US Patent 9,241,915: Ospemifene Food-Effect Claims, Patent Scope, Expiry and Generic Risk

US Patent No. 9,241,915 protects the oral administration of ospemifene with food to enhance bioavailability. Its commercially relevant protection is a method-of-use claim covering ospemifene administered orally in connection with food intake, with dependent claims defining a narrower timing window and therapeutic uses. The patent does not claim ospemifene as a chemical compound, a tablet composition, or a manufacturing process.

The patent is strategically important because the FDA-approved Osphena label directs patients to take ospemifene with food. That labeling creates a potential infringement pathway for an ANDA applicant whose proposed labeling preserves the same food-administration instruction. The patent therefore presents a use-patent issue rather than a conventional active-ingredient or formulation-patent barrier.

What does US Patent 9,241,915 cover?

US 9,241,915 covers a method for increasing the bioavailability of a therapeutically active compound by administering it orally in connection with food. Claim 2 identifies ospemifene as the relevant compound.

The claim hierarchy is:

Claim	Scope
1	Oral administration of a compound of formula (I), or a permitted isomer, stereoisomer, salt, ester or metabolite, in connection with food intake to enhance bioavailability
2	Claim 1 limited to ospemifene
3	Administration from one hour before food begins through two hours after food begins
4	Administration during food intake through one hour after food begins
5	Administration during food intake through no later than 0.5 hour after food begins
6	Food capable of causing bile-acid secretion
7	Treatment of osteoporosis
8	Treatment of skin, epithelial or mucosal atrophy
9	Urinary or vaginal symptoms associated with the conditions in claim 8

The commercial core is claim 2. Claims 3 through 5 narrow the administration timing. Claims 7 through 9 narrow the therapeutic indication.

The exact chemical genus in claim 1 depends on the structural definition of formula (I) in the patent specification. Based on the claims provided, the broadest claim is not limited to ospemifene. The issued claim set, however, makes ospemifene the principal commercial subject through claim 2.

What is the legal status and expiration date of US 9,241,915?

US 9,241,915 was granted on January 26, 2016. The patent is a US method-of-treatment patent with a statutory term extending into 2029. Public patent-family records identify a March 2008 priority basis and an expected expiration in March 2029, subject to any applicable patent-term adjustment or terminal-disclaimer information in the USPTO patent record.[1]

Field	Data
Patent	US 9,241,915 B2
Title	Method for enhancing the bioavailability of ospemifene
Grant date	January 26, 2016
Technology	Food-effect administration of ospemifene
Patent type	Method of treatment and administration
Principal product	Osphena, ospemifene tablets
Expected statutory expiry	March 2029
Primary jurisdiction	United States
Relevant regulatory pathway	ANDA Paragraph IV and section viii analysis

The patent should be analyzed together with the USPTO Patent Center record and the FDA Orange Book because the effective expiration date can be affected by patent-term adjustment, terminal disclaimers and listing corrections.[2][3]

What is the claim scope for ospemifene administration with food?

Claim 2 requires four principal elements:

The active compound is ospemifene.
Ospemifene is administered orally.
Administration occurs in connection with food intake.
The purpose is enhancement of bioavailability.

A product label that instructs patients to take ospemifene with food can supply evidence for the administration element and the food-related purpose. The claim does not require a particular meal, calorie level, fat content, tablet strength or excipient system unless those limitations are imported from a dependent claim or the specification.

Claim 2 is broader than claims 3 through 5 because it does not expressly impose the one-hour-before or two-hour-after timing limits. A generic product administered orally with food could therefore implicate claim 2 even if its labeling does not adopt the narrower preferred timing range.

How do the timing claims narrow the patent?

Claim 3 covers administration from one hour before food intake begins until two hours after food intake begins.

Claim 4 narrows that range to administration during food intake through one hour after food intake begins.

Claim 5 narrows it further to administration during food intake through no later than 30 minutes after food intake begins.

The timing claims create a layered enforcement structure:

Timing condition	Claim exposure
Oral ospemifene taken with food, without a stated time	Claim 2
One hour before to two hours after food starts	Claim 3
During food through one hour after food starts	Claim 4
During food through 30 minutes after food starts	Claim 5

A generic label that says "take with food" may read directly on claim 2 while leaving an infringement dispute over claims 3 through 5 unless the label or prescribing information specifies a narrower time period.

What therapeutic uses are protected?

Claim 7 covers osteoporosis treatment. Claims 8 and 9 cover atrophy-related conditions, including urinary and vaginal symptoms.

The commercially significant indication is treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause, consistent with the FDA-approved Osphena indication.[4] Claim 9 is potentially relevant because it expressly reaches urinary or vaginal symptoms. The claim language supplied does not expressly recite dyspareunia, so claim construction would determine whether the FDA-labeled indication falls within the urinary or vaginal symptom limitation.

The patent does not cover every use of ospemifene. It is limited by the food-administration and bioavailability elements in claim 1 and the dependent therapeutic limitations.

Is US 9,241,915 an Orange Book patent?

The patent is relevant to Orange Book analysis because the approved Osphena labeling requires administration with food. FDA Orange Book listings identify patents and use codes submitted by the NDA holder, but an Orange Book listing does not itself establish infringement or patent validity.[2]

For an ospemifene ANDA, the key questions are:

Whether US 9,241,915 is listed against Osphena.
Whether the listed use code covers food-effect administration, a labeled indication, or both.
Whether the ANDA applicant seeks approval for the patented method.
Whether the applicant files a Paragraph IV certification or a section viii statement.

The label instruction "Take one 60 mg tablet with food once daily" is central to the analysis because it tracks the patented administration concept and the approved dosing instruction.[4]

An applicant that seeks a fully labeled generic version of Osphena is more likely to face a Paragraph IV issue if the patent remains listed and unexpired. An applicant that omits a patented indication or administration instruction may pursue a section viii carve-out, but a carve-out must be consistent with the proposed labeling and the statutory requirements for approval.

What Paragraph IV challenges and generic entry risks exist?

The principal generic-entry risk is a method-of-use challenge rather than a challenge to the ospemifene molecule itself.

Under the Hatch-Waxman framework, an ANDA applicant can certify that a listed patent is invalid, unenforceable or will not be infringed. A Paragraph IV certification can trigger patent litigation under 21 U.S.C. § 355(j)(5)(B)(iii), potentially creating a 30-month stay of approval if the NDA holder or patent owner files suit within the statutory period.[5]

The main generic scenarios are:

Generic strategy	Effect on US 9,241,915
Full Osphena label, including administration with food	Highest exposure to claim 2
Label with timing language matching the patent	Exposure to claims 2 through 5
Section viii carve-out of a patented indication	May reduce exposure to claims 7 through 9
Label that omits food administration	Could avoid literal label-based infringement, but may conflict with approved dosing and bioavailability requirements
Alternative formulation with different food behavior	Does not automatically avoid method claims if administered orally with food
Product approved for a non-patented use only	Potentially lower exposure, depending on label language and actual marketing conduct

The patent does not automatically prevent approval of every ospemifene product. Its practical effect depends on the scope of the ANDA label and the patent certifications filed by the applicant.

Does the patent protect a formulation or manufacturing process?

No. The supplied claims do not claim:

A particular ospemifene tablet composition.
A specific excipient.
Particle size or polymorph.
Coating technology.
Dissolution profile.
Manufacturing process.
Packaging configuration.
A fixed dose independent of food.
A food composition or nutritional product.

Claim 6 refers to food capable of causing bile-acid secretion. That is a functional limitation on the food associated with administration. It does not claim the food itself or a pharmaceutical formulation containing bile acids.

A generic manufacturer could therefore develop a different tablet composition without avoiding the patent if its product is still administered orally with food in a manner covered by the method claims.

How strong is the patent estate for Osphena?

The estate is stronger as a labeled-use barrier than as a broad product barrier.

Estate component	Strategic value
Ospemifene compound patents	Protect the active ingredient during their terms; older core protection may have expired
Use patents for vaginal atrophy or related symptoms	Can restrict approval or marketing for specific indications
US 9,241,915 food-effect patent	Can attach patent risk to the labeled administration instruction
Formulation patents	No formulation protection appears in the supplied claim set
Manufacturing patents	No manufacturing protection appears in the supplied claim set
Regulatory exclusivity	Separate from patent rights and generally shorter than the asserted patent term

The patent's strongest feature is the alignment between the claim language and the product label. Its principal weakness is that it does not control the ospemifene molecule, tablet technology or every possible therapeutic use. A competitor that can obtain approval without adopting the patented administration instruction may have a narrower design-around path.

What other ospemifene patents are relevant?

US 9,241,915 should be reviewed with the broader Osphena patent family and other ospemifene use patents. US Patent No. 8,541,451 is associated with ospemifene treatment for vulvar and vaginal atrophy and represents a separate use-patent layer.[6]

Patent category	Relevance to Osphena
Core ospemifene compound patents	Historical composition-of-matter protection
Vulvar and vaginal atrophy use patents	Protection for the principal commercial indication
Food-effect patent, US 9,241,915	Administration with food to enhance bioavailability
Dosage and regimen patents	Potential protection for dose or frequency
Formulation patents	Relevant only if separately issued and listed
Process patents	Potential manufacturing barrier, generally less relevant to ANDA labeling

The principal freedom-to-operate question is not whether a generic can manufacture ospemifene. It is whether the generic can obtain approval and market the product without practicing an unexpired, listed method claim.

What litigation and settlement issues affect the patent?

A Paragraph IV notice concerning US 9,241,915 could lead to litigation by the NDA holder, patent owner or an exclusive licensee. The likely causes of action would be induced infringement based on the proposed ANDA label and, depending on the facts, contributory infringement or direct infringement theories.

The key litigation issues would include:

Whether "in connection with the intake of food" requires a specific temporal relationship.
Whether a "take with food" instruction satisfies the bioavailability-enhancement limitation.
Whether the claimed purpose is a limiting claim element.
Whether the patent is enabled across the full formula (I) genus.
Whether the asserted claims are anticipated or obvious based on ospemifene food-effect data.
Whether the patent adequately supports the claimed timing ranges.
Whether the patent is enforceable against an ANDA applicant using a section viii carve-out.

A settlement could permit an agreed generic launch date before patent expiry, but the supplied information does not establish a particular settlement, authorized generic arrangement or final court judgment involving US 9,241,915. Patent litigation databases, FDA records and the USPTO assignment and maintenance records should be read together when assessing a specific applicant.

Is biosimilar risk relevant to ospemifene?

No. Ospemifene is a small-molecule drug, not a biologic. The relevant competitive pathway is an ANDA for a generic drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act, not a biosimilar application under the Biologics Price Competition and Innovation Act.

Bioequivalence, labeling, patent certification and potential therapeutic-equivalence ratings are the principal regulatory issues. Biosimilar interchangeability standards do not apply.

What is the commercial exposure from the patent?

The commercial exposure is concentrated in the US Osphena market and in generic approval for the same indication. A generic applicant may be unable to reproduce the full approved label without addressing the food-effect patent. That can delay approval, require a Paragraph IV strategy or force a narrower label.

The patent has less leverage over:

Non-US markets, unless corresponding national patents remain active.
Non-labeled research use.
Alternative products not marketed as ospemifene.
A formulation sold for a use and administration method outside the asserted claims.
Products approved with a legally effective label carve-out.

Geographic coverage is jurisdiction-specific. A US patent cannot block a product sold solely outside the United States, and corresponding foreign family members must be assessed separately by country.

Key Takeaways

US 9,241,915 is a method-of-use patent focused on administering ospemifene orally with food.
Claim 2 is the core commercial claim because it covers ospemifene without the narrower timing limitations in claims 3 through 5.
Claims 3 through 5 define progressively narrower administration windows, ending at no later than 30 minutes after food begins.
Claims 7 through 9 cover osteoporosis, atrophy-related symptoms and urinary or vaginal symptoms.
The patent does not claim the ospemifene molecule, tablet formulation or manufacturing process.
The patent's commercial strength comes from the FDA label's instruction to take Osphena with food.
Generic applicants face a potential Paragraph IV issue if they seek the full Osphena label while the patent remains listed and unexpired.
Ospemifene is a small molecule, so biosimilar rules do not apply.
The expected US patent term extends into March 2029, subject to the USPTO's final term calculation.
The patent is a meaningful labeled-use barrier but does not create a complete product-level monopoly over ospemifene.

FAQs About US Patent 9,241,915

Does US 9,241,915 prevent generic ospemifene approval?

No. It can delay or complicate approval of a generic seeking the full Osphena label, but an applicant may challenge the patent under Paragraph IV or pursue a legally compliant section viii carve-out.

Can a generic avoid the patent by using a different tablet formulation?

Not necessarily. A different formulation may avoid separate formulation claims, but it does not avoid a method claim if the product is administered orally with food in the claimed manner.

Does the patent cover taking ospemifene after a meal?

Claim 2 does not state a precise timing period. Claims 3 through 5 impose increasingly specific windows after food begins. Whether a particular post-meal instruction infringes depends on the claim and the facts of administration.

Is ospemifene subject to biosimilar competition?

No. Ospemifene is a small-molecule drug. Competition proceeds through the generic ANDA pathway.

Can the patent be enforced outside the United States?

US 9,241,915 has territorial effect only in the United States. Foreign enforcement depends on corresponding patents in each country and their individual claim scope, validity and expiration dates.

References

United States Patent and Trademark Office. (2016). US Patent No. 9,241,915 B2: Method for enhancing the bioavailability of ospemifene.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
United States Patent and Trademark Office. (n.d.). Patent Center: Patent prosecution and patent-term information.
U.S. Food and Drug Administration. (2020). Osphena (ospemifene) prescribing information.
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).
United States Patent and Trademark Office. (2013). US Patent No. 8,541,451: Ospemifene for the treatment of vulvar and vaginal atrophy.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1713458	⤷ Start Trial	CA 2015 00031	Denmark	⤷ Start Trial
European Patent Office	1713458	⤷ Start Trial	C300742	Netherlands	⤷ Start Trial
European Patent Office	1713458	⤷ Start Trial	92736	Luxembourg	⤷ Start Trial
European Patent Office	1713458	⤷ Start Trial	PA2015023	Lithuania	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,241,915

Summary for Patent: 9,241,915