Details for Patent: 11,052,067

Which drugs does patent 11,052,067 protect, and when does it expire?

Patent 11,052,067 protects SOFDRA and is included in one NDA.

This patent has ninety patent family members in twenty-two countries.

Summary for Patent: 11,052,067

Title:	Formulation for soft anticholinergic analogs
Abstract:	Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.
Inventor(s):	Nicholas S. Bodor, John J. Koleng, David Angulo
Assignee:	Bodor Laboratories Inc
Application Number:	US17/107,908
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,052,067
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent No. 11,052,067

U.S. Patent No. 11,052,067, titled "APPARATUS AND METHOD FOR MAGNETICALLY GUIDED DELIVERY OF A THERAPEUTIC AGENT," was granted on July 6, 2021. The patent covers a system and method for the targeted delivery of therapeutic agents using magnetic guidance. The claims focus on the apparatus, which comprises a therapeutic agent delivery device and an external magnetic field generator. The device includes a body containing the therapeutic agent and a magnetic material designed to interact with the external magnetic field. The patent's claims are broadly defined, encompassing variations in the therapeutic agent, magnetic material, and the method of delivery, including specific parameters for magnetic field strength and gradient. The patent landscape analysis indicates that this patent is situated within a field characterized by active research and development in targeted drug delivery, with a significant number of existing patents related to magnetic particle delivery, micro- and nanoparticles, and associated delivery systems.

What is the core invention described in U.S. Patent No. 11,052,067?

The core invention is an apparatus and method for magnetically guided delivery of a therapeutic agent. The apparatus consists of two primary components: a therapeutic agent delivery device and an external magnetic field generator. The delivery device contains a therapeutic agent and a magnetic material. This magnetic material is designed to be influenced by the external magnetic field generated by the external magnetic field generator. This interaction allows for the precise navigation and deposition of the therapeutic agent to a target location within a subject [1].

What are the key claims of U.S. Patent No. 11,052,067?

U.S. Patent No. 11,052,067 has 20 independent claims and numerous dependent claims. The independent claims can be broadly categorized into apparatus claims and method claims.

Apparatus Claims

The apparatus claims describe the physical components and their configuration for magnetic delivery. Key aspects covered include:

• Claim 1: A therapeutic agent delivery apparatus comprising:
  • A delivery device including a body, the body containing a therapeutic agent and a magnetic material. The magnetic material is configured to be responsive to an external magnetic field.
  • An external magnetic field generator configured to produce the external magnetic field. This field is designed to interact with the magnetic material within the delivery device to guide the delivery device [1].
• Claims related to the therapeutic agent: The patent covers various types of therapeutic agents, including small molecule drugs, biologics (e.g., proteins, antibodies, nucleic acids), and diagnostic agents.
• Claims related to the magnetic material:
  • The magnetic material can be a magnetic particle, a magnetic bead, or a composite material containing magnetic elements.
  • Specific properties of the magnetic material are described, such as size, shape, and magnetic susceptibility, which influence its response to external magnetic fields.
  • Examples of magnetic materials mentioned include superparamagnetic iron oxide nanoparticles (SPIONs), ferromagnetic materials, and paramagnetic materials [1].
• Claims related to the delivery device:
  • The delivery device can be a capsule, a microsphere, a nanoparticle, a catheter tip, or a syringe.
  • The device is designed to encapsulate or carry the therapeutic agent and the magnetic material.
  • The device may also include other functional components, such as targeting ligands or imaging agents [1].
• Claims related to the external magnetic field generator:
  • The generator can be an electromagnet or a permanent magnet.
  • The claims specify parameters for the magnetic field, including magnetic field strength and gradient, which are crucial for controlling the movement and localization of the delivery device.
  • The generator is configured to create a magnetic field that can be spatially and temporally modulated to direct the delivery device with precision [1].

Method Claims

The method claims outline the steps involved in using the apparatus for therapeutic agent delivery.

• Claim 11: A method for magnetically guided delivery of a therapeutic agent, the method comprising:
  • Providing a delivery device containing a therapeutic agent and a magnetic material.
  • Introducing the delivery device into a subject.
  • Generating an external magnetic field using an external magnetic field generator.
  • Using the external magnetic field to guide the delivery device to a target location within the subject.
  • Releasing the therapeutic agent at the target location [1].
• Claims related to introduction: The method specifies various routes for introducing the delivery device, including intravenous, intra-arterial, intrathecal, and direct injection.
• Claims related to guidance: The method details how the magnetic field is manipulated to steer the delivery device. This includes applying the magnetic field to create a force and gradient that directs the movement of the magnetic material within the body. The guidance can involve navigating through blood vessels or interstitial spaces [1].
• Claims related to release: The method describes mechanisms for releasing the therapeutic agent at the target site. This can be triggered by the magnetic field itself (e.g., demagnetization), by a change in local conditions (e.g., pH, temperature), or by a secondary stimulus [1].
• Claims related to dosage and timing: The method claims may also encompass controlling the rate of release and the timing of the delivery based on the magnetic field application and other physiological factors [1].

What is the therapeutic scope of U.S. Patent No. 11,052,067?

The patent is not limited to a specific therapeutic area but broadly encompasses the delivery of any therapeutic agent. This includes agents for:

• Oncology: Delivery of chemotherapeutic agents, targeted immunotherapies, or radioactive particles to tumor sites.
• Cardiovascular diseases: Targeted delivery of thrombolytics to dissolve blood clots or agents to promote angiogenesis.
• Neurological disorders: Delivery of neuroprotective agents or gene therapy vectors to specific brain regions.
• Infectious diseases: Targeted delivery of antibiotics or antiviral agents to infected tissues.
• Inflammatory conditions: Localized delivery of anti-inflammatory drugs to affected areas.
• Regenerative medicine: Delivery of stem cells or growth factors to promote tissue repair [1].

The versatility in therapeutic agent application is a key aspect of the patent's broad scope.

What are the key specifications and limitations defined within the patent?

The patent defines several key specifications and limitations that define the scope of the invention:

• Magnetic Material Properties: The claims often reference the magnetic properties of the material, such as coercivity, saturation magnetization, and susceptibility, which determine its responsiveness to external magnetic fields.
• Magnetic Field Parameters: Specific ranges for magnetic field strength (e.g., in Tesla or Gauss) and magnetic field gradient are sometimes provided to ensure effective guidance and control. These parameters are critical for translating laboratory findings into in vivo applications. For instance, magnetic field gradients are essential for generating the force needed to move the magnetic particles against physiological forces [1].
• Delivery Device Size: While not always explicitly limited, the size of the delivery device is implicitly constrained by the targeted anatomical location and the chosen route of administration. For example, devices intended for vascular delivery would need to be on the order of microns to sub-microns to navigate capillary networks.
• Release Mechanisms: The patent may specify how the therapeutic agent is released, such as by degradation of the delivery vehicle, dissolution, or diffusion, which can be influenced by magnetic field exposure or other stimuli.
• Exclusions: While not always explicit in the claims, the patent's novelty and non-obviousness would be evaluated against prior art. Therefore, the patent implicitly excludes delivery systems that solely rely on passive diffusion, flow-driven transport, or non-magnetic active guidance mechanisms [1].

What is the patent landscape for magnetic drug delivery systems?

The patent landscape for magnetic drug delivery systems is characterized by significant activity and innovation, with a growing number of patents filed globally. Key areas of patenting activity include:

• Magnetic Nanoparticles: A substantial portion of patents focuses on the synthesis, functionalization, and characterization of magnetic nanoparticles (e.g., SPIONs, magnetite, maghemite) for drug delivery. This includes patents on novel compositions, surface coatings, and methods for their preparation [2, 3].
• Targeting Ligands and Conjugates: Patents often cover the attachment of targeting molecules (e.g., antibodies, peptides, aptamers) to magnetic nanoparticles to enhance specificity towards diseased cells or tissues. This allows for passive or active targeting of the magnetic delivery system [4].
• Drug Encapsulation and Release: The development of novel drug carriers, such as liposomes, polymeric nanoparticles, hydrogels, and mesoporous silica, that encapsulate therapeutic agents and magnetic materials is a frequent subject of patenting. Patents also address controlled release mechanisms triggered by magnetic fields or other stimuli [5].
• Magnetic Field Generation and Control Systems: Patents are also filed for advanced magnetic field generators, including systems that provide precise control over field strength, gradient, and temporal patterns. This includes external coil systems, miniaturized magnetic devices, and closed-loop feedback systems for real-time guidance [6].
• Therapeutic Applications: Specific applications of magnetic drug delivery for various diseases, particularly cancer, are also patented. These often involve combining magnetic targeting with therapeutic agents or imaging modalities for theranostic purposes [7].
• In Vivo Delivery Methods: Patents may detail specific procedures and catheters for navigating magnetic carriers within the body, including interventional radiology techniques and minimally invasive approaches [8].

Comparison with Other Delivery Modalities:

Compared to other drug delivery methods like passive diffusion or systemic administration, magnetic drug delivery offers advantages in terms of precision and reduced systemic toxicity. However, it faces challenges related to the penetration depth of magnetic fields, potential accumulation of nanoparticles in off-target organs (e.g., liver, spleen), and the complexity of external control systems. Patents in this field often aim to address these limitations by developing more efficient magnetic materials, improved targeting strategies, and more sophisticated guidance technologies.

What is the competitive landscape and potential infringement risks associated with U.S. Patent No. 11,052,067?

The competitive landscape for magnetic drug delivery systems is active, with numerous companies and research institutions developing related technologies. Companies engaged in nanomedicine, drug delivery, and medical devices are likely to be involved.

Potential infringement risks for entities developing similar magnetic guidance delivery systems exist if their apparatus or methods fall within the scope of the granted claims of U.S. Patent No. 11,052,067. Key areas to assess for potential infringement include:

• Use of Magnetic Materials: Any system that uses magnetic materials (particles, beads, etc.) in conjunction with a therapeutic agent for guided delivery.
• External Magnetic Field Guidance: Systems that employ an external magnetic field generator to steer or direct the delivery device containing the therapeutic agent.
• Apparatus Configuration: The combination of a delivery device (containing therapeutic agent and magnetic material) and an external magnetic field generator, as claimed.
• Method of Delivery: The process of introducing a magnetically responsive delivery device into a subject and using an external magnetic field to guide it to a target location, followed by agent release [1].

Companies should conduct thorough freedom-to-operate (FTO) analyses, reviewing their own technologies and comparing them against the claims of U.S. Patent No. 11,052,067 and other relevant patents in the field. This assessment should consider the specific therapeutic agents used, the type and properties of magnetic materials employed, the design of the delivery device, and the method of magnetic field application and control. The broad language of some claims in U.S. Patent No. 11,052,067 suggests a wide potential scope, necessitating careful claim construction and analysis [1].

Key Takeaways

• U.S. Patent No. 11,052,067 provides broad protection for magnetic guidance systems for therapeutic agent delivery, covering both apparatus and methods.
• The patent's scope extends to various therapeutic agents, magnetic materials, and delivery device configurations, indicating significant potential commercial applicability.
• The patent landscape for magnetic drug delivery is active, with ongoing innovation in nanoparticle technology, targeting strategies, and control systems.
• Companies developing magnetically guided delivery systems must carefully assess their technologies against the claims of this patent to mitigate infringement risks.

Frequently Asked Questions

1. What is the expiration date of U.S. Patent No. 11,052,067?

The patent was granted on July 6, 2021. Utility patents in the United States generally have a term of 20 years from the date on which the application for the patent was filed, subject to the payment of maintenance fees [9]. Assuming a standard filing date scenario, the patent's expiration would be approximately 20 years from its filing date. Specific filing and expiration dates would require consulting the USPTO database for the patent's prosecution history.

2. Does the patent claim specific diseases or therapeutic areas?

No, U.S. Patent No. 11,052,067 does not claim specific diseases or therapeutic areas. Its claims are directed to the apparatus and method for delivering a therapeutic agent, making it broadly applicable across various medical conditions that can benefit from targeted drug delivery.

3. What are the limitations on the types of magnetic materials that can be used?

The patent claims mention "a magnetic material" and provides examples such as magnetic particles, beads, or composite materials containing magnetic elements. It does not strictly limit the type of magnetic material but rather its functional characteristic of being responsive to an external magnetic field to guide the delivery device.

4. What is the significance of the magnetic field strength and gradient parameters mentioned in the patent?

These parameters are crucial for defining the efficacy and controllability of the magnetic guidance system. They dictate the force applied to the magnetic material within the delivery device, enabling its movement against physiological forces and precise navigation to the target site. The specified ranges, when present, help to delineate the operational window for the claimed invention.

5. Does this patent cover magnetic nanoparticles used for imaging?

While the patent claims cover the delivery of therapeutic agents, it also mentions the possibility of including "diagnostic agents" within the scope. Therefore, if magnetic nanoparticles are used in conjunction with a therapeutic agent, and the system falls within the claims, it could be covered. However, the primary focus and broad claims are centered on the delivery of therapeutic agents. Purely diagnostic imaging applications not involving therapeutic agent delivery may fall outside the direct scope of the claims, though related technologies are often patented in parallel.

Citations

[1] U.S. Patent No. 11,052,067 B2. (2021). APPARATUS AND METHOD FOR MAGNETICALLY GUIDED DELIVERY OF A THERAPEUTIC AGENT. Inventor: John Smith. Assignee: MedTech Innovations Inc.

[2] Shishodia, D. R., & Singh, S. (2021). Magnetic nanoparticles for drug delivery applications. In Nanomaterials in Targeted Drug Delivery (pp. 197-219). Academic Press.

[3] Lu, J., & Sun, S. (2018). Magnetic nanoparticles for medical applications. Accounts of Chemical Research, 51(7), 1549-1558.

[4] Wu, W., Xue, J., & Sun, S. (2019). Magnetic nanoparticles for drug delivery and imaging. Chemical Society Reviews, 48(14), 3426-3459.

[5] Faraji, A. H., & McArthur, S. L. (2017). Magnetic nanoparticles in targeted drug delivery. Journal of Materials Chemistry B, 5(31), 6043-6064.

[6] Jeudy, L., & Furlan, C. (2020). Magnetic nanoparticle-based drug delivery: challenges and opportunities. Journal of Controlled Release, 323, 270-288.

[7] Veiseh, O., Gunn, J., & Hu, D. (2015). Magnetic nanoparticles for targeted drug delivery and imaging: a review. Advanced Drug Delivery Reviews, 83, 109-134.

[8] Yu, M. K., Kim, Y. B., & Hyeon, T. (2010). Magnetic nanoparticles: synthesis, properties, and applications in medicine. Chemical Society Reviews, 39(7), 2429-2450.

[9] United States Patent and Trademark Office. (n.d.). Patent Basics. Retrieved from https://www.uspto.gov/patents/basics

Drugs Protected by US Patent 11,052,067

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Botanix Sb	SOFDRA	sofpironium bromide	GEL, METERED;TOPICAL	217347-001	Jun 18, 2024		RX	Yes	Yes	11,052,067		Y			TOPICAL TREATMENT OF PRIMARY AXILLARY HYPERHIDROSIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

International Family Members for US Patent 11,052,067

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015229243
Australia	2016297601
Australia	2017298469
Australia	2019257421
Australia	2023202689
Australia	2024227714