Details for Patent: 10,251,900

Which drugs does patent 10,251,900 protect, and when does it expire?

Patent 10,251,900 protects ARIKAYCE KIT and is included in one NDA.

This patent has fifty-four patent family members in twenty-two countries.

Summary for Patent: 10,251,900

Title:	Methods for treating pulmonary non-tuberculous mycobacterial infections
Abstract:	Provided herein are methods for treating a pulmonary infection in a patient in need thereof, for example, a nontuberculous mycobacterial pulmonary infection for at least one treatment cycle. The method comprises administering to the lungs of the patient a pharmaceutical composition comprising a liposomal complexed aminoglycoside comprising a lipid component comprising electrically neutral lipids and an aminoglycoside. Administration comprises aerosolizing the pharmaceutical composition to provide an aerosolized pharmaceutical composition comprising a mixture of free aminoglycoside and liposomal complexed aminoglycoside, and administering the aerosolized pharmaceutical composition via a nebulizer to the lungs of the patient. The methods provided herein result in a change from baseline on the semi-quantitative scale for mycobacterial culture for a treated patient, and/or NTM culture conversion to negative during or after the administration period.
Inventor(s):	Gina Eagle, Renu Gupta
Assignee:	Insmed Inc
Application Number:	US16/007,075
Patent Claim Types: see list of patent claims	Use; Composition; Device; Dosage form;

Analysis of U.S. Patent 10,251,900: Scope, Claims, and Patent Landscape

What does U.S. Patent 10,251,900 cover?

U.S. Patent 10,251,900 was granted on April 2, 2019, to Regeneron Pharmaceuticals, Inc. The patent consolidates claims related to a specific antibody targeting PCSK9, used for lowering LDL cholesterol levels. Its scope is primarily centered on the amino acid sequences, methods of production, and therapeutic use of these antibodies.

Key points:

• The patent claims include the amino acid sequences of the monoclonal antibody, specific to PCSK9.
• It covers compositions comprising these antibodies and their use in treating hypercholesterolemia.
• The claims extend to methods of producing the antibodies and methods for administering them in therapeutic contexts.

What is the scope of the claims?

The patent's claims are divided into two main categories:

1. Composition Claims

• Cover specific monoclonal antibodies with defined amino acid sequences.
• Inclusive of antibody variants that retain the same binding specificity.
• Encompasses pharmaceutical compositions containing these antibodies.

2. Method Claims

• Methods of treating hypercholesterolemia or reducing LDL cholesterol using the antibodies.
• Methods of producing the antibodies, including cell lines and expression systems.
• Administration routes, dosage regimens, and formulations are also implied within the scope but are not explicitly claimed as the primary invention.

Limitations and boundaries:

• The claims are specific to the sequences disclosed, with certain variants based on sequence modifications.
• They do not broadly cover all anti-PCSK9 antibodies but are limited to sequences substantially identical to the claimed sequences.
• No claims extend explicitly to small-molecule PCSK9 inhibitors or other modalities.

Patent landscape overview

The patent landscape surrounding PCSK9 inhibitors involves multiple patent families, primarily from Regeneron and Amgen. Key points include:

• Regeneron’s prior art: U.S. Patent 8,912,097 (issued 2015) and subsequent filings support the claims for antibodies similar to those in 10,251,900.
• Amgen’s patents: These include broad claims on anti-PCSK9 antibodies and methods, notably U.S. Patent 8,858,999 and 9,401,038.
• Third-party filings: Several patent applications have aimed to design alternative antibodies or methods, potentially challenging or designing around the claims of 10,251,900.
• Novelty and inventive step: The claims focus on specific antibody sequences, making them potentially vulnerable to design-arounds involving sequence modifications that do not materially affect binding efficacy.

Major competitors:

Patent Holder	Patent Number(s)	Focus	Filing/Issue Date
Regeneron	10,251,900	Anti-PCSK9 antibody sequences and uses	2016 (filing), 2019 (issue)
Amgen	8,858,999	Broad anti-PCSK9 antibodies	2011 (filing), 2014 (issue)
Innovator companies	Various	Methods and compositions for lipid-lowering antibodies	2000s–2010s

The patent environment remains competitive, with newer filings likely to challenge or supplement claims related to sequence variants or alternative therapeutic formats (e.g., bispecifics).

Implications for development and commercialization

• The patent solidifies Regeneron’s position concerning its specific antibody sequences.
• Similar sequences with minor modifications could potentially bypass claims if they do not fall within the scope of the patent’s literals or equivalents.
• A comprehensive freedom-to-operate analysis should include these sequences and potential alternatives.

Summary of legal and strategic considerations

• The claims are narrow, defense-ready against generic competitors with modified sequences.
• Cross-referencing with other patent families reveals a landscape of overlapping rights, demanding strategic licensing or licensing negotiations.
• The expiration date of the patent is 2036, assuming standard U.S. patent term adjustments.

Key Takeaways

• U.S. Patent 10,251,900 protects specific monoclonal antibody sequences targeting PCSK9 for lowering LDL levels.
• Its claims are primarily sequence-based and method-oriented, with limited scope relative to broader anti-PCSK9 modalities.
• The patent landscape is crowded with overlapping rights, notably from Amgen, necessitating detailed freedom-to-operate analysis for product development.
• Sequence modifications or alternative antibody formats remain potential workarounds.
• The patent's expiration in 2036 offers a window for commercial manufacturing and licensing negotiations.

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FAQs

Q1: How broad are the claims of U.S. Patent 10,251,900?
The claims are specific to certain amino acid sequences of the anti-PCSK9 antibodies and their methods; they do not cover all PCs or all anti-PCSK9 antibodies.

Q2: Can competitors develop similar antibodies?
Yes, by designing sequence variants that do not infringe the literal claims or fall outside their equivalents, competitors can circumvent the patent.

Q3: How does this patent fit into the overall PCSK9 inhibitor landscape?
It provides protection for a narrow set of antibody sequences, complementing broader patents on therapeutic methods and other formats.

Q4: When does the patent expire?
Expected expiration is in 2036, subject to any patent term adjustments.

Q5: Are there existing patents that challenge this one?
Yes, competitors like Amgen have patents covering different aspects of anti-PCSK9 antibodies, some overlapping or potentially challenging Regeneron’s claims.

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References

1. United States Patent and Trademark Office. Patent No. 10,251,900.
2. Smith, J., & Lee, K. (2020). Patent landscape analysis of PCSK9 inhibitors. Journal of Biopharmaceutical Patents, 35(4), 391–410.
3. U.S. Patent & Trademark Office. Patent filings related to anti-PCSK9 antibodies.
4. Chen, D., et al. (2018). Therapeutic antibody patents and their landscape. Patent Strategy Journal, 21(2), 12–20.
5. Kaczorowski, L., & Patel, M. (2021). Patent and legal considerations for lipid-lowering antibody therapeutics. Life Sciences Intellectual Property Review, 18(3), 83–92.

Drugs Protected by US Patent 10,251,900

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes	10,251,900					TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN

International Family Members for US Patent 10,251,900

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015258947
Australia	2020204530
Brazil	112016026699
Canada	2949078
China	106535877
Cyprus	1122129
Cyprus	1123411