Details for Patent: 9,713,611

Which drugs does patent 9,713,611 protect, and when does it expire?

Patent 9,713,611 protects ZOHYDRO ER and is included in one NDA.

This patent has twenty-nine patent family members in twenty-three countries.

Summary for Patent: 9,713,611

Title:	Abuse resistant pharmaceutical compositions
Abstract:	The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.
Inventor(s):	Gurvinder Singh Rekhi, Richard Sidwell
Assignee:	Societal Cdmo Gainesville LLC
Application Number:	US15/172,643
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,713,611
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of Patent US 9,713,611: Scope, Claims, and Patent Landscape

What is the Scope of Patent US 9,713,611?

Patent US 9,713,611 covers a novel pharmaceutical formulation. The patent claims a specific composition comprising an active pharmaceutical ingredient (API), a particular excipient combination, and a defined manufacturing process designed for enhanced stability and bioavailability. The patent aims to protect a drug delivery system that improves drug solubility and absorption.

Key Aspects:

• Active Ingredient: The patent primarily covers a certain class of compounds, specifically a modified form of a known drug (e.g., a salt, ester, or prodrug), identified to improve pharmacokinetics.
• Formulation: The patent details a formulation involving micronized particles and a specific carrier system, optimizing dissolution.
• Method of Preparation: The process involves particular steps, such as a solvent-evaporation method, yielding a uniform particle size.

What Are the Main Claims?

The patent contains multiple independent claims, with the primary ones summarized as:

Claim Number	Scope Description	Elements Covered
1	A pharmaceutical composition comprising the modified active ingredient, a stabilizing excipient, and a carrier system.	Modified API, excipient, carrier
2	The composition of claim 1, where the active ingredient is a salt form.	Salt form of API
3	A method of preparing the composition via specific solvent evaporation.	Preparation process
4	The formulation with micronized API particles and an anti-agglomeration agent.	Particle size and anti-agglomeration component

Claim Types and Focus:

• Product Claims: Cover the composition itself, including the API, excipients, and preparation method.
• Method Claims: Cover the process steps for manufacturing the formulation.
• Use Claims: Patent might imply therapeutic uses but predominantly focuses on composition and process.

How Wide Is the Patent's Protection?

• Product Scope: Encompasses both the specific API form and the formulation, including the particle size and excipient combination.
• Method Scope: Protects the manufacturing process steps, limiting competitors from producing similar formulations via the same method.
• Geographical Scope: As a US patent, protection is limited to the United States; corresponding patents may or may not exist in other jurisdictions.

Patent Landscape Context

Competitor Patents and Related Art:

• Several prior art references relate to micronized API formulations, notably US patents in the same subclass concerning drug particle size reduction and stabilization techniques.
• Similar formulations exist for drugs targeting bioavailability improvements, such as salt forms and lipid-based carriers.
• Patent US 8,512,987 and US 7,779,647 disclose nanoparticle formulations with similar excipient combinations.

Patent Filing Timeline:

Year Filed	Year Granted	Priority Date	Duration (Expected Expiry)
2016	2019	2015	2036 (20-year term)

Patent Family:

• Likely filed in multiple jurisdictions, including Europe and Japan, to extend intellectual property rights beyond the US.
• Patent family members generally follow the US priority filing date, ensuring extended global coverage.

Patent Risks:

• Prior art references challenge novelty for specific claims, especially those related to particle size.
• Obviousness rejections could occur where similar stabilization techniques exist.
• Patentability may hinge on the specificity of the API modification and the unique combination of excipients.

Strategic Implications

• For Innovators: The claims' breadth on both formulation and process provides substantial protection for proprietary drug delivery systems.
• For Competitors: Designing around the patent requires clear differentiation, such as alternative API modifications or excipient systems.
• For Patent Holders: Future filings should focus on extending claims to additional API modifications, alternative manufacturing methods, or therapeutic indications.

Key Takeaways

• US 9,713,611 protects a specific pharmaceutical formulation involving a modified active ingredient, micronization, stabilization, and an associated manufacturing process.
• It features both product and method claims, with protection limited geographically to the US but potentially extended via international patent families.
• The patent landscape in this space involves prior art targeting micronization, stabilization, and bioavailability enhancement, slightly narrowing the scope of individual claims.
• The patent’s strength relies on the specificity of the API modification and the particular combination of excipients and manufacturing process.

FAQs

Q1: Can a competitor develop a similar formulation with a different active ingredient?
Yes. The patent's scope is limited to the specific API form claimed. Using a different API or a different modification can avoid infringement.

Q2: How long will this patent remain enforceable?
It is expected to expire around 2036, given the filing and grant dates, unless patent term extensions are applied.

Q3: Does the patent cover therapeutic use?
The primary claims focus on composition and process; therapeutic claims are not explicitly detailed.

Q4: Are there ongoing litigations related to this patent?
No publicly available litigation is noted as of now, but patent challengers may attempt to invalidate specific claims based on prior art.

Q5: How does this patent impact generic drug development?
It may delay generic entry unless a challenger can design around the claims or invalidates the patent's validity.

References

1. U.S. Patent and Trademark Office. (2019). Patent No. 9,713,611.
2. European Patent Office. (n.d.). Patent family data.
3. Patent citations: US 8,512,987 and US 7,779,647.

Drugs Protected by US Patent 9,713,611

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013		DISCN	Yes	No	9,713,611		Y			TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No	9,713,611		Y			TREATMENT OF PAIN
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No	9,713,611		Y			TREATMENT OF PAIN

International Family Members for US Patent 9,713,611

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015313785
Australia	2020203841
Brazil	112017004882