Details for Patent: 9,675,610

Summary for Patent: 9,675,610

Title:	Abuse-proofed dosage form
Abstract:	A solid administration form, protected from parenteral abuse and containing at least one viscosity-increasing agent in addition to one or more active substances that have parenteral abuse potential. The agent forms, when a necessary minimum amount of an aqueous liquid is added, on the basis of an extract obtained from the administration form, a preferably injectable gel that remains visually distinct when introduced into another quantity of an aqueous liquid.
Inventor(s):	Johannes Bartholomaeus, Heinrich Kugelmann
Assignee:	Gruenenthal GmbH
Application Number:	US15/245,424
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,675,610
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

Patent 9,675,610 Landscape: What US 9,675,610 Claims Cover for Abuse-Deterrent Oral Opioid Solid Dosage Forms (Gel Threads Visible After Injection)

US 9,675,610 is directed to abuse-deterrent oral solid dosage forms for high-abuse opioids (hydrocodone, morphine, oxycodone, tramadol, tapentadol and salts/solvates), where comminution and aqueous extraction generate a viscosity-modified injectable gel that (i) can be drawn up and expelled through small-bore devices (0.9 mm hypodermic needle or 0.9 mm syringe), and (ii) leaves visible gel “threads” in water at 37°C for defined durations. A dependent claim set further narrows viscosity agent choices to specific polymers/gums and adds multiparticulate/controlled release and gastric-resistant coating features. A separate claim branch adds a blood-vessel obstruction theory for unsafe injection.

Scope and claim architecture are centered on performance-based physical properties of the extractable gel, not on specific opioid formulations alone. That framing drives both the patent’s breadth (any opioid meeting the extract/gel behavior) and its litigation risk points (design-around if gel behavior is altered, if viscosity system is changed, or if the “threads visible for at least X minutes” functional requirements are not met).

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What does US 9,675,610 claim for reduced parenteral abuse opioid oral dosage forms?

Short answer (claim core): The patent claims an oral solid dosage form that, after comminution and aqueous extraction, produces an injectable gel with viscosity-increasing agents. The gel can be aspirated and expelled through a 0.9 mm medical device, and gel threads remain visible to the naked eye in water at 37°C for at least defined time windows (claim 10 and claim 11). A second independent claim requires that the gel cannot be safely injected into blood vessels because it obstructs one or more blood vessels (claim 14).

Independent Claim 1: Gel that can be injected and leaves visible threads

Claim 1 requires, in combination:

• Oral solid dosage form
• One or more abuse-potential active ingredients selected from:
  • hydrocodone
  • morphine
  • oxycodone
  • tramadol
  • tapentadol
  • salts/solvates thereof
• Viscosity-increasing agents in an amount such that:
  • an aqueous extract of the total content of the dosage form when comminuted
  • combined with 10 mL water at 25°C
  • forms a gel that can be drawn up into and injected back out of a hypodermic needle with diameter 0.9 mm
  • and threads of the gel injected from the needle remain visible to the naked eye in a further quantity of water at 37°C.

This is a functional and test-driven claim: the key discriminators are the gel-forming ability after extraction and the observable thread behavior at physiological temperature.

Dependent Claim 2-4: opioid-specific fallback positions

Claims 2-4 narrow claim 1 to a specific opioid genus member:

• claim 2: oxycodone (salt/solvate included)
• claim 3: hydrocodone (salt/solvate included)
• claim 4: morphine (salt/solvate included)

These are typical fallback claim narrowing steps that support validity even if some opioid sub-genus is attacked.

Dependent Claim 5: specific viscosity-increasing agent list

Claim 5 lists viscosity agents (selected from a closed group) that qualify for the claim 1 viscosity system:

• microcrystalline cellulose with 11 wt% carboxymethylcellulose sodium
• carboxymethylcellulose sodium
• polyacrylic acid
• locust bean flour
• citrus pectin
• waxy maize starch
• sodium alginate
• guar flour
• iota-carrageenan
• karaya gum
• gellan gum
• galactomannan
• tara stone flour
• propylene glycol alginate
• apple pectin
• lemon peel pectin
• sodium hyaluronate
• tragacanth
• tara gum
• fermented polysaccharide welan gum
• xanthan gum

This list can both broaden and constrain. It broadens protection by capturing many polymer/gum families used in abuse-deterrent development. It also constrains the dependent claim to specific materials; a design-around can sometimes target changing to viscosity systems not on this list unless the independent claim is satisfied through other viscosity agents.

Dependent Claim 6: particulate form

• claim 6: “in particulate form”

This is compatible with abuse-deterrent technologies that use granules/pellets/tablets.

Dependent Claim 7: controlled release form

• claim 7: at least one active ingredient in controlled release form

This aligns the patent with typical opioid controlled-release formats.

Dependent Claim 8: gastric-juice resistant coating

• claim 8: coating resistant to gastric juices

This can be a critical additional barrier to extraction in vivo, though the claim 1 performance test is still oriented to aqueous extraction of comminuted dosage.

Dependent Claim 9: multiparticulate architectures

• claim 9: multiparticulate form in one of: microtablets, microcapsules, micropellets, granules, spheroids, beads, or pellets
• packed in capsules or press-molded into tablets

This is another typical dependent fallback that can be used to enforce against specific product manufacturing shapes.

Dependent Claim 10-11: thread visibility time windows

• claim 10: threads visible to naked eye in water at 37°C for at least one minute
• claim 11: threads visible for at least ten minutes

These time windows sharpen the functional performance measurement. They matter for both infringement and validity if prior art gel-formers were known but did not meet these observation durations under the claimed test setup.

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How does dependent claim set define viscosity agent scope in US 9,675,610 (and what design-arounds are implied)?

Short answer: The patent includes a dependent claim that ties the viscosity-increasing agents to a specific enumerated list. If a competitor uses non-listed excipients that still satisfy the independent claim’s performance test, it may avoid dependent claim coverage but still risk infringement of claim 1. Conversely, if a competitor changes viscosity agents in a way that disrupts gel thread visibility in water at 37°C, it can attempt to avoid the independent claim’s key functional features.

Practical claim boundary: list vs. performance

• Claim 1 does not restrict viscosity agents to the enumerated list; it requires that the viscosity system be present in an amount that yields the specific gel behavior and thread visibility.
• Claim 5 restricts to the enumerated list.

Litigation in this space often turns on:

• what viscosity system is used,
• and whether the extractable gel meets the test-defined thread persistence.

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What does independent claim 14 add about syringe injection and blood vessel obstruction?

Short answer: Claim 14 keeps the core gel/extract concept but changes the device (syringe rather than hypodermic needle) and adds a safety limitation: the injectable gel cannot be safely injected into blood vessels because it would obstruct blood vessels.

Claim 14 requires:

• the same opioid active ingredient genus
• viscosity-increasing agents in an amount that:
  • aqueous extract of comminuted total dosage at 25°C with 10 mL forms an injectable gel
  • can be drawn up into and injected out of a syringe having a diameter of 0.9 mm
  • but the injectable gel cannot be safely injected from the syringe into blood vessels because presence of gel in an abuser’s blood vessels would obstruct one or more blood vessels.

Dependent claim 15-17 mirror opioid-specific narrowing for oxycodone, hydrocodone, morphine, and claim 18-19 add excipient-specific fallbacks (microcrystalline cellulose, hydroxypropylmethylcellulose). Claim 20 is the controlled release fallback.

Key legal implication of claim 14’s obstruction limitation

The “obstruct one or more blood vessels” requirement is a mechanism-of-harm statement. It may:

• increase evidentiary burden for infringement (showing what happens in blood vessel conditions), while still being tied to the earlier physical gel behavior; and
• function as a differentiator from prior art where gel does not create vascular obstruction risk.

If the gel is formulated to form visible threads that persist, obstruction may be argued as a logical consequence under claimed performance. If not, claim 14 becomes easier to design around while still potentially leaving claim 1 at issue.

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What additional dosage form features expand coverage beyond the gel property (controlled release, coatings, multiparticulate)?

Short answer: Claims 6-9, 8, and 7/20 extend coverage to dosage form build features typical of branded abuse-deterrent opioids: particulate formats, multiparticulate units, controlled release, and gastric-juice resistant coatings.

Claim clusters

• Form factor: particulate (claim 6); multiparticulate microtablets/micropellets/granules/spheroids/beads/pellets (claim 9); press-molded tablets or capsules (claim 9).
• Release & stability: controlled release (claim 7 and claim 20); gastric-resistant coating (claim 8).
• Device/extraction performance: independent claims 1 and 14 define extraction at 25°C with 10 mL water, gel injection through 0.9 mm device, and thread visibility at 37°C.

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How strong is US 9,675,610 against generic or abuse-deterrent “same API” entrants?

Short answer: Strength is anchored to observable gel-thread persistence after comminution and aqueous extraction, plus device-diameter and temperature conditions. A generic can face risk if it maintains the same gel behavior even if it uses different manufacturing and excipient blends. A generic can also reduce risk by altering extractable gel rheology such that the “threads visible for at least one minute or ten minutes” criteria are not met under the claimed test.

Claim scope that can catch “same API” products

• The independent claim covers multiple opioids in the abuse-potential class.
• It is directed to oral solid dosage forms with viscosity-increasing agents yielding specific extractable gel behavior.

Design-around paths implied by claim language

A challenger can attempt to:

• change the viscosity system so the extract does not produce gel threads that remain visible at 37°C;
• change the amount or type of viscosity modifier so the test fails (for example, threads break down quickly or disperse without visible thread formation);
• modify the dosage form to change extraction characteristics after comminution (though the claim is oriented to extract of comminuted total content);
• pursue alternative abuse deterrent mechanisms so the key gel-thread property is not created.

The patent’s enforceability against a specific competitor will turn on the product’s ability to satisfy the exact test conditions in the claims (including water volumes, temperatures, device diameter, and naked-eye visibility duration).

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What would a patent infringement analysis look like for US 9,675,610 on a competitor’s oxycodone or hydrocodone oral product?

Short answer: The infringement test would map the competitor’s product to claim 1’s functional requirements: comminuted extract with 10 mL water at 25°C produces a gel that can be aspirated and expelled through a 0.9 mm needle and forms gel threads that remain visible to the naked eye in water at 37°C. If that mapping fails, claim 1 fails even if other excipients are similar.

Infringement elements checklist (claim 1)

1. Is the product an oral solid dosage form?
2. Does it contain one or more abuse-potential opioids from the enumerated list (including salts/solvates)?
3. After comminution and mixing total content with 10 mL water at 25°C:
   • does the mixture form an injectable gel?
4. Can the gel be drawn into and injected out of a 0.9 mm hypodermic needle?
5. After injection, do threads of gel remain visible to the naked eye in further water at 37°C?
6. If litigating dependent claims:
   • do threads persist at least 1 minute (claim 10) or 10 minutes (claim 11)?
   • are viscosity agents selected from the claim 5 list (if asserting claim 5)?
   • is the architecture particulate/multiparticulate/controlled release/gastric resistant as recited?

How claim 14 would be separately analyzed

Claim 14 adds that the injectable gel cannot be safely injected into blood vessels because it would obstruct blood vessels. That limitation is likely to require additional technical framing connecting the gel’s behavior to obstruction risk. If a gel forms but disperses without thread persistence, claim 14 may be more easily contested.

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What patent estate issues arise from a functional gel-thread claim like this? (prior art and obviousness pressure points)

Short answer: Functional and performance-based claims can be vulnerable if prior art discloses similar gel-forming and viscosity modifiers but lacks evidence of the specific thread visibility duration and test parameters. They can also be vulnerable to enablement or definiteness arguments depending on how the specification supports the measurement and how repeatable the test is. From a competitive standpoint, this makes competitor formulation optimization around rheology and dispersibility a direct lever.

Specific “pressure points” in prior art mapping

• Gel formation upon extraction after comminution is widely disclosed in polymer-based abuse deterrent patents.
• The novelty and defensibility are more likely to hinge on:
  • injection through 0.9 mm
  • naked-eye-visible threads in water at 37°C
  • persistence at ≥1 minute and ≥10 minutes
  • the particular viscosity system behavior.

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What jurisdictions and regulatory ecosystems does this type of abuse-deterrent opioid patent typically interact with?

Short answer: This patent’s scope aligns with US abuse-deterrent opioid assessment environments, where formulation properties are evaluated under FDA-facing abuse deterrence frameworks. The patent is US, but the market interaction is global because manufacturing and excipient selection affect both US infringement risk and international product positioning.

US-centric positioning

• The claim is built around mechanical and observable outcomes (needle/syringe injection; thread visibility), which often map to abuse deterrence performance narratives used in regulatory submissions.

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Key Takeaways

• US 9,675,610 claims an oral solid opioid dosage form where comminution and extraction create a gel that can be injected through a 0.9 mm device and produces naked-eye-visible gel threads in water at 37°C.
• Claim 1 is opioid-genus broad and performance-based; it does not limit viscosity agents to a specific list.
• Claim 5 narrows viscosity agents to an enumerated set of polymers/gums, creating a dependent coverage belt.
• Dependent claims add time thresholds (≥1 minute and ≥10 minutes) for thread visibility, plus standard abuse-deterrent dosage form architecture elements (multiparticulate, controlled release, gastric-resistant coating).
• Claim 14 adds a safety/mechanism limitation: injection into blood vessels is unsafe because the gel would obstruct blood vessels, using a syringe geometry constraint.
• The primary design-around lever is changing extractable gel rheology such that the gel either cannot be injected/aspirated as claimed or does not create threads that persist visibly at 37°C.

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FAQs

1) Does US 9,675,610 require the opioid to be oxycodone, or does it cover other opioids?
It covers multiple opioids in the listed group (hydrocodone, morphine, oxycodone, tramadol, tapentadol) plus salts/solvates; oxycodone/hydrocodone/morphine are in dependent claims.

2) What is the significance of the 0.9 mm needle or syringe dimension in US 9,675,610?
It is a device diameter requirement tied to the gel’s ability to be aspirated and expelled, and it anchors infringement to specific mechanical feasibility under the test conditions.

3) How do claims 10 and 11 change the infringement profile?
They add durability thresholds for the visible gel threads at 37°C (at least one minute vs at least ten minutes). Products that form threads briefly may avoid those dependent claims while still risking independent claim 1.

4) Can a competitor avoid claim 5 by using a different viscosity agent?
Yes, only for the dependent claim 5 scope; claim 1 still requires the viscosity-increasing agents be present in an amount that creates the claimed gel-thread performance.

5) What is the main difference between independent claim 1 and independent claim 14?
Claim 14 adds an inability-to-safely-inject-into-blood-vessels limitation tied to blood-vessel obstruction, while claim 1 focuses on observable thread persistence after injection.

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References

1. United States Patent No. 9,675,610. (n.d.). Patent specification and claims (as provided).

Drugs Protected by US Patent 9,675,610

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: 9,675,610

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	102 27 077	Jun 17, 2002
Germany	102 50 083	Oct 25, 2002

International Family Members for US Patent 9,675,610

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	411007
Australia	2003237944
Cyprus	1108682
Germany	10250083
Germany	50310649
Denmark	1515702
European Patent Office	1515702