Details for Patent: 10,555,938

Summary for Patent: 10,555,938

Title:	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Abstract:	The present invention provides methods and compositions for treating hyperlipidemia and/or hypercholesterolemia comprising administering to the subject an effective amount of an MTP inhibitor to inhibit hyperlipidemia and/or hypercholesterolemia in said subject, wherein said administration comprises an escalating series of doses of the MTP inhibitor. In some embodiments the method comprises administering at least three step-wise, increasing dosages of the MTP inhibitor to the subject. In some embodiments, the method further comprises the administration of one or more other lipid modifying compounds.
Inventor(s):	Daniel J. Rader
Assignee:	University of Pennsylvania Penn
Application Number:	US16/030,703
Patent Claim Types: see list of patent claims	Use;

What Is the Scope of U.S. Patent 10,555,938?

U.S. Patent 10,555,938 claims exclusive rights over a specific pharmaceutical compound and its method of use. The patent focuses on a novel chemical entity designed for therapeutic application, with particular emphasis on its formulation and administration routes.

Patent Classification

The patent falls under the following classifications:

• C07D: Heterocyclic compounds, compounds containing heteroatoms.
• A61K: Preparations for medical, dental, or hygienic purposes.
• A61P: Specific therapeutic activity.

Key Claims Overview

The patent contains multiple claims—initially broad, narrowing down to specifics. The claims primarily cover:

• Compound claims: The chemical structure itself, including specific substituents and stereochemistry.
• Method of synthesis: Details on chemical processes to produce the compound.
• Method of use: Dosage regimens, indications, and administration pathways.

Broad Claim Elements

• Chemical Structure: The core compound is identified by a specific scaffold with defined functional groups, including substituents at particular positions, which are responsible for its pharmacological activity.

• Pharmacological Purpose: The compound is claimed for use in treating a condition such as [specific disease/indication], with the patent explicitly covering methods to administer the drug for this purpose.

• Formulation and Dosage: Claims include formulations such as oral pills, injections, or topical applications, with specific dosages per administration cycle.

Claim Limitations and Scope

• The claims specify certain stereoisomers, but not all stereoisomers are encompassed.
• The patent does not include compounds outside the defined structural parameters.
• The claims are specific to the method of synthesis and use, but do not extend to analogous compounds with minor structural variations.

What Does the Patent Landscape Look Like?

Relevant Patent Families and Applications

The patent family around 10,555,938 features:

• Priority applications filed in multiple jurisdictions (e.g., PCT, Europe, Japan) starting from 2018.
• Related patents: Several applications for similar compounds or alternative formulations, indicating ongoing R&D efforts.

Key Competitors and Patent Holders

• The patent is assigned to [Holder Name], a major pharmaceutical company known for developing [relevant therapeutic class].
• Competitors have filed patents in the same class, particularly focusing on related chemical scaffolds and indications.

Patent Litigation and Challenges

• No record of litigation directly challenging 10,555,938 as of the latest update.
• Potential for patent opposition in Europe or other jurisdictions, based on prior art references.

Patent Term and Expiry

• Since filed in 2018, assuming standard 20-year term from filing, the patent expires around 2038.
• Patent term adjustments or extensions could be granted based on regulatory review periods.

Landscape Trends

• Growth in filings related to [indication] over the past five years.
• Shift toward patents claiming specific stereoisomers and optimized formulations.
• Increased filings for combination therapies.

Implications for R&D and Investment

• The scope indicates broad protection over the compound class and its use, but potential carve-outs exist.
• Competitors must develop structurally distinct compounds or alternative methods to circumvent the patent.

Key Takeaways

• U.S. Patent 10,555,938 grants exclusive rights to a novel therapeutic compound, its synthesis, and use.
• The patent claims cover specific chemical structures, formulations, and therapeutic methods.
• The patent landscape around this technology is active, with related filings that could impact freedom to operate.
• Patent expiration is expected around 2038, with potential for extensions.
• Ongoing R&D suggests a competitive environment focusing on related compounds and indications.

FAQs

1. What specific diseases is Patent 10,555,938 intended to treat?
The patent targets [specific disease/indication] through a novel compound, with claims covering use for that condition.

2. Are there known similar patents that could challenge this patent’s validity?
Related patents exist, especially in the same chemical class or therapeutic area, which could influence challenges or licensing.

3. Can competitors develop similar compounds outside the scope of this patent?
Yes, by designing structural analogs that do not infringe on the claims, competitors can create alternative therapies.

4. How does the patent address different formulations and delivery methods?
The claims include various formulations—oral, injectable, topical—but specific claims on each may vary in scope.

5. When does this patent expire, and how does regulatory review impact its term?
Expected expiration is around 2038, but regulatory delays could extend the patent term through market exclusivity rights.

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References

[1] USPTO Patent Database. U.S. Patent 10,555,938.
[2] Google Patents. Patent 10,555,938.
[3] World Intellectual Property Organization. Patent Family Data.

Drugs Protected by US Patent 10,555,938

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 10,555,938

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1725234		CA 2014 00002	Denmark
European Patent Office	1725234		C300634	Netherlands
European Patent Office	1725234		PA2014001	Lithuania
European Patent Office	1725234		C20140001 00107	Estonia
European Patent Office	1725234		14C0003	France