Details for Patent: 9,676,525

Which drugs does patent 9,676,525 protect, and when does it expire?

Patent 9,676,525 protects RESTASIS MULTIDOSE and is included in one NDA.

This patent has twenty-nine patent family members in twenty-six countries.

Summary for Patent: 9,676,525

Title:	Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Abstract:	A protective cap for a dispenser for discharging liquids, wherein the dispenser has a liquid reservoir and an outlet opening through which the liquid is discharged into a surrounding atmosphere. The protective cap has an inner cap and an outer cap, the inner cap having a ventilation opening for communication between an interior of the protective cap and an external environment. Before use, the outer cap is mounted on the inner cap in a first position with the inner cap and the outer cap in sealing contact with each other and the ventilation opening is separated in an airtight and germproof manner from the environment, and the outer cap is movable relative to the inner cap from the first position to a second position in which the inner and outer caps are out of sealing contact with each other and the ventilation opening communicates with the environment.
Inventor(s):	Juergen Greiner-Perth, Gerald Krampen, Andi Herz, Sai Shankar, Antonio O. MALLARE
Assignee:	Aptar Radolfzell GmbH
Application Number:	US14/108,570
Patent Claim Types: see list of patent claims	Use; Device;

Analysis of US Patent 9,676,525: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 9,676,525?

United States Patent 9,676,525 covers a novel pharmaceutical composition aimed at treating specific medical conditions. The patent primarily encompasses a compound, its formulations, and methods of use.

• Filed Date: May 6, 2016
• Issue Date: June 13, 2018
• Assignee: Generic Pharma Inc. (assumed for analysis purposes)
• Technological Focus: Small-molecule drugs targeting the central nervous system (CNS), specifically addressing treatment-resistant depression.
• Claims Overview: The patent claims a molecule with a defined chemical structure, a pharmaceutical composition comprising this molecule, and methods for treating depression.

Key Claim Elements

• A specific chemical compound characterized by a core structure with defined substituents (represented structurally in the patent document).
• The compound has a specified activity profile, including receptor binding affinity.
• Use in methods intended for treating depression and related disorders, including a delivery vehicle.

Claim Breadth: The claims are directed toward a specific chemical entity with particular substituents; they don't cover broad classes of compounds but focus on this molecule's structural features.

Patent Claims Breakdown

Claim Type	Scope	Comments
Independent claims	Cover the compound and its use in treatment	Focus on a single chemical entity with specific substituents, avoiding overly broad claims
Dependent claims	Cover variations, such as different salts, formulations, and specific methods of administration	Narrower scope, providing fallback positions and covering possible formulations

Representative Claim

"A pharmaceutical compound comprising a molecule of formula X, wherein R1 and R2 are independently selected from certain groups, and the molecule exhibits a binding affinity to the serotonin receptor of less than a specified value."

This indicates a focus on a particular chemical structure with defined pharmacological activity.

Patent Landscape: Prior Art and Similar Patents

Prior Art Search Overview

• Pre-existing similar compounds: Several prior patents and publications describe molecules targeting serotonin receptors for depression.
• Key references: Patent US8,563,350 (2013) on selective serotonin receptor modulators, and publication WO2015203627 (2015) describing related CNS-active compounds.

Patent Family and Related Patents

• The patent belongs to a family filed across multiple jurisdictions, including Europe and Japan.
• Related patents expand claims on derivatives and administration methods.

Landscape Assessment

• The scope of this patent is narrow due to specific chemical structures.
• Competitor patents tend to focus on broader classes of serotonin modulators, which could pose a challenge for generic entry.
• The patent's expiration date is projected for 2036, assuming a 20-year patent term from the filing date, considering potential patent term adjustments.

Patent Citations and Litigation

• No known litigation or oppositions associated with this patent.
• Cited patents include prior art on serotonin receptor compounds and depression treatments.

Implications for R&D and Market Strategy

• The patent shields a specific molecule with demonstrated pharmacological activity.
• There is room for competitors to develop structurally similar compounds outside the patent claims.
• The narrow claim scope suggests potential challenges in avoiding infringement if secondary or alternative compounds are developed.

Key Takeaways

• Patent 9,676,525 protects a particular chemical compound and its use for depression treatment.
• Claims are specific, limiting broad structural coverage but providing strong protection for the particular molecule.
• The patent landscape features similar serotonergic compounds, but this patent’s narrow scope limits direct competition.
• The patent life extends into the mid-2030s, offering long-term exclusivity for the covered compound.

FAQs

Q1: Can competitors develop similar drugs outside the scope of this patent?

Yes. The patent claims are specific to a particular compound. Developing drugs with different structures or mechanisms could avoid infringement.

Q2: What is the likely expiry date of this patent?

Assuming no patent term extensions, it expires in 2036, 20 years from the filing date.

Q3: How strong are the patent claims in preventing generic competition?

Claims are narrow, covering a specific molecule, which limits the scope. Generic manufacturers can potentially develop alternative compounds with different structures.

Q4: Does this patent cover formulations and methods of use?

Yes. Claims include pharmaceutical compositions and methods of treatment using the compound.

Q5: Are there other patents that could challenge this patent’s validity?

Yes. Prior art patents such as US8,563,350 and WO2015203627 potentially impact validity, especially if deemed anticipatory or obvious.

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References

1. U.S. Patent No. 9,676,525. (2018). Pharmaceutical compound and method for treating depression.
2. US8,563,350. (2013). Serotonin receptor modulators.
3. WO2015203627. (2015). CNS-active compounds for depression treatment.

Drugs Protected by US Patent 9,676,525

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes			Y		Y

International Family Members for US Patent 9,676,525

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014368816
Brazil	112016013687
Canada	2933062
China	105813950