United States Patent 9,365,500: Scope, Claims, Expiration and Patent Landscape

U.S. Patent No. 9,365,500 protects specific therapeutic uses of an aminomethylcycline tetracycline compound, including treatment of infections caused by resistant gram-positive and gram-negative bacteria. The patent is a method-of-treatment patent rather than a broad composition-of-matter patent. Its commercial value depends on whether the claimed compound is the active ingredient in the marketed product and whether a generic applicant’s proposed label would practice the listed methods.

The supplied claims omit the chemical structures displayed in the original patent. The claim language and bacterial coverage identify the patent as a Paratek aminomethylcycline use patent associated with omadacycline, marketed in the United States as Nuzyra. The exact infringement analysis remains structure-dependent because claims 1, 11 and 21 are defined by the omitted structures.

What does U.S. Patent 9,365,500 protect?

Patent 9,365,500 protects administering the claimed aminomethylcycline compound, or specified salts or esters, to treat bacterial infection in a subject.

The independent claims divide the chemical coverage into three related categories:

Claim	Protected subject matter	Key distinction
1	Treatment with the illustrated compound, or a pharmaceutically acceptable salt or ester	Broadest apparent parent method claim
11	Treatment with the second illustrated compound, or a pharmaceutically acceptable salt	Salt-containing method claim
21	Treatment with a pharmaceutically acceptable salt of the illustrated compound	Express salt method claim

Claims 2-10 depend from claim 1. Claims 12-20 depend from claim 11. Claims 22-30 depend from claim 21. Claims 31-38, 39-45 and 46-54 add further bacterial species to each independent-claim group.

The core legal limitation in each independent claim is not merely the administration of any tetracycline. It is the administration of the particular compound represented by the omitted chemical structure. A product containing a different tetracycline, even one used against the same bacteria, would not literally satisfy the compound limitation.

How broad are the claims of Patent 9,365,500?

The claims are broad in disease and patient coverage but narrow in chemical identity.

Chemical scope

The claims cover:

The specifically illustrated aminomethylcycline compound.
Pharmaceutically acceptable salts under the applicable independent claims.
A pharmaceutically acceptable ester under claim 1, based on the supplied text.
Administration with a pharmaceutically acceptable carrier.
Treatment of mammals, including humans.

The claims do not appear, based on the supplied claim set, to cover every tetracycline, every aminomethylcycline, or every antibacterial compound. They are use claims tied to one or more defined chemical structures.

Therapeutic scope

The infection limitation is broad. It includes treatment of bacterial infection generally in the independent claims, with dependent claims identifying particular organisms and resistance profiles.

The dependent claims cover infections associated with:

Organism or category	Claims
Gram-positive bacteria	2, 12, 22
Gram-negative bacteria	3, 13, 23
E. coli	4, 14, 24
S. aureus	5, 15, 25
E. faecalis	6, 16, 26
Tetracycline-resistant bacteria	7, 17, 27
K. pneumoniae	31, 39, 47
Salmonella	32, 40, 48
E. hirae	33, 41, 49
A. baumannii	34, 42, 50
B. catarrhalis	35, 43, 51
H. influenzae	36, 44, 52
P. aeruginosa	37, 45, 53
E. faecium	38, 46, 54

The bacterial list expands practical coverage but does not create independent protection. If an independent claim is invalid or not infringed, the dependent organism claims generally cannot survive unless their additional limitations provide a legally meaningful distinction.

Which claims are most commercially important?

Claims 1, 11 and 21 are the commercial center of the patent.

Claims 1, 11 and 21 create overlapping protection around the active compound and salt forms. Claims 2-10, 12-20 and 22-30 add patient, carrier, organism and resistance limitations. Claims 31-54 extend the organism list, including pathogens relevant to hospital-acquired and multidrug-resistant infections.

The strongest practical claims are likely:

Claim 1, if the marketed product contains the claimed compound or a covered ester or salt.
Claim 7, 17 or 27, if the approved label expressly covers infections involving resistance to other tetracyclines.
Claims 4-6, 14-16 and 24-26, if the label or prescribing information identifies the listed organisms.
Claims 31-54, if the patent owner can prove that the accused product is promoted or labeled for those specific organisms.

Claims requiring a pharmaceutically acceptable carrier, mammalian subject or human subject may be easier to practice but are narrower than the corresponding parent claims.

Does Patent 9,365,500 cover Nuzyra and omadacycline?

The patent is associated with the aminomethylcycline program that produced omadacycline and Nuzyra. Nuzyra contains omadacycline as the active antibacterial ingredient and is approved for adult patients with community-acquired bacterial pneumonia and acute bacterial skin and skin-structure infections.[2]

The relevant infringement question is whether the chemical structure in claims 1, 11 and 21 corresponds to omadacycline or a covered pharmaceutical form of omadacycline. The supplied text does not reproduce those structures. The original patent drawings and specification control.

If the claimed structure is omadacycline, a product containing omadacycline would likely satisfy the compound limitation when used for a claimed bacterial infection. The use must still fall within the method limitations and the accused party must have the required act of administration, instruction, inducement or other basis for infringement.

What formulations are protected by Patent 9,365,500?

Patent 9,365,500 does not appear, from the supplied claims, to contain a standalone formulation claim directed to a tablet, capsule, vial, excipient system or dosage regimen.

The formulation-related protection is indirect:

Claim 1 covers administration with a pharmaceutically acceptable carrier through dependent claim 8.
Claim 11 includes the corresponding carrier limitation in claim 18.
Claim 21 includes the corresponding carrier limitation in claim 28.
Claims 1 and 11 may cover specified salt or ester forms, depending on the omitted structures and the precise patent wording.

A carrier limitation generally does not create the same protection as a formulation claim directed to defined excipients, concentrations, release profiles or dosage forms. A separate formulation patent would normally provide stronger protection against a product-level generic challenge.

Does the patent cover intravenous and oral administration?

The supplied claims do not expressly limit administration to oral, intravenous, intramuscular or another route. Unless the patent specification or prosecution history imports a route limitation, the method claims may cover any medically acceptable administration route consistent with the claim language.

Nuzyra is marketed in both oral and intravenous presentations.[2] A generic applicant seeking approval for only one route could still face infringement allegations if that route and proposed labeling satisfy the method claims.

The practical scope depends on:

The approved indication.
The proposed generic label.
Instructions concerning the organisms treated.
Whether the label identifies resistant infections.
The dosage form and active salt.
Evidence of induced infringement through labeling or promotional materials.

When does U.S. Patent 9,365,500 expire?

The patent issued on July 5, 2016, from an application in the Paratek aminomethylcycline patent family.[1] Its effective expiration date must be calculated from the earliest nonprovisional priority application, adjusted for patent-term adjustment and any terminal disclaimer.

Public patent databases generally identify the patent as having an expiration in the early 2030s, subject to the official USPTO term calculation. The issue date alone does not determine the expiration date.

Event	Date or status
Patent issued	July 5, 2016
Patent type	Utility patent
Technology	Aminomethylcycline antibacterial treatment
Patent term basis	Twenty years from the applicable earliest nonprovisional filing, subject to adjustments
Expected commercial term	Early 2030s, subject to USPTO term data and terminal disclaimers
Patent status	Requires confirmation against current USPTO and FDA records for live status and listing

Any patent-term extension under 35 U.S.C. § 156 must be distinguished from patent-term adjustment under 35 U.S.C. § 154. Regulatory exclusivity is separate from patent expiration.

What is the Orange Book status of Patent 9,365,500?

FDA Orange Book listings identify patents submitted by the NDA holder for an approved drug and its approved uses. The listing status determines whether an ANDA applicant must provide a Paragraph IV certification or may rely on a section viii statement for a patented use.[3]

For a use patent associated with Nuzyra:

A listed method-of-use patent can create a Paragraph IV challenge.
An ANDA applicant may attempt a skinny label that omits the patented use.
The patent may still create litigation risk if the proposed label encourages the patented use.
The Orange Book listing does not itself establish validity or infringement.
The listing may be removed, corrected or limited by FDA action or litigation.

The FDA Orange Book must be checked for the current patent-use code, listed expiration date and any changes to the patent record. The statutory framework is in the Hatch-Waxman provisions governing patent certifications and generic approval timing.[4]

What Paragraph IV challenges could target Patent 9,365,500?

A generic applicant could challenge the patent through a Paragraph IV certification asserting that the listed patent is:

Invalid.
Unenforceable.
Not infringed by the proposed product or labeling.

The likely invalidity theories would include:

Anticipation under 35 U.S.C. § 102.
Obviousness under 35 U.S.C. § 103.
Lack of written description under 35 U.S.C. § 112.
Lack of enablement under § 112.
Indefiniteness under § 112.
Improper claim construction concerning the chemical structure.
Double patenting or terminal-disclaimer issues.

The most credible technical defenses would depend on the full specification and prosecution history. A challenger could argue that prior art disclosed the compound and its antibacterial use, or that a skilled person would have selected the compound for treatment of the claimed infections. The patent owner would likely rely on the compound’s activity against resistant organisms, spectrum, pharmacokinetics and clinical utility.

A Paragraph IV notice would generally trigger the NDA holder’s opportunity to file suit under 35 U.S.C. § 271(e)(2). A timely action can impose a 30-month stay on FDA approval, subject to statutory exceptions and court decisions.[4]

What is the generic launch risk?

The generic launch risk is moderate to high if the patent remains listed with an expiration in the early 2030s and the product’s label substantially overlaps the claimed uses.

Launch scenario	Risk under Patent 9,365,500
Full-label generic for all approved Nuzyra uses	High
Generic including treatment of listed organisms	High
Generic label expressly covering resistant tetracycline infections	High
Skinny label omitting the patented use	Moderate
Product using a different active compound	Low under these claims
Product using a non-covered salt or ester	Potentially reduced, subject to claim construction
Product with a different indication and no inducement evidence	Lower
Launch after patent expiration	Low from this patent

A skinny-label strategy may reduce literal infringement exposure, but it does not eliminate induced-infringement risk if the remaining label, prescribing information, marketing materials or ordinary use encourage the patented treatment.

How strong is the patent estate around omadacycline?

Patent 9,365,500 is one layer of a likely multi-patent estate. The relevant estate categories are:

Estate category	Function
Composition-of-matter patents	Protect omadacycline or related aminomethylcycline compounds
Salt and solid-form patents	Protect pharmaceutical salts, polymorphs or crystalline forms
Method-of-treatment patents	Protect use against bacterial infections and specific pathogens
Formulation patents	Protect oral or injectable compositions, excipients and stability
Manufacturing patents	Protect synthetic routes, intermediates and purification
Regulatory exclusivity	Delays approval independently of patent validity

The strongest portfolio is usually a layered estate in which a challenger must defeat composition, use, formulation and process rights separately. Method patents such as 9,365,500 are valuable when the approved label tracks the claim language. They are weaker when the sponsor’s commercial use is outside the claimed indication or when a generic can remove the patented use from its label.

How does Patent 9,365,500 compare with competing tetracycline patents?

Product	Active ingredient	Company or originator	Primary protection profile
Nuzyra	Omadacycline	Paratek	Aminomethylcycline composition, use, formulation and related rights
Xerava	Eravacycline	Tetraphase, later La Jolla Pharmaceuticals	Synthetic tetracycline composition and use rights
Tygacil	Tigecycline	Wyeth/Pfizer	Earlier glycylcycline patents and regulatory exclusivity
Vibramycin and generics	Doxycycline	Multiple sponsors	Mature composition and generic market
Minocin and generics	Minocycline	Multiple sponsors	Mature tetracycline franchise
Sarecycline products	Sarecycline	Almirall	Narrow-spectrum tetracycline use and formulation rights

Patent 9,365,500 does not block competing tetracyclines merely because they treat the same pathogens. Its competitive effect is strongest against products using the claimed aminomethylcycline compound.

What patent litigation affects the patent?

The supplied information does not identify a specific Paragraph IV case, settlement agreement or final judgment involving Patent 9,365,500. Litigation status must be assessed through the FDA Orange Book, PACER, district-court dockets and USPTO records.

The relevant litigation questions are:

Whether an ANDA applicant has served a Paragraph IV notice.
Whether Paratek or an NDA successor filed a timely § 271(e)(2) action.
Whether the parties entered a license or launch settlement.
Whether the patent was upheld, invalidated or narrowed.
Whether a court entered a judgment of non-infringement.
Whether any settlement permits an agreed launch date before expiry.

No biosimilar pathway is relevant because omadacycline is a small-molecule antibacterial, not a biologic. The principal competitive challenge is an ANDA or, in some circumstances, a 505(b)(2) application.

What licensing and commercial issues matter?

The commercial value of Patent 9,365,500 depends on ownership and commercialization rights in the underlying aminomethylcycline portfolio. Paratek developed omadacycline and commercialized Nuzyra in the United States. Any assignment, co-development arrangement, regional license or commercialization transaction should be confirmed through USPTO assignment records, SEC filings and FDA application records.

Key diligence points include:

Current patent owner and NDA holder.
Any exclusive license covering U.S. commercialization.
Rights to enforce method patents.
Royalty obligations.
Change-of-control provisions.
Patent-maintenance-fee status.
Patent-term adjustment.
Orange Book patent-use codes.
Any generic settlement restricting launch timing.

The patent is more commercially significant if it is enforceable by the party controlling the Nuzyra NDA and if its claims track the FDA-approved labeling.

What manufacturing and geographic barriers exist?

The claims supplied are U.S. method claims. They do not directly prevent manufacture outside the United States unless the conduct creates U.S. infringement exposure under applicable law.

Manufacturing risk may arise from separate process patents covering:

Aminomethylcycline intermediates.
Selective methylation or substitution steps.
Salt formation.
Purification.
Crystallization.
Sterile injectable production.
Oral tablet or capsule manufacture.

Geographic protection must be analyzed separately in each jurisdiction. A U.S. patent does not provide direct protection in Europe, Canada, Japan, China or other markets. The relevant international family members may have different claim scope, expiration dates, prosecution histories and validity outcomes.

Key Takeaways

U.S. Patent 9,365,500 is a method-of-treatment patent directed to an aminomethylcycline compound associated with omadacycline and Nuzyra.
Claims 1, 11 and 21 are the principal claims; the remaining claims add organisms, resistance, carriers and patient categories.
The claims cover treatment of both gram-positive and gram-negative infections, including E. coli, S. aureus, E. faecalis, K. pneumoniae, A. baumannii and P. aeruginosa.
The patent does not appear to be a general tetracycline patent. Its scope depends on the exact omitted chemical structures.
A full-label generic or a label identifying patented organisms or resistant infections would face substantial infringement risk.
A skinny-label generic could reduce risk, but induced infringement remains a central issue.
The patent is associated with an early-2030s term profile, subject to official USPTO patent-term calculations.
Orange Book listing, patent-use codes, Paragraph IV notices and litigation records are decisive for launch timing.
No biosimilar pathway applies; the relevant competitors are ANDA and 505(b)(2) applicants.
The patent should be evaluated as one component of a broader omadacycline estate covering composition, formulation, manufacturing and regulatory rights.

Frequently Asked Questions

Does Patent 9,365,500 cover all omadacycline products?

Only if the chemical structure in the claims covers the omadacycline form used in the product. The omitted structure must be compared with the active ingredient, salt and ester in the accused product.

Can a generic launch before Patent 9,365,500 expires?

A generic could launch before expiry after a successful invalidity or non-infringement decision, under a settlement license, or with a label that avoids the patented use. A launch without resolving the patent could create infringement exposure.

Is Patent 9,365,500 a composition-of-matter patent?

No. Based on the supplied claims, it is a method-of-treatment patent. Composition-of-matter protection must be assessed from other patents in the aminomethylcycline family.

Do the organism-specific claims protect treatment of hospital infections?

They can cover treatment involving the listed organisms, including A. baumannii, P. aeruginosa, K. pneumoniae and E. faecium, if the other claim limitations are satisfied. The claims do not automatically cover every hospital-acquired infection.

Does FDA approval prove that Patent 9,365,500 is valid?

No. FDA approval and Orange Book listing do not determine patent validity, enforceability or infringement. Those issues are decided under patent law and, when litigated, by the courts.

References

United States Patent and Trademark Office. (2016). U.S. Patent No. 9,365,500, methods of treating bacterial infections.
U.S. Food and Drug Administration. (2018). Nuzyra (omadacycline) prescribing information. Paratek Pharmaceuticals, Inc.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
United States Code. (2023). 35 U.S.C. §§ 154, 156, 271(e), 271(e)(2), 102, 103 and 112; 21 U.S.C. § 355.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	336481	⤷ Start Trial
Austria	544745	⤷ Start Trial
Australia	2001286388	⤷ Start Trial
Australia	2003220123	⤷ Start Trial
Australia	2005201623	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,365,500

Summary for Patent: 9,365,500