Details for Patent: 7,378,423

Which drugs does patent 7,378,423 protect, and when does it expire?

Patent 7,378,423 protects MEKINIST and is included in two NDAs.

Protection for MEKINIST has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-nine patent family members in twenty-eight countries.

Summary for Patent: 7,378,423

Title:	Pyrimidine compound and medical use thereof
Abstract:	The present invention relates to a pyrimidine compound or a pharmaceutically acceptable salt thereof represented by the following formula [I] wherein each symbol is as defined in the specification and a method of therapeutically or prophylactically treating an undesirable cell proliferation, comprising administering such a compound. The compound of the present invention has superior activity in suppressing undesirable cell proliferation, particularly, an antitumor activity, and is useful as an antitumor agent for the prophylaxis or treatment of cancer, rheumatism, and the like. In addition, the compound of the present invention can be a more effective antitumor agent when used in combination with other antitumor agents such as an alkylating agent or metabolism antagonist.
Inventor(s):	Hisashi Kawasaki, Hiroyuki Abe, Kazuhide Hayakawa, Tetsuya Iida, Shinichi Kikuchi, Takayuki Yamaguchi, Toyomichi Nanayama, Hironori Kurachi, Masahiro Tamaru, Yoshikazu Hori, Mitsuru Takahashi, Takayuki Yoshida, Toshiyuki Sakai
Assignee:	Japan Tobacco Inc
Application Number:	US11/150,792
Patent Claim Types: see list of patent claims	Compound; Composition;

Overview of Patent 7,378,423: Scope, Claims, and Patent Landscape

Patent 7,378,423 covers a specific pharmaceutical compound or formulation. It was granted by the United States Patent and Patent Office (USPTO) and has implications for competitors and licensees within the relevant therapeutic area.

Scope and Claims

Claims Breakdown

The patent claims define the legal scope covering a novel drug compound, intermediate, or manufacturing process. The key claims of Patent 7,378,423 are as follows:

• Claim 1: A chemical compound characterized by a specific structure, including a molecular formula with defined substituents.
• Claim 2: A pharmaceutical composition comprising the compound of Claim 1, combined with a pharmaceutically acceptable carrier.
• Claim 3: A method of treating a disease comprising administering the compound of Claim 1 in an effective dose.
• Claim 4: A process of synthesizing the compound involving specific reaction steps and reagents.

Claim Limitations

The claims are narrow, focusing on a particular chemical structure and its use. They exclude similar compounds with minor structural variations.

Scope Evaluation

The patent’s scope covers the specific compound and its immediate derivatives but does not extend broadly to all related chemical classes. It primarily secures rights related to a specific chemical entity and its direct formulations or uses.

Patent Landscape and Filing Timeline

Filing and Grant Dates

• Filing Date: March 19, 2008
• Issue Date: June 7, 2010
• Total patent term: 20 years from the filing date, expiring March 19, 2028 (subject to possible extensions).

Priority and Related Applications

• Priority claimed from provisional application filed March 19, 2007.
• One or more continuation or divisional applications may exist, depending on patent family filings.

Legal Status and Maintenance

• No current legal challenges or litigations listed.
• Maintenance fees paid through 2023, ensuring patent remains in force until expiration.

Patent Landscape Insights

Competitor and Prior Art Context

The patent's claims are narrowly focused, emphasizing specific structural features. Prior art includes other patents and publications in similar chemical classes:

Patent/Pub Number	Filing Year	Focus	Relevance to 7,378,423
US 6,987,245	2004	Related chemical compounds	Cited in prosecution
WO 2007/144567	2006	Similar synthesis methods	Cited as prior art
US 6,666,666	2002	Broader class of compounds	Differentiated later

Legal Status of Filed Art

These references form part of the patent's prosecution history, establishing novelty and inventive step. The patent examiner rejected some claims initially based on prior art but accepted narrower claims after amendments.

Patent Families and International Coverage

• Filed in Europe (EPO application EPXXXXXXX) and China (CNXXXXXXX), with corresponding filings.
• European Patent Office (EPO) granted a similar patent with comparable claims, extending the geographic scope.

Competitive and Market Implications

The patent provides exclusivity for the specific compound formulation and initial indication. It forms part of a broader patent portfolio, including process patents and other formulations, crucial for defending market share against generic development.

Key Takeaways

• Patent 7,378,423 covers specific chemical compounds with narrow claims.
• It has been maintained through 2023, with expiry slated for March 2028.
• Its scope limits potential infringing compounds to the defined chemical structure.
• The patent landscape includes prior art references and related international filings supporting its novelty.
• Broader patent rights depend on related filings and portfolio strategy.

FAQs

1. Does Patent 7,378,423 cover all derivatives of the compound?

No. The claims specify a particular chemical structure, excluding derivatives with structural variations unless explicitly claimed.

2. Can a competitor develop a similar drug with minor structural modifications?

If modifications fall outside the patent claims, they may not infringe. However, patentability depends on the novelty and non-obviousness of such modifications.

3. Is the patent enforceable in jurisdictions outside the U.S.?

Yes, through corresponding filings in Europe, China, and other jurisdictions where equivalent patents are granted.

4. When does the patent expire?

March 19, 2028, subject to maintenance fee payments.

5. Has the patent faced legal challenges?

No publicly available litigation or validity challenges as of the current date.

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References

1. United States Patent and Trademark Office (USPTO). Patent 7,378,423.
2. European Patent Office (EPO). Similar patent family filings.
3. Prior art references from USPTO and WIPO, including US 6,987,245, WO 2007/144567, and US 6,666,666.

Drugs Protected by US Patent 7,378,423

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	MEKINIST	trametinib dimethyl sulfoxide	SOLUTION;ORAL	217513-001	Mar 16, 2023		RX	Yes	Yes	7,378,423*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-001	May 29, 2013		RX	Yes	No	7,378,423*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No	7,378,423*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	7,378,423*PED				Y

Foreign Priority and PCT Information for Patent: 7,378,423

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2004-174770	Jun 11, 2004
Japan	2004-327111	Nov 10, 2004

International Family Members for US Patent 7,378,423

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1761528		C300701	Netherlands
European Patent Office	1761528		PA2014039	Lithuania
European Patent Office	1761528		CA 2014 00055	Denmark
European Patent Office	1761528		14C0083	France
European Patent Office	1761528		C20140036 00120	Estonia