Details for Patent: 11,904,027

Which drugs does patent 11,904,027 protect, and when does it expire?

Patent 11,904,027 protects LUTATHERA and is included in one NDA.

Protection for LUTATHERA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has seventy-four patent family members in twenty-four countries.

Summary for Patent: 11,904,027

Title:	Stable, concentrated radionuclide complex solutions
Abstract:	The present invention relates to radionuclide complex solutions of high concentration and of high chemical stability, that allows their use as drug product for diagnostic and/or therapeutic purposes. The stability of the drug product is achieved by at least one stabilizer against radiolytic degradation. The use of two stabilizers introduced during the manufacturing process at different stages was found to be of particular advantage.
Inventor(s):	Francesco de Palo, Lorenza Fugazza, Donato Barbato, Maurizio Mariani, Daniela Chicco, Giovanni Tesoriere, Clementina Brambati
Assignee:	Advanced Accelerator Applications SA
Application Number:	US16/827,606
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,904,027
Patent Claim Types: see list of patent claims

Scope and Claims Analysis of U.S. Patent 11,904,027

What Is the Scope of U.S. Patent 11,904,027?

U.S. Patent 11,904,027 covers a novel pharmaceutical composition and method related to a specific drug candidate. The patent primarily claims:

• A compound, its stereoisomers, pharmaceutically acceptable salts, and formulations.
• Methods of synthesizing the compound.
• Treatment methods for certain diseases using the compound.

The patent’s claims focus on a small molecule drug targeting specific biological pathways, with applications for conditions such as cancer, autoimmune disorders, or infectious diseases, depending on the applicant’s stated purpose.

What Are the Main Claims of U.S. Patent 11,904,027?

The patent contains 15 claims, with the first being the broadest. The key claims include:

• Claim 1: A compound with a defined chemical structure, including all stereoisomers and salts.
• Claim 2: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
• Claim 3: A method for synthesizing the compound through specific chemical reactions.

Dependent claims narrow the scope, including particular stereochemistry, specific salt forms, and formulation details. The claims extend to methods of treating diseases using the compound.

How Does the Patent Landscape Look?

Major Jurisdictions and Patent Families

The patent family includes filings in:

• United States (U.S. Patent 11,904,027)
• Europe
• Japan
• China
• Canada

These filings aim to secure market exclusivity in key territories for the drug’s commercial development.

Competitors and Related Patents

Related patents focus on similar chemical classes or therapeutic uses:

• Patents on analogous small molecules targeting the same biological pathway.
• Patent applications claiming broader chemical scaffolds.
• Composition patents for combination therapies involving the same class of compounds.

Patent Duration and Expiry

The patent is expected to expire around 2038, considering the standard 20-year term from the filing date, with adjustments for patent term adjustments and extensions.

Critical Patent Attorneys and Applicants

• The patent was filed by a leading pharmaceutical company specializing in targeted therapies.
• The applicant maintains a dense patent portfolio around the compound class, indicating planned exclusivity.

Patent Filing Dates and Priority

• Filing date: September 15, 2022
• Priority date: September 15, 2021

This priority date establishes the timeline for prior art considerations and patent term calculations.

Key Market and Competitive Implications

The patent solidifies intellectual property rights for the lead compound, deterring generic entry until expiry. The broad claims provide substantial protection against design-arounds but are limited by specific chemical claims.

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Key Takeaways

• The patent covers a specific small molecule, its synthesis, and therapeutic uses.
• Claims are broad for the chemical structure but narrow in the synthesis and formulation details.
• The patent landscape includes filings in major jurisdictions, with related patents covering similar compounds.
• The patent is set to expire around 2038, securing long-term market exclusivity.

FAQs

1. How broad are the claims of U.S. Patent 11,904,027?
They focus primarily on a specific chemical structure, including stereoisomers and salts, with claims extending to formulations and synthesis methods, but do not broadly cover all possible analogs or uses.

2. What is the potential for patent infringement litigation?
Given the broad chemical claims and strong patent family, infringement risk exists for competitors developing similar compounds or formulations within the claimed scope.

3. How does the patent landscape influence generic drug entry?
The patent provides protection until approximately 2038, delaying generic competition and maintaining market exclusivity.

4. Are there significant related patents I should consider?
Yes, competitors have filed similar structure and use patents, especially in jurisdictions like Europe and China, which may impact the freedom to operate.

5. What are the key strategic considerations for licensing or partnership?
The patent’s strength and territorial coverage suggest opportunities for licensing in restricted markets or collaborations to expand the compound’s application scope.

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Citations

[1] United States Patent and Trademark Office. (2023). Patent No. 11,904,027.
[2] European Patent Office. (2023). Patent application EPXXXXXXX.
[3] World Intellectual Property Organization. (2023). Patent landscape reports for small molecule drugs.

Drugs Protected by US Patent 11,904,027

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes					Y

International Family Members for US Patent 11,904,027

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	119655
Australia	2018433575
Australia	2022203683
Australia	2024201217
Australia	2025202231