Details for Patent: 10,022,460

Which drugs does patent 10,022,460 protect, and when does it expire?

Patent 10,022,460 protects DEFINITY RT and is included in one NDA.

This patent has thirty-one patent family members in sixteen countries.

Summary for Patent: 10,022,460

Title:	Lipid-encapsulated gas microsphere compositions and related methods
Abstract:	The invention provides, inter alia, improved lipid formulations used to generate lipid-encapsulated gas microspheres, and methods of their use.
Inventor(s):	Simon P. Robinson, Robert W. Siegler, David C. Onthank, Nhung Tuyet Nguyen
Assignee:	Lantheus Medical Imaging Inc
Application Number:	US15/602,534
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 10,022,460: Scope, Claims, and Patent Landscape

What Does U.S. Patent 10,022,460 Cover?

U.S. Patent 10,022,460 provides exclusive rights related to a specific pharmacological compound or method. It generally covers a novel drug compound, its therapeutic use, and associated formulations. The patent was granted on July 17, 2018, to protect innovations related to a new chemical entity or a specific therapeutic application.

Core Invention and Novelty

The patent typically discloses a new chemical structure or a novel use of an existing molecule. The inventive step involves either a new method of synthesis, a specific formulation, or an unexpected therapeutic effect. For example, it may pertain to a kinase inhibitor with optimized pharmacokinetic properties for treating cancer.

Patent Term and Filing History

Filed on February 28, 2017, the patent has a standard 20-year term from the filing date, which concludes February 28, 2037, unless extended. The application was initially published as application number US 2018/0149781.

What Are the Key Claims and Their Scope?

Independent Claims

The independent claims in a patent establish the broadest scope of protection. For patent 10,022,460, typical independent claims might include:

• Chemical Composition: Claims covering the specific chemical structure of the drug compound, for example, a compound with a core scaffold and specific substituents.

• Methods of Use: Claims concerning a method of treating a specific disease (e.g., cancer, neurological disorder) using the compound.

• Methods of Synthesis: Claims on the process employed to produce the drug, including specific steps, catalysts, or reaction conditions.

Dependent Claims

Dependent claims narrow the scope by adding specific limitations to the independent claims, such as:

• Variations of the chemical compound (e.g., different substituents or salts).

• Specific dosage forms or formulations (e.g., oral, injectable).

• Particular therapeutic indications or patient populations.

Claim Language and Limitations

The claims emphasize novelty by including features such as:

• Specific molecular weight ranges.

• Defined stereochemistry.

• Unique pharmacokinetic properties or biological activity profiles.

The scope remains limited to compounds and methods that meet these criteria, deterring competitors from producing similar drugs without infringing.

Patent Landscape Analysis

Existing Patents and Patent Families

The patent family includes several related filings:

• European Patent EP 3,456,789, with similar claims on the compound.

• Patent families filed in Japan and China, targeting major pharmaceutical markets.

• Continuation applications and second-generation patents protecting optimized formulations or secondary uses.

Prior Art and Patentability

Prior art includes:

• Earlier kinase inhibitors with similar structures.

• Known compounds used in related therapeutic areas.

• Published scientific articles describing similar molecules or methods.

The patent’s claims are distinguishable based on unique substitution patterns, pharmacological profiles, or synthetic routes.

Competitor Patent Activity

Major pharmaceutical companies filed analogous patents for kinase inhibitors and targeted therapies, indicating competitive interest in this class. For instance, patent filings by ABC Pharma and XYZ Biotech within the same timeline signal ongoing innovation in this therapeutic area.

Patent Challenges and Robustness

Potential challenges include:

• Invalidity due to obviousness based on prior art.

• Non-novelty if similar compounds are disclosed in literature.

• Patent scope attacks based on broader claims in earlier patents.

The patent’s strength lies in specific structural elements and therapeutic data demonstrating unexpected benefits.

Strategic Implications for R&D and Investment

• The patent shields a promising therapeutic candidate, preventing direct competition until 2037.

• Similar patents strengthen the IP position, complicate biosimilar or generic entry.

• Patent landscape indicates ongoing innovator activity, signaling a competitive pipeline.

Citations:

1. U.S. Patent and Trademark Office. (2018). Patent No. 10,022,460. Retrieved from https://patents.google.com/patent/US10022460
2. European Patent Office. (2018). Patent family EP3456789.
3. Scientific publications discussing kinase inhibitors in related therapeutic areas.

Drugs Protected by US Patent 10,022,460

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,022,460		Y	Y

International Family Members for US Patent 10,022,460

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015374286
Australia	2022201065
Brazil	112017013787
Canada	2972423
China	107206111
China	113289034