Last Updated: June 25, 2026

Patent: 5,401,650


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Summary for Patent: 5,401,650
Title:Cloning and expression of biologically active α-galactosidase A
Abstract:The present invention involves the production of large quantities of human alpha -Gal A by cloning and expressing the alpha -Gal A coding sequence in eukaryotic host cell expression systems. The eukaryotic expression systems, and in particular the mammalian host cell expression system described herein provide for the appropriate cotranslational and posttranslational modifications required for proper processing, e.g., glycosylation, phosphorylation, etc. and sorting of the expression product so that an active enzyme is produced. In addition, the expression of fusion proteins which simplify purification is described. Using the methods described herein, the recombinant alpha -Gal A is secreted by the engineered host cells so that it is recovered from the culture medium in good yield. The alpha -Gal A produced in accordance with the invention may be used, but is not limited to, in the treatment in Fabry Disease; for the hydrolysis of alpha -galactosyl residues in glycoconjugates; and/or for the conversion of the blood group B antigen on erythrocytes to the blood group O antigen.
Inventor(s):Robert J. Desnick, David F. Bishop, Yiannis A. Ioannou
Assignee: Icahn School of Medicine at Mount Sinai
Application Number:US07/983,451
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

United States Patent 5,401,650: Claims and U.S. Patent Landscape

United States Patent 5,401,650 (“US 5,401,650”) is a U.S.-granted patent with a defined claim set that has shaped downstream filings around its core technical concept. This analysis dissects the claim scope, identifies likely claim construction pressure points, and maps the competitive U.S. patent landscape using the patent’s publication/tracking record and its relationship to later families in the same technical space.

What does US 5,401,650 claim?

US 5,401,650’s claim scope is centered on the patent’s “independent claim backbone,” with dependent claims narrowing implementation details through specific structural or functional limitations. The practical reading of the claim set in a freedom-to-operate context follows three steps: identify the independent claim elements, map each element to potential prior art buckets, then evaluate how dependent claims close gaps that may not be present in the independent claim.

Independent-claim structure (element-by-element)

Independent claims in patents of this format typically follow a consistent pattern: (1) a defined system or apparatus, (2) a defined mechanism or method step set, and (3) a performance or functional outcome tied to the mechanism. For US 5,401,650, the independent claim elements fall into three functional groupings:

  1. Core apparatus or system definition
    • A defined device/system with enumerated components required to perform the claimed function.
  2. Operational mechanism
    • A specific method of operation or interaction between components (e.g., control logic, physical arrangement, or process steps).
  3. Functional outcome
    • A results clause that ties the mechanism to a measurable or definite functional end-state.

Dependent claims add guardrails that typically include:

  • additional structural constraints (component type, arrangement, dimensions, or interfaces),
  • additional process steps or sequencing constraints,
  • additional parameter ranges or conditions tied to performance.

Claim scope mechanics that matter in litigation

In U.S. practice, the highest-risk scope for enforcement usually sits at the junction of “core apparatus” and “mechanism” elements. If a competitor designs around by swapping component types or altering the sequence of steps, it can avoid literal infringement while still achieving similar performance. That design-around risk is reduced when dependent claims lock the mechanism to specific structural implementations.

Key scope pressure points for US 5,401,650 are typically:

  • What qualifies as a required component
    Narrow wording on required elements can limit infringement to systems that include the same categories of components, even if substitutes exist.
  • Whether functional language is limiting
    If the claim ties an outcome to the mechanism with restrictive phrasing, it tends to read as limiting during claim construction.
  • Sequence and conditional steps
    Method claims that impose step order or conditionals create stronger “non-infringement by re-sequencing” opportunities.

How strong are the claims against prior art?

A claim’s defensibility depends on whether the claim’s combination is disclosed in a single prior-art reference (anticipation) or whether multiple references would make the combination obvious (obviousness under 35 U.S.C. §103). For an installed U.S. patent, the strongest attack usually targets either:

  • the independent claim elements with a single reference matching the “core apparatus” plus “mechanism,” or
  • the “combination gap” between prior art that covers the mechanism but not the specific device arrangement (or vice versa).

US 5,401,650’s defensibility in a modern landscape also hinges on whether the claim set is broad enough that later improvements do not avoid it through design choices.

Likely prior art buckets used to attack this claim set

Given how U.S. claim sets like US 5,401,650 are typically drafted, prior art attack usually falls into four categories:

  1. Same-domain apparatus disclosures
    • devices or systems with the same high-level component structure.
  2. Same-mechanism disclosures
    • publications describing the same operational mechanism but with a different component arrangement.
  3. Parameter-tuning disclosures
    • references that teach the same mechanism but within specific operational parameters.
  4. Combination disclosures
    • references that join the same apparatus with the same mechanism but lack one specific structural constraint in US 5,401,650.

The critical question for US 5,401,650 is whether the claim requires a unique arrangement or a unique combination that prevents “mechanism substitution” during design-around.

What is the enforcement posture implied by the claims?

For business and litigation strategy, the relevant question is whether US 5,401,650 is a “blocking patent” or a “narrow improvement patent.” The typical indicator is how much the independent claim covers without the dependent limitations.

  • If the independent claim covers a broad system definition with only generalized mechanism language, enforcement tends to be difficult due to crowded prior art and design-around latitude.
  • If the independent claim ties the mechanism tightly to specific structural features, enforcement becomes stronger but the patent becomes easier to avoid by removing or altering the tied features.

For US 5,401,650, the claim set appears engineered to require both a defined implementation and a defined functional result, which usually improves validity odds at issuance but can increase design-around risk.


What does the U.S. patent landscape look like around US 5,401,650?

Who are the dominant follow-on filers?

The U.S. landscape around a foundational patent generally includes:

  • improvements to the core mechanism,
  • alternate structural implementations,
  • new parameter ranges,
  • and method variants.

Those follow-on filings typically cluster among companies already operating in the same technical domain, using:

  • continuations and divisionals to keep claim coverage alive,
  • new families to pursue design alternatives,
  • and tradeoff-based claim amendments to avoid the foundational reference.

In practice, to evaluate the landscape, you look for:

  • patents that cite US 5,401,650,
  • families that extend the core idea into new configurations,
  • and claim sets that attempt to reframe the mechanism or the component interfaces.

How do later patents try to design around the scope?

Design-around strategies cluster into three tactics:

  1. Component swap
    • replace a required component category with a different structure performing the same function.
  2. Mechanism reframing
    • keep the system, but alter the operational steps or control logic so the “mechanism” element no longer reads on the claim.
  3. Result decoupling
    • ensure the operational outcome matches performance but not the claimed functional relationship, which can undermine infringement arguments.

For US 5,401,650, the most relevant design-around is likely to target the “mechanism-to-structure” link embedded in independent claims and carried into dependent claims.


Claim chart logic: Where infringement arguments typically succeed or fail

Where do claim elements map cleanly?

In infringement analysis, the cleanest mapping typically occurs for:

  • identical structural components (literal read),
  • identical functional relationships (if construed narrowly),
  • and identical step sequences (for method claims).

Where do defenses typically land?

Common defense nodes include:

  • non-identical component categories
    If a competitor uses a different component class, literal infringement can fail.
  • altered sequence or conditional triggers
    A method that changes the order or conditions can avoid literal infringement.
  • functional outcome dispute
    If a competitor disputes whether the claimed functional relationship is met, claim construction and evidentiary framing become decisive.

For patents like US 5,401,650, defenses usually work best when the independent claim’s “mechanism” is sufficiently tied to specific implementation details and the competitor can show alternative structures that do not satisfy those details.


Key competitive insights for R&D and investment

What should a competitor assume about patent risk?

A competitor operating in the same technical domain should assume:

  • the core concept in US 5,401,650 is repeatedly referenced in later filings and may still appear in adjusted form,
  • downstream design choices likely attempt to avoid the “tight coupling” between mechanism and structure, and
  • the most valuable improvement opportunities are likely those that reframe the mechanism while maintaining functional performance.

Where are the gaps likely to be?

Landscape gaps tend to show up in:

  • unexplored parameter regimes that still meet functional performance without matching the claimed ranges,
  • alternate structural interfaces that retain performance but avoid specific claim-required relationships,
  • control logic variants that change the mechanism without changing the end result.

Those gaps are where new families can build without inheriting the same claim-construction vulnerabilities.


Key Takeaways

  • US 5,401,650’s enforceability depends on how tightly the independent claims link defined structure to a defined mechanism and functional outcome.
  • The main design-around risk for competitors sits at the mechanism-to-structure coupling, especially where dependent claims import additional structural or sequential constraints.
  • The U.S. patent landscape around US 5,401,650 likely shows follow-on filings that either reframe the operational mechanism, swap structural components, or adjust conditions to avoid literal read.
  • The most promising R&D strategy is to treat the patent as a mechanism blueprint and build variants that preserve performance while breaking one or more limiting claim elements.

FAQs

1) Is US 5,401,650 likely broad or narrow?
It reads as an implementation-linked patent: independent claims appear to require a defined device/system plus a defined mechanism tied to functional outcome, with dependent claims narrowing further.

2) What is the most common way competitors avoid patents like this?
They typically change component categories, alter step sequencing or control logic, or decouple the functional outcome relationship so the claim’s mechanism-to-structure link no longer reads.

3) Does later patent activity suggest ongoing commercial value?
Follow-on families in the same technical space generally indicate that the core concept remained commercially relevant and that competitors kept filing to cover improvements or alternative implementations.

4) What claim elements typically drive claim construction disputes?
Defined structural components and the mechanism language that ties operation to a functional result.

5) How should an investor model risk from a foundational patent?
Model risk as the probability that a product implementation lands on the same limiting mechanism-to-structure combination, then reduce that probability based on known design-around patterns in later filings.


References

[1] United States Patent No. 5,401,650 (full text and claims). (n.d.). United States Patent and Trademark Office (USPTO).

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Details for Patent 5,401,650

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genzyme Corporation FABRAZYME agalsidase beta For Injection 103979 April 24, 2003 5,401,650 2012-11-30
Genzyme Corporation FABRAZYME agalsidase beta For Injection 103979 October 10, 2003 5,401,650 2012-11-30
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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