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;

United States Patent 9,676,525: Scope, Claim Construction, and Patent Landscape for Dual-Cap Liquid Dispensers

U.S. Patent No. 9,676,525 protects a mechanical discharge device combining a liquid dispenser, a removable two-piece protective cap, sterile or germproof ventilation before first use, an outlet valve, and a resilient cap-locking element. The patent does not claim a pharmaceutical active ingredient, therapeutic method, formulation, or biologic. Its commercial relevance is concentrated in packaging systems for ophthalmic, pharmaceutical, cosmetic, and other liquid products.

The independent claims are narrow combination claims. A competing product must generally include each required element, including the cap’s first sealed position, second ventilated position, and resilient element that resists return of the outer cap toward the pre-use position.[1]

What does U.S. Patent 9,676,525 protect?

The patent protects a discharge device with two principal subsystems:

1. A dispenser containing or connected to a liquid reservoir and outlet.
2. A removable protective cap having an inner cap, outer cap, ventilation structure, and anti-reset blocking element.

The core inventive relationship is between the cap positions and the blocking element:

Feature	Required by independent claims
Liquid dispenser and reservoir	Yes
Outlet opening	Yes
Protective cap removable from dispenser	Yes
Inner cap and outer cap	Yes
Ventilation opening in inner cap	Yes
First position sealed against external environment	Yes
Second position communicating with external environment	Yes
Resilient blocking element	Yes
Blocking element resisting movement back toward first position	Yes
Outlet channel and valve	Claims 1, 16 and certain dependent claims
Inner cap covering outlet opening when attached	Claims 1, 9 and 16
Outer cap spaced from and not engaging dispenser	Claims 8 and 17
Blocking element resiliently tensioned in first position	Claims 7, 15, 16 and 17

The patent therefore does not cover every two-piece cap or every sterile liquid dispenser. It targets a specific cap architecture in which the pre-use seal is changed after initial opening and an anti-return mechanism prevents or resists restoration of the original sealed configuration.

What are the independent claims in U.S. Patent 9,676,525?

Claim 1: valve-equipped dispenser with cap blocking mechanism

Claim 1 requires:

• A dispenser with a liquid reservoir;
• An outlet opening;
• An outlet channel between the reservoir and outlet;
• A pressure-operated or manually actuated outlet valve;
• A removable protective cap;
• An inner cap and outer cap;
• At least one ventilation opening in the inner cap;
• A first pre-use position in which the caps are sealingly engaged and the ventilation opening is isolated from the external environment;
• A second position in which the sealing engagement is released and the ventilation opening communicates with the external environment;
• An inner cap that covers the outlet opening when attached;
• An inner cap that no longer covers the outlet opening when detached; and
• A resilient blocking element that directly counteracts axial return of the outer cap toward the first position.

The outlet valve is a material limitation. A product with the cap arrangement but no valve in the outlet channel would not literally meet claim 1, although it could remain relevant to claims with different scope if the patent family contains them.

Claim 8: separate cap and dispenser architecture

Claim 8 is structurally similar to claim 1 but emphasizes that:

• The outer cap is spaced from the dispenser; and
• The outer cap does not engage the dispenser.

This limitation may distinguish a cap in which the outer shell is supported entirely by or moves relative to the inner cap, rather than being mechanically coupled to the dispenser body.

Claim 8 also recites the outlet valve but does not initially include the inner-cap coverage limitations. Those limitations appear in dependent claim 9.

Claim 16: tensioned blocking element

Claim 16 requires the principal combination of claim 1 and adds that the resilient blocking element is tensioned when the outer and inner caps occupy the first position.

The claim is narrower than claim 1 because the blocking element must have a tensioned condition in the pre-use configuration. A product with a blocking element that becomes resilient only after movement into the second position may avoid literal infringement of claim 16 while still requiring analysis under claim 1.

Claim 17: separate cap, return resistance, and pre-use tension

Claim 17 combines the principal limitations of claim 8 with the pre-use tension requirement in claim 16. It is the narrowest independent claim among the four because it requires:

• The valve-equipped dispenser;
• The two-piece cap;
• The ventilated second position;
• The outer cap’s non-engagement with the dispenser;
• A blocking element that resists return; and
• Resilient tension in the first position.

How should the key claim terms be construed?

"First position"

The first position is the pre-use configuration. The outer cap is mounted on the inner cap, and the caps are sealingly engaged so the ventilation opening is isolated from the external environment in an airtight and germproof manner.

A product may face risk even if its manufacturer describes the first position as a shipping, storage, sterilization, or tamper-evident position rather than a "pre-use" position. Function and structure generally matter more than commercial terminology.

"Second position"

The second position is a post-opening or post-initial-use condition. The outer cap has moved relative to the inner cap, the sealing contact is released, and the ventilation opening communicates with the outside environment.

The claim language requires communication with the external environment, but it also uses the phrase "in an airtight and germproof manner." That language creates a technical distinction: the cap must permit the specified ventilation relationship without exposing the relevant protected interior to uncontrolled contamination.

"Resilient blocking element"

The blocking element must be capable of resilient movement or deformation and must directly counteract axial movement of the outer cap toward the first position.

The dependent claims identify examples:

• A spring-biased or elastically restoring element;
• A tab projecting radially outward;
• An element located on the outer cap;
• A complementary opening in the inner cap; and
• A protection element that prevents or discourages manual operation.

The independent claims are not limited to a tab. A flexible finger, snap feature, cantilever, elastomeric projection, spring feature, or equivalent structure could potentially fall within the broader language if it performs the claimed blocking function.

"Airtight and germproof"

This limitation is central to the patent’s sterilization and contamination-control concept. A cap design that merely has a loose vent or an open slot may not satisfy the claimed relationship. The relevant question is whether the claimed cap positions create the specified sealed and ventilated states while preserving the claimed protection against air and microorganism transmission.

What do the dependent claims add?

Claim	Added limitation
2	Blocking element adjustable between blocking and release positions; resiliently forced toward blocking
3	Resilient force results from elastic restoring forces
4	Blocking element on outer cap; complementary opening in inner cap
5	Blocking element is a radially outwardly projecting tab
6	Protection element reduces or prevents manual operation
7	Blocking element is resiliently tensioned in first position
9	Inner cap covers outlet opening when connected and does not cover it when removed
10	Blocking and release positions for claim 8 device
11	Elastic restoring force
12	Outer-cap element and inner-cap complementary opening
13	Radially outwardly projecting tab
14	Protection element against manual operation
15	Blocking element tensioned in first position

The most commercially important dependent-claim combination is likely claims 4, 5, 6, 12, 13 and 14. These claims focus on the physical implementation of the anti-reset feature and may provide narrower positions for enforcement or validity analysis.

How broad is the patent’s practical scope?

The patent has meaningful but limited scope. Its strength depends on whether a competing product uses the same functional sequence:

1. Pre-use sealed cap;
2. Relative cap movement;
3. Ventilation after movement;
4. Cap reconfiguration that is not readily reversible; and
5. A resilient structure that directly blocks return.

A product is more exposed if it has a nested inner and outer cap, a radial locking tab, a complementary inner-cap window, a sterile vent path, and a valve-equipped liquid dispenser.

A product is less exposed if it uses:

• A single-piece cap;
• A breakaway band instead of a movable outer cap;
• A threaded cap without a distinct first and second cap position;
• A valve that is not located in the outlet channel;
• A vent formed in the dispenser body rather than the inner cap;
• A blocking mechanism that operates circumferentially rather than axially;
• A rigid stop rather than a resilient blocking element; or
• An outer cap that engages the dispenser, where claims 8 and 17 require non-engagement.

These design alternatives may avoid literal infringement, but they do not automatically eliminate doctrine-of-equivalents risk. The risk is greatest where the alternative performs the same cap-positioning, ventilation, and anti-return functions in substantially the same structural manner.

What formulations and dosage forms are covered?

The claims do not identify a specific active ingredient or formulation. They expressly refer to pharmaceutical and/or cosmetic liquids. Potential product categories include:

• Preserved or preservative-free ophthalmic solutions;
• Nasal sprays and drops;
• Dermatological liquids;
• Topical pharmaceutical liquids;
• Cosmetic serums and treatments;
• Antiseptic liquids;
• Liquid nutraceuticals; and
• Other sterile or contamination-sensitive liquids.

The claims do not expressly require sterility of the liquid, a particular viscosity, pH, preservative system, concentration, dosage, or therapeutic indication. The "germproof" limitation relates to the cap and ventilation relationship, not to a specific formulation composition.

What outlet-valve structures may create infringement risk?

Claims 1, 8, 16 and 17 require an outlet valve that opens based on pressure or manual actuation and closes the outlet channel. Relevant structures may include:

• Elastomeric slit valves;
• Duckbill valves;
• Umbrella valves;
• Pressure-responsive membrane valves;
• Manually actuated check valves; and
• Pump-associated outlet valves.

A dispensing pump that merely meters liquid without a valve that closes the outlet channel may present a claim-construction issue. The analysis turns on the actual flow-control structure and whether it closes the claimed outlet channel in the closed state.

What is the likely patent strength?

Strengths

The patent has several features that can support infringement enforcement:

• Four independent claims;
• Repetition of the core cap architecture across independent claims;
• Functional and structural limitations directed to physical packaging;
• Specific protection for both valve-equipped and cap-separated configurations;
• Dependent claims covering common implementation details such as radial tabs and complementary openings; and
• A technical relationship between sealed storage, post-use ventilation, and anti-reset protection.

Vulnerabilities

The principal validity and enforcement vulnerabilities are:

• Combination-claim density;
• Multiple functional limitations, including "airtight and germproof" communication;
• Potential prior art involving sterile caps, nested caps, tamper-evident packaging, vented closures, and resilient snap tabs;
• Ambiguity over the boundary between axial blocking and general resistance to movement;
• Potential enablement or written-description scrutiny for broad implementations of the resilient blocking element; and
• Difficulty proving that a commercial package maintains the claimed germproof relationship in both cap positions.

The claims are strongest against products that visibly reproduce the nested-cap geometry. They are weaker against competing systems using different closure architecture.

What is the Orange Book status of U.S. Patent 9,676,525?

U.S. Patent 9,676,525 is a packaging and dispensing-device patent, not a patent claiming a drug substance, drug formulation, or approved method of use. It would not ordinarily be listed in the FDA Orange Book as a drug patent merely because it is used with a pharmaceutical liquid.[2]

The patent therefore does not ordinarily create:

• A statutory Orange Book patent listing;
• A 30-month stay based on an ANDA Paragraph IV notice;
• Drug-product exclusivity;
• Active-ingredient exclusivity; or
• A formulation-specific generic approval barrier.

A drug company could still face commercial or contractual exposure if it incorporates the patented dispensing device into an NDA product, obtains the device from a licensed supplier, or sells a combination product subject to device-patent restrictions.

When does U.S. Patent 9,676,525 lose exclusivity?

The patent was granted on June 13, 2017.[1] Patent term ordinarily runs 20 years from the earliest effective U.S. nonprovisional or PCT filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory adjustments.[3]

A precise expiration date cannot be determined from the claim text alone. The relevant date is not necessarily the earliest foreign priority date. Patent-term calculations generally use the applicable U.S. filing chain and any adjustment recorded by the USPTO.

Because this is a device patent, Hatch-Waxman patent-term extension for an approved drug generally is not the governing commercial pathway. The practical exclusivity period depends on ordinary patent-term rules and the patent’s prosecution record.

Are Paragraph IV challenges or biosimilar challenges relevant?

Paragraph IV

A Paragraph IV challenge is generally directed to an Orange Book-listed patent associated with an approved drug product.[2] U.S. Patent 9,676,525 does not, based on the claims supplied, claim an active pharmaceutical ingredient or drug formulation. A generic applicant would more likely encounter this patent through commercial contracting, device procurement, or product-development diligence than through a conventional Paragraph IV certification.

Biosimilar risk

Biosimilar litigation under the Biologics Price Competition and Innovation Act concerns patents associated with biological products and their manufacturing or use.[4] The claims here are directed to a physical discharge device and do not claim a biologic molecule, biologic formulation, cell line, or biological manufacturing process. The patent therefore presents no direct biosimilar patent risk.

Which companies are likely to compete in this technology area?

The relevant competitive landscape includes manufacturers of pharmaceutical and cosmetic liquid dispensing systems, sterile ophthalmic containers, pump closures, airless packaging, and medical-device components. The principal commercial groups commonly active in adjacent technologies include AptarGroup, Nemera, Silgan Dispensing, Berry Global, Gerresheimer, West Pharmaceutical Services, and medmix.

This does not establish that any particular company infringes or owns a conflicting patent. A reliable freedom-to-operate analysis must compare each company’s actual cap geometry, outlet valve, vent path, and locking mechanism against the issued claims and the relevant patent family.

What patent landscape surrounds the claimed technology?

The surrounding patent landscape is likely to contain four overlapping technology clusters:

Sterile and contamination-controlled dispensers

These patents concern one-way valves, preservative-free delivery, airless containers, and structures that limit contact between the liquid and the ambient environment.

Nested protective caps

These patents concern inner and outer caps, cap liners, removable covers, tamper evidence, and seals protecting dispensing openings.

Venting and pressure equalization

These patents cover controlled air communication, pressure balancing, post-opening ventilation, and vent paths that preserve contamination control.

Anti-reset and tamper-evident mechanisms

These patents cover breakaway parts, ratchets, snap tabs, detents, radial projections, frangible links, and structures preventing a cap from returning to a prior position.

The primary clearance risk is cumulative. A product may avoid this patent but still fall within separate patents covering the valve, sterile vent, pump, cap seal, or tamper-evident mechanism.

What generic launch risks exist?

The patent does not by itself delay generic approval in the same manner as an Orange Book-listed drug patent. Its effect is instead commercial and operational:

• A generic sponsor may need a non-infringing container-closure system;
• The sponsor may need a license from the device manufacturer;
• A contract manufacturer may impose indemnity restrictions;
• Regulatory comparability may limit the feasibility of changing the dispensing system; and
• A redesign may require container-closure, extractables, leachables, dose-delivery, stability, and human-factors work.

A launch using the same dispenser supplied by the originator or its packaging vendor creates the greatest risk. A redesigned cap with different ventilation and locking mechanics may reduce exposure but can increase development and regulatory costs.

What litigation and settlement issues should be reviewed?

The supplied claim text does not establish a litigation history, settlement agreement, license, covenant not to sue, reexamination proceeding, or inter partes review outcome. Those matters cannot be inferred from the claims.

For transaction diligence, the critical records are:

• USPTO Patent Center prosecution history;
• Assignment and ownership records;
• Patent-term adjustment;
• Maintenance-fee status;
• Federal district court docket searches;
• PTAB proceedings;
• Related U.S. continuation and divisional applications;
• Foreign family members;
• License agreements; and
• Any settlement restricting manufacture, supply, or sale of the dispenser.

How does this patent compare with ordinary pump and cap patents?

Issue	U.S. 9,676,525	Ordinary pump patent	Ordinary tamper-evident cap patent
Liquid reservoir	Required	Usually required	Not always
Outlet valve	Required in independent claims	Often required	Usually absent
Inner and outer caps	Required	Often absent	Sometimes present
Ventilation opening	Required	Sometimes present	Usually absent
Pre-use airtight/germproof state	Required	Sometimes present	Sometimes present
Post-movement ventilation	Required	Not usually central	Not usually central
Resilient anti-return element	Required	Sometimes present	Common in some designs
Pharmaceutical/cosmetic use	Expressly contemplated	Broad	Broad
Active ingredient claim	No	No	No

Key Takeaways

• U.S. Patent 9,676,525 is a mechanical packaging patent for liquid dispensers.
• Its central combination is a two-piece protective cap with sealed pre-use and ventilated post-movement positions.
• A resilient blocking element prevents or resists axial return of the outer cap toward the first position.
• Claims 1, 8, 16 and 17 are independent combination claims with overlapping but distinct limitations.
• Claims 8 and 17 specifically require the outer cap to be spaced from and not engage the dispenser.
• Claims 16 and 17 require the blocking element to be resiliently tensioned in the first position.
• The patent does not claim an active ingredient, formulation, biologic, or method of treatment.
• Orange Book, Paragraph IV and biosimilar pathways are generally not the direct mechanisms for challenging this patent.
• The principal commercial risk concerns use of the same nested-cap, vented, valve-equipped architecture.
• Design-around options include changing the cap architecture, vent location, locking direction, outlet-valve arrangement, or post-use ventilation mechanism.
• Patent expiration requires review of the U.S. filing chain, patent-term adjustment, terminal disclaimers, and maintenance status.

FAQs

Does U.S. Patent 9,676,525 cover a specific eye-drop drug?

No. The claims cover a discharge-device structure. They do not identify a particular active ingredient, formulation, dosage, or therapeutic indication.

Can a product infringe if it uses a flexible cap tab instead of a rigid locking tab?

Potentially. The independent claims require a resilient blocking element, not specifically a rigid or flexible tab. Claims 5 and 13 expressly narrow the tab configuration, but the broader independent claims may reach other resilient structures.

Does removing the outlet valve avoid all claims?

It may avoid claims that require an outlet valve, including the principal independent claims as written. It does not eliminate the need to review related patent family members or other patents covering the cap and ventilation system.

Is a breakaway tamper-evident ring equivalent to the claimed resilient blocking element?

Usually it presents a materially different structure, but the answer depends on whether it directly counteracts axial movement of the outer cap toward the first position and whether an equivalence theory is available.

Can a packaging supplier license this patent for multiple pharmaceutical customers?

Yes, licensing scope would depend on the patent owner’s rights and the agreement. A supplier license may cover manufacture, while a pharmaceutical customer may still require rights covering use, sale, or importation of the complete discharge device.

References

1. United States Patent and Trademark Office. (2017). U.S. Patent No. 9,676,525, Discharge device.
2. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations (Orange Book).
3. United States Code, Title 35, §§ 154 and 156.
4. U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products.

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