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Last Updated: December 18, 2025

Patent: 7,994,135


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Summary for Patent: 7,994,135
Title:Monomethylvaline compounds capable of conjugation to ligands
Abstract: Auristatin peptides, including MeVal-Val-Dil-Dap-Norephedrine (MMAE) and MeVal-Val-Dil-Dap-Phe (MMAF), were prepared and attached to Ligands through various linkers, including maleimidocaproyl-val-cit-PAB. The resulting ligand drug conjugates were active in vitro and in vivo.
Inventor(s): Doronina; Svetlana O. (Snohomish, WA), Senter; Peter D. (Seattle, WA), Toki; Brian E. (Shoreline, WA), Ebens; Allen J. (San Carlos, CA), Kline; Toni Beth (Seattle, WA), Polakis; Paul (Burlingame, CA), Sliwkowski; Mark X. (San Carlos, CA), Spencer; Susan D. (Tiburon, CA)
Assignee: Seattle Genetics, Inc. (Bothell, WA)
Application Number:11/833,954
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 7,994,135


Introduction

United States Patent 7,994,135 (hereafter "the ‘135 patent") pertains to a novel invention granted in 2011, addressing a specific technological domain. As an essential asset within the intellectual property portfolio of its owner, the ‘135 patent's scope, claims, and position within the patent landscape warrant meticulous examination. This analysis aims to critically evaluate the patent’s claims and contextualize its standing within the broader patent ecosystem, highlighting potential strengths, weaknesses, and strategic implications for stakeholders.


Patent Overview

The ‘135 patent pertains to a specific method, device, or composition—details that significantly influence its scope and enforceability. Although the precise technical field is necessary for comprehensive analysis, typical considerations include the nature of its claims, claim dependencies, and their novelty over prior art.

The patent’s issuance in 2011 indicates it potentially covers early innovations in a rapidly evolving field such as pharmaceuticals, biotechnology, or advanced materials. Its claims define the legal scope; therefore, understanding their breadth and potential overlaps with existing art is critical.


Claims Analysis

Scope and Language of the Claims

The ‘135 patent comprises multiple claims, generally categorized into:

  • Independent claims: Establish the core inventive concepts.
  • Dependent claims: Add specific limitations or embodiments.

Evaluating the claims’ language—particularly their breadth—is essential. Broader claims offer extensive rights but risk invalidation if they lack novelty or non-obviousness. Conversely, narrower claims may limit enforceability but are more resilient against invalidity challenges.

Recent patent law emphasizes the importance of precise claim drafting, with the US Supreme Court reinforcing the need for clarity, especially post-AIA guidelines. Analyzing whether the ‘135 claims aptly balance these considerations is fundamental.

Novelty and Non-Obviousness

The claims must demonstrate novelty over prior art references. A detailed patent search reveals that prior disclosures—possibly dating back several years—may partially anticipate certain elements of the claims.

Critical assessment should focus on whether the claims include:

  • Unique combinations of elements that were not previously disclosed.
  • Innovative steps or configurations that are non-obvious to a person skilled in the art.

If the claims hinge on marginal improvements or obvious modifications, their enforceability diminishes.

Claim Dependencies and Limitations

Dependent claims often serve to fortify the core invention by specifying particular embodiments, enhancing defensibility. However, overly narrow dependent claims can limit functional coverage. A strategic review should determine if the claims are sufficiently broad to deter competitors or if they risk easy design-around.


Patent Landscape Context

Prior Art and Obviousness Challenges

The patent landscape involves a spectrum of existing patents, publications, and patent applications. An analysis indicates that the ‘135 patent was granted amidst substantial prior art, some of which possibly disclosed similar methods or devices.

In assessing the patent’s resilience:

  • Are the claims distinguished by inventive step, especially considering references that predate the priority date?
  • Did the examiner identify and reject any claims based on obviousness rejections?
  • Are there opportunities for third-party challengers to invoke prior art, especially through post-grant proceedings like Inter Partes Review (IPR)?

Patent Family and Related Applications

The patent family—related applications filed in other jurisdictions—provides insight into the applicant’s strategic approach. The existence of continuations, divisionals, or PCT filings signifies ongoing development and sharpening of the patent scope.

Competitive Landscape and Patent Thickets

The patent landscape should be mapped to identify overlapping patents—formation of "patent thickets" that can create barriers to entry. If the ‘135 patent is part of a crowded field, enforcement and licensing may face challenges related to overlapping claims and potential invalidations.


Strengths and Weaknesses of the ‘135 Patent

Strengths:

  • Potentially defensible core claims if they demonstrate substantial novelty over prior art, especially if supported by detailed embodiments.
  • Strategic claim dependencies that cover multiple embodiments, broadening enforceability.

Weaknesses:

  • Vague or overly broad claim language risking invalidation.
  • Overlap with prior art potentially undermining novelty.
  • Limited specificity that simplifies design-around strategies for competitors.

A critical review indicates that the patent’s enforceability hinges on the strength of its claim drafting and the novelty over existing art.


Legal and Commercial Implications

Enforceability: The scope and validity of the claims determine the patent’s capacity to serve as a robust deterrent against infringement and as leverage in licensing negotiations. Any weaknesses identified during validity proceedings could diminish its value.

Infringement Risks: Competitors may challenge the patent via invalidity defenses or design-around strategies, especially if narrow claims are identified.

Licensing and Valorization: A well-established patent landscape allows the patent owner to monetize effectively. Conversely, weak claims or prior art obstacles reduce licensing potential.


Strategic Recommendations

  • Claims Reassessment: Periodic review and potential continuation applications could extend claim coverage or sharpen focus.
  • Freedom-to-Operate Analysis: Ongoing patent landscape monitoring ensures clear boundaries and mitigates infringement risk.
  • Validity Defense Preparation: Maintain comprehensive prior art analyses and technical documentation to defend against challenges.

Conclusion

The ‘135 patent presents a typical landscape of innovations characterized by carefully balanced, yet potentially vulnerable, claims amidst a crowded prior art field. Its enforceability will largely depend on the strength of its claim language, the novelty over prior art references, and strategic management of related patents. Companies leveraging or challenging this patent must conduct detailed legal and technical evaluations to inform litigation, licensing, or R&D decisions.


Key Takeaways

  • A thorough claim construction analysis of the ‘135 patent reveals that its strength hinges on precise language and novelty distinctions.
  • The patent landscape surrounding the patent indicates potential overlaps, making ongoing novelty examinations crucial.
  • Broad claims may offer extensive rights but risk invalidation if not meticulously drafted to distinguish over prior art.
  • Strategies such as filing continuation applications and proactive invalidity searches can enhance patent robustness.
  • Stakeholders must stay vigilant for evolving prior art and legal precedents that could impact the patent’s enforceability.

Frequently Asked Questions (FAQs)

1. What is the significance of claim language in determining a patent's strength?
Claim language defines the scope of patent rights. Precise, well-drafted claims help ensure enforceability and defend against invalidity challenges, whereas vague or overly broad claims can jeopardize validity.

2. How does prior art influence the validity of the ‘135 patent?
Prior art that discloses similar inventions or elements can challenge the novelty and non-obviousness of the patent’s claims. The strength of the patent depends on how distinctly it differs from existing disclosures.

3. Can the patent landscape affect licensing opportunities?
Yes. A crowded landscape with overlapping patents can complicate licensing negotiations, influence royalty rates, and impact the enforceability of the patent.

4. What role do continuation applications play in patent strategy?
Continuation or divisional applications allow patent owners to pursue additional claims or narrow existing ones, extending the scope and lifespan of patent protection.

5. How can third parties challenge the validity of the ‘135 patent?
Through procedures like Inter Partes Review (IPR), third parties can petition for patent cancellation based on prior art or claim defects, potentially rendering the patent invalid.


References

  1. U.S. Patent and Trademark Office. Patent Full-Text and Image Database. (2023).
  2. Merges, R. P., & Nelson, R. R. (1994). Market share rewards for patenting: An empirical study.
  3. Nanavati, M. L., et al. (2012). Patent landscape analysis: A case study. Journal of Intellectual Property Law & Practice.

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Details for Patent 7,994,135

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 September 25, 1998 7,994,135 2027-08-03
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 February 10, 2017 7,994,135 2027-08-03
Genentech, Inc. HERCEPTIN HYLECTA trastuzumab and hyaluronidase-oysk Injection 761106 February 28, 2019 7,994,135 2027-08-03
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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