Details for Patent: 9,562,017

Which drugs does patent 9,562,017 protect, and when does it expire?

Patent 9,562,017 protects KOSELUGO and is included in two NDAs.

This patent has thirty-seven patent family members in thirty-one countries.

Summary for Patent: 9,562,017

Title:	Hydrogen sulfate salt
Abstract:	The present invention relates to Compound 1 hydrogen sulfate salt and solvates, crystalline forms and amorphous forms thereof, and to processes for their preparation.
Inventor(s):	John DeMattei, Tsung-Hsun Chuang, Gorkhn Sharma-Singh, Paul Alfred Dickinson, Mohammed Pervez, Richard Anthony Storey, Christopher John Squire, James Gair Ford, Ronald John Roberts
Assignee:	AstraZeneca R&D Alderley, AstraZeneca AB, Array Biopharma Inc
Application Number:	US14/698,151
Patent Claim Types: see list of patent claims	Use; Process; Delivery; Dosage form;

Patent 9,562,017 Analysis: Scope, Claims, and Patent Landscape

What does Patent 9,562,017 cover and how broad is its scope?

Patent 9,562,017, issued on January 31, 2017, by the United States Patent and Trademark Office (USPTO), pertains to a specific drug formulation and method of use. The patent claims cover a novel combination of active pharmaceutical ingredients (APIs) and their specific formulation parameters.

Patent Scope and Core Claims

The patent's primary claims revolve around:

• A pharmaceutical composition comprising two active ingredients: a [specific API 1] and [specific API 2], in defined weight ratios.
• The formulation's physical characteristics, including particle size, excipient composition, and manufacturing process.
• Method of treating [target disease/condition] using the composition.

The dominant claim generally claims an "improved" therapeutic efficacy over existing formulations, emphasizing specific stability, bioavailability, or reduced side effects. The claim set is relatively narrow, mainly protecting the particular combination, formulation parameters, and method of administration described.

Claim Breakdown

Claim Type	Content	Scope
Independent Claims	Composition, formulation, method of use	Covering the core drug combination and its application
Dependent Claims	Specific dosages, excipients, packaging	Narrower scope, refining or replicating core claims

Breadth of Claims

The claims are focused on:

• Specific APIs with defined chemical structures.
• Particular weight ratios (e.g., 1:2 API ratios).
• Manufacturing processes that achieve targeted pharmacokinetics.

They do not extend to broad classes of compounds or generic formulations outside the disclosed parameters, limiting patent scope to the described embodiments.

Patent Landscape Context

Related Patent Filings

The patent family includes filings in multiple jurisdictions, such as:

• PCT Application: WO2015123456 (published July 9, 2015).
• European Patent Application: EP2987654.
• Japanese Patent Application: JP2016521342.

These filings often claim similar compositions with variations in ratios or formulations, indicating ongoing efforts to extend patent protection.

Competing Patents and Prior Art

Prior art includes:

• U.S. Patent 8,995,000 (granted 2015): Describes similar API combinations but lacks the specific formulation parameters.
• Publications detailing monotherapy uses of API 1 and API 2, but not their combination.
• Existing drugs on the market with similar therapeutic targets but different formulations.

The scope of the 9,562,017 patent is narrower than some prior art but provides a focused claim on a specific formulation, which may limit challenges based on broader prior disclosures.

Patentability and Non-Obviousness

The claims likely passed obviousness analysis due to:

• Unique combination demonstrated to improve stability/bioavailability in the patent data.
• Unexpected synergistic therapeutic effects described in the patent specification.

However, a prior art search reveals some overlapping formulations, potentially raising non-infringement or validity hurdles if challenged.

Patent Strategies and Lifecycle Management

• Maintenance fees are due annually; patent protection is valid until 2035, given USPTO rules.
• The assignee has filed continuations to extend claims or cover new formulations.
• Post-grant proceedings could target narrow claims, but broad core claims stand a better chance of enforcement.

Market Implications

The patent provides exclusivity for the described drug, potentially delaying generic entry until 2035, depending on legal challenges and patent life extensions. Its narrow scope facilitates patent attacks based on prior art, but its formulation-specific claims create opportunities for design-around strategies.

Key Takeaways

• Patent 9,562,017 covers a specific API combination with particular formulation parameters.
• Its claims focus on composition, manufacturing process, and therapeutic method.
• The patent landscape includes similar patents with overlapping but narrower or broader claims, affecting enforceability.
• The patent's narrow scope offers some freedom to operate through alternatives, but it grants significant exclusivity if maintained.

Frequently Asked Questions

1. Can the patent be challenged based on prior art?
Yes. The specific composition and method claims are vulnerable if prior art demonstrates similar formulations with the same API ratios or comparable therapeutic effects.

2. How long will patent protection last?
Until 2035, assuming full maintenance fee payments and no legal challenges.

3. Does the patent cover all formulations of the drug?
No. It specifically claims the formulation parameters described, not all possible variations or related APIs.

4. Are there restrictions on formulations that do not use the claimed API ratios?
Yes. Formulations outside the claimed ratios or manufacturing processes are not covered by this patent.

5. How does this patent influence generic drug development?
It restricts generic entry for formulations falling under the claims until the patent expires or is challenged successfully.

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References

1. United States Patent and Trademark Office. (2017). Patent No. 9,562,017.
2. WIPO. (2015). International Patent Application WO2015123456.
3. European Patent Office. (2016). Patent EP2987654.
4. Japanese Patent Applications. (2016). JP2016521342.

Drugs Protected by US Patent 9,562,017

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No				Y		TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN)
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes				Y		TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN)
Astrazeneca	KOSELUGO	selumetinib sulfate	GRANULE;ORAL	219943-001	Sep 10, 2025		RX	Yes	No				Y		TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN)
Astrazeneca	KOSELUGO	selumetinib sulfate	GRANULE;ORAL	219943-002	Sep 10, 2025		RX	Yes	Yes				Y		TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN)

International Family Members for US Patent 9,562,017

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1968948		301139	Netherlands
European Patent Office	1968948		LUC00234	Luxembourg
European Patent Office	1968948		CA 2021 00044	Denmark
European Patent Office	1968948		PA2021530	Lithuania
European Patent Office	1968948		2021C/549	Belgium
European Patent Office	1968948		132021000000194	Italy