US Patent 11,760,760: Scope, Claims, Exclusivity, and Patent Landscape for Capivasertib Plus Fulvestrant
US Patent 11,760,760 protects the use of capivasertib, including specified chemical analogs, together with fulvestrant to treat breast cancer. The patent is directed to a combination-treatment method rather than a standalone composition-of-matter claim. Its commercial relevance is high because capivasertib is marketed by AstraZeneca as Truqap and is FDA-approved with fulvestrant for certain patients with HR-positive, HER2-negative advanced or metastatic breast cancer harboring qualifying AKT1, PIK3CA, or PTEN alterations.
The patent’s broadest claim covers a Markush genus of compounds used with fulvestrant. Claim 10 narrows the scope to capivasertib. Claim 11, as supplied, appears duplicative of claim 10 and should be checked against the issued patent text before relying on the transcription for claim-construction or litigation analysis.
What drug and therapeutic combination does US Patent 11,760,760 cover?
The patent covers the combination of:
| Component |
Covered product or agent |
| Endocrine therapy |
Fulvestrant |
| Targeted therapy |
Capivasertib, also known as AZD5363 |
| Disease |
Breast cancer |
| Patent type |
Method of treatment |
| Patent holder/assignee |
AstraZeneca-related entity |
| Patent |
US 11,760,760 |
| Issue date |
September 19, 2023 |
| Core commercial product |
Truqap, capivasertib tablets |
Capivasertib is an oral AKT inhibitor. Fulvestrant is an estrogen-receptor antagonist and degrader administered by intramuscular injection. The claimed combination reflects the clinical and regulatory use of AKT inhibition with endocrine therapy.
The FDA approved Truqap on November 16, 2023, in combination with fulvestrant for adults with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations after progression on at least one endocrine-based regimen in the metastatic setting or recurrence during or within 12 months after adjuvant therapy. The approval was based principally on the CAPItello-291 study (FDA, 2023a; FDA, 2023b).
What are the independent claims in US Patent 11,760,760?
The supplied claims contain three method-of-treatment claims of primary commercial importance.
Claim 1: Broad combination-treatment genus
Claim 1 requires:
- A person in need of treatment;
- Administration of a therapeutically effective amount of fulvestrant; and
- Administration of a therapeutically effective amount of a Formula (I) compound or pharmaceutically acceptable salt.
The Formula (I) genus includes compounds with:
- A pyrrolopyrimidine-type core;
- Variable ring nitrogen or carbon substitution through Y;
- A variable alkene or substituted alkene represented by Z1-Z2;
- Broad R1 side-chain options;
- Halogen, cyano, alkyl, and trifluoromethyl substitutions at R4 and R5;
- Multiple stereochemical configurations, subject to the narrower claims.
The claim is therefore not limited to capivasertib. It covers a structurally defined family of AKT-inhibitor compounds when used with fulvestrant for breast cancer.
Claim 10: Capivasertib species claim
Claim 10 narrows the compound to:
(S)-4-amino-N-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)piperidine-4-carboxamide
This is capivasertib, also designated AZD5363, or a pharmaceutically acceptable salt.
Claim 10 is the most direct patent claim covering the marketed Truqap-plus-fulvestrant regimen. A generic or other competitor seeking approval for the same combination could face infringement exposure even if it avoids other capivasertib composition patents.
Claim 11: Apparent duplicate species claim
The text supplied for claim 11 is identical to claim 10. That duplication may result from:
- A transcription error;
- Omission of a salt limitation;
- Omission of a dosage or administration limitation;
- Formatting loss when the chemical structure was copied; or
- An issued-claim numbering issue in the source used.
The exact issued claim language should control. The difference between “compound or pharmaceutically acceptable salt thereof” and the neutral free-base compound could materially affect infringement and validity analysis.
How broad is the Formula (I) Markush claim?
Claim 1 is materially broader than capivasertib. Its scope extends across several substituent classes.
| Variable |
Claimed scope |
| Y |
CH or N |
| Z1-Z2 |
C(R6)=CH |
| R6 |
H, F, Cl, Br, cyano, methyl, ethyl, difluoromethyl, trifluoromethyl, or cyclopropyl |
| n |
0, 1, or 2 |
| R1 |
Alkyl, alkenyl, alkynyl, alkoxy, aminoalkyl, hydroxyalkyl, cyanoalkyl, cycloalkyl, amide, sulfonamide, urea, amino, or aryl/heteroaryl-linked groups |
| R4 |
H, F, Cl, Br, cyano, or trifluoromethyl |
| R5 |
H, F, Cl, or Br |
The dependent claims narrow the genus in several ways:
- Claim 2 limits the compound to a specified configuration;
- Claim 3 limits Z1-Z2 to CH=CH;
- Claim 4 narrows the R1 substituent classes;
- Claim 5 limits R1 to a methylene-linked phenyl or selected heterocycle;
- Claim 6 specifically claims a hydroxyethyl R1 group;
- Claim 7 limits R4 to chloro or bromo;
- Claim 8 limits R5 to hydrogen;
- Claim 9 limits n to 0 or 1.
The claim architecture gives AstraZeneca multiple fallback positions. If the broad genus is challenged for written-description, enablement, or obviousness reasons, the capivasertib species and narrower stereochemical or substitution claims may remain separately relevant.
Does the patent claim capivasertib itself?
No. US 11,760,760 is principally a combination-use patent, not the foundational composition-of-matter patent for capivasertib.
The patent does claim capivasertib when administered with fulvestrant for breast cancer. It does not, based on the supplied claims, independently prohibit:
- Manufacturing capivasertib;
- Selling capivasertib for every indication;
- Administering capivasertib without fulvestrant;
- Administering capivasertib with an endocrine agent other than fulvestrant; or
- Treating a non-breast-cancer disease.
Those activities may implicate other AstraZeneca patents, regulatory exclusivities, labeling restrictions, or inducement theories.
What patent protects the underlying capivasertib molecule?
The foundational capivasertib estate is separate from US 11,760,760. AstraZeneca has held earlier patents directed to pyrrolopyrimidine AKT inhibitors, including capivasertib and related compounds. Those earlier patents may contain:
- Composition-of-matter claims;
- Salt and crystal-form claims;
- Pharmaceutical-composition claims;
- Synthetic-process claims;
- Broad therapeutic-use claims; and
- Combination claims involving endocrine therapy or other antineoplastic agents.
The composition-of-matter estate is generally more important for a generic seeking to market capivasertib because it can block a broad range of uses and labeling strategies. US 11,760,760 has narrower use-based relevance because it requires both fulvestrant and the claimed AKT-inhibitor compound.
Public patent records identify AstraZeneca-related ownership and prosecution activity for capivasertib compounds and therapeutic uses. The relevant family members should be analyzed as a portfolio rather than in isolation because the earliest composition patent, continuation patents, terminal disclaimers, patent-term adjustment, and Orange Book listings determine practical launch risk (USPTO, 2023).
What is the expected expiration date of US Patent 11,760,760?
The ordinary statutory expiration date is expected to fall in August 2037, based on the patent family’s priority timing. The practical date should be calculated from the complete prosecution record, including:
- Earliest effective nonprovisional priority date;
- Patent-term adjustment;
- Any terminal disclaimer;
- Patent-term extension;
- Pediatric exclusivity; and
- Orange Book listing data.
A working portfolio date for US 11,760,760 is August 2037. The FDA Orange Book, rather than the face of the patent alone, controls the regulatory timing analysis for an ANDA applicant addressing listed patents.
| Event |
Date or period |
| Patent issued |
September 19, 2023 |
| Expected ordinary expiration |
August 2037 |
| FDA capivasertib approval |
November 16, 2023 |
| Product |
Truqap |
| Combination in claim 10 |
Capivasertib plus fulvestrant |
| Likely commercial relevance |
Through the 2030s, subject to Orange Book and term adjustments |
What is the Orange Book status of US Patent 11,760,760?
US 11,760,760 is relevant to the Orange Book analysis for Truqap if it is listed against the approved capivasertib product and its approved method of use. Orange Book listing must be evaluated together with the patent’s use code and the approved labeling.
A method patent does not automatically block every generic version of capivasertib. Its impact depends on whether the proposed ANDA:
- Uses the patented capivasertib-plus-fulvestrant regimen;
- Carries a label that induces use of that regimen;
- Uses a “skinny label” excluding the patented indication;
- Challenges the patent with a Paragraph IV certification; or
- Delays approval until patent expiration.
For a product with an approved indication that substantially overlaps the claimed combination, a Paragraph IV certification would create litigation risk under the Hatch-Waxman Act. The filing of a Paragraph IV notice can trigger a 30-month FDA approval stay if the patent holder timely files an infringement action (FDA, 2023c).
When does capivasertib lose regulatory exclusivity?
Patent expiration and FDA regulatory exclusivity are separate.
For Truqap:
- FDA approval occurred on November 16, 2023.
- Small-molecule new chemical entity exclusivity generally lasts four years from approval.
- NCE exclusivity would therefore ordinarily expire in November 2027.
- ANDA approval may be available after the NCE period, subject to listed patents and other exclusivities.
- A generic launch could still be delayed by a listed patent expiring in or after 2037.
The product may also have three-year exclusivity associated with new clinical investigations supporting a new indication, depending on the FDA’s exclusivity determination. Orphan-drug exclusivity does not appear to be the primary protection for the approved Truqap indication.
Are there biosimilar risks for capivasertib?
No biosimilar pathway applies. Capivasertib is a chemically synthesized small molecule, not a biologic. Competitors would generally pursue an abbreviated new drug application under section 505(j), not a biosimilar application under the Public Health Service Act.
The relevant competitive risks are:
- ANDA-based generic entry;
- Paragraph IV patent challenges;
- Label-carve-out strategies;
- Authorized-generic strategies;
- Alternative AKT inhibitors; and
- Competing PI3K, mTOR, CDK4/6, and endocrine therapies.
What generic launch scenarios exist?
Scenario 1: Full-label generic challenge
A generic applicant seeks approval for capivasertib with the breast-cancer indication that includes fulvestrant. This creates the clearest infringement risk under claim 10 and any listed composition-of-matter patents.
Scenario 2: Skinny-label launch
The applicant removes the patented fulvestrant indication from its labeling. This strategy may reduce direct infringement risk but does not eliminate exposure if the remaining label, promotional activity, or clinical use encourages the patented combination.
Scenario 3: Paragraph IV challenge
The applicant argues that US 11,760,760 is invalid, not infringed, or unenforceable. Likely grounds could include:
- Obviousness based on fulvestrant plus prior AKT inhibitors;
- Lack of written description for the broad Markush genus;
- Lack of enablement across the full genus;
- Claim construction limiting the chemical scope;
- Failure to meet method-of-treatment requirements; or
- Noninfringement based on the proposed label.
Scenario 4: Post-expiration entry
A generic waits until the relevant listed patent and regulatory barriers expire. This minimizes litigation cost but sacrifices first-filer advantages and delays market entry.
How strong is the patent estate?
The estate has different strength levels by claim category.
| Claim category |
Relative strength |
Reason |
| Capivasertib composition claims |
High, if unexpired and properly listed |
Directly cover the active molecule |
| Capivasertib plus fulvestrant method claim |
Moderate to high |
Directly tracks the approved combination |
| Broad Formula (I) genus |
Moderate |
Broad coverage creates written-description and enablement pressure |
| Narrow capivasertib species |
Stronger than genus |
Specific structure is easier to identify and enforce |
| Formulation claims |
Product-specific |
Strength depends on whether a commercial dosage form is claimed |
| Manufacturing claims |
Variable |
May create process barriers but usually do not block use of a non-infringing process |
| Biomarker-defined treatment claims |
Potentially strong commercially |
Closely aligned with the FDA-approved patient population |
The main weakness of US 11,760,760 is that the broadest claim reaches a large chemical genus while the commercial product is a single species. The main strength is that the narrower claim directly identifies capivasertib in combination with fulvestrant, closely matching the approved regimen.
Are formulation and manufacturing patents important?
They may be, but they are not apparent from the supplied claims. The claims provided do not recite:
- A tablet formulation;
- Specific excipients;
- Particle size;
- Polymorph or crystalline form;
- Dissolution profile;
- Solid dispersion;
- Coated dosage form;
- Synthetic intermediate; or
- Manufacturing process.
A complete freedom-to-operate review should therefore separate US 11,760,760 from other patent families covering capivasertib solid forms, pharmaceutical compositions, and processes. A generic may avoid a formulation or process patent while still infringing the combination-use claim, or may avoid the combination-use claim while remaining blocked by a composition patent.
What litigation or settlement activity affects the patent?
The supplied record does not identify litigation, a Paragraph IV notice, or a settlement involving US 11,760,760. The patent was issued after Truqap’s FDA approval and would become a likely target for future ANDA challenges if capivasertib generic development advances.
No conclusion about enforceability should be drawn solely from the absence of a reported case. The relevant litigation questions would include:
- Whether AstraZeneca listed the patent in the Orange Book;
- Whether the listing includes a method-of-use code;
- Whether an ANDA applicant filed a Paragraph IV certification;
- Whether a 30-month stay was triggered;
- Whether any settlement restricted launch timing; and
- Whether the settlement was submitted to the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act.
What geographic coverage does the patent provide?
US 11,760,760 provides rights only in the United States. Corresponding patent-family members may exist in Europe, Japan, China, Canada, Australia, and other markets, but each jurisdiction has separate:
- Claim scope;
- Prosecution history;
- Patent-term calculation;
- Supplementary protection certificate rules;
- Invalidity standards;
- Regulatory linkage rules; and
- Litigation status.
A US method patent cannot directly prevent a foreign manufacturer from making capivasertib outside the United States unless related foreign rights apply or the conduct satisfies US importation or contributory-infringement rules.
Key Takeaways
- US 11,760,760 is a combination-treatment patent covering fulvestrant with Formula (I) AKT-inhibitor compounds.
- Claim 10 specifically covers capivasertib with fulvestrant for breast cancer.
- The patent does not, based on the supplied claims, independently claim capivasertib as a molecule.
- The broad Markush genus creates wide theoretical coverage but faces greater validity pressure than the narrow capivasertib species.
- The expected ordinary expiration is in August 2037, subject to the official patent-term and Orange Book records.
- Truqap received FDA approval on November 16, 2023.
- Small-molecule generic applicants, not biosimilar applicants, present the relevant competitive threat.
- A full-label ANDA challenge would create the highest infringement risk.
- A skinny-label strategy could reduce risk but would not automatically avoid induced-infringement exposure.
- The supplied versions of claims 10 and 11 appear duplicative and should not be used as the controlling issued text without checking the official patent document.
FAQs About US Patent 11,760,760 and Truqap
Does US Patent 11,760,760 cover fulvestrant alone?
No. The supplied claims require fulvestrant together with a Formula (I) compound, including capivasertib.
Is capivasertib the same compound named in claim 10?
Yes. The chemical name in claim 10 corresponds to capivasertib, also known as AZD5363.
Can a generic sell capivasertib for a non-breast-cancer indication?
Possibly, but other composition, use, formulation, or regulatory barriers may apply. US 11,760,760 alone is directed to breast-cancer treatment with fulvestrant.
Does a patent on the fulvestrant combination block all capivasertib products?
No. The patent’s supplied claims require the claimed combination. Separate capivasertib composition patents may have broader product-level effect.
What is the principal invalidity risk for claim 1?
The principal technical risks are the breadth of the Markush genus and whether the specification adequately supports and enables the full claimed chemical and therapeutic scope. The narrow capivasertib claim is less exposed to those genus-wide objections.
References
-
AstraZeneca. (2023). Truqap (capivasertib) prescribing information. U.S. Food and Drug Administration.
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U.S. Food and Drug Administration. (2023a, November 16). FDA approves capivasertib with fulvestrant for breast cancer. https://www.fda.gov/
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U.S. Food and Drug Administration. (2023b). FDA grants accelerated approval to capivasertib with fulvestrant for breast cancer. https://www.fda.gov/
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U.S. Food and Drug Administration. (2023c). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.
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U.S. Patent and Trademark Office. (2023). U.S. Patent No. 11,760,760: Combination therapies for the treatment of breast cancer. Patent Center.
