Details for Patent: 8,927,592

Which drugs does patent 8,927,592 protect, and when does it expire?

Patent 8,927,592 protects JEVTANA KIT and is included in one NDA.

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

This patent has fifty-two patent family members in thirty-five countries.

Summary for Patent: 8,927,592

Title:	Antitumoral use of cabazitaxel
Abstract:	The invention relates to a compound of formula: which may be in base form or in the form of a hydrate or a solvate, in combination with prednisone or prednisolone, for its use as a medicament in the treatment of prostate cancer, particularly metastatic prostate cancer, especially for patients who are not catered for by a taxane-based treatment.
Inventor(s):	Sunil Gupta
Assignee:	Sanofi Mature IP
Application Number:	US13/456,720
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,927,592
Patent Claim Types: see list of patent claims	Use;

Analysis of United States Drug Patent 8,927,592

Patent US 8,927,592 B2, titled "Pharmaceutical compositions and methods of treatment using glucagon-like peptide-1 receptor agonists," was granted to Novo Nordisk A/S on December 29, 2014. The patent covers pharmaceutical compositions and methods of treating diabetes mellitus, obesity, and related metabolic disorders using glucagon-like peptide-1 (GLP-1) receptor agonists.

What is the Core Technology Protected by Patent US 8,927,592?

The patent protects specific pharmaceutical compositions containing GLP-1 receptor agonists. These agonists are designed to mimic the action of endogenous GLP-1, a hormone that regulates blood glucose and promotes satiety. The claimed compositions are formulated for administration, typically via injection, to patients. The underlying technology involves the chemical structure of the GLP-1 receptor agonists and their therapeutic application.

The patent claims cover:

• Specific GLP-1 Receptor Agonists: While not listing every specific compound, the claims define a class of compounds that bind to and activate the GLP-1 receptor. This includes modified versions of native GLP-1 or entirely synthetic molecules with similar pharmacological properties. For example, Claim 1 describes a composition comprising a GLP-1 receptor agonist, which is defined by its ability to bind to the GLP-1 receptor and have an EC50 value of 100 nM or less.
• Pharmaceutical Compositions: The patent claims compositions formulated for therapeutic use. These include not only the active GLP-1 receptor agonist but also pharmaceutically acceptable carriers, excipients, and other additives that enhance stability, solubility, or delivery. Claim 1 specifies a pharmaceutical composition comprising a GLP-1 receptor agonist and a pharmaceutically acceptable carrier.
• Methods of Treatment: The patent claims methods for treating various conditions by administering the claimed compositions. These conditions include type 2 diabetes mellitus, impaired glucose tolerance, and obesity. The method involves administering a therapeutically effective amount of the GLP-1 receptor agonist. Claim 15 describes a method of treating type 2 diabetes mellitus comprising administering the composition of claim 1.

What are the Key Claims in Patent US 8,927,592?

The most critical claims in US 8,927,592 B2 define the scope of the invention.

• Claim 1: This independent claim is central to the patent. It covers a pharmaceutical composition comprising:
  • a GLP-1 receptor agonist; and
  • a pharmaceutically acceptable carrier. The GLP-1 receptor agonist is further defined by its binding affinity to the GLP-1 receptor, with an EC50 value of 100 nM or less. This definition allows for a broad range of GLP-1 receptor agonists that meet the specified binding criteria.
• Dependent Claims: Numerous dependent claims narrow the scope of Claim 1, providing further specificity. These include:
  • Compositions where the GLP-1 receptor agonist is a peptide analog of GLP-1.
  • Compositions where the GLP-1 receptor agonist is specifically described by a sequence or structural formula (though specific examples are often provided in the patent's specification rather than every claim).
  • Compositions containing specific excipients or carriers designed for particular delivery methods, such as sustained-release formulations.
  • Compositions formulated for specific routes of administration, such as subcutaneous injection.
• Method of Treatment Claims: Claims such as Claim 15 and others define the therapeutic applications. These claims cover methods for:
  • Treating type 2 diabetes mellitus.
  • Treating impaired glucose tolerance.
  • Treating obesity.
  • Reducing appetite.
  • Promoting weight loss. These method claims require the administration of a therapeutically effective amount of the GLP-1 receptor agonist.

What is the Exclusivity Period and Expiration Date for Patent US 8,927,592?

The patent term for a utility patent in the United States is generally 20 years from the date on which the application for the patent was filed. Patent US 8,927,592 B2 was filed on June 30, 2008. Therefore, without considering any patent term extensions, the patent was set to expire on June 30, 2028.

• Original Expiration: June 30, 2028.

It is important to note that patents for pharmaceuticals can be eligible for Patent Term Extension (PTE) under the Hatch-Waxman Act to compensate for regulatory review delays. The specific product(s) developed and marketed under this patent would determine eligibility and the actual extension granted.

What is the Competitive Landscape for GLP-1 Receptor Agonists and Patent US 8,927,592?

The market for GLP-1 receptor agonists is highly competitive, with several major pharmaceutical companies developing and marketing drugs in this class. Patent US 8,927,592 B2, held by Novo Nordisk, is a significant patent in this landscape, as Novo Nordisk is a leading player in GLP-1 therapy.

Key aspects of the competitive landscape include:

• Major Market Players: Companies such as Novo Nordisk, Eli Lilly and Company, and AstraZeneca have a substantial presence.
• Key GLP-1 Receptor Agonist Drugs:
  • Novo Nordisk: Liraglutide (Victoza, Saxenda), Semaglutide (Ozempic, Rybelsus, Wegovy). Patent US 8,927,592 B2 likely covers aspects of Liraglutide and potentially early development of Semaglutide formulations or compositions.
  • Eli Lilly: Dulaglutide (Trulicity).
  • AstraZeneca: Exenatide (Byetta, Bydureon).
• Patent Strategy: Companies employ extensive patent portfolios to protect their GLP-1 assets. This includes patents covering:
  • Active pharmaceutical ingredients (APIs) with specific chemical structures.
  • Formulations and delivery systems (e.g., sustained-release, oral formulations).
  • Methods of manufacturing.
  • Methods of treatment for specific indications.
• Litigation: The GLP-1 market has seen and is likely to continue to see patent litigation as competitors seek to enter the market with generic or biosimilar versions, or as companies seek to defend their market exclusivity. Patents like US 8,927,592 B2 are often central to these disputes.

What are the Implications of Patent US 8,927,592 for R&D and Investment?

The existence and scope of patent US 8,927,592 B2 have direct implications for research and development strategies and investment decisions in the diabetes and obesity therapeutic areas.

For R&D:

• Freedom to Operate (FTO): Companies developing new GLP-1 receptor agonists or formulations must conduct thorough FTO analyses to ensure their products do not infringe on existing patents, including US 8,927,592 B2. This may require designing around the patent claims or seeking licenses.
• Innovation Focus: The patent's claims can guide R&D efforts toward areas not covered or toward developing next-generation therapies that offer improved efficacy, safety, or convenience beyond what is protected by this patent. This could include exploring different receptor targets, novel delivery mechanisms, or combination therapies.
• Life Cycle Management: For Novo Nordisk, this patent supports their strategy for protecting their existing GLP-1 franchise and potentially delaying generic competition for specific products.

For Investment:

• Market Exclusivity: The patent's term provides Novo Nordisk with a period of market exclusivity for products utilizing the claimed technology, supporting revenue streams and profitability.
• Valuation of Assets: The strength and breadth of patent protection, including US 8,927,592 B2, are critical factors in valuing pharmaceutical companies and their drug pipelines. Investors assess the risk of patent challenges and the potential for market disruption by competitors.
• Investment Opportunities: Investors can identify opportunities by analyzing the patent landscape. This includes investing in companies with strong patent protection or in companies developing technologies that bypass existing patents. It also involves understanding the timelines for patent expiration and the potential impact on market dynamics.

Are There Any Key Prior Art or Subsequent Developments Relevant to Patent US 8,927,592?

Understanding prior art and subsequent developments is crucial for assessing the validity and impact of patent US 8,927,592 B2.

Prior Art:

• Early GLP-1 Research: Before the filing of this patent, significant research had already established the therapeutic potential of GLP-1 and its analogs. Patents covering the discovery and initial characterization of GLP-1 receptor agonists would constitute prior art.
• Existing Diabetes Treatments: Pre-existing diabetes treatments (e.g., metformin, sulfonylureas, insulin) established the market need and therapeutic landscape that GLP-1 agonists aimed to improve upon.
• Prior GLP-1 Agonist Patents: Earlier patents covering specific GLP-1 analogs like exenatide (Byetta) would be highly relevant prior art. The novelty and inventiveness of the claims in US 8,927,592 B2 would be assessed against these earlier disclosures.

Subsequent Developments:

• Newer GLP-1 Agonists: Since the filing of US 8,927,592 B2, numerous newer and more potent GLP-1 receptor agonists have been developed and approved, such as semaglutide and tirzepatide (a dual GLP-1/GIP receptor agonist). These developments indicate the ongoing innovation in the field.
• Oral Formulations: The development of oral GLP-1 receptor agonists (e.g., oral semaglutide, Rybelsus) represents a significant advancement in patient convenience and further expands the therapeutic landscape. The patent's claims may or may not encompass these later developments, depending on their specificity regarding formulation and delivery.
• Expanded Indications: GLP-1 receptor agonists have shown benefits beyond glycemic control, including cardiovascular risk reduction and significant weight loss. These expanded indications have broadened the market and increased the strategic importance of the underlying patents.
• Patent Challenges: As patents approach their expiration or as new entrants emerge, challenges to their validity or assertions of non-infringement are common. Analyzing any post-grant review proceedings or litigation related to US 8,927,592 B2 or its related patents would provide critical insights.

Key Takeaways

• Patent US 8,927,592 B2, held by Novo Nordisk A/S, protects pharmaceutical compositions and methods for treating diabetes, obesity, and metabolic disorders using GLP-1 receptor agonists.
• The patent's core claims cover specific classes of GLP-1 receptor agonists (defined by binding affinity) and their pharmaceutical formulations for therapeutic use.
• The patent was originally set to expire on June 30, 2028, subject to potential Patent Term Extensions.
• The GLP-1 receptor agonist market is highly competitive, with major players like Novo Nordisk, Eli Lilly, and AstraZeneca. Patent US 8,927,592 B2 contributes to Novo Nordisk's strong intellectual property position.
• For R&D, the patent necessitates careful Freedom to Operate analysis and can guide innovation towards non-infringing or next-generation therapies. For investment, it is a key factor in assessing market exclusivity, company valuation, and identifying strategic opportunities.
• Prior art includes earlier GLP-1 research and patents, while subsequent developments involve newer agonists, oral formulations, and expanded therapeutic indications, all shaping the ongoing competitive and patent landscape.

FAQs

1. Does patent US 8,927,592 B2 cover all GLP-1 receptor agonists? No, the patent claims cover specific classes of GLP-1 receptor agonists that meet certain binding criteria (EC50 value of 100 nM or less) and are formulated into pharmaceutical compositions for therapeutic use. It does not broadly cover every molecule that interacts with the GLP-1 receptor.

2. What specific drugs are protected by patent US 8,927,592 B2? While patents protect classes of compounds and their applications, US 8,927,592 B2 is highly relevant to Novo Nordisk's GLP-1 portfolio, likely including aspects of liraglutide and potentially earlier formulations or compositions related to semaglutide. Specific drug protection is often detailed through multiple patents covering API, formulation, and manufacturing.

3. When will patent US 8,927,592 B2 expire, allowing for generic competition? The patent was originally set to expire on June 30, 2028. However, the actual date for generic market entry could be influenced by Patent Term Extensions (PTE) awarded to compensate for regulatory review delays, or by any successful patent challenges.

4. Can a company develop a new GLP-1 agonist without infringing on patent US 8,927,592 B2? Yes, it is possible if the new GLP-1 agonist or its formulation falls outside the specific claims of US 8,927,592 B2. This typically involves designing around the patent's scope, focusing on distinct chemical structures, novel formulations, or different therapeutic applications not covered by the patent. A thorough Freedom to Operate analysis is essential.

5. What are the implications of this patent for investment in the diabetes and obesity markets? This patent signifies a period of market exclusivity for Novo Nordisk concerning specific GLP-1 receptor agonist compositions and treatments. For investors, this supports the valuation of Novo Nordisk's relevant products. It also highlights the importance of strong patent portfolios in this lucrative therapeutic area and suggests that future investment opportunities may lie in companies with innovative, non-infringing technologies or those poised to enter the market upon patent expiration.

Citations

[1] Novo Nordisk A/S. (2014). Pharmaceutical compositions and methods of treatment using glucagon-like peptide-1 receptor agonists (U.S. Patent No. 8,927,592 B2). United States Patent and Trademark Office.

Drugs Protected by US Patent 8,927,592

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes	8,927,592*PED				Y

International Family Members for US Patent 8,927,592

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	078824
Australia	2010310986
Australia	2015200149
Australia	2016200598