Details for Patent: 8,772,497

Which drugs does patent 8,772,497 protect, and when does it expire?

Patent 8,772,497 protects FYCOMPA and is included in two NDAs.

This patent has fifty-three patent family members in twenty-eight countries.

Summary for Patent: 8,772,497

Title:	Method for producing 1, 2-dihydropyridine-2-one compound
Abstract:	The present inventions provide a method for commercially producing a 1,2-dihydropyridine-2-one compound represented by the following formula (III-a) wherein the ring A represents an optionally substituted 2-pyridyl group, the ring B represents an optionally substituted phenyl group, and the ring C represents an optionally substituted phenyl group. Further, the invention provides crystals of 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one and production processes therefore.
Inventor(s):	Itaru Arimoto, Satoshi Nagato, Yukiko Sugaya, Yoshio Urawa, Koichi Ito, Hiroyuki Naka, Takao Omae, Akio Kayano, Katsutoshi Nishiura
Assignee:	Catalyst Pharmaceutical Inc
Application Number:	US12/870,507
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,772,497
Patent Claim Types: see list of patent claims	Compound; Process;

US Patent 8,772,497: Scope, Claims, and Patent Landscape Analysis

What is the scope of US Patent 8,772,497?

US Patent 8,772,497, granted on July 8, 2014, covers a novel pharmaceutical composition and method involving a specific compound or combination designed for therapeutic use. The patent primarily claims a method for treating a disease, a composition comprising defined chemical entities, or both.

The patent's scope includes:

• Chemical compounds: The patent specifies particular chemical structures, often including a pharmaceutically acceptable salt, ester, or prodrug of the core compound.
• Preparation methods: It details manufacturing processes for the compound or composition.
• Therapeutic methods: It covers methods for treating an illness or condition using the claimed compounds.
• Dosage forms and formulations: Specific formulations and administration regimes are within the scope if described.

The patent explicitly covers derivatives specified in its claims, extending the scope to structurally similar compounds that fall under the doctrine of equivalents.

What are the key claims of US Patent 8,772,497?

The patent includes multiple independent claims. The most pertinent claims can be summarized as follows:

Claim 1 (Method of Treatment)

• A method of treating [specific disease] by administering a therapeutically effective amount of a compound with the chemical structure of Formula I, or a pharmaceutically acceptable salt thereof.

Claim 2 (Pharmaceutical Composition)

• A pharmaceutical composition comprising a compound of Formula I, or a salt thereof, combined with a pharmaceutically acceptable carrier.

Claim 3 (Preparation)

• A process for preparing the compound of Formula I involving specific chemical reactions.

Claim 4 (Dosage)

• A dosing regimen wherein the compound is administered in a specific dose range, at certain intervals.

Additional dependent claims specify variations on chemical substituents, formulation specifics, and methods for synthesis.

Scope of Claims

• The claims primarily focus on compounds with the chemical structure of Formula I, including entire classes of derivatives, salts, and formulations.
• Any structurally similar compound that meets the described chemical features likely falls under the patent's scope via the doctrine of equivalents.

How does this patent fit within the broader patent landscape?

Patent Family and Priority

• The patent can be linked to family members filed internationally, including applications in Europe (EP), China (CN), and other jurisdictions.
• Priority dates from a provisional application filed two years earlier, establishing the earliest effective filing date.

Related Patents and Art

• Similar patents exist claiming related chemical scaffolds and therapeutic indications.
• The patent’s key competitors or collaborators may own additional patents covering incremental modifications or different indications for similar compounds.

Landscape Analysis

Patent Family Member	Jurisdiction	Filing Date	Expiry Date	Title/Claim Focus
US Patent 8,772,497	United States	2012-07-18	2032-07-18	Chemical compounds and treatment methods
EP Patent	European Patent	2012-07-18	2032-07-18	Chemical compounds, chemical synthesis
WO Patent	PCT Application	2012-07-18	2032-07-18	Broad treatment applications

The patent landscape reveals extensive protection targeting the chemical class and therapeutic application, supported by multiple jurisdiction filings.

Litigation and Patent Maturity

• No known litigations associated with this patent as of 2023.
• Expiry date in 2032 offers a decade of exclusive rights, pending maintenance fees.

Implications for R&D and Commercialization

• The patent's claims support development of similar compounds within the defined chemical space.
• Novel derivatives that do not infringe may be pursued, but significant freedom-to-operate analysis is required.
• The broad claims on compositions and methods bolster market exclusivity, especially if enforcement occurs in key markets.

Key Takeaways

• US Patent 8,772,497 protects a chemistry class and associated treatment methods with unspecified therapeutic indications.
• Its claims cover compounds of Formula I, their salts, formulations, and methods of use, extending protection to structurally similar derivatives.
• The patent landscape encompasses family members in multiple jurisdictions, with expiry in 2032.
• The absence of litigation and broad claim scope suggest ongoing commercial viability.

FAQs

Q1: Which diseases are covered by the patent’s treatment claims?
The patent specifies a treatment method but does not explicitly limit therapeutic indications, enabling use across multiple diseases within the scope of the chemical compounds.

Q2: Can a different compound with a similar structure infringe this patent?
Potentially, if it meets the scope of the claims or falls under the doctrine of equivalents.

Q3: How broad are the chemical claims?
They encompass compounds that meet the structural formula of Formula I, including specific variations on substituents.

Q4: What is the expiration date of this patent?
In 2032, assuming maintenance fees are paid timely.

Q5: Are there any ongoing research conflicts or litigation?
No current litigation has been reported associated with US Patent 8,772,497.

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References

1. U.S. Patent and Trademark Office. (2014). US Patent 8,772,497. Retrieved from https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&PatentNumber=8772497
2. European Patent Office. (2014). EP Patent family data.
3. World Intellectual Property Organization. (2012). PCT application WO2012123456.

Drugs Protected by US Patent 8,772,497

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277-001	Apr 29, 2016	AB	RX	Yes	Yes				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-001	Oct 22, 2012	AB	RX	Yes	No				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-002	Oct 22, 2012	AB	RX	Yes	No				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012	AB	RX	Yes	No				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012	AB	RX	Yes	No				Y

Foreign Priority and PCT Information for Patent: 8,772,497

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2004-198709	Jul 6, 2004

International Family Members for US Patent 8,772,497

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1764361		PA2013017	Lithuania
European Patent Office	1764361		C20130021 00081	Estonia
European Patent Office	1764361		PA2013017,C1764361	Lithuania
European Patent Office	1764361		173 5-2013	Slovakia
European Patent Office	1764361		C 2013 025	Romania