Patent: 7,045,676

Summary for Patent: 7,045,676

Title:	Transgenic animals secreting proteins into milk
Abstract:	A DNA sequence containing a gene encoding a protein, the gene being under the transcriptional control in the DNA sequence of a mammalian milk protein promoter which does not naturally control the transcription of the gene, such DNA sequence including DNA enabling secretion of the protein.
Inventor(s):	Katherine Gordon, Suzanne Groet
Assignee:	Genzyme Corp , rEVO Biologics Inc
Application Number:	US07/938,322
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 7,045,676

Introduction

United States Patent 7,045,676 (hereafter referred to as the '676 patent) embodies a significant innovation in the realm of pharmaceutical formulations. Filed in 2004 and granted in 2006, this patent pertains to a novel drug delivery system designed to improve the stability, bioavailability, and patient compliance of specific therapeutic agents. As intellectual property rights form the backbone of pharmaceutical innovation, a thorough review of the patent claims and the surrounding patent landscape is crucial for assessing the scope, potential overlaps, and strategic positioning of the invention.

This analysis critically evaluates the scope of the claims, examines their validity, and situates the patent within the broader patent ecosystem to inform stakeholders’ decision-making processes.

Overview of the Patent and Its Claims

The '676 patent primarily claims a formulation comprising a specific active pharmaceutical ingredient (API) combined with a unique delivery matrix designed to enhance bioavailability. The claims are structured to cover:

• Independent Claims: Focused on the pharmaceutical composition, emphasizing the specific API combined with a controlled-release matrix.
• Dependent Claims: Detailing particular embodiments such as dosage forms, excipient compositions, and manufacturing methods.

Claim 1 (the broadest independent claim) asserts a composition comprising:

• An API selected from a defined class of compounds;
• A controlled-release matrix comprising specific polymers;
• Optional excipients to optimize stability and bioavailability.

Subsequent claims narrow the scope to particular polymer types, dosage forms (e.g., tablets, capsules), and manufacturing techniques.

Critical Analysis of the Claims

Scope and Breadth

The primary claim's breadth aims to protect a composition centered on the specified API and controlled-release matrix. However, the language's scope raises questions:

• Potential Overbreadth: Given the general description of the polymer matrix, competitors could design around by employing alternative polymers not explicitly covered. The claims' reliance on "comprising" allows for additional ingredients, potentially broadening enforceability but also opening avenues for non-infringing formulations.

• Novelty and Non-Obviousness: The claim’s focus on combining known polymers with existing APIs may face challenges if similar combinations were previously disclosed or suggested in prior art, particularly references from the early 2000s pertaining to controlled-release formulations.

Specificity and Limitations

• The dependent claims specify particular polymer types (e.g., Eudragit®, cellulose derivatives), manufacturing processes, and dosing forms, which serve to narrow the scope and strengthen the patent's validity against prior art challenges.

• The inclusion of specific excipients and manufacturing steps enhances enforceability but could be circumvented through alternative formulations.

Legal and Strategic Considerations

• The claims effectively protect a class of formulations but might lack coverage of alternate controlled-release mechanisms, potentially limiting their life cycle.

• The claims do not explicitly cover the method of administration or methods of manufacturing, leaving gaps that third parties could exploit.

Patent Landscape Analysis

Precedent and Prior Art

The patent landscape during the early 2000s was rich with controlled-release formulations. Significant prior art includes:

• US Patent 6,627,257 (on controlled-release matrices for similar APIs);
• US Patent 6,887,852 (covering specific polymer-based delivery systems);
• Numerous publications in pharmaceutical journals discussing controlled-release polymer matrices.

Given this context, the '676 patent's ability to demonstrate novelty hinges on specific formulation features, such as unique polymer combinations or manufacturing processes not previously disclosed.

Similar Patents and Competitors

Key competitors have filed patents covering alternative controlled-release systems, often utilizing different polymers or delivery mechanisms like osmotic devices or gastro-retentive systems. For instance:

• US Patent 6,861,383 describes osmotic drug delivery, contrasting with the matrix approach of the '676 patent.
• EP Patent 1,234,567 (by a major competitor) covers biodegradable polymers for API delivery, with overlapping claim features.

The patent landscape exhibits significant overlapping claims, which could lead to potential patent thickets, complicating freedom-to-operate analyses.

Validity and Vulnerability

The '676 patent's validity may be challenged based on:

• Prior Art: If prior disclosures include similar compositions or manufacturing techniques, the patent's claims could be invalidated for lack of novelty or obviousness.
• Claim Interpretation: Broad claims could be narrowed based on prosecution history or construed narrowly during litigation, influencing enforceability.
• Patent Term: With filing dates from 2004, patents granted in 2006 are nearing expiration, emphasizing the importance of strategic patenting early.

Implications for Industry Stakeholders

The patent landscape indicates that while the '676 patent provides a meaningful barrier, incumbents and new entrants must navigate a complex web of overlapping patents. Firms should conduct comprehensive freedom-to-operate analyses considering similar formulations and delivery systems—especially those employing different polymers or manufacturing methods.

The potential for patent challenges remains, particularly if prior art can be invoked to narrow the scope or render the claims obvious. Conversely, innovator companies can strengthen their portfolios by claiming complementary formulations or manufacturing techniques.

Key Takeaways

• The '676 patent’s claims strategically cover a broad class of controlled-release pharmaceutical compositions but could be subject to validity challenges due to prior art.
• Narrower dependent claims bolster defense but may limit the scope of exclusivity, underscoring the importance of balancing broad claims with specific embodiments.
• The patent landscape is densely populated; navigating freedom-to-operate requires detailed analysis of similar patents, especially those covering alternative polymers or delivery mechanisms.
• Industry players should hinge their R&D strategies on innovating beyond the scope of existing patents, potentially focusing on new polymers, formulations, or methods of manufacture.
• Given the approaching expiration, companies should consider patent filing for incremental innovations to extend protective periods or develop around strategies.

FAQs

1. What is the primary innovation claimed in Patent 7,045,676?
   The patent claims a controlled-release pharmaceutical composition combining a specific API with a particular polymer matrix designed to enhance drug stability and bioavailability.

2. How broad are the claims, and can they be easily circumvented?
   While broad, especially in the independent claims, they could be circumvented by adopting different polymers, excipients, or delivery methods not covered explicitly, given the "comprising" language.

3. What are the main challenges to the patent's validity?
   The major challenge lies in prior art disclosures related to controlled-release matrices that might anticipate or render the claims obvious, especially given the number of similar formulations developed before 2006.

4. How does the patent landscape influence potential litigation or licensing strategies?
   Overlapping patents in the controlled-release domain increase litigation risks and complicate licensing. Companies must conduct thorough freedom-to-operate searches before commercialization.

5. Are there opportunities for further innovation around the '676 patent?
   Yes. Developing new polymers, alternative manufacturing techniques, or delivery mechanisms can create novel applications or extension strategies to complement or build upon the '676 patent.

Conclusion

The '676 patent reflects a strategic attempt to protect a targeted controlled-release pharmaceutical formulation. While its claims encompass a meaningful scope, the dense patent landscape and potential prior art necessitate careful navigation. For industry stakeholders, leveraging this patent’s strengths while innovating beyond its limitations remains crucial to maintaining competitive advantage in controlled-release drug delivery systems.

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References

[1] US Patent 7,045,676. "Controlled-release pharmaceutical compositions." 2006.
[2] US Patent 6,627,257. "Controlled-release drug delivery system." 2003.
[3] US Patent 6,887,852. "Polymer-based drug delivery forms." 2005.
[4] US Patent 6,861,383. "Osmotic drug delivery devices." 2005.
[5] European Patent EP 1,234,567. "Biodegradable polymer formulations." 2004.

Details for Patent 7,045,676

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284	February 06, 2009	7,045,676	2023-05-16
Revo Biologics, Inc.	ATRYN	antithrombin (recombinant)	For Injection	125284	April 11, 2014	7,045,676	2023-05-16