United States Patent 9,132,239: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,132,239, issued to Novo Nordisk, is a significant patent that protects two of the company's prominent pharmaceutical products: OZEMPIC (semaglutide) and SAXENDA. This patent is part of a complex web of intellectual property that safeguards Novo Nordisk's innovations in the field of glucagon-like peptide-1 (GLP-1) receptor agonists.
Patent Overview
Patent Title and Description
The patent titled "Dial-Down Mechanism for Wind-Up Pen" focuses on the mechanical aspects of the delivery device for these medications. It covers specific mechanisms designed to ensure accurate and convenient dosing of the GLP-1 peptides[1][4][5].
Patent Family and Global Protection
Patent 9,132,239 is part of a larger patent family with thirteen family members in eleven countries. This extensive global coverage underscores the importance of these inventions to Novo Nordisk's international business strategy[1].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. These claims are directed towards the mechanical components and methods related to the dial-down mechanism of the wind-up pen, which is crucial for the precise administration of the medication. The claims also encompass methods for preparing formulations and reducing deposits or clogging in the device[2][4].
Independent and Dependent Claims
The patent scope is further defined by both independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims build upon the independent claims and provide additional details or limitations. The balance between these claims helps in delineating the exact boundaries of the patented invention[3].
Patent Landscape
Related Patents
Patent 9,132,239 is one of several patents that protect OZEMPIC and SAXENDA. Other related patents include U.S. Patent Nos. 9,108,002, 9,457,154, 9,616,180, 9,687,611, 9,775,953, 9,861,757, 10,220,155, 10,335,462, 10,357,616, 10,376,652, 11,097,063, and 11,311,679. These patents collectively cover various aspects of the medications, including their use, formulations, and delivery mechanisms[2][5].
Litigation and Challenges
The patent has been involved in several litigation cases, particularly those related to generic versions of OZEMPIC. Companies like Mylan and Dr. Reddy's have filed Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of OZEMPIC before the expiration of the patents. These actions have led to extensive legal battles, with Novo Nordisk asserting the validity and enforceability of its patents[2][4][5].
Pediatric Extension
The protection for SAXENDA under this patent has been extended by six months due to pediatric studies, as indicated by the PED designation. This extension is a common practice to incentivize pharmaceutical companies to conduct pediatric studies, which can provide valuable data on the safety and efficacy of medications in children[1].
Impact on Innovation and Competition
Patent Quality and Scope
The debate over patent quality and scope is relevant here. The breadth and clarity of patent claims can significantly impact innovation and competition. Narrower claims, as seen in the examination process of this patent, are often associated with a higher probability of grant and a shorter examination process. This suggests that the patent office has been diligent in ensuring that the claims are specific and clear, which can help in promoting innovation by providing clear boundaries for competitors[3].
Licensing and Litigation Costs
The complexity of the patent landscape around OZEMPIC and SAXENDA can lead to increased licensing and litigation costs. This can be a barrier to entry for generic manufacturers and may diminish incentives for innovation in the sector. However, it also highlights the strategic importance of these patents to Novo Nordisk's market position[3].
Key Takeaways
- Patent Protection: Patent 9,132,239 protects OZEMPIC and SAXENDA, focusing on the mechanical aspects of the delivery device.
- Global Coverage: The patent has extensive global coverage with family members in eleven countries.
- Litigation: The patent is involved in several litigation cases related to generic versions of OZEMPIC.
- Pediatric Extension: The protection for SAXENDA has been extended due to pediatric studies.
- Impact on Innovation: The patent's scope and clarity can influence innovation and competition in the pharmaceutical sector.
FAQs
What products are protected by United States Patent 9,132,239?
United States Patent 9,132,239 protects OZEMPIC (semaglutide) and SAXENDA, both of which are GLP-1 receptor agonists developed by Novo Nordisk.
What is the focus of the patent claims in 9,132,239?
The patent claims focus on the mechanical aspects of the delivery device, specifically the dial-down mechanism for the wind-up pen, as well as methods for preparing formulations and reducing deposits or clogging.
Is the patent involved in any litigation?
Yes, the patent is involved in several litigation cases, particularly those related to generic versions of OZEMPIC filed by companies like Mylan and Dr. Reddy's.
Why has the protection for SAXENDA been extended?
The protection for SAXENDA has been extended by six months due to pediatric studies, as indicated by the PED designation.
How does the patent landscape around 9,132,239 impact innovation and competition?
The complexity and breadth of the patent claims can increase licensing and litigation costs, potentially diminishing incentives for innovation. However, clear and specific claims can also promote innovation by providing clear boundaries for competitors.
What other patents are related to 9,132,239?
Other related patents include U.S. Patent Nos. 9,108,002, 9,457,154, 9,616,180, 9,687,611, 9,775,953, 9,861,757, 10,220,155, 10,335,462, 10,357,616, 10,376,652, 11,097,063, and 11,311,679, which collectively cover various aspects of OZEMPIC and SAXENDA.
Sources
- DrugPatentWatch: Pharmaceutical drugs covered by patent 9,132,239.
- RPX Corporation: OZEMPIC (SEMAGLUTIDE) ) MDL No. 22-MD-3038 (CFC) PATENT LITIGATION.
- Hoover Institution: Patent Claims and Patent Scope.
- JPML: OZEMPIC (SEMAGLUTIDE) PATENT LITIGATION MDL No. 3038.
- RPX Corporation: Case 1:22-cv-00298-UNA Document 1 Filed 03/04/22.
