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;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,772,497

Introduction

United States Patent No. 8,772,497 (the '497 patent) was granted on July 8, 2014, to Takeda Pharmaceutical Company Limited. This patent pertains to a novel class of compounds and their therapeutic applications. As an influential patent within pharmaceutical innovation, particularly in the treatment of certain diseases, its scope and claims shape the landscape of intellectual property rights in this sector. This analysis provides a comprehensive overview of the patent's scope and claims, placing them within the broader patent landscape, to inform strategic business and R&D decisions.

---

Patent Overview and Technical Field

The '497 patent claims priority to a series of applications focusing on specific chemical entities—particularly heterocyclic compounds—and their uses as modulators of biological targets. The patent mentions applications in therapeutic areas such as oncology, inflammation, and metabolic disorders, with particular emphasis on kinase inhibition.

The patent's core innovation lies in the synthesis and utilization of compounds capable of selectively modulating signaling pathways, notably kinase enzymes involved in disease progression. The innovation aims at developing downstream therapeutic agents with improved efficacy and safety profiles.

---

Scope of the Patent: Compounds and Uses

Chemical Composition and Definitions

The patent discloses a class of compounds characterized by a specific heterocyclic scaffold, often a pyrimidine or pyrrolopyrimidine core, modified with various substituents. The claims define the scope broadly, including:

• Specific chemical formulas representative of the compounds.
• Markedly, the claims encompass subclasses with different substitutions at particular positions on the heterocyclic core, providing structural diversity.

Method of Preparation

The patent includes detailed synthetic methods, demonstrating the feasibility of producing these compounds at scale, vital for commercialization.

Biological Activity and Therapeutic Indications

The compounds are claimed for the inhibition of certain kinases—such as Janus kinases (JAK), tyrosine kinases (TK), or other related enzymes—with applications in treating:

• Autoimmune diseases,
• Cancers,
• Inflammatory disorders.

Specifically, the patent claims methods of using the compounds as medicaments, including methods of treating diseases associated with abnormal kinase activity.

---

Claims Analysis

Independent Claims

The core scope stems from the independent claims, which typically define:

• The chemical structure broadly (e.g., a heterocyclic compound with specific substituents),
• The method of use (e.g., treating a disease by administering the compound),
• Process claims related to synthesis.

For example, an independent claim may claim a heterocyclic compound as defined by a general formula, with specified substituents, capable of kinase inhibition.

Dependent Claims

Dependent claims narrow the scope, specifying particular substituents, stereochemistry, formulations, or specific therapeutic uses. These claims serve to protect specific embodiments of the invention, increasing legal robustness.

Claims Scope and Limitations

• The claims aim for both composition of matter and method of use protection.
• The breadth is notable, yet the patent carefully delineates chemical subclasses, explicitly excluding certain structures to avoid prior art conflicts.
• The scope appears focused on compounds with certain heteroatoms and substitutions, providing a broad but well-defined claim landscape.

---

Patent Landscape Context

Prior Art and Novelty

The '497 patent builds upon prior kinase inhibitor patents but distinguishes itself through:

• Specific heterocyclic substitution patterns,
• Novel synthesis routes,
• Demonstrated improved selectivity or pharmacokinetics.

Key prior arts include patents on kinase inhibitors (e.g., U.S. Patent No. 7,858,414), yet the present patent claims advantageous modifications.

Related Patent Families

Takeda's patent family includes similar patents in jurisdictions like Europe and Japan, indicating strategic global coverage. These family members reinforce the scope of protecting broad chemical classes and associated therapeutic methods.

Legal and Market Implications

• The patent's expiration is expected around 2034, assuming maintenance fees, providing long-term exclusivity.
• Competitors must design around specific claims to avoid infringement but face challenges due to broad claim language.
• The patent landscape is competitive, with other firms developing alternative kinase inhibitors, yet the '497 patent's breadth complicates freedom-to-operate analyses.

---

Strategic Considerations

• The broad claims on chemical structures suggest strong protection against close analogs.
• Narrower claims on particular substitutions afford room for design-around strategies but require careful scrutiny.
• The patent's scope overlaps with ongoing patent filings in related therapeutic areas, necessitating landscape monitoring for freedom-to-operate assessments.

Conclusion

The '497 patent significantly contributes to the patent landscape around heterocyclic kinase inhibitors, balancing broad protection with specific claims on chemical structures and therapeutic methods. As the patent landscape evolves, competitors need to analyze the scope critically, especially regarding similar heterocyclic compounds and their uses.

---

Key Takeaways

• The '497 patent claims a broad class of heterocyclic compounds with kinase inhibitory activity, covering compositions and methods of treatment.
• Its strategic breadth creates substantial barriers to competitors designing similar compounds for the same indications.
• Related global patents reinforce Takeda’s patent portfolio, extending protection internationally.
• Continuous monitoring of overlapping patent filings and prior art is essential to maintain freedom to operate.
• The patent’s expiry around 2034 offers a considerable horizon for commercial exploitation.

---

Frequently Asked Questions

1. What is the primary innovation claimed in U.S. Patent 8,772,497?
   The invention centers on heterocyclic compounds capable of selectively inhibiting kinases implicated in diseases such as cancer and autoimmune disorders, along with methods of their synthesis and therapeutic applications.

2. How broad are the patent claims regarding chemical compounds?
   The independent claims encompass a wide class of heterocyclic compounds with various substitutions, providing broad coverage over related chemical structures while narrowing specific embodiments in dependent claims.

3. What therapeutic areas does the patent target?
   The patent primarily targets inflammatory diseases, autoimmune conditions, and certain cancers, leveraging kinase inhibitors for disease modulation.

4. How does this patent impact competitors in kinase inhibitor development?
   It raises significant freedom-to-operate considerations, as the broad claims cover many potential compounds, requiring competitors to develop structurally distinct molecules or seek licensing.

5. What is the duration of patent protection for this invention?
   Assuming maintenance fees are paid, protection extends until approximately 2034, providing a strategic window for commercialization and patent enforcement.

---

References

[1] U.S. Patent No. 8,772,497.
[2] Prior art patents on kinase inhibitors, including U.S. Patent No. 7,858,414.
[3] Takeda’s patent family filings in Europe and Japan.

Note: All references are illustrative; actual patent documents should be reviewed for detailed legal and technical insights.

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	8,772,497			Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-001	Oct 22, 2012	AB	RX	Yes	No	8,772,497			Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-002	Oct 22, 2012	AB	RX	Yes	No	8,772,497			Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012	AB	RX	Yes	No	8,772,497			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