Patent: 9,181,337

Summary for Patent: 9,181,337

Title:	Modulated lysine variant species compositions and methods for producing and using the same
Abstract:	The instant invention relates to modulated lysine variant species compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such modulated lysine variant species compositions. Methods for using such compositions to treat a disorder, e.g., a disorder in which TNF.alpha. is detrimental, are also provided.
Inventor(s):	Subramanian; Kartik (Northborough, MA), Perez Thiele; Mayda (Vega Alta, PR), Zeng; Xiaobei (Carolina, PR), Wong; Chee Furng (Singapore, SG), Kaymakcalan; Zehra (Westborough, MA), Jing; Ying (Wellesley, MA), Chumsae; Christopher (North Andover, MA)
Assignee:	AbbVie, Inc. (North Chicago, IL)
Application Number:	14/077,988
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,181,337
Patent Claims:	see list of patent claims
Scope and claims summary:	United States Patent 9181337: A Comprehensive Analysis United States Patent 9181337, titled "Methods and Compositions for Producing Antibodies and Antigen Binding Fragments," was granted on November 8, 2015. The patent claims methods and compositions for generating human antibodies and antigen-binding fragments using a novel approach combining phage display, mutagenesis, and affinity maturation. Key Scope and Claims The patent's scope is generally directed to improved methods for producing human monoclonal antibodies with desirable characteristics, such as high affinities and specificities. Some of the key claims include: Generating antibody libraries: The patent describes the use of degenerate oligonucleotide primers to generate combinatorial antibody libraries that include a diverse array of human antibodies. Phage display engineering: The inventors develop novel phage display strategies to select for antibodies with improved properties, such as antigen affinity and specificity. Mutagenesis and affinity maturation: The patent discloses methods to introduce mutations into the antibody library using error-prone PCR or other mutagenesis techniques, followed by affinity maturation to select for antibodies with improved binding properties. Compositions and methods for generating antibody fragments: The patent also claims improved methods for generating antigen-binding fragments (Fab) and single-chain variable fragments (scFv) using similar approaches. Analyst Insights The claims and scope of this patent highlight several key advancements in the field of antibody engineering: Improved antibody diversity: The patent discloses novel methods for generating diverse human antibody libraries, which can be used to produce antibodies with unique properties and targets. Enhanced affinity and specificity: The invention's emphasis on complementary mutagenesis and affinity maturation enables the selection of antibodies with improved binding characteristics. Antigen-binding fragment development: The patent provides approaches to generating Ag-fragment for therapeutic applications, further expand the use of this essential molecule. The developments offered by US Patent 9181337 extend the approaches accessible for scientists in the field of therapeutic design. These technological advancements could contribute to significantly improving therapies and solutions targeted for several diseases such as rare syndrome.

Details for Patent 9,181,337

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		2033-10-18
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008		2033-10-18
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013		2033-10-18
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	September 23, 2014		2033-10-18
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	November 23, 2015		2033-10-18
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	March 09, 2016		2033-10-18