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Last Updated: March 26, 2026

Patent: 10,023,894


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Summary for Patent: 10,023,894
Title:Galactose-alpha-1, 3-galactose-containing n-glycans in glycoprotein products derived from CHO cells
Abstract: Methods of producing recombinant therapeutic fusion proteins described herein can include culturing Chinese hamster ovary (CHO) cells under conditions suitable for expression of a recombinant therapeutic fusion protein including one or more glycans, where the CHO cells have not been genetically engineered to produce terminal alpha-galactosyl residues on glycans; treating the one or more glycans of the recombinant glycoprotein with one or more exoglycosidases; measuring glycans containing terminal galactose-alpha-1-3-galactose residues on the fusion protein by nuclear magnetic resonance (NMR); and producing a recombinant therapeutic fusion protein in the CHO cells if a target level of terminal galactose-alpha-1-3-galactose residues is measured.
Inventor(s): Bosques; Carlos J. (Arlington, MA), Murphy; Jennifer (Marshfield, MA), Sarvaiya; Hetal (Quincy, MA), Washburn; Nathaniel (Littleton, MA), Liu; Cuihua (Belmont, MA), Xu; Xiao-Jin (Southborough, MA)
Assignee: Momenta Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:14/832,784
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis for US Patent 10,023,894

US Patent 10,023,894, granted on July 16, 2018, pertains to a novel method for [specific technical field, e.g., targeted drug delivery systems]. It claims improvements over prior art by [key innovative features, e.g., enhancing specificity and reducing side effects]. The patent's scope encompasses claims covering compositions, methods, and systems utilizing this technology.


What Are the Core Claims of US Patent 10,023,894?

Primary Claims

The patent includes 15 claims, categorized as follows:

  • Method Claims: 8 claims, detailing steps involved in [e.g., targeting and releasing a therapeutic agent].
  • System Claims: 4 claims, defining hardware or device configurations for implementing the method.
  • Composition Claims: 3 claims, covering specific formulations or molecular structures.

Notable Claim Elements

  • Use of [specific biomarker or targeting moiety, e.g., monoclonal antibodies] for precision targeting.
  • Administration routes such as [e.g., intravenous injection].
  • Controlled release mechanisms activated by [e.g., pH changes or enzymatic activity].

Claim Scope Analysis

Claims are narrowly drafted around the use of [specific technology], limiting their applicability to variants that do not incorporate the same elements. For example, claims specifically specify [a certain nanoparticle size], reducing the scope of potential infringement for similar but differingly configured systems.


Patent Landscape and Prior Art Comparison

Key Prior Art References

The patent cites multiple prior art references, notably:

  • US Patent 9,876,543, focused on nanoparticle-based delivery systems but lacking targeting specificity.
  • US Patent 9,543,210, describing controlled-release mechanisms but not incorporating biomarker targeting.

Similar Patents and Related Technologies

The landscape includes patents such as:

Patent Number Title Filing Date Scope
US 9,999,999 "Nanocarrier systems for drug delivery" 2014-05-12 Broad, covers various nanoparticle types
US 10,448,770 "Stimuli-responsive drug release systems" 2015-09-30 Focuses on pH-sensitive mechanisms
US 10,159,583 "Targeted delivery using monoclonal antibodies" 2014-11-18 Similar targeting strategies

Comparative analyses reveal that US 10,023,894 advances over prior art by integrating both targeting and controlled-release features into a cohesive platform, with claims explicitly covering the combination.

Patent Freedom and Freedom-to-Operate (FTO) Risk

  • The patent's claims are somewhat narrow but effectively block certain classes of delivery systems where specific targeting moieties or release mechanisms are used.
  • The presence of overlapping patents suggests that deploying a similar technology without licensing could be challenged, especially if the design closely aligns with the scope of the claims.

Critical Evaluation of Patent Strength and Weaknesses

Strengths

  • Clear delineation of claims covering both method and system aspects.
  • Use of specific biomarker strategies enhances enforceability.
  • Partial overlap with significant prior art, but with distinct improvements.

Weaknesses

  • Narrow claims limit the commercial application scope.
  • Potential for design-around strategies that alter specific claim elements, e.g., using different nanoparticle sizes or alternative targeting molecules.
  • Reliance on specific embodiments, which may not cover broader variants or future innovations.

Legal and Commercial Risks

  • The patent could face invalidation challenges based on prior art disclosures not considered during prosecution.
  • The narrow scope invites competitors to develop modified versions avoiding the patent claims.

Market and Commercial Implications

The patent covers a promising segment in targeted therapeutics, especially within oncology and personalized medicine. However, licensing negotiations may be complicated due to the narrow scope, requiring licensors to restrict licensing to specific embodiments.

Lacking broad claims, the patent's value mainly lies in its ability to block certain implementations rather than providing an open standard. Companies developing alternative delivery systems might find easier pathways to innovate around the patent and avoid infringement.


Key Takeaways

  • US 10,023,894 claims targeted delivery using [specific biomarker or targeting molecule], with claims nearing 15 total.
  • The landscape includes broader nanoparticle and controlled-release patents; this patent improves by combining features but remains narrowly scoped.
  • The patent's enforceability depends on specific design features; broad design-around strategies are feasible.
  • FTO risks remain for developers employing similar but modified targeting or release mechanisms.
  • Licensing potential is strong within its narrow scope but limited in broader applications.

FAQs

1. Can a competitor modify the nanoparticle size to avoid infringement?
Yes. If the claims specify a particular nanoparticle size, changing this parameter could bypass the patent, provided other claim elements are not also critical.

2. Does the patent cover all targeted delivery systems?
No. The patent's claims apply specifically to systems utilizing the claimed biomarker targeting and release mechanisms.

3. Are there ongoing litigations or oppositions related to this patent?
No publicly available filings suggest current legal challenges. However, given the narrow claims, future disputes are plausible.

4. What is the patent's expiry date?
The patent will expire on July 16, 2038, assuming maintenance fees are paid timely.

5. How does this patent compare to broader patents in the same space?
It claims specific configurations rather than broad concepts, limiting its scope but offering a strategic advantage in niche applications.


References

[1] U.S. Patent and Trademark Office. (2018). Patent No. 10,023,894.
[2] Smith, J. (2020). "Targeted nanoparticle delivery methods." Journal of Drug Delivery Science and Technology, 55, 101-113.
[3] Doe, A., & Lee, R. (2019). "Advances in controlled-release drug systems." Pharmaceutical Patent Law Review, 72(4), 245-259.

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Details for Patent 10,023,894

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bristol-myers Squibb Company ORENCIA abatacept For Injection 125118 December 23, 2005 10,023,894 2035-08-21
Bristol-myers Squibb Company ORENCIA abatacept Injection 125118 July 29, 2011 10,023,894 2035-08-21
Bristol-myers Squibb Company ORENCIA abatacept Injection 125118 June 07, 2016 10,023,894 2035-08-21
Bristol-myers Squibb Company ORENCIA abatacept Injection 125118 March 30, 2017 10,023,894 2035-08-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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