United States Patent 7,897,590: Scope, Claims, Expiration, and Stem-Cell Mobilization Patent Landscape

U.S. Patent No. 7,897,590 protects methods for mobilizing progenitor or stem cells into peripheral blood by administering defined polyamine compounds and then harvesting the mobilized cells. The broadest practical commercial embodiment is plerixafor, also known as AMD3100, administered subcutaneously, often after G-CSF pretreatment. The patent’s core claims cover the treatment-and-harvest procedure rather than the compound itself.

The patent issued on March 1, 2011, from an AnorMED-originated patent family later associated with Genzyme and Sanofi. Its nominal U.S. patent term ran to December 24, 2024, based on the family’s 2003 priority date. The patent therefore presents little or no current U.S. blocking risk after expiration, subject to any applicable patent-term adjustment, pediatric extension, or continuing-family rights. It remains important historically because it covered the principal clinical use of plerixafor in hematopoietic stem-cell mobilization.

What does U.S. Patent 7,897,590 protect?

The patent protects a multi-step method:

Administer a qualifying compound to a subject.
Mobilize progenitor or stem cells into peripheral blood.
Harvest those cells.

Claim 1 is the independent claim and defines the invention through a broad chemical genus. The compound must have the structure:

Z-linker-Z'

where:

Z is a cyclic polyamine or a specified nitrogen-containing fused ring system;
Z' is either another qualifying cyclic polyamine or a substituted aminomethyl aromatic group;
the linker may be a bond, alkylene group, aromatic system, fused aromatic system, or a chain containing oxygen, nitrogen, sulfur, or keto groups;
the compound is administered in an amount effective to mobilize cells; and
the cells are subsequently harvested.

The claim is therefore a method-of-use claim with chemical limitations. It does not claim every method of harvesting stem cells, every CXCR4 antagonist, or the plerixafor molecule as a standalone composition.

Claim architecture

Claim group	Subject matter	Commercial significance
Claim 1	Broad genus of compounds used to mobilize and harvest cells	Principal scope
Claims 2-4	Two cyclic polyamines, identical or structurally defined polyamines	Narrows the chemical class
Claims 5, 8	Bis-tetraazacyclotetradecane compounds	Covers the plerixafor-type bicyclam structure
Claims 6-7	Aromatic linker, especially 1,4-phenylene-bis-methylene	Narrows the linker
Claims 9-13	Heterocyclic Z or aminomethyl-pyridine Z' alternatives	Covers additional analogues
Claims 14-15	Acid-addition salts, including hydrochloride salts	Covers pharmaceutical salt forms
Claims 16-17	Intravenous or subcutaneous administration and dosage range	Aligns with clinical use
Claims 18-20	G-CSF pretreatment	Covers combination mobilization protocols
Claims 21-22, 27	Human subjects	Limits selected embodiments to humans
Claims 23-26	Salt, route, and dosage limitations for the bicyclam embodiment	Narrows the plerixafor method
Claims 28-29	Administration with macrophage inflammatory protein	Covers an additional combination approach

Does U.S. Patent 7,897,590 cover plerixafor?

Yes. Claims 5 and 8 are directed to the bis-cyclic-polyamine structure corresponding to plerixafor, also known as AMD3100, when used to mobilize and harvest progenitor or stem cells.

Plerixafor is chemically associated with the compound:

1,1'-[1,4-phenylene-bis(methylene)]-bis-1,4,8,11-tetraazacyclotetradecane

The marketed product Mozobil contains plerixafor as the active ingredient and is administered by subcutaneous injection. The approved indication is use in combination with G-CSF to mobilize hematopoietic stem cells into peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin lymphoma or multiple myeloma. The FDA label identifies Sanofi as the sponsor of Mozobil (FDA, 2008).

Claim 8 is especially important because it combines:

the bicyclam compound;
the 1,4-phenylene-bis-methylene linker; and
the stem-cell mobilization-and-harvest method.

Claims 23-27 further narrow that embodiment to the acid-addition salt, subcutaneous administration, a stated dose range, and human use.

How broad is claim 1?

Claim 1 is materially broader than the marketed plerixafor embodiment.

It covers two principal chemical branches:

Compounds in which both terminal groups are cyclic polyamines.
Compounds in which one terminal group is a cyclic polyamine and the other is an aminomethyl aromatic or heteroaromatic group, including the claim 12 2-aminomethyl-pyridine embodiment.

The claim also allows a wide range of linkers. The linker may be:

a direct bond;
a C1-C6 alkylene group;
an aromatic or fused aromatic system;
an alkylene chain containing oxygen;
a chain containing keto, nitrogen, or sulfur functionality.

This structure creates a broad genus around CXCR4-active polyamine compounds, although enforceability depends on the patent’s specification, examples, prosecution history, written-description support, and claim construction.

The functional limitation, "in an amount effective to mobilize" cells, is important. A compound falling within the chemical genus would not necessarily infringe unless it is administered in a manner that produces the claimed mobilization result and the cells are harvested.

What compounds are protected by the dependent claims?

Plerixafor and bicyclam compounds

Claims 5-8 and 19, 23-27 focus on the bicyclam class. The key structural limitations are:

two 1,4,8,11-tetraazacyclotetradecane rings;
a 1,4-phenylene-bis-methylene linker;
an acid-addition salt, particularly hydrochloride;
subcutaneous administration;
a dose of about 0.1 microgram/kg to 5 mg/kg;
human treatment.

These claims are closely aligned with the clinical use of plerixafor in Mozobil.

Aminopyridyl analogue

Claims 12 and 13 cover a compound in which Z' is 2-aminomethyl-pyridine. This is structurally distinct from the symmetric bicyclam in claim 8. The claim set therefore reaches beyond plerixafor and includes asymmetric polyamine-aromatic analogues.

G-CSF combination

Claims 18-20 require administration of G-CSF before the claimed compound. This limitation reflects the established clinical protocol in which filgrastim or another G-CSF is administered before plerixafor.

The G-CSF limitation narrows the claims but also increases commercial relevance because the approved Mozobil regimen uses G-CSF pretreatment. A protocol using the claimed compound without G-CSF would not infringe claims 18-20, although it could fall within claim 1 or other claims.

Macrophage inflammatory protein

Claims 28 and 29 require administration of macrophage inflammatory protein. These claims are narrower and appear less important to the approved commercial product than the G-CSF claims.

What are the main infringement elements?

A likely infringement analysis for claim 8 would examine whether the accused process includes all of the following:

Element	Analysis
Subject	A subject receiving treatment
Compound	Plerixafor or a compound meeting the claim 8 structure
Route	Subcutaneous administration for claims 25 and related claims
Amount	Dose within the claimed range for claims 26 and related claims
Biological result	Mobilization of progenitor or stem cells into peripheral blood
Harvest	Collection of the mobilized cells
Human limitation	Required for claim 27
Salt limitation	Required for claims 23-24, but not necessarily claim 8

A manufacturer of plerixafor could face direct method infringement exposure if it performs the claimed treatment protocol. A manufacturer or distributor could face inducement theories if it knowingly encourages healthcare providers to perform the patented method. The commercial risk would turn on the patent’s enforceability and remaining term, the product label, promotional materials, and any carve-out from the approved indication.

The patent does not automatically cover every sale of plerixafor. Method claims generally require performance of the claimed steps. A product-only sale, without evidence of the claimed use or inducement, raises a different infringement analysis.

When did U.S. Patent 7,897,590 expire?

The patent’s nominal expiration date was December 24, 2024, based on the earliest claimed priority date of December 24, 2003 and the standard 20-year patent term under 35 U.S.C. § 154.

Event	Date
Earliest family priority	December 24, 2003
Patent issued	March 1, 2011
Nominal expiration	December 24, 2024
Current commercial significance	Primarily historical unless a term extension or adjustment applies

A complete legal-status determination requires review of the USPTO Patent Center record for patent-term adjustment and any terminal disclaimer, as well as FDA records for pediatric exclusivity. The patent should not be treated as an active blocking right solely because it remains listed in historical patent databases.

Patent expiration does not eliminate other patents in the plerixafor or stem-cell-mobilization family. A generic or follow-on product must be assessed against the entire relevant patent estate, including formulation, manufacturing, crystalline-form, dosing, and method-of-use patents.

What was the Orange Book status of U.S. Patent 7,897,590?

U.S. Patent 7,897,590 was associated with the Mozobil regulatory patent estate and was relevant to the approved use of plerixafor. Orange Book-listed patents can create an ANDA certification issue under the Hatch-Waxman framework, including Paragraph IV certification where an applicant asserts that a listed patent is invalid, unenforceable, or not infringed (FDA, Approved Drug Products with Therapeutic Equivalence Evaluations).

The relevant distinction is:

an Orange Book listing identifies a patent submitted for an approved drug;
it does not independently establish validity;
it does not extend a patent beyond its statutory term;
it does not prevent approval after expiration if no other regulatory or patent barrier remains.

For plerixafor, the commercial significance of the 7,897,590 listing was greatest before December 2024. After expiration, the patent should no longer block an ANDA on its own.

Which patent families were most relevant to plerixafor?

The plerixafor landscape included foundational compound patents, clinical-use patents, and later product-specific patents.

Patent or family	General subject matter	Strategic role
U.S. Patent No. 5,583,131	Early bicyclam and related compounds	Foundational chemistry
U.S. Patent No. 5,807,831	Related polyamine/CXCR4 chemistry	Foundational or follow-on compound protection
U.S. Patent No. 6,001,826	Polyamine compounds and biological uses	Chemistry and use coverage
U.S. Patent No. 6,987,102	Stem-cell mobilization use	Core clinical-use protection
U.S. Patent No. 7,897,590	Mobilization and harvesting methods using defined compounds	Method-of-use protection
U.S. Patent No. 8,148,356	Later plerixafor-related use or dosing protection	Follow-on Orange Book risk
Additional continuations	Dosing, combinations, and specific patient populations	Residual launch risk

The specific scope, expiration, and listing status of each family must be confirmed against the USPTO and FDA records. A patent landscape based only on U.S. Patent 7,897,590 would understate the historical and commercial protection around Mozobil.

Were there Paragraph IV challenges and litigation risks?

Plerixafor was exposed to the normal ANDA challenge pathway for small-molecule products. A generic applicant seeking approval before expiry of listed patents could file Paragraph IV certifications against relevant Orange Book patents. That filing can trigger patent litigation under 35 U.S.C. § 271(e)(2) and potentially a 30-month stay of approval under 21 U.S.C. § 355(j)(5)(B)(iii).

The central risk categories were:

invalidity challenges based on obviousness;
lack of written description for the broad chemical genus;
enablement of the full genus;
anticipation by earlier bicyclam disclosures;
noninfringement based on a different compound, dose, route, or use;
product-label carve-outs for nonprotected indications;
expiration of earlier foundational compound patents;
remaining method-of-use patents listed for Mozobil.

The supplied claim text does not establish whether a particular generic company filed a Paragraph IV certification against U.S. Patent 7,897,590, whether the patent was litigated to judgment, or whether a settlement agreement included a licensed entry date. Those conclusions require docket and FDA records rather than claim analysis alone.

How strong was the patent estate?

Strengths

The estate had several commercially useful features:

Claim 8 mapped directly onto the plerixafor structure.
Claims 16-17 covered clinically relevant administration routes and doses.
Claims 18-20 addressed the G-CSF pretreatment regimen used in practice.
Claims 21-27 targeted human use and the approved clinical setting.
Method claims could be asserted against treatment protocols even after foundational compound patents expired.

Vulnerabilities

The principal vulnerabilities were:

broad genus language in claim 1;
extensive Markush definitions;
functional language requiring an effective mobilization result;
potential written-description and enablement issues;
possible prior-art overlap with known bicyclam CXCR4 antagonists;
the need to prove the harvesting step;
expiration of the core patent term;
the ability of a generic applicant to design around a narrow dependent claim while challenging broader claims.

The strongest historical commercial claims were likely the plerixafor-specific claims tied to the approved treatment protocol. The broadest claim was not necessarily the strongest litigation claim because broader chemical genera often present greater validity and construction disputes.

How does this patent compare with newer stem-cell mobilization products?

Plerixafor competes primarily with G-CSF-based mobilization and newer CXCR4-directed approaches.

Product or approach	Active agent	Regulatory position	Patent-risk profile
Mozobil	Plerixafor	FDA-approved with G-CSF	Mature small-molecule estate; core claims largely expired by late 2024
Filgrastim products	G-CSF	FDA-approved	Separate biologic and biosimilar landscape
Pegfilgrastim products	Long-acting G-CSF	FDA-approved	Biosimilar and formulation patents
Aphexda	Motixafortide	FDA-approved in 2023 for stem-cell mobilization with G-CSF	Newer composition, formulation, and method estate
Investigational CXCR4 agents	Various	Development-stage or indication-specific	Earlier-stage composition and use risk

Plerixafor is a small molecule, so the principal follow-on pathway is an ANDA, not a biosimilar application. G-CSF competitors are biologics and may involve 351(k) biosimilar applications, interchangeability issues, manufacturing patents, and cell-line or process protection.

What generic launch scenarios existed?

A generic plerixafor launch historically depended on four variables:

Whether listed patents remained unexpired.
Whether the applicant filed Paragraph III or Paragraph IV certifications.
Whether the approved label implicated protected methods.
Whether settlements imposed a delayed-entry date.

Potential launch routes included:

launch after expiration of all blocking patents;
Paragraph IV launch after litigation risk was accepted;
label-based design-around for unprotected uses;
launch under a settlement license;
launch after invalidation or noninfringement findings.

For U.S. Patent 7,897,590 specifically, expiration substantially reduced the value of a Paragraph IV challenge after December 24, 2024. Remaining risk would have depended on other Orange Book-listed patents, regulatory exclusivity, and any valid patent-term adjustment or extension.

What manufacturing and geographic barriers existed?

U.S. Patent 7,897,590 does not primarily protect manufacturing. Its claims are directed to therapeutic use. A supplier could therefore avoid this patent’s direct scope by manufacturing the compound outside the United States, although importation, inducement, contributory infringement, regulatory use, and other patent claims could remain relevant.

Manufacturing barriers for plerixafor may instead arise from:

process patents;
polymorph or salt patents;
stereochemical or impurity-control claims;
pharmaceutical composition patents;
analytical methods;
trade secrets;
regulatory data and manufacturing validation requirements.

Geographic protection is jurisdiction-specific. Expiration of the U.S. patent does not determine the status of corresponding patents in Europe, Japan, Canada, China, or other markets. Foreign family members must be checked separately for national-phase prosecution, opposition outcomes, terminal disclaimers, and local patent-term rules.

Did the patent protect a biosimilar product?

No. Plerixafor is a chemically synthesized small molecule. The relevant follow-on products are generics submitted through the ANDA pathway. Biosimilar risk applies more directly to G-CSF products such as filgrastim and pegfilgrastim, not to plerixafor itself.

Key Takeaways

U.S. Patent 7,897,590 is a method-of-use patent covering administration of specified polyamine compounds, mobilization of progenitor or stem cells into peripheral blood, and subsequent harvesting.
Claims 5 and 8 are the principal plerixafor-related claims.
Claims 18-20 cover G-CSF pretreatment, while claims 23-27 narrow the plerixafor method to salt, route, dose, and human-use limitations.
The patent does not claim plerixafor as a composition independently of its use.
The nominal U.S. expiration date was December 24, 2024.
The patent’s historical commercial value was significant because it covered the approved Mozobil treatment protocol.
Current generic entry analysis must include the full Mozobil Orange Book estate, not this patent alone.
Plerixafor is subject to ANDA and Paragraph IV analysis, not biosimilar regulation.
The principal technical vulnerabilities are broad genus language, functional limitations, enablement, written description, prior art, and proof of the harvesting step.
Manufacturing, formulation, and foreign patent rights require separate family-level review.

FAQs

Does U.S. Patent 7,897,590 claim Mozobil itself?

No. It claims methods using specified compounds. The plerixafor embodiment is covered when the compound is used for the claimed mobilization and harvesting procedure.

Can a generic plerixafor product avoid claim 8?

Potentially, but only by avoiding at least one required limitation or prevailing on invalidity or unenforceability. A different active compound would not meet the specific compound limitation in claim 8, but could still implicate claim 1 or another patent family.

Does claim 18 require both G-CSF and plerixafor?

Yes. Claim 18 depends on claim 1 and requires G-CSF administration before the claimed compound. Claims 19 and 20 apply the same concept to narrower compounds.

Is a stem-cell collection center a potential infringer?

A center performing the claimed administration and harvesting steps could be exposed to method-claim theories. The analysis depends on the exact protocol, compound, dose, route, timing, and patent term.

Does expiration of U.S. Patent 7,897,590 clear all plerixafor patent risk?

No. Expiration removes this patent as a standalone barrier. Other patents covering plerixafor, formulations, dosing, manufacturing, or approved uses must be reviewed independently.

References

Food and Drug Administration. (2008). Mozobil (plerixafor) prescribing information. U.S. Department of Health and Human Services.
Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.
Genzyme Corporation. (2011). U.S. Patent No. 7,897,590, Stem cell mobilization. United States Patent and Trademark Office.
United States Code. (2024). 21 U.S.C. § 355: New drugs.
United States Code. (2024). 35 U.S.C. § 154: Contents and term of patent; provisional rights.
United States Patent and Trademark Office. (n.d.). Patent Center: U.S. Patent No. 7,897,590. U.S. Department of Commerce.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1411918	⤷ Start Trial	C300537	Netherlands	⤷ Start Trial
European Patent Office	1411918	⤷ Start Trial	CA 2012 00026	Denmark	⤷ Start Trial
European Patent Office	1411918	⤷ Start Trial	PA2012011	Lithuania	⤷ Start Trial
European Patent Office	1411918	⤷ Start Trial	92033	Luxembourg	⤷ Start Trial
European Patent Office	1411918	⤷ Start Trial	122012000044	Germany	⤷ Start Trial
European Patent Office	1411918	⤷ Start Trial	PA2012011,C1411918	Lithuania	⤷ Start Trial
European Patent Office	1411918	⤷ Start Trial	C20120014 00064	Estonia	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,897,590

Summary for Patent: 7,897,590