Details for Patent: 9,060,976

Summary for Patent: 9,060,976

Title:	Pharmaceutical formulation containing gelling agent
Abstract:	Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.
Inventor(s):	Curtis Wright, Benjamin Oshlack, Christopher Breder
Assignee:	Purdue Pharma LP
Application Number:	US13/726,324
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,060,976
Patent Claim Types: see list of patent claims	Compound; Dosage form;

Patent 9,060,976 Scope and US Patent Landscape for Extended-Release Oxycodone Abuse-Deterrent Dosage Forms (PEO/Magnesium Stearate + PEG-Coated Core)

Executive summary: US Drug Patent 9,060,976 claims an extended-release, abuse-deterrent oxycodone oral dosage form built around a core matrix containing melted PEO (MW 300,000 to 5,000,000 daltons) plus magnesium stearate, followed by PEG applied onto the core matrix, with extended-release performance. The claim is composition- and process-linked (PEO melting during preparation) and includes a specific polymer MW window and specific excipient pairing (PEO + magnesium stearate + oxycodone; plus a PEG overlay). The landscape around this family typically clusters into: (1) other PEO/PEG abuse-deterrent or extended-release oxycodone formulations, (2) method/process patents around PEO melting and overlaying/coating, and (3) packaging or physical abuse-deterrence technologies (tamper-resistant coatings, particulate barriers) that can be designed around by shifting polymer chemistry, MW ranges, or overlay functionality.

---

What does US Patent 9,060,976 claim: scope of extended-release abuse-deterrent oxycodone with melted high-MW PEO and PEG overlayer?

Claim 1 defines a specific dosage-form architecture with three essential structural elements plus one process condition and one functional outcome.

1) Element A: core matrix composition and the PEO molecular-weight window

Claim 1 requires a core matrix comprising a blended mixture of:

• PEO with molecular weight about 300,000 to about 5,000,000 daltons
• magnesium stearate
• oxycodone or a pharmaceutically acceptable salt

Scope impact (what is captured):

• The PEO MW window is a bright-line constraint. Products using PEO outside 300k–5M fall outside this limitation.
• “PEO having a molecular weight of from about 300,000 daltons to about 5,000,000 daltons” covers a broad range within that bracket. The claim does not specify a number-average vs weight-average MW in the text you provided; many polymer patents use “molecular weight” generically, which can broaden interpretation to the stated metric used in prosecution/testing.

Scope impact (what is not required):

• The claim does not require additional core excipients (other than the blend containing PEO + magnesium stearate + oxycodone). That gives interpretive room, but any extra excipients still permit infringement as long as the recited components are present in the required relationships.
• The claim does not limit PEO as only component (it says blended mixture comprising PEO, MgSt, oxycodone).

2) Element A process limitation: heating to melt at least a portion of PEO

Claim 1 requires:

• “core matrix is heated to melt at least a portion of the PEO included in the core matrix during preparation of the dosage form”

Scope impact:

• Infringement hinges partly on manufacturing conditions. A generic or alternative-manufacturing process that avoids melting “at least a portion” of PEO during preparation could avoid the literal process limitation, even if the finished dosage form still contains the required composition.
• The phrasing “during preparation” suggests the relevant step happens in the manufacture, not necessarily that PEO is melted in final state. That matters for infringement analysis.

Typical design-around vectors:

• Use a process that gelatinizes or disperses PEO without melting (if feasible).
• Use the same polymers but adjust preparation to avoid melting “at least a portion.”
• Use different polymer (not meeting the MW window).

3) Element B: PEG applied onto the core matrix

Claim 1 requires:

• “PEG applied onto the core matrix”

Scope impact:

• PEG is distinct from PEO as written. The claim specifies PEG overlay without stating MW for PEG in your claim excerpt.
• “Applied onto” is broad: it can include coating, spraying, melt application, layering, or deposition, so long as PEG is deposited on the core matrix.

Potential ambiguity that expands capture:

• Many abuse-deterrent/extended-release patents use both PEG/PEO terms interchangeably in commercial practice. But the claim explicitly distinguishes them. That distinction can be litigated: if “PEG” in the patent is construed to cover poly(ethylene oxide) broadly, that can broaden infringement. If “PEG” is construed as poly(ethylene glycol) typically with different characterization methods, it can narrow.

4) Functional limitation: the dosage form provides extended release

Claim 1 requires extended release:

• “wherein the dosage form provides extended release of the drug.”

Scope impact:

• Functional limitations are typically met by performance. If a competitor’s formulation is not extended release (or is materially outside extended-release behavior), it may avoid infringement even if composition overlaps.

---

How broad is US 9,060,976 compared with typical oxycodone abuse-deterrent formulation patents?

Compared with broader abuse-deterrent families, this claim is narrower because it ties abuse deterrence and extended release to:

1. A specific polymer MW window for PEO in the core,
2. magnesium stearate in the core,
3. a manufacturing melt step (“heated to melt at least a portion of the PEO”),
4. a PEG overlay, and
5. extended-release performance.

Compared with narrower patents that claim a specific dosage shape (bilayer tablet, multiparticulate beads, specific thickness, specific overlay weight percent, specific dissolution profile), this claim is still broad on many degrees:

• It does not limit dosage form geometry.
• It does not specify layer weights, ratios, or thickness.
• It does not specify dissolution curves numerically.
• It does not specify specific abuse deterrence mechanism beyond what is inherent in the claimed extended-release abuse-deterrent dosage form.

Net effect: the claim is likely best-in-class for enforceability against “same technology” reformulations that keep the PEO MW and use melting + PEG overlay. It is less likely to catch radical platform shifts that change the polymer system or manufacturing route.

---

What design-arounds are likely against US 9,060,976: avoid the PEO MW window, avoid melting, or change the overlay polymer?

1) PEO molecular weight substitution

Because the claim requires PEO 300,000 to 5,000,000 daltons, a design-around can target:

• PEO below 300k (lower MW)
• PEO above 5M (higher MW)

This is the cleanest literal design-around.

Landscape implication: Many follow-on oxycodone ER patents use multiple polymer grades; freedom-to-operate studies usually map polymer MWs and whether the final product uses a grade that falls inside the claimed bracket.

2) Avoiding “heated to melt at least a portion of the PEO”

This is process-sensitive. A competitor can:

• Maintain core temperatures below melting for PEO fraction used
• Use solvent processing where PEO is not melted, only dissolved and then solidified
• Use granulation steps that do not require bulk melting

Landscape implication: Process patents and process-related claim limitations become crucial in litigation, even for composition-matching competitors.

3) Replace PEG overlay

The claim requires PEG “applied onto” the core matrix. Alternatives could include:

• A different overlay polymer or excipient (e.g., different polymer not falling under PEG)
• A physical barrier layer that prevents erosion but is not described as PEG “applied onto”
• Surface coating without PEG

Landscape implication: Many companies can shift from PEG/PEO overlays to other hydrophilic polymers or waxy polymers.

4) Change from abuse-deterrent ER to non-analogous ER

If a formulation is not an “abuse-deterrent dosage form” under the patent’s construction, or fails the functional extended-release requirement, infringement is less likely.

---

How many claims are typically in this family and what other claim elements usually matter for freedom-to-operate?

You provided only claim 1. The scope of a patent family often includes dependent claims that narrow:

• specific PEO grades (more specific MWs)
• ratio ranges (PEO:oxycodone; MgSt level; PEG overlayer weight)
• specific salts (oxycodone HCl vs free base)
• specific coating methods (melt coating vs solution coating)
• specific extended-release mechanisms or dissolution profile parameters
• abuse deterrence testing outcomes

Without the dependent claims text, the safe infringement mapping is necessarily anchored to the elements embedded in claim 1. Those elements likely remain the “center of gravity” for claim construction and licensing leverage.

---

What other US patents are likely to overlap with US 9,060,976 for oxycodone abuse-deterrent extended release?

At a high level, the likely overlap categories in the US are:

1) PEO/PEG-based ER matrices for opioids

Patents covering hydrophilic gel-forming polymers for ER and tamper resistance can overlap in the polymer platform. The key differentiators are:

• polymer MW ranges
• whether melting/solidification steps are claimed
• whether a PEG overlay is required versus a single-phase matrix

2) Magnesium stearate as a matrix/tamper or extrusion aid

Magnesium stearate appears in many solid oral dosage formulations. Patents that make it a required excipient can overlap if they tie it to ER + abuse-deterrent performance, not only as a glidant.

3) PEG/PEO coatings and barriers

Overlay patents may claim:

• polymer coating layers
• barrier layers that hinder grinding or dissolution
• surface-treated cores for extended-release behavior

4) Manufacturing process patents

Process claims are frequent in formulation abuse-deterrence IP. Where US 9,060,976 ties to melting the PEO during preparation, other families may tie to:

• mixing temperature profiles
• extrusion/spheronization
• solvent casting
• coating process parameters

---

What is the US litigation and licensing posture typically associated with oxycodone ER abuse-deterrent patents like 9,060,976?

Abuse-deterrent opioid formulations in the US commonly attract:

• Hatch-Waxman Paragraph IV certifications against Orange Book-listed patents
• motion practice on claim construction and infringement of both the composition and the manufacturing process
• settlement licensing that frequently pairs with agreed generic launch dates and non-infringement carve-outs

For US Patent 9,060,976 specifically, litigation posture depends on:

• whether it is listed in the FDA Orange Book for the drug product
• whether it is asserted in active NDA/ANDA litigation
• whether settlements reference it by number or by family

Because you did not provide Orange Book listing data, the only defensible conclusions from the claim are structural: the patent is positioned to be enforced against competitors using the same polymer/overlay architecture and melt-processing route.

---

What is the Orange Book status of US 9,060,976 and which product does it cover?

Your prompt does not include the FDA application number (NDA/BLA) or the drug product name linked to US Patent 9,060,976, so the Orange Book listing cannot be determined from the claim text provided.

---

How does the claim’s phrasing (“abuse deterrent dosage form”) affect infringement and construction?

The claim calls the dosage form “extended release abuse deterrent.” This can be treated as:

• an inherent property of the claimed construction that manifests in abuse-deterrence testing, or
• an express functional limitation tied to particular tamper outcomes.

In infringement practice, courts often resolve:

• whether abuse deterrence is required as an actual performance limitation
• whether the technology inherently produces it given the core/overlay structure

For freedom-to-operate, the operational assumption should be that an accused product using the same polymer/overlay/melt process will be tested or argued as producing abuse-deterrent behavior.

---

Claim chart style breakdown: mapping claim 1 to elements for infringement screening

Claim 1 element	Requirement	High-risk infringement indicators	Common design-around targets
Extended-release abuse-deterrent dosage form	Dosage form must be ER and abuse-deterrent	ER dissolution profile + tamper-resistant behavior	Use non-ER system or non-abuse-deterrent platform
Core matrix blend	PEO (MW 300k–5M) + magnesium stearate + oxycodone/salt	Same polymer grade window + MgSt present	Change PEO MW, remove MgSt, swap polymer system
PEO melting during preparation	Heating melts at least a portion of PEO during manufacturing	Manufacturing temperatures/steps that melt PEO	Process that avoids melting PEO; different processing route
PEG applied onto core	PEG layer deposited on core matrix	PEG coating/overlay on core	Use different overlay material; avoid PEG overlay
Extended release	Functionally provides ER	Sustained oxycodone release	Release profile changes to non-ER or different kinetics

---

US patent landscape implications for generic or next-gen ER oxycodone entrants

Generic entry risk drivers

A generic or authorized generic must match:

• the same active, strength, and release profile
• and any required bioequivalence standards
• while also avoiding infringement of the listed patents

For this patent, the “risk concentration” is not bioequivalence. It is:

• whether the ANDA product uses PEO 300k–5M in a melt-processed core with MgSt, and
• whether the product applies PEG onto the core.

What typically prevents “easy workarounds”

If the platform is already optimized around PEO melting and PEG overlay, competitors often cannot change one variable without affecting ER behavior and manufacturability. That increases the leverage of the patent in settlement contexts.

---

Key Takeaways

• US 9,060,976 claim 1 requires a tightly defined core/overlay polymer architecture: high-MW PEO (300k–5M) + magnesium stearate + oxycodone, with PEO melted during preparation, plus PEG applied onto the core, producing extended release.
• The PEO MW window and the melting step are the most direct literal scope controls and the most practical design-around levers.
• The PEG overlay requirement is a second major control: switching overlay chemistry or eliminating PEG deposition can reduce infringement risk.
• For freedom-to-operate screening, infringement analysis should focus on polymer grade selection (MW), manufacturing temperature/processing evidence (melting), and whether a PEG overlay exists in the final dosage form.

---

FAQs

1) Does US 9,060,976 require a specific dosage form geometry like a tablet or pellet?

Claim 1 does not specify geometry in the text provided. It requires an extended-release abuse-deterrent dosage form with the recited core/overlay composition and processing limitations.

2) If a competitor uses PEO within 300k–5M but never melts it during manufacturing, does it avoid claim 1?

The claim includes an express process condition: the core is heated to melt at least a portion of the PEO during preparation. Avoiding that process condition is a plausible literal design-around vector.

3) Is magnesium stearate mandatory for infringement of claim 1?

Yes. Claim 1’s core matrix is a blended mixture that includes magnesium stearate.

4) Can a formulation infringe if it is extended-release but not abuse-deterrent?

Claim 1 characterizes the dosage form as an “abuse deterrent dosage form.” If abuse deterrence is construed as a performance requirement, a non-abuse-deterrent system could avoid infringement.

5) Are dependent claims likely to narrow the polymer MW or overlay layer details?

Families of this type often include dependent claims that refine ranges, methods, and quantities. Claim 1 already sets a key PEO MW window and a PEG overlay requirement, so dependent claims often add further constraints.

---

References (APA)

1. US Patent 9,060,976, “Extended release abuse deterrent dosage form comprising PEO and PEG,” claim 1 text as provided by user.

Drugs Protected by US Patent 9,060,976

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 9,060,976

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2002319774
Brazil	0212019
Brazil	0212020
Canada	2455420
Canada	2456322