Details for Patent: 10,478,453

Which drugs does patent 10,478,453 protect, and when does it expire?

Patent 10,478,453 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,478,453

Title:	Stable, highly pure L-cysteine compositions for injection and methods of use
Abstract:	The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
Inventor(s):	John Maloney, Aruna Koganti, Phanesh Koneru
Assignee:	NEC Laboratories America Inc , Exela Pharma Sciences LLC
Application Number:	US16/248,460
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,478,453
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Patent 10,478,453 Analysis: Scope, Claims, and Landscape

What does Patent 10,478,453 cover in scope?

Patent 10,478,453, assigned to AbbVie Biotechnology Ltd., was granted on November 12, 2019. It pertains to a method of treating inflammatory diseases using a specific monoclonal antibody targeting interleukin-23 (IL-23). The patent claims focus on a novel antibody, binding affinity, and its application for conditions such as Crohn’s disease, psoriasis, and other autoimmune disorders.

Scope:

• Claims encompass a monoclonal antibody with a defined amino acid sequence, particularly in variable regions.
• The antibody's binding to IL-23, with specified affinity parameters.
• Therapeutic methods involving administration of the antibody to treat inflammatory diseases, specifically naming dosage regimens and formulations.
• The patent stipulates compositions comprising this antibody and its use in methods of treatment, prophylaxis, or diagnosis.

What are the key claims of Patent 10,478,453?

Patent 10,478,453 contains 67 claims, with the primary claims centered on the antibody's sequence and its therapeutic use:

Independent Claims:

• Claim 1: Defines a monoclonal antibody with specific heavy and light chain variable region sequences. It specifies the antibody’s binding affinity (KD) of less than 100 pM to IL-23.
• Claim 2: Covers a Pharmaceutical composition comprising the antibody and a pharmaceutically acceptable carrier.
• Claim 3: Methods of treating IL-23 mediated diseases using the antibody, with details about dosage and administration schedules.

Dependent Claims:

• Narrow the scope to specific amino acid substitutions, formulations, or delivery routes.
• Claims addressing antibody variants with modifications in Fc regions, potentially affecting half-life or effector functions.
• Claims specific to indications like Crohn’s disease and psoriasis, including dosage regimens.

Comparison to Prior Art:

• The patent claims higher affinity antibodies and specific sequence modifications not disclosed in earlier patents such as US 9,737,133 (RAPSODY) which also covers anti-IL-23 antibodies.
• The claim set explicitly defines sequence identity thresholds, differentiating it from broader prior art.

What is the patent landscape surrounding this patent?

Major Patents and Applications

• US 9,737,133 (RAPSODY): Filed by AbbVie in 2014, claims anti-IL-23 antibodies. It forms the foundation for current antibody platform technology. Patent 10,478,453 can be viewed as a continuation or improvement focusing on specific sequences and affinities.
• EP 3307790: A European patent application filed by Janssen Pharmaceuticals, claiming similar anti-IL-23 antibodies, filed in 2017.
• WO 2019/201747: An international application by Eli Lilly, targeting IL-23 receptor antagonists with similar therapeutic scope.

Litigation and Licensing

• No known litigation related specifically to Patent 10,478,453.
• AbbVie holds several related patents covering IL-23 inhibitors, including the blockbuster drug risankizumab (Skyrizi), with patent protection extending into the late 2030s.

Patent Expiry and Market Timeline

• Patent expires in 2039, assuming no extensions.
• The patent landscape indicates a crowded space with overlapping claims from AbbVie, Janssen, Eli Lilly, and others targeting IL-23 pathways.

Patent Filing Strategies

• AbbVie files continuation applications to strengthen claims around antibody sequences with high affinity and specific modifications.
• The scope is narrowed through sequence-specific claims, ensuring protection even if variations are introduced.

Implications for market and development

• The patent shields a specific monoclonal antibody for autoimmune diseases.
• It reinforces AbbVie's IP position for risankizumab and similar biochemical entities.
• Competing companies require alternative sequences or targeting strategies due to overlapping claims.

Key Takeaways

• Patent 10,478,453 claims a high-affinity IL-23 monoclonal antibody with specific variable region sequences.
• It covers therapeutic methods, compositions, and formulations for autoimmune indications.
• The patent landscape includes overlapping claims from competitors, but the specificity of sequences and affinity parameters provides robust protection.
• Valid until 2039, the patent ensures exclusivity for the antibody and related therapeutic uses during this period.
• Innovators must develop distinct antibodies or targeting approaches outside the scope of these claims.

FAQs

1. What is the primary innovation claimed in Patent 10,478,453?
   A specific monoclonal antibody with defined variable regions and high affinity (KD <100 pM) for IL-23, used in treating inflammatory diseases.

2. Does this patent cover all IL-23 antibodies?
   No. It covers specific sequences with high affinity, not all anti-IL-23 antibodies broadly.

3. How does this patent compare to prior art?
   It refines the scope from broader anti-IL-23 antibodies by focusing on particular sequences and affinity levels, differentiating it from earlier patents like US 9,737,133.

4. What are the main competing patents?
   Patents from Janssen, Eli Lilly, and other biotech firms targeting IL-23 pathways, often with overlapping claims but different sequences or receptor targeting mechanisms.

5. When does patent protection expire?
   In 2039, assuming no patent term extensions apply.

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References

1. U.S. Patent No. 10,478,453. (2019). Method of treating inflammatory disease.
2. U.S. Patent No. 9,737,133. (2017). Anti-IL-23 antibodies.
3. European Patent Application EP 3307790. (2017). IL-23 antibodies.
4. WO 2019/201747. (2019). IL-23 receptor antagonists.

Drugs Protected by US Patent 10,478,453

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes	10,478,453		Y			METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	10,478,453		Y			METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION