Details for Patent: 11,007,206
Which drugs does patent 11,007,206 protect, and when does it expire?
Patent 11,007,206 protects VABOMERE and is included in one NDA.
This patent has one patent family member in one country.
Summary for Patent: 11,007,206
| Title: | Cyclic boronic acid ester derivatives and therapeutic uses thereof | ||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | Method of treating or ameliorating a bacterial infection comprising administering a composition comprising a cyclic boronic acid ester compound in combination with a carbapenem antibacterial agent such as Biapenem, and the pharmacokinetics studies thereof are provided. | ||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | David C. Griffith, Michael N. Dudley, Olga Lomovskaya | ||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Melinta Subsidiary Corp | ||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US16/746,574 | ||||||||||||||||||||||||||||||||||||||||||||||||
|
Patent Claim Types: see list of patent claims | Use; Composition; Delivery; | ||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | US Patent 11,007,206: Vaborbactam-Carbapenem Claims, Patent Scope and Generic RiskUS Patent 11,007,206 protects methods of treating human bacterial infections with vaborbactam, also known as Compound I or RPX7009, administered with a carbapenem at specified pharmacokinetic exposure levels. Its principal commercial relevance is the meropenem-vaborbactam combination marketed as Vabomere. The patent is a method-of-use asset rather than a basic composition-of-matter patent. The claims cover two independent pharmacokinetic endpoints:
The patent does not claim every use of vaborbactam. A potentially infringing product or regimen must satisfy the combination, disease, patient, and pharmacokinetic limitations recited in the claims. What drug and compound does US 11,007,206 protect?Compound I is vaborbactam, a cyclic boronic acid beta-lactamase inhibitor developed by Rempex Pharmaceuticals and subsequently commercialized by The Medicines Company and Melinta Therapeutics. Vaborbactam inhibits selected serine beta-lactamases, particularly class A enzymes such as KPC, and restores the antibacterial activity of carbapenems against certain resistant Gram-negative organisms. The patent is directed to vaborbactam administered with a carbapenem antibacterial agent. The specified carbapenems are:
Claim 3 and claim 13 narrow the carbapenem to biapenem. Meropenem is not separately singled out in a dependent claim, but it is expressly included in the Markush group in claims 2 and 12. How many independent claims does US 11,007,206 have?The patent has two independent method claims. Claim 1: plasma-clearance pathwayClaim 1 requires:
Claims 2 through 10 depend from claim 1. Claim 11: half-life pathwayClaim 11 requires:
Claims 12 through 20 depend from claim 11. The two independent claims create alternative infringement theories. A regimen may fall within the patent through the clearance limitation, the half-life limitation, or both. What formulations are protected by US 11,007,206?The patent protects a composition containing both vaborbactam and a carbapenem, but the claims do not require a particular fixed-dose ratio, excipient system, vial configuration, or dosage form. Claim 8 and claim 18 specify intravenous administration. The independent claims themselves are broader regarding route, although the claimed compositions and pharmacokinetic targets are most commercially consistent with intravenous administration. The claim language may cover:
The distinction between a single physical formulation and two separately administered products could become material in litigation. The claim requires administering “a composition comprising” vaborbactam and a carbapenem, which gives the patentee a stronger position against a combined formulation than against products supplied and administered entirely separately. The specification and prosecution history would control the final construction of “composition.” The claims do not expressly require the commercial Vabomere ratio of 1:8, corresponding to 2 g of vaborbactam with 4 g of meropenem per dosing interval in the marketed product’s administration scheme. A competing ratio could therefore remain within the claim scope if it meets the other limitations. What bacterial infections fall within the patent?Claims 9 and 19 list a broad range of Gram-negative and other bacterial pathogens. The listed organisms include:
Claims 1 and 11 do not themselves recite the organism list. Claims 9 and 19 narrow the independent claims to infections caused by the listed bacteria. The list includes clinically important carbapenem-resistant Enterobacterales and Pseudomonas organisms, but the patent is not limited to KPC-producing pathogens or to a specific resistance mechanism. What dose ranges are protected?Claims 4 and 14 recite a vaborbactam dose of approximately 0.1 to 1,000 mg/kg of body weight. Claims 5 and 15 narrow the range to approximately 0.5 to 500 mg/kg. These ranges are extremely broad compared with commercial intravenous dosing. Their practical value is less likely to be a stand-alone barrier than the combination and pharmacokinetic limitations. A generic or follow-on developer would likely focus on whether its proposed regimen reaches the claimed clearance or half-life range rather than on avoiding the broad dose language alone. What pharmacokinetic ranges are claimed?
The ranges overlap substantially. A regimen producing clearance of 0.05 to 1 L/h/kg would fall within claim 7 and also within the broader claims 1 and 6. A half-life of 0.3 to 5 hours would fall within claim 17 and the broader claims 11 and 16. The “to achieve” language makes pharmacokinetic evidence central. In a product liability or infringement dispute, relevant evidence could include:
The claim does not expressly require a particular therapeutic outcome, microbiological endpoint, or minimum vaborbactam concentration. The method does require treatment of a bacterial infection in a human. When does US 11,007,206 lose exclusivity?US 11,007,206 issued on May 18, 2021. Its enforceable term is generally calculated from the earliest effective nonprovisional priority or application filing date, subject to patent-term adjustment, terminal disclaimers, and other USPTO term determinations. The patent term should therefore be taken from the USPTO Patent Center record and the patent’s front page rather than inferred solely from the grant date. [1] The patent is part of the Vabomere and vaborbactam patent landscape. Its expiration date should be distinguished from:
A later-expiring method patent can remain commercially relevant after earlier composition patents expire if a generic applicant’s proposed label induces use of the patented combination. What is the Orange Book status of US 11,007,206?Vabomere is an FDA-approved small-molecule antibacterial product containing meropenem and vaborbactam. It is not a biologic and therefore is not subject to the biosimilar framework. The FDA Orange Book is the relevant source for listed patents and approved therapeutic-equivalence information. A patent’s inclusion in the Orange Book does not itself establish validity or infringement. It gives an ANDA applicant notice of the listed patent and triggers the statutory certification framework under the Hatch-Waxman Act. [2] The commercial patent estate for Vabomere has included patents directed to:
US 11,007,206 is most important as a combination-treatment and pharmacokinetic method patent. It should not be treated as interchangeable with a composition-of-matter patent. Which companies are challenging Vabomere patents?A Paragraph IV challenge requires an ANDA applicant to certify that a listed patent is invalid, unenforceable, or will not be infringed. The patent holder may then bring an infringement action under 35 U.S.C. §271(e)(2), generally creating a 30-month stay of FDA approval for the relevant ANDA, subject to statutory exceptions. [3] Public Orange Book and FDA records should be checked for current certifications and litigation. The absence of an identified public Paragraph IV case does not mean that a patent cannot be challenged. A generic company may instead:
For this patent, a Paragraph IV strategy would face a claim-by-claim analysis of whether the proposed product and labeled regimen achieve the claimed clearance or half-life. The pharmacokinetic limitation creates a potentially narrower infringement case than a claim directed only to the presence of vaborbactam and meropenem. What patent litigation affects US 11,007,206?The relevant litigation questions are:
A search should cover USPTO Patent Center, PACER, district-court dockets, Federal Circuit decisions, and FDA Orange Book updates. Patent-family litigation involving earlier vaborbactam patents does not automatically establish the enforceability or validity of US 11,007,206. No settlement terms should be inferred from the existence of a generic filing. Hatch-Waxman settlements can include confidential commercial provisions and different entry dates for authorized generics, licensees, or independent ANDA applicants. How strong is the patent estate for vaborbactam and Vabomere?The estate is stronger when viewed as a layered portfolio rather than through US 11,007,206 alone.
US 11,007,206 has meaningful blocking potential because a commercial meropenem-vaborbactam product will ordinarily be designed to produce the claimed pharmacokinetic profile. Its weaknesses are equally specific: the claims are limited to human treatment, require a carbapenem combination, and depend on measurable pharmacokinetic outcomes. What generic launch risks exist?Scenario 1: launch after all relevant patents expireThis is the lowest-risk route. The applicant avoids Paragraph IV litigation but accepts a later launch. Scenario 2: Paragraph IV challengeThe applicant could argue that:
The patent holder could respond that the ranges are expressly disclosed, clinically achievable, and met by standard dosing. Scenario 3: skinny labelA narrow label could omit patented uses. This strategy is difficult where the approved product’s principal commercial use is the patented combination itself. A label that recommends meropenem and vaborbactam for the same bacterial infections could support an induced-infringement theory even if the patent text is not reproduced verbatim. Scenario 4: alternative carbapenem or separate administrationThe claims expressly cover five carbapenems, including meropenem. Switching to another listed carbapenem does not avoid the patent. Separate administration may create a stronger non-infringement argument, but the result depends on the construction of “composition comprising” and the actual instructions for use. How does US 11,007,206 compare with biosimilar and generic barriers?Vaborbactam is a chemically synthesized small molecule. A competing product would proceed through the ANDA pathway, not a 351(k) biosimilar application. The relevant risks are therefore:
There is no biosimilar interchangeability issue for vaborbactam. The principal regulatory challenge is demonstrating pharmaceutical equivalence and bioequivalence or satisfying FDA requirements applicable to injectable products. What manufacturing and IP barriers remain?Vaborbactam manufacturing may require control of:
A generic company could avoid one manufacturing patent while remaining exposed to another patent covering the final combination, a key intermediate, or the labeled clinical use. Freedom-to-operate analysis therefore must map the entire family, including continuations and divisionals, not only US 11,007,206. Key Takeaways
FAQs About US Patent 11,007,206Does US 11,007,206 cover meropenem-vaborbactam?Yes. Meropenem is expressly included in the carbapenem group recited in claims 2 and 12, provided the other claim limitations are satisfied. Is US 11,007,206 a compound patent?No. It is principally a method patent. It does not claim vaborbactam as a standalone chemical entity in the claims supplied. Can a generic avoid the patent by using imipenem instead of meropenem?Not necessarily. Imipenem is expressly included in the claimed carbapenem group. The generic would need to avoid the applicable combination and pharmacokinetic limitations. Does the patent cover oral vaborbactam?The independent claims do not require intravenous administration, but claims 8 and 18 expressly cover intravenous administration. Whether an oral product falls within the broader claims would depend on whether it satisfies the composition, carbapenem, human-treatment, and pharmacokinetic requirements. Is vaborbactam eligible for a biosimilar application?No. Vaborbactam is a chemically synthesized small molecule. A competing product would generally use the FDA ANDA pathway. References
More… ↓ |
Drugs Protected by US Patent 11,007,206
| 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 |
International Family Members for US Patent 11,007,206
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013184845 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
