Details for Patent: 10,206,813

Which drugs does patent 10,206,813 protect, and when does it expire?

Patent 10,206,813 protects IDOSE TR and is included in one NDA.

This patent has fifty-five patent family members in seven countries.

Summary for Patent: 10,206,813

Title:	Implants with controlled drug delivery features and methods of using same
Abstract:	Disclosed herein are drug delivery devices and methods for the treatment of ocular disorders requiring targeted and controlled administration of a drug to an interior portion of the eye for reduction or prevention of symptoms of the disorder. The devices are capable of controlled release of one or more drugs and may also include structures which allow for treatment of increased intraocular pressure by permitting aqueous humor to flow out of the anterior chamber of the eye through the device.
Inventor(s):	David S. Haffner, Thomas W. Burns, Harold A. Heitzmann, Kenneth M. Curry
Assignee:	Glaukos Corp
Application Number:	US14/201,470
Patent Claim Types: see list of patent claims	Delivery; Device;

Patent 10,206,813: US drug delivery ocular implant (anterior chamber) scope, claim construction, and US landscape

US Patent 10,206,813 claims an ocular implant for delivery of a therapeutic agent from an interior space in an outer shell, using a proximal cap whose aperture(s) are occluded by a permeable or semi-permeable material (often a membrane). The implant is configured so the proximal end sits in the anterior chamber of an eye, with additional optional elements for prostaglandin-class therapy, fluid inlet/outlet directing flow to Schlemm’s Canal, and distal retention via a sharpened conical element.

The claims are structurally tight around: (1) an implant architecture with a proximal cap and interior reservoir, (2) an occlusion-elution mechanism where elution occurs only through a membrane/material between cap and shell that blocks aperture(s), and (3) placement in the anterior chamber. Dependent claims narrow to specific drug classes (prostaglandins/analogs/inhibitors), flow-path geometry (Schlemm’s Canal; outlet closer to distal end than inlet), membrane thickness (50–100 microns), and long-duration elution (12–48 months). The patent estate is therefore best read as covering “anterior chamber ocular implant with reservoir + occluded cap aperture + diffusion-controlled delivery,” with optional add-ons for prostaglandins and fluidics to outflow pathways.

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What is the scope of US Patent 10,206,813’s independent claims (1, 10, 17)?

Claim 1 scope (outer shell + cap with aperture(s) + occluding permeable/semi-permeable material + anterior chamber positioning)

Independent claim 1 requires all of the following core elements:

1. Outer shell with proximal and distal ends defining an interior space.
2. At least a first therapeutic agent disposed within the interior space.
3. A cap positioned on the proximal end of the outer shell.
4. The cap comprises at least one aperture (explicit).
5. A permeable or semi-permeable material positioned between the cap and the proximal end of the outer shell.
6. That permeable/semi-permeable material is:
   • permeable to the therapeutic agent, and
   • dimensioned based on permeability to the therapeutic agent, and
   • occludes the aperture(s), so that elution occurs only through the permeable/semi-permeable material.
7. The proximal end of the outer shell is configured to be positioned in the anterior chamber of an eye.

Practical claim center of gravity: delivery is controlled by a diffusion/partition membrane that blocks the aperture(s) and constitutes the sole elution path. The cap aperture(s) are not the delivery surface; they are structurally present but occluded by the permeable/semi-permeable layer.

Claim 10 scope (cap permeable portion instead of separate aperture occluded by membrane)

Claim 10 recasts the aperture concept into a “cap portion permeable or semi-permeable to the agent” structure:

• Cap sits over the proximal end and extends toward distal, enclosing only a portion of the shell.
• The cap includes at least one permeable/semi-permeable portion dimensioned by permeability.
• Elution occurs only through the permeable/semi-permeable portion.
• Proximal end configured for anterior chamber positioning.

Key difference vs claim 1: claim 10 does not require an aperture occluded by an intermediate occlusion layer. It instead requires the cap itself includes the permeable/semi-permeable delivery region.

Claim 17 scope (cap with aperture + occluding permeable/semi-permeable material + retention protrusion + thickness/time optional in dependents)

Claim 17 introduces an explicit distal retention feature:

• Outer shell with proximal/distal ends and interior space.
• Therapeutic agent in interior space.
• Cap:
  • has at least one aperture,
  • is dimensioned for positioning over proximal end,
  • extends toward distal and encloses a portion of the shell.
• A first material between cap and proximal end:
  • through which the therapeutic agent elutes,
  • is permeable/semi-permeable to the therapeutic agent,
  • occludes the aperture to force elution only through that first material.
• Retention protrusion on distal end with a sharpened element.
• Proximal end configured for anterior chamber positioning.

Key difference vs claim 1: claim 17 adds a retention protrusion with sharpened element, and expresses the intermediate delivery material as a “first material through which elution occurs,” still occluding cap aperture(s).

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How are the aperture and membrane “occlusion-elution” limitations likely construed?

Claim requirement: aperture existence + occlusion by permeable/semi-permeable layer (claim 1, 17)

Where the cap comprises an aperture, the claims require the permeable/semi-permeable material to occlude the aperture. That is a functional limitation expressed as:

• aperture is blocked/covered by the material; and
• elution happens only through the material.

Scope implication: an accused implant that provides a cap aperture but allows agent to pass directly through the aperture without the permeable/semi-permeable layer being the sole elution route is vulnerable. Conversely, designs where a membrane seals over the aperture (or a permeable layer covers aperture openings) map closely.

Dimensioned based on permeability

Claims 1 and 10 recite “dimensioned based on permeability.” This is a design parameter tying membrane geometry (thickness/area/porosity) to permeability of the drug agent.

Scope implication: generic “permeable film” without design linkage to permeability can still infringe if the resulting configuration meets the claimed “dimensioned based on permeability” requirement; in practice, most diffusion-controlled membranes are engineered based on permeability anyway. For non-infringement, designers generally target a different diffusion boundary (different interface) or a non-membrane delivery mechanism.

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What drug classes are covered (prostaglandin-related limitations)?

Dependent claim coverage

• Claim 2, 11, 19: at least one first therapeutic agent comprises:
  • a prostaglandin,
  • a prostaglandin analog, and/or
  • a prostaglandin inhibitor,
  • and combinations.

This anchors the patent to glaucoma and ocular hypertension pharmacology, where prostaglandin analogs are standard.

Scope implication: the independent claims are not limited to prostaglandins, but the most “pharma-relevant” commercial embodiments likely invoke dependent claims. Prostaglandin/analog selection plus diffusion-controlled elution is the practical value proposition.

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What additional structural and functional elements are claimed as optional vs required?

Fluid inlets/outlets and outflow pathway

• Claim 3, 12: at least one fluid inlet and one fluid outlet deliver ocular fluid to a physiological outflow pathway.
• Claim 4: the outflow pathway is Schlemm’s Canal.
• Claim 5: outlet positioned closer to distal end than inlet.

Scope implication: two-tier coverage:

1. implant architecture with anterior chamber positioning and membrane delivery (independent),
2. optional fluidic system delivering to outflow pathway (dependent).

For infringement risk, whether a competitor includes the fluid inlet/outlet system matters only if the competitor’s device is intended to practice/protect the same embodiment. An “implant-only” diffusion device without fluidic inlet/outlet may still hit independent claims 1/10/17.

Membrane definition

• Claim 6, 18: permeable/semi-permeable material is a membrane.

Retention protrusion and sharpened conical element

• Claim 7: retention protrusion on distal end anchors at target tissue site.
• Claim 9: retention protrusion comprises a sharpened conical element partially penetrating tissue.

Scope implication: dependent retention claims can be used to segregate design-arounds. A competitor could avoid these by changing anchoring method (e.g., non-sharpened flange, suture-based fixation, coating adhesion rather than penetration). However, independent claim 1 lacks a retention protrusion, so anchoring changes alone may not avoid infringement.

Cap-extension geometry

• Claim 8: upon positioning cap over proximal end, cap extends toward distal end and encloses only a portion of outer shell.

Scope implication: this limits cap length/coverage. A competitor that uses a different cap geometry (fully enclosing, or not extending toward distal in the same manner) may avoid the dependent claim but still face independent claim 1 if the key cap placement is met.

Membrane thickness

• Claim 21: first material thickness between 50 and 100 microns.

Scope implication: creates a clear numeric design target. Devices using different thicknesses may still infringe independent claims but could avoid the dependent thickness claim.

Elution duration

• Claim 22: elutes for 12 to 48 months.

Scope implication: another numeric design target. Devices with substantially shorter or longer profiles could avoid dependent claim 22, but independent claims remain broad on elution timing unless tied as a further limitation.

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What does the claim set imply about the technology platform (diffusion-controlled anterior chamber implant)?

The patent set is built around:

• Reservoir model: therapeutic agent in interior space.
• Proximal sealing/capping: cap on proximal end.
• Delivery boundary: diffusion/semi-permeable material between cap and shell, occluding any cap apertures and acting as the only elution path.
• Anterior chamber placement: proximal end in anterior chamber.
• Optional outflow fluidics: inlet/outlet for flow to Schlemm’s Canal.
• Optional anchoring: sharpened conical element penetration.

Commercially relevant interpretation: This reads like an ocular implant for chronic delivery of intraocular drugs, with prostaglandin analogs being the leading commercial class, and optional integration with aqueous humor outflow pathways.

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How strong is the patent coverage versus likely generic or competitor design-arounds?

High-signal infringement anchors

1. Anterior chamber placement of proximal end.
2. Cap + occluded aperture with a permeable/semi-permeable occluding material (claims 1/17).
3. Elution only through permeable/semi-permeable material.
4. Dimensioning based on permeability.

These are the core non-negotiables for independent claim 1 and 17 (aperture occlusion + anterior chamber + delivery-only-through membrane).

Most effective “partial” design-arounds

• Remove aperture(s) or remove the requirement that elution occurs only through the occlusion layer by changing the delivery mechanism (e.g., a wholly permeable cap with no occluding aperture interface, more aligned to claim 10 structure).
• Change implantation location such that proximal end is not configured for anterior chamber placement (target different compartment such as vitreous/retinal subspace). That is often the hardest engineering change.
• Avoid sharpened conical retention protrusion to escape dependents 7/9/16 without necessarily escaping independent coverage.

Most effective numeric design-arounds (avoid dependents)

• Cap material thickness outside 50–100 microns.
• Elution window outside 12–48 months.

These do not necessarily remove independent claim exposure.

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What is the US patent landscape around this ocular implant concept?

What can be stated from the claim text alone

The provided text is sufficient to identify the claimed feature set, but not sufficient to map the full US patent family, priority chain, assignees, examiner citations, prosecution history, or co-pending continuation coverage for US 10,206,813.

Because a complete, accurate landscape requires those bibliographic and legal records (publication numbers, assignee, related continuations, cited references, terminal disclaimers, maintenance status, and any Orange Book/FDA linkage), the only accurate landscape content here is the claim-driven technological neighborhood: anterior chamber implants for chronic ocular therapy with diffusion-controlled membranes and optional outflow fluidics.

Landscape categories you should expect to exist around this claim set

1. Anterior chamber drug-eluting implant patents (architecture with cap, reservoir, diffusion barrier).
2. Membrane-occluded aperture drug release patents (controlled elution via membrane over openings).
3. Prostaglandin delivery ocular implant patents (prostaglandin analogs in chronic delivery systems).
4. Glaucoma/outflow pathway implants (Schlemm’s Canal-related fluidic delivery systems).
5. Retention/anchoring mechanism patents (tissue anchoring including conical sharpened elements).

No additional US patent numbers or case outcomes can be provided from the claim text alone without risking fabrication.

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What is the likely claim coverage for FDA-facing embodiments (Orange Book / NDA relevance)?

The claim set is compatible with a sustained-release glaucoma therapy delivery system. However, determining Orange Book status, listed patents, and FDA linkage requires the patent’s bibliographic identifiers and FDA database records.

No Orange Book status, FDA approval pathways (505(b)(2) vs ANDA listing), or listing-based exclusivity statements can be produced accurately from the claim text provided.

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Key Takeaways

• US 10,206,813 protects a drug delivery ocular implant with an anterior chamber placement configuration, a reservoir shell, and a proximal cap whose aperture(s) are occluded by a permeable/semi-permeable delivery material so that elution occurs only through the permeable/semi-permeable material.
• Independent claim scope splits into:
  • claim 1: aperture(s) + occluding permeable/semi-permeable material between cap and shell.
  • claim 10: permeable/semi-permeable cap portion as the elution path.
  • claim 17: aperture + occluding delivery material plus a distal retention protrusion with a sharpened element.
• Most meaningful claim narrowing for commercial embodiments includes prostaglandin/prostaglandin analog/prostaglandin inhibitor therapy, optional Schlemm’s Canal fluidic routing, optional sharpened conical anchoring, numeric membrane thickness (50–100 microns), and numeric elution duration (12–48 months).
• The highest infringement-risk design anchors are anterior chamber configuration and the “elution only through occluding permeable/semi-permeable material” requirement.

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FAQs

1. Can a competitor avoid claim 1 by eliminating cap apertures?
   Claim 1 requires cap aperture(s) and occlusion; a design without apertures may shift coverage to claim 10-type permeable cap portion structures, changing infringement analysis.

2. Does using a membrane outside the 50–100 micron thickness band avoid the patent?
   It targets dependent claim 21 but does not by itself remove independent claim 1/10/17 exposure unless thickness is also the basis for meeting or missing the independent “permeable/semi-permeable material dimensioned based on permeability” constraint.

3. If a device delivers drug through the aperture openings directly, does it avoid infringement?
   Claim 1 and 17 require elution to occur only through the permeable/semi-permeable occluding material, so direct aperture delivery conflicts with the claim’s structural-functional limitation.

4. Is the sharpened conical retention required for independent claim coverage?
   No. Retention protrusion with sharpened element appears in dependent claim 7/9/16 and independent claim 17, but independent claim 1 lacks a sharpened retention requirement.

5. How do prostaglandin drug selection and device mechanics interact in infringement?
   Prostaglandin/analog/inhibitor language is in dependent claims. Device mechanics can infringe independent claims regardless of therapeutic agent type, while agent selection is needed for dependent claim coverage.

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References (APA)

1. US Patent 10,206,813 (claims provided in prompt).

Drugs Protected by US Patent 10,206,813

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glaukos	IDOSE TR	travoprost	IMPLANT;INTRACAMERAL	218010-001	Dec 13, 2023		RX	Yes	Yes	10,206,813		Y

International Family Members for US Patent 10,206,813

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010249683
Australia	2014237278
Australia	2014348667
Australia	2015230797
Australia	2018229507
Australia	2019201946
Australia	2020204427