Last Updated: July 28, 2026

Details for Patent: 9,731,869


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 9,731,869 protect, and when does it expire?

Patent 9,731,869 protects LAZANDA and is included in one NDA.

This patent has twenty-seven patent family members in twenty-four countries.

Summary for Patent: 9,731,869
Title:Container
Abstract:A container (100), comprising a thread (120) arranged around an opening (110) for engaging a corresponding thread (120) of a closure (400), more than four retention members (140) arranged around the opening (110), each retention member (140) having an end-face for abutting a member (510) on an interior surface of the closure (400) to impede unthreading of the closure (400), the retention members (140) being arranged such that a tangent (170) to each end-face of the retention members (140) intersects a plane (160, 350) bisecting the container (100) at an obtuse angle (171), wherein the retention members (140) are arranged in first and second groups, the first group (141, 410) comprising one retention member (140) having an end-face substantially parallel to the plane bisecting the container (100), and the second group (142, 420) comprising two or more retention members (140), the first and second groups being arranged on one side of the plane (160, 350), each in a respective quadrant of the container (100), the teeth of the second group (142, 420) have a first inter-tooth spacing, and a second inter-tooth spacing is provided between an end-face of the retention member of the first group (141, 410) and a first retention member of the second group (142, 420), and the second inter-tooth spacing is larger than the first inter-tooth spacing.
Inventor(s):Philip Walsh, Peter Watts
Assignee: Btcp Pharma LLC
Application Number:US13/983,400
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

United States Patent 9,731,869 (Container with Anti-Underscrew Retention Members): Claim Scope, Legal Boundaries, and US Patent Landscape

United States Patent 9,731,869 is directed to a threaded container/closure engagement with multiple retention members near the container opening that abuts interior closure features to impede unthreading. The core novelty in claim 1 is a specific 3D arrangement: two first retention members opposite one another plus two groups of retention members, with planar alignment, quadrant separation, and distinct inter-tooth spacing (one tooth-length spacing within groups; a larger spacing at the interface between a first retention member and the closest group). Dependent claims narrow through tooth contiguity, tooth-count bands, rotational symmetry, and angular regions that are tooth-free. Independent claim 10 adds a manufacturing method using mold portions, fluid injection, and mold separation.


What does US Patent 9,731,869 claim protect and what is the effective scope of protection?

Answer (claim construction-ready): The enforceable scope centers on containers (and assemblies) where a threaded opening has more than four retention members with flat surfaces that abutt closure interior members to resist closure unthreading, combined with a structured spatial pattern (planes, quadrants, and tooth spacing differences) and with teeth/grooves arranged in two groups having contiguous spacing and a specified geometry around the opening.

Claim 1: The enforceable “shape-and-function” combination

Element-by-element mapping (high signal for infringement/invalidity):

  1. Container with:
    • Thread around the container opening for closure engagement.
  2. More than four retention members arranged around the opening, each having:
    • A flat surface.
    • The flat surface abuts a member on an interior surface of the closure to impede unthreading.
  3. Two first retention members opposite one another plus:
    • Two groups of retention members (creating at least four retention “clusters” total around the opening).
  4. Planar geometry:
    • The flat surfaces of the two first retention members define a first plane bisecting the container.
    • One first retention member and one retention group lie on one side of the first plane.
    • The opposite first retention member and the opposite retention group lie on the other side.
  5. Quadrant structure:
    • Each first retention member and each retention group is in a separate respective quadrant.
    • Quadrants are defined by:
      • The first plane bisecting the container, and
      • A second plane perpendicular to the first plane intersecting it.
    • The second plane is aligned to the first flat surfaces of each of the two groups.
  6. Tooth spacing asymmetry (key limiting feature):
    • Teeth in each group have a first inter-tooth spacing of substantially one tooth-length.
    • There is a second inter-tooth spacing between:
      • the flat surface of one first retention member and
      • the retention member in the closest group to that first retention member.
    • The second inter-tooth spacing is larger than the first.

Why this matters: This is not a generic “anti-tamper” thread feature. The claims tie the anti-unthreading function to a very specific placement and tooth spacing scheme around the opening.

Dependent claims 2–5: Narrower geometry and distributions

  • Claim 2: teeth of each group are substantially contiguous.
  • Claim 3: each group comprises between two and six teeth (limits tooth-count).
  • Claim 4: first retention members arranged for only a single plane of rotational symmetry (limits overall symmetry pattern).
  • Claim 5: defines two teeth-free regions around opening of generally between 35° and 80° (limits angular extent of gaps).

Claim 6: Use as a pharmaceutical bottle

  • Claim 6: container is a bottle for storing a pharmaceutical.
    • Practically, this adds industry context without changing the mechanical container/retention structure already required by claim 1. It may matter for labeling/market scope and for some obviousness analysis if the prior art is tied to non-pharma closures.

Claims 7–9: Closure assembly and flexible interior members

  • Claim 7: assembly where closure has interior members that abut at least some flat surfaces.
  • Claim 8: interior members are resiliently flexible.
  • Claim 9: fingers inwardly extending at 10°–80° from the closure interior surface.
    • This likely captures “snap-flex” anti-removal finger designs.

Claim 10: Method of manufacturing (mold portions + injection + separation)

Claim 10 recites:

  • Forming a container with a plurality of mould portions producing the full retention-member geometry (including planar/quadrant/tooth spacing features).
  • Injecting a fluid into the mold.
  • Moving apart mould portions to release the container.

This is consistent with an injection molding process with multi-part molds to create undercuts or retention features without post-machining.


What patents protect anti-untreading containers and how does 9,731,869 fit into that landscape?

Answer (landscape posture): Patent 9,731,869 sits at the intersection of:

  1. Threaded closure interfaces that resist torque reversal (unthreading),
  2. Internal closure fingers that engage flats/shoulders on the container, and
  3. Anti-tamper/snap/rachet-like retention geometries that create controlled gaps and tooth spacing patterns.

The claims’ distinguishing features are the exact spatial arrangement (planes/quadrants) and the tooth spacing asymmetry (one-tooth-length inside groups versus larger spacing at the junction with opposite flat retention members). Those two limitations are the primary “landscape separator” against prior general anti-rotation/anti-tamper closure designs.

What matters most for assessing prior art strength

For invalidity or design-around, the key prior-art discriminators are:

  • Retention members count and “two first + two groups” configuration
  • Flat surface abutment (not just interference ribs)
  • Tooth spacing scheme:
    • group internal inter-tooth spacing ~ one tooth-length
    • junction inter-tooth spacing larger
  • Angular gaps (tooth-free regions) in dependent claim 5
  • Symmetry constraints in dependent claim 4

A prior art reference that shows anti-unthreading but lacks the quadrant/plane geometry or lacks the spacing asymmetry likely hits a narrower role because claim 1 is a tight combination claim.


When does US 9,731,869 lose exclusivity and what are the practical entry windows for generics or biosimilars?

Answer: This patent is a container/closure technology patent, not an active ingredient or biologic therapeutic composition patent. It governs packaging/closure designs for a particular bottle configuration rather than the drug’s FDA exclusivity.

Practical “entry” risk for competitors is:

  • whether they can market the same pharmaceutical with a non-infringing container or non-infringing closure interface, not whether they can launch a drug before NDA/BLA exclusivity expires.

Because the patent-specific expiration date is not included in the provided data, this analysis does not produce a timeline.


What does the filing and claim set imply about continuations, continuations-in-part, and claim breadth?

Answer (based on the provided claims only): Claim 10’s method mirrors the container claim’s structure and uses manufacturing steps that strongly suggest the applicant sought protection that reaches:

  • the product (container and assembly), and
  • the making (mold portion injection process producing the retention geometry).

That structure typically indicates an intent to cover both downstream packaging supply and upstream manufacturing of the container geometry. Without prosecution history, you cannot map whether this is the broadest possible claim set, but the presence of tight geometric limitations suggests those were deliberately maintained as core differentiators.


Which claim elements are most likely to be asserted in litigation for infringement of US 9,731,869?

Answer (most likely asserted): In infringement, plaintiffs generally start with independent claim 1 and then use dependent claims to tighten the match where the defendant’s product is “close but not exact.”

The strongest asserted targets likely include:

  • More than four retention members with flat surfaces
  • Flat-surface abutment to impede unthreading via interior closure member contact
  • Two opposite first retention members and two groups on opposite sides of a bisecting plane
  • Quadrant placement using two perpendicular planes
  • Inter-tooth spacing asymmetry (one-tooth-length within groups; larger spacing at the junction)

Then, if the accused product matches the narrowing:

  • tooth count band (2–6 teeth per group),
  • tooth contiguity (substantially contiguous),
  • tooth-free regions (35°–80°),
  • and symmetry constraints.

Which design-arounds are most plausible without changing the anti-unthreading function?

Answer: Because claim 1 is geometry-specific, design-arounds typically target one of the limiting structural features:

  1. Change quadrant/plane alignment
    • Move retention members so the “defined first plane bisecting” + perpendicular second plane quadrant separation no longer matches.
  2. Remove inter-tooth spacing asymmetry
    • Ensure the junction spacing is not “larger than” the internal group spacing as claimed, or alter spacing to make it not “substantially one tooth-length.”
  3. Replace flat-surface abutment
    • Use different contact surfaces on retention members so they do not have the claimed flat surfaces that abut interior closure members in the required way.
  4. Change symmetry/teeth-free region angle
    • For dependent claim 5, alter angular extents so teeth-free regions are outside the stated 35°–80° range.
  5. Change number of teeth or tooth contiguity
    • For claim 3 and claim 2, use fewer or more teeth than allowed, or break contiguity.

The most practical design-around in packaging is often geometry shift (planes/quadrants) and tooth spacing adjustments because manufacturing can be tuned via mold/cavity changes.


What patent issues arise for closure suppliers and bottling OEMs (manufacturing and licensing risk)?

Answer: The combination of product claims (container and assembly) plus method claim 10 can create IP exposure across:

  • container molding supply chain (method claim),
  • packaging assembly (product assembly claim),
  • and possibly closure design that must provide abutting interior members.

This can influence licensing negotiations for:

  • contract packaging lines,
  • closure sourcing strategy,
  • and mold design ownership (who controls cavity geometry).

How does US 9,731,869 compare with other container/closure anti-tamper or anti-rotation patents?

Answer: Compared with many anti-tamper patents that rely on general ratchet-like retention or broad anti-rotation threads, 9,731,869 is more “engineering constrained” due to:

  • quadrant placement and two perpendicular planes, and
  • explicit tooth spacing relationships across interfaces.

If competing prior patents show general retention ridges or generic anti-rotation structures without the spacing asymmetry or quadrant planes, they are less directly responsive to claim 1.

If competing patents do show detailed retention geometry, the differentiation turns on:

  • whether they disclose the same plane bisecting container with two first members aligned, and
  • whether their tooth spacings track the “substantially one tooth-length” internal group feature plus “larger” junction spacing.

What is the likely Orange Book status of US 9,731,869?

Answer: For this patent to appear in the Orange Book, it would need to be listed for a specific FDA-approved drug product (NDA/BLA) as a patent covering:

  • the drug substance, drug product, or
  • a method of use, not packaging-only container IP in most cases. Container/closure patents sometimes appear but often do not unless tied to a listed product in a specific way.

Orange Book status cannot be determined from the provided data.


Key Takeaways

  • US 9,731,869 protects a threaded container/closure engagement system where multiple retention members with flat surfaces abut closure interior members to impede unthreading.
  • The claim scope is driven by specific geometry: two opposite first retention members, two retention groups arranged in defined quadrants using a first bisecting plane and a perpendicular second plane, plus distinct inter-tooth spacing (internal ~ one tooth-length; junction spacing larger).
  • Dependent claims narrow with contiguous teeth, 2–6 teeth, single plane rotational symmetry, and two tooth-free angular regions (35°–80°).
  • Assembly and manufacturing claims add enforceable coverage for closure interior finger designs (flexible inward fingers at 10°–80°) and an injection molding method with multiple mold portions to create the retention geometry.
  • The most effective design-arounds typically modify plane/quadrant placement and/or tooth spacing relationships, because those features are core limiting elements.

FAQs

1) Is US 9,731,869 a drug substance or drug product patent?
It is a container/closure technology patent. Based on the provided claims, it is not directed to the active ingredient itself.

2) Which is harder to design around: the closure fingers or the container retention members?
Claim 1 places the critical limitations on the container retention member geometry (flat surfaces, planes/quadrants, spacing). Container-side changes are usually the highest-leverage.

3) Does claim 6 materially expand scope beyond claim 1?
Claim 6 narrows by specifying the container is a pharmaceutical bottle, but the core mechanical requirements still come from claim 1.

4) Can a competitor avoid infringement by keeping anti-unthreading but altering tooth count?
Potentially. Dependent claim 3 limits the number of teeth in the groups to between two and six. If the accused structure avoids that, it may avoid dependent coverage, though independent claim 1 may still capture.

5) Does the method claim (claim 10) increase risk for contract manufacturers?
Yes. Claim 10 targets an injection molding process that forms the same retention geometry using mold portions. That can pull manufacturing disputes into the IP scope even if the end product is supplied by a different entity.


References (APA)

  1. United States Patent No. 9,731,869.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 9,731,869

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-001 Jun 30, 2011 DISCN Yes No 9,731,869 ⤷  Start Trial Y ⤷  Start Trial
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-003 Dec 21, 2015 DISCN Yes No 9,731,869 ⤷  Start Trial Y ⤷  Start Trial
Btcp Pharma LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-002 Jun 30, 2011 DISCN Yes No 9,731,869 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 9,731,869

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
11153387Feb 4, 2011
PCT Information
PCT FiledJanuary 26, 2012PCT Application Number:PCT/GB2012/050163
PCT Publication Date:August 09, 2012PCT Publication Number: WO2012/104607

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.