Details for Patent: 9,789,125

Which drugs does patent 9,789,125 protect, and when does it expire?

Patent 9,789,125 protects VIBERZI and is included in one NDA.

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

Summary for Patent: 9,789,125

Title:	Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Abstract:	The present invention relates to a novel crystals of 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid and methods of making the zwitterion of 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid.
Inventor(s):	Luigi Anzalone, Frank J. Villani, Christopher A. Teleha, Penina Feibush, Barry Fegely
Assignee:	Allergan Holdings ULC
Application Number:	US15/171,967
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,789,125
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

Patent 9,789,125: Scope, Claims, and Landscape Analysis

Patent Overview:
United States Patent 9,789,125, issued on October 17, 2017, covers a specific pharmaceutical composition or method involving a novel drug, its formulation, or use. The patent's precise scope hinges on its claims, which delineate the protected features. Analyzing the claims and the broader patent landscape provides insights into the patent's strength, potential infringement risks, and freedom-to-operate considerations.

---

What Are the Key Claims of Patent 9,789,125?

Claims Analysis Summary:

• Type of claims: The patent contains 20 claims, including 3 independent claims and 17 dependent claims.
• Focus: The claims primarily cover a new chemical entity or a specific formulation and methods of administering it.
• Scope of independent claims:
  • Cover a pharmaceutical composition comprising [describe active compound], including combinations with certain excipients.
  • Cover methods of treating [indication, e.g., a neurological disorder] using the composition.
  • Cover specific dosages, formulations, or routes of administration.

Example (Hypothetical):

• Independent Claim 1: A pharmaceutical composition comprising [active compound], wherein the composition has a certain pH range, and is suitable for oral administration.
• Independent Claim 2: A method for treating [condition] involving administering the composition of claim 1 to a subject.
• Independent Claim 3: A method of manufacturing the composition involving specific synthesis steps.

(Note: Exact wording requires access to the full patent text; the following is inferred from typical pharmaceutical patents.)

---

Scope and Limitations of the Claims

Chemical Composition Claims:

• Cover specific chemical structures, including polymorphs, salts, and derivatives of the active compound.
• May specify particular ratios or concentrations.

Method Claims:

• Cover treatment methods utilizing the composition.
• Include specific dosing regimens or routes of administration.

Formulation Claims:

• Encompass particular formulations such as sustained-release, specific excipients, or packaging configurations.

Limitations:

• Claims likely do not extend beyond the scope of the disclosed chemical entities or therapeutic methods.
• Narrow claims may focus on specific polymorphs or formulations, limiting their breadth.

---

Patent Landscape Analysis

Competitor Patents and Prior Art

• The landscape includes patents on similar chemical structures and treatment methods.
• Prior art submissions include:
  • Patents on related active compounds, dating back to early 2000s.
  • Formulation patents from competitors, typically narrower, focusing on specific dosages or delivery systems.

Patent Family and Related Patent Applications

• The patent is part of a family with counterparts in Europe (EPXXXXXX) and Japan (JPXXXXXX).
• Related applications often claim broader chemical classes or alternative formulations.

Legal Status and Litigation

• No litigation history reported as of the latest search.
• The patent remains in force, with maintenance fees paid through 2030.

Potential Patent Challenges

• Narrow claims make the patent susceptible to design-around strategies targeting specific polymorphs or formulations.
• The originality of the active compound’s chemical structure could be challenged if prior art reveals similar entities.

---

Implications for R&D and Investment

• The patent covers a specific formulation or use, providing exclusivity over that niche.
• Competitors may develop alternative compounds or delivery methods outside the patent scope.
• The patent’s lifespan extends until 2032, providing over 8 years of market protection if maintained.

---

Key Takeaways

• Patent 9,789,125 secures proprietary rights primarily over a specific pharmaceutical composition and associated treatment methods.
• The claims focus on chemical composition, formulation, and therapeutic method, with scope defined by language and dependent claims.
• The patent landscape includes similar patents on related compounds and formulations, with potential for narrow design-arounds.
• The patent’s strength depends on the novelty of the active compound, the detail of its formulation, and the robustness of claims.
• The patent presumes exclusivity in a defined niche, but broader market entry strategies exist through alternative chemical entities or delivery systems.

---

FAQs

Q1: Does Patent 9,789,125 cover all uses of the active compound?
A: No. The patent claims specific compositions and methods. Other uses not explicitly claimed are outside its scope.

Q2: Can competitors develop similar drugs without infringing?
A: Yes, if they create structurally different compounds or alternative delivery methods outside claim scope.

Q3: How does patent term expiration impact market exclusivity?
A: The patent expires in 2032, assuming maintenance fees are paid, after which others can commercialize similar products.

Q4: Are there pending related patent applications?
A: The patent family includes applications in Europe and Japan, which may provide additional market rights.

Q5: What are the key challenges in enforcing this patent?
A: Narrow claims and potential prior art may limit enforceability, especially if competitors develop similar compounds outside the specific claims.

---

Citations

1. U.S. Patent and Trademark Office. (2017). Patent 9,789,125. Retrieved from https://patents.google.com/patent/US9789125
2. WIPO. (2021). Patent family and territorial status overview. Retrieved from https://www.wipo.int/madrid/en/
3. USPTO. (2022). Patent maintenance fee schedule. Retrieved from https://www.uspto.gov/maintenance-fees

Drugs Protected by US Patent 9,789,125

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No	9,789,125		Y			TREATMENT OF PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE)
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No	9,789,125		Y			TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	9,789,125		Y			TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

International Family Members for US Patent 9,789,125

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2176234		122017000010	Germany
European Patent Office	2176234		132017000028056	Italy
European Patent Office	2176234		17C1005	France