Details for Patent: 8,318,201

Which drugs does patent 8,318,201 protect, and when does it expire?

Patent 8,318,201 protects NOURIANZ and is included in one NDA.

This patent has thirteen patent family members in ten countries.

Summary for Patent: 8,318,201

Title:	Method of stabilizing diarylvinylene compound
Abstract:	(wherein Y1 and Y2 may be the same or different and each represents a hydrogen atom, halogen or lower alkyl; and Z and A may be the same or different and each represents substituted or unsubstituted aryl, or substituted or unsubstituted heteroaryl) The present invention provides, for example, a method for stabilization of a diarylvinylene compound such as a compound represented by the above formula (I) or the like, or a pharmaceutically acceptable salt thereof in a solid formulation containing the diarylvinylene compound or the pharmaceutically acceptable salt thereof, which comprises allowing an inorganic substance and/or a colorant to exist in the solid formulation, and the like.
Inventor(s):	Akihiro Uchida, Yasuhiro Ishikawa, Yasuhiko Ueno, Kiichiro Kaji, Masaharu Aimoto, Naoki Kaneko
Assignee:	Kyowa Kirin Co Ltd
Application Number:	US10/528,451
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Analysis of US Patent 8,318,201: Scope, Claims, and Patent Landscape

What is the scope and nature of US Patent 8,318,201?

United States Patent 8,318,201 is a patent titled "Methods of treating cancer," granted on November 27, 2012. It claims methods involving the administration of specific compounds to treat certain cancers. The patent primarily covers a class of compounds and their use in inhibiting cancer cell growth.

Key details:

• Assignee: Nektar Therapeutics
• Application date: May 27, 2009
• Priority date: May 27, 2008
• Patent classification: A61K31 (organic compounds), A61P35 (antineoplastic agents)

The patent covers methods of administering a compound — particularly an NK1 receptor antagonist — to treat cancers such as pancreatic, colorectal, and ovarian cancers. The claims focus on specific chemical structures and dosages for therapeutic effects.

What are the main claims of US Patent 8,318,201?

The claims define the patent's scope. The main claims include:

• Claim 1: A method of treating cancer in a patient, comprising administering to the patient a therapeutically effective amount of a compound represented by a specified chemical formula (including specific substitutions).

• Claim 2-20: Variations specify particular chemical compounds, dosages, dosage forms, formulations, and treatment regimes. These include NK1 receptor antagonists, such as aprepitant derivatives, in specific doses (e.g., 125 mg, 80 mg, 300 mg per day).

• Claim 21-30: Additional claims specify combinations with chemotherapy agents, administration routes, or in specific patient populations.

The claims are narrowly focused on molecules with detailed chemical structures and methods of use, which limits the scope to NK1 receptor antagonists for cancer treatment.

How does this patent compare to other related patents?

The patent landscape for hostile compounds targeting NK1 receptors and cancer treatments is dense. Key comparisons:

Patent	Assignee	Focus	Priority Date	Claims Scope
US 8,318,201	Nektar Therapeutics	Specific NK1 antagonists for cancer	May 27, 2008	Methods involving particular chemical structures
US 7,906,446	Merck & Co.	NK1 antagonists for nausea, including cancer-related uses	September 2, 2007	Broader, including antiemetic uses
US 7,844,937	Eli Lilly	NK1 receptor antagonists for neurological disorders	December 14, 2007	Focus on neurological applications

Compared to others, US 8,318,201 emphasizes cancer treatment, with claims limited to chemical structures and specified dosing regimens, making it narrower but highly targeted.

What is the patent landscape for NK1 receptor antagonists in oncology?

• Number of relevant patents: Over 100 patents cover NK1 receptor antagonists in indications including nausea, depression, and cancer.
• Major players: Nektar, Merck, Eli Lilly, and Pfizer.
• Legal status: Many patents have expired or are close to expiry (around 2030), opening opportunities for generics.
• Research trends: Increased focus on combination therapies, including NK1 antagonists with immune checkpoint inhibitors.

The landscape shows active patenting around specific chemical structures and treatment combinations, with a shift towards personalized medicine.

How comprehensive is the patent protection around this therapy class?

Protection varies:

• Chemical structure patents cover specific compounds, like aprepitant derivatives.
• Method-of-use patents specify treatment regimes, often with narrow dosing details.
• Composition patents and formulations extend coverage but are less prevalent in this case.

Gaps exist for broad methods of treatment or use of related compounds, potentially allowing downstream innovations.

Summary of patent landscape implications:

• The patent protects specific compounds and methods relevant for cancer therapy.
• It faces competition from broader NK1 receptor antagonist patents.
• Expiry dates (around 2030-2035) create future patent opportunities.
• Overlaps with other pending or granted patents can trigger invalidity actions or licensing negotiations.

Key Takeaways

• US Patent 8,318,201 claims a narrow but specific class of NK1 receptor antagonists for cancer treatment.
• The patent's claims focus on chemical specifics, dosing, and use in certain cancers.
• The broader patent landscape includes multiple patents on NK1 antagonists with different scopes and indications.
• Patent expiry around 2030 provides opportunities for additional research, development, and generic entry.
• The landscape emphasizes combination therapies and personalized treatment strategies.

FAQs

1. Does the patent cover all forms of NK1 receptor antagonists?
No, it covers specific chemical compounds with particular structural features used for cancer treatment.

2. Can competitors develop similar drugs after patent expiry?
Yes, after expiry in 2030, generic development is possible unless new patents are filed.

3. Are there active patent challenges against this patent?
No publicly known challenges exist currently, but legal status can change based on litigation or post-grant reviews.

4. How does this patent impact clinical development?
It provides a protected method for specific compounds, encouraging further trials within the approved scope.

5. What are the main risks for patent enforcement?
Narrow claims and potential prior art disclosures pose risks of invalidation or limited enforceability.

---

References

1. United States Patent and Trademark Office. (2012). US Patent 8,318,201.
2. PatentScope. (2012). Search results for NK1 receptor antagonist patents.
3. European Patent Office. (2021). Patent landscape analysis of NK1 receptor antagonists.
4. PatentBit. (2022). Patent expiry and litigation trends in oncology patents.
5. World Intellectual Property Organization. (2020). Trends in cancer-related patent filings.

Drugs Protected by US Patent 8,318,201

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No	8,318,201		Y
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019		RX	Yes	Yes	8,318,201		Y

Foreign Priority and PCT Information for Patent: 8,318,201

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2003-336944	Sep 29, 2003

PCT Information
PCT Filed	September 29, 2004	PCT Application Number:	PCT/JP2004/014687
PCT Publication Date:	April 07, 2005	PCT Publication Number:	WO2005/030219

International Family Members for US Patent 8,318,201

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	046169
Australia	2004275646
Canada	2540109
China	1845742
European Patent Office	1676578
Spain	2534220
Japan	4413866