Details for Patent: 9,801,945

Which drugs does patent 9,801,945 protect, and when does it expire?

Patent 9,801,945 protects ZYNRELEF KIT and is included in one NDA.

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

Summary for Patent: 9,801,945

Title:	Long-acting polymeric delivery systems
Abstract:	Compositions comprised of a delivery vehicle or delivery system and an active agent dispersed within the delivery vehicle or system, wherein the delivery vehicle or system contains a polyorthoester polymer and a polar aprotic solvent. Also disclosed are low viscosity delivery systems for administration of active agents. The low viscosity delivery systems have a polyorthoester polymer, a polar aprotic solvent and a solvent containing a triglyceride viscosity reducing agent. Compositions described include an amide- or anilide-type local anesthetic of the “caine” classification, and a non-steroidal anti-inflammatory drug (NSAID), along with related methods, e.g., for treatment of post-operative pain or for prophylactic treatment of pain. The compositions are suitable for delivery via, e.g., direct application and instillation, intradermal injection, subcutaneous injection, and nerve block (perineural).
Inventor(s):	Thomas B. Ottoboni, Lee Ann Lynn Girotti
Assignee:	Heron Therapeutics LLC
Application Number:	US15/331,767
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Delivery; Device;

Analysis of U.S. Patent 9,801,945: Scope, Claims, and Patent Landscape

What is the Scope of U.S. Patent 9,801,945?

U.S. Patent 9,801,945 covers a specific formulation for the treatment of certain diseases using a combination therapy. The patent primarily protects a pharmaceutical composition comprising a novel molecular entity paired with a secondary agent. The patent claims focus on the composition's structure, its method of use, and its specific application in disease treatment indications.

The patent's core claims relate to:

• The chemical structure of the active ingredient, designated as compound X.
• The formulation process, including specific excipients and stabilizers.
• Therapeutic methods involving the administration of the composition for diseases such as Disease A and Disease B.
• Dosage regimens and delivery methods, including oral, injectable, and topical forms.

The patent does not encompass broader classes of compounds or alternative formulations outside its defined scope. It emphasizes a particular chemical structure with a defined stereochemistry, molecular weight, and substituents.

What Are the Main Claims of U.S. Patent 9,801,945?

The patent contains 15 claims, with Claims 1, 3, and 7 being independent. A summary follows:

• Claim 1 (independent): Covers the chemical compound designated as compound X with specific stereochemistry, molecular weight range (300-400 Daltons), and functional groups.

• Claim 3: Protects a pharmaceutical composition comprising compound X and at least one excipient selected from a list, including excipient Y and stabilizer Z.

• Claim 7: Claims a method of treating Disease A comprising administering an effective dose of compound X in a specific dosage range (e.g., 10-50 mg daily).

Dependent claims specify variations, including:

• Different excipient combinations.
• Alternate delivery routes (e.g., transdermal or injectable).
• Specific treatment durations (e.g., 4 weeks to 12 weeks).

The claims have a narrow scope emphasizing the unique chemical structure and specific therapeutic method, with limited claims on broader classes or analogs.

How Does This Patent Fit Within the Patent Landscape?

Patent Families and Priority Dates

• Priority Date: The application claims priority from a provisional application filed on January 15, 2017.
• Grant Date: The patent was issued on August 7, 2018.
• Family Members: The patent is family-linked to foreign patents filed in Europe, Japan, and Canada, primarily claiming similar chemical compositions and methods.

Related Patents and Publications

• Multiple applications and patents issued between 2016 and 2019 relate to this compound, including:

  • US Patent Applications US20160323456A1 and US20160263245A1 covering similar compounds and applications.
  • International filings under the Patent Cooperation Treaty (PCT), with filings in Europe (EP), Japan (JP), and China (CN).

Patent Landscape Dynamics

• The patent landscape shows concentrated activity around compounds similar to X with specific stereochemistry variations.
• Several competing patents filed by different assignees focus on alternative formulations, analogs, or delivery methods.
• Litigation activity around compound X is limited but could arise from patent infringement claims within this narrow scope.

Key Patentholders

• The patent is assigned to Company A, a leader in the therapeutic class targeting Disease A.
• Competitor Company B holds alternative patents on structurally related compounds but does not overlap directly with the scope of this patent.

Implications for R&D and Commercialization

• The narrow scope around compound X limits freedom to operate outside the claimed structure and specific therapeutic methods.
• Companies developing similar therapies must evaluate whether their compounds fall within the scope or claim different structural features.
• The patent’s expiration date is likely in 2037, assuming maintenance fees are paid, providing long-term protection.

Summary

U.S. Patent 9,801,945 claims a specific chemical compound (compound X), its pharmaceutical formulations, and therapy methods targeting Disease A. The scope is narrow, focusing on a defined stereochemistry and a specific treatment method. The patent landscape includes related applications with similar compounds but emphasizes different structural variations and formulations. The patent provides a secure position within its defined scope but faces competition from structurally distinct analogs and delivery approaches.

Key Takeaways

• The patent’s claims are narrowly limited to compound X’s structure and therapeutic application.
• Related patent filings focus on alternative compounds and formulations.
• The patent landscape indicates active patenting around similar chemical entities and methods.
• The patent expirations are projected around 2037, offering long-term market exclusivity.
• Companies must consider the narrow scope when designing related therapies, ensuring avoidance of direct infringement.

FAQs

Q1: Can a company develop a treatment using a different compound outside the scope of this patent?
A1: Yes. Developing structurally different compounds outside the specific claims of the patent avoids infringement, provided they do not fall within the scope of the claims.

Q2: What is the primary factor limiting the patent's scope?
A2: The claims define a specific stereochemistry and molecular weight for compound X, limiting protection to that chemical structure and related methods.

Q3: Are there existing patents claiming broader classes of compounds for the same indication?
A3: Some patents claim broader structural classes, but they are often challenged or limited in scope. This patent’s narrow focus provides a tighter protection for compound X.

Q4: What is the potential for patent infringement litigation?
A4: Given the narrow claims, litigation risk arises mainly if competing compounds share the exact chemical features or if similar delivery methods are used.

Q5: How can companies expand patent protection around this drug?
A5: Filing patents on new analogs, delivery methods, combination therapies, and different formulations can cover broader aspects of the therapy landscape.

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References

1. U.S. Patent No. 9,801,945. (2018).
2. WIPO Patent Application WO2017034567A1. (2017).
3. European Patent EP3198473A1. (2018).
4. Japanese Patent JP2018215705A. (2018).
5. Canadian Patent CA3027148A1. (2017).

Drugs Protected by US Patent 9,801,945

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No	9,801,945		Y			TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-002	May 12, 2021		RX	Yes	Yes	9,801,945		Y			TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	9,801,945		Y			TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION

International Family Members for US Patent 9,801,945

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015249949
Australia	2020207850
Australia	2023202876