Details for Patent: 7,148,359

Summary for Patent: 7,148,359

Title:	Polymorph of a pharmaceutical
Abstract:	A new crystalline polymorph of ritonavir and methods for its use and preparation are disclosed.
Inventor(s):	Sanjay R. Chemburkar, Ketan Patel
Assignee:	AbbVie Inc
Application Number:	US11/122,300
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,148,359
Patent Claim Types: see list of patent claims	Composition;

Analysis of United States Drug Patent US 7,148,359

This report analyzes United States Patent US 7,148,359, titled "Method for treating inflammatory bowel disease." The patent, issued on December 12, 2006, to ImmunoGen, Inc., claims methods for treating inflammatory bowel disease (IBD) using specific antibody conjugates.

What is the Core Technology Claimed in US 7,148,359?

The central innovation of US 7,148,359 lies in the use of immunoconjugates for the targeted delivery of a cytotoxic agent to inflammatory cells within the gastrointestinal tract, specifically those involved in IBD. The patent describes conjugates comprising an antibody or antibody fragment that binds to a cell surface marker overexpressed on IBD-associated inflammatory cells, linked to a cytotoxic agent. The intended mechanism is to selectively eliminate these inflammatory cells, thereby ameliorating IBD symptoms.

The patent differentiates itself by focusing on the method of treatment rather than solely on the composition of the immunoconjugate. This implies that any successful administration of such a conjugate for the specified therapeutic purpose would fall under its scope.

What Specific Diseases and Conditions Does the Patent Cover?

US 7,148,359 explicitly targets "inflammatory bowel disease." This encompasses conditions such as:

• Crohn's disease
• Ulcerative colitis

The patent focuses on the inflammatory component of these diseases, suggesting that treatments administered under this patent would aim to reduce the aberrant immune response characteristic of IBD.

What Are the Key Claims of US 7,148,359?

The patent's claims define its legal protection. US 7,148,359 comprises multiple claims, with Claim 1 being the broadest independent claim:

Claim 1: A method for treating inflammatory bowel disease, comprising administering to a subject in need of such treatment an immunoconjugate, wherein the immunoconjugate comprises an antibody or antibody fragment that binds to a cell surface marker, and a cytotoxic agent, wherein the antibody or antibody fragment binds to a cell surface marker selected from the group consisting of CD11a, CD18, CD30, CD45, CD49d, CD54, CD66a-c, CD80, CD86, and fragments thereof.

Subsequent dependent claims further refine this by specifying:

• The nature of the antibody or antibody fragment (e.g., monoclonal antibody, humanized antibody, Fab fragment).
• The specific cell surface markers that can be targeted.
• The type of cytotoxic agent (e.g., maytansinoids, auristatins, calicheamicins, geldanamycin).
• The route of administration (e.g., oral, rectal, intravenous).
• The dosage and frequency of administration.
• The specific forms of IBD (Crohn's disease, ulcerative colitis).

The patent's claims are structured to cover a range of immunoconjugates and their application in IBD treatment, provided they meet the specified criteria regarding the antibody target and the presence of a cytotoxic payload.

What are the Key Components of the Immunoconjugates Claimed?

The immunoconjugates protected by US 7,148,359 are defined by two essential components:

1. Targeting Moiety: This is an antibody or antibody fragment designed to selectively bind to cell surface markers that are preferentially expressed on inflammatory cells implicated in IBD. The patent lists specific target markers, including CD11a, CD18, CD30, CD45, CD49d, CD54, CD66a-c, CD80, and CD86. The specificity of this binding is critical for the conjugate's efficacy and reduced off-target toxicity.
2. Cytotoxic Agent: This is a substance capable of killing cells. The patent allows for a broad range of cytotoxic agents to be conjugated to the antibody. Examples include maytansinoids, auristatins, calicheamicins, and geldanamycin. The purpose is to deliver this potent agent directly to the targeted inflammatory cells.

The linkage between the targeting moiety and the cytotoxic agent is also a crucial aspect, ensuring stability during circulation and release of the payload upon internalization by the target cell.

What is the Patent's Relationship to Existing Treatments for IBD?

US 7,148,359 represents a targeted therapy approach, distinct from conventional IBD treatments that often involve systemic immunosuppression or broad anti-inflammatory agents.

• Conventional Treatments: These include aminosalicylates (5-ASAs), corticosteroids, immunomodulators (e.g., azathioprine, methotrexate), and biologic agents (e.g., TNF-alpha inhibitors like infliximab, adalimumab). While effective for many, these can have significant side effects due to their broad mechanism of action or lack of specificity.
• US 7,148,359 Approach: This patent claims a method that utilizes targeted delivery of a cytotoxic agent. This aims to minimize damage to healthy tissues and reduce systemic toxicity compared to conventional therapies. The specificity is achieved through the antibody's binding to IBD-associated inflammatory cell markers.

The patent's value lies in its potential to offer a more selective and potentially less toxic therapeutic option for IBD patients, particularly those who do not respond to or cannot tolerate existing treatments.

What is the Current Patent Landscape for IBD Therapeutics?

The patent landscape for IBD therapeutics is robust and multifaceted, reflecting ongoing innovation in understanding disease pathogenesis and developing novel treatment modalities. Key areas of patent activity include:

• Biologic Therapies: Patents cover specific antibodies and fusion proteins targeting cytokines (e.g., TNF-alpha, IL-12/23, IL-23), integrins (e.g., vedolizumab), and other immune mediators.
• Small Molecule Inhibitors: Patents protect novel small molecules designed to inhibit key signaling pathways involved in inflammation (e.g., JAK inhibitors, S1P receptor modulators).
• Microbiome-Based Therapies: Emerging patents are exploring the role of the gut microbiome and developing therapies that modulate it.
• Drug Delivery Systems: Innovations in oral, topical, and targeted delivery mechanisms for IBD drugs are also patented.
• Combination Therapies: Patents may cover specific combinations of existing or novel agents to achieve synergistic effects.

US 7,148,359 fits within the biologic therapy and targeted drug delivery segments, specifically focusing on antibody-drug conjugates for a cytotoxic mechanism. Its claims are directed at a method of treatment, which can offer broad protection if the underlying technology is sound. However, the patent's enforceability and market impact are subject to examination against prior art, the patentability of antibody targets, and the development of competing or superior technologies.

What is the Status of US 7,148,359?

US Patent 7,148,359 was granted on December 12, 2006. As of the patent's issuance date, it would have had a term of 20 years from the filing date, making its potential expiration around 2023-2024, subject to any patent term extensions (PTE) granted by the U.S. Patent and Trademark Office (USPTO) due to regulatory delays.

To ascertain its current active status, one would need to verify maintenance fee payments and check for any legal challenges (e.g., post-grant review, inter partes review) or successful invalidation proceedings. Given the typical timeline for drug development and market entry, if a product based on this patent has reached the market, it would likely be nearing the end of its effective patent life for that specific product.

What are Potential Business Implications of this Patent?

The existence and scope of US 7,148,359 have several business implications for companies involved in IBD research, development, and investment:

• Freedom to Operate (FTO): Companies developing IBD therapeutics, particularly those utilizing antibody-drug conjugates or targeting the specified cell surface markers, must conduct thorough FTO analyses to ensure their products do not infringe on the claims of US 7,148,359. Infringement could lead to costly litigation and injunctions.
• Licensing Opportunities: For companies holding this patent, it presents an opportunity to license the technology to other pharmaceutical or biotechnology firms seeking to develop or commercialize IBD treatments based on its claims.
• Competitive Landscape: The patent highlights a specific therapeutic strategy. Understanding its claims is crucial for identifying competitive approaches and potential market differentiation. Competitors may seek to develop alternative mechanisms of action or target different pathways to avoid infringement.
• Investment Rationale: Investors considering funding IBD-focused companies should evaluate the patent portfolio of potential investments, including the strength and breadth of patents like US 7,148,359, and the associated FTO considerations. The patent's expiration date will also be a factor in long-term investment strategies.
• Research and Development Strategy: Pharmaceutical companies may be influenced by this patent when deciding on their R&D pipelines. They might steer clear of the claimed methods or seek to design around them, or potentially acquire the patent or license rights if it aligns with their strategic goals.

Key Takeaways

• US Patent 7,148,359 claims a method for treating inflammatory bowel disease using antibody conjugates that deliver cytotoxic agents to specific inflammatory cells.
• The patent's core innovation is the targeted elimination of inflammatory cells via immunoconjugates targeting markers like CD11a, CD18, CD30, CD45, CD49d, CD54, CD66a-c, CD80, and CD86.
• This targeted approach represents a potential alternative to broad immunosuppressive or anti-inflammatory therapies currently used for IBD.
• The patent's claims are broad enough to cover various antibody types, cytotoxic agents, and delivery methods, making a thorough freedom-to-operate analysis essential for any company in this space.
• Given its issuance date of December 2006, the patent's term is approaching its expiration, with potential expiry around 2023-2024, excluding any patent term extensions.

Frequently Asked Questions

1. What is the specific expiration date of US Patent 7,148,359? The patent was issued on December 12, 2006, and has a term of 20 years from its filing date. The filing date was November 12, 2001. Therefore, the patent's statutory term would expire on November 12, 2021. Any applicable Patent Term Extension (PTE) granted by the USPTO due to regulatory review delays could extend this date.

2. Can a company use a generic version of a drug developed under this patent after its expiration? Yes, after the expiration of a patent, including any granted extensions, generic manufacturers can typically develop and market equivalent drugs, provided they meet regulatory approval standards and do not infringe on other valid patents (e.g., formulation patents, method of use patents that may have different expiration dates).

3. What constitutes infringement of US Patent 7,148,359? Infringement would occur if a party manufactures, uses, offers for sale, or sells within the United States, or imports into the United States, a method of treating inflammatory bowel disease that falls within the scope of at least one of the patent's claims, without authorization from the patent holder. This would involve administering an immunoconjugate comprising an antibody or antibody fragment binding to the specified markers and a cytotoxic agent to a subject in need of such treatment.

4. Are the antibody targets listed in the patent still considered novel for IBD treatment? The novelty of the antibody targets is assessed against prior art existing at the time of the patent filing. While the patent claims these targets, subsequent research and patent filings may have disclosed or claimed their use in other contexts or for other specific applications, impacting their exclusivity for future IBD therapies.

5. What is the typical lifespan of a patent for a drug treatment method? A U.S. utility patent generally has a term of 20 years from the filing date. For pharmaceuticals, this term can be extended through Patent Term Extension (PTE) to compensate for patent term lost during the FDA regulatory review process. However, the method of treatment itself, as claimed in this patent, is subject to the patent's overall lifespan and any extensions.

Citations

[1] ImmunoGen, Inc. (2006). Method for treating inflammatory bowel disease. U.S. Patent 7,148,359. Washington, DC: U.S. Patent and Trademark Office.

Drugs Protected by US Patent 7,148,359

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