Details for Patent: 11,013,734

Which drugs does patent 11,013,734 protect, and when does it expire?

Patent 11,013,734 protects REZLIDHIA and is included in one NDA.

This patent has eighteen patent family members in fifteen countries.

Summary for Patent: 11,013,734

Title:	Treating patients harboring an isocitrate dehydrogenase-1 (IDH-1) mutation
Abstract:	Methods of treating patients diagnosed with AML or MDS harboring mutant IDH-1 include detecting an IDH1 mutation and the therapeutic administration of an inhibitor of a mutant IDH-1 as a single agent, or in combination with azacitidine (AZA) or cytarabine.
Inventor(s):	Patrick F. Kelly, Alan Collis, Jeff Davis, Duncan Walker, Susan Ashwell, Blythe Thomson, Wei Lu
Assignee:	Forma Therapeutics Inc
Application Number:	US16/526,593
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Patent 11,013,734 (Olutasidenib/IDH1 AML) Claim Scope and US Patent Landscape

Executive summary: US Drug Patent 11,013,734 is a US method-of-treatment and treatment-selection patent that ties acute myeloid leukemia (AML) with an IDH1 R132 mutation to (i) patient testing workflows (DNA isolation, mutation detection, including real-time PCR/SNV calling for specific R132 variants) and (ii) a defined dosing regimen of olutasidenib 150 mg twice daily. The core claim scope is narrow in drug substance (olutasidenib and a specific regimen) and narrow in target (IDH1 R132 mutations), but it is broad in how the testing is performed (within the claim’s enumerated PCR/SNV embodiments) and broad in where the sample comes from (blood or bone marrow). Competitive freedom-to-operate hinges on whether an accused regimen performs the patented test-and-treat sequencing using the claimed diagnostic modality and mutation set, and whether competing developers are using different doses, different IDH1 mutation panels, different analytes (RNA vs DNA), or different assay formats that fall outside the dependent claim funnels.

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What is US Drug Patent 11,013,734 and what is it trying to protect?

Short answer: The patent claims methods that combine (1) detecting an IDH1 R132 mutation in patient DNA and (2) administering olutasidenib at 150 mg twice daily for treating AML, with dependent claims narrowing mutation types, detection technique (real-time fluorescence PCR), sample source (blood/bone marrow), formulation (oral capsule), and a conditional “test-then-treat” workflow.

Core protection theme: test-to-dose pairing

Across the independent claim set in your text, the patent treats IDH1-mutant AML as a biomarker-defined indication and protects a specific therapeutic regimen that is explicitly tied to mutation detection. That structure tends to create two enforcement vectors:

1. Clinician workflow capture: use of a diagnostic pathway and subsequent administration at the claimed dose.
2. Commercial medical device/diagnostic coupling: if olutasidenib programs are licensed or packaged with specific companion-testing steps (or FDA-approved tests), the patent’s method claims track those steps tightly.

Key factual anchors from the claim language

• Indication: acute myeloid leukemia (AML)
• Biomarker: IDH1 mutation, specifically R132 variants
• Detectable genetic changes: SNVs coding selected R132 mutations
• Dosing: olutasidenib 150 mg twice daily
• Detection modalities in dependent claims:
  • PCR with homogeneous real-time fluorescence
  • qualitative SNV detection via in vitro PCR assay
  • discriminating fluorescence in a single well for mutation subgroups
• Sample sources: bone marrow and blood
• Formulation: oral capsule
• Test dependency: one claim requires the IDH1 test to be FDA-approved

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What is the scope of claim 1 (independent) and where is the strongest claim coverage?

Short answer: Claim 1 captures the broadest enforceable method: DNA extraction, IDH1 mutation detection, and administration of olutasidenib 150 mg twice daily to patients with an IDH1 mutation. It is not limited to a specific assay type in claim 1, which increases risk for challengers using any valid IDH1 mutation detection workflow.

Claim 1 element-by-element

1. Isolating and purifying DNA from a patient sample
2. Detecting an IDH1 mutation in that DNA
3. Administering olutasidenib at 150 mg twice daily in a pharmaceutically acceptable composition

Strongest “hook” for infringement

The presence of (DNA isolation + DNA mutation detection + olutasidenib dose) in one claim makes it difficult to design around merely by changing the assay brand, if the alternative still performs DNA detection of IDH1 mutation and still uses the same dosing regimen.

Where claim 1 is weak

Claim 1 is constrained by:

• olutasidenib (not another IDH1 inhibitor)
• 150 mg twice daily (fixed regimen)
• AML with IDH1 mutation (not broader IDH1-positive cancers)
• DNA and mutation detection steps

If an accused regimen uses a different dose, a different drug, does not include DNA detection, or uses different mutation categories not covered by the dependent claim limitations (R132), litigation typically shifts toward claim construction and whether the independent claim can read on the accused facts absent the dependent limitations.

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How do dependent claims narrow the mutation set (R132C/R132H/R132S/R132G/R132L)?

Short answer: Claims 2–4 and 18–19 narrow the biomarker to IDH1 R132 and then enumerate the included amino-acid substitutions. This creates multiple design-around axes: target different IDH1 variants outside the list, or structure testing and treatment decisions so the patient does not fall within the claimed mutation set.

Mutation coverage in your claim set

• Claim 2: IDH1 R132 mutation
• Claim 3: R132 among R132C, R132H, R132S, R132G, R132L
• Claim 4: SNV coding those R132 variants
• Claim 18–19 repeats the same narrowing for adult treatment conditional claims

Practical enforcement implication

If clinical testing identifies an IDH1 mutation that is not among those enumerated R132 variants, the risk of reading on the dependent claims decreases substantially. Claim 1 remains broader than the dependent claims, but the presence of the listed mutation panels in the dependent claim ladder often influences how courts construe the intended invention.

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What does the PCR and real-time fluorescence limitation require, and how can assay developers design around it?

Short answer: Dependent claims 5–6 narrow to PCR with homogeneous real-time fluorescence for SNVs, and further to in vitro qualitative SNV detection of the specified R132 mutations. Design-arounds include using:

• a different nucleic-acid detection chemistry (non-PCR),
• sequencing-based genotyping (NGS/Sanger) where the claim requires PCR,
• or fluorescence readouts that do not meet the “homogeneous real-time fluorescence” construction.

Claims 5–6 in your text

• Claim 5: mutation detection via PCR with homogeneous real-time fluorescence detection
• Claim 6: in vitro PCR assay for qualitative detection of SNVs coding specified R132 mutations in DNA

Design-around vectors commonly litigated

• NGS-based IDH1 genotyping instead of PCR (if claim construction treats “comprises using PCR” as requiring PCR)
• Digital PCR vs “homogeneous real-time fluorescence” (only avoids if it fails claim terms)
• Different assay format: e.g., endpoint fluorescence rather than real-time homogeneous detection
• Different sample types: if claims are limited to blood/bone marrow (though claim 1 already does not require the sample type)

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How do the “sample source” and “oral capsule” limitations affect claim enforceability?

Short answer: Sample source narrowing (claims 7–8) and formulation narrowing (claims 9–10) are dependent. They add specificity if the accused practice uses those exact features, but they are not required for the broadest claim 1 coverage.

Sample source (dependent)

• Claim 7: sample obtained from patient bone marrow
• Claim 8: sample obtained from patient blood

Formulation (dependent)

• Claim 9: composition formulated for oral administration
• Claim 10: composition is a capsule

Enforcement implication

If a competitor uses a different oral dosage form (tablet, solution, sprinkle) while still using olutasidenib 150 mg BID and DNA mutation detection, the claim 9–10 limitations may not read. Claim 1 and many other independent elements may still read, depending on how claim construction handles “pharmaceutically acceptable composition” without the capsule dependency.

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What does claim 11’s “primer combination” do to the claim boundary?

Short answer: Claim 11 adds a specific multiplexing/primer strategy: extracted DNA combined with primers designed to amplify either:

• (i) R132C and R132H, or
• (ii) R132G, R132S, and R132L.

Claim 12’s additional requirement

• Real-time fluorescence signal for each mutation subset is distinguishable in a single well.

Interpretive impact

These features can narrow infringement to specific assay architectures. Many diagnostic labs multiplex in a different format or use separate wells. If the accused test does not use the claimed amplification grouping and “single well” discrimination, dependent claims 11–12 may not reach, pushing enforcement toward broader claims (e.g., claim 1’s detection step).

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What is claim 13’s “FDA-approved diagnostic test” linkage, and why does it matter legally?

Short answer: Claim 13 is a tighter method that explicitly conditions treatment on use of an FDA-approved diagnostic test for detecting the IDH1 mutation. This can convert a broad “test and treat” practice into a more provable infringement pathway because FDA approval and labeling typically establish the test’s identity.

Claim 13 content

• Administer olutasidenib 150 mg twice daily
• Patient has IDH1 mutation
• IDH1 mutation “has been detected using an FDA-approved diagnostic test”

Dependent claim 14

• FDA-approved diagnostic test detects IDH1 mutation in DNA from patient sample.

Litigation leverage

This structure can be used to argue that once a provider follows the FDA-labeled diagnostic pathway, the method steps are met if dosing matches. It also reduces uncertainty about whether the mutation detection step was performed with an “FDA-approved” product.

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How do the “prior therapy” and “relapsed/refractory” limitations change the clinical population?

Short answer: Claims 15 and 16 limit the method to:

• patients receiving/received azacitidine or cytarabine, and
• patients with relapsed or refractory AML.

These are dependent features that affect the clinical scope of infringement and can be used to narrow trial strategy, population selection, and physician inducement arguments.

Claim 15

• therapy comprising azacitidine or cytarabine

Claim 16

• AML is relapsed or refractory

Claims 22 and 23 repeat the pattern

• Claim 22: relapsed/refractory AML
• Claim 23: selecting patient based on presence of IDH1 mutation in blood or bone marrow prior to administration

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What is the scope of the “conditional administration” workflow claims (17 and 21)?

Short answer: Claims 17 and 21 protect a decision tree method: perform an assay, and administer olutasidenib at the claimed dose only if IDH1 mutation is present, otherwise do not administer. This matters because many commercial pathway arguments focus on whether physicians “use the drug conditioned on test results,” even when diagnosis is not part of the product labeling.

Claim 17 structure

1. Obtain sample
2. Perform assay to determine if IDH1 mutation is present
3. If positive, administer olutasidenib 150 mg BID
4. If negative, do not administer at that dose

Claim 21 structure

• Treat adult AML patient with susceptible IDH1 mutation as detected by an FDA-approved test
• Administer 150 mg BID

Dependent claim 24

• Mutation is among the enumerated R132 variants.

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What formulations are protected, and does this cover generic liquid or tablet versions?

Short answer: Based on your claim text, only oral capsule is explicitly claimed in dependent claim 10. However, claim 1 and claim 13-type dosing methods are not formulation-limited beyond “pharmaceutically acceptable composition” (and oral in claim 9). Substitution of dosage form is more likely to escape dependent formulation claims than to escape the core test-and-dose method.

Formulation claim boundaries

• Claim 9: oral administration (dependent)
• Claim 10: capsule (dependent)
• Claim 1: pharmaceutically acceptable composition (not necessarily capsule)

Generic risk posture

A generic olutasidenib product at 150 mg BID could still infringe claim 1 or claim 13 if the method steps (DNA detection and treatment decision) are performed as claimed. Conversely, if a challenger uses a different dosage form that avoids capsule dependency, the formulation-dependent claims may not read, but method claims remain the primary risk.

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What patents in the US likely cluster around US 11,013,734 (and how should you map the estate)?

Short answer: Without the patent’s bibliographic details (publication numbers, assignee, priority, related continuations), a complete US landscape cannot be accurately enumerated from the claim text alone. Still, the claim design strongly indicates an estate that typically includes:

• composition and dosage form patents for olutasidenib,
• method-of-treatment patents tied to IDH1 mutation subsets,
• diagnostic/testing method patents for DNA SNV detection of IDH1 R132,
• and potential companion diagnostic-related patents that align to “FDA-approved test” language.

Actionable mapping approach for counsel/in-house IP teams: identify and chart:

1. All US patents listing olutasidenib and the IDH1 R132 AML biomarker
2. Any US patents naming diagnostic assays for IDH1 R132 SNVs, including PCR/fluorescence workflows
3. Continuation family members likely sharing the same priority on test-then-treat and dose regimen

Because this response cannot cite specific patent numbers without verifiable bibliographic data, it ends at a functional estate map consistent with the claim scaffold you provided.

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When does the patent lose exclusivity (and what expiry events control US exclusivity)?

Short answer: Not determinable from the claim text alone. Expiration depends on:

• earliest priority date,
• granted term adjustments,
• patent term extension (if any),
• and whether there are terminal disclaimers across continuations.

A correct exclusivity timeline requires the actual patent’s priority/filing/grant data and any listed PTA/PTE figures.

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What generic entry risks exist for olutasidenib based on this claim set?

Short answer: Entry risk is highest for any ANDA/authorized generic product that is used in practice exactly as claimed: DNA-based IDH1 mutation detection followed by olutasidenib 150 mg BID treatment decisions in AML patients with the claimed R132 mutations.

High-risk scenarios

• Clinicians use an FDA-labeled diagnostic test and then prescribe 150 mg BID
• Trial protocols condition enrollment and dosing on IDH1 R132 DNA SNV detection
• The commercial diagnostic workflow uses PCR with homogeneous real-time fluorescence as in dependent claims 5–6, plus mutation grouping in claims 11–12

Lower-risk scenarios

• Different dosing regimen (dose outside “150 mg twice daily”)
• Different drug (non-olutasidenib IDH1 inhibitor)
• Use of a different molecular target panel that excludes the enumerated R132 variants
• Diagnostic workflows that do not use DNA SNV detection by PCR as claimed (depending on claim construction)
• Different sequencing so that the “test then treat” conditional administration is not performed in the patented manner

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How strong is the patent estate for olutasidenib IDH1-mutant AML, based on claim structure alone?

Short answer: The claim set is strong on specificity that helps enforcement: fixed dose, fixed therapeutic agent, fixed biomarker concept (IDH1 R132), and direct procedural steps tying diagnosis to therapy. It is weaker on breadth over assay modality because many embodiments are concentrated in dependent claims (PCR/fluorescence, multiplex single well).

Net effect: litigation leverage increases if the accused diagnostic test is FDA-approved and uses DNA-based SNV detection consistent with the claim architecture. If accused practice uses other diagnostic chemistries, claim 1’s broader “detecting an IDH1 mutation” step becomes central.

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Key Takeaways

• US 11,013,734 protects test-and-treat methods for AML with IDH1 R132 mutations that culminate in olutasidenib 150 mg twice daily.
• The broadest claim coverage (claim 1) is anchored on DNA isolation + IDH1 mutation detection + olutasidenib 150 mg BID, without assay-type restriction.
• Dependent claims narrow to R132C/R132H/R132G/R132S/R132L, and to PCR with homogeneous real-time fluorescence and qualitative SNV detection; additional dependent claims narrow multiplex primer grouping and “single well” discrimination.
• Dependent limitations for blood/bone marrow and oral capsule may not matter if infringement is proved under broader method claims.
• Claim 13 and claim 21’s “FDA-approved diagnostic test” wording provides a practical infringement pathway tied to regulator-recognized testing.

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FAQs

1) Does US 11,013,734 cover olutasidenib dosing if the diagnostic test is RNA-based instead of DNA-based?
The dependent claims emphasize DNA isolation and DNA mutation detection; claim 1 also requires isolating and purifying DNA. RNA-based assays would not meet the DNA isolation/detection steps.

2) Can a competitor avoid infringement by using a different R132 variant panel that includes IDH1 mutations outside R132C/R132H/R132S/R132G/R132L?
Dependent claims 2–4 and 18–19 limit to the enumerated R132 variants; escape depends on whether the asserted independent claim is restricted by construction to R132 enumerations in the specification and prosecution history.

3) If a provider administers olutasidenib 150 mg BID without performing the DNA extraction and mutation detection steps in the method, is there infringement risk?
Method claims require the steps be performed as claimed. If testing is not performed in a way that meets the claim elements, infringement risk reduces, subject to how “method comprising steps” is construed.

4) Are formulation changes sufficient to avoid liability?
Changing from capsules may avoid dependent claim 10 but not necessarily claim 1, where “pharmaceutically acceptable composition” is not capsule-limited.

5) Does claim coverage extend to first-line AML only, or relapsed/refractory?
Relapsed/refractory is in dependent claims (16 and 22) and does not limit claim 1 or claim 13 as written. First-line use can still present risk under broader independent claims if biomarker and dosing steps are met.

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References

1. Not provided.

Drugs Protected by US Patent 11,013,734

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rigel Pharms	REZLIDHIA	olutasidenib	CAPSULE;ORAL	215814-001	Dec 1, 2022		RX	Yes	Yes						A METHOD OF TREATING ACUTE MYELOID LEUKEMIA (AML) IN PATIENTS WITH AN ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION

International Family Members for US Patent 11,013,734

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Denmark	3720442
European Patent Office	3720442
European Patent Office	4215197
Spain	2941079
Finland	3720442