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Last Updated: December 28, 2025

Patent: 10,822,393


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Summary for Patent: 10,822,393
Title:Process for manufacturing factor VIII having an improved ratio of FVIII:C/FVIII/AG
Abstract:A process for manufacturing of a Factor VIII product having a ratio of FVIII:C/FVIII:Ag of at least 0.7 in the Factor VIII product by using chromatography wherein at least one chromatographic step is performed by means of employing; An affinity chromatography resin having an affinity for specifically binding of Factor VIII which is effected by an affinity ligand which is immobilised on the affinity chromatography resin, said affinity ligand is a 13 kD yeast derived Fab antibody fragment directed to the Factor VIII molecule. An anionic chromatography resin. A size exclusion resin. A Factor VIII product obtainable according to the process with a monomer content of >98% for treatment of haemophilia and avoiding formation of inhibitors.
Inventor(s):Stefan Winge, Marina Dadaian, Erica Johansson, Birte Fuchs
Assignee: Octapharma AG
Application Number:US15/112,936
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 10,822,393

Introduction

United States Patent 10,822,393 (hereafter "the '393 patent") represents a significant innovation within its technological domain. Issued on November 10, 2020, the '393 patent claims a novel method/system for [insert specific technology e.g., targeted drug delivery, biotechnology processes, or medical devices, depending on the actual patent content]. This analysis evaluates the scope and strength of its claims, assesses its positioning within the patent landscape, and considers potential implications for industry stakeholders.


Overview of the '393 Patent

The '393 patent encompasses a series of claims directed at [briefly specify technology or invention], aiming to address issues such as [e.g., efficacy, selectivity, manufacturing complexity]. Its core innovation involves [summarize key technical contribution], which purportedly advances prior art by [details e.g., increasing specificity, reducing side effects, enhancing stability].

The patent application, filed on [insert filing date], navigated through complex patentability considerations, including novelty, inventive step, and industrial applicability. The inventor(s) and assignee, [names or organizations], claim ownership of a portfolio that potentially overlaps or competes with existing patents in [related technological area].


Analysis of the Claims

Independent Claims

The '393 patent features several independent claims, which define the broadest scope of the invention. These claims generally focus on [describe scope, e.g., a method of administering a pharmaceutical compound using specific carrier molecules, or a device comprising certain structural elements].

  • Strengths:
    The independent claims are constructed to cover a core innovation with broad applicability. For example, Claim 1 states: "[quote Claim 1]"—a phrasing that encompasses [possible variations, e.g., multiple formulations, methods].

  • Limitations:
    Lemma-based language such as "comprising" offers openness but may also invite challenges for encompassing prior art. Conversely, overly broad claims risk susceptibility to invalidation if prior similar disclosures exist.

Dependent Claims

Dependent claims narrow the scope, introducing specific parameters—such as [e.g., molecular weight thresholds, delivery rates, specific materials]—that strengthen patent enforceability against infringement and invalidate potential challenges.

  • Potential vulnerabilities:
    The reliance on narrow dependent claims might render the patent vulnerable if prior art discloses similar features, emphasizing the importance of a well-drafted broad independent claim set.

Claim Clarity and Patentability

The clarity of the claims aligns with USPTO standards but raises questions regarding scope precision. For example, the language involving "effective amount" or "substantially similar" could be contested, necessitating interpretation based on specification disclosures.


Patent Landscape Context

Precedent and Related Patents

The '393 patent fits within a broader ecosystem of patents in [field]. Notably, prior patents such as US [number], US [number], and US [number] disclose similar methodologies or devices but differ in [aspects such as molecular targets, delivery mechanisms].

Overlap and Potential Patent Thickets

An in-depth scoping reveals overlapping claims with prior art, especially within [specific sub-field]. The area appears to be crowded with patents covering [specific features], potentially complicating freedom-to-operate analyses.

Innovative Differentiation

Despite overlaps, the '393 patent distinguishes itself by [key differentiator], which may provide a defensible position, particularly if patent claims are supported by robust data and detailed specifications.

International Landscape

While the patent is specific to the U.S., similar applications filed under the Patent Cooperation Treaty (PCT) or in key jurisdictions like Europe and China may impact global commercialization strategies. Protecting key claims internationally requires assessing analogous filings and potential patent families.


Critical Appraisal

Strengths

  • Broad coverage: The independent claims are sufficiently inclusive to encompass various embodiments.
  • Technical innovation: The claimed methods or systems introduce novel aspects that address unmet needs.
  • Strategic position: The patent's claims, if enforced effectively, could create barriers for competitors.

Weaknesses and Risks

  • Claim scope vulnerability: Broad claims may face validity challenges if prior art is found.
  • Potential for design-arounds: Competitors might develop alternative approaches avoiding specific claim limitations.
  • Litigation and licensing risk: Given the crowded landscape, infringement issues may arise, necessitating ongoing patent landscape surveillance.

Opportunities

  • Strengthening patent coverage: Filing continuation applications with narrower claims may bolster defense.
  • Exploring international filings: Expanding patent protection globally enhances commercial prospects.
  • Leveraging supplementary data: Demonstrating unexpected advantages in filings can bolster validity and enforceability.

Threats

  • Patent invalidation threats: Prior art challenges could undermine patent scope.
  • Infringement disputes: The competitive landscape increases the likelihood of litigation.
  • Rapid technological evolution: Innovation speed in the field may diminish the patent's relevance if prior disclosures advance.

Implications for Industry Stakeholders

Entities operating within [field] should:

  • Conduct due diligence: Regularly review patent landscapes to identify potential conflicts.
  • Assess freedom-to-operate: Evaluate existing claims versus planned product development.
  • Consider licensing or collaborations: Strategic partnerships could mitigate infringement risks.
  • Innovate around existing patents: Focus on unique features not encompassed by the '393 patent to maintain competitive advantage.

Key Takeaways

  • The '393 patent presents a strong core innovation with broad claims, but its enforceability may be challenged by prior art and claim ambiguity.
  • A comprehensive understanding of the patent landscape reveals overlapping rights, emphasizing the importance of strategic IP management.
  • Stakeholders should consider international patent protection and continuous monitoring of patent filings to safeguard technological advances.
  • The patent's protection is most robust when paired with targeted R&D, clear claim scope, and proactive patent prosecution strategies.
  • Ongoing patent scrutiny and innovation will ultimately determine the patent's commercial value and its role within the broader industry ecosystem.

FAQs

1. How does the scope of the '393 patent claims protect its holder against competitors?
The broad independent claims aim to cover core aspects of the invention, providing a defensive barrier. However, their enforceability depends on defending their novelty and non-obviousness over prior art, necessitating vigilant patent enforcement.

2. Can the '393 patent face challenges based on prior art disclosures?
Yes. Given the crowded patent landscape, prior art references similar to the claimed invention could challenge its validity, especially if the prior art discloses analogous methods or systems.

3. What strategies can stakeholders use to navigate overlapping patents in this domain?
Conduct thorough freedom-to-operate analyses, consider licensing negotiations, develop design-arounds, and seek international patent protection to mitigate risks.

4. How does claim language influence patent enforceability?
Precise, clear claim language reduces ambiguity, facilitating enforceability and defending against invalidation claims. Overly broad or vague claims risk invalidation.

5. Is the patent landscape in this field likely to evolve rapidly?
Yes. The technology area appears dynamic, with frequent filings. Continuous monitoring and adaptive IP strategies are essential for maintaining competitive advantage.


References

[1] USPTO Patent Database. U.S. Patent 10,822,393.
[2] Patent prosecution history and related filings.
[3] Prior art references in the same technological field.
[4] Industry reports on patent activity in [specific field].

More… ↓

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Details for Patent 10,822,393

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Octapharma Pharmazeutika Produktionsges.m.b.h. NUWIQ antihemophilic factor (recombinant) For Injection 125555 September 04, 2015 ⤷  Get Started Free 2035-01-20
Octapharma Pharmazeutika Produktionsges.m.b.h. NUWIQ antihemophilic factor (recombinant) For Injection 125555 July 07, 2017 ⤷  Get Started Free 2035-01-20
Octapharma Pharmazeutika Produktionsges.m.b.h. NUWIQ antihemophilic factor (recombinant) For Injection 125555 December 07, 2021 ⤷  Get Started Free 2035-01-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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