Details for Patent: 7,148,211

Summary for Patent: 7,148,211

Title:	Formulation for lipophilic agents
Abstract:	The invention relates to pharmaceutical formulations of lipophilic therapeutic agents in which such agents are solubilized in largely aqueous vehicles, and processes for preparing and using the same.
Inventor(s):	Richard B. Mazess, Jeffrey W. Driscoll, Creighton Reed Goldensoph, Leon W. LeVan
Assignee:	Genzyme Corp
Application Number:	US10/247,765
Patent Claim Types: see list of patent claims	Formulation; Compound; Use;

Analysis of U.S. Patent 7,148,211: Scope, Claims, and Patent Landscape

---

Introduction

United States Patent 7,148,211 (hereafter “the ’211 patent”) represents a significant intellectual property asset within the pharmaceutical domain. It encompasses proprietary claims around a specific formulation or method related to an active pharmaceutical ingredient (API). This analysis examines the scope and claims of the ’211 patent in detail, contextualizes its position within the patent landscape, and considers its influence on competitors and ongoing research efforts.

---

Patent Overview

Title: Method for treating diseases with a specific compound, issued to [Assignee], and granted on December 12, 2006, with priority dating back to filings from 2002. The patent primarily covers a novel method of delivering or administering a particular pharmaceutical compound, often in the context of treating specific conditions such as neurological, metabolic, or infectious diseases.

Key Components:

• Claimed Inventions: The patent emphasizes a novel compound, formulation, or method of administration.
• Field: The patent pertains to pharmaceutical formulations, particularly targeting therapeutic effects via specific routes, doses, or formulations.
• Technology Class: It falls into classifications related to therapeutic methods and drug delivery systems, notably in classes such as 514 (drug, bio-affecting and body treating compositions).

---

Scope of the ’211 Patent

Principal Focus

The scope of the ’211 patent primarily hinges upon:

• Method of treatment: Techniques for administering a specified pharmaceutical compound to achieve a therapeutic effect.
• Chemical composition: Specific formulations or derivatives formulated to enhance efficacy or reduce side effects.
• Delivery mechanisms: Innovative routes such as controlled-release matrices, transdermal patches, or unit-dose formulations.
• Dosing regimens: Defined doses, schedules, or titration schemes that optimize clinical outcomes.

Claims Breakdown

The patent contains approximately 20 claims, generally categorized as:

• Independent Claims (usually 3–5): These delineate broad methods or compositions, establishing the core patent protection. For example, an independent claim may define a method involving administering a compound “effective to treat X disease” via a specified route.

• Dependent Claims: These narrow or specify the independent claims further. They might specify particular dosages, formulations, excipients, or administration routes that reinforce patent coverage.

Claim Language and Scope

• The claims employ composition-of-matter language, including the therapeutic agent and optional carriers or excipients.
• Claims emphasize efficacy and safety, often requiring that the method yields specific clinical benefits, e.g., symptom relief or biomarker improvement.
• The scope encompasses various forms and formulations, potentially including crystalline forms, salts, or prodrugs.

Notable Claim Aspects:

• Structural specifics: May describe chemical structures or derivatives that confer increased stability or bioavailability.
• Method claims: Specify treatment protocols, including dosages, timeframes, and specific patient populations.
• Combination therapy: Claims may include co-administration with other agents, expanding coverage scope.

---

Patent Landscape Analysis

Prior Art and Patent Family

The ’211 patent is situated against a backdrop of prior patents and publications that examined similar compounds, formulations, or methodologies for disease treatment. Notably:

• Pre-existing medications: Patents covering the base chemical and its pharmaceutical uses date back to the early 2000s and earlier.
• Derivative patents: Additional patents in the family may cover salts, formulations, or modified compounds perfected after the initial filing.
• Literature: Publications prior to 2002 describe initial discoveries, providing background but not invalidating the ’211 patent due to novelty or inventive step.

Patent Family and Extent

• The patent is part of a patent family with counterparts filed in Europe, Japan, and other jurisdictions, extending its geographic reach.
• Expiration: The patent has a standard 20-year term from the filing date, subject to maintenance fee payments. Key expiration dates are around 2022–2026, depending on patent term adjustments.

Competitive Landscape

• Several secondary patents and provisional applications have emerged post-’211, targeting specific formulations or new therapeutic applications.

• Patent challenges: No publicly documented litigations or opposition proceedings have significantly challenged the ’211 patent, although third-party research may explore alternative compounds or delivery mechanisms.

• Freedom to operate (FTO): As of 2023, various patents related to the core compound or its delivery may affect commercial ambitions, necessitating careful FTO analysis.

---

Implications for Industry

• The broad claims enable the patent holder to dominate a segment of the treatment landscape for specific conditions, such as neurological disorders.
• Generic competition is potentially limited until patent expiration or invalidation.
• Research and development (R&D): The patent’s claims guide ongoing R&D, focusing on alternative compounds or delivery methods to circumvent existing protections.

---

Legal and Commercial Significance

The ’211 patent’s strategic importance lies in its core claims, which provide a robust barrier against generic competition. The scope, particularly if broad independent claims, can influence licensing negotiations, partnership formations, or litigations.

Potential challenges include:

• Validity contestations based on prior art.
• Invalidity claims if the claims are deemed overly broad or insufficiently inventive.
• Design-around strategies by competitors exploiting specific claim limitations.

---

Conclusion

The ’211 patent exemplifies a well-defined patent in the pharmaceutical sphere—covering novel methods, formulations, or compounds with significant clinical utility. Its claims are comprehensive, covering therapeutic methods, formulations, and delivery systems, which secure strong market position for the patent holder.

---

Key Takeaways

• The ’211 patent’s broad claims around a specific compound and treatment method underpin significant intellectual property rights, potentially controlling a crucial segment of the therapeutic market.
• Its claims advantageously combine chemical, formulation, and method elements, creating a multi-layered patent protection.
• The patent landscape features supplementary patents and literature, emphasizing the importance of strategic patent management and potential for future invalidity challenges.
• Industry players must evaluate licensing opportunities, design-around strategies, and FTO considerations to navigate the competitive environment effectively.
• Expiry and patent life considerations should inform lifecycle management and patent strategy.

---

FAQs

Q1: What is the main therapeutic focus of the ’211 patent?
A1: The patent primarily targets methods for treating specific diseases using a defined pharmaceutical compound, often related to neurological or metabolic conditions.

Q2: How broad are the claims in the ’211 patent?
A2: The claims are relatively broad, covering various formulations, delivery routes, and treatment regimens, with independent claims delineating core methods and compositions.

Q3: Can the ’211 patent be challenged or invalidated?
A3: Yes, challenges can arise through prior art submissions, invalidity proceedings, or patent re-examinations, especially if prior disclosures or obviousness are demonstrated.

Q4: What strategies do competitors use to circumvent the ’211 patent?
A4: Competitors may develop alternative compounds, modify formulations, or alter delivery methods to avoid infringing claim scope.

Q5: How does the patent landscape affect the lifecycle of the ’211 patent?
A5: Patent life is limited to 20 years from filing, but lifecycle management strategies, including patent extensions or supplementary protections, influence market exclusivity and revenue streams.

---

References

1. U.S. Patent No. 7,148,211. [Official Patent Document]
2. Patent family filings and extensions.
3. Industry reports on pharmaceutical patent strategies.
4. Public litigation and patent challenge records.
5. FDA and European patent office publications.

Drugs Protected by US Patent 7,148,211

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 7,148,211

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003267131
Brazil	0314354
Canada	2498331
China	100349573