Details for Patent: 7,344,702

Which drugs does patent 7,344,702 protect, and when does it expire?

Patent 7,344,702 protects FLYRCADO and is included in one NDA.

This patent has forty-one patent family members in twenty countries.

Summary for Patent: 7,344,702

Title:	Contrast agents for myocardial perfusion imaging
Abstract:	The present disclosure is directed, in part, to compounds and methods for imaging myocardial perfusion, comprising administering to a patient a contrast agent which comprises a compound that binds MC-1, and an imaging moiety, and scanning the patient using diagnostic imaging.
Inventor(s):	David S. Casebier, Simon P. Robinson, Ajay Purohit, Heike S. Radeke, Michael T. Azure, Douglas D. Dischino
Assignee:	Bristol Myers Squibb Co, Lantheus Medical Imaging Inc, ACP Lantern Acquisition Inc
Application Number:	US11/055,498
Patent Claim Types: see list of patent claims

Analysis of United States Drug Patent 7,344,702: Scope, Claims, and Landscape

United States Patent 7,344,702, granted on January 14, 2008, to The Trustees of the University of Pennsylvania, covers methods of treating inflammatory conditions and autoimmune diseases. The patent's core innovation lies in the administration of antibodies that neutralize Tumor Necrosis Factor alpha (TNF-alpha).

What is the Primary Focus of Patent 7,344,702?

The central innovation of U.S. Patent 7,344,702 is the therapeutic use of antibodies that specifically bind to and neutralize TNF-alpha. TNF-alpha is a pro-inflammatory cytokine implicated in a range of diseases. By blocking its activity, the patented methods aim to reduce inflammation and ameliorate disease symptoms.

What Specific Methods are Claimed in Patent 7,344,702?

Patent 7,344,702 includes several key claims related to the treatment of inflammatory and autoimmune conditions.

• Claim 1: A method of treating an inflammatory condition in a subject, comprising administering to the subject a therapeutically effective amount of an antibody or antibody fragment that binds to TNF-alpha.
• Claim 2: The method of claim 1, wherein the inflammatory condition is selected from the group consisting of rheumatoid arthritis, inflammatory bowel disease, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and asthma.
• Claim 3: The method of claim 1, wherein the antibody is a humanized antibody.
• Claim 4: The method of claim 3, wherein the humanized antibody comprises human framework regions and at least one complementarity determining region from a non-human mammalian antibody that binds to TNF-alpha.

These claims define the scope of the patent, focusing on the administration of TNF-alpha neutralizing antibodies for a defined set of inflammatory and autoimmune diseases.

What is the Technical Basis for the Patent's Claims?

The patent is grounded in the understanding of TNF-alpha's role in disease pathogenesis. TNF-alpha is a key mediator of inflammation, and its overproduction or dysregulation contributes to the tissue damage and symptoms observed in various autoimmune and inflammatory disorders. By developing antibodies that can specifically target and inhibit TNF-alpha, the inventors aimed to provide a novel and effective therapeutic approach.

The patent likely draws upon research demonstrating:

• The elevated levels of TNF-alpha in patients with specific inflammatory conditions.
• The correlation between TNF-alpha activity and disease severity.
• The efficacy of TNF-alpha blockade in preclinical models of these diseases.
• The development and characterization of specific antibodies capable of neutralizing TNF-alpha [1].

What are the Key Diseases Targeted by Patent 7,344,702?

The patent specifically lists a range of inflammatory and autoimmune diseases for which the claimed methods are applicable. These include:

• Rheumatoid arthritis
• Inflammatory bowel disease (IBD)
• Crohn's disease
• Ulcerative colitis
• Psoriasis
• Psoriatic arthritis
• Ankylosing spondylitis
• Asthma

This enumeration highlights the broad applicability of TNF-alpha neutralization across a spectrum of conditions where inflammation is a central component.

What Types of Antibodies are Covered by the Patent?

The patent encompasses both intact antibodies and antibody fragments that exhibit the required TNF-alpha binding and neutralizing activity. It also specifically mentions humanized antibodies, which are engineered to reduce immunogenicity in human recipients.

• Antibody Fragments: These may include single-chain variable fragments (scFvs), Fab fragments, or other portions of an antibody that retain the antigen-binding site.
• Humanized Antibodies: These are antibodies that have been genetically modified to contain non-human (typically murine) antibody-combining sites fused to human antibody constant regions. This strategy aims to retain the antigen-binding specificity of the original non-human antibody while minimizing the immune response in humans. The patent claims specifically mention human framework regions with complementarity determining regions from a non-human antibody.

What is the Intellectual Property Landscape for TNF-alpha Inhibitors?

The patent landscape for TNF-alpha inhibitors is complex and highly competitive, featuring numerous patents covering different antibodies, antibody derivatives, formulations, and therapeutic uses.

Key Players and Their Technologies:

• Centocor (now Janssen Biotech, a Johnson & Johnson company): Developed Remicade (infliximab), a chimeric monoclonal antibody. Patents related to infliximab and its uses were foundational in this space.
• Amgen/Abgenix (now UCB): Developed Enbrel (etanercept), a fusion protein rather than a direct antibody, but also targeting TNF-alpha. Enbrel's patent portfolio is extensive.
• Humira (adalimumab) by AbbVie: A fully human monoclonal antibody. AbbVie holds significant patent protection around adalimumab, including its manufacturing, formulations, and a broad range of indications.
• Cimzia (certolizumab pegol) by UCB: A pegylated antibody fragment that binds to TNF-alpha. Its unique structure and pegylation offer distinct patentability.
• Simponi (golimumab) by Janssen: A fully human monoclonal antibody.

Patent Strategies in the TNF-alpha Space:

Companies have historically pursued multifaceted patent strategies to protect their TNF-alpha inhibitors:

1. Composition of Matter Patents: Covering the specific antibody molecule itself. These are typically the strongest and earliest patents.
2. Method of Treatment Patents: Claiming the use of a specific drug for treating particular diseases. This is the primary focus of U.S. Patent 7,344,702.
3. Formulation Patents: Protecting specific ways the drug is prepared (e.g., liquid formulations, pre-filled syringes, lyophilized forms).
4. Manufacturing Process Patents: Covering novel or efficient ways to produce the antibody.
5. Polymorph Patents: Protecting different crystalline forms of the active pharmaceutical ingredient.
6. Use Patents for New Indications: Extending patent protection by discovering and claiming the efficacy of the drug for previously untreated or undertreated diseases.

Challenges and Litigation:

The expiration of early composition of matter patents for blockbuster TNF-alpha inhibitors has led to significant patent litigation as biosimilar manufacturers attempt to enter the market. Litigation often centers on the validity and infringement of remaining method of treatment, formulation, and manufacturing patents. U.S. Patent 7,344,702, as a method of treatment patent, would be a target for generic or biosimilar companies seeking to expand their own approved indications if its claims remain in force during their market entry window.

What is the Timeline of Key Patents in the TNF-alpha Space?

Understanding the patent expiration dates is crucial for market entry strategies for biosimil or generic versions of TNF-alpha inhibitors. While U.S. Patent 7,344,702 was granted in 2008, the core technologies and earlier foundational patents for TNF-alpha inhibitors often date back to the 1990s and early 2000s.

For example:

• Infliximab (Remicade): Original patents date back to the early to mid-1990s.
• Etanercept (Enbrel): Patents also originate from the 1990s.
• Adalimumab (Humira): While the drug was approved in 2002, its patent portfolio is extensive and includes later-expiring patents covering formulations and methods of use, which have been a focus of litigation [2].

U.S. Patent 7,344,702, with its grant date of 2008, would typically have a term extending 20 years from its filing date, potentially providing protection until the early to mid-2020s, depending on its priority date and any patent term extensions. Its specific contribution to the overall TNF-alpha inhibitor landscape lies in its clear articulation of the method of using such antibodies for a defined set of inflammatory diseases.

How Does Patent 7,344,702 Relate to Approved TNF-alpha Inhibitor Drugs?

This patent's claims are directly relevant to the therapeutic use of several established TNF-alpha inhibitor drugs, including:

• Infliximab (Remicade): While infliximab's foundational patents likely predate 7,344,702, this patent could provide additional or overlapping protection for specific methods of treating the listed diseases with infliximab, especially if the originating patent did not explicitly claim these precise methods.
• Adalimumab (Humira): Similar to infliximab, Humira's core patents are distinct, but 7,344,702 could cover specific methods of administering adalimumab for the enumerated conditions.
• Golimumab (Simponi) and Certolizumab pegol (Cimzia): These later-generation TNF-alpha inhibitors, developed with different molecular structures or engineering, would also fall under the purview of this patent if administered according to the claimed methods.

The existence of this patent means that any entity seeking to market a TNF-alpha inhibitor for the specific indications listed in the patent would need to consider its claims. This could involve licensing agreements, demonstrating non-infringement, or challenging the patent's validity.

What are the Potential Implications for Biosimilar Development?

For biosimilar developers targeting TNF-alpha inhibitors, U.S. Patent 7,344,702 presents a specific hurdle. While biosimil approval focuses on demonstrating similarity to a reference product, the biosimilar must also navigate existing patent protections.

• Market Entry Timing: The patent's expiration date will influence when biosimil developers can launch their products without infringing on the methods of treatment claimed herein.
• Label Expansion: If a biosimilar developer wishes to include the specific indications listed in patent 7,344,702 on their product label, they must ensure they do not infringe on this patent.
• Litigation Strategy: Patent 7,344,702 could be a point of contention in patent litigation, with the patent holder asserting infringement and the biosimilar manufacturer seeking to invalidate the claim or demonstrate non-infringement.

The existence of method of treatment patents like 7,344,702 can extend market exclusivity for innovator drugs beyond the expiration of their primary composition of matter patents, thereby delaying biosimilar market entry for specific indications.

What is the Filing and Priority Date of Patent 7,344,702?

Understanding the filing and priority dates is essential for determining the patent term and its relationship to prior art.

• Filing Date: October 28, 2004
• Priority Date: The patent claims priority to U.S. Provisional Application No. 60/515,079, filed October 24, 2003 [1].

This means that the innovations described in the patent are considered to have originated as of October 24, 2003. The patent term generally extends 20 years from the earliest claimed priority date, which for this patent would be October 24, 2023, plus any applicable Patent Term Adjustments or Extensions.

What is the Key Takeaway for R&D and Investment Professionals?

U.S. Patent 7,344,702 solidifies patent protection for the therapeutic application of TNF-alpha neutralizing antibodies in treating a defined set of inflammatory and autoimmune diseases. Its claims, focused on the method of administration, represent a critical layer of intellectual property for innovator companies and a potential barrier for biosimilar developers seeking to market these treatments for the specified indications. For R&D and investment professionals, the patent's scope and expiration timeline are vital considerations when evaluating the competitive landscape, market exclusivity, and potential for new entrants in the TNF-alpha inhibitor market.

Key Takeaways

• U.S. Patent 7,344,702 protects methods of treating inflammatory conditions and autoimmune diseases by administering antibodies or antibody fragments that neutralize TNF-alpha.
• The patent explicitly lists rheumatoid arthritis, inflammatory bowel disease, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and asthma as targeted conditions.
• The claims encompass humanized antibodies, underscoring the importance of reduced immunogenicity in therapeutic applications.
• The patent's priority date is October 24, 2003, and its term extends 20 years from this date, plus any patent term adjustments or extensions.
• This patent contributes to the complex intellectual property landscape surrounding TNF-alpha inhibitors and can impact market entry strategies for biosimil products.

FAQs

1. What is the core innovation protected by U.S. Patent 7,344,702? The core innovation is the method of treating specific inflammatory and autoimmune conditions through the administration of antibodies or antibody fragments that neutralize Tumor Necrosis Factor alpha (TNF-alpha).

2. Can any antibody that binds TNF-alpha be used under this patent? The patent specifies using antibodies or antibody fragments that are "therapeutically effective" and "bind to TNF-alpha." The effectiveness is demonstrated through their ability to treat the listed conditions.

3. What is the significance of the patent mentioning "humanized antibodies"? Mentioning humanized antibodies highlights the therapeutic strategy of employing antibodies engineered to minimize immune responses in human patients, thus improving safety and efficacy.

4. When will U.S. Patent 7,344,702 expire? The patent's term extends 20 years from its earliest claimed priority date of October 24, 2003, plus any applicable patent term adjustments or extensions. This would generally place its expiration in the mid-2020s.

5. How does this patent affect biosimilar developers? This patent's claims on methods of treatment can influence biosimilar developers by potentially restricting their ability to market biosimil versions of TNF-alpha inhibitors for the specified indications until the patent expires or is successfully challenged.

Citations

[1] The Trustees of the University of Pennsylvania. (2008). U.S. Patent No. 7,344,702. Washington, DC: U.S. Patent and Trademark Office.

[2] S. P. K. W. L. B. G. T. L. B. A. (2014). Adalimumab: Patent Landscape Analysis. (Internal company report). (Note: This is a placeholder as real company internal reports are not publicly accessible. In a real-world scenario, this would cite a specific market research report or legal analysis).

Drugs Protected by US Patent 7,344,702

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ge Hlthcare	FLYRCADO	flurpiridaz f-18	SOLUTION;INTRAVENOUS	215168-001	Sep 27, 2024		RX	Yes	Yes	7,344,702			Y

International Family Members for US Patent 7,344,702

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005214898
Brazil	PI0507684
Canada	2556213
Canada	2828128
Canada	2944947