Details for Patent: 7,762,994

Which drugs does patent 7,762,994 protect, and when does it expire?

Patent 7,762,994 protects OZEMPIC, SAXENDA, and VICTOZA, and is included in three NDAs.

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

This patent has twenty-two patent family members in thirteen countries.

Summary for Patent: 7,762,994

Title:	Needle mounting system and a method for mounting a needle assembly
Abstract:	A needle mounting system and methods for mounting a needle assembly on a needle mount are disclosed. The needle mounting system includes a needle hub having protrusions extending radially inward. A needle mount has a plurality of slots to receive the protrusions. The slots have a first portion that defines a passageway substantially parallel to a longitudinal axis of the needle mount and a second portion substantially perpendicular to the axis. The needle hub and mount provide a method wherein a needle assembly may be mounted on an injection device without completely rotating the needle hub relative to the needle mount.
Inventor(s):	Klint; Henrik Sonderskov (Lyngby, DK), Radmer; Jim (Fredensborg, DK), Smedegaard; Jorgen K (Frederiksberg, DK), Nielsen; Jan Frank (Lyngby, DK), Jensen; Peter Moller (Horsholm, DK), Jensen; Jens Moller (Copenhagen, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	11/778,274
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,762,994
Patent Claim Types: see list of patent claims	Device;

Understanding the Scope and Claims of United States Patent 7,762,994

Introduction

United States Patent 7,762,994, owned by Novo Nordisk A/S, is a significant patent in the pharmaceutical industry, particularly for drugs like OZEMPIC, SAXENDA, and VICTOZA. This patent is part of a broader landscape that includes multiple patents and legal battles. Here’s a detailed analysis of its scope, claims, and the surrounding patent landscape.

Patent Overview

Title and Description The patent, titled "Needle Mounting System and a Method for Mounting a Needle Assembly," was issued on July 27, 2010. It pertains to systems and methods for mounting needle assemblies to injection devices and/or ampoules, which is crucial for the administration of various pharmaceutical products[4].

Inventors and Assignee

The patent was invented by Henrik Sonderskov Klint, Jim Radmer, Jorgen K Smedegaard, Jan Frank Nielsen, Peter Moller Jensen, and Jens Moller Jensen, all associated with Novo Nordisk A/S in Denmark[1].

Patent Claims

The patent includes several claims that define the scope of the invention. These claims are critical in determining what constitutes infringement. Here are some key aspects:

• Device Claims: The patent includes claims related to the device itself, such as the needle mounting system and the method for mounting a needle assembly. These claims are designed to protect the specific mechanical and functional aspects of the invention[4].
• Method Claims: In addition to device claims, the patent also includes method claims that describe the process of mounting the needle assembly. These claims ensure that the specific steps and techniques used in the invention are protected[4].

Patent Protection and Expiration

The patent protects OZEMPIC, SAXENDA, and VICTOZA, which are all GLP-1 analogs used in the treatment of diabetes and obesity. The protection for SAXENDA has been extended by six months due to pediatric studies, as indicated by the PED designation[1].

International Protection

The patent has twenty-two patent family members in thirteen countries, providing extensive international protection for Novo Nordisk’s intellectual property[1].

Litigation and Patent Disputes

Novo Nordisk has been involved in several patent infringement lawsuits related to this and other related patents. For example, Novo Nordisk Inc. and Novo Nordisk A/S have sued Mylan Institutional LLC and Sandoz Inc. for alleged infringement of various patents, including the ‘994 patent. These lawsuits highlight the importance of this patent in protecting Novo Nordisk’s market position[2][5].

Impact on the Pharmaceutical Industry

The patent landscape in the pharmaceutical industry is complex and highly litigious. Patents like the ‘994 patent are crucial for companies like Novo Nordisk to protect their investments in research and development. The broad scope of these patents, however, can sometimes lead to legal challenges and disputes over infringement.

Challenges in Patent Scope

The Federal Circuit’s stance on genus claims has made it challenging for pharmaceutical and biotechnology companies to obtain and maintain broad patent protection. Genus claims, which cover a class of compounds rather than specific embodiments, are often subject to strict disclosure requirements under 35 U.S.C. § 112(a). This can limit the scope of patent protection, making it easier for competitors to design around the claims[3].

Economic and Market Implications

The market for pharmaceuticals and biologics is vast and growing, with estimates suggesting the market for therapeutic antibodies could reach $300 billion by 2025. Robust and predictable patent protection is essential for innovators to recoup their significant investments in bringing new drugs to market. Patents like the ‘994 patent play a critical role in this ecosystem by protecting intellectual property and preventing generic competition during the patent term[3].

Key Takeaways

• Patent Scope: The ‘994 patent covers specific systems and methods for mounting needle assemblies, which is vital for the administration of drugs like OZEMPIC, SAXENDA, and VICTOZA.
• International Protection: The patent has extensive international coverage, protecting Novo Nordisk’s interests in multiple countries.
• Litigation: The patent has been central in several infringement lawsuits, highlighting its importance in the pharmaceutical industry.
• Industry Impact: The patent landscape, including the ‘994 patent, significantly influences the development and commercialization strategies of pharmaceutical companies.
• Challenges in Patent Law: The strict application of genus claim requirements under 35 U.S.C. § 112(a) poses challenges for broad patent protection in the pharmaceutical and biotechnology sectors.

FAQs

1. What does United States Patent 7,762,994 protect?

   • This patent protects the needle mounting system and the method for mounting a needle assembly, particularly relevant for drugs like OZEMPIC, SAXENDA, and VICTOZA.

2. Who owns United States Patent 7,762,994?

   • The patent is owned by Novo Nordisk A/S, a Danish pharmaceutical company.

3. When was the patent issued?

   • The patent was issued on July 27, 2010.

4. What is the significance of the PED designation for SAXENDA?

   • The PED designation indicates that the protection for SAXENDA has been extended by six months due to pediatric studies.

5. Why is the ‘994 patent important in the pharmaceutical industry?

   • The patent is crucial for protecting Novo Nordisk’s intellectual property and preventing generic competition during the patent term, which is essential for recouping investments in research and development.

Sources

1. DrugPatentWatch - Details for Patent: 7762994
2. RPX Insight - AUG2 20ig: Patent Infringement Lawsuit
3. DigitalCommons@NYLS - Eviscerating Patent Scope
4. Google Patents - US7762994B2: Needle mounting system and a method for mounting a needle assembly
5. RPX Insight - in the united states district court: Patent Infringement Lawsuit Against Sandoz Inc.

Drugs Protected by US Patent 7,762,994

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		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-004	Oct 6, 2022		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-002	Apr 9, 2019		RX	Yes	Yes			Y
Novo	OZEMPIC	semaglutide	SOLUTION;SUBCUTANEOUS	209637-003	Mar 28, 2022		RX	Yes	Yes			Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 7,762,994

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2002 01169	Aug 1, 2002

International Family Members for US Patent 7,762,994

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	344076
Austria	439883
Australia	2003243922
Canada	2491356
China	100502968