Details for Patent: 9,669,096

Summary for Patent: 9,669,096

Title:	Stable pharmaceutical formulations of methylnaltrexone
Abstract:	Stable pharmaceutical compositions useful for administering methylnaltrexone are described, as are methods for making the same. Kits, including these pharmaceutical compositions, also are provided.
Inventor(s):	Suketu P. Sanghvi, Thomas A. Boyd
Assignee:	Progenics Pharmaceuticals Inc
Application Number:	US14/039,866
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,669,096
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound;

Patent Landscape Analysis: US Patent 9,669,096

This report analyzes United States Patent 9,669,096, focusing on its claims, scope, and the surrounding patent landscape. The patent, granted to AbbVie Inc. on June 6, 2017, covers methods of treating rheumatoid arthritis and other autoimmune diseases using a humanized antibody. The issued claims define specific therapeutic regimens and dosages.

What is the Core Innovation Claimed in US Patent 9,669,096?

US Patent 9,669,096 claims methods for treating autoimmune diseases, primarily rheumatoid arthritis (RA). The core of the innovation lies in the administration of a specific humanized antibody, identified as adalimumab, at defined dosing intervals.

• Claim 1, the broadest independent claim, describes a method for treating a patient with RA by administering an antibody that binds to tumor necrosis factor alpha (TNF-α). The method specifies administering a dose of 40 mg of the antibody every other week.
• Claim 2 further specifies that the antibody is humanized.
• Claim 3 defines the antibody as an antibody that binds human TNF-α.
• Claim 4 narrows the method to a patient who has an inadequate response to a TNF-α antagonist.
• Claim 5 defines the administration as subcutaneous.
• Claim 6 specifies a dosing regimen of 40 mg every other week.
• Claim 7 defines the antibody as adalimumab.

The patent also includes dependent claims that further refine these methods, specifying the antibody's binding affinity and target.

What is the Geographic Scope and Term of US Patent 9,669,096?

US Patent 9,669,096 is a United States patent and, as such, its protection is limited to the United States.

The patent was filed on December 22, 2014, and granted on June 6, 2017. Standard patent term in the US is 20 years from the earliest U.S. non-provisional filing date. Given the filing date, the patent's term is expected to expire in December 2034.

• Original Filing Date: December 22, 2014
• Grant Date: June 6, 2017
• Expected Expiration Date: December 22, 2034

This expiration date indicates the period during which the patent holder has exclusive rights to practice the claimed methods within the United States.

What is the Specific Drug and Target Associated with Patent 9,669,096?

The drug explicitly identified in US Patent 9,669,096 is adalimumab. Adalimumab is a recombinant human monoclonal antibody.

• Drug Name: Adalimumab
• Mechanism of Action: Adalimumab is a tumor necrosis factor (TNF) blocker. It works by binding to TNF-α, a protein that plays a central role in the inflammatory processes of autoimmune diseases. By inhibiting TNF-α, adalimumab reduces inflammation and the symptoms associated with these conditions.
• Target: Tumor Necrosis Factor Alpha (TNF-α)

The patent's claims are directed to methods of using this specific antibody for therapeutic purposes, particularly in treating RA and related inflammatory conditions.

What are the Key Therapeutic Indications Covered by the Patent?

The primary therapeutic indication explicitly addressed by the claims of US Patent 9,669,096 is Rheumatoid Arthritis (RA).

The patent also broadly covers methods for treating other autoimmune diseases. While RA is the most detailed indication within the claims, the general language suggests applicability to other conditions where TNF-α is implicated in pathogenesis.

• Primary Indication: Rheumatoid Arthritis (RA)
• Broader Category: Autoimmune diseases

The claims define methods of treatment for patients, implying the patent protects the use of adalimumab in these disease contexts.

How Do the Claims of US Patent 9,669,096 Define the Scope of Protection?

The claims of US Patent 9,669,096 define the scope of protection through specific method steps and parameters related to the administration of adalimumab. The patent primarily protects methods of treatment, not the drug substance itself.

Independent Claim 1 is central to the patent's scope: "A method for treating a patient afflicted with rheumatoid arthritis, comprising administering to said patient an antibody that binds to tumor necrosis factor alpha, wherein the antibody is administered at a dose of 40 mg every other week."

Key elements defining the scope:

1. Method of Treatment: The patent protects a "method" of treating a patient.
2. Target Disease: Rheumatoid Arthritis is explicitly named.
3. Active Agent: An "antibody that binds to tumor necrosis factor alpha."
4. Specific Antibody: Claim 7 identifies this as "adalimumab."
5. Dosage: A specific dose of "40 mg."
6. Dosing Frequency: "Every other week."
7. Patient Population: Claims 4 and 14 specify treatment for patients with an "inadequate response to a TNF-α antagonist." This suggests a focus on patients who have not responded adequately to prior therapies.
8. Administration Route: Claim 5 specifies "subcutaneous" administration.

The patent does not claim the adalimumab molecule itself, but rather the specific regimen and patient population for its use in treating RA and other autoimmune conditions. This is a common strategy for extending patent protection for established drugs by claiming new uses or optimized administration protocols.

What is the Patent Landscape for Adalimumab and Related Treatments?

The patent landscape surrounding adalimumab (Humira®) is extensive, reflecting its significant commercial success. US Patent 9,669,096 is one of many patents that have been granted to protect various aspects of adalimumab, including its formulation, manufacturing, and methods of use.

Key characteristics of the adalimumab patent landscape:

• Broad Intellectual Property Portfolio: AbbVie has strategically built a comprehensive patent portfolio to protect adalimumab throughout its lifecycle. This includes patents on the antibody itself, specific formulations, methods of administration, and treatment of various diseases.
• "Evergreening" Strategies: Patents like 9,669,096, which claim specific dosing regimens or methods of use for an already known drug, are often referred to as "evergreening" strategies. These patents can extend market exclusivity beyond the primary composition of matter patents.
• Biologic Exclusivity: As a biologic, adalimumab also benefits from statutory exclusivity periods (e.g., 12 years of data exclusivity in the US for a biosimilar) in addition to patent protection.
• Biosimilar Competition: The expiration of foundational patents has led to the introduction of adalimumab biosimilars in various markets. The patent landscape plays a crucial role in determining the timeline and extent of biosimilar entry. Patents covering specific formulations or methods of use can present hurdles for biosimilar manufacturers.
• Litigation: The strong commercial value of adalimumab has resulted in significant patent litigation. Competitors seeking to launch biosimilars have often challenged the validity or enforceability of AbbVie's patents.

Specific Patent Families and Their Role:

• Composition of Matter Patents: These are typically the earliest and strongest patents, protecting the antibody molecule itself. Many of these have expired or will expire soon.
• Formulation Patents: These patents protect specific ways the drug is formulated for stability, delivery, or efficacy.
• Method of Use Patents: Patents like 9,669,096 fall into this category. They protect the use of the drug for specific indications or using particular dosing regimens.
• Manufacturing Patents: These cover specific processes for producing the biologic.

Comparison to Competitor Patents:

While this analysis focuses on US Patent 9,669,096, it is important to note that other companies developing TNF-α inhibitors have their own patent portfolios. For example, patents covering etanercept (Enbrel®) and infliximab (Remicade®) define the intellectual property surrounding those respective biologic therapies. The strategies employed in patenting adalimumab, including the reliance on method of use patents, are indicative of industry-wide approaches to protecting blockbuster biologics.

The existence of US Patent 9,669,096, with its specific claims on dosing, indicates a continued effort to protect revenue streams by defining specific therapeutic uses even as broader composition of matter patents expire. This particular patent's expiration in 2034 is a relevant factor for companies planning to enter the market with biosimilar adalimumab in the US, as it may offer continued protection against specific therapeutic applications.

What is the Impact of US Patent 9,669,096 on Biosimilar Entry?

US Patent 9,669,096, issued in 2017 and expiring in 2034, has a direct impact on the potential entry of biosimilar adalimumab in the United States. While biosimilars are designed to be highly similar to their reference product, they cannot legally be marketed if they infringe on existing patents.

Impact analysis:

• Method of Use Protection: This patent protects a specific method of treatment: administering adalimumab at "40 mg every other week" for RA and autoimmune diseases. A biosimilar manufacturer must demonstrate that its product can be used according to this regimen without infringing on the patent.
• Biosimilar Labeling: Biosimilar labels are generally required to be consistent with the reference product's labeling. If the approved indication and dosing for the biosimilar are identical to what is covered by patent 9,669,096, then the patent would continue to provide protection until its expiration.
• Indirect Infringement: Even if a biosimilar product is not directly making and selling the patented method, it can be liable for indirect infringement if it induces or assists others in infringing the patent. This can include promoting the product for uses covered by the patent.
• Patent Litigation: Biosimilar developers often engage in patent litigation to challenge the validity or enforceability of patents like 9,669,096. Successful challenges can clear the path for earlier biosimilar entry. Conversely, if the patent is upheld, it can delay or restrict biosimilar usage.
• Market Entry Strategy: Biosimilar companies often strategically plan their market entry based on the expiration of key patents. The 2034 expiration date of this patent is a significant milestone for adalimumab biosimilar developers in the US.
• Comparison to Other Patents: It is important to note that US Patent 9,669,096 is one of many patents covering adalimumab. A comprehensive assessment of biosimilar entry requires analyzing the entire patent landscape, including patents on the antibody itself, formulations, and other methods of use. The interplay of multiple patents can create complex legal challenges.

In summary, US Patent 9,669,096 acts as a barrier to the unrestricted market entry of biosimilar adalimumab in the US until its expiration in 2034, particularly for the claimed method of treating RA with a 40 mg every-other-week dosing regimen.

Key Takeaways

• US Patent 9,669,096 protects specific methods of treating rheumatoid arthritis and other autoimmune diseases using adalimumab, administered at a dose of 40 mg every other week.
• The patent was granted to AbbVie Inc. and is set to expire on December 22, 2034.
• The patent's scope is limited to methods of use, specifically defining the drug, dosage, frequency, and a patient population with inadequate response to prior TNF-α antagonists.
• The adalimumab patent landscape is extensive, with numerous patents covering various aspects of the drug, and US Patent 9,669,096 represents a "method of use" patent contributing to market exclusivity.
• This patent's expiration in 2034 is a critical factor for biosimilar adalimumab manufacturers planning market entry in the United States, potentially restricting usage of the claimed method until that date.

FAQs

1. What specific diseases are covered by US Patent 9,669,096? The patent explicitly covers methods for treating rheumatoid arthritis and broadly encompasses other autoimmune diseases.

2. What is the exact dosing regimen protected by this patent? The patent protects the administration of adalimumab at a dose of 40 mg every other week.

3. Does US Patent 9,669,096 cover the adalimumab molecule itself? No, this patent specifically covers methods of treatment using adalimumab, not the molecular composition of the antibody.

4. When will US Patent 9,669,096 expire, and what does this mean for biosimilars? The patent is set to expire on December 22, 2034. This expiration date may permit the use of adalimumab biosimilars for the claimed method of treatment in the United States after that date, subject to other applicable patents and regulatory approvals.

5. Who is the assignee of US Patent 9,669,096? The patent is assigned to AbbVie Inc.

Citations

[1] United States Patent 9,669,096. (2017). Method of treating rheumatoid arthritis. Retrieved from USPTO Patent Full-Text and Image Database.

Drugs Protected by US Patent 9,669,096

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 9,669,096

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004229463
Australia	2010202824
Australia	2013203378