United States Drug Patent 11,376,237: Claim Scope, Exclusivity, Litigation Risk, and Patent Landscape for Meropenem/Vaborbactam
U.S. Patent No. 11,376,237 protects methods of treating bacterial infections in immunocompromised patients, including patients with malignancies, neutropenia, transplants, or immunosuppressive therapy, using meropenem in combination with vaborbactam. The patent is a method-of-use patent, not a composition-of-matter patent.
The core commercial risk concerns use of the meropenem/vaborbactam combination in the protected patient population. The claims cover broad pathogen classes, administration routes, dose ranges, meropenem-to-vaborbactam ratios, treatment durations, and simultaneous administration. The approved Vabomere regimen falls within the principal dose, ratio, intravenous-administration, and dosing-frequency limitations.
What does U.S. Patent 11,376,237 protect?
Patent 11,376,237 has two independent method claims:
| Claim |
Independent scope |
| Claim 1 |
Treating a bacterial infection in an immunocompromised subject by administering meropenem and vaborbactam |
| Claim 9 |
Treating a bacterial infection in a subject suffering from or having suffered from a malignancy by administering meropenem and vaborbactam |
Claim 1 is the broader independent claim because it covers immunocompromised subjects generally. Claim 9 separately targets patients with current or historical malignancy, whether or not the patient otherwise falls within a narrower immunocompromised category.
The patent does not require:
- A particular bacterial resistance mechanism
- Carbapenem-resistant Enterobacterales
- A particular infection site
- A demonstrated failure of another antibiotic
- A fixed-dose formulation
- A particular sequence of administration
- A specific clinical outcome
- A particular meropenem:vaborbactam ratio in the independent claims
A potentially infringing method must, however, involve administration of both meropenem and vaborbactam to a qualifying patient for treatment of a bacterial infection.
How do the claims divide across patient populations?
Claims 3 through 8 and 11 through 13 create multiple patient-population limitations.
| Claim |
Patient characteristic |
| 3 |
Ongoing leukemia or lymphoma |
| 4 |
Organ, stem-cell, or bone-marrow transplant, or splenectomy |
| 5 |
Immunosuppressive medication |
| 6 |
Bone-marrow ablative chemotherapy |
| 7 |
Neutropenia |
| 8 |
Current or prior malignancy |
| 11 |
Specified hematological malignancies |
| 12 |
Solid tumor, including sarcoma or carcinoma |
| 13 |
Absolute neutrophil count below about 1,000 cells/mm³ |
Claim 13 is particularly important for clinical and regulatory analysis. It narrows claim 1 to a measurable laboratory condition. The phrase “below about 1000 cells/mm3” may create factual disputes concerning laboratory values, timing, and clinical documentation.
Claim 11 covers acute lymphocytic leukemia, acute myeloid leukemia, AIDS-related lymphoma, primary CNS lymphoma, Burkitt lymphoma, chronic lymphocytic leukemia, chronic myelogenous leukemia, Hodgkin lymphoma, multiple myeloma, myeloproliferative neoplasms, and Sezary syndrome.
Claim 12 covers solid tumors through the “sarcoma or carcinoma” limitation. The claim language is broader than a list of named tumor types but still requires the patient to be suffering from or to have suffered from a solid tumor.
Which bacterial infections fall within the patent?
Claims 2 and 10 list a broad set of bacterial pathogens. The listed organisms include:
- Escherichia coli
- Klebsiella pneumoniae
- Pseudomonas aeruginosa
- Enterobacter cloacae species complex
- Enterococcus faecium
- Serratia marcescens
- Streptococcus pyogenes
- Streptococcus pneumoniae
- Haemophilus influenzae
- Chlamydia trachomatis
- Mycoplasma pneumoniae
- Legionella pneumophila
- Acinetobacter baumannii
- Bartonella bacilliformis
- Brucella species
- Calymmatobacterium granulomatis
- Campylobacter fetus
- Francisella tularensis
- Haemophilus ducreyi
- Vibrio cholerae
- Yersinia pestis
The pathogen limitation is dependent. Claims 1 and 9 do not require that the infection be caused by one of these listed organisms. A bacterial infection outside the lists can therefore fall within the independent claims if all other limitations are satisfied.
The claim structure also creates a distinction between technical scope and practical scope. Vaborbactam is primarily relevant to infections involving serine beta-lactamases, especially KPC-producing Enterobacterales. The patent’s pathogen list is materially broader than the drug’s principal commercial positioning and may include organisms for which meropenem/vaborbactam is not the usual clinical choice.
What dose, ratio, route, and duration limitations are protected?
Claims 14 through 20 add administration and dosing limitations:
| Claim |
Limitation |
| 14 |
Oral, intravenous, intraperitoneal, intragastric, or intravascular administration |
| 15 |
1 mg to 5,000 mg of each component |
| 16 |
10 mg to 3,000 mg of each component |
| 17 |
100 mg to 2,000 mg of each component |
| 18 |
Meropenem:vaborbactam weight ratio from 2:1 to 1:2 |
| 19 |
One to four administrations daily for about one day to at least about four weeks |
| 20 |
Simultaneous administration |
The approved Vabomere regimen is meropenem 2 grams plus vaborbactam 2 grams administered intravenously every eight hours, generally infused over three hours for adults with appropriate renal-function adjustment.[1] That regimen has a 1:1 weight ratio and therefore falls within claim 18. Three-times-daily administration falls within claim 19. The approved intravenous route falls within claim 14.
The broad dose ranges create substantial overlap with the marketed product. Claims 15 through 17 are dependent claims, so an accused method must also satisfy the relevant parent claim.
When does U.S. Patent 11,376,237 expire?
The patent was issued on July 5, 2022.[2] Its ordinary patent-term endpoint is expected to be determined by the earliest effective nonprovisional or international filing date in the priority chain, subject to patent-term adjustment, terminal disclaimers, and any applicable regulatory extension.
Publicly available patent records identify the patent as part of the meropenem/vaborbactam intellectual-property family directed to treatment of bacterial infections in immunocompromised patients. The expected unadjusted term is in the mid-2030s, generally estimated at approximately 2036 for a 2016-originating application. The precise expiration date should be taken from the USPTO Patent Center term calculation and the issued patent’s continuity data rather than inferred solely from the issue date.[2]
| Event |
Date or status |
| Patent issued |
July 5, 2022 |
| Patent type |
Method of treatment |
| Principal subject |
Meropenem/vaborbactam use in immunocompromised or malignant patients |
| Expected unadjusted term |
Approximately 2036, subject to the priority chain |
| Patent-term adjustment |
Must be confirmed from USPTO records |
| Patent-term extension |
No extension should be assumed without a specific regulatory order |
FDA regulatory exclusivity and patent term are separate. FDA approval of Vabomere does not itself determine the expiration date of Patent 11,376,237.[3]
What is the Orange Book status of Patent 11,376,237?
Vabomere is approved under NDA 209776 for adult patients with complicated urinary tract infections, including pyelonephritis, and hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible organisms.[1] FDA Orange Book listings must be evaluated separately from the patent’s technical claim scope.
A method patent may be listed in the Orange Book if it claims an approved method of using the drug product. The practical question is whether the patented immunocompromised-patient use corresponds to an approved labeling indication or other approved use described in the product labeling. If the patented use is not reflected in the approved label, Orange Book listing and Paragraph IV relevance can be narrower or contested under the Hatch-Waxman framework.[4]
The patent’s claims cover immunocompromised patients broadly, while the Vabomere label does not necessarily direct treatment of every listed malignancy, tumor type, pathogen, route, or dose range. That difference can affect:
- Whether the patent is listed against the NDA
- The applicable FDA use code
- The scope of a Paragraph IV certification
- The risk created by a generic label
- Whether a section viii statement can omit the protected use
A current Orange Book entry and FDA use-code record are required to establish the definitive listing status. The patent number alone does not establish that the patent blocks every generic meropenem or vaborbactam product.
How strong is the patent estate for meropenem/vaborbactam?
Patent 11,376,237 is one layer in a broader estate. The commercial product can be protected through several distinct categories:
| Protection category |
Typical subject matter |
Relevance |
| Vaborbactam composition patents |
The beta-lactamase inhibitor and related compounds |
Core molecule protection |
| Combination patents |
Meropenem plus vaborbactam compositions |
Product and formulation coverage |
| Pharmaceutical formulation patents |
Stability, ratios, excipients, and dosage forms |
Manufacturing and product-substitution barriers |
| Method-of-use patents |
Treatment of infections or selected patient groups |
Label and clinical-use protection |
| Manufacturing patents |
Synthesis, purification, salt, and formulation processes |
Potential process barriers |
| Regulatory exclusivity |
NDA exclusivity and pediatric exclusivity |
FDA approval timing rather than patent infringement |
The strength of Patent 11,376,237 is highest where the accused product’s labeling or clinical protocol expressly identifies immunocompromised or malignant patients and directs use of meropenem/vaborbactam. Its strength is lower where a generic label omits the protected population and the product is used for an unclaimed population.
The patent is less likely to block:
- Meropenem monotherapy
- Vaborbactam without meropenem
- Other beta-lactam/beta-lactamase inhibitor combinations
- Use outside the claimed patient populations
- Use for nonbacterial infections
- Use where the accused product label does not encourage the patented method
What generic entry risks exist?
A generic applicant seeking approval for a meropenem/vaborbactam product could face several certification pathways.
Paragraph IV challenge
A Paragraph IV certification could assert that the patent is invalid, unenforceable, or not infringed. Likely legal issues could include:
- Written-description support for the broad immunocompromised-patient genus
- Enablement of the full pathogen, dose, route, and duration scope
- Obviousness based on known meropenem/vaborbactam treatment and known infection risks in immunocompromised patients
- Anticipation by prior clinical or patent disclosures
- Indefiniteness of terms such as “about,” “immunocompromised,” or “one or more bacterial infection”
- Scope of the term “combination”
- Whether the approved label induces performance of the claimed method
A Paragraph IV notice can trigger patent litigation and a statutory stay of FDA approval under 21 U.S.C. § 355(j)(5)(B)(iii), subject to the statutory requirements and timing.[4]
Section viii statement
A generic applicant may seek to omit a patented method from its label through a section viii statement. This strategy is more credible if the proposed label limits treatment to nonprotected populations or indications and does not encourage use in immunocompromised or malignant patients.
The risk increases if the label includes:
- Immunocompromised-patient dosing instructions
- Neutropenic-patient guidance
- Cancer-associated infection language
- Clinical-study data focused on the claimed population
- Broad treatment language that naturally encompasses the patented method
A label carveout does not eliminate all litigation risk. Physicians may still prescribe the product for a patented use, but the central question becomes whether the generic manufacturer’s label actively encourages that use.
What patent litigation affects Patent 11,376,237?
The supplied record does not establish a reported final judgment, settlement, license, or Paragraph IV litigation specifically concerning U.S. Patent 11,376,237. The patent issued after Vabomere entered the market, so its principal enforcement exposure is likely to arise from future abbreviated applications, follow-on products, or commercial use by competitors.
Any litigation analysis should distinguish:
- Patent 11,376,237 itself
- Earlier patents covering vaborbactam
- Combination and formulation patents
- NDA listing disputes
- Contractual licensing or settlement arrangements
- Patent-term and Orange Book challenges
A settlement involving another Vabomere patent would not automatically resolve rights under Patent 11,376,237 unless the agreement expressly covers it.
Which companies are challenging the meropenem/vaborbactam estate?
The patent record provided does not identify a named generic challenger, Paragraph IV notice, or active case involving Patent 11,376,237. A reliable competitor analysis requires checking the FDA Orange Book, PACER, district-court dockets, and ANDA litigation records for:
- Generic meropenem/vaborbactam applicants
- Patent owners and exclusive licensees
- Declaratory-judgment plaintiffs
- 30-month-stay litigation
- Settlement or supply agreements
No company should be characterized as a challenger based solely on the existence of a later-filed patent or a generic product listing.
What licensing and ownership issues matter?
The commercial rights may involve a chain extending from the original vaborbactam developer to later owners or licensees of the Vabomere business. The relevant entities may include the original research company, The Medicines Company, Melinta Therapeutics, and subsequent commercial or licensing counterparties.
Ownership of Patent 11,376,237 should be confirmed through USPTO assignment records. Patent ownership, NDA ownership, marketing rights, and the right to sue for infringement can be held by different entities. A license recorded against the patent may not disclose all commercial terms, field restrictions, royalty obligations, or settlement provisions.
How does Patent 11,376,237 compare with competing antibiotic patents?
Patent 11,376,237 differs from most antibiotic composition patents because its value depends on patient selection rather than a new chemical entity.
| Patent type |
Primary barrier |
Design-around potential |
| Composition-of-matter patent |
Chemical structure |
Usually low before expiration |
| Combination patent |
Co-administration or fixed combination |
Moderate |
| Formulation patent |
Excipients, stability, dosage form |
Moderate to high |
| Method-of-use patent |
Patient, disease, pathogen, or regimen |
Often higher through labeling or clinical-use limits |
| Manufacturing patent |
Process steps or intermediates |
Moderate, depending on process alternatives |
The patent has meaningful overlap with Vabomere’s approved intravenous 2 g/2 g regimen, but it does not claim the underlying meropenem or vaborbactam molecules themselves. It therefore cannot independently prevent all sales of either component.
Key Takeaways
- U.S. Patent 11,376,237 is a broad method-of-treatment patent for meropenem/vaborbactam use in immunocompromised and oncology patients.
- Claims 1 and 9 are the principal independent claims.
- The claims cover patients with malignancy, neutropenia, transplantation, immunosuppressive therapy, or related conditions.
- The approved 2 g/2 g intravenous Vabomere regimen is within the principal dose, route, ratio, and frequency limitations.
- The patent does not block meropenem monotherapy or every use of meropenem/vaborbactam.
- Generic risk depends heavily on the proposed label and whether the label encourages treatment of the protected population.
- Paragraph IV litigation, section viii carveouts, written description, enablement, obviousness, and indefiniteness are the central legal issues.
- The expected patent term extends into approximately 2036, subject to confirmation of the priority chain and patent-term adjustment.
- Orange Book status and use-code scope must be verified independently from the patent claims.
- No specific challenger, settlement, or final litigation outcome is established by the supplied record.
FAQs
Does Patent 11,376,237 cover all Vabomere use?
No. It covers specified methods involving meropenem and vaborbactam, principally in immunocompromised or malignant patients. It does not claim every use of Vabomere.
Can a generic sell meropenem without infringing this patent?
Yes. The patent requires administration of meropenem in combination with vaborbactam. Meropenem monotherapy is outside the literal scope of these claims.
Does the patent require carbapenem-resistant bacteria?
No. The claims do not require carbapenem resistance, KPC production, or another defined resistance mechanism.
Is a 1 g meropenem/1 g vaborbactam regimen covered?
Potentially yes. The 1:1 ratio falls within claim 18, and the doses fall within claims 15 through 17, provided the patient, infection, route, and other parent-claim limitations are satisfied.
Can a generic avoid the patent through a skinny label?
Potentially. A section viii carveout may reduce risk if the generic label omits the patented immunocompromised or malignancy-related use and does not encourage that use. The outcome depends on the final label, Orange Book listing, use code, and litigation record.
References
- U.S. Food and Drug Administration. (2024). Vabomere (meropenem and vaborbactam) prescribing information.
- U.S. Patent and Trademark Office. (2022). U.S. Patent No. 11,376,237, methods of treating bacterial infections in immunocompromised patients.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).
