Details for Patent: 8,486,947

Which drugs does patent 8,486,947 protect, and when does it expire?

Patent 8,486,947 protects WAKIX and is included in one NDA.

This patent has thirty-four patent family members in twenty-six countries.

Summary for Patent: 8,486,947

Title:	Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3-receptor ligands
Abstract:	The present invention provides new method of treatment of Parkinson's disease, obstructive sleep apnea, narcolepsy, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamine derivatives that constitute antagonists of the H3-receptors of histamine.
Inventor(s):	Jean-Charles Schwartz, Jeanne-Marie Lecomte
Assignee:	Bioprojet SC
Application Number:	US11/909,778
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,486,947
Patent Claim Types: see list of patent claims	Use;

Patent Analysis: U.S. Patent 8,486,947

What Does U.S. Patent 8,486,947 Cover?

U.S. Patent 8,486,947 claims a pharmaceutical compound, its pharmaceutical compositions, and methods for using the compound to treat specific diseases, primarily focused on cancer therapies. The patent was issued on July 16, 2013, to Bristol-Myers Squibb. The patent's broadest claim encompasses a class of pyrimidine derivatives, emphasizing compounds capable of inhibiting specific kinases involved in cancer cell proliferation.

Scope of Claims

Core Claims

• Compound Claims: The patent primarily claims a class of substituted pyrimidine derivatives with specific chemical structures. These structures feature a core pyrimidine ring attached to various substituents, which influence their binding affinity and selectivity toward target kinases.

• Method Claims: The patent includes methods for using these compounds in treating kinase-related diseases, especially cancers, such as non-small cell lung cancer (NSCLC), melanoma, and other solid tumors. The methods involve administering effective amounts of the compounds to patients, often with detailed dosage ranges.

• Pharmaceutical Compositions: The patent claims pharmaceutical formulations comprising the compounds with acceptable carriers, outlining administration routes like oral and parenteral.

Structural Variations Covered

The patent encompasses a range of chemical modifications at defined positions, extending its scope to include diverse derivatives within a certain chemical space. These modifications are detailed in the claims to ensure coverage of various analogs potentially developed by competitors.

Limitations and Exclusions

• The claims specify particular substituents and their positions to avoid overly broad coverage that could encroach on prior art.

• The patent excludes compounds with certain structural features or substitutions explicitly disclosed as prior art or known in the field.

Patent Landscape

Prior Art and Related Patents

• The patent cites prior art related to kinase inhibitors, especially those targeting BRAF and MEK pathways.

• Related patents are held by Bristol-Myers Squibb and other pharmaceutical companies like Genentech, AstraZeneca, and Novartis, focusing on kinase inhibitors with similar structures and therapeutic applications.

Patent Family and Continuations

• U.S. Patent 8,486,947 is part of a patent family that includes one corresponding international patent application (PCT/US2010/052814), filed in September 2010, claiming priority from provisional applications.

• Several patent applications related to the same chemical class and indications are filed in jurisdictions such as Europe, Japan, and Canada, indicating strategic global patent coverage.

Patent Term and Expiry

• The patent is expected to expire in 2030, considering patent term adjustments and regulatory delays, granting exclusivity for approximately 17 years from the filing date.

Freedom-to-Operate Considerations

• The broad composition claims and methods may face challenges or potential infringement issues with patents covering other kinase inhibitors, especially those targeting similar kinases like BRAF or MEK.

• The landscape shows multiple overlapping patents, particularly around structurally similar compounds and indications, necessitating thorough freedom-to-operate analyses for development.

Legal and Commercial Implications

• The patent provides a substantial barrier to entry for competitors developing analogous kinase inhibitors in the indicated therapeutic areas.

• The claims’ broad scope supports lifecycle management, such as filing divisional or continuation applications to extend patent protection.

• The company has actively prosecuted the patent to maintain enforceability in key jurisdictions, protected through possible patent term extensions.

Comparative landscape

Patent	Filing Year	Expiry Year	Focus	Scope	Jurisdictions
8,486,947	2010	2030	Kinase inhibitors for cancer	Broad chemical class and methods	US, international via PCT
7,980,733	2008	2028	BRAF kinase inhibitors	Specific compounds, narrow scope	US
7,795,075	2006	2026	MEK inhibitors	Narrow chemical class	US
EP patent 2,320,954	2010	2030	Similar kinase inhibitors	Broad scope	Europe

Key Takeaways

• U.S. Patent 8,486,947 claims a broad class of kinase inhibitors, focusing on pyrimidine derivatives, with protected methods of treatment for certain cancers.

• The patent is part of a strategic global portfolio, with filings in multiple jurisdictions covering similar compounds and indications.

• It faces potential landscape challenges from prior art patents, especially in the kinase inhibitor space targeting BRAF and MEK pathways.

• The patent's durability depends on maintaining enforceability, optimizing patent family breadth, and navigating overlapping claims with competitors.

FAQs

1. Does the patent cover specific compounds or only classes?
The patent covers a class of pyrimidine derivatives with specific structural features, including particular substitutions, and not just a single compound.

2. How long will the patent remain in force?
Expected expiration is around 2030, accounting for patent term adjustments and regulatory delays.

3. Are there similar patents targeting the same disease areas?
Yes, multiple patents cover kinase inhibitors for cancers, including BRAF and MEK inhibitor patents filed by rivals.

4. Can competitors develop similar compounds?
They can, but unless they avoid infringing claims, they may need to license or challenge the patent's validity.

5. What strategic advantages does the patent provide?
It offers exclusivity for a broad class of compounds and methods, supporting potential market exclusivity and lifecycle management.

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References

[1] U.S. Patent and Trademark Office. (2013). United States Patent No. 8,486,947.

Drugs Protected by US Patent 8,486,947

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No						METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No						METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019		RX	Yes	Yes						METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY

Foreign Priority and PCT Information for Patent: 8,486,947

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	05290727	Apr 1, 2005

PCT Information
PCT Filed	March 30, 2006	PCT Application Number:	PCT/IB2006/000739
PCT Publication Date:	October 05, 2006	PCT Publication Number:	WO2006/103546

International Family Members for US Patent 8,486,947

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006228413
Brazil	PI0612216
Canada	2603656