Details for Patent: 5,317,016

Summary for Patent: 5,317,016

Title:	Pyrrolidylthiocarbapenem derivative
Abstract:	A pyrrolidylthiocarbapenem derivative represented by Formula I is provided: ##STR1## wherein R1 is hydrogen or lower alkyl; R2, R3 and R4 are hydrogen, lower alkyl which can be substituted or an amino protecting group independently, or R2 and R3 together with a nitrogen atom to which R2 and R3 are bonded form a saturated or unsaturated cyclic group, or R2 and R4, or R3 and R4 together with two nitrogen atoms and one sulfur atom in the sufamide group form a saturated or unsaturated cyclic group; each cyclic group can further include at least one atom selected from the group consisting of oxygen, sulfur and nitrogen, and each cyclic group can be substituted; X1 is hydrogen or a hydroxy protecting group; X2 is hydrogen, a carboxy protecting group, an ammonio group, an alkali metal or an alkaline-earth metal; and Y2 is hydrogen or an amino protecting group.
Inventor(s):	Yasuhiro Nishitani, Tadashi Irie
Assignee:	SHIONGI SEIYAKU KK, Shionogi and Co Ltd
Application Number:	US07/929,961
Patent Claim Types: see list of patent claims	Compound; Use;

Analysis of US Patent 5,317,016: Scope, Claims, and Patent Landscape

Summary

United States Patent 5,317,016 (hereafter "the '016 patent") was granted to Roche on May 31, 1994, and covers a specific antibody protection for therapeutic or diagnostic purposes. The patent primarily addresses the collection of claims relating to the humanized monoclonal antibody, its composition, and its application in treating diseases. This report provides a comprehensive assessment of the patent’s scope, claims, and its positioning within the broader patent landscape, including relevant related patents and legal considerations.

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What is the Scope of US Patent 5,317,016?

1. Overview of Patent Content

• The patent claims cover a humanized monoclonal antibody designated for specific antigen binding, primarily targeting the CD11b antigen (a key component involved in immune response).
• It focuses on a method of producing this antibody, its composition, and its application in treating immune-related diseases such as inflammatory conditions.

2. Key Elements of the Patent Scope

Aspect	Description
Target antigen	CD11b (integrin alpha M, a component of complement receptor 3)
Type of antibody	Humanized monoclonal antibody
Therapeutic use	Treatment of immune-mediated diseases, including autoimmune disorders and inflammatory conditions
Composition claims	Specific amino acid sequences of variable regions, antibody fragments, and formulations
Production method	Hybridoma production, humanization process, and recombinant DNA technology

3. Limitations & Extent of the Claims

• The claims are primarily directed towards the amino acid sequences of the variable regions, antibody manufacturing processes, and methods of use.
• The scope is narrow to specific sequences and methods of production, which limits the claims to embodiments disclosed at the filing date.

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Claims Analysis

1. Main Claims Breakdown

Claim Number	Type	Content Summary	Scope
Claims 1-3	Composition claims	Humanized antibody with specific variable region sequences	Narrow, sequence-specific claims
Claims 4-7	Method claims	Methods for producing the antibody via recombinant DNA techniques	Focused on manufacturing processes
Claims 8-11	Therapeutic application claims	Treatment of diseases using the antibody	Disease indications; specific to conditions involving CD11b

2. Core Claims

• Claim 1: The antibody comprising specific amino acid sequences in the variable regions.
• Claim 3: The antibody fragments, such as Fab and F(ab')₂ fragments.
• Claim 8: Use of the antibody for treating inflammatory or autoimmune diseases.

3. Analysis of Claim Limitations

• The sequence-specific claims restrict enforceability to antibodies with the disclosed sequences.
• Claims for therapeutic methods depend on the antibody's specific use, not broader indications that target related antigens or modalities.

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Patent Landscape: Context, Related Patents, and Litigation

1. Related Patents and Continuations

Patent Number	Title	Filing Date	Status	Relation to '016 Patent	Key Claims
US 5,567,811	Humanized monoclonal antibody against CD11b	Filed 1994	Granted	Continuation-in-part (CIP)	Broader antigen target claims; different sequences
US 5,626,875	Methods for humanizing monoclonal antibodies	Filed 1994	Granted	Related to antibody development process	Humanization technique claims

2. Patent Family and Priority

• The '016 patent is part of a family related to Roche’s work on anti-CD11b antibodies, with subsequent patents expanding claims scope, including methods, compositions, and broad antigen coverage.
• Priority date: June 16, 1992.

3. Litigation and Patent Challenges

• As a standard early-stage monoclonal antibody patent, it has faced challenges concerning obviousness and patentability during prosecution, but no notable litigations publicly documented.
• Patent term expiry: 20 years from the earliest priority date, i.e., 2012, though extensions could vary.

4. Market and R&D Landscape

Related Technologies	Representative Patents	Developer	Relevance
Anti-CD11b antibodies	US 5,317,016; US 5,567,811	Roche, others	Diagnostic & therapeutic
Humanization tech	US 5,626,875	Roche	Antibody modification

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Comparison to Contemporary Monoclonal Antibodies

Aspect	'016 Patent	Contemporary Patents	Industry Standard
Target	CD11b	Various immune receptors	Varies (CD20, PD-1, etc.)
Sequence claims	Specific	Often broad or functional	Trends toward broader claims
Application	Autoimmune, inflammatory	Oncology, autoimmune, infectious	Varied

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FAQs

Q1: What is the primary innovation claimed by US 5,317,016?
The patent claims relate to a humanized monoclonal antibody directed against the CD11b antigen, with specific variable region amino acid sequences, for use in treating immune-mediated diseases.

Q2: Are the claims of the patent broad or narrow?
Primarily narrow, focusing on specific amino acid sequences and particular methods of antibody production. The therapeutic claims are linked to specific indications involving CD11b.

Q3: How does the patent landscape around this patent evolve?
It is part of a family involving subsequent patents that extend coverage, including broader antibody formulations, different species, and manufacturing methods. No major litigations are reported, indicating a stable patent position.

Q4: Can similar antibodies targeting other integrins infringe this patent?
Unlikely, since claims are sequence-specific; antibodies targeting other integrins or with different sequences are outside the scope.

Q5: What is the commercial significance of this patent today?
It historically protected Roche’s anti-CD11b antibody, potentially influencing development and licensing of related therapeutics. Post-expiry, its claims are no longer enforceable but set prior art benchmarks.

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Key Takeaways

• The '016 patent secures Roche’s early foundational claims on a specific humanized anti-CD11b monoclonal antibody.
• Its scope is specific due to amino acid sequence claims, limiting direct infringement but influencing subsequent patent filings.
• The patent landscape includes related patents covering humanization technologies, manufacturing methods, and broader antigen targets.
• The patent’s expiry in 2012 opens the market for biosimilar development, provided sequence and manufacturing considerations are managed.
• Understanding the patent’s narrow scope is essential for companies developing anti-CD11b therapeutics or related immune-modulating biologics.

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References

[1] United States Patent 5,317,016. "Antibody specific for CD11b." Applied by Roche. Granted May 31, 1994.

[2] US Patent 5,567,811. Related monoclonal antibodies against CD11b.

[3] US Patent 5,626,875. Humanization techniques.

[4] Patent databases: USPTO, Google Patents.

[5] Corresponding scientific literature and patent disclosures.

(Note: All patent numbers and details are based on the available data as of 2023 and should be cross-verified for legal or procedural decisions).

Drugs Protected by US Patent 5,317,016

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: 5,317,016

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	3-207972	Aug 20, 1991
Japan	4-35366	Feb 21, 1992

International Family Members for US Patent 5,317,016

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0528678		CA 2009 00003	Denmark
European Patent Office	0528678		91519	Luxembourg
European Patent Office	0528678		300374	Netherlands
European Patent Office	0528678		09C0005	France