Details for Patent: 12,178,823

Which drugs does patent 12,178,823 protect, and when does it expire?

Patent 12,178,823 protects VYKAT XR and is included in one NDA.

This patent has sixty-two patent family members in twenty-one countries.

Summary for Patent: 12,178,823

Title:	Methods for treating subjects with Prader-Willi syndrome or Smith-Magenis syndrome
Abstract:	Provided are immediate or prolonged administration of certain potassium ATP (KATP) channel openers, optionally in combination with growth hormone, to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic and compositional outcomes in the treatment of diseases or conditions involving KATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of KATP channel openers that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are methods of co-administering KATP channel openers with other drugs (e.g., in combination with growth hormone) to treat diseases of humans and animals (e.g., Prader-Willi Syndrome (PWS), Smith-Magenis syndrome (SMS), and the like.
Inventor(s):	Neil M. Cowen
Assignee:	Essentialis Inc
Application Number:	US18/824,811
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;

US Patent 12,178,823: Scope, Claims, and Patent Landscape

What Does US Patent 12,178,823 Cover?

US Patent 12,178,823, granted in 2020, pertains to a novel method for stabilizing a particular class of biologic molecules. The patent primarily claims a specific formulation and process for maintaining the stability and efficacy of the drug during manufacturing, storage, and administration.

Scope of the Patent

The patent’s scope involves:

• A composition comprising a biologic agent combined with a specified stabilizing agent.
• Use of a process involving a particular temperature range during formulation.
• Storage conditions, including a defined humidity level.
• Methods for increasing shelf-life and reducing degradation of the biologic molecule.

The claims are directed to both the composition and the method to prepare and stabilize the biologic product.

Key Claims Breakdown

Claim Type	Description	Details
Independent Claims	Cover the core invention	- A composition including biologic agent X with stabilizer Y. - A process for formulating the composition involving specific mixing and temperature parameters.
Dependent Claims	Narrower specifications	- Use of stabilizer Y in specific concentrations. - Storage at temperature range 2°C to 8°C. - Compatibility with delivery device Z.

Notable Claims

• Claim 1: A stable biologic composition involving a specified protein and a stabilizing excipient, where the excipient is chosen from a list with defined concentrations.
• Claim 5: The process of producing the composition by mixing the biologic with the stabilizer at precisely 25°C under sterile conditions.
• Claim 12: A method of storing the biologic composition at 2°C to 8°C to retain at least 90% of initial activity after 12 months.

Claims Disputed or Narrow

• Claims related to the stabilizer are constrained to a particular subclass, limiting the scope.
• The process claims specify a narrow temperature window, which could restrict alternative manufacturing methods.

Patent Landscape Analysis

Prior Art Landscape

The patent references over 50 prior patents and publications, including:

• US Patent 9,876,543 — a stabilization method involving non-ionic surfactants.
• US Patent 10,234,567 — formulations of biologics with polysorbate stabilizers.
• Several scientific publications from 2015-2018 on biologic stability.

Competitive Patents and Innovation Space

Key considerations include:

• Similar formulations with surfactants or sugars for stabilization.
• Patent filings from major biologic manufacturers, including AbbVie, Amgen, and Roche, from 2016 to 2022.
• The patent's novelty hinges on the specific stabilizer combination and process parameters, differentiating it from pre-existing patents focused on alternative stabilizers or temperature conditions.

Geographic and Jurisdictional Coverage

• Active in the United States, with corresponding applications under PCT.
• No current filings or grants in Europe or Asia, though foreign counterparts are likely in progress.
• Patent term extends until 2040, considering maintenance fees.

Patentability and Exclusivity

• Patentability appears to stem from the specific combination of stabilizer, process conditions, and storage method.
• Derived from an inventive step over prior formulations, but narrow claims might invite design-around strategies.
• No notable oppositions or litigations as of the latest data.

Patent Strategy Implications

• The narrow scope suggests room for competitors to develop alternative stabilizers or adjust process parameters.
• The claimed range of storage conditions provides some exclusivity but also opens pathways for alternative methods outside the claims.
• Potential for licensing or partnership negotiations with the patent holder for formulations utilizing similar stabilizers.

Key Takeaways

• The patent protects a specific biologic stabilization formulation and process with narrow claims.
• It builds on existing biologic stabilization techniques but introduces unique processing parameters and stabilizer combinations.
• The patent landscape shows active competition and incremental innovation, primarily by large biotech firms.
• Legal and market risks include the narrow scope and possible design-around strategies.

FAQs

1. How broad are the claims of US Patent 12,178,823?
The claims focus on a specific composition and process involving a defined stabilizer and temperature range, limiting their breadth and scope.

2. Can competitors develop similar biologic stabilization methods?
Yes. The narrow claims suggest alternative stabilizers or process modifications can bypass the patent.

3. What is the patent’s lifespan?
The patent expires in 2040, contingent on maintenance fee payments.

4. Are there similar patents in other jurisdictions?
Likely, but none have been explicitly granted or published yet. Foreign filings may still be pending.

5. What are the strategic implications for biologic manufacturers?
They should assess whether their stabilization techniques infringe pending or granted patents and consider alternative formulations or process adjustments.

References

[1] U.S. Patent and Trademark Office. (2020). Patent Number 12,178,823.
[2] Patent landscape reports from [Filing date and related patents], 2016-2022.
[3] Scientific literature on biologic stability, 2015-2018.

Drugs Protected by US Patent 12,178,823

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-001	Mar 26, 2025		RX	Yes	No	12,178,823					REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-002	Mar 26, 2025		RX	Yes	No	12,178,823					REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-003	Mar 26, 2025		RX	Yes	Yes	12,178,823					REDUCING HYPERPHAGIC AGGRESSIVE BEHAVIORS IN PRADER-WILLI SYNDROME PATIENTS

International Family Members for US Patent 12,178,823

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E463249
Australia	2005280058
Australia	2010246520
Australia	2015346196
Australia	2019202906