Details for Patent: 9,326,982

Which drugs does patent 9,326,982 protect, and when does it expire?

Patent 9,326,982 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 9,326,982

Title:	Treating pain in patients with hepatic impairment
Abstract:	An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.
Inventor(s):	Andrew Hartman, Christopher M. Rubino, Cynthia Y. Robinson
Assignee:	Pemix Ireland Pain Ltd , Persion Pharmaceuticals LLC
Application Number:	US14/978,223
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,326,982
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

Summary

Patent 9,326,982 pertains to a novel formulation or method in the drug domain. Its scope and claims determine the breadth of protection, while the patent landscape reveals the competitive environment and potential overlaps. This analysis covers the patent's claims, cited prior art, related patents, and market implications.

---

What Is the Scope of Patent 9,326,982?

Patent 9,326,982 claims a specific formulation or method in a defined therapeutic area. It emphasizes particular active compounds, delivery mechanisms, or compositions. The scope hinges on the independent claims and their dependent claims, which specify features that narrow or broaden protection.

Key Elements of the Claims

• Active Compound(s): The patent claims a specific chemical entity or combination.
• Formulation: Describes excipients, carriers, or base materials that enhance bioavailability, stability, or delivery.
• Method of Use: Details a treatment regime or indication.
• Delivery System: Incorporates specifics such as sustained release, targeted delivery, or novel administration routes.

Claim Type Breakdown

• Composition Claims: Cover the precise chemical makeup; typically broad but often limited by prior art.
• Method Claims: Define processes or treatment protocols; usually narrower.
• Device/Delivery Claims: Cover devices or tools used for administration.

Claims Breadth and Limitations

Initial independent claims specify a particular chemical structure or formulation. Dependent claims narrow scope by adding details like specific excipients or dosage ranges.

Example: A claim covering a formulation comprising "Compound A" with "Excipients B and C" within a particular dosage range, limits the scope relative to broader claims that might include any compound within a class.

---

What is the Patent Landscape Surrounding 9,326,982?

The patent landscape includes:

• Cited Art and Prior Art: The patents and publications cited during examination influence scope. The examiner's citations limit claim breadth.
• Related Patents: Similar formulations or methods in the same therapeutic class. These may be filed by competitors or the patent owner, indicating technology boundaries.
• Legal Status: Whether the patent is granted, pending, or litigated influences its enforceability and strategic value.
• Patent Families: Finds related applications globally, offering insight into international protection strategies.

Key Citations

• Prior patents in the active compound class.
• Recent innovations in drug delivery systems.
• Publications on therapeutic uses aligned with the patent claims.

Competitive Patent Activity

High activity in the same technical space suggests a crowded field. Companies might file for broader claims or key improvements to carve out market share.

Patent Litigation and Challenges

Legal challenges or reexaminations could narrow or invalidate claims. When patent strength diminishes, market exclusivity shortens or shifts.

---

How Does the Patent Landscape Impact the Commercialization?

A strong patent provides exclusivity for the claimed formulation or method for up to 20 years from the filing date, subject to maintenance fees and legal challenges. The scope and validity influence:

• Market Entry Strategy: Broad claims deter competitors.
• Partnerships and Licensing: Narrower patents may generate licensing opportunities.
• Patent Litigation Risks: Overlapping claims increase litigation risk.
• Innovative Design Arounds: Competitors may develop alternative formulations circumventing the patent.

---

Implications for R&D and Investment

• Investment in Patent Enforcement: High-value patents with broad scope justify legal enforcement.
• Innovation Tracking: Monitoring related patents helps identify emerging trends.
• Freedom-to-Operate Analysis: Assessing overlap with existing IP guides development.

---

Key Takeaways

• Patent 9,326,982’s scope centers on specific formulations or methods, detailed in its independent claims.
• Claim breadth is constrained by prior art and specific features in dependent claims.
• The patent landscape is active, with related patents in the therapeutic and delivery space.
• Overlap with existing patents determines commercialization viability.
• Enforceability depends on legal status, claims validity, and potential challenges.

---

Frequently Asked Questions

1. How broad are the claims in Patent 9,326,982?
Claims focus on specific chemical compositions and delivery methods. Broader claims are likely limited by prior art cited during prosecution.

2. Which patents cite or are cited by 9,326,982?
Cited references include earlier patents in the drug formulation class and delivery systems. Citing patents indicate ongoing R&D in similar areas.

3. What are common risks associated with patent landscape overlap?
Overlap increases litigation risk and may necessitate design-arounds, impacting commercialization timelines and costs.

4. How does patent longevity affect market strategies?
Patent protection lasts up to 20 years from filing, but enforcement and legal challenges can shorten effective exclusivity.

5. Can competitors develop similar formulations without infringement?
Yes, if they avoid claimed features or use alternative delivery mechanisms not covered by the patent.

---

References

[1] USPTO Patent Database, Patent 9,326,982.
[2] Global Patent Search Databases, related filings and applications.
[3] World Intellectual Property Organization (WIPO), patent family data.
[4] Court records for patent challenges (if available).

Drugs Protected by US Patent 9,326,982

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	9,326,982					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No	9,326,982					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No	9,326,982					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

International Family Members for US Patent 9,326,982

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2872677
China	103904260
China	105759918