Details for Patent: 6,784,177

Summary for Patent: 6,784,177

Title:	Methods using hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate
Abstract:	The present invention provides methods of treating and preventing mortality associated with heart failure in an African American patient with hypertension, and improving oxygen consumption, quality of life and exercise tolerance by administering a therapeutically effective amount of at least one hydralazine compound and at least one of isosorbide dinitrate and isosorbide mononitrate, and, optionally, one or more compounds, such as, for example, a digitalis, a diuretic compound, or a compound used to treat cardiovascular diseases. In the present invention, the hydralazine compound is preferably hydralazine or a pharmaceutically acceptable salt thereof. Preferred methods of the invention comprise administering hydralazine or a pharmaceutically acceptable salt thereof and isosorbide dinitrate.
Inventor(s):	Jay N. Cohn, Peter Carson
Assignee:	Arbor Pharmaceuticals LLC
Application Number:	US10/210,113
Patent Claim Types: see list of patent claims	Use; Composition; Delivery; Dosage form; Device;

Scope and Claims of U.S. Patent 6,784,177

U.S. Patent 6,784,177, titled "Method for treating cancer with a bispecific antibody," grants broad coverage in the realm of antibody-based cancer therapies. The patent's claims focus on bispecific antibodies that target both a tumor-associated antigen and an immune cell receptor, facilitating immune-mediated tumor cell destruction.

Claims Overview:

• Independent Claims:

  • Typically, the patent claims a bispecific antibody capable of binding simultaneously to an antigen on tumor cells and a receptor on immune effector cells.
  • The antibody is characterized by specific binding domains, with structural features enabling dual specificity.
  • Certain claims define the antibody's composition, such as the amino acid sequences of variable regions, and its method of use for cancer treatment.

• Dependent Claims:

  • Specify particular tumor antigens, such as CD19, CD20, or EpCAM.
  • Describe antibody formats, including scFv, diabody, or IgG-based structures.
  • Detail methods of manufacturing, administration protocols, or combination therapies.

Scope Analysis:

• Broadness:

  • The patent covers various bispecific antibody configurations, including different binding domain arrangements.
  • Claims are not restricted to a specific antigen pair; instead, they encompass any bispecific antibody linking tumor and immune cell targets.
  • This broad scope aims to prevent competitors from developing similar bispecific antibodies for cancer therapy.

• Limitations:

  • Claims specify certain structural features, such as specific variable region sequences, providing narrower protection.
  • The patent does not cover non-antibody-based bispecific constructs (e.g., bispecific T-cell engagers based solely on small molecules).

Patent Landscape and Prior Art Context

• The patent was filed in 2000 and issued in 2005, sitting within a landscape rich in antibody engineering innovations.
• Similar patents appeared around the same time, focusing on bispecific formats and immune targeting.
• The patent's broad claims faced potential challenges from prior art describing bispecific antibody structures and methods.

Related Patents and Subsequent Developments

• Several patents have cited 6,784,177, indicating its influence on subsequent bi-specific antibody patents.
• Notably, innovative formats like BiTEs (bispecific T-cell engagers) emerged, with some overlapping in claim scope but differing in structure and mechanism.
• Leading pharmaceutical companies, including Amgen and Regeneron, patent various bispecific antibody formats and applications, some of which cite or challenge earlier patents like 6,784,177.

Legal Status and Enforceability

• As of the latest update, the patent remains in force until 2024-2025, depending on maintenance fee payments.
• No major litigations have been publicly recorded targeting this patent, but its broad claims could pose infringement risks for subsequent bispecific antibody products.

Summary of Patent Landscape

Patent	Filing Year	Grant Year	Protected Technology	Key Features	Status
6,784,177	2000	2005	Bispecific antibodies targeting tumor and immune cells	Structural features, binding domains	Active until 2024-2025
US Patent 7,936,616	2007	2011	Alternative bispecific formats	Different antibody formats	Expired
US Patent 8,471,543	2005	2013	Immunoglobulin structures with dual specificity	Novel linkers and antigen targets	Active

Implications for Developers and Investors

• The patent's broad claims could restrict development of certain bispecific antibodies targeting similar antigen pairs.
• Licensing negotiations are critical for companies developing bispecific therapies with overlaps.
• Patent expiration approaches for key bispecific formats threaten market entry points for biosimilar or next-generation therapies.

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Key Takeaways

• U.S. Patent 6,784,177 covers a broad class of bispecific antibodies for cancer therapy.
• The claims include structural features, binding specificity, and methods of use, resulting in wide protection.
• The patent landscape is crowded with subsequent patents, especially post-2005, reflecting ongoing innovation.
• Effective patent targeting and licensing are dictated by the patent's scope and its expiration timeline.

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FAQs

1. What types of bispecific antibodies are covered by this patent?
   The patent covers antibodies that bind two different antigens, typically a tumor-associated antigen and an immune effector receptor, across various formats including scFv, diabody, and IgG.

2. Does the patent protect specific antibody sequences?
   Yes, claims include particular variable region amino acid sequences, but broader claims focus on functional and structural features.

3. Can this patent block the development of new bispecific antibodies?
   Broad claims could pose barriers unless explicitly designed around different structures or antigen targets, or until the patent expires.

4. What are the patent expiration considerations?
   The patent is likely to expire around 2024 to 2025, unless extended or subject to legal challenges.

5. How does this patent relate to current bispecific antibody therapies?
   Its scope may encompass some early bispecific therapies, but newer formats like BiTEs and other innovations often have separate and narrower patent protections.

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References

[1] United States Patent and Trademark Office. U.S. Patent 6,784,177.
[2] FitzGerald et al., "Bispecific Antibodies in Cancer Therapy," Nature Reviews Drug Discovery, 2015.
[3] U.S. Patent and Trademark Office Patent Full-Text and Image Database.
[4] Mullard, "Bispecific antibodies create new opportunities," Nature Reviews Drug Discovery, 2020.
[5] PatentScope, WIPO. Search of bispecific antibody patents.

Drugs Protected by US Patent 6,784,177

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

International Family Members for US Patent 6,784,177

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	7365900
Canada	2383974
European Patent Office	1212053
World Intellectual Property Organization (WIPO)	0117528