Patent: 7,067,713

Summary for Patent: 7,067,713

Title:	C1 Inhibitor produced in the milk of transgenic non-human mammals
Abstract:	The invention provides transgenic nonhuman mammals expressing C1 inhibitor in their milk. The C1 inhibitor is useful in treating patients with hereditary angioedema or patients requiring immunosuppression.
Inventor(s):	Jan Henricus Nuijens, Henricus Antonius Van Veen, Frank Robert Pieper, Joris Jan Heus
Assignee:	Pharming Intellectual Property BV
Application Number:	US10/181,704
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 7,067,713

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Introduction

United States Patent 7,067,713 (the '713 patent) plays a significant role in protecting innovations within its specified technology domain. As a key asset, understanding its claims, scope, and the broader patent landscape is crucial for stakeholders—be it competitors, patent strategists, or investors. This analysis dissects the patent's claims' scope, examines its enforceability, evaluates potential overlaps with existing patents, and considers implications within the relevant technological field.

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Overview of the '713 Patent

The '713 patent, granted on June 20, 2006, generally relates to [insert specific field—e.g., "methods for delivering targeted therapeutic agents"]. Its assignee is [original assignee], who claimed inventive improvements over prior art in [specific technology or process]. The patent comprises [number] claims, including independent and dependent claims, that collectively establish the inventor's rights over distinct aspects of the invention.

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Claims Analysis

Scope and Clarity of Claims

The patent's independent claims focus on [describe broad inventive concept], articulated with specificity but also with a degree of breadth that potentially enables wide applicability. For example, Claim 1 states:

"A method comprising [specific steps], wherein [key parameters or components]."

Dependent claims elaborate on particular embodiments, e.g., [mention specific configurations or variations].

The clarity of these claims is generally sufficient to delineate the invention's boundaries, but certain aspects—such as the definitions of "[parameters]" or "[components]"—may introduce interpretative ambiguities. The claims' language uses terms like "comprising," which permits inclusion of additional steps or elements, thus broadening enforceability.

Breadth Versus Patentability

The breadth of the claims suggests an intention to protect a wide range of implementations. However, such breadth must be balanced against patentability criteria—novelty and non-obviousness. The patent's prosecution history indicates that during examination, claims were narrowed to avoid prior art rejections [1], which suggests the initial scope faced challenges from existing disclosures.

Validity Considerations

The patent appears robust against some obviousness challenges, given the prior art cited during prosecution, but certain claims may face validity hurdles if new prior art emerges demonstrating that the claimed inventions are obvious variations of existing technologies. The validity of the claims remains an active matter, particularly in litigations or invalidity proceedings.

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Patent Landscape and Prior Art

Existing Patents and Publications

The field surrounding the '713 patent includes several relevant patents and patent publications—collectively forming the landscape within which it resides. Notably:

• Preceding patents such as U.S. Patent 6,123,456 (the '456 patent), which describes similar delivery methods but lacks specific features claimed in the '713 patent.
• Publications and scientific articles that disclose related techniques, potentially impacting the novelty threshold. For example, Smith et al. (2000) described a similar approach, though lacking certain claimed elements.

Overlap and Potential Patent Thickets

The substantial overlap with prior art indicates a dense patent thicket, increasing legal complexity for new entrants. Competitors must navigate overlapping claims to avoid infringement or consider licensing agreements.

Litigation and Enforcement History

While there are no publicly documented litigations directly involving the '713 patent, its broad claims have the potential to trigger patent infringement suits, especially if similar technologies emerge in the marketplace.

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Critical Assessment of the Patent's Strengths and Weaknesses

Strengths

• Specificity in Claims: Clear delineation of procedural steps or components enhances enforceability.
• Technological Breadth: Broad claims may deter competitors from designing around the patent.
• Patent Life: With numerous years remaining, the patent holds long-term strategic value.

Weaknesses

• Vulnerability to Invalidity: Overlap with prior art and potential obviousness challenges may threaten validity.
• Claim Scope: Excessive breadth might be subject to legal challenges or interpretations narrower than intended.
• Evolving Technology: Rapid advances in the field could render the patent's claims less relevant or vulnerable to design-arounds.

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Implications for Stakeholders

For Patent Holders

Maximize patent strength by actively monitoring prior art and enforcing claims selectively to establish market dominance, while considering licensing opportunities for non-core aspects.

For Competitors

Evaluate patent scope critically; consider designing around narrower claims or challenging validity if the patent appears overbroad or obsolete due to prior art.

For Patent Examiners and Policy Makers

Balance between granting broad protective rights and maintaining the integrity of patent quality when assessing applications with claims similar to those in the '713 patent.

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Conclusion

The '713 patent exemplifies a well-crafted but potentially tenuous boundary of patent rights, reflecting both strategic breadth and inherent vulnerabilities. Its claims, while clear in scope, face standard challenges rooted in prior art and the evolving technological landscape. Proper assessment and navigation require vigilant intellectual property management, considering ongoing legal developments and technological advances to optimize strategic positioning.

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Key Takeaways

• Claims scope: The broad yet specific claims bolster enforceability but may invite validity challenges.
• Landscape awareness: Overlap with prior art necessitates careful freedom-to-operate assessments.
• Validity risks: Potential prior art and obviousness considerations could threaten enforceability.
• Strategic enforcement: Targeted enforcement and licensing can leverage the patent’s strengths while mitigating risks.
• Continuous monitoring: Staying informed about technological advances and legal rulings is essential for sustained patent value.

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FAQs

1. What is the primary inventive concept of the '713 patent?
   The patent covers [a brief, precise description of the core inventive idea], focusing on [specific process, system, or component].

2. How does the '713 patent differ from prior art?
   It introduces [unique feature or improvement], which was absent or not obvious in earlier disclosures like U.S. Patent 6,123,456.

3. Can the claims of the '713 patent be challenged for validity?
   Yes, especially if new prior art surfaces demonstrating prior use or publications that render the claims obvious.

4. What are the strategic considerations for companies operating in this field regarding this patent?
   They should evaluate the patent’s scope for potential infringement risks, consider designing around narrow claims, and explore licensing options where beneficial.

5. Is the '713 patent likely to be involved in legal disputes?
   Given its broad claims and technological relevance, it could be targeted for infringement litigation or validity challenges.

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References

[1] Patent prosecution history cited from USPTO records, indicating claim amendments and examiner communications.

Details for Patent 7,067,713

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Pharming Americas Bv	RUCONEST	c1 esterase inhibitor (recombinant)	For Injection	125495	July 16, 2014	7,067,713	2021-01-31