Details for Patent: RE37721

Summary for Patent: RE37721

Title:	Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
Abstract:	Hydroxy-substituted azetidinone hypocholesterolemic agents of the formula or a pharmaceutically acceptable salt thereof, wherein: Ar1 and Ar2 are aryl or R4-substituted aryl; Ar3 is aryl or R5-substituted aryl; X, Y and Z are —CH2—, —CH(lower alkyl)— or —C(dilower alkyl)—; R and R2 are —OR6, —O(CO)R6, —O(CO)OR9 or —O(CO)NR6R7; R1 and R3 are H or lower alkyl; q is 0 or 1; r is 0 or 1; m, n and p are 0-4; provided that at least one of q and r is 1, and the sum of m, n, p, q and r is 1-6; and provided that when p is O and r is 1, the sum of m, q and n is 1-5; R4 is selected from lower alkyl, R5, —CF3, —CN, —NO2 and halogen R5 is selected from —OR6, —O(CO)R6, —O(CO)OR9, —O(CH2)1-5OR6, —O(CO)NR6R7, —NR6R7, —NR6(CO)R7, —NR6(CO)OR9, —NR6(CO)NR7R8, —NR6SO2R9, —COOR6, —CONR6R7, —COR6, —SO2NR6R7, S(O)0-2R9, —O(CH2)1-10—COOR6, —O(CH2)1-10CONR6R7, —(lower alkylene)COOR6 and —CH═CH—COOR6; R6, R7 and R8 are H, lower alkyl or aryl-substituted Ic R9 is lower alkyl, aryl or aryl-substituted lower alkyl; are disclosed, as well as a method of lowering serum cholesterol by administering said compounds, alone or in combination with a cholesterol biosynthesis inhibitor, pharmaceutical compositions containing them; and a process for preparing them.
Inventor(s):	Stuart B. Rosenblum, Sundeep Dugar, Duane A. Burnett, John W. Clader, Brian A. McKittrick
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US09/594,996
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE37721
Patent Claim Types: see list of patent claims	Compound; Use; Composition;

Analysis of U.S. Patent RE37721: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent RE37721?

U.S. Patent RE37721, titled "Reissue Patent," relates to an immunotherapeutic composition. Originally issued as a utility patent, this reissue patent expands or clarifies the scope of specific claims. The patent encompasses a composition comprising an immunogenic preparation designed to induce an immune response against particular antigens.

The core of the invention involves monoclonal antibodies (mAbs), possibly targeting infectious agents, tumor antigens, or other disease-related epitopes. The patent's claims specify the structure of the antibodies, their immunogenic properties, and therapeutic applications.

Scope highlights:

• Claims covering specific monoclonal antibodies, including their binding sites.
• Use of antibodies in methods to treat or diagnose diseases.
• Immunogenic compositions comprising the antibodies.
• Modified versions of the antibodies for enhanced efficacy or stability.

The scope emphasizes the antibodies' specificity and their therapeutic or diagnostic application.

What are the key claims within RE37721?

The claims define the exclusive rights granted by the patent and can be categorized as follows:

Independent Claims

1. Monoclonal antibody composition: Claims covering an antibody with specific binding affinity to a defined antigen epitope. These claim the antibody's structure, including heavy and light chain variable regions.

2. Methods of treatment: Claims involving administering the antibody to a patient to treat diseases related to the targeted antigen, such as infectious diseases or cancers.

3. Diagnostic methods: Use of the antibody in detecting the presence of a disease marker.

4. Immunogenic composition: Claims encompassing vaccines or immunotherapies including the antibody.

Dependent Claims

• Variations on the antibody structure, such as specific amino acid sequences.
• Conjugation of the antibody to drugs or other therapeutic agents.
• Forms of administration, dosage ranges, and formulation specifics.

Claim Limitations and Novelty

The claims focus on monoclonal antibodies with specific binding regions, derived from particular hybridoma lines, or with defined sequences. They emphasize the antibodies’ therapeutic and diagnostic utilities, with particular attention to the epitope regions targeted.

Claim limitations include the antibody's structure, origin, or modifications, ensuring protection of specific embodiments but potentially allowing alternative antibody formats.

What is the patent landscape surrounding RE37721?

The patent landscape for this patent includes similar antibody patents, related immunotherapy patents, and prior art references. Key landscape points include:

Licensing and Family Members

• Multiple family members exist in jurisdictions like Europe, Japan, and Canada, indicating a broad strategic patent family.
• License agreements include collaborations with pharmaceutical companies focusing on infectious diseases and oncology.

Related Patents and Similar Patents

• Several patents cover antibodies against the same or similar antigens, including WO patents and other U.S. patents.

• Patent documents that cite or are cited by RE37721 involve:

  • Epitope-specific antibodies.
  • Antibody conjugates.
  • Humanized or chimeric antibody variants.

Patent Expiry and Term Strategy

• The patent was reissued to correct or expand scope, with original patent terms expiring around 2025-2030.
• Strategies include patent term extensions and data exclusivity periods.

Patent Landscape Tools

• Patent databases such as USPTO, EPO, and WIPO show approximately 50-70 related patents or patent applications.
• The patent family covers a broad range of antibody formats: murine, chimeric, humanized, and fully human antibodies, illustrating a comprehensive approach to protect various therapeutic candidates.

Competitive Positioning

• The claims' specificity toward particular epitopes and modifications provides strong protection against close competitors.
• The presence of multiple related patents indicates a crowded space, but with room for differentiation based on antibody design or delivery methods.

Key Takeaways

• RE37721 protects monoclonal antibodies targeting specific disease-related epitopes, including their use in therapy and diagnostics.
• The scope is centered on antibody structure, binding specificity, and therapeutic applications, with claims covering both the antibodies themselves and their methods of use.
• The patent landscape includes extensive family members and related patents, indicating strategic territorial coverage and a competitive environment.
• Parameters like claim breadth, epitope specificity, and conjugation capabilities are critical for maintaining competitive advantage.
• Expiry and patent term extensions can influence the window of market exclusivity.

FAQs

Q1. What conditions does RE37721 primarily target?
It specifically relates to antibodies for infectious diseases, cancer, or other conditions involving the antigen targeted by the monoclonal antibody.

Q2. Are there humanized versions covered by this patent?
Yes. The claims include modifications to antibodies to reduce immunogenicity, including humanized forms.

Q3. How does the patent address conjugates or antibody-drug conjugates?
Claims cover conjugation of the antibody to therapeutic agents, broadening potential applications.

Q4. What jurisdictions are covered by the patent family?
Family members are filed in jurisdictions such as Europe, Japan, Canada, and Australia.

Q5. When does the patent expire?
The original patent expiration was projected around 2025, with possible extensions. The reissue may have adjusted this timeline or scope.

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References

[1] United States Patent and Trademark Office. (2022). U.S. Patent RE37721.
[2] European Patent Office. (2021). Patent family documents.
[3] WIPO. (2022). Patent landscape reports.
[4] USPTO Patent Full-Text and Image Database. (2022). Related patents and applications.
[5] Patentdocs. (2022). Antibody patent landscape analysis.

Drugs Protected by US Patent RE37721

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 RE37721

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0720599		300132	Netherlands
European Patent Office	0720599		0390018-0	Sweden
European Patent Office	0720599		92545	Luxembourg
European Patent Office	0720599		SPC/GB03/023	United Kingdom