United States Patent 9,174,982: Claim Scope, Exclusivity, and Oncology Patent Landscape
U.S. Patent No. 9,174,982 is a narrow method-of-treatment patent directed to administering one specific small-molecule compound, or a pharmaceutically acceptable salt in claim 1, for selected cancers. The claims do not independently cover the compound as a chemical entity, pharmaceutical compositions, formulations, manufacturing processes, dosing schedules, combination regimens, or delivery systems. The principal commercial value therefore depends on whether the claimed compound is an approved or clinically developed drug and whether separate composition-of-matter or formulation patents protect it.
What does U.S. Patent 9,174,982 claim?
The patent claims treatment of cancer using the following defined molecule:
4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide.
The compound is claimed by structure rather than by a generic chemical formula, Markush definition, or compound code. That creates a chemically precise infringement boundary.
| Claim |
Cancer indication |
Compound or salt |
Scope |
| 1 |
CLL, lymphoblastic leukemia, follicular lymphoma, T-cell or B-cell lymphoid malignancy, myelogenous leukemia, myeloma, or breast cancer |
Compound or pharmaceutically acceptable salt |
Broadest claim |
| 2 |
Chronic lymphocytic leukemia |
Compound or salt through dependency on claim 1 |
Narrower cancer limitation |
| 3 |
Lymphoblastic leukemia |
Compound or salt through dependency on claim 1 |
Narrower cancer limitation |
| 4 |
Chronic lymphocytic leukemia |
Specifically recited compound |
Independent method claim |
| 5 |
Lymphoblastic leukemia |
Specifically recited compound |
Independent method claim |
| 6 |
Myeloma |
Specifically recited compound |
Independent method claim |
| 7 |
Breast cancer |
Specifically recited compound |
Independent method claim |
Claims 2 and 3 depend on claim 1. Claims 4 through 7 are independent claims that repeat the compound and identify a specific cancer.
How broad is the therapeutic indication coverage?
Claim 1 covers seven indication categories:
- Chronic lymphocytic leukemia.
- Lymphoblastic leukemia.
- Follicular lymphoma.
- Lymphoid malignancies of T-cell or B-cell origin.
- Myelogenous leukemia.
- Myeloma.
- Breast cancer.
The phrase "a lymphoid malignancy of T cell or B cell origin" is broader than the separately identified CLL, lymphoblastic leukemia, and follicular lymphoma categories. It may capture additional lymphoid cancers if the disease is established as T-cell or B-cell in origin.
The claim does not require:
- A particular disease stage.
- Relapsed or refractory disease.
- A biomarker.
- A mutation or target-expression threshold.
- Monotherapy.
- A particular dose.
- A dosing interval.
- A route of administration.
- A treatment duration.
- A response level.
- A combination partner.
The absence of these limitations increases the range of potentially infringing clinical uses. It also leaves the claim dependent on proving that the administered dose was "therapeutically effective" for the specified cancer.
What is the chemical scope of the patent?
The chemical scope is narrow because the claims recite one fully defined compound. Claim 1 extends that compound to pharmaceutically acceptable salts. Claims 4 through 7 do not expressly include salts.
The claims do not expressly cover:
- Alternative substituents on the chlorophenyl group.
- Other piperazine substituents.
- Analogs of the pyrrolopyridine ether.
- Isomers not encompassed by the recited structure.
- Prodrugs.
- Metabolites.
- Deuterated versions.
- Polymorphs as such.
- Solvates unless they fall within the claimed compound or salt.
- Formulations containing the compound.
- Intermediates used to manufacture the compound.
A salt may be within claim 1 if it is a pharmaceutically acceptable salt of the claimed compound. A materially different counterion, prodrug, or covalent derivative would require a separate infringement analysis. The patent text supplied does not establish whether the specification contains broader genus claims, definitions, examples, stereochemical disclosures, or prosecution-history statements that could affect claim construction.
Which claims are strongest for enforcement?
Claim 1 is the broadest claim because it covers the compound and its pharmaceutically acceptable salts across the listed cancer categories. It also includes the broad lymphoid malignancy language.
Claims 4 through 7 provide indication-specific fallback positions. Their independent status can be commercially useful if a court narrows claim 1 or rejects one portion of its cancer grouping. The claims can be ranked as follows:
| Enforcement position |
Claim |
Practical significance |
| Broadest therapeutic claim |
1 |
Covers the compound or salt across multiple cancers |
| CLL fallback |
2 and 4 |
Two claim formats directed to CLL |
| Lymphoblastic leukemia fallback |
3 and 5 |
Two claim formats directed to lymphoblastic leukemia |
| Myeloma protection |
6 |
Independent indication claim |
| Breast cancer protection |
7 |
Independent indication claim |
| Follicular lymphoma and myelogenous leukemia |
1 |
No separate independent claim supplied |
Claims 2 and 3 add little practical breadth over claim 1 because they depend on it. Claims 4 through 7 are more important as separately drafted independent claims.
What acts could infringe the patent?
Potential direct infringement would generally require all of the following elements:
- Administration to a patient.
- Administration of the specifically claimed compound, or an eligible salt for claim 1.
- A therapeutically effective amount.
- Treatment of one of the claimed cancers.
- Performance of the conduct during the enforceable patent term and within the relevant territory.
The claims are directed to treatment conduct, not merely possession or sale. A generic manufacturer selling tablets could face a different infringement theory from a physician administering the compound. Under 35 U.S.C. §271(e)(2), an abbreviated new drug application or related regulatory filing may create a statutory patent dispute if the patent is listed and the filing seeks approval for a relevant use or product [2].
A label that omits all patented uses can reduce method-of-use exposure, but it does not automatically eliminate risk. The analysis can depend on the proposed label, promotional conduct, product characteristics, prescribing patterns, and inducement evidence.
Does the patent cover formulation or manufacturing rights?
No formulation or manufacturing coverage appears in the supplied claims.
The patent does not claim:
- Tablets.
- Capsules.
- Injectable formulations.
- Liposomal delivery.
- Nanoparticle delivery.
- Specific excipients.
- Particle-size distributions.
- Crystalline forms.
- Amorphous solid dispersions.
- A manufacturing process.
- A synthetic intermediate.
- Purification steps.
- A particular polymorph or solvate.
A competitor could therefore avoid these claims by producing a noninfringing analog, but not by using a different formulation of the same compound for a claimed cancer. Conversely, a separate composition-of-matter patent could create a blocking right even if a competitor avoids the method claims.
What is the likely role of composition-of-matter patents?
For a small-molecule oncology product, the composition-of-matter patent is normally the central exclusivity asset. A method patent such as U.S. 9,174,982 is more dependent on the compound patent, regulatory indication, and commercial label.
The likely patent stack for the compound would include several possible layers:
| Patent layer |
Relevance to this patent |
| Composition of matter |
May block all commercial uses of the compound |
| Salt and polymorph patents |
May protect the commercial solid form |
| Formulation patents |
May protect the marketed dosage form |
| Treatment-method patents |
U.S. 9,174,982 falls in this category |
| Combination-treatment patents |
May protect use with another anticancer agent |
| Biomarker patents |
May narrow treatment to a responsive population |
| Manufacturing patents |
May create process barriers |
| Use-specific continuation patents |
May extend protection for particular indications |
The supplied claims do not identify priority filings, continuation applications, terminal disclaimers, patent-term adjustment, or related family members. Those records are necessary to calculate the effective expiration date and determine whether later patents create additional barriers.
When does U.S. Patent 9,174,982 lose exclusivity?
The patent’s expiration date cannot be determined from the claims alone. U.S. patent term is generally measured from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory rules [4].
The key term variables are:
- Earliest claimed priority date.
- Nonprovisional filing date.
- Patent-term adjustment.
- Patent-term extension under 35 U.S.C. §156.
- Terminal disclaimers.
- Any disclaimer or expiration affecting a related patent.
- Patent maintenance-fee status.
The issue date, November 3, 2015, does not by itself determine expiration. A patent’s term generally does not run for 20 years from issuance.
What is the Orange Book status of the compound?
An Orange Book listing cannot be established from the claim language. The claims do not identify:
- The active ingredient’s generic name.
- A trade name.
- An approved New Drug Application.
- An NDA holder.
- A dosage form.
- A marketed strength.
- A listed indication.
- A use code.
- A listed patent expiration date.
FDA Orange Book listing is tied to an approved drug product and an NDA, not merely to the existence of a patent [3]. If the compound has no approved NDA, the patent would not have a conventional Orange Book role. If it is approved, the relevant question would be whether the NDA holder submitted the patent for listing and whether the listed claims cover the approved use.
What Paragraph IV risks apply?
A Paragraph IV challenge could target the patent on several grounds:
| Challenge |
Potential argument |
| Noninfringement |
The proposed product is not the claimed compound, salt, cancer use, or therapeutic administration |
| Invalidity for anticipation |
An earlier reference disclosed the compound and claimed cancer treatment |
| Obviousness |
Prior art made the compound’s use for the claimed cancers predictable |
| Written description |
The specification did not adequately support the full disease grouping |
| Enablement |
The disclosure did not enable treatment across all claimed cancers |
| Indefiniteness |
A term such as "therapeutically effective amount" or the disease grouping is argued to lack adequate boundaries |
| Divided infringement |
No single actor performs every required treatment step |
| Regulatory carve-out |
The ANDA label omits the patented indications |
The compound-specific nature of the claims may make a pure noninfringement case difficult for an identical active ingredient. Invalidity risk would likely center on whether the compound and its anticancer activity were disclosed or rendered obvious by earlier composition and pharmacology references.
How strong is the patent estate?
Based solely on the supplied claims, U.S. 9,174,982 has moderate method-of-use value but cannot be characterized as a complete patent estate.
Strengths
- The compound is structurally precise.
- Claim 1 covers multiple cancer categories.
- CLL and lymphoblastic leukemia receive duplicate protection through dependent and independent claims.
- The claims do not require a narrow biomarker or specific regimen.
- The patent may cover off-label use if the compound is administered for a listed cancer during the term.
Weaknesses
- The patent does not cover the compound as a product.
- It does not cover manufacturing or formulation.
- The cancer list may face written-description or enablement scrutiny if the specification contains limited supporting data.
- The claim requires proof of treatment of a specified cancer with a therapeutically effective amount.
- Claims 4 through 7 omit the express salt language in claim 1.
- Commercial value depends heavily on the existence and term of related composition patents.
What generic or biosimilar entry risks exist?
A biosimilar pathway is generally irrelevant if the product is a conventional small molecule. The claimed compound is a defined organic molecule, not a biologic. Competitive entry would more likely occur through an ANDA, a 505(b)(2) application, or a non-U.S. generic pathway.
The principal entry scenarios are:
- A generic submits an ANDA for the same active ingredient and challenges the patent under Paragraph IV.
- The applicant omits the patented cancer uses through a label carve-out.
- A competitor develops a structurally distinct molecule with the same pharmacologic target.
- A licensee launches after a settlement date.
- The compound patent expires while this method patent remains in force.
- The method patent expires while formulation or composition patents remain active.
The patent is most valuable where the approved or commercial label includes one or more of the claimed cancers. It has less practical value if the compound is discontinued, never approved, or marketed only for an unrelated indication.
What litigation and settlement issues should be reviewed?
The supplied information does not establish any infringement action, Paragraph IV notice, settlement agreement, license, assignment, or terminal disclaimer involving U.S. 9,174,982.
A complete litigation review should identify:
- District-court complaints.
- ANDA filing dates.
- Paragraph IV notices.
- Declaratory-judgment actions.
- PTAB inter partes review petitions.
- Claim-construction rulings.
- Preliminary-injunction decisions.
- Consent judgments.
- License agreements.
- Launch-at-risk activity.
- Settlement entry dates and licensed launch dates.
A settlement may materially change commercial exclusivity even where the patent remains formally unexpired. Conversely, a patent may have limited practical value if no approved product, NDA listing, or enforceable commercial license exists.
What is the geographic coverage?
The claims apply only to conduct within the United States. Foreign counterparts would require separate analysis by jurisdiction. Relevant issues include:
- PCT application and national-phase filings.
- European Patent Office prosecution.
- Patent term in Canada, Japan, China, and Australia.
- Supplementary protection certificates in Europe.
- Local claim scope and patentability standards.
- Foreign litigation and opposition records.
- Regulatory approval and marketing status by country.
A U.S. method claim does not itself block manufacturing or treatment activity conducted wholly outside the United States, subject to U.S. importation and other applicable doctrines.
Key Takeaways
- U.S. 9,174,982 is a narrow, compound-specific oncology method patent.
- Claim 1 is the broadest claim and includes pharmaceutically acceptable salts.
- Claims 4 through 7 independently cover CLL, lymphoblastic leukemia, myeloma, and breast cancer.
- Follicular lymphoma and myelogenous leukemia appear only in claim 1.
- The patent does not, based on the supplied claims, cover the compound as a product, formulation, manufacturing process, or generic analog.
- The patent’s commercial value depends on the compound’s regulatory status and related composition-of-matter patents.
- The expiration date cannot be calculated from the claims alone.
- Orange Book status, Paragraph IV activity, litigation, settlements, licenses, and related patent-family rights are not established by the supplied claim text.
FAQs About U.S. Patent 9,174,982
Does U.S. 9,174,982 cover all uses of the claimed compound?
No. It covers administration of the compound for specified cancers. It does not claim every therapeutic, nontherapeutic, or commercial use of the molecule.
Can a generic avoid the patent by using a different salt?
Not necessarily. Claim 1 expressly covers pharmaceutically acceptable salts of the claimed compound. The specific salt, formulation, and claim construction would determine the result.
Does the patent protect treatment of non-Hodgkin lymphoma generally?
No. Claim 1 identifies follicular lymphoma and lymphoid malignancies of T-cell or B-cell origin. A lymphoma outside those categories would require a separate claim-construction and infringement analysis.
Is a different dose outside the patent?
No. The claims do not specify a dose. A different dose could still infringe if it is a therapeutically effective amount and all other claim elements are met.
Is this patent sufficient to block a competing product?
Not by itself in every scenario. The patent is a method-of-use right. A complete blocking analysis requires the related composition, formulation, manufacturing, regulatory-listing, and foreign patent families.
References
-
United States Patent No. 9,174,982, claims 1-7 (2015).
-
35 U.S.C. §§ 271(e)(2), 271(e)(4) (2023).
-
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.
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35 U.S.C. §§ 154, 156, 271(e)(4) (2023).
