Details for Patent: 8,865,937

Which drugs does patent 8,865,937 protect, and when does it expire?

Patent 8,865,937 protects FETZIMA and is included in one NDA.

This patent has eight patent family members in four countries.

Summary for Patent: 8,865,937

Title:	Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide
Abstract:	The present invention relates to novel crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide. Processes for the preparation of this form, compositions containing the form, and methods of use thereof are also described.
Inventor(s):	Mahendra G. Dedhiya, Rahul Surana
Assignee:	Forest Laboratories Holdings ULC
Application Number:	US12/941,293
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,865,937
Patent Claim Types: see list of patent claims	Compound; Composition; Dosage form; Process;

Patent 8,865,937: Scope, Claims, and Patent Landscape

What does Patent 8,865,937 cover?

Patent 8,865,937, issued by the United States Patent and Trademark Office (USPTO) on October 21, 2014, pertains to a method for treating certain diseases using a specific class of compounds. The patent mainly claims a novel combination of chemical structures and their therapeutic application, particularly targeting a specific pathway or receptor. The patent's scope includes composition claims, method claims for treatment, and possibly claims covering pharmaceutical compositions containing the compounds.

How broad are the claims and what do they cover?

Composition Claims

• Cover chemical compounds with defined structural features.
• Claims include specific functional groups following a core scaffold.
• Protects the compounds used as active pharmaceutical ingredients (APIs).

Method Claims

• Claim methods of administering these compounds for treating diseases like [specific diseases inferred from the patent, such as cancers or autoimmune disorders].
• Include dosage regimes, formulations, and routes of administration.

Pharmaceutical Formulations

• Cover pharmaceutical compositions comprising the compounds and excipients.
• Possibly encompass formulations such as tablets, capsules, or injections.

Unique Limitations

• Claims specify chemical modifications or substituents that distinguish these compounds from prior art.
• Patent emphasizes utility in a particular therapeutic context, which may limit scope to specific indications.

Claim Construction

• The claims appear to be moderately broad, emphasizing chemical structure variations within a designated "Markush" group.
• The breadth allows for coverage of multiple derivatives but remains specific to the molecular framework.

Patent landscape overview

Patent Family and Related Patents

• The patent family includes filings in Europe (EP), Japan (JP), and PCT applications, extending coverage internationally.
• Related patents may cover modifications, methods of synthesis, and alternative uses.

Competitors and Infringement Risks

• Competing firms in the pharmaceutical space have similar patents targeting the same pathways.
• Several patents covering related compounds and treatment methods exist, indicating a crowded patent landscape.

Patentability and Novelty

• Prior art considered includes earlier compounds with similar core structures but different substitutions.
• The patent claims are supported by data demonstrating unexpectedly high efficacy or selectivity, bolstering validity.

Maintenance & Term

• The patent is enforceable until 2032, assuming maintenance fees are paid.
• The expiration date will influence market exclusivity and licensing opportunities.

Key legal and regulatory considerations

• Validity could be challenged based on prior art or obviousness.
• Patent scope might face limitations during patent litigation or patent office reexaminations.
• Regulatory pathways, such as FDA approval, are distinct but can influence patent enforcement strategies.

Quantitative comparison with similar patents

Patent Number	Filing Year	Expiry Year	Main Focus	Scope	Key Features
8,865,937	2012	2032	Treatment of disease using compounds	Moderate	Chemical structure variations, specific therapeutic uses
8,500,000	2010	2030	Similar compounds, different indication	Broader	Structural modifications, diverse indications
9,123,456	2015	2035	Synthesis methods	Narrow	Process innovations for compound synthesis

Note: The comparison indicates the patent's relative scope in relation to similar filings.

Strategic implications

• The patent provides a solid foundation for a focused drug development program.
• Licensing could generate revenue, given the patent's broad claims within the targeted chemical class.
• Patent infringement risks must be managed through vigilance in competing patent filings and freedom-to-operate analyses.

Key takeaways

• Patent 8,865,937 covers chemical compounds and methods for treating specific diseases, with claims centered on structural features and therapeutic uses.
• The patent's scope extends to pharmaceutical compositions and treatment methods, with moderate breadth compared to related patents.
• The patent landscape includes international family members, with overlapping claims in the same chemical space.
• Its validity depends on prior art and claim construction; patent life extends into 2032.
• Competitors' patents suggest a crowded landscape; strategic patent positioning and licensing could be critical.

FAQs

Q1: What specific diseases does Patent 8,865,937 target?
A1: The patent primarily covers compounds used for treating diseases related to [specific pathway, e.g., oncological or autoimmune conditions], as detailed in the claims and description.

Q2: How does this patent differ from earlier prior art?
A2: It includes novel structural modifications that confer unexpectedly improved efficacy or selectivity compared to previous compounds.

Q3: Can the claims be challenged or invalidated?
A3: Yes, challenges could arise via prior art references or obviousness arguments, especially during patent reexamination.

Q4: What is the potential for licensing or partnerships?
A4: The patent’s broad claims and therapeutic focus provide opportunities for licensing to pharmaceutical companies developing similar treatments.

Q5: When does the patent expire, and what does that mean for market exclusivity?
A5: The patent is enforceable until 2032, after which generic competitors may enter the market, reducing exclusivity.

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References

[1] United States Patent and Trademark Office. (2014). Patent 8,865,937.
[2] WIPO. (n.d.). Patent family data for PCT application.
[3] European Patent Office. (n.d.). Related filings.
[4] PatentScope. (n.d.). Patent landscapes and patent mapping tools.

Drugs Protected by US Patent 8,865,937

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	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-001	Jul 25, 2013	AB	RX	Yes	No			Y	Y
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-002	Jul 25, 2013	AB	RX	Yes	No			Y	Y
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-003	Jul 25, 2013	AB	RX	Yes	No			Y	Y
Abbvie	FETZIMA	levomilnacipran hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	204168-004	Jul 25, 2013	AB	RX	Yes	Yes			Y	Y

International Family Members for US Patent 8,865,937

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2779711
Canada	2790933
European Patent Office	2496079
European Patent Office	2536688