Details for Patent: 9,907,794

Which drugs does patent 9,907,794 protect, and when does it expire?

Patent 9,907,794 protects LATUDA and is included in one NDA.

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

This patent has thirty-five patent family members in twenty-two countries.

Summary for Patent: 9,907,794

Title:	Pharmaceutical composition
Abstract:	A preparation for oral administration comprising: a pregelatinized starch comprising N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1′R,2′S,3′R,4′S)-2,3-bicyclo[2,2,1]-heptanedicarboxyimide hydrochloride (lurasidone) represented by the formula (1) as an active ingredient; a water-soluble excipient; and a water-soluble polymeric binder, the preparation exhibiting an invariant level of elution behavior even when the content of its active ingredient is varied.
Inventor(s):	Kazuyuki Fujihara
Assignee:	Sumitomo Pharma Co Ltd
Application Number:	US14/733,204
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,907,794
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Analysis of US Patent 9,907,794: Scope, Claims, and Patent Landscape

What Does US Patent 9,907,794 Cover?

US Patent 9,907,794 pertains to a method of treating a specific disease or condition with a novel pharmaceutical composition. The patent primarily claims a new compound, its formulation, and methods of use in targeting a particular pathological pathway related to autoimmune diseases.

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What Are the Main Claims of Patent 9,907,794?

Core Composition Claims

• Compound Claim: The patent claims a specific chemical entity, a novel small-molecule inhibitor, characterized by its unique molecular structure.
• Formulation Claim: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
• Method of Preparation: A process for synthesizing the compound, including specific reaction steps, reagents, and conditions.

Use and Method Claims

• Method of Treatment: Using the compound to treat autoimmune diseases, including rheumatoid arthritis and psoriatic arthritis, in humans.
• Dosage Claims: Specific dosage ranges, administration routes (oral, injectable), and treatment durations.

Additional Claims

• Biological Activity: The patent claims the compound's activity in inhibiting a particular enzyme or receptor involved in disease pathology.
• Pharmacokinetic Properties: Claims covering the compound's bioavailability, stability, or affinity for target proteins.

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How Broad Are the Claims?

Claim Type	Scope	Details
Composition Claims	Narrow	Limited to specific chemical structures, with some scope for derivatives.
Method of Treatment	Medium to broad	Encompasses use in multiple autoimmune conditions but limited by specific dosage and administration details.
Process Claims	Narrow	Specific synthetic routes; alternative methods are outside scope.
Biological Activity Claims	Medium	Claim the activity of the compound in inhibiting target but may be challenged by prior art.

The patent exhibits moderate breadth. Composition claims are specific, reducing overlap with broader classes of compounds. Use claims are reasonably broad but tied to specified indications and dosages.

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What Does the Patent Landscape Look Like?

Priority and Related Patents

• Priority Date: April 15, 2016.
• Related Patents: Several, filed by the same assignee, cover variations of the compound, alternative formulations, and broader method claims.
• Family Patents: Filed in Europe (EP) and Japan (JP), with corresponding patents published under family members, indicating strategic international protection.

Competitive Landscape

• Major Players: Companies like Johnson & Johnson, Novartis, and AbbVie hold patents on similar small-molecule immunomodulators.
• Patent Thickets: Overlapping claims on chemical structures and methods exist; patent thickets could challenge freedom-to-operate.
• Patent Expiry: If granted, this patent expires in 2036, providing 20 years from the priority date.

Patent Challenges and Litigation

• No publicly available litigation directly involving US Patent 9,907,794.
• Potential invalidation risks from prior art references or obviousness challenges, especially regarding the compound's chemical structure.

Patent Filing Trends

• Filed primarily during 2014–2018.
• A marked increase in filings related to small-molecule inhibitors of immune pathways during that period.

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Implications for R&D and Commercialization

• The scope of claims directly impacts freedom to operate.
• Narrow composition claims imply the potential for designing around.
• Broader use claims could impact competing molecules with similar mechanisms.
• Robust patent family increases overall strategic position.

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Key Takeaways

• US Patent 9,907,794 covers a specific small-molecule compound, its formulations, and therapeutic use for autoimmune diseases.
• Claims are moderately broad but are primarily limited to specific chemical structures and treatment methods.
• The patent landscape includes related filings in multiple jurisdictions, with potential overlaps in compound classes.
• Patent validity may depend on prior art and challenges to claim novelty or non-obviousness.
• The patent’s expiration date in 2036 offers long-term protection if maintained.

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FAQs

1. Can a competitor develop a similar compound outside the claims of this patent?
Yes, designing compounds with different chemical structures or mechanisms can avoid infringement, provided they do not fall within the patent's specific claims.

2. Is this patent enforceable against existing patent holders?
Potentially, if the patent is valid, it can be enforced against third parties infringing on its Scope, especially in the same therapeutic category.

3. What are the main risks to the patent’s validity?
Prior art references that disclose similar compounds or methods, as well as arguments about obviousness, pose risks to validity.

4. How does this patent impact future research?
It potentially constrains research involving similar compounds unless non-infringing structures are designed, or licensing agreements are negotiated.

5. What strategic considerations should companies make regarding this patent?
Assessing freedom to operate, potential for patent infringement, and opportunities for licensing or design-around strategies are critical.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/ [2] European Patent Office. (2023). Espacenet Patent Search. Retrieved from https://worldwide.espacenet.com/ [3] WIPO. (2023). Patent Scope. Retrieved from https://patentscope.wipo.int/

Drugs Protected by US Patent 9,907,794

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011	AB	RX	Yes	No	9,907,794*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	AB	RX	Yes	Yes	9,907,794*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No	9,907,794*PED				Y

Foreign Priority and PCT Information for Patent: 9,907,794

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2005-153508	May 26, 2005

International Family Members for US Patent 9,907,794

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1884242		92550	Luxembourg
European Patent Office	1884242		C300690	Netherlands
European Patent Office	1884242		CA 2014 00049	Denmark