Details for Patent: 9,597,409

Which drugs does patent 9,597,409 protect, and when does it expire?

Patent 9,597,409 protects ABRAXANE and is included in one NDA.

Protection for ABRAXANE has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-five patent family members in twenty-three countries.

Summary for Patent: 9,597,409

Title:	Methods of treating cancer
Abstract:	The present invention provides methods and compositions for treating non-small-cell lung cancer (NSCLC) by administering a) a composition comprising nanoparticles that comprise paclitaxel and an albumin and b) a platinum-based agent (e.g., carboplatin). The present application also provides methods of treating prostate cancer by administering to the individual a) an effective amount of a composition comprising nanoparticles comprising docetaxel and an albumin; and b) an effective amount of a steroid.
Inventor(s):	Neil P. Desai, Patrick Soon-Shiong
Assignee:	Abraxis Bioscience LLC
Application Number:	US13/782,990
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,597,409
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

US Patent 9,597,409: Scope, Claim Construction, Exclusivity, and Patent Landscape for Albumin-Bound Paclitaxel in NSCLC

US Patent No. 9,597,409 protects selected treatment regimens combining albumin-bound paclitaxel nanoparticles, commercially associated with ABRAXANE, and a platinum-based agent for squamous-cell non-small-cell lung cancer (NSCLC). The core claim is a method-of-treatment claim directed to patient selection by squamous histology, not a composition claim covering albumin-bound paclitaxel generally.

The commercially important embodiment is claim 7: albumin-bound paclitaxel at 100 mg/m² weekly combined with carboplatin at AUC 6 every three weeks. The patent also covers narrower nanoparticle, albumin-to-paclitaxel ratio, intravenous administration, disease-stage, radiation, and dosing limitations.

What does US Patent 9,597,409 claim?

Claim 1 requires all of the following:

1. Treatment of NSCLC.
2. An individual with squamous cellular carcinoma.
3. Administration of an effective amount of albumin-bound paclitaxel nanoparticles.
4. Administration of an effective amount of a platinum-based agent.
5. Treatment based on the patient having squamous cellular carcinoma.

The claim is cumulative. A party would generally need to practice every limitation to directly infringe claim 1. Claims 2 through 27 add increasingly specific limitations.

Claim group	Protected subject matter
Claims 1-2	NSCLC treatment selected on the basis of squamous histology
Claims 3-4	Albumin-bound paclitaxel dose of about 50-125 mg/m², administered weekly
Claims 5-7	Platinum-agent exposure of AUC 2-6, every three weeks; claim 7 specifies 100 mg/m² weekly plus carboplatin AUC 6 every three weeks
Claims 8-9	Albumin coating and nanoparticle diameter of no greater than about 200 nm
Claims 10-14	Stage IIIB or IV disease, parenteral or intravenous administration, carboplatin, and human patients
Claims 15-16	Concurrent thoracic radiation and chemoradiation dosing
Claims 17-18	Albumin-to-paclitaxel weight ratio of about 1:1 to 9:1, including 9:1
Claims 19-27	Dependent combinations of ratio, coating, particle size, carboplatin, and administration limitations

The claims do not cover every use of paclitaxel, every use of carboplatin, or every albumin-containing formulation. They target a specific clinical combination in a defined NSCLC population.

How broad is the independent method claim?

Claim 1 is relatively broad within its therapeutic field but has important boundaries.

Covered treatment elements

The claim does not require:

• A particular brand name;
• A specific manufacturer;
• A precise nanoparticle manufacturing process;
• Intravenous administration;
• Carboplatin specifically;
• A stated paclitaxel dose;
• A particular albumin-to-paclitaxel ratio;
• A particular nanoparticle size.

A competing product could therefore fall within claim 1 even if it does not use the exact ABRAXANE manufacturing process, provided it is an albumin-bound paclitaxel nanoparticle composition and is administered with a platinum agent to a squamous-cell NSCLC patient.

Limitations that narrow enforcement

Claim 1 requires that treatment be "based upon" the individual having squamous cellular carcinoma. This language creates a patient-selection limitation. The claim is stronger against a protocol, label, treatment guideline, or prescribing decision that expressly identifies squamous histology as the basis for treatment.

The limitation may be more difficult to prove where:

• The product label recommends treatment for all NSCLC patients without distinguishing squamous histology;
• The physician selects treatment for reasons unrelated to histology;
• The patient receives the drugs off-label;
• The accused company merely sells the drug without directing or controlling the clinical decision.

The practical infringement analysis will turn on product labeling, promotional materials, clinical protocols, electronic order sets, payer policies, and physician records.

What does claim 7 protect?

Claim 7 is the principal commercial claim because it captures the regimen associated with the phase III ABRAXANE-plus-carboplatin NSCLC program:

• Albumin-bound paclitaxel: 100 mg/m²;
• Administration: weekly;
• Platinum agent: carboplatin;
• Carboplatin exposure: AUC 6;
• Carboplatin schedule: once every three weeks.

This regimen corresponds closely to the FDA-approved ABRAXANE NSCLC dosing framework, although the approved label and patent claim must be compared as separate legal documents. FDA labeling identifies ABRAXANE in combination with carboplatin for locally advanced or metastatic NSCLC in patients who are not candidates for curative surgery or radiation therapy, with ABRAXANE administered at 100 mg/m² on days 1, 8, and 15 of each 21-day cycle and carboplatin administered on day 1 of each 21-day cycle at AUC 6 [1].

The claim is narrower than a general combination claim because it requires selection based on squamous cellular carcinoma. It is broader than a label-limited claim because the claim does not expressly require days 1, 8, and 15, provided the albumin-bound paclitaxel is administered weekly.

What formulations are protected by US 9,597,409?

The patent protects use of a nanoparticle composition containing paclitaxel and albumin. Claims 8, 17, and 18 identify formulation characteristics associated with albumin-bound paclitaxel.

Albumin coating

Claim 8 requires paclitaxel in the nanoparticles to be coated with albumin. The language distinguishes a nanoparticle structure in which albumin is associated with or surrounds the paclitaxel particle from a conventional paclitaxel solution merely mixed with albumin.

A formulation containing paclitaxel and albumin in a non-nanoparticle emulsion or solution would not necessarily satisfy this limitation.

Particle size

Claim 9 requires an average nanoparticle diameter of no greater than about 200 nm. The "about" qualifier introduces an interpretation issue around measurement method, sample preparation, and analytical variability.

The particle-size limitation appears in dependent claims and is not required by claim 1. A product may therefore be evaluated under claim 1 even if its particle size exceeds 200 nm, assuming it otherwise qualifies as albumin-bound paclitaxel nanoparticles.

Albumin-to-paclitaxel ratio

Claims 17 and 18 specify an albumin-to-paclitaxel weight ratio of approximately 1:1 to 9:1, including approximately 9:1. The ratio is not required by claim 1 but narrows the protected formulation.

The ratio is potentially important in design-around analysis. A formulation outside the claimed range could avoid claims 17-27, but it would not automatically avoid claim 1 if it remains an albumin-bound paclitaxel nanoparticle composition used in the claimed patient population.

Does the patent cover carboplatin and other platinum agents?

Yes. Claim 1 uses the broader term "platinum-based agent." Claim 13 narrows the agent to carboplatin.

Potential platinum agents under the broad claim may include carboplatin, cisplatin, and other clinically suitable platinum compounds, subject to claim construction and enablement considerations. Claims 5-7 establish an AUC-based exposure range, with claim 7 specifically requiring carboplatin at AUC 6 every three weeks.

The broad claim therefore has two enforcement paths:

• A combination using carboplatin;
• A combination using another platinum-based agent that satisfies the remaining limitations.

The commercial relevance is highest for carboplatin because ABRAXANE's FDA-approved NSCLC regimen uses carboplatin.

Does US 9,597,409 cover chemoradiation?

Claims 15 and 16 cover treatment that also includes thoracic radiation.

Claim 16 requires:

• Albumin-bound paclitaxel at approximately 20-60 mg/m² weekly;
• A platinum-based agent at approximately AUC 2-6 weekly;
• Thoracic radiation;
• Approximately 25-40 fractions;
• Three-dimensional conformal or intensity-modulated radiation;
• Concurrent administration.

These claims are materially different from claim 7. Claim 7 covers systemic therapy using 100 mg/m² weekly paclitaxel and carboplatin AUC 6 every three weeks. Claim 16 covers a lower-dose concurrent chemoradiation protocol.

The radiation claims may have narrower practical relevance because FDA-approved ABRAXANE NSCLC use is generally directed to advanced NSCLC patients who are not candidates for curative surgery or radiation therapy [1]. A concurrent thoracic-radiation regimen should be evaluated separately from the approved metastatic-disease regimen.

What is the patent's likely infringement risk for a generic or follow-on product?

A generic or follow-on albumin-bound paclitaxel product faces two distinct risks.

Product-level risk

US 9,597,409 is not primarily a product-composition patent. It does not, by itself, prevent manufacture or sale of every albumin-bound paclitaxel product. The risk arises from the labeled or induced use of that product in combination with a platinum agent for squamous NSCLC.

Label-based induced infringement

Risk increases if an ANDA label, promotional material, clinical protocol, or prescribing information:

• Identifies squamous NSCLC as a target population;
• Recommends carboplatin combination therapy;
• Specifies 100 mg/m² weekly dosing;
• Specifies carboplatin AUC 6 every three weeks;
• Identifies the regimen as appropriate for stage IIIB or IV squamous NSCLC.

A skinny label omitting the patented squamous-NSCLC indication may reduce induced-infringement exposure, but it does not eliminate all risk. Actual prescribing behavior, product instructions, distribution materials, and the scope of the FDA-approved use remain relevant.

When does US Patent 9,597,409 lose exclusivity?

The patent issued on March 21, 2017. Its nominal expiration cannot be determined from the claim text alone because patent term depends on the relevant nonprovisional filing date, priority chain, patent-term adjustment, terminal disclaimers, and any patent-term extension.

The public patent record should be checked for:

• Earliest effective nonprovisional filing date;
• Patent-term adjustment;
• Terminal disclaimer;
• Patent-term extension;
• Continuation or divisional relationships;
• Maintenance-fee status;
• Reexamination or post-grant proceedings.

A continuation patent generally receives the term of the earliest relevant nonprovisional application, not a new 20-year term from its issue date. The issue date therefore should not be used as the expiration date.

What is the Orange Book status of the patent?

The Orange Book must be reviewed separately from the patent document. Listing depends on whether the patent was submitted for the relevant NDA and whether FDA accepted it as claiming the drug, a formulation, or an approved method of use.

For ABRAXANE, the relevant regulatory product is paclitaxel protein-bound particles for injectable suspension, marketed by Bristol Myers Squibb following its acquisition of Celgene, which previously acquired Abraxis BioScience. FDA approval for the NSCLC indication was based on the phase III trial comparing nab-paclitaxel plus carboplatin with solvent-based paclitaxel plus carboplatin [1,2].

An Orange Book listing would be commercially significant because an ANDA applicant may need to submit a Paragraph IV certification or a section viii statement, depending on the listed patent and the relationship between the patent claims and the proposed label.

The patent number alone does not establish that a patent is currently listed, active, or enforceable against a particular ANDA.

Which companies could challenge the patent through Paragraph IV?

A Paragraph IV challenge would most likely arise from an applicant seeking approval for a generic or alternative albumin-bound paclitaxel product. The principal legal theories would include:

Challenge theory	Relevance to US 9,597,409
Non-infringement	The proposed label does not direct treatment based on squamous histology
Invalidity for anticipation	Earlier clinical or patent references disclose the claimed combination
Obviousness	Combining known nab-paclitaxel NSCLC therapy with carboplatin and selecting squamous patients was predictable
Indefiniteness	Terms such as "based upon," "effective amount," "about," and "platinum-based agent" may be challenged
Written description	The applicant may argue that the full breadth of the squamous-cell selection claim was not adequately supported
Enablement	The challenger may contest whether the entire scope of the claimed combination is enabled

The strongest invalidity analysis will focus on the priority date and the contents of the clinical-development record before that date. The phase III evidence supporting ABRAXANE plus carboplatin was published after the relevant development period, but earlier patents, protocols, conference disclosures, and regulatory submissions may be relevant depending on their public availability.

How strong is the patent estate?

The estate appears strongest as a targeted method-of-use right and weaker as a stand-alone barrier to manufacture.

Strengths

• Claim 1 reaches the clinically important combination of albumin-bound paclitaxel and platinum therapy.
• The claim identifies squamous histology, a clinically meaningful selection criterion.
• Claim 7 maps closely to the commercially important 100 mg/m² plus carboplatin AUC 6 regimen.
• Dependent claims provide fallback positions for carboplatin, intravenous use, particle size, albumin coating, and formulation ratio.
• The claims can create induced-infringement risk even where the underlying product composition is independently designed.

Vulnerabilities

• The patent does not broadly claim albumin-bound paclitaxel as a composition.
• "Treatment is based upon" may create proof and claim-construction disputes.
• The combination of nab-paclitaxel and carboplatin may face obviousness challenges if the prior art disclosed both agents and the relevant NSCLC setting.
• Some dependent claims recite overlapping or redundant limitations, which may narrow their practical value.
• Method-of-use claims are sensitive to label design and physician behavior.

How does this patent compare with formulation and manufacturing patents?

US 9,597,409 should be analyzed as one layer of a broader ABRAXANE patent estate.

Patent category	Primary barrier	Typical risk to a competitor
Method-of-use patents	Treatment regimen and patient selection	Induced infringement and label restrictions
Formulation patents	Particle composition, albumin association, excipients	Product-level infringement
Manufacturing patents	Homogenization, particle formation, drying, sterilization, scale-up	Process infringement and technical design-around
Regulatory exclusivity	FDA approval protections	Delays independent of patent validity
Clinical-data rights	Label-specific approval and data access	ANDA or 505(b)(2) timing constraints

A competitor that avoids US 9,597,409 may still face separate formulation or manufacturing patents. Conversely, a competitor may avoid composition patents but remain exposed to this method patent through a label that directs the patented NSCLC regimen.

What generic launch scenarios exist?

Scenario 1: Full-label approval

A full label identifying albumin-bound paclitaxel with carboplatin for NSCLC, including squamous disease, presents the highest risk under claims 1 and 7.

Scenario 2: Section viii or skinny label

Removing the squamous-cell indication and regimen-specific language may reduce the risk of induced infringement. The commercial penalty is that the applicant may not be able to market the product for the full approved NSCLC use.

Scenario 3: Alternative dosing

A regimen outside 50-125 mg/m² weekly or outside the claimed platinum exposure range could avoid some dependent claims. It may not avoid claim 1.

Scenario 4: Non-albumin nanoparticle formulation

A formulation that does not contain albumin-bound paclitaxel nanoparticles could avoid the patent, but it may not be therapeutically or regulatorily substitutable for ABRAXANE.

Key Takeaways

• US 9,597,409 is a method-of-use patent, not a general composition patent.
• Its central protection is treatment of squamous-cell NSCLC with albumin-bound paclitaxel plus a platinum agent.
• Claim 7 is the most commercially important claim because it recites 100 mg/m² weekly albumin-bound paclitaxel with carboplatin AUC 6 every three weeks.
• Claims 8-9 and 17-27 provide narrower protection for albumin coating, particle size, and albumin-to-paclitaxel ratio.
• Claims 15-16 separately cover concurrent thoracic chemoradiation.
• Label language and treatment-selection evidence are central to induced-infringement risk.
• The patent should be analyzed together with Orange Book listings, continuation patents, formulation patents, manufacturing patents, FDA exclusivity, and any ANDA Paragraph IV litigation.
• The patent's expiration cannot be calculated reliably from the issue date or claim text alone.

Frequently Asked Questions

Does US 9,597,409 cover ABRAXANE for breast cancer or pancreatic cancer?

No. The supplied claims are directed to NSCLC, with the central limitation requiring treatment based on squamous cellular carcinoma. They do not claim the approved breast-cancer or pancreatic-cancer uses.

Can a competitor avoid the patent by using cisplatin instead of carboplatin?

Not necessarily. Claim 13 is limited to carboplatin, but claim 1 covers a broader "platinum-based agent." A cisplatin regimen would require a separate analysis under claim 1.

Is a nanoparticle size above 200 nm sufficient to avoid infringement?

It may avoid claims requiring the no-greater-than-200-nm limitation, including claim 9 and several dependent claims. It would not necessarily avoid claim 1, which does not recite a particle-size ceiling.

Does removing the word "squamous" from a generic label eliminate patent risk?

No. Label wording is important, but induced infringement can also depend on promotional materials, clinical protocols, distribution communications, and the uses actively encouraged by the applicant.

Is a biosimilar pathway relevant to albumin-bound paclitaxel?

Generally no. Paclitaxel is a small-molecule active ingredient, and ABRAXANE is regulated as a drug rather than a biologic subject to the biosimilar pathway. A competitor would ordinarily consider an ANDA or, depending on the product, a 505(b)(2) application rather than a biosimilar application.

References

1. U.S. Food and Drug Administration. (2023). ABRAXANE (paclitaxel protein-bound particles for injectable suspension) prescribing information.
2. Socinski, M. A., Bondarenko, I., Karaseva, N. A., Makhson, A., Vynnychenko, I., Okamoto, I., Hon, J. K., Hirsh, V., Bhar, P., & others. (2012). Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: A phase III trial. Journal of Clinical Oncology, 30(17), 2055-2062.
3. U.S. Patent No. 9,597,409. (2017). Methods of treating non-small cell lung cancer.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.

Drugs Protected by US Patent 9,597,409

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	9,597,409*PED				Y

International Family Members for US Patent 9,597,409

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011235344
Australia	2016202000
Brazil	112012024442
Canada	2793974
Canada	3087813
China	103118665
Costa Rica	20120528