Details for Patent: 9,682,061

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Which drugs does patent 9,682,061 protect, and when does it expire?

Patent 9,682,061 protects KIMYRSA and ORBACTIV and is included in two NDAs.

This patent has seven patent family members in seven countries.

Summary for Patent: 9,682,061

Title:	Methods of treating bacterial infections using oritavancin
Abstract:	The present invention is directed to methods of treating a bacterial infection in a subject through the administration of a therapeutically effective amount of a glycopeptide antibiotic to a subject having a bacterial infection. The effective amount of the glycopeptide antibiotic that is administered to the subject provides a fraction of the glycopeptide antibiotic administered to the subject bound to serum proteins within the subject and within a selected range.
Inventor(s):	Dario Lehoux, Thomas Parr, JR., Gregory Moeck
Assignee:	Melinta Subsidiary Corp
Application Number:	US12/740,571
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

US Patent 9,682,061: Oritavancin Claims, Patent Scope, Exclusivity, and Generic Risk

US Patent 9,682,061 protects treatment methods that administer oritavancin at 15-50 mg/kg and achieve defined serum-protein-binding fractions. Its principal commercial relevance is the overlap between the patented dose range and Orbactiv’s FDA-approved intravenous treatment for acute bacterial skin and skin-structure infections. The patent is method-of-use protection, not a composition-of-matter patent. Its strongest claims are tied to measured or calculated serum protein binding, particularly the nine-sample mean specified in claim 14.

What does US Patent 9,682,061 protect?

The patent covers methods of treating bacterial infections by administering oritavancin, or a pharmaceutically acceptable salt, hydrate, solvate, or mixture, at 15-50 mg/kg body weight.

The core limitations are:

Claim element	Scope
Active ingredient	Oritavancin or specified pharmaceutical forms
Therapeutic use	Treatment of a bacterial infection
Patient	Human subject in claim 1; subject in claim 10
Dose	About 15-50 mg/kg
Pharmacokinetic limitation	50%-95% fraction bound to serum proteins
Narrower binding ranges	55%-65%, 70%-90%, or 80%-90%
Sampling	Approximately 30 minutes or 24 hours after administration
Mean-binding claim	Mean value over approximately 30 minutes to 24 hours
Specific calculation	Nine serum measurements at defined time points
Infection	Includes complicated skin and skin-structure infection, or cSSSI
Formulation	Pharmaceutical composition with carrier or diluent
Route	Intravenous or oral administration

Claims 1-9 form a first claim group. Claims 10-17 form a second group directed to a mean fraction of protein-bound drug over the post-dose interval.

The patent does not claim every use of oritavancin. A potentially infringing treatment must satisfy the dose limitation and the serum-protein-binding limitation, either directly or inherently.

How broad are the independent claims?

Claim 1: single or measured serum-binding result

Claim 1 requires:

1. A human with a bacterial infection.
2. Administration of oritavancin.
3. A dose of approximately 15-50 mg/kg.
4. A serum protein-binding fraction of approximately 50%-95%.
5. Determination from serum obtained from the treated subject.

The claim is broad as to the bacterial infection. Claim 7 narrows it to cSSSI, but claim 1 is not limited to cSSSI, methicillin-resistant Staphylococcus aureus, bacteremia, osteomyelitis, or another named pathogen.

The phrase "provides a fraction" creates a pharmacokinetic limitation. The claim is not limited merely to a physician’s intent to achieve a particular concentration. The administered dose must produce the specified binding result, and the result must be determined from patient serum.

Claim 10: mean serum-binding result

Claim 10 requires a mean fraction of oritavancin bound to serum proteins within 50%-95% over approximately 30 minutes to 24 hours after administration.

This claim is materially narrower than claim 1 because it is directed to a mean over a time interval rather than a single measurement. It also requires the drug to be administered at 15-50 mg/kg.

Claim 14: nine-measurement calculation

Claim 14 specifies nine measurements:

• 30 minutes
• 1.5 hours
• 2.5 hours
• 3.5 hours
• 4.5 hours
• 5.5 hours
• 6.5 hours
• 12 hours
• 24 hours

The mean is calculated from those measurements. This limitation gives claim 14 substantial analytical specificity but also creates additional non-infringement positions. A competing treatment protocol that uses fewer samples, different sampling times, or no serum protein-binding analysis may fall outside the literal language of claim 14.

What dose range does US 9,682,061 cover?

The patent covers 15-50 mg/kg. For a 70-kilogram adult, the range corresponds to approximately 1,050-3,500 mg:

Patient weight	15 mg/kg	50 mg/kg
50 kg	750 mg	2,500 mg
70 kg	1,050 mg	3,500 mg
80 kg	1,200 mg	4,000 mg
100 kg	1,500 mg	5,000 mg

Orbactiv’s FDA-approved regimen is a single 1,200 mg intravenous dose infused over three hours for adults with acute bacterial skin and skin-structure infections. That fixed dose corresponds to 15 mg/kg in an 80-kilogram patient and exceeds 15 mg/kg in lighter patients. The approved regimen therefore overlaps the patent’s weight-based range for some patients, although the label does not generally prescribe weight-based dosing (FDA, 2024).

The overlap does not mean that every approved administration necessarily infringes. Infringement analysis depends on the actual patient weight, dose, serum-binding result, claim construction, and whether the serum limitation is satisfied.

What serum protein-binding ranges are protected?

The dependent claims contain overlapping ranges:

Claim	Binding range
Claim 1	About 50%-95%
Claim 2	About 55%-65%
Claim 3	About 80%-90%
Claim 4	About 70%-90%
Claim 10	Mean of about 50%-95%
Claim 11	Mean of about 55%-65%
Claim 12	Mean of about 80%-90%
Claim 13	Mean of about 70%-90%

Claims 3 and 4 overlap completely from 80% to 90%. Claim 3 is narrower because it begins at 80%, while claim 4 extends downward to 70%. Claims 2 and 3 do not overlap.

Oritavancin is highly protein bound. FDA labeling reports approximately 85% protein binding, placing the drug within the 80%-90% ranges recited in claims 3, 4, 12, and 13 (FDA, 2024). That pharmacokinetic characteristic makes the binding limitations commercially relevant rather than merely theoretical.

What formulations and administration routes are protected?

Claim 8 covers a pharmaceutical composition containing oritavancin and a pharmaceutically acceptable carrier or diluent. It does not require a particular excipient, vial configuration, concentration, pH, stabilizer, reconstitution method, or infusion volume.

Claim 9 covers intravenous or oral administration. The intravenous branch aligns with Orbactiv’s approved route. Oritavancin is marketed as an intravenous product; the FDA label does not establish an approved oral Orbactiv regimen (FDA, 2024).

The formulation claim is dependent on the underlying dose and serum-binding limitations. A composition alone, without the claimed treatment method, does not necessarily practice claim 8.

When does US Patent 9,682,061 lose exclusivity?

The patent was granted on June 20, 2017. Its nominal statutory term is tied to the earliest relevant nonprovisional or international application in the family, not to the grant date. Based on the family’s 2010 priority framework, the expected patent-term endpoint is in 2031, subject to any patent-term adjustment, terminal disclaimer, disclaimer filing, or other USPTO term event.

Event	Date or status
Patent	US 9,682,061
Grant date	June 20, 2017
Patent type	Method-of-treatment patent
Core product	Oritavancin
Expected nominal term endpoint	2031
FDA product	Orbactiv
NDA	206334
Approved route	Intravenous
Approved adult dose	1,200 mg once, infused over three hours

Patent expiration and FDA regulatory exclusivity are separate. A patent can remain enforceable after FDA orphan, new-drug, or other regulatory exclusivity expires. Conversely, regulatory exclusivity can expire before the patent term ends.

What is the Orange Book status of US 9,682,061?

Orbactiv is approved under NDA 206334. The Orange Book is the relevant FDA database for listed patents and approved drug products. Method-of-use patents may be listed with a corresponding use code, depending on FDA listing practice and the patent holder’s submission.

The commercial significance of US 9,682,061 depends on four separate questions:

1. Whether it is listed against NDA 206334.
2. Whether the listed use code covers the proposed generic labeling.
3. Whether the generic applicant seeks a Paragraph IV certification.
4. Whether the patent owner brings suit within the statutory period.

A generic applicant may use a section viii statement to carve out a patented method of use if the proposed label does not include the protected indication or use. That strategy is less effective where the patent claim reaches the core labeled dose or administration protocol rather than a separately identifiable indication.

What Paragraph IV risks exist for a generic oritavancin applicant?

A generic applicant seeking approval before patent expiry would evaluate at least four certification positions:

Issue	Potential generic position
No infringement	The proposed product is not administered within 15-50 mg/kg or does not practice the serum-binding limitations
Invalidity	Claims are anticipated, obvious, indefinite, insufficiently enabled, or improperly supported
Section viii carve-out	The label omits the patented use
Paragraph IV	The listed patent is invalid, unenforceable, or not infringed

The serum limitation creates both risk and defense opportunities.

For the patent owner, the argument would be that standard dosing inherently produces the claimed binding fraction because oritavancin is highly protein bound. For the generic applicant, the counterargument would focus on whether binding is patient-specific, variable, measurement-dependent, and required to be determined in actual serum.

The phrase "about" introduces ordinary claim-construction questions. Variability in assay method, sample handling, patient physiology, timing, and rounding may affect whether a result falls inside or outside a claimed range.

How strong is the patent estate for oritavancin?

US 9,682,061 is strongest as a secondary or late-life method patent. It does not have the exclusionary profile of a basic compound patent. Its value depends on whether a generic product can be marketed without practicing the claimed dosing and pharmacokinetic limitations.

Strengths

• It covers the approved active ingredient.
• The 15-50 mg/kg range is broad.
• The 50%-95% binding range is broad.
• The 80%-90% dependent ranges align with reported oritavancin protein binding.
• Claims 7 and 15 reach cSSSI, the core Orbactiv indication.
• The claim groups provide multiple infringement theories.

Weaknesses

• The claims are treatment-method claims rather than composition claims.
• Protein binding may vary by patient and assay.
• Claims 5, 6, and 14 require specific sampling timing.
• Claim 14 requires nine measurements.
• Oral administration is commercially unsupported by the approved Orbactiv label.
• The claims may face written-description, enablement, obviousness, indefiniteness, or inherent-infringement challenges depending on the prosecution record and prior art.

The patent’s practical strength is therefore higher against a labeled generic that mirrors the branded dose and indication than against an applicant using a narrow label carve-out or a nonoverlapping dosing strategy.

What other patents and exclusivity rights affect Orbactiv?

The relevant landscape includes more than US 9,682,061.

Compound and manufacturing patents

Earlier oritavancin patents may cover:

• The glycopeptide compound and related analogs.
• Salt, hydrate, and solvate forms.
• Synthetic intermediates.
• Fermentation or purification processes.
• Pharmaceutical compositions.
• Stability and reconstitution characteristics.

These rights can create manufacturing barriers even where a method-of-use patent is avoided. A generic applicant may need to develop a noninfringing synthesis, obtain a licensed process, or rely on an expired compound patent.

Formulation patents

Formulation claims can cover excipients, lyophilized powders, vial presentations, concentration ranges, reconstitution conditions, and stability profiles. US 9,682,061 is not narrowly directed to those formulation attributes. Its formulation limitation is functional and dependent on practicing the treatment method.

Method-of-use patents

The patent is part of the method-of-use layer. Competing rights may address:

• cSSSI treatment.
• Single-dose intravenous treatment.
• Treatment of gram-positive infections.
• Methicillin-resistant Staphylococcus aureus.
• Pharmacokinetic exposure.
• Dosing in renal impairment or other special populations.

Each patent must be analyzed against the proposed label and actual use, not simply against the molecule.

Which companies challenge oritavancin exclusivity?

Melinta Therapeutics commercializes Orbactiv in the United States after acquiring The Medicines Company’s infectious-disease assets. Oritavancin was originally developed through predecessor companies associated with Eli Lilly, Targanta Therapeutics, and The Medicines Company. The commercial rights history is therefore separate from the identity of the current patent owner or NDA holder.

No specific Paragraph IV litigation, settlement agreement, or approved generic launch is established by the claim text supplied for this analysis. The principal competitive threats are likely to arise from:

• A paragraph IV ANDA applicant.
• A section viii label carve-out.
• Hospital use of alternative long-acting lipoglycopeptides.
• Off-label use of dalbavancin or other agents.
• Intravenous vancomycin and newer anti-MRSA therapies.

How does oritavancin compare with dalbavancin?

Attribute	Oritavancin	Dalbavancin
Brand	Orbactiv	Dalvance
Drug class	Lipoglycopeptide	Lipoglycopeptide
FDA-approved use	Acute bacterial skin and skin-structure infections	Acute bacterial skin and skin-structure infections
Typical dosing concept	Single 1,200 mg IV dose	Two-dose or selected single-dose regimens
Key patent issue here	15-50 mg/kg plus protein-binding limitations	Separate compound, formulation, and dosing patent estate
Administration	Intravenous	Intravenous
Biosimilar pathway	Not applicable	Not applicable
Generic pathway	ANDA	ANDA

Neither product is a biologic. Biosimilar risk is therefore not the relevant regulatory pathway. The applicable competitive pathway is generic drug approval under an ANDA, subject to patent certifications and labeling constraints.

What generic launch scenarios exist?

Early launch after a successful Paragraph IV case

A generic applicant could challenge the patent and launch before the expected 2031 endpoint if the patent is invalidated, found unenforceable, or held not infringed.

Launch after a section viii carve-out

A carve-out could omit cSSSI or another protected use. This strategy is more difficult if the patent is read to cover the standard dose itself rather than only a separately labeled indication.

Launch after patent expiration

The lowest legal risk arises after expiration of the relevant listed patents and any applicable regulatory exclusivity. The applicant would still need to address manufacturing, bioequivalence, sterile injectable controls, and any surviving formulation or process patents.

At-risk launch

An applicant could launch while litigation is pending after a Paragraph IV certification. That creates potential damages and injunctive exposure if the patent is upheld.

What is the revenue exposure?

Orbactiv revenue is exposed primarily through the loss of branded price premium after generic entry. The economic impact depends on:

• Annual Orbactiv net sales.
• Hospital and outpatient purchasing mix.
• Number of ANDA entrants.
• Generic substitution rules.
• Contracting with group purchasing organizations.
• Whether a generic label can retain the full cSSSI indication.
• Remaining patent and regulatory exclusivity.

The patent’s value is greater if it blocks a full-label generic. Its value is lower if a generic can obtain approval with a narrow label that avoids the serum-binding or dosing limitations.

Key Takeaways

• US 9,682,061 is a method-of-treatment patent covering oritavancin dosing at 15-50 mg/kg.
• The claims require serum protein-binding results of 50%-95%, with narrower ranges reaching 80%-90%.
• Claims 10-14 add a mean-binding requirement over approximately 30 minutes to 24 hours, with claim 14 specifying nine sampling times.
• The patent overlaps Orbactiv’s single-dose intravenous cSSSI regimen for some patient weights.
• It is not a composition-of-matter patent and does not itself establish protection for every oritavancin product.
• The expected nominal patent-term endpoint is in 2031, subject to the official USPTO term calculation.
• The main generic defenses are noninfringement, invalidity, section viii label carve-out, and avoidance of the serum-testing limitations.
• Oritavancin is a small-molecule antibacterial, so generic rather than biosimilar competition is the relevant pathway.
• Manufacturing, formulation, and earlier compound patents must be analyzed separately from US 9,682,061.

FAQs

Does US 9,682,061 cover the 1,200 mg Orbactiv dose?

It can overlap the 1,200 mg dose when the patient’s body weight places the dose within 15-50 mg/kg and the serum-binding limitation is satisfied. The overlap is not automatic for every patient or administration.

Is serum protein binding required to be measured for infringement?

The claim language requires the fraction to be determined from serum obtained from the subject. Whether actual measurement is required, or whether the result can be established through inherent properties and litigation evidence, depends on claim construction and proof of infringement.

Does the patent cover oral oritavancin?

Claim 9 recites intravenous or oral administration. The commercial Orbactiv product is approved for intravenous use, and the patent’s oral branch has limited current product relevance.

Can a generic avoid US 9,682,061 by using a fixed dose instead of weight-based dosing?

Possibly, but only if the fixed dose falls outside the claimed 15-50 mg/kg range for the relevant patients and does not otherwise satisfy the claim limitations. A fixed dose can still overlap the claimed range for some body weights.

Are biosimilars a threat to Orbactiv?

No. Oritavancin is a small-molecule drug. The relevant competitive pathway is an ANDA for a generic injectable product, not a biosimilar application under the Public Health Service Act.

References

1. U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,682,061, methods of treating bacterial infections using oritavancin. https://patents.google.com/patent/US9682061B2/en

2. U.S. Food and Drug Administration. (2024). Orbactiv (oritavancin) prescribing information, NDA 206334. https://www.accessdata.fda.gov/drugsatfda_docs/label/

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

4. U.S. Food and Drug Administration. (2024). Electronic Orange Book patent and exclusivity information. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files/for-patent-and-exclusivity-information-referenced-orange-book-therapeutic-equivalence-evaluations.

Drugs Protected by US Patent 9,682,061

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Melinta Therap	KIMYRSA	oritavancin diphosphate	POWDER;INTRAVENOUS	214155-001	Mar 12, 2021		RX	Yes	Yes						TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT
Melinta Therap	ORBACTIV	oritavancin diphosphate	POWDER;INTRAVENOUS	206334-001	Aug 6, 2014		RX	Yes	Yes						TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

Foreign Priority and PCT Information for Patent: 9,682,061

PCT Information
PCT Filed	April 26, 2010	PCT Application Number:	PCT/US2010/032441
PCT Publication Date:	November 11, 2010	PCT Publication Number:	WO2010/129233

International Family Members for US Patent 9,682,061

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010245097
Brazil	PI1014767
Canada	2760159
China	102573882
European Patent Office	2424559
Japan	2012525391
World Intellectual Property Organization (WIPO)	2010129233