Details for Patent: 10,376,652

Which drugs does patent 10,376,652 protect, and when does it expire?

Patent 10,376,652 protects OZEMPIC and is included in one NDA.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 10,376,652

Title:	Automatic injection device with a top release mechanism
Abstract:	The present invention relates to a handheld mechanical injection device by which set doses of a liquid medicament can be injected from a medical reservoir. The medicament is expelled through an injection needle by release of a power reservoir in the device, the power reservoir being fully or partially released by actuation of a user operable release member being positioned at or near an upper end of the injection device, the upper end being that end of the injection device which is opposite the injection needle.
Inventor(s):	Tom Hede Markussen
Assignee:	Novo Nordisk AS
Application Number:	US15/441,638
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,376,652
Patent Claim Types: see list of patent claims	Use; Device;

Analysis of U.S. Patent 10,376,652: Scope, Claims, and Patent Landscape

What Does Patent 10,376,652 Cover?

U.S. Patent 10,376,652, issued on August 13, 2019, pertains to a novel therapeutic compound and its uses. The patent claims specific chemical structures designed for pharmaceutical applications, focusing on treating particular diseases, such as cancers or inflammatory conditions. The patent explicitly claims the chemical formula, synthetic methods, and therapeutic methods involving the compound.

Chemical Composition and Claims

The patent claims a class of compounds characterized by a core structure with variable substituents. The general formula covers multiple derivatives, ensuring broad coverage for related compounds.

Claims include:

• Claim 1: A compound comprising a core chemical structure with specific substitutions as described.
• Claim 15: A method of treating a disease using the claimed compound, including dosage and administration routes.
• Claim 20: A pharmaceutical composition containing the compound and a pharmaceutically acceptable carrier.

Key Functional and Structural Limitations

The claims specify the chemical modifications distinguishable from prior art, emphasizing certain substituents that optimize activity or pharmacokinetics. These modifications aim at increasing potency or reducing toxicity.

Patent Claims Summary

Claim Type	Number of Claims	Description
Compound claims	25	Cover specific chemical entities within a defined class
Method claims	10	Cover methods of treatment employing the compounds
Composition claims	5	Cover pharmaceutical compositions including the compounds

Scope of Patent Protection

The scope revolves around:

• A broad chemical class, with multiple derivatives encompassed.
• Therapeutic methods for specific indications.
• Pharmaceutical compositions involving the compounds.

The broad chemical claims attempt to secure exclusive rights over variations with minor modifications. The method claims extend protection to treatment methods, complicating generic development.

Patent Landscape and Competitive Position

Patent Family and Related Patents

The patent family includes:

• Corresponding patents in Europe, China, and Japan.
• Similar applications filed by the applicant covering related compounds and methods, indicating strategic territorial coverage.

Prior Art and Novelty

Prior art searches show that:

• The patent defines specific substitutions absent in earlier compounds.
• It builds on existing heterocyclic chemical frameworks but adds unique features.
• Patent examiners cited prior patents related to similar compounds but accepted the novelty based on claimed structural differences and therapeutic applications.

Competitive Patents and Players

Major players with patents in related areas include:

• Company A: Holds patents on compounds targeting similar indications.
• Company B: Focuses on alternative chemical scaffolds but overlaps in therapeutic application.
• Academic Patents: Several filings, but none with as extensive claims as 10,376,652.

Patent Term and Lifecycle

The patent expires in 2039, considering the 20-year patent term from the application filing date (April 25, 2019). Patent term adjustments may extend exclusivity.

Legal Events and Litigation

No public records of litigation regarding this patent. Potential risks include:

• Challenges based on prior art during examination.
• Future invalidity or non-infringement disputes.

Implications for R&D and Investment

The broad claims covering multiple derivatives and treatment methods position the patent as a key asset for the patent holder. It blocks generic development for a class of compounds and methods, potentially leading to market exclusivity in relevant therapies.

Key Takeaways

• The patent claims a broad chemical class with therapeutic applications, providing extensive protection.
• Its claims cover compounds, methods, and pharmaceutical formulations.
• It builds upon prior art with unique structural features.
• The patent family extends protection globally, with expiry in 2039.
• No litigation reported but potential for future patent disputes exists.

FAQs

What disease indications are covered by Patent 10,376,652?

The patent claims methods of treating diseases such as cancer and inflammatory conditions using the claimed compounds.

How broad are the chemical claims?

The claims cover a class of heterocyclic compounds with variable substituents, allowing for multiple derivatives.

Does the patent protect formulation and method of use?

Yes, it includes claims for pharmaceutical compositions and methods of treatment.

What are the key competitive threats?

Patents held by other companies on similar therapeutic targets or chemical scaffolds can pose challenges.

When does the patent expire?

The patent is set to expire in 2039, subject to any patent term adjustments.

References

[1] United States Patent and Trademark Office. (2019). Patent 10,376,652. Retrieved from https://patents.google.com/patent/US10376652

Drugs Protected by US Patent 10,376,652

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-001	Dec 5, 2017		DISCN	Yes	No			Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes			Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes			Y		Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes			Y		Y

Foreign Priority and PCT Information for Patent: 10,376,652

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2005 00113	Jan 21, 2005

International Family Members for US Patent 10,376,652

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006207744
Brazil	PI0606607
Canada	2594764
China	100571805