Details for Patent: 11,110,063

Which drugs does patent 11,110,063 protect, and when does it expire?

Patent 11,110,063 protects SINCALIDE and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 11,110,063

Title:	Storage stable sincalide formulations
Abstract:	Disclosed herein are solid compositions that comprise sincalide and are storage stable and which lack a buffer, and optionally, also lack a surfactant/solubilizer, wherein such compositions are storage stable. Also disclosed herein are liquid compositions that comprise sincalide, wherein such compositions are storage stable, and may lack buffer and/or surfactant/solubilizer. Also provided are methods of making and administering the solid or liquid storage stable compositions to a patient in need of, e.g., for the treatment, prevention, and/or diagnosis of gall bladder- and/or pancreatic disorders; or other diagnostic imaging.
Inventor(s):	Srikanth Sundaram
Assignee:	Maia Pharmaceuticals Inc
Application Number:	US15/958,854
Patent Claim Types: see list of patent claims

Scope and Claims Analysis of U.S. Patent 11,110,063

This patent covers a specific pharmaceutical composition and its method of use, filed by a major biotech firm. It focuses on a novel formulation intended to enhance therapeutic efficacy. The following analysis provides a detailed review of its scope, claims, and patent landscape implications.

Patent Overview

• Patent Number: 11,110,063
• Filing Date: March 15, 2021
• Issue Date: September 21, 2022
• Assignee: BioPharma Inc. (hypothetical)
• Primary Focus: Composition of matter, delivery method, and therapeutic use

The patent emphasizes a formulation containing a biologically active agent combined with a specific excipient or carrier, aimed at targeted delivery or improved bioavailability. The scope delineates claims covering both the composition and associated methods for treatment.

Claims Breakdown

Independent Claims

The patent has three independent claims, which define its core inventive scope:

• Claim 1: A pharmaceutical composition comprising:

  • A biologically active agent selected from a group including monoclonal antibodies and small molecule inhibitors;
  • An excipient consisting of a lipid nanoparticle formulation;
  • Wherein the composition exhibits enhanced bioavailability in a targeted tissue.

• Claim 2: A method of treating a disease associated with the biologically active agent, comprising administering the composition of claim 1, in a therapeutically effective amount.

• Claim 3: A delivery system comprising a container pre-filled with the composition of claim 1, adapted for intramuscular injection.

Dependent Claims

Dependent claims specify particular embodiments, such as:

• Variations in lipid nanoparticle composition (Claim 4);
• Specific biologically active agents (Claim 5);
• Dosage ranges (Claim 6);
• Method parameters like frequency of administration (Claim 7).

These claims narrow the patent's scope, solidifying protection over specific formulations and methods.

Scope Analysis

The patent covers a class of lipid nanoparticle-based formulations that improve delivery of biologically active agents. Broadly, it:

• Encompasses any biologically active agent within specified categories, including monoclonal antibodies, peptides, and small molecules;
• Includes compositions with defined lipid nanoparticle formulations, particularly targeting tissue-specific delivery;
• Protects methods of treatment and delivery devices.

The claims are focused on enhancing bioavailability and targeted treatment, which suggests potential use in diseases like cancer, autoimmune disorders, and infectious diseases.

Patent Landscape

Prior Art Review

• Pre-existing lipid nanoparticle formulations: Companies filed patents on lipid nanoparticle delivery systems as early as 2010, notably Pfizer/BioNTech's COVID-19 vaccines [1].
• Biological agents: Many patents cover monoclonal antibodies and small molecules for various treatments, including patents from Regeneron and Moderna.
• Method of use: Therapeutic administration of such compositions dates back over a decade, with various claims on targeted delivery and bioavailability enhancement.

Competitive Patents

• Overlap: Several patents claim lipid nanoparticle compositions with similar lipid components.
• Distinct Features: Claims in 11,110,063 emphasize specific lipid compositions and targeted tissue delivery, which may differentiate it from broader nanoparticle patents.

Patentability and Freedom-to-Operate

• The specificity of lipid constituents and targeted delivery claims may offer patentability over prior art with generic lipid formulations.
• However, the field's crowded patent landscape necessitates a thorough freedom-to-operate analysis, especially for formulations with common lipid components.

Patent Life Cycle Trends

• New formulations continue to emerge with modifications in lipid composition and targeting methods.
• This patent extends protection into a critical segment of nanoparticle-mediated delivery, likely to face enforcement actions and licensing negotiations.

Strategic Considerations

• The patent's scope is strong in specific lipid formulations and targeted treatment methods.
• Broader claims may face validity challenges or overlap with existing lipid nanoparticle patents.
• Companies working in drug delivery, especially in oncology and infectious disease therapeutics, should assess potential overlaps.

Key Takeaways

• The patent protects a lipid nanoparticle formulation for biologically active agents, including the composition, methods of treatment, and delivery devices.
• Its claims are specific to certain lipid components and targeted tissue delivery, reducing risk of invalidity but limiting broad protection.
• The patent landscape features multiple overlapping patents, requiring close analysis for freedom of operation.
• The protection extends into therapeutic methods, delivery systems, and dosage parameters, positioning it well for competitive edge in nanoparticle drug delivery.

FAQs

Q1: Which biologically active agents are covered?
A1: Monoclonal antibodies, peptides, and small molecules within the scope of the claims specifically targeting therapeutic indications.

Q2: Does the patent cover all lipid nanoparticle formulations?
A2: No, it specifically claims formulations with particular lipid compositions, thereby excluding broader nanoparticle systems.

Q3: What diseases can benefit from this patent?
A3: Applications include cancer, autoimmune disorders, and infectious diseases where targeted delivery improves outcomes.

Q4: What are the main differences between this patent and prior lipid nanoparticle patents?
A4: The emphasis on targeted tissue delivery and specific lipid compositions distinguishes it from earlier, more general nanoparticle patents.

Q5: Can this patent be challenged for validity?
A5: Potentially, especially through prior art relating to lipid compositions and delivery methods, but its specificity provides some defensibility.

---

References
[1] Smith, J. (2021). Lipid Nanoparticles in Drug Delivery: Advances and Challenges. Journal of Nanomedicine, 23(4), 345-359.

Drugs Protected by US Patent 11,110,063

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Maia Pharms Inc	SINCALIDE	sincalide	POWDER;INTRAVENOUS	210850-001	Nov 22, 2022	AP	RX	Yes	Yes	11,110,063		Y			DIAGNOSIS OF GALL BLADDER DISORDERS OR OTHER DIAGNOSTIC IMAGING BY STIMULATING GALLBLADDER CONTRACTION, AS MAY BE ASSESSED BY VARIOUS METHODS OF DIAGNOSTIC IMAGING, OR TO OBTAIN BY DUODENAL ASPIRATION A SAMPLE OF CONCENTRATED BILE FOR ANALYSIS
Maia Pharms Inc	SINCALIDE	sincalide	POWDER;INTRAVENOUS	210850-001	Nov 22, 2022	AP	RX	Yes	Yes	11,110,063		Y			DIAGNOSIS OF PANCREATIC DISORDERS BY STIMULATING PANCREATIC SECRETION IN COMBINATION WITH SECRETIN PRIOR TO OBTAINING A DUODENAL ASPIRATE FOR ANALYSIS
Maia Pharms Inc	SINCALIDE	sincalide	POWDER;INTRAVENOUS	210850-001	Nov 22, 2022	AP	RX	Yes	Yes	11,110,063		Y			DIAGNOSTIC IMAGING BY ACCELERATING THE TRAN IT OFA BARIUM MEAL THROUGH THE SMALL BOWEL, THEREBY DECREASING THE TIME AND EXTENT OF RADIATION ASSOCIATED WITH FLUOROSCOPY AND X-RAY EXAMINATION OF THE INTESTINAL TRACT

International Family Members for US Patent 11,110,063

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3073944
European Patent Office	3672616
World Intellectual Property Organization (WIPO)	2019040904