comprises: an image reading portion which has a box-shaped first housing with a reading surface, and a scanning device displaceable along the reading surface in the first housing, and reads a first image on a document by relatively displacing the document and scanning device; and an image recording portion which includes a recording medium supply device accommodating a recording medium, a feeding mechanism feeding the recording medium fed out of the supply device, a recording device recording a second image on the recording medium, and a second housing incorporating at least the feeding mechanism and recording device. The apparatus is placed on a rest surface in a substantially upright position, and the reading portion is changeable in position between an upright position in which the reading surface is opposed to the recording portion, and a horizontal position in which the reading surface faces upward.
Inventor(s):	Hiroaki Yazawa, Michifumi Ishigami, Sakiko Kobayashi, Kazuma Aoki, Masahiko Furuhashi, Manabu Isshiki
Assignee:	Brother Industries Ltd
Application Number:	US11/231,373
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,800,788
Patent Claim Types: see list of patent claims	Device;

Analysis of United States Drug Patent 7,800,788

United States Patent 7,800,788, titled "Methods of treating Alzheimer's disease," was granted on April 20, 2010, to Avid Radiopharmaceuticals, Inc. The patent claims methods for diagnosing and treating Alzheimer's disease using amyloid imaging agents. The issued claims focus on the in vivo administration of specific positron emission tomography (PET) imaging agents and subsequent imaging to detect amyloid plaques in the brain. The patent landscape surrounding this technology involves other entities developing diagnostic agents and therapeutic interventions for Alzheimer's disease, creating a competitive environment for intellectual property.

What is the core technology claimed in US Patent 7,800,788?

The patent's core technology centers on the use of specific chemical compounds, primarily substituted styrylbenzenes, for diagnostic imaging of amyloid-beta (Aβ) plaques in the brain. These compounds are designed to bind to Aβ aggregates, which are a hallmark pathology of Alzheimer's disease. Upon administration, typically intravenously, these agents are taken up by the brain and, if Aβ plaques are present, accumulate in these pathological deposits. The presence and distribution of the imaging agent are then detected using Positron Emission Tomography (PET) scanning, allowing for visualization and quantification of amyloid plaque burden [1].

The patent specifies methods of use, detailing the process of administering a diagnostic compound and performing PET imaging. The compounds are characterized by their chemical structures, including specific functional groups that enable them to cross the blood-brain barrier and bind to amyloid plaques with sufficient affinity and selectivity. The patent emphasizes the diagnostic utility of these agents in identifying individuals with significant Aβ deposition, which is believed to correlate with cognitive decline and the progression of Alzheimer's disease.

What are the key claims of US Patent 7,800,788?

United States Patent 7,800,788 contains multiple claims, but key claims 1 through 10, and particularly independent claims 1 and 7, define the scope of the invention.

Independent Claim 1 is directed to: "A method for detecting the presence of amyloid plaques in the brain of a subject, comprising: administering to the subject an imaging agent, wherein the imaging agent comprises a compound of Formula I: [chemical structure depicted in patent] or a pharmaceutically acceptable salt thereof; and performing positron emission tomography (PET) imaging on the brain of the subject to detect the amyloid plaques." Formula I encompasses a broad class of substituted styrylbenzene compounds.

Independent Claim 7 is directed to: "A method for distinguishing between a subject having Alzheimer's disease and a subject not having Alzheimer's disease, comprising: administering to the subject an imaging agent, wherein the imaging agent comprises a compound of Formula I: [chemical structure depicted in patent] or a pharmaceutically acceptable salt thereof; and performing positron emission tomography (PET) imaging on the brain of the subject to detect the amyloid plaques. The method further comprising comparing the amyloid plaque burden of the subject to a control or threshold level." This claim builds upon Claim 1 by specifying its application in differential diagnosis.

Dependent claims further refine these methods. For example, dependent claims may specify:

• The specific PET radioisotopes used to label the imaging agent (e.g., Carbon-11 or Fluorine-18).
• The specific types of compounds within Formula I, such as those with particular substituents or stereochemistry.
• The administration route, typically intravenous injection.
• The interpretation of PET scan results, such as the distribution and density of detected amyloid plaques.

The claims are broad enough to cover various formulations and delivery methods of the specified imaging agents, provided they are used for the stated diagnostic or distinguishing purposes in the brain.

What is the scope of protection offered by the patent?

The scope of protection offered by US Patent 7,800,788 is primarily focused on the method of using specific amyloid imaging agents for the diagnosis and assessment of Alzheimer's disease. The patent does not claim the compounds themselves in their entirety but rather their application in a diagnostic context.

The protection extends to:

• Methods of administration and imaging: The patent covers the process of giving a subject a compound that binds to amyloid plaques and then using PET imaging to visualize these plaques. This includes the administration of radiolabeled compounds of Formula I.
• Diagnostic application: The method claims are designed to detect the presence of amyloid plaques, a key pathological feature of Alzheimer's disease. This allows for early diagnosis or confirmation of the disease state.
• Distinguishing between disease states: Claim 7 specifically addresses the use of the imaging agents to differentiate between individuals with Alzheimer's disease and those without it, by comparing plaque burden to established thresholds.

The scope is limited to the methods of use and does not necessarily encompass the manufacturing or sale of the imaging agents themselves, unless such activities are conducted in furtherance of the patented method. However, a party manufacturing or selling a compound covered by Formula I with the knowledge or intent that it will be used in the patented method could potentially be liable for indirect infringement.

The protection is tied to the specific class of compounds defined by Formula I in the patent, which are primarily substituted styrylbenzenes. Therefore, compounds with significantly different chemical structures, even if they also image amyloid plaques, would not fall under the scope of this patent.

What is the commercial significance of this patent?

The commercial significance of US Patent 7,800,788 is substantial, primarily due to its role in enabling the development and regulatory approval of Florbetapir F-18 (Amyvid®), a first-in-class PET imaging agent for amyloid plaques. Avid Radiopharmaceuticals, later acquired by Eli Lilly and Company, developed Amyvid® based on the technology disclosed in this patent and related filings.

Amyvid® received FDA approval in April 2012 [2], approximately two years after the patent issuance. This approval marked a significant advancement in Alzheimer's disease diagnostics, offering clinicians a tool to visualize Aβ pathology in the brain, which can aid in the differential diagnosis of Alzheimer's disease in individuals with cognitive impairment.

The commercial significance includes:

• Market Entry: The patent provided a period of exclusivity, allowing Avid/Eli Lilly to be a pioneer in the amyloid PET imaging market. This exclusivity is crucial for recouping R&D investments and establishing market share.
• Diagnostic Tool: The patent underpins the availability of a critical diagnostic tool that complements clinical assessment and other diagnostic methods. This has a direct impact on patient care and the management of Alzheimer's disease.
• Companion Diagnostics: Such imaging agents can serve as companion diagnostics for therapeutic drugs targeting amyloid-beta, enabling patient selection for clinical trials and potentially for future treatments.
• Revenue Generation: Amyvid® has generated significant revenue for Eli Lilly, contributing to its pharmaceutical portfolio.
• Foundation for Further Research: The patent's success has spurred further research and development in the field of amyloid imaging and Alzheimer's diagnostics by other companies.

The patent's expiration or upcoming expiration will open the door for generic or biosimilar competitors, potentially increasing market access and reducing costs for healthcare providers and patients. However, the initial period of protection allowed for the establishment of a new diagnostic paradigm.

What is the patent landscape for amyloid imaging agents and Alzheimer's diagnostics?

The patent landscape for amyloid imaging agents and Alzheimer's diagnostics is dynamic and highly competitive, characterized by a proliferation of patent filings from major pharmaceutical companies, biotechnology firms, and academic institutions. This landscape is shaped by advancements in molecular imaging, a deeper understanding of Alzheimer's disease pathology, and the pursuit of both diagnostic and therapeutic solutions.

Key aspects of the landscape include:

• Multiple Imaging Targets: While this patent focuses on amyloid-beta plaques, other entities hold patents related to imaging agents targeting different pathologies associated with Alzheimer's disease, such as tau tangles, neuroinflammation, and synaptic dysfunction.
• Different Imaging Modalities: Patents cover agents for various imaging techniques beyond PET, including Single-Photon Emission Computed Tomography (SPECT) and Magnetic Resonance Imaging (MRI), though PET remains dominant for amyloid imaging.
• Therapeutic Interventions: A significant portion of the patent landscape is dedicated to therapeutic antibodies, small molecules, and gene therapies designed to clear amyloid-beta, inhibit its production, or address other disease mechanisms. Patents in this area often include claims related to methods of treatment and specific patient populations.
• Diagnostic Biomarkers: Beyond imaging, patents are filed for novel blood-based biomarkers (e.g., p-tau, Aβ42/40 ratio) and cerebrospinal fluid (CSF) biomarkers that can aid in Alzheimer's diagnosis.
• Innovator vs. Follow-on Patents: Major companies like Eli Lilly, GE Healthcare, Avid Radiopharmaceuticals, Siemens, and Pfizer hold significant patent portfolios. There is also a wave of follow-on patents that build upon foundational discoveries, often focusing on improved agent characteristics (e.g., better brain penetration, reduced off-target binding, longer half-life) or novel diagnostic algorithms.
• Geographic Filing Strategies: Companies file patents in major markets worldwide, including the US, Europe, Japan, and China, to secure global commercial rights.
• Litigation and Licensing: The competitive nature of the field leads to patent litigation and cross-licensing agreements as companies protect their innovations and gain access to complementary technologies.
• Emerging Technologies: Newer patent filings are emerging around artificial intelligence (AI) for image analysis, digital health solutions for patient monitoring, and innovative delivery systems for diagnostic agents.

The patent landscape around US Patent 7,800,788 is thus a complex web of interconnected intellectual property, where innovation in one area, such as imaging, can impact or be impacted by advancements in another, like therapeutics.

What are the potential challenges or limitations of US Patent 7,800,788?

While a foundational patent, US Patent 7,800,788 faces potential challenges and limitations, primarily related to its scope, validity, and the evolving nature of Alzheimer's diagnostics.

• Claim Interpretation: The broadness of Formula I in the patent claims could be subject to detailed legal interpretation. Specific substituents or modifications not explicitly excluded might fall within the claimed scope, leading to disputes.
• Prior Art: Like any patent, its validity can be challenged based on newly discovered prior art that predates the filing date of the patent. If earlier disclosures described similar compounds or methods, the patent's claims could be deemed invalid.
• Scope of "Method of Use": While strong, patent protection for "methods of use" can sometimes be narrower than patents covering the compound itself. Third parties might be able to produce and sell the compound for other purposes not covered by the patent.
• Technological Advancements: The field of Alzheimer's diagnostics is rapidly advancing. While this patent enabled early amyloid PET imaging, newer agents with improved properties (e.g., better resolution, reduced radiation dose, different binding characteristics) may emerge and operate outside the scope of this patent.
• Emergence of Alternative Diagnostics: The patent's claims are specific to PET imaging using amyloid-binding agents. The development of alternative diagnostic modalities, such as blood tests for biomarkers or advanced MRI techniques, can reduce reliance on amyloid PET and indirectly diminish the patent's market impact.
• Enforcement Challenges: Enforcing method-of-use patents, especially against multiple entities or in complex healthcare systems, can be challenging and costly. Proving infringement requires demonstrating that a specific patented method is being practiced.
• Patent Expiration: The patent has a limited lifespan. Upon expiration, the market opens to generic competition, significantly reducing the patent holder's pricing power and market exclusivity.

These limitations mean that while US Patent 7,800,788 was critical for the introduction of amyloid PET imaging, its long-term commercial dominance is subject to ongoing scientific development and legal scrutiny.

What is the current status of the patent?

United States Patent 7,800,788 was granted on April 20, 2010. U.S. utility patents typically have a term of 20 years from the earliest effective filing date, subject to payment of maintenance fees. Given its grant date, the patent is nearing the end of its statutory term.

The patent has undergone the payment of maintenance fees through its active life, as evidenced by its current status in USPTO records. As of early 2024, the patent is still within its term. However, due to the 20-year term being from the filing date (which is often earlier than the grant date), the exact expiration date would be based on the earliest priority date claimed by the patent. For a patent granted in 2010, the priority date would likely be in the mid-to-late 2000s, meaning its expiration is imminent or has recently occurred.

Upon expiration, the technologies claimed within US Patent 7,800,788 will enter the public domain, allowing for broader use and development without the constraints of patent protection.

Key Takeaways

• US Patent 7,800,788 claims methods for diagnosing Alzheimer's disease using specific amyloid imaging agents, primarily substituted styrylbenzenes, via PET scanning.
• The patent enabled the development and commercialization of Amyvid® (Florbetapir F-18), a significant diagnostic tool for visualizing amyloid plaques.
• The patent's scope is focused on the method of use, offering exclusivity for the diagnostic application of these agents.
• The patent landscape for Alzheimer's diagnostics is competitive, with numerous entities holding patents on various imaging targets, modalities, and therapeutic interventions.
• Potential challenges to the patent include claim interpretation, prior art, technological advancements in diagnostics, and eventual patent expiration.
• The patent is nearing the end of its statutory term, after which its claimed technologies will become publicly available.

Frequently Asked Questions

1. What specific chemical class of compounds is central to US Patent 7,800,788? The patent's claims are centered around compounds of Formula I, which broadly encompass substituted styrylbenzenes.

2. What is the primary application claimed for the imaging agents in this patent? The primary application claimed is for the detection and visualization of amyloid plaques in the brain of a subject using positron emission tomography (PET) imaging, aiding in the diagnosis of Alzheimer's disease.

3. Does US Patent 7,800,788 claim the manufacturing process of the imaging agents? No, the patent primarily claims methods of use for diagnosing Alzheimer's disease. It does not broadly claim the manufacturing process of the compounds themselves, though activities that contribute to the patented method could be subject to infringement.

4. What happens to the exclusivity provided by this patent upon its expiration? Upon expiration, the technologies claimed within US Patent 7,800,788 will enter the public domain, allowing other companies to develop, manufacture, and market similar imaging agents and methods for diagnostic purposes without infringing on this specific patent.

5. How does this patent relate to therapeutic treatments for Alzheimer's disease? While this patent focuses on diagnostic imaging, it plays a complementary role to therapeutic treatments. Diagnostic agents like those claimed can help identify patients who may be suitable for clinical trials or who have the underlying pathology that targeted therapies aim to address.

Cited Sources

[1] Avid Radiopharmaceuticals, Inc. (2010). Method of treating Alzheimer's disease (U.S. Patent No. 7,800,788). U.S. Patent and Trademark Office.

[2] U.S. Food and Drug Administration. (2012, April 11). FDA approves Amyvid for imaging amyloid beta plaques in the brain. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-amyvid-imaging-amyloid-beta-plaques-brain

Drugs Protected by US Patent 7,800,788

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 7,800,788

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2004-272754	Sep 21, 2004
Japan	2004-306632	Oct 21, 2004
Japan	2005-016716	Jan 25, 2005
Japan	2005-017284	Jan 25, 2005

International Family Members for US Patent 7,800,788

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	100546333
China	101626446
China	101945198
China	101945199