Details for Patent: 11,376,237
Which drugs does patent 11,376,237 protect, and when does it expire?
Patent 11,376,237 protects VABOMERE and is included in one NDA.
This patent has sixteen patent family members in fifteen countries.
Summary for Patent: 11,376,237
| Title: | Methods of treating bacterial infections | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | Methods of treating bacterial infection in immunocompromised subjects and subjects with one or more underlying malignancies include administering a combination of meropenem and vaborbactam to the subject. Suitable subjects to be treated can include a subject with a history of ongoing leukemia or lymphoma, a subject that has had an organ transplant, stem cell transplant, bone marrow transplant, or splenectomy, a subject receiving immunosuppressive medications, a subject receiving bone marrow ablative chemotherapy, a subject with neutropenia and subject suffering from or having suffered from a malignancy. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Elizabeth Alexander, Jeffrey S. Loutit, Michael N. Dudley | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Rempex Pharmaceuticals Inc , Melinta Subsidiary Corp | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US16/753,288 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Use; Device; | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | United States Drug Patent 11,376,237: Claim Scope, Exclusivity, Litigation Risk, and Patent Landscape for Meropenem/VaborbactamU.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 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 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 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:
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:
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]
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:
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:
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:
What generic entry risks exist?A generic applicant seeking approval for a meropenem/vaborbactam product could face several certification pathways. Paragraph IV challengeA Paragraph IV certification could assert that the patent is invalid, unenforceable, or not infringed. Likely legal issues could include:
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 statementA 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:
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:
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:
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.
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
FAQsDoes 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
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Drugs Protected by US Patent 11,376,237
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rempex | VABOMERE | meropenem; vaborbactam | POWDER;INTRAVENOUS | 209776-001 | Aug 29, 2017 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI,KLEBSIELLA PNEUMONIA,ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
Foreign Priority and PCT Information for Patent: 11,376,237
| PCT Information | |||
| PCT Filed | October 01, 2018 | PCT Application Number: | PCT/US2018/053772 |
| PCT Publication Date: | April 11, 2019 | PCT Publication Number: | WO2019/070591 |
International Family Members for US Patent 11,376,237
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2018345317 | ⤷ Start Trial | |||
| Brazil | 112020006658 | ⤷ Start Trial | |||
| Canada | 3078238 | ⤷ Start Trial | |||
| Chile | 2020000892 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
