Patent: 8,905,979

Summary for Patent: 8,905,979

Title:	Method of administration of a pulmonary surfactant
Abstract:	The present invention concerns a method for treating a respiratory distress in a infant in need of such treatment, the method comprising intratracheal administration of a pulmonary surfactant by a thin tube. The invention also concerns a kit for performing said method.
Inventor(s):	Herting; Egbert (Parma, IT), Gopel; Wolfgang (Parma, IT), Chiesi; Paolo (Parma, IT)
Assignee:	Chiesi Farmaceutici S.p.A. (Parma, IT)
Application Number:	13/252,532
Patent Claims:	see list of patent claims

US Patent 8,905,979 Claims & Patent Landscape (nCPAP + Intratracheal Surfactant via 5 Fr Tube with Marked Scale)

US 8,905,979 centers on a combined, nonintubated respiratory support regimen for preterm infants: nCPAP (1 to 12 cm H2O) plus intratracheal delivery of a pulmonary surfactant suspension (100 to 200 mg/kg) through a thin tube (5 Fr) introduced into the trachea, delivered by syringe over 1 to 5 minutes, with suspension viscosity 5 to 15 mPa·s and a marked tube scale for correct insertion length. Dependent claims narrow to viscosity 6 to 10 mPa·s, surfactant concentration 40 to 80 mg/mL, modified or reconstituted surfactant (poractant alfa, beractant, bovactant, calfactant), nCPAP via nasal mask, pressure 2 to 8 cm H2O, and small delivery volumes (≤3 mL, ≤2.5 mL), with RDS and etiologies including meconium aspiration and pulmonary infection.

A critical read-through indicates the patent’s enforceability risk is driven by (1) whether the “5 Fr tube with marked scale” insertion-length concept and syringe-based surfactant delivery under nCPAP were already disclosed in the prior art (especially in “less invasive surfactant administration,” LISA, and related techniques), and (2) whether the specific parameter windows (viscosity, concentration, dose, delivery time, and volume) are novel relative to earlier therapeutic and formulation disclosure. The strongest novelty footholds are the explicit coupling of nCPAP pressure range with syringe delivery characteristics and the marked-scale 5 Fr intratracheal tube.

What does US 8,905,979 actually claim for surfactant delivery in spontaneously breathing preterm infants?

Core independent claim (Claim 1) elements in litigation-ready form

1. Patient setting: “spontaneously breathing pre-term infant” with respiratory distress syndrome in need of treatment.
2. Respiratory support: nCPAP applied “with a nasal device” at 1 to 12 cm H2O.
3. Airway access: introduce a tube selected from:
   • gastric tubes
   • nasogastric tubes
   • catheters having outer diameter of 5 Fr
4. Surfactant administration method:
   • administer a pulmonary surfactant suspension via said tube by syringe
   • delivery time: 1 to 5 minutes
5. Dose and rheology constraints:
   • dose: 100 to 200 mg/kg
   • viscosity: 5 to 15 mPa·s
6. Insertion control: tube has a marked scale to allow correct length introduction into the trachea.
7. Formulation: “suspended in a vehicle consisting of a buffered physiological aqueous saline solution.”

Dependent claims and their practical narrowing

• Claim 2: viscosity 6 to 10 mPa·s
• Claim 3: surfactant concentration 40 to 80 mg/mL
• Claim 4: surfactant is “modified natural” or “reconstituted”
• Claim 5: surfactant selection includes poractant alfa, beractant, bovactant, calfactant
• Claim 6: nCPAP applied with a nasal mask
• Claim 7: nCPAP pressure 2 to 8 cm H2O
• Claim 8: suspension volume ≤3 mL
• Claim 9: volume ≤2.5 mL
• Claim 10: respiratory distress syndrome is infant RDS
• Claim 11: RDS due to meconium aspiration or pulmonary infection

What is the novelty-risk profile for each claim element under common LISA and “less invasive” prior art?

The following risk mapping assumes typical LISA-relevant disclosures are in the background of the claim’s parameterization. Without incorporating specific patent-number references, the enforceability assessment can still be made on claim drafting structure: the patent is a “method-of-use + method-of-administration + formulation parameter windows” hybrid, which is often where prior art overlaps.

nCPAP + intratracheal surfactant without intubation: where is the overlap most likely?

Most LISA-style approaches aim to avoid mechanical ventilation and provide surfactant via a thin catheter through the vocal cords, typically under spontaneous breathing. The patent’s unique hook is explicit nCPAP pressure windows (1–12 cm H2O) while administering surfactant via a 5 Fr outer diameter tube introduced into the trachea with syringe delivery.

Enforceability pressure points

• If prior art already describes delivering surfactant through a thin tube in spontaneously breathing preterms while on CPAP, then the novelty must rest on the narrower technical conditions: tube selection (5 Fr), marked scale, syringe delivery duration (1–5 min), and viscosity/concentration/volume windows.
• If prior art provides CPAP during LISA but does not set it as a defined pressure range, claim 1 may still be vulnerable on “obviousness” or “lack of inventive step,” even if the exact range is not cited.

5 Fr “gastric/nasogastric tubes or catheters” with a marked scale: where is novelty most defensible?

The “tube has a marked scale to allow correct length” limitation is the type of detail that can be both:

• defensively useful (it narrows to insertion-length control), and
• fragile if any earlier catheter or tube disclosure includes a measured depth marking and is used for intratracheal delivery.

Because claim 1 is drafted broadly to include “gastric tubes” and “nasogastric tubes” as alternatives, it may capture many real-world devices and therefore increase infringement scope. However, that broad device taxonomy also increases the chance that prior art methods already used similar tubes.

Syringe-based administration over 1–5 minutes: does prior art teach timing?

Many surfactant delivery techniques involve instillation over seconds to minutes; the claim locks that to 1 to 5 minutes. If earlier disclosures instill over an unspecified short period, or over a range not matching 1–5 minutes, it can create a factual difference.

But because the delivery is performed “by syringe,” courts often interpret method claims around functional steps: if practitioners routinely instill over approximately that window, timing limitations can be attacked as non-distinct.

Dose window (100–200 mg/kg) and formulation rheology (viscosity 5–15 mPa·s)

This is the second main defensibility pillar. Prior art surfactant dosing is often described in mg/kg, but the specific dose window (100–200 mg/kg) is consistent with clinical surfactant practice depending on product and reconstitution. The claim’s unique contribution likely lies in combining:

• dosing window,
• a buffered saline vehicle, and
• a viscosity window (and dependent viscosity narrower 6–10 mPa·s).

If earlier formulation disclosure shows reconstituted or modified surfactant with comparable viscosities in buffered saline, novelty risk rises. If earlier reports focus on ready-to-use product with stated viscosity not mapped to the claimed mPa·s window, then claim 1 may preserve distinctiveness.

Concentration (40–80 mg/mL) and volume limits (≤3 mL; ≤2.5 mL)

These are highly technical parameters. They may be protective if they were not previously tied to the same administration method under nCPAP.

However, because marketed surfactants have defined concentrations and reconstitution protocols, the concentration window could be viewed as inherent or obvious when using standard preparations, especially if “modified natural/reconstituted” surfactants are explicitly named.

Which surfactants are named?

Claim 5 explicitly names:

• poractant alfa
• beractant
• bovactant
• calfactant

This increases enforceability against methods using these actives, but also increases novelty risk if prior art already used these exact surfactants in LISA under CPAP and with similar suspension parameters.

What patents protect similar “LISA with CPAP” methods in the US, and how does US 8,905,979 likely sit relative to them?

How the landscape typically clusters Even without mapping specific family members, “less invasive surfactant administration” and “SIS-LISA” (surfactant instillation via thin catheter, with or without procedural variations) tend to produce patent estates across three categories:

1. Device-and-access patents

   • thin catheters/tubes
   • insertion depth marking
   • delivery controllers
   • syringe/instillation systems

2. Method-of-treatment patents

   • applying CPAP or similar noninvasive respiratory support
   • positioning and delivery sequence (airway access without intubation)
   • timing and dosing steps

3. Formulation patents

   • buffered saline vehicles
   • modified or reconstituted surfactants
   • viscosity and concentration targets
   • maximum instillation volumes

US 8,905,979’s position US 8,905,979 reads like an attempt to consolidate categories 2 and 3 while capturing elements of category 1 via the “5 Fr tube” and “marked scale” constraints. That consolidation is a common strategy to avoid straightforward anticipation by a device-only or formulation-only reference.

Critical business implication Enforcement leverage is highest when accused conduct matches all categories simultaneously:

• nCPAP in the claimed pressure window,
• thin 5 Fr catheter/tube insertion with measurable insertion length control,
• syringe-based 1–5 minute surfactant instillation,
• suspension properties and dose matching the claimed parameter windows.

If an accused protocol deviates on any one technical axis (for example, uses a different catheter size than 5 Fr, delivers over a shorter time, uses different vehicle, or uses a different CPAP pressure range), the claim can become easier to design around.

How strong is the patent estate for US 8,905,979 across key claim dimensions?

Claim strength drivers

• Parameter coupling: simultaneous constraints on nCPAP pressure, delivery time, dose, viscosity, concentration, volume, and marked insertion length. This reduces the chance that one prior art reference discloses everything.
• Named surfactants: creates direct relevance to clinical standard products (poractant alfa, beractant, bovactant, calfactant).

Claim weakness drivers

• Broad tube taxonomy: “gastric tubes” and “nasogastric tubes” widen the prior-art surface area and may be easier to find in earlier methods.
• Clinical dose and concentration windows: these may be consistent with known surfactant preparations and could be argued as routine.
• Technique prevalence: LISA-like methods are widely studied and may have multiple overlapping disclosures on CPAP-assisted intratracheal surfactant delivery.

When does US 8,905,979 lose exclusivity in the US?

No expiration timeline can be reliably produced from the information provided. The patent term in the US depends on filing date, potential patent term adjustments, and whether terminal disclaimers apply. Without the patent’s filing and priority data, any exclusivity date would be speculative.

What is the Orange Book status of the drug or product implicated by US 8,905,979?

No Orange Book entry can be mapped from the claim text alone. Orange Book status is tied to specific FDA-approved drug products (NDA/BLA) and labeled indications, including whether the referenced product is a surfactant and which active ingredient/dosage form corresponds to the claim’s modified or reconstituted vehicle.

What Paragraph IV or biosimilar litigation risks exist for a method patent like US 8,905,979?

US 8,905,979 is a method claim directed to treating preterm infant RDS using nCPAP and intratracheal surfactant delivery. A typical regulatory pathway for “method-of-treatment” infringement risk is indirect:

• Generics generally do not submit for “method patents,” but they can still be sued if their product label and practice induce infringement.
• For biologics or biosimilars, litigation risk hinges on whether the biosimilar is used in the claimed method, including any labeling instructions that enable or direct the infringement.

Without the patent’s asserted parties, any known litigation docket, or the referenced surfactant’s FDA product, no specific Paragraph IV/biosimilar risk can be stated.

How could a generic or competitor design around the claim without losing clinical function?

US 8,905,979 offers several explicit design-around levers:

1. Tube geometry/ID

   • Claim 1 requires 5 Fr outer diameter catheters.
   • Using a different catheter/tube size outside 5 Fr can avoid literal infringement.

2. Marked scale requirement

   • If delivery uses unmarked tubing or lacks the claimed “marked scale” functionality, infringement risk declines (depending on claim interpretation).

3. Delivery timing

   • Claim requires syringe administration over 1 to 5 minutes.
   • Delivery outside that time window could be argued to avoid literal performance.

4. Viscosity and concentration windows

   • Viscosity 5–15 mPa·s (and narrower 6–10).
   • Concentration 40–80 mg/mL.
   • Using formulations that fall outside these rheology or concentration bounds can reduce exposure, assuming the accused product and instructions lead to those exact properties.

5. Dose window

   • Dose required is 100–200 mg/kg.
   • Alternative dosing strategies outside that range can be designed to avoid claim 1.

6. nCPAP pressure window

   • Claim 1 covers 1–12 cm H2O; dependent claim 7 narrows to 2–8 cm H2O.
   • If clinical protocols use CPAP outside the range, literal infringement is less likely.

What commercial exposure does US 8,905,979 create for surfactant manufacturers and neonatal care providers?

Commercial exposure is limited for “method patents” unless:

• the manufacturer’s label or materials are tied to the claimed method,
• clinical practice in the US aligns with the claimed technical parameter windows, and
• enforcement targets either product suppliers (inducement/contribution theories) or provider groups (direct performance).

Given the claim’s complexity, exposure is higher for centers or programs that standardize LISA-like workflows to tightly specified parameters (tube size, insertion depth markings, instillation time, and measured formulations).

Key Takeaways

• US 8,905,979 is a tightly parameterized method claim combining nCPAP (1–12 cm H2O) with intratracheal surfactant instillation via a 5 Fr tube that has a marked insertion-length scale, delivered by syringe over 1–5 minutes at 100–200 mg/kg, using a buffered saline surfactant suspension with viscosity 5–15 mPa·s.
• Dependent claims narrow to specific rheology (6–10 mPa·s), surfactant concentration (40–80 mg/mL), and small instillation volumes (≤3 mL; ≤2.5 mL), and explicitly name surfactants (poractant alfa, beractant, bovactant, calfactant).
• Enforceability risk concentrates on whether prior art already discloses the combined combination of nCPAP-assisted spontaneous delivery with thin-tube intratracheal surfactant instillation and whether the viscosity/concentration/volume and insertion-length marking were previously taught for the same clinical scenario.
• Strongest design-around levers are tube size (not 5 Fr), absence of a marked scale, instillation time outside 1–5 minutes, and formulation properties outside the viscosity/concentration windows.

FAQs

1) Can a provider avoid infringement by using a catheter sized different from 5 Fr?
Yes. Claim 1 is limited to “catheters having an outer diameter of 5 Fr,” and the tube options include gastric/nasogastric tubes and 5 Fr catheters. Using a different outer diameter can avoid literal claim 1.

2) Does US 8,905,979 require intubation or mechanical ventilation?
The claim is directed to “spontaneously breathing” preterm infants and uses nCPAP plus a tube introduced into the trachea for surfactant delivery, not mechanical ventilation as a required element in the claim text.

3) Are the viscosity and concentration limitations likely to be the main factual disputes in court?
They are likely to be central because they are narrow and technical (mPa·s and mg/mL). Accused infringers can test formulations and argue performance outside the windows.

4) Do named surfactants (poractant alfa, beractant, bovactant, calfactant) limit the claim’s coverage to those products only?
Claim 5 limits only dependent claim 5. Claim 1 is not restricted to those listed actives unless the surfactant is a “pulmonary surfactant suspended” in buffered physiological saline meeting the dose/rheology requirements.

5) Could labeling changes reduce infringement exposure for the method?
For method patents, exposure often depends on whether product labeling or marketing induces performance of the claimed steps. Changing instructions to avoid directing the claimed CPAP pressure, tube/scale use, delivery time, or formulation parameters can reduce inducement theories.

References (APA)

1. U.S. Patent 8,905,979.

Details for Patent 8,905,979

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	SURVANTA	beractant	Suspension	020032	1-Jul-91	8,905,979	2031-10-04
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	1-Jul-98	8,905,979	2031-10-04
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	12-Dec-02	8,905,979	2031-10-04
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521		8,905,979	2031-10-04
Chiesi Usa, Inc.	CUROSURF	poractant alfa	Suspension	020744	18-Nov-99	8,905,979	2031-10-04