Details for Patent: 9,289,586

Which drugs does patent 9,289,586 protect, and when does it expire?

Patent 9,289,586 protects AXIRON and is included in one NDA.

This patent has seventeen patent family members in fourteen countries.

Summary for Patent: 9,289,586

Title:	Spreading implement
Abstract:	An implement for applying a volume of liquid to a treatment surface includes a support onto which is mounted a receptacle. The receptacle defines a reservoir space which receives the liquid. The receptacle includes a wall having a working surface that is used to spread the liquid over the treatment surface. The wall is resiliently deformable such that in use the working surface maintains contact with the treatment surface when spreading the liquid. The implement is used in applying a transdermal lotion to the axilla area of a user. A system for transdermal administration of a physiological active agent from a liquid composition and a method of conducting the same are also provided.
Inventor(s):	Peter Bayly, Mark Simon Bayly, Magnus Ahlstrom, Adam Charles Watkinson
Assignee:	Acrux DDS Pty Ltd
Application Number:	US14/317,412
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,289,586
Patent Claim Types: see list of patent claims	Use; Composition; Device;

United States Patent 9,289,586: Scope, Claims, Expiration and Competitive Patent Landscape

US Patent 9,289,586 protects a transdermal drug-delivery method that combines a liquid hormone formulation with a specific flexible applicator. Its strongest commercial relevance is to testosterone products applied to the axilla, including pump-dispensed liquids or gels. The patent does not broadly cover every testosterone transdermal product. Infringement requires the claimed applicator architecture, liquid composition, and method of use to be present in combination.

What does US Patent 9,289,586 protect?

US 9,289,586 is directed to a method of administering a physiologically active agent through the skin using an implement with a flexible, open-top receptacle.

The independent claim requires all of the following:

Required element	Claim 1 requirement
Implement	An implement having a support and a receptacle mounted on the support
Reservoir	The receptacle has a reservoir space with an open top
Flexible structure	A flexible membrane forms the base and wall
Wall geometry	The wall is substantially perpendicular to the base
Impermeable base	The base has a continuous surface that prevents liquid passage
Working surface	The wall has a working surface for spreading liquid over the subject
Deformation	At least the wall is resiliently deformable
Liquid loading	Liquid composition is applied through the open top
Skin contact	The wall is deformed against the treatment surface
Spreading	The liquid is spread with the working surface of the wall

The claim is a combination claim. A competitor that uses the same testosterone formulation but applies it through a conventional metered-dose pump, packet, roll-on, or rigid spatula may avoid literal infringement if it does not use the claimed flexible receptacle.

The patent is therefore best characterized as an applicator-and-method patent with formulation limitations added in dependent claims.

How do claims 2 through 8 narrow the patent scope?

Claims 2 through 8 add structural limitations concerning the dispensing system and the mechanical behavior of the applicator.

Dispensing-device limitations

Claims 2 to 4 require a container and a dispensing device that delivers the liquid into the receptacle. Claim 3 adds a detachable connection between the support and dispensing device. Claim 4 narrows the arrangement further by requiring the support to surround a pump and reduce inadvertent pump discharge.

These limitations are commercially significant because they target an integrated product architecture:

1. A container stores the liquid.
2. A pump dispenses a measured quantity.
3. The applicator support attaches to or surrounds the pump.
4. The liquid is transferred into the applicator reservoir.
5. The applicator is detached and used on skin.

A product with a pump but no surrounding support, or with a permanently attached applicator, may fall outside claims 3 and 4 while remaining potentially relevant to claim 1.

Mechanical deformation limitations

Claims 7 and 8 require the support to be relatively rigid compared with the receptacle wall and require the wall to move relative to the support. Claim 8 specifically requires the wall to collapse relative to the support during application.

These limitations create potential design-around routes. A manufacturer could consider:

• A rigid spreading surface rather than a collapsing wall.
• A flexible pad that does not form a reservoir.
• A reservoir whose wall flexes but does not collapse.
• A closed cartridge that transfers the dose directly to skin.
• A roller, brush, sponge, or nozzle-based delivery system.

Whether a redesigned device avoids infringement would depend on claim construction, prosecution history, and the doctrine of equivalents.

What formulations are protected by US 9,289,586?

The formulation claims are narrower than the core applicator claim but materially expand the patent’s practical reach over testosterone products.

Penetration enhancers

Claims 9 to 12 cover a liquid containing a penetration enhancer. Claim 10 lists broad enhancer classes, including:

• Fatty acids and fatty acid esters
• Fatty alcohols
• Glycols and glycol esters
• 1,3-dioxolanes and 1,3-dioxanes
• Macrocyclic ketones with at least 12 carbon atoms
• Oxazolidinones and derivatives
• Amino-substituted alkyl esters
• Sunscreen esters
• Mixtures of those materials

Claim 11 narrows the enhancer to one or more of:

• Octyl dimethyl-para-aminobenzoate
• Octyl para-methoxycinnamate
• Octyl salicylate

Claim 12 requires the penetration enhancer to constitute 1% to 15% by weight of the total composition.

These limitations are relevant to testosterone solutions using sunscreen-ester-type enhancers, especially octyl salicylate and related ingredients. A generic developer could potentially avoid claims 11 and 12 by using a different enhancer or concentration, but claim 9 and the broader classes in claim 10 may remain relevant depending on the precise formulation.

Volatile solvents

Claim 13 requires approximately 40% to 90% by weight of a volatile solvent selected from ethanol, ethyl acetate, isopropanol, acetone, ethyl formate, methyl acetate, methyl ethyl ketone, pentane, chloroform, dimethyl ether, R134a, or mixtures of those solvents.

This claim is particularly relevant to fast-drying testosterone liquids and aerosols. A formulation outside the specified solvent range, or one using a solvent not listed in the claim, may avoid literal infringement of claim 13.

Testosterone composition

Claims 14 to 20 focus the invention on hormone delivery. Claim 15 identifies testosterone and testosterone derivatives. Claim 16 requires:

• A pharmaceutically effective amount of testosterone
• One or more lower alkyl alcohols
• At least 60% v/v combined lower alkyl alcohols
• One or more penetration enhancers
• A viscosity-modulating agent

Claim 17 requires at least 1% w/v testosterone. Claim 18 covers a lotion or gel. Claim 19 requires viscosity greater than water and less than 300 centipoise. Claim 20 targets treatment of male hypogonadism with a serum testosterone target of 300 to 1,000 ng/dL.

Claim 20 is a method-of-use claim. It does not merely cover applying testosterone to skin. It requires treatment of a male with hypogonadism and a specified serum testosterone range.

What is the strongest claim in US 9,289,586?

Claim 1 is the principal enforcement claim because it does not require testosterone, a penetration enhancer, a particular solvent, or hypogonadism. It covers transdermal administration of a physiologically active agent using the claimed flexible applicator.

Its breadth is constrained by the detailed device structure. The following features are likely to receive close attention in infringement analysis:

• The open-top reservoir
• The flexible membrane base and wall
• The substantially perpendicular wall
• The continuous, liquid-impermeable base
• Resilient deformation against skin
• Spreading with the working surface of the wall

Claims 16 and 20 may be commercially stronger against testosterone products because they combine the applicator with formulation and therapeutic-use limitations. They are narrower but may align more closely with a branded product’s approved label and formulation.

When does US Patent 9,289,586 lose exclusivity?

The patent issued on March 22, 2016. Patent expiration is determined primarily by the earliest effective nonprovisional filing date of the relevant family, not by the issue date. The family appears to have a statutory term anchor in approximately 2029, subject to any patent-term adjustment, terminal disclaimer, or other USPTO-recorded term event. The controlling expiration date should be taken from the USPTO Patent Center record and the patent’s official term calculation. (United States Patent and Trademark Office, n.d.-a)

The patent does not receive a separate biologic exclusivity period because testosterone is a small-molecule drug. Its commercial relevance depends on the patent term, FDA exclusivity for the relevant drug product, and any Orange Book-listed patents.

Exclusivity timeline

Event	Date or period	Commercial significance
US 9,289,586 issued	March 22, 2016	Patent rights became enforceable, subject to applicable post-grant procedures
Expected statutory term	Approximately 2029	Patent-based exclusion for covered methods and products
FDA small-molecule pathway	505(b)(2) or ANDA, depending on product	No biosimilar pathway applies
Generic challenge mechanism	Paragraph IV certification	May trigger Hatch-Waxman litigation and a 30-month stay
Post-expiry market	After patent expiration	Generic entry remains subject to FDA approval and non-patent barriers

The exact terminal date matters because a few months of patent-term adjustment can affect launch timing. A patent expiration date should not be inferred solely from the March 2016 issue date.

What is the Orange Book status of US 9,289,586?

Orange Book treatment depends on whether the NDA holder submitted the patent to FDA for the approved drug product and whether the patent claims the drug, an approved method of using the drug, or a product-by-process limitation. FDA publishes patent and exclusivity information in the Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book. (U.S. Food and Drug Administration, n.d.-a)

For a testosterone topical solution such as Axiron, the relevant Orange Book analysis should distinguish among:

Patent category	Relevance to US 9,289,586
Drug-substance patent	Low; the claims do not claim testosterone itself
Composition patent	Potentially relevant through claims 9-19
Device patent	Potentially relevant if the applicator is submitted as part of the drug product
Method-of-use patent	Potentially relevant through claims 14, 15 and 20
Manufacturing patent	Not apparent from the supplied claims
Formulation patent	Relevant where the product uses the claimed alcohol, enhancer and viscosity profile

An ANDA applicant that relies on the reference product may need to address listed patents through Paragraph III or Paragraph IV certifications. If the patent is not listed for the reference product, it may still be asserted in ordinary patent litigation, but it would not automatically generate the Hatch-Waxman 30-month stay.

Which companies are challenging testosterone topical products?

The principal competitive threat comes from manufacturers developing generic testosterone topical solutions rather than biosimilars. Testosterone is a chemically defined small molecule, so FDA approval generally proceeds under the ANDA framework when the proposed product can demonstrate pharmaceutical equivalence and bioequivalence to the reference product. (Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355)

Relevant competitive groups include:

• Generic pharmaceutical companies pursuing testosterone topical solutions.
• Contract manufacturers supplying pump, bottle and applicator systems.
• Firms developing alternative testosterone gels, creams or transdermal patches.
• Sponsors pursuing 505(b)(2) products with different delivery devices or formulations.

A generic product that uses the same applicator geometry and a substantially similar liquid formulation faces greater risk under US 9,289,586 than a conventional testosterone gel supplied in a packet.

What patent litigation affects US 9,289,586?

The patent’s litigation risk is likely tied to the branded testosterone product and its related patent family rather than to the patent in isolation. In Hatch-Waxman litigation, the plaintiff typically asserts multiple patents covering the active ingredient, formulation, applicator, labeling or approved method of use.

The most important litigation questions are:

1. Whether the patent was listed in the Orange Book.
2. Whether an ANDA applicant made a Paragraph IV certification.
3. Whether the NDA holder sued within 45 days.
4. Whether the litigation triggered a 30-month approval stay.
5. Whether the asserted claims survived claim construction and validity challenges.
6. Whether the parties settled and, if so, the agreed generic launch date.

A Paragraph IV filing creates a statutory cause of action for the NDA or patent holder. The existence of a Paragraph IV certification does not establish infringement or validity. The outcome depends on claim construction, written-description and enablement defenses, obviousness, anticipation, and the accused product’s actual design.

No settlement terms should be treated as controlling unless recorded in a court docket, consent judgment, FDA settlement disclosure, or an executed agreement disclosed by the parties.

How strong is the patent estate for testosterone transdermal delivery?

The patent estate is strongest when a product uses all three protected layers:

1. A flexible open-top reservoir applicator.
2. A high-alcohol testosterone formulation with penetration enhancer and viscosity modifier.
3. Axillary administration for treatment of hypogonadism.

The estate is weaker against products that change the delivery platform. A packet-delivered gel, a rigid applicator, a metered spray, or a conventional gel pump may avoid one or more required elements.

Product strategy	Risk under US 9,289,586
Same flexible reservoir applicator	High
Same applicator and testosterone formulation	High
Conventional testosterone gel packet	Lower
Rigid spreading device	Lower
Testosterone patch	Low under these claims
Oral or injectable testosterone	No direct relevance
Different penetration-enhancer system	Reduced formulation-claim risk
Different alcohol concentration	Reduced claim 16 or 13 risk
Same product but different label	Claim 20 risk may change, but device and composition claims remain

What geographic coverage does the patent provide?

US 9,289,586 provides rights only in the United States. Foreign counterparts must be assessed separately by jurisdiction. The commercial family may include Australian, European, Canadian and other national-stage applications, but foreign claim scope, prosecution amendments, lapse status and expiration dates cannot be inferred from the US claims.

For licensing and freedom-to-operate work, geographic review should cover:

• United States
• European Patent Office member states
• United Kingdom
• Australia
• Canada
• Japan
• South Korea
• China
• Countries where testosterone topical products are marketed or manufactured

Manufacturing outside the United States does not automatically eliminate US risk. Importation, sale, offer for sale, or use of an accused product in the United States can create separate infringement exposure under 35 U.S.C. § 271.

What manufacturing and intellectual-property barriers remain?

The patent does not appear to claim a manufacturing process. Its manufacturing relevance comes from the need to produce a device with:

• A flexible membrane reservoir
• A liquid-impermeable continuous base
• A deformable spreading wall
• Controlled attachment to a pump or support
• Compatible materials for high-alcohol testosterone compositions

Material selection, dimensional tolerances, dose uniformity and pump compatibility may create practical barriers even when they are not independently patented. Regulatory bridging is also important. A generic sponsor changing the applicator may need to demonstrate that the change does not alter delivered dose, absorption, usability or bioequivalence.

Key Takeaways

• US 9,289,586 is principally an applicator-and-method patent for transdermal administration from a flexible open-top reservoir.
• Claim 1 is broad in the active agent but narrow in the required applicator structure.
• Claims 9 to 19 add meaningful formulation protection for penetration enhancers, volatile solvents, testosterone, alcohol content and viscosity.
• Claim 20 covers treatment of male hypogonadism to a specified serum testosterone range.
• The expected statutory term appears to run to approximately 2029, subject to the official USPTO term calculation.
• Testosterone is a small molecule. Generic competition proceeds through ANDA or, in some cases, 505(b)(2), not the biosimilar pathway.
• The highest infringement risk applies to a generic product reproducing both the flexible applicator and the testosterone liquid formulation.
• A conventional packet, rigid applicator, patch, spray or materially different formulation offers stronger design-around potential.
• Orange Book listing, Paragraph IV activity, litigation and settlement timing must be confirmed from FDA and court records rather than inferred from the claims alone.

Frequently Asked Questions

Does US 9,289,586 claim testosterone itself?

No. The patent does not claim testosterone as a compound. It claims methods using an applicator and, in narrower claims, liquid testosterone compositions with specified formulation characteristics.

Can a testosterone gel in a packet infringe US 9,289,586?

Potentially, but risk is lower if the packet is applied directly by hand and does not use the claimed flexible open-top receptacle, support and deformable spreading wall.

Does the patent cover testosterone patches?

The supplied claims do not specifically cover patches. A patch generally lacks the claimed open-top reservoir and wall that deforms against skin to spread liquid.

Is a biosimilar application required for a generic testosterone topical product?

No. Testosterone is a small molecule. The principal abbreviated pathway is an ANDA under section 505(j), although a 505(b)(2) application may be used for certain modified products.

What is the main design-around strategy?

The most direct strategy is to change the applicator architecture, particularly by eliminating the open-top flexible reservoir or the deformable wall that spreads the liquid over skin.

References

Acrux Limited. (2010). Annual report 2010. https://www.acrux.com.au/

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355.

United States Patent No. 9,289,586. (2016). Methods of transdermal administration of a physiologically active agent. United States Patent and Trademark Office. https://patents.google.com/patent/US9289586B2/en

United States Patent and Trademark Office. (n.d.-a). Patent term adjustment search. https://www.uspto.gov/patents/apply/adjustment

United States Patent and Trademark Office. (n.d.-b). Patent Center. https://patentcenter.uspto.gov/

U.S. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

U.S. Food and Drug Administration. (n.d.-b). Axiron testosterone topical solution prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/label.htm

Drugs Protected by US Patent 9,289,586

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eli Lilly And Co	AXIRON	testosterone	SOLUTION, METERED;TRANSDERMAL	022504-001	Nov 23, 2010		DISCN	Yes	No						A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF

International Family Members for US Patent 9,289,586

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007343579
Brazil	PI0720945
Canada	2674661
China	101636194
Eurasian Patent Organization	015473