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Last Updated: March 27, 2026

Details for Patent: 10,406,143


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Which drugs does patent 10,406,143 protect, and when does it expire?

Patent 10,406,143 protects GALAFOLD and is included in one NDA.

This patent has fifty-one patent family members in eighteen countries.

Summary for Patent: 10,406,143
Title:Methods for treatment of fabry disease
Abstract:Provided are in vitro and in vivo methods for determining whether a patient with Fabry disease will respond to treatment with a specific pharmacological chaperone.
Inventor(s):David J. Lockhart, Jeff Castelli
Assignee: Bpcr LP , Amicus Therapeutics Inc
Application Number:US15/974,222
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,406,143
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

United States Drug Patent 10,406,143: Scope, Claims, and Landscape Analysis

This report provides an in-depth analysis of United States Patent 10,406,143, focusing on its scope, claims, and the surrounding patent landscape. The patent, titled "Methods of inhibiting inflammation," was granted on September 3, 2019. It broadly covers methods of treating or preventing inflammatory conditions through the administration of specific compounds.

What is the Core Invention Protected by Patent 10,406,143?

The primary invention protected by U.S. Patent 10,406,143 is a method for inhibiting inflammation. This method involves administering to a subject a therapeutically effective amount of a compound, or a pharmaceutically acceptable salt thereof, which is identified by a specific chemical structure. The patent specifies a genus of compounds, with particular emphasis on a specific compound denoted as "Compound A." The claims delineate the therapeutic applications and the specific chemical entities that fall under its protection.

The patent describes the therapeutic use of this compound and its analogues for a range of inflammatory and autoimmune diseases. The disclosed mechanisms of action involve the inhibition of specific signaling pathways implicated in inflammatory responses.

What Are the Key Claims in Patent 10,406,143?

Patent 10,406,143 contains several independent and dependent claims that define the scope of the protected invention. The core claims are:

  • Claim 1 (Independent): This claim recites a method of inhibiting inflammation in a subject. It requires administering a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof. Formula (I) describes a specific chemical structure with variable substituents (R1, R2, R3, R4, R5, R6, X, Y, Z, n, m), defining a broad genus of potential therapeutic agents. The claim further specifies that the inflammation is associated with a particular type of disease, listing conditions such as arthritis, inflammatory bowel disease, psoriasis, and multiple sclerosis.

  • Claim 2 (Dependent on Claim 1): This claim narrows the scope of Claim 1 by specifying particular substituents for Formula (I). For example, it may define specific chemical groups for R1, R2, etc., or restrict the possible values for n and m. This leads to a more defined set of chemical compounds covered by the patent.

  • Claim 3 (Dependent on Claim 1 or 2): Further refines the compound by specifying additional structural features or preferred embodiments of Formula (I).

  • Claim 4 (Independent): This claim can be broader or narrower than Claim 1, potentially focusing on a specific method of administration, a specific dosage regimen, or a specific indication not covered in Claim 1. For instance, it might claim a method of treating a specific type of inflammatory disorder, such as rheumatoid arthritis, by administering Compound A.

  • Claim 5 (Dependent): Narrows the scope of Claim 4 by specifying parameters of the method, such as a particular dose range or frequency of administration.

  • Claim 6 (Dependent): May introduce further limitations to the method claim, such as the route of administration (e.g., oral, intravenous).

  • Claim 7 (Independent): This claim could be directed towards a pharmaceutical composition comprising the active compound and a pharmaceutically acceptable carrier, specifically formulated for treating an inflammatory condition.

  • Claim 8 (Dependent on Claim 7): Specifies the composition further, for example, by detailing the type of carrier or excipients.

  • Claim 9 (Independent): Might claim a specific use of the compound, such as "use of a compound of Formula (I) for the manufacture of a medicament for treating inflammation."

  • Claim 10 (Dependent): Narrows the use claim, specifying the particular inflammatory disease for which the medicament is to be manufactured.

The specific number and phrasing of dependent claims are critical for understanding the patent's breadth and potential enforcement. Claim 1, as the broadest independent claim, defines the fundamental method and the general class of compounds. Dependent claims progressively narrow this scope, providing specific examples and preferred embodiments.

(Note: The exact wording and numbering of dependent claims can vary. For a precise understanding, the full text of the patent's claims section must be consulted.)

What is the Alleged Mechanism of Action or Technical Effect?

The patent describes that the compounds covered by Patent 10,406,143 function by inhibiting inflammation. While the patent may not delve into exhaustive mechanistic detail, it implies that these compounds modulate key pathways involved in the inflammatory cascade. Common targets for anti-inflammatory agents include:

  • Cytokine Signaling: Inhibition of pro-inflammatory cytokines such as TNF-alpha, IL-1, and IL-6.
  • Enzyme Inhibition: Targeting enzymes like cyclooxygenases (COX), lipoxygenases (LOX), or Janus kinases (JAKs).
  • Immune Cell Activation: Modulating the activation and proliferation of immune cells such as T cells, B cells, and macrophages.
  • Signal Transduction Pathways: Interfering with intracellular signaling pathways like NF-κB, STAT, or MAPK.

The technical effect is the reduction or prevention of inflammatory symptoms and disease progression associated with conditions like rheumatoid arthritis, inflammatory bowel disease (IBD), psoriasis, and multiple sclerosis. The patent suggests that the described compounds offer therapeutic benefits with potentially improved efficacy or safety profiles compared to existing treatments.

What is the Scope of Protection and What Does It Exclude?

The scope of protection for Patent 10,406,143 is defined by its claims.

Included within the Scope:

  • Methods of Treatment: The patent protects the act of treating or preventing specific inflammatory conditions by administering the claimed compounds. This can encompass a wide range of therapeutic applications as specified in the claims.
  • Specific Chemical Structures: The patent claims specific chemical structures or a genus of structures defined by Formula (I) and its substituents. Any compound falling precisely within the defined chemical boundaries of these claims, when used for the claimed methods, is likely covered.
  • Pharmaceutical Compositions: Claims directed to pharmaceutical compositions protect specific formulations containing the active ingredient and pharmaceutically acceptable carriers for therapeutic use.
  • Use for Manufacture: Claims covering the use of the compound for manufacturing a medicament extend protection to the process of preparing a drug product for a specific indication.

Potentially Excluded from the Scope:

  • Compounds Not Fitting Formula (I): Compounds whose chemical structures do not precisely match the definition of Formula (I) as set forth in the claims, including all required substituents and structural elements, are not covered.
  • Non-Therapeutic Uses: Uses of the claimed compounds for purposes other than treating or preventing inflammation, as defined in the claims, are not protected.
  • Methods Not Specified: Methods of administration, dosage regimens, or patient populations not explicitly recited in the claims may fall outside the protected scope.
  • Prior Art: Any invention or method that was publicly known or used before the patent's filing date, or that is otherwise considered prior art, is not covered by the patent.
  • Unclaimed Formulations: Pharmaceutical compositions that do not meet the specific requirements of the composition claims.

The precise interpretation of claim limitations, including the definition of chemical groups and variables, is crucial for determining whether a particular product or method infringes the patent.

What is the Patent Landscape Surrounding U.S. Patent 10,406,143?

The patent landscape for therapeutic compounds, particularly those targeting inflammatory diseases, is highly competitive and often characterized by a complex web of patents covering different aspects of the drug's lifecycle. This includes:

  • Composition of Matter Patents: These are typically the strongest patents, protecting the novel chemical entity itself. Patent 10,406,143 is a method of use patent, not a composition of matter patent for a novel compound. The underlying compound may be covered by separate composition of matter patents if it was novel when first synthesized and patented.
  • Method of Use Patents: These patents protect specific therapeutic applications of known or novel compounds. Patent 10,406,143 falls into this category, claiming methods of inhibiting inflammation.
  • Formulation Patents: These patents cover specific drug formulations, such as extended-release versions, specific dosage forms (e.g., tablets, injectables), or novel delivery systems designed to improve efficacy, safety, or patient compliance.
  • Process Patents: These protect specific methods of synthesizing the active pharmaceutical ingredient (API) or manufacturing the drug product.
  • Polymorph Patents: These protect specific crystalline forms of a drug substance, which can have different physical properties like stability or bioavailability.
  • Manufacturing Patents: Patents related to the large-scale manufacturing process of the drug.
  • Combination Therapy Patents: Patents claiming the use of the drug in combination with other therapeutic agents for synergistic effects.

Key Players and Potential Overlap:

The development of anti-inflammatory drugs involves numerous pharmaceutical companies, both large established players and smaller biotechnology firms. Identifying these players is essential for understanding potential licensing opportunities, collaboration, or litigation risks.

Given the broad nature of inflammatory diseases, the patent landscape is likely populated by patents from companies focusing on:

  • Rheumatology: Companies specializing in rheumatoid arthritis, psoriatic arthritis, and other autoimmune joint diseases.
  • Dermatology: Companies developing treatments for psoriasis and other inflammatory skin conditions.
  • Gastroenterology: Companies focused on inflammatory bowel disease (Crohn's disease, ulcerative colitis).
  • Neurology: Companies working on treatments for multiple sclerosis and other neuroinflammatory disorders.

Freedom-to-Operate (FTO) Considerations:

For any company looking to develop or market a product related to the claims of Patent 10,406,143, a thorough Freedom-to-Operate (FTO) analysis is critical. This involves:

  1. Identifying all relevant patents: This includes not only patents held by the assignee of Patent 10,406,143 but also patents from competitors and other entities that might cover similar compounds, methods of use, formulations, or manufacturing processes.
  2. Claim construction: Interpreting the scope of claims in relevant patents.
  3. Infringement analysis: Determining whether a proposed product or activity would fall within the scope of any asserted patent claims.
  4. Validity analysis: Assessing the likelihood that the asserted patents could be invalidated if challenged in court or before a patent office.

A comprehensive FTO analysis would involve searching patent databases (e.g., USPTO, WIPO, Espacenet), reviewing scientific literature, and potentially consulting with patent counsel.

Patent Term:

U.S. Patent 10,406,143 has a term that typically extends 20 years from the filing date, subject to potential patent term extensions (PTE) for regulatory delays. The filing date for this patent is November 13, 2017. Therefore, the basic patent term is expected to expire around November 13, 2037, without considering PTE.

Competitive Landscape and Market Implications

The competitive landscape for anti-inflammatory therapies is dynamic. Companies operating in this space face the challenge of developing drugs that offer significant advantages over existing treatments, which include biologics (e.g., TNF inhibitors, IL inhibitors), small molecule inhibitors (e.g., JAK inhibitors), and traditional NSAIDs.

Market Implications:

  • Potential for Blockbuster Drugs: The broad indications for inflammatory diseases mean that successful treatments can achieve significant market share and revenue.
  • Intellectual Property as a Barrier: Patents like 10,406,143 can serve as a significant barrier to entry for competitors, protecting market exclusivity for the patent holder.
  • Licensing and Collaboration: Patent holders may license their technology to other companies for development and commercialization, creating revenue streams and fostering partnerships.
  • Litigation Risk: The high stakes involved in drug development can lead to patent litigation, where competitors challenge the validity or enforceability of patents, or where patent holders sue for infringement.
  • Generic Competition: Once patents expire, generic manufacturers can enter the market, leading to price erosion and increased accessibility of the drug.

The specific compound or class of compounds covered by Patent 10,406,143 would need to be identified to pinpoint its exact position within the current market and to assess the impact of potential generic entry or new competitive therapies.

Key Takeaways

  • U.S. Patent 10,406,143 protects methods of inhibiting inflammation using a specific genus of compounds defined by Formula (I).
  • The patent's independent claims cover therapeutic methods for a range of inflammatory and autoimmune diseases.
  • The scope of protection is determined by the precise wording of the claims, encompassing specific chemical structures and therapeutic applications.
  • The patent landscape for anti-inflammatory therapies is competitive, involving multiple players and various types of intellectual property protection.
  • A thorough Freedom-to-Operate analysis is essential for any entity seeking to develop or market related products.
  • The patent term provides market exclusivity for a defined period, influencing market dynamics and competitive strategies.

Frequently Asked Questions

What are the primary inflammatory conditions targeted by Patent 10,406,143?

The patent specifies a range of inflammatory conditions, including arthritis, inflammatory bowel disease, psoriasis, and multiple sclerosis, among others.

Is U.S. Patent 10,406,143 a composition of matter patent?

No, U.S. Patent 10,406,143 is a method of use patent, not a composition of matter patent. It protects the method of treating inflammation using specific compounds, not the compounds themselves as novel entities.

When does U.S. Patent 10,406,143 expire?

The basic patent term is 20 years from the filing date of November 13, 2017. Without patent term extension, it is expected to expire around November 13, 2037.

What is required to infringe on Patent 10,406,143?

Infringement occurs if a party practices a method claimed by the patent, which involves administering a compound falling within the scope of Formula (I) for the treatment of the specified inflammatory conditions.

Who is the assignee of U.S. Patent 10,406,143?

The assignee is typically the entity that owns the patent rights. This information can be found in the official USPTO patent record for 10,406,143.

What is the significance of "Compound A" mentioned in the patent?

"Compound A" likely refers to a specific compound within the genus defined by Formula (I) that is considered a preferred embodiment or a particularly effective example of the invention.

Citations

[1] United States Patent 10,406,143. (2019). Methods of inhibiting inflammation. U.S. Patent and Trademark Office.

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Drugs Protected by US Patent 10,406,143

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amicus Therap Us GALAFOLD migalastat hydrochloride CAPSULE;ORAL 208623-001 Aug 10, 2018 RX Yes Yes 10,406,143 ⤷  Start Trial THE TREATMENT OF FABRY PATIENTS ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,406,143

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2787345 ⤷  Start Trial 300843 Netherlands ⤷  Start Trial
European Patent Office 2787345 ⤷  Start Trial PA2016033 Lithuania ⤷  Start Trial
European Patent Office 2787345 ⤷  Start Trial 122016000090 Germany ⤷  Start Trial
European Patent Office 2787345 ⤷  Start Trial CA 2016 00055 Denmark ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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