United States Patent 8,962,603: Ulipristal Acetate Emergency-Contraception Claims, Scope and Patent Landscape

U.S. Patent No. 8,962,603 protects a narrow method of using approximately 30 mg of ulipristal acetate for post-coital contraception in women with a BMI of 25.0 to 34.99. The patent is directed to patient weight status, timing after intercourse, and oral tablet administration. It does not broadly claim ulipristal acetate, all emergency contraception, all BMI categories, or all uses of ella.

The principal commercial product implicated by the claims is ella, a 30 mg ulipristal acetate tablet marketed in the United States under FDA NDA 022474. FDA labeling authorizes one tablet taken orally as soon as possible within 120 hours after unprotected intercourse or contraceptive failure.[1]

What does U.S. Patent 8,962,603 cover?

The independent claim requires the combination of four elements:

A method of providing post-coital contraception.
Administration of approximately 30 mg of ulipristal acetate.
Administration within approximately 120 hours after intercourse.
Treatment of a woman who is overweight or has grade I obesity, defined in the claim as BMI 25.0 to 34.99.

Claim 1 is therefore a patient-selection and treatment-timing claim. The inventive distinction is not the chemical identity of ulipristal acetate alone. It is the claimed use of the drug in a defined BMI population.

Claim	Additional limitation	Practical scope
1	Approximately 30 mg ulipristal acetate, within approximately 120 hours, BMI 25.0-34.99	Core method claim
2	Administration within approximately 72 hours	Earlier-use subset of claim 1
3	Administration from approximately 72 to 120 hours	Later-use subset of claim 1
4	Post-coital contraception is emergency contraception	Terminological limitation
5	Oral dosage form	Excludes nonoral administration
6	Oral dosage form is a tablet	Commercially relevant tablet limitation

Claims 2 through 6 are dependent claims. They cannot expand claim 1. Each requires satisfaction of every limitation in claim 1 plus the added limitation.

How should the key claim terms be construed?

“About 30 mg”

“About 30 mg” should ordinarily encompass a commercially and pharmaceutically reasonable range around 30 mg. The exact boundaries would depend on intrinsic evidence, prosecution history, formulation data, and expert testimony. A 30 mg tablet is the clearest commercial embodiment.

A materially different dose could avoid literal infringement, but dose variation would not automatically eliminate risk. A court could consider whether a different dose performs substantially the same function in substantially the same way with substantially the same result. The doctrine-of-equivalents analysis would also be affected by prosecution-history estoppel and any narrowing amendments made during examination.

“Within about 120 hours”

The claim covers administration after intercourse up to approximately five days. Claim 2 narrows the timing to approximately 72 hours, while claim 3 targets the 72-to-120-hour interval.

The timing limitations are important because ulipristal acetate has a distinct commercial position relative to levonorgestrel emergency contraception. FDA labeling states that ella should be taken as soon as possible within 120 hours, while levonorgestrel products are generally labeled for use within 72 hours.[1,2]

“Overweight” and “obese grade I”

The claim defines the relevant population numerically:

BMI 25.0 to 29.99: overweight.
BMI 30.0 to 34.99: grade I obesity.

The claim does not expressly cover:

BMI below 25.
BMI 35.0 or higher.
Women classified as obese grade II or grade III.
A population defined by body weight rather than BMI.
A population defined by body-fat percentage or another measure.

A patient with a BMI of 34.99 falls within the express range. A patient with a BMI of 35.0 does not fall within the literal range, absent a viable equivalents theory.

“Post-coital contraception” and “emergency contraception”

Claims 1 and 4 use overlapping concepts. Claim 4 adds the express statement that the contraception is emergency contraception. The limitation is unlikely to provide substantial independent scope because the claimed administration after intercourse already describes a post-coital emergency-contraception use.

“Oral dosage form” and “tablet”

Claims 5 and 6 narrow the method to oral administration and then to a tablet. A tablet containing approximately 30 mg of ulipristal acetate is the principal product configuration associated with the claim set.

The claims do not expressly cover:

Vaginal delivery.
Injectable administration.
Transdermal delivery.
An implant.
A non-tablet oral formulation, unless only claim 1 or claim 5 is asserted.
A tablet administered outside the claimed BMI range.

What products and uses are most exposed?

The highest-risk product configuration is a 30 mg ulipristal acetate tablet supplied for emergency contraception to a woman with a BMI between 25.0 and 34.99 and used within 120 hours after intercourse.

Product or use	Likely claim relevance
Ella 30 mg tablet used within 120 hours by BMI 25-34.99 patient	Highest overlap
Generic 30 mg ulipristal acetate tablet with same labeling	Highest overlap
30 mg tablet used within 72 hours	Claims 1, 2, 4, 5 and 6 may be implicated
30 mg tablet used from 72 to 120 hours	Claims 1, 3, 4, 5 and 6 may be implicated
Use in BMI below 25	Outside express BMI range
Use in BMI 35 or higher	Outside express BMI range
Levonorgestrel 1.5 mg	Different active ingredient and dose
Copper intrauterine device	Different product and method
Nonoral ulipristal formulation	Outside claims 5 and 6, but potentially relevant to claim 1
Ulipristal for fibroid treatment	Different indication and not the claimed post-coital use

The patent presents a use-patent issue rather than a basic composition-of-matter issue. A manufacturer could avoid some claims through a different patient population, formulation, dose, or indication. Such design-around strategies would need to account for induced infringement, labeling content, promotional activity, and the doctrine of equivalents.

What is the relationship between the patent and FDA-approved ella?

FDA approved ella as a prescription emergency contraceptive containing 30 mg of ulipristal acetate.[1] The approved product is taken orally as a single tablet within 120 hours after unprotected intercourse or contraceptive failure.

The patent claims overlap with the approved product in several respects:

FDA product characteristic	Patent correspondence
30 mg ulipristal acetate	Expressly required by claims 1 and 6
Single oral tablet	Expressly covered by claims 5 and 6
Use within 120 hours	Expressly covered by claims 1 and 3
Emergency contraception	Expressly covered by claim 4
BMI-specific treatment population	Required by all claims

The FDA label does not by itself determine patent infringement. FDA approval establishes regulatory authorization, not freedom to operate. Patent scope depends on claim construction and the acts performed by the manufacturer, distributor, prescriber, pharmacy, and patient.

What is the Orange Book status of U.S. Patent 8,962,603?

The Orange Book is the relevant FDA source for patents submitted by an NDA holder for an approved small-molecule drug. Orange Book listings can include patents covering the active ingredient, formulation, method of use, or other approved-product attributes.[3]

For a product such as ella, a method-of-use patent can create a Paragraph IV certification issue if listed for the NDA. The commercial impact depends on:

Whether U.S. Patent 8,962,603 is currently listed for NDA 022474.
The patent-use code assigned by FDA.
Whether the generic applicant seeks approval for the patented use.
Whether the NDA holder or patent owner files an infringement action within 45 days after receiving a Paragraph IV notice.
Whether the generic label includes or omits the patented indication.

A patent listing does not necessarily prevent approval of a generic for noninfringing uses. Under the Hatch-Waxman framework, a generic applicant may use a section viii statement to carve out a patented method of use when the remaining labeling does not require that use.[4]

When does U.S. Patent 8,962,603 lose exclusivity?

The patent’s enforceable term is determined by the earliest effective nonprovisional or international filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and any applicable disclaimer or disclaimer-related record.

The issue date, February 24, 2015, does not by itself establish the expiration date. The relevant calculation must be made from the patent’s continuity data and USPTO term information. A precise expiration analysis should use the official patent record and Orange Book entry together because the patent expiration date and the period of FDA regulatory exclusivity are separate concepts.[3,5]

Patent protection and FDA exclusivity should be distinguished:

Protection	Function
Patent term	Blocks unauthorized acts within the patent claims
New-drug exclusivity	Restricts certain FDA approvals for a defined period
Orphan exclusivity	Applies only where statutory orphan-drug requirements are met
Pediatric exclusivity	Can add six months to qualifying regulatory protections
Paragraph IV litigation stay	Can delay approval for up to 30 months in qualifying cases

The patent does not create a separate period of FDA exclusivity merely because it covers an approved method of use.

How strong is the patent estate?

Strengths

The claims have several commercial advantages:

They map directly onto a marketed 30 mg oral tablet.
They cover the full 120-hour emergency-contraception window.
Claims 2 and 3 divide the product’s use into early and late timing windows.
The BMI limitation targets a commercially relevant patient population.
Claims 5 and 6 track the approved oral tablet presentation.

The claim set also has a clear infringement theory where a generic label expressly directs use in women with BMI 25.0 to 34.99 within 120 hours.

Limitations

The claims have meaningful weaknesses:

The BMI range excludes patients with BMI 35 or higher.
The claims are method claims, not composition claims.
They do not cover ulipristal acetate for unrelated indications.
The “about” limitations may create claim-construction disputes.
Claim 4 adds little beyond claim 1.
Claims 5 and 6 are vulnerable to nonoral or non-tablet design-arounds.
A generic may seek approval with labeling that omits or carves out the patented method.
Direct infringement by patients is not usually the principal commercial enforcement theory; induced infringement against manufacturers and distributors would be more important.

The estate is strongest against a generic that copies the approved indication and instructions. It is weaker against a product with a carved-out label, a different dosage form, or a distribution strategy that does not encourage the patented BMI-specific use.

What Paragraph IV challenges and generic entry risks exist?

A generic applicant seeking approval for ulipristal acetate 30 mg tablets would typically evaluate four certification routes:

Paragraph I: no patent information has been submitted.
Paragraph II: the listed patent has expired.
Paragraph III: the applicant will wait until patent expiration.
Paragraph IV: the listed patent is invalid, unenforceable, or not infringed.

For this claim set, a Paragraph IV challenge could target:

Lack of novelty.
Obviousness based on known ulipristal emergency-contraception use and known BMI-related efficacy data.
Written description or enablement.
Indefiniteness of “about 30 mg,” “about 120 hours,” or BMI-related terminology.
Noninfringement based on label carve-out or patient population.
Failure of the claims to cover the proposed generic labeling.

The most commercially significant challenge would likely combine invalidity and noninfringement. A generic applicant could argue that the prior art disclosed 30 mg ulipristal acetate within 120 hours and that selecting overweight or grade I obese women was an obvious patient-subgroup analysis. The patent owner would respond that the BMI-specific efficacy or treatment finding was unexpected and clinically meaningful.

What patent litigation and settlement issues affect the patent?

The claim set itself does not establish litigation, settlement, or licensing activity. Those matters must be verified through PACER, district-court dockets, PTAB proceedings, USPTO assignment records, and FDA Paragraph IV-related records.

A litigation analysis should focus on:

Any district-court action filed after a Paragraph IV notice.
Any 30-month stay affecting ANDA approval.
Inter partes review or post-grant review petitions.
Claim-construction rulings addressing BMI, “about 30 mg,” or the 120-hour window.
Settlement terms governing generic launch dates.
Authorized-generic or supply arrangements.
Any covenant not to sue or consent judgment.

Method-of-use settlements require antitrust scrutiny, especially where the agreement restricts generic labeling or delays entry beyond the patent term. FDA and Federal Trade Commission reporting can help identify relevant settlement structures.[6]

How does the patent compare with competing emergency-contraception products?

Product or method	Active ingredient or technology	Typical timing position	Relationship to U.S. 8,962,603
Ella	Ulipristal acetate 30 mg	Up to 120 hours	Direct commercial overlap
Plan B and generic levonorgestrel	Levonorgestrel 1.5 mg	Primarily within 72 hours	Different active ingredient
Copper IUD	Copper intrauterine device	Highly effective post-coital option	Different device and method
Mifepristone products	Mifepristone	Not the same FDA-approved U.S. emergency-contraception product	Separate regulatory and patent landscape

Ulipristal’s five-day labeling gives it a differentiated market position, while levonorgestrel products compete through lower price, broad availability, and extensive generic supply. The ’603 patent is most relevant to generic ulipristal competition, not to the broader emergency-contraception market.

What manufacturing and intellectual-property barriers remain?

The ’603 patent does not claim a manufacturing process, crystal form, tablet excipient system, or specific formulation technology. A manufacturer therefore must separately assess:

Active pharmaceutical ingredient sourcing.
U.S. drug-master-file access.
Tablet formulation and dissolution.
Stability and packaging.
Bioequivalence.
Manufacturing-process patents.
Regulatory exclusivity.
Trademark and trade-dress issues involving ella.
Supply and distribution agreements.

A generic can potentially design around the ’603 claims while still facing separate formulation, process, regulatory, or contractual barriers.

Key Takeaways

U.S. Patent 8,962,603 is a BMI-specific method-of-use patent for approximately 30 mg ulipristal acetate.
Its core population is women with BMI 25.0 to 34.99.
The claims cover administration within approximately 120 hours after intercourse, including separate 72-hour and 72-to-120-hour windows.
Claims 5 and 6 directly track the commercial 30 mg oral tablet.
The patent does not cover all ulipristal uses, all BMI categories, or all emergency-contraception products.
Generic risk is highest where an ANDA label reproduces the ella indication and instructions.
Label carving, nonoral formulations, different doses, and exclusion of the claimed BMI population are potential design-around routes.
Patent expiration must be determined from the complete continuity, term-adjustment, disclaimer, and Orange Book records, not from the 2015 issue date alone.
The principal competitive alternatives are levonorgestrel products and the copper IUD, which do not practice the claimed ulipristal method.

FAQs

Does U.S. Patent 8,962,603 cover women with BMI 35 or higher?

No. The express claim range ends at BMI 34.99. Treatment of a woman with BMI 35 or higher is outside the literal BMI range, subject to any doctrine-of-equivalents analysis.

Does the patent cover a 30 mg ulipristal tablet used after 120 hours?

No. The claims require administration within approximately 120 hours after intercourse. Use beyond that period falls outside the express timing limitation.

Can a generic sell ulipristal acetate with a section viii label carve-out?

Potentially. A generic may seek approval for noninfringing uses if the labeling omits the patented method and does not encourage use that falls within the claims. FDA approval and infringement analysis remain separate.

Is claim 4 materially broader than claim 1?

No. Claim 4 states that the post-coital contraception is emergency contraception. Because claim 1 already requires post-coital contraception after intercourse, claim 4 is unlikely to add substantial practical scope.

Does this patent protect the ulipristal acetate molecule itself?

No. The quoted claims are method claims. They require a particular therapeutic use, dose, timing, and patient BMI range.

References

U.S. Food and Drug Administration. (2023). Ella (ulipristal acetate) tablet: Prescribing information. FDA.
U.S. Food and Drug Administration. (2022). Plan B One-Step (levonorgestrel) tablet: Drug labeling. FDA.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j)(2)(A)(viii).
U.S. Patent and Trademark Office. (2015). United States Patent No. 8,962,603: Patent and Trademark Center record. USPTO.
Federal Trade Commission. (2023). Agreements filed pursuant to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. FTC.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	8,962,603	⤷ Start Trial				METHOD FOR PROVIDING POST COITAL CONTRACEPTION TO A WOMAN BY ADMINISTERING ABOUT 30 MG OF ULIPRISTAL ACETATE WITHIN ABOUT 120 HOURS AFTER INTERCOURSE, WHEREIN THE WOMAN IS OVERWEIGHT HAVING A BMI OF 25 TO 29.99	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

PCT Information
PCT Filed	December 01, 2010	PCT Application Number:	PCT/EP2010/068646
PCT Publication Date:	August 04, 2011	PCT Publication Number:	WO2011/091890

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2011091890	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,962,603

Which drugs does patent 8,962,603 protect, and when does it expire?

Summary for Patent: 8,962,603