US Patent 9,216,183: Bimatoprost for Chemotherapy-Related Eyelash Loss

US Patent 9,216,183 protects methods of using 0.03% w/v bimatoprost to prevent, reduce, or treat eyelash loss in patients receiving chemotherapy. The patent is method-of-use protection, not a composition patent. Its commercial relevance depends on whether a competing product is marketed for chemotherapy-associated eyelash loss and whether the use is induced or direct.

The patent issued on December 22, 2015, to Allergan, Inc. The claimed priority dates trace to a March 2012 U.S. filing, producing an estimated ordinary patent-term endpoint in March 2033, subject to the patent’s official term-adjustment and terminal-disclaimer records. [1]

What does US Patent 9,216,183 protect?

The patent covers applying 0.03% w/v bimatoprost to the eyelids of chemotherapy patients at least once daily. The application may occur:

Before chemotherapy;
During chemotherapy;
After chemotherapy; or
Before, during, and after chemotherapy.

The claims require a comparison showing greater eyelash growth in treated patients than in untreated patients. Dependent claims narrow the method by treatment timing, eyelid location, duration, formulation, and the resulting eyelash characteristics.

Element	Scope under the claims
Active ingredient	Bimatoprost
Concentration	0.03% w/v
Patient population	Patients receiving or having received chemotherapy
Treatment target	Eyelashes and eyelids
Frequency	At least once daily
Timing	Before, during, or after chemotherapy
Treatment result	Greater eyelash growth than in untreated patients
Physical result	Longer or thicker eyelashes
Application site	Upper eyelid, lower eyelid, or both
Formulation	Solution or emulsion
Longest express duration	At least 12 months after chemotherapy

The patent does not claim every use of bimatoprost for eyelash growth. It focuses on the intersection of three limitations: the 0.03% concentration, a chemotherapy-related patient population, and eyelash-growth treatment.

How are the independent claims structured?

Claims 1 and 8 are the two independent claims.

Claim 1: growing eyelashes

Claim 1 covers a method of growing eyelashes in chemotherapy patients. It requires:

A chemotherapy patient;
Application of 0.03% w/v bimatoprost;
Application to the eyelids;
At least once daily dosing;
Application before, during, or after chemotherapy; and
Greater eyelash growth compared with patients not receiving the drug.

The claim is directed to a positive growth outcome. It does not expressly require that the patient first experience complete eyelash loss.

Claim 8: treating eyelash loss

Claim 8 uses substantially the same treatment architecture but characterizes the objective as treating eyelash loss. This creates a second independent claim category that may capture treatment of chemotherapy-induced eyelash hypotrichosis even when the clinical objective is restoration rather than generalized growth.

Claims 1 and 8 overlap materially. The distinction is primarily the stated therapeutic purpose: “growing eyelashes” versus “treating eyelashes loss.” In infringement analysis, the practical issue would be whether the accused use satisfies the chemotherapy-patient and dosing limitations, not the semantic difference between the two objectives.

What limitations do the dependent claims add?

Claims 2 through 7 depend from claim 1. Claims 9 through 20 depend from claim 8.

Claims	Added limitation
2, 9	Treatment after chemotherapy and greater growth than in untreated patients
3, 10	Longer or thicker eyelashes
4, 11	Pretreatment before chemotherapy produces greater growth than treatment during or after chemotherapy
5, 12	Application to the upper eyelid
6, 13	Application to the lower eyelid
7	Application before, during, and after chemotherapy
14	Application after completing chemotherapy
15	Continued treatment for at least 12 months after chemotherapy
16	Treatment before chemotherapy
17	Continued treatment for six months after chemotherapy
18	Solution or emulsion formulation
19	Upper eyelid or both upper and lower eyelids
20	Treatment after chemotherapy is completed

Claim 15 is commercially important because it extends the claimed regimen beyond the chemotherapy course. A product label, physician instruction, patient-support program, or promotional material recommending at least 12 months of post-treatment use could create stronger evidence of induced infringement if the other limitations are met.

Claim 18 is narrower than the independent claims because it specifies a solution or emulsion. It does not cover every possible dosage form unless the formulation falls within one of those categories.

What is the patent’s likely claim scope?

The broadest commercially relevant scope is a daily 0.03% bimatoprost regimen for chemotherapy patients, regardless of whether treatment begins before, during, or after chemotherapy.

The claim does not expressly require:

A particular chemotherapy agent;
A particular cancer type;
A particular age group;
Complete eyelash loss;
A specific number of drops;
A specific treatment duration in the independent claims;
A specific commercial product;
A particular preservative system;
A particular device or applicator; or
FDA approval for the chemotherapy indication.

The absence of a chemotherapy-agent limitation gives the claims potentially broad patient-population coverage. The absence of a cancer-type limitation has the same effect.

The principal narrowing features are the 0.03% concentration, daily application, eyelid administration, and comparative growth outcome. A product using another concentration, another prostaglandin analog, or a non-eyelid route could avoid literal infringement, although the doctrine of equivalents could become relevant depending on the facts and prosecution history.

When does US Patent 9,216,183 lose exclusivity?

The ordinary patent term is expected to run approximately 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment. Based on the public patent record, the practical expiration estimate is in March 2033. [1]

Event	Date or period
Earliest reported U.S. priority period	March 2012
U.S. filing period	March 2013
Patent issued	December 22, 2015
Estimated ordinary expiration	March 2033, subject to USPTO term calculation

Patent expiration does not itself authorize a product. FDA approval, labeling, manufacturing compliance, and other regulatory requirements remain separate matters.

Any precise expiration analysis should use the USPTO Patent Center term-adjustment calculation and the patent’s continuity data. A terminal disclaimer, if present in the prosecution record, could shorten the term. [2]

What is the Orange Book status of US Patent 9,216,183?

US Patent 9,216,183 is not a composition patent for bimatoprost. Its claims are directed to a chemotherapy-associated eyelash-growth use.

The FDA Orange Book lists patents submitted by NDA sponsors for approved drug products and approved methods of use. A method patent may be listed only when it meets the statutory and regulatory listing requirements and corresponds to an approved indication or use. [3]

The key commercial question is whether the patent is listed against the Latisse NDA, NDA 022369, or another bimatoprost product. A patent directed to a use absent from the approved labeling may face listing limitations. A separate question is whether an ANDA applicant would be required to address the patent through a Paragraph IV certification or could use a section viii statement carving out the patented use.

Because US 9,216,183 claims chemotherapy-associated eyelash treatment, its practical Orange Book impact depends on the relationship between the patent claims and the approved labeling for the relevant bimatoprost product. Latisse is approved for hypotrichosis of the eyelashes, but its approved labeling does not necessarily establish chemotherapy-associated eyelash loss as a separately protected indication. [4]

Are Paragraph IV challenges possible?

Yes. A generic applicant could challenge the patent through a Paragraph IV certification if the patent is listed for the relevant reference-listed drug and the applicant asserts that the patent is invalid, unenforceable, or not infringed. [3]

Potential challenge theories include:

Anticipation and obviousness

Bimatoprost was known before this patent as an ophthalmic drug and eyelash-growth agent. The likely validity dispute would focus on whether the chemotherapy-specific patient population, timing, concentration, and observed eyelash-growth result were disclosed or rendered obvious by earlier references.

The chemotherapy context may provide the principal distinction over earlier Latisse and glaucoma literature. The challenger would likely argue that applying a known eyelash-growth agent to patients experiencing chemotherapy-related eyelash loss was an expected application. The patent owner would rely on clinical data, treatment timing, and any unexpected comparative results.

Written description and enablement

The claims cover chemotherapy patients broadly. A challenger could examine whether the specification supports the full scope across chemotherapy regimens, cancer types, treatment schedules, and degrees of eyelash loss.

Indefiniteness

The phrase “greater eyelash growth as compared to patients not receiving 0.03% w/v bimatoprost” may create litigation questions concerning the comparator population, measurement method, baseline status, and statistical threshold. The patent specification and prosecution history would control how a court construes those terms.

Section viii carve-out

If the patent is listed only for a method not required by the generic label, an ANDA applicant may attempt to omit the patented use through a section viii statement. That strategy depends on the proposed label, the scope of the listed use, FDA requirements, and whether the generic’s labeling would still encourage the patented chemotherapy use.

What litigation affects the patent?

No widely reported infringement action centered specifically on US Patent 9,216,183 is identified in the principal public patent and FDA materials. The absence of a reported case does not establish that the patent has never been asserted or licensed.

The most likely litigation posture would involve:

A Paragraph IV suit following an ANDA filing;
A dispute over whether a generic label induces chemotherapy-related use;
A claim-construction dispute over “greater eyelash growth”;
An obviousness challenge based on prior bimatoprost eyelash-growth studies; or
A dispute over whether a product’s use instructions satisfy the chemotherapy timing limitations.

How does this patent compare with earlier bimatoprost patents?

US 9,216,183 is narrower in molecule and broader in patient context than many earlier bimatoprost patents.

Patent category	Typical subject matter	Relationship to US 9,216,183
Early bimatoprost composition patents	Bimatoprost molecule, salts, formulations, ophthalmic use	Earlier and structurally broader for the drug or formulation
Glaucoma patents	Lowering intraocular pressure through ocular administration	Different therapeutic objective
Eyelash-growth patents	Bimatoprost for eyelash hypotrichosis	Closest prior-art category
US 9,216,183	0.03% bimatoprost for chemotherapy patients	Patient-population and timing-specific method protection

The principal commercial distinction is that a competitor may be able to sell bimatoprost for an unpatented indication after earlier composition patents expire while still facing risk from use directed to chemotherapy-associated eyelash loss.

What formulations are protected?

Claim 18 expressly covers bimatoprost in a solution or emulsion. The independent claims do not require either formulation type, so a formulation outside those categories could still fall within claims 1 or 8 if it satisfies the other limitations.

The patent does not appear, from the supplied claims, to require:

A particular pH;
A particular preservative;
A particular viscosity;
A particular container;
A particular applicator brush;
A specific excipient system; or
A specific particle size or release profile.

That structure limits the ability of a competitor to avoid the independent claims through routine formulation changes.

What generic launch risks exist?

A generic bimatoprost product faces different risk levels depending on labeling and marketing conduct.

Launch scenario	Principal risk
Bimatoprost labeled only for an unpatented indication	Lower direct infringement risk, subject to induced-use evidence
Label includes chemotherapy-associated eyelash loss	High risk under claims 1 and 8
Label recommends daily 0.03% eyelid application	Directly tracks core claim limitations
Label omits chemotherapy use but promotional materials recommend it	Induced-infringement risk
Product uses a different concentration	Literal-infringement defense, subject to equivalents analysis
Product uses a different active ingredient	Stronger noninfringement position
Product is supplied for physician-directed off-label chemotherapy use	Risk depends on evidence of intent and commercialization conduct

A skinny-label strategy is not automatically sufficient. Courts analyze the complete label, promotional materials, distribution practices, and foreseeable use. The relevant question is whether the generic applicant encourages the patented use, not merely whether the label avoids the exact words of the patent claims.

How strong is the patent estate?

US 9,216,183 has moderate strategic value as a use patent and limited value as a standalone barrier to all bimatoprost competition.

Strengths include:

A long remaining term relative to the earlier bimatoprost composition estate;
Coverage of treatment before, during, and after chemotherapy;
No limitation to a particular chemotherapy drug or cancer type;
Separate independent claims for eyelash growth and eyelash-loss treatment;
Coverage of upper, lower, or both eyelids;
Extended post-chemotherapy treatment claims.

Weaknesses include:

Dependence on a specific 0.03% concentration;
Dependence on a chemotherapy-patient population;
Potential prior-art issues involving known bimatoprost eyelash growth;
Comparative-result language that may complicate infringement proof;
Possible regulatory limitations on listing or enforcing an indication not reflected in approved labeling;
Lack of composition or manufacturing claims in the supplied claim set.

The patent is strongest against a product intentionally labeled or promoted for chemotherapy-related eyelash loss. It is weaker as a tool to block a generic bimatoprost product marketed for unrelated ophthalmic or cosmetic uses.

What licensing deals and commercial exposure are relevant?

The patent was assigned to Allergan, the developer and marketer of Latisse. Allergan was acquired by AbbVie in 2020, transferring Allergan’s pharmaceutical portfolio to AbbVie, subject to transaction terms and asset-specific ownership records. [5]

The patent’s direct revenue exposure is likely smaller than the exposure associated with broad glaucoma or primary eyelash-hypotrichosis products because the claims address a specialized chemotherapy population. Its strategic value is greater in:

Indication-specific licensing;
Oncology supportive-care partnerships;
Specialty dermatology commercialization;
Patient-support programs;
Label expansion strategies; and
Settlements with generic applicants.

No public settlement agreement specifically tied to US 9,216,183 is identified in the principal cited sources.

Key Takeaways

US 9,216,183 is a method-of-use patent for 0.03% bimatoprost in chemotherapy patients.
Claims 1 and 8 are the central independent claims.
The patent covers treatment before, during, or after chemotherapy.
Daily eyelid application and greater eyelash growth versus untreated patients are core limitations.
Dependent claims cover upper and lower eyelids, solution or emulsion formulations, and treatment lasting six or 12 months after chemotherapy.
The estimated patent-term endpoint is approximately March 2033, subject to USPTO term-adjustment records.
The patent is not a broad composition patent and should not block all bimatoprost products.
Generic risk is highest when labeling or promotional activity directs use for chemotherapy-associated eyelash loss.
The key validity issues are obviousness, written description, enablement, and the interpretation of the comparative-growth limitation.
The patent’s commercial value depends heavily on Orange Book listing, approved labeling, generic certification strategy, and induced-infringement evidence.

FAQs

Does US Patent 9,216,183 cover Latisse for ordinary eyelash hypotrichosis?

Not necessarily. The supplied claims require treatment of chemotherapy patients. Ordinary eyelash hypotrichosis unrelated to chemotherapy would not satisfy that patient-population limitation.

Can a competitor avoid the patent by using bimatoprost once weekly?

Potentially. The independent claims require application at least once a day. A genuinely once-weekly regimen would not literally satisfy that limitation, although equivalence and induced-use issues could remain fact-dependent.

Does the patent cover chemotherapy-induced eyebrow loss?

The supplied claims refer to eyelashes and eyelids. They do not expressly cover eyebrow treatment.

Is a bimatoprost solution automatically covered by claim 18?

No. Claim 18 also requires the chemotherapy-patient, 0.03% concentration, daily application, eyelid-application, and eyelash-loss treatment limitations inherited from claim 8.

Could a generic sell bimatoprost before the patent expires?

Possibly, if it obtains FDA approval with an appropriate label, avoids the patented chemotherapy use, and does not induce that use. A Paragraph IV challenge, section viii carve-out, licensing agreement, or settlement could also affect launch timing.

References

United States Patent and Trademark Office. (2015). U.S. Patent No. 9,216,183, Methods of treating eyelash loss in chemotherapy patients.
United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
U.S. Food and Drug Administration. (n.d.). Latisse (bimatoprost ophthalmic solution) prescribing information, NDA 022369.
AbbVie Inc. (2020). AbbVie completes acquisition of Allergan. https://news.abbvie.com/###

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003207843	⤷ Start Trial
Australia	2008203212	⤷ Start Trial
Australia	2010227111	⤷ Start Trial
Australia	2012261499	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,216,183

Summary for Patent: 9,216,183