Details for Patent: 11,207,311

Which drugs does patent 11,207,311 protect, and when does it expire?

Patent 11,207,311 protects AKEEGA and is included in one NDA.

This patent has fifty-two patent family members in thirty-five countries.

Summary for Patent: 11,207,311

Title:	Method of treating prostate cancer
Abstract:	Disclosed are methods of treating prostate cancer by administering niraparib to a human in need thereof.
Inventor(s):	Marco Gottardis, Rebecca Hawkins, Linda A Snyder, Douglas H Yamada
Assignee:	Janssen Pharmaceutica NV
Application Number:	US16/131,772
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

US Patent 11,207,311: Niraparib Prostate Cancer Claims, Patent Scope, Expiration and Generic Risk

US Patent 11,207,311 protects selected methods of treating antiandrogen-resistant prostate cancer with niraparib, including castration-resistant and metastatic castration-resistant prostate cancer. Its broadest claim covers patients who are not BRCA deficient, while separate claim paths cover patients with specified DNA-repair anomalies, including FANCA, PALB2, CHEK2, BRIP1, HDAC2 and ATM.

The patent is a method-of-use patent. It does not claim niraparib as a chemical compound, a general PARP inhibitor, or a niraparib tablet formulation. Its commercial significance depends on whether a competing product is marketed for the claimed prostate cancer population and dosing regimen.

What does US Patent 11,207,311 claim?

The patent claims administration of niraparib or a salt of niraparib to a human with antiandrogen-resistant prostate cancer. The claims cover both biomarker-selected and biomarker-unselected patients.

Claim group	Covered subject matter
Claim 1	Niraparib treatment of antiandrogen-resistant prostate cancer in a patient who is not BRCA deficient or who has one of six listed DNA-repair anomalies
Claims 2 and 5	Castration-resistant prostate cancer and metastatic castration-resistant prostate cancer
Claims 3 and 4	Separate genetic-status alternatives: listed DNA-repair anomalies or no BRCA deficiency
Claims 6 and 7	Daily niraparib dose of about 30 mg to about 400 mg, including about 300 mg
Claim 8	Oral, once-daily administration using 100 mg niraparib dosage forms
Claim 9	Castration- and antiandrogen-resistant prostate cancer treated with 100 mg niraparib dosage forms once daily
Claims 10 and 11	Claim 9 narrowed to non-BRCA-deficient or listed DNA-repair-anomaly patients
Claims 12-15	Dose limitations linked to the genetic-status claims
Claims 16-20	Patients previously treated with taxane-based chemotherapy
Claims 21-23	Tumors previously exposed to enzalutamide, apalutamide or abiraterone acetate

The independent claims are claims 1 and 9. Claim 1 is biomarker and disease-status focused. Claim 9 is regimen focused.

How broad is independent claim 1?

Claim 1 has four principal elements:

1. A method of treating prostate cancer.
2. Administration of a safe and effective amount of niraparib or a salt.
3. The cancer is antiandrogen resistant.
4. The patient either is not BRCA deficient or carries at least one specified DNA-repair anomaly.

The alternative covering a patient who is “not BRCA deficient” is commercially important. It is broader than a conventional BRCA-mutated or homologous-recombination-deficiency claim because it does not require a listed mutation. A patient can fall within this branch based on the absence of BRCA deficiency, assuming the other claim limitations are satisfied.

The anomaly branch is narrower. It requires at least one of:

• FANCA
• PALB2
• CHEK2
• BRIP1
• HDAC2
• ATM

The claim does not require that the listed anomaly be pathogenic, biallelic, germline, somatic, or functionally demonstrated in the wording supplied. Those issues would become important in infringement and validity disputes.

What prostate cancer populations are covered?

The dependent claims progressively narrow the disease population.

Antiandrogen-resistant prostate cancer

“Antiandrogen resistant” is the gateway disease limitation in claim 1. The patent does not define the term in the claim text provided. In practice, infringement analysis would examine prior treatment, biochemical progression, radiographic progression, clinical progression and the relevant antiandrogen exposure.

Claims 21-23 specifically identify prior exposure to:

• Enzalutamide
• Apalutamide
• Abiraterone acetate

Those claims create a narrower post-androgen-receptor-pathway-treatment subgroup. The wording “exposed to” is potentially broader than “failed” or “progressed on,” depending on the specification and the court’s construction.

Castration-resistant prostate cancer

Claim 2 narrows claim 1 to castration-resistant prostate cancer. Claim 9 independently requires both castration resistance and antiandrogen resistance.

A patient may be castration resistant without satisfying every possible construction of antiandrogen resistance. For that reason, claims 1 and 2 should not be treated as interchangeable with claim 9.

Metastatic castration-resistant prostate cancer

Claim 5 covers metastatic castration-resistant prostate cancer. It depends from claim 1 and therefore retains the biomarker alternatives and niraparib requirement.

The claims do not appear to require a particular metastatic site, measurable disease, PSA level, radiographic progression standard or prior treatment line unless those requirements are imposed through claim construction or the specification.

What dosage and formulation does US 11,207,311 protect?

The patent does not claim every possible niraparib administration. The principal dosage limitations are:

Limitation	Claim coverage
About 30 mg to about 400 mg niraparib per day	Claim 6
About 300 mg niraparib per day	Claim 7
Oral administration once daily	Claim 8
100 mg niraparib oral dosage forms	Claims 8 and 9

Claim 9 is commercially significant because it combines the disease requirements with a recognizable commercial regimen: 300 mg per day when administered as three 100 mg units once daily.

The claims are directed to the amount of niraparib, not merely the total mass of a salt or finished tablet. A product using a different strength, schedule or route may avoid claims 8 and 9 while remaining exposed to broader claims 1-7, depending on the disease and patient characteristics.

The claims do not appear to require:

• A specific excipient system
• A specific polymorph
• A specific crystal form
• A particular dissolution profile
• A specific capsule or tablet composition
• A fixed-release mechanism
• Co-administration with abiraterone

Accordingly, the patent is not a conventional formulation patent. It is a regimen and patient-selection patent.

How do the claims treat DNA-repair anomalies?

The anomaly claims create a non-BRCA biomarker pathway. The listed genes are:

Gene	Commercial and technical relevance
FANCA	Fanconi anemia pathway and homologous-recombination repair
PALB2	Homologous-recombination repair and BRCA-pathway biology
CHEK2	DNA-damage checkpoint signaling
BRIP1	DNA repair and Fanconi/BRCA pathway
HDAC2	Chromatin regulation and DNA-damage response
ATM	DNA-damage sensing and checkpoint control

The claim language does not state that every listed alteration must produce homologous-recombination deficiency. That distinction may affect both infringement and validity. A competing sponsor could challenge whether the patent specification adequately supports treatment across all listed genes, particularly where clinical evidence is uneven across subgroups.

The “not BRCA deficient” branch also raises construction issues. The claim does not specify whether BRCA deficiency means:

• A pathogenic BRCA1 or BRCA2 mutation
• Biallelic loss
• Loss of heterozygosity
• A genomic-scarring assay result
• A clinical test interpretation
• A tumor-only or germline result

Testing methodology and report interpretation may therefore be central to enforcement.

How does claim 9 differ from claim 1?

Claim 9 is narrower in some respects and potentially more commercially targeted in others.

Issue	Claim 1	Claim 9
Disease	Antiandrogen-resistant prostate cancer	Castration- and antiandrogen-resistant prostate cancer
Drug	Niraparib or salt	Niraparib or salt
Dose	No mandatory dose	100 mg oral dosage forms once daily
Biomarker	Non-BRCA deficient or listed anomaly	Same alternatives
Metastatic requirement	Added in dependent claim 5	Not stated in claim 9
Prior treatment	Added in dependent claims	Added in claims 19 and 20 for taxane exposure

Claim 9 may be the most relevant claim against a commercial product that uses the standard 300 mg daily niraparib regimen. Claims 1-7 remain relevant to products using other doses or dosage forms.

What are the principal validity risks?

The patent’s strength is likely concentrated in the combination of disease status, patient selection and dosing. The principal challenges would be the following.

Anticipation

An anticipation challenge would require a single prior-art reference disclosing all elements of a claim, including the relevant prostate cancer resistance status, the biomarker limitation where applicable, niraparib administration and the claimed dose or dosage form.

Earlier niraparib disclosures for ovarian cancer, breast cancer or unselected solid tumors may not anticipate the prostate cancer claims unless they expressly disclose the claimed prostate cancer population and treatment conditions.

Obviousness

Obviousness is a more substantial risk for the broad non-BRCA branch. A challenger could combine:

• Prior PARP inhibitor activity in prostate cancer
• Niraparib’s known pharmacology
• Synthetic-lethality rationale involving DNA repair defects
• Clinical or preclinical prostate cancer data
• Standard 300 mg once-daily niraparib dosing

The patentee would likely rely on unexpected clinical efficacy, biomarker findings, patient-selection rationale and evidence that the non-BRCA population responded in a manner not reasonably predictable from the prior art.

Written description and enablement

The claims reach a broad group of non-BRCA-deficient patients and six different DNA-repair anomalies. A challenger could argue that the specification does not demonstrate or adequately predict efficacy across the full scope.

The risk is higher if the patent examples are concentrated in a limited subset of mutations or if the clinical data show materially different outcomes among BRCA, non-BRCA and individual gene cohorts.

Claim construction

Potential construction disputes include:

• Meaning of “antiandrogen resistant”
• Meaning of “not BRCA deficient”
• Whether “carrying” requires a pathogenic alteration
• Whether “DNA repair anomaly” requires functional impairment
• Whether “safe and effective amount” is limiting
• Whether prior “exposure” requires progression or treatment failure
• Whether “about 300 mg” includes materially different daily doses

These terms could determine whether a generic or combination product falls within the claims.

When does US Patent 11,207,311 lose exclusivity?

US Patent 11,207,311 is a post-grant US patent issued on December 28, 2021. Its term is governed by the 20-year term measured from the applicable earliest nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers and any applicable regulatory extension under 35 U.S.C. §§ 154 and 156.

The patent’s expected unadjusted expiration is in the mid-2030s, approximately 2036, based on the family’s filing chronology. The legally operative date is the USPTO term calculation, not the issue date. A precise expiration analysis must account for:

• Earliest effective nonprovisional filing
• Continuation or divisional status
• Patent-term adjustment
• Terminal disclaimer
• Patent-term extension
• Any disclaimer or post-grant change

A method-of-use patent can remain enforceable after FDA regulatory exclusivity ends. Generic approval timing therefore depends on both Hatch-Waxman certification and the scope of the listed or unlisted patent claims.

What is the Orange Book status of US 11,207,311?

The patent claims niraparib monotherapy for prostate cancer. FDA-approved niraparib products and indications must be analyzed separately from the claimed method.

Niraparib is marketed as Zejula. Niraparib is also used in the fixed-dose combination Akeega with abiraterone acetate for certain adult patients with metastatic castration-resistant prostate cancer and BRCA1/2 mutations, subject to the FDA-approved labeling.

The patent claims supplied here do not require abiraterone and extend to non-BRCA-deficient patients. That creates a potential mismatch with an approved combination indication limited to a narrower biomarker population.

Regulatory issue	Effect on 11,207,311
Niraparib monotherapy	Directly aligned with the claim structure
Niraparib plus abiraterone	Not required by the claims
Prostate cancer use	Claimed, but regulatory approval must be assessed separately
Non-BRCA population	Broader than a BRCA-limited approval
100 mg oral dosage forms	Consistent with commercial niraparib dosing
Orange Book listing	Depends on FDA-listed product, approved indication and patent submission; the patent number alone does not establish listing

An Orange Book listing would create a statutory patent-certification pathway for an abbreviated new drug application. If the patent is not listed against the relevant approved product and indication, enforcement may instead proceed under ordinary infringement provisions, regulatory-use exceptions and product-label analysis.

Which companies and products create competitive risk?

Niraparib and Akeega

The closest commercial products are Zejula and Akeega. Zejula contains niraparib. Akeega contains niraparib and abiraterone acetate.

A product using the same active ingredient does not automatically infringe a method claim. The relevant questions are whether the product is:

• Labeled for the claimed prostate cancer population
• Promoted for the claimed use
• Administered at the claimed dose
• Used in patients meeting the biomarker criteria
• Prescribed after the specified prior therapies

Akeega may create a distinct analysis because the patent claims niraparib administration but do not require monotherapy. If the claimed steps are performed with a combination product, the presence of abiraterone does not necessarily avoid infringement.

Other PARP inhibitors

Competing PARP inhibitors include olaparib, rucaparib and talazoparib. Their use does not directly infringe a niraparib-specific claim.

Product	Active ingredient	Prostate cancer relevance
Zejula	Niraparib	Direct product relevance
Akeega	Niraparib plus abiraterone acetate	Direct ingredient and regimen relevance
Lynparza	Olaparib	Competing PARP inhibitor, no niraparib claim exposure
Rubraca	Rucaparib	Competing PARP inhibitor
Talzenna	Talazoparib	Competing PARP inhibitor, often used in combination strategies

These products can reduce the commercial value of the patent without creating literal infringement because US 11,207,311 requires niraparib or a salt thereof.

What generic launch scenarios exist?

Scenario 1: Label carve-out

A generic applicant could seek approval for uses that avoid the patented prostate cancer indication, if the FDA labeling framework permits an adequate carve-out. This would not eliminate risk if the product is later promoted or intentionally used for the patented indication.

Scenario 2: Paragraph IV challenge

If the patent is listed in the Orange Book for the relevant reference product, a generic applicant could file a Paragraph IV certification asserting that the patent is invalid, unenforceable or not infringed. The patent owner could then file suit within the statutory period, potentially triggering a 30-month stay of approval under the Hatch-Waxman framework.

The strongest Paragraph IV theories would likely focus on:

• Obviousness of niraparib treatment in resistant prostate cancer
• Lack of written description across the non-BRCA population
• Enablement across six DNA-repair anomalies
• Indefiniteness or construction of “antiandrogen resistant”
• Noninfringement based on label scope, dosing or biomarker testing

Scenario 3: Launch after patent expiration

A generic product could launch after all enforceable claims expire, subject to other composition, formulation, process or regulatory exclusivity rights covering the relevant reference product.

Scenario 4: Non-infringing regimen

A competing sponsor could use another PARP inhibitor, a different administration schedule, a different patient population or a product label that omits the claimed use. That strategy may reduce direct infringement exposure but would not eliminate risk from induced infringement based on prescribing information or promotional conduct.

How strong is the patent estate for niraparib prostate cancer treatment?

US 11,207,311 is strongest as a targeted method-of-use patent against a product that combines:

• Niraparib
• Antiandrogen-resistant or castration-resistant prostate cancer
• A non-BRCA or specified DNA-repair-anomaly population
• Once-daily oral dosing
• A 300 mg daily regimen
• Use after taxane or androgen-receptor-pathway therapy

Its broader claim 1 has greater commercial reach but also greater validity exposure. Claims 8 and 9 are narrower and easier to map to a branded regimen, but they may be easier to avoid through dose, dosage-form or label differences.

The patent does not by itself block:

• Manufacture of niraparib for unrelated indications
• Use of another PARP inhibitor
• A different formulation absent the claimed method
• Research use within applicable statutory exceptions
• A product labeled only for a non-infringing indication

Key Takeaways

• US 11,207,311 is a niraparib method-of-use patent focused on resistant prostate cancer.
• Claim 1 reaches antiandrogen-resistant prostate cancer in patients who are not BRCA deficient or who carry FANCA, PALB2, CHEK2, BRIP1, HDAC2 or ATM anomalies.
• Claim 9 targets the commercially recognizable regimen of 100 mg oral dosage forms once daily.
• The patent does not claim niraparib’s chemical structure or a general tablet formulation.
• The broad non-BRCA claim creates significant commercial coverage but also increases obviousness, written-description and enablement risk.
• Akeega and other niraparib-containing regimens require separate product-label and induced-infringement analysis.
• Competing PARP inhibitors such as olaparib, rucaparib and talazoparib do not literally satisfy the niraparib limitation.
• The expected patent term is in the mid-2030s, approximately 2036, subject to the USPTO’s final term calculation and any adjustment or disclaimer.
• Generic exposure will depend on Orange Book listing, the approved indication, Paragraph IV certifications, label carve-outs and the scope of any settlement.

FAQs

Does US 11,207,311 cover niraparib for all prostate cancer patients?

No. The claims require antiandrogen resistance and, in claim 1, either a non-BRCA-deficient status or one of six specified DNA-repair anomalies. Additional claims require castration resistance, metastasis, prior treatment or specific dosing.

Does the patent cover Akeega?

Potentially, depending on the prescribed use and patient population. The claims require niraparib but do not exclude co-administration with abiraterone. Product-label, dosing and biomarker facts determine the infringement analysis.

Can a generic avoid the patent by using a 200 mg daily dose?

A 200 mg regimen may avoid claims specifically requiring about 300 mg or 100 mg dosage forms once daily. It could remain exposed to broader claims that do not require those limitations if the disease and patient criteria are met.

Are ATM or CHEK2 mutations enough to satisfy the biomarker claims?

The claim wording identifies a patient “carrying” at least one listed DNA-repair anomaly. Whether a particular variant qualifies may depend on claim construction, the patent specification, clinical interpretation and whether the alteration is pathogenic or functionally significant.

Does patent expiration end FDA exclusivity at the same time?

No. Patent expiration and FDA regulatory exclusivity are separate legal mechanisms. A product can lose patent protection while regulatory exclusivity remains, or face no regulatory exclusivity while valid method, formulation or compound patents continue.

References

1. United States Patent and Trademark Office. (2021). US Patent No. 11,207,311 B2: Methods of treating prostate cancer.
2. U.S. Food and Drug Administration. (2023). Akeega (niraparib and abiraterone acetate) prescribing information.
3. U.S. Food and Drug Administration. (2024). Zejula (niraparib) prescribing information.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
5. United States Code, Title 35, §§ 154, 156, 271 and 282.
6. United States Code, Title 21, § 355(j).
7. Chi, K. N., Rathkopf, D. E., Smith, M. R., et al. (2023). Niraparib plus abiraterone acetate with prednisone in metastatic castration-resistant prostate cancer. New England Journal of Medicine.

Drugs Protected by US Patent 11,207,311

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	11,207,311					A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	11,207,311					A METHOD FOR TREATING METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA2-MUTATION
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	11,207,311					A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	11,207,311					A METHOD FOR TREATING METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA2-MUTATION

International Family Members for US Patent 11,207,311

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3490560		C20250026	Finland
European Patent Office	3490560		301336	Netherlands
European Patent Office	3490560		PA2025528	Lithuania
European Patent Office	3490560		CA 2025 00023	Denmark
European Patent Office	3490560		2025C/531	Belgium