Details for Patent: 9,687,611

Which drugs does patent 9,687,611 protect, and when does it expire?

Patent 9,687,611 protects OZEMPIC and SAXENDA and is included in two 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 seventeen patent family members in fourteen countries.

Summary for Patent: 9,687,611

Title:	Injection device with torsion spring and rotatable display
Abstract:	The present invention relates to an injection device comprising a torsion spring operatively connected to a dose setting member being adapted to set a dose to be ejected from the injection device. A rotatably mounted display member adapted to display the dose to be ejected in accordance with a setting of the dose setting member is also provided. The rotatably mounted display member is adapted to be rotated over an angle corresponding to at least one revolution of the display member. The display member may be implemented as a dose indicator barrel having numerals arranged along a helical path on an outer surface thereof, or alternatively, as a counting device having two or more display wheels having numerals arranged on an outer surface thereof.
Inventor(s):	Moeller; Claus Schmidt (Fredensborg, DK), Markussen; Tom Hede (Bagsvaerd, DK), Enggaard; Christian Peter (Vejby, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	14/167,558
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,687,611
Patent Claim Types: see list of patent claims	Device;

Understanding the Scope and Claims of United States Patent 9,687,611

Introduction

United States Patent 9,687,611 is one of the patents involved in the ongoing litigation surrounding Ozempic (semaglutide), a medication used for the treatment of type 2 diabetes and long-term weight management. This patent is part of a complex patent landscape that includes multiple patents asserted by the original patent holders against generic drug manufacturers.

Patent Overview

• Patent Number: 9,687,611
• Title: The specific title of the patent is not provided in the sources, but it is associated with the use and formulations of semaglutide, a long-acting GLP-1 peptide.
• Asserted Claims: This patent is one of several asserted in various Hatch-Waxman patent infringement lawsuits related to Ozempic. The claims involve methods and formulations related to semaglutide[2].

Claim Scope and Construction

The claim scope of a patent is crucial for determining its validity and enforceability. Here are some key points regarding the claim scope of U.S. Patent 9,687,611:

Specificity and Breadth

• The claims must be specific enough to be supported by the patent specification but not so broad that they risk being invalidated. Overly broad claims can be challenged under the abstract idea exception or for failing to meet the written description requirement[3].

Anchoring to Embodiments

• The claims in the patent must be anchored to the embodiments described in the specification. This ensures that the claims are not overly broad and are supported by the disclosed inventions[3].

Patent Landscape and Litigation

Centralization of Litigation

• The patent is part of a multidistrict litigation (MDL) case, MDL No. 3038, which centralizes various patent infringement actions related to Ozempic in the District of Delaware. This centralization aims to eliminate duplicative discovery, prevent inconsistent pretrial rulings, and promote the efficient conduct of the litigation[1].

Common Patents and Claims

• U.S. Patent 9,687,611 is one of several patents asserted in multiple actions. Other patents, such as U.S. Patent Nos. 9,132,239 and 10,335,462, are also commonly asserted across different lawsuits. This overlap in patents suggests that the claims and issues involved are substantially similar, justifying the centralization of the litigation[1].

Defendants and ANDA Filings

• Generic drug manufacturers, such as Mylan, have filed Abbreviated New Drug Applications (ANDAs) with paragraph IV certifications, stating that the patents, including U.S. Patent 9,687,611, are invalid or will not be infringed by their generic versions of Ozempic. This certification constitutes a statutory act of infringement, allowing the original patent holders to sue for patent infringement before the generic drugs are marketed[1][2].

Specific Claims and Infringement Allegations

• The patent covers specific methods and formulations related to semaglutide. For example, claims might involve methods for preparing formulations, reducing deposits, or preventing clogging in the injection device[2].
• The plaintiffs allege that the generic versions of Ozempic infringe on one or more claims of the asserted patents, including U.S. Patent 9,687,611. These allegations are based on the ANDA filings and the paragraph IV certifications submitted by the generic manufacturers[1].

Validity and Enforceability

• The validity and enforceability of U.S. Patent 9,687,611 are under scrutiny in the ongoing litigation. The defendants argue that the patents are invalid or unenforceable, while the plaintiffs assert that the patents are valid and infringed by the generic products[1][2].

Industry Impact

• The outcome of this litigation will have significant implications for the pharmaceutical industry, particularly in the context of generic drug approvals and the competitive landscape for diabetes and weight management treatments.

Key Takeaways

• Centralized Litigation: U.S. Patent 9,687,611 is part of a centralized litigation effort to streamline patent infringement cases related to Ozempic.
• Claim Scope: The patent's claims must be carefully constructed to avoid being overly broad and to ensure they are supported by the patent specification.
• Generic Competition: The litigation involves generic drug manufacturers challenging the validity and enforceability of the patent to enter the market with generic versions of Ozempic.
• Industry Implications: The outcome will impact the availability of generic versions of Ozempic and the competitive dynamics in the pharmaceutical market.

FAQs

1. What is the main subject of U.S. Patent 9,687,611?

   • The patent is related to the use and formulations of semaglutide, a long-acting GLP-1 peptide used in the treatment of type 2 diabetes and long-term weight management.

2. Why is U.S. Patent 9,687,611 part of a multidistrict litigation?

   • It is part of MDL No. 3038 to centralize various patent infringement actions, eliminate duplicative discovery, and promote the efficient conduct of the litigation.

3. What is the significance of paragraph IV certifications in ANDA filings?

   • These certifications state that the patents are invalid or will not be infringed by the generic versions, constituting a statutory act of infringement that allows the original patent holders to sue for patent infringement.

4. How do overly broad claims affect patent validity?

   • Overly broad claims can be invalidated under the abstract idea exception or for failing to meet the written description requirement, making it crucial to ensure claims are anchored to the embodiments described in the specification.

5. What are the potential industry implications of the litigation involving U.S. Patent 9,687,611?

   • The outcome will affect the availability of generic versions of Ozempic and influence the competitive landscape in the pharmaceutical market for diabetes and weight management treatments.

Sources

1. U.S. Courts, "OZEMPIC (SEMAGLUTIDE) PATENT LITIGATION MDL No. 3038"
2. Insight.RPXCorp, "OZEMPIC (SEMAGLUTIDE) MDL No. 22-MD-3038 (CFC)"
3. Rimon Law, "The Importance of Getting the Claim Scope Right in a US Patent Application"

Drugs Protected by US Patent 9,687,611

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

Foreign Priority and PCT Information for Patent: 9,687,611

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	04077899	Oct 21, 2004

International Family Members for US Patent 9,687,611

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E445430
Australia	2005298946
Canada	2584762