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Details for Patent: 8,853,197
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Which drugs does patent 8,853,197 protect, and when does it expire?
Patent 8,853,197 protects ZAYNICH and is included in one NDA.
This patent has twenty-two patent family members in seventeen countries.
Summary for Patent: 8,853,197
| Title: | Nitrogen containing compounds | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | Compounds of Formula (I), their preparation and use in preventing or treating bacterial infection is disclosed. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Mahesh Vithalbhai Patel, Prasad Keshav Deshpande, Satish Bhawasar, Sachin Bhagwat, Mohammad Alam Jafri, Amit MISHRA, Laxmikant Pavase, Sunil Gupta, Rajesh Kale, Sanjeev Joshi | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Wockhardt Ltd | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US14/294,364 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Composition; Compound; | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | United States Drug Patent 8,853,197: Claim Scope, Patent Strength and Generic Entry RiskUS Patent No. 8,853,197 protects a broad genus of trans-1,6-diazabicyclo[3.2.1]octane beta-lactamase inhibitor compounds, together with selected stereoisomers, salts and pharmaceutical compositions. The claims center on a 7-oxo-1,6-diazabicyclo[3.2.1]octane core bearing a substituted hydrazinocarbonyl group and an acidic or acid-functional substituent, particularly a sulfate ester. The patent has meaningful chemical breadth in claim 1, but its practical enforcement value depends heavily on whether a marketed product contains one of the expressly claimed species in claims 2 through 6. Claims 5 and 6 are the narrowest and commercially most relevant species claims. Claims 7 through 14 protect compositions containing the claimed compounds, but they do not independently claim a method of treatment, dosing regimen, formulation technology or manufacturing process. What compounds does US 8,853,197 protect?The patent's principal subject matter is a class of substituted diazabicyclooctanone compounds. These compounds are structurally associated with beta-lactamase inhibition, particularly inhibition of serine beta-lactamases that can degrade beta-lactam antibiotics. The core structural requirements are:
Claim 1 is a Markush claim. It does not identify one commercial compound. It covers a large chemical genus defined through alternative substituent lists for R1, R2, R3, R4, R5, R6 and R7. The claim's central structural limitation is the combination of:
The claim is therefore broader than the individual examples in dependent claims 2 through 6. A compound can infringe claim 1 even if it is not one of the named compounds in those dependent claims, provided it falls within the Formula I variables. How broad is claim 1 of US 8,853,197?Claim 1 has substantial genus breadth, but the breadth is constrained by the defined Formula I structure and substituent dictionaries. R1 scopeR1 may be hydrogen, an acyl-derived group or a carboxylate-derived group. The acyl option is particularly broad because R3 can be:
The permitted substituents include halogen, hydroxyl or alkoxy groups, cyano, ester, amide, amino, sulfonamide-related groups, aryl groups and heterocyclic groups. This creates coverage for many polar and ionizable side chains. The listed species demonstrate the intended chemical direction: pyrrolidine, piperidine, piperazine, morpholine, azetidine, amino acids, aminobutyric acid derivatives, amino-thiazole compounds and substituted cyclic amino-acyl groups. R2 scopeR2 is narrower in type but important in product coverage. It includes:
The sulfate option, SO3M, is prominent in the named species. The use of M as hydrogen or a cation permits free-acid and salt forms, including sodium salts. The inclusion of carboxymethyl, difluorocarboxymethyl and monofluorocarboxymethyl groups expands the claim beyond sulfate analogs. A product with the same core and hydrazide side chain but a different acidic substituent could remain within claim 1. R6 and R7 scopeR6 and R7 may be independently substituted or may join to form a four- to seven-membered ring. This ring-closing provision supports coverage of cyclic amines such as pyrrolidine, piperidine, piperazine and morpholine derivatives. The ring option is commercially relevant because cyclic amino substituents can materially affect permeability, solubility, stability and beta-lactamase binding. It also increases the number of possible claimed compounds without requiring a separate claim for every ring system. Which specific compounds are protected by claims 2 through 6?Claims 2 through 6 narrow the broad Formula I genus to listed compounds or defined subclasses.
Claims 5 and 6 are species claims. They are materially easier to evaluate against a specific drug substance than claim 1 because they identify the stereochemical configuration and side-chain identity. Claim 5 covers:
Claim 6 covers:
Each claim also covers stereoisomers and pharmaceutically acceptable salts. The salt language can be important for infringement analysis because a sodium, potassium or other pharmaceutically acceptable salt may still fall within the claim even though the isolated solid-state form differs from the free acid. What pharmaceutical compositions are protected?Claims 7 through 14 are composition claims. They cover pharmaceutical compositions containing:
Claims 13 and 14 specifically identify compositions containing the claim 5 and claim 6 compounds. These claims do not recite:
The composition claims are therefore broad as to formulation content but narrow as to the active compound. A generic manufacturer using a different active compound outside the Formula I scope would not infringe claims 7 through 14 merely because it used a similar pharmaceutical composition. Does the patent protect a method of use?No method-of-use claim appears in the provided claim set. The patent claims compounds and compositions only. That distinction affects both enforcement and regulatory exclusivity. The claims do not expressly cover:
Any protection for therapeutic use would have to arise from separate method-of-treatment patents or from infringement by making, using, selling or importing the claimed compound or composition. What formulations are protected by US 8,853,197?The provided claims do not contain a detailed formulation limitation. Claims 7 through 14 require only a pharmaceutical composition comprising a covered compound. Potentially covered dosage forms could include:
The absence of a specific dosage-form limitation reduces the ability of a generic manufacturer to avoid the composition claims by changing excipients or presentation. A formulation redesign would not avoid infringement if the active compound remains within the claims. At the same time, the patent does not appear to protect a specialized delivery system. A competitor could potentially avoid formulation overlap by using a nonclaimed active ingredient, even if the delivery technology is similar. How strong is the patent estate?The patent's strength is mixed and should be assessed claim by claim.
The most defensible infringement theory would generally focus on claims 5 or 6 when the accused active pharmaceutical ingredient matches one of those named stereochemical species. Claim 1 may provide a broader fallback position, but its extensive Markush structure creates more potential validity issues. What invalidity issues could affect claim 1?The principal validity risks for a broad chemical genus are predictable. Written descriptionA challenger may argue that the specification does not demonstrate possession of the full range of compounds covered by every R1, R2 and R3 alternative. This issue becomes more significant where the claim includes multiple unrelated functional groups and ring systems. EnablementThe breadth of claim 1 may require synthesis and testing of a large number of compounds. A challenger could argue that practicing the full genus requires undue experimentation, particularly if the specification provides limited examples for some substituent classes. AnticipationEarlier beta-lactamase inhibitor patents and publications may disclose overlapping diazabicyclooctane cores, sulfate groups, hydrazide substituents or specific cyclic amino-acyl side chains. Anticipation requires a single reference to disclose every claim element, including the required stereochemistry where applicable. ObviousnessObviousness risk is greater where prior art teaches:
Unexpected potency, improved stability, improved spectrum, reduced toxicity or superior beta-lactam synergy could support validity, but those facts must be tied to the claimed scope rather than isolated examples. Claim constructionTerms such as "pharmaceutically acceptable salt," "stereoisomer," "optionally substituted" and the various functional-group definitions can become central in litigation. The prosecution history and specification definitions would determine whether these terms receive their ordinary meaning or a narrower patent-specific construction. When does US 8,853,197 lose exclusivity?The patent's enforceable term cannot be calculated reliably from the patent number and claims alone. The relevant date is generally the expiration of the patent term under 35 U.S.C. §154, adjusted for any applicable patent-term adjustment, terminal disclaimer or other recorded limitation. A patent's grant date does not establish its expiration date. The patent may also be affected by:
Patent expiration and FDA exclusivity are separate. A compound patent can remain enforceable after regulatory exclusivity ends, while an FDA exclusivity period can expire before the relevant patent term. What is the Orange Book status?No Orange Book listing can be established from the supplied claims alone. The claims identify a chemical genus and selected compositions but do not identify an approved drug, NDA, sponsor, active ingredient name or marketed brand. If the patent is not associated with an FDA-approved drug product, it would not necessarily appear in the Orange Book. FDA listing depends on an approved NDA and the sponsor's patent submission. An unlisted patent can still be enforceable under ordinary patent law, but it would not necessarily generate an Orange Book Paragraph IV notice. Are there Paragraph IV challenges or generic litigation?No Paragraph IV challenge, ANDA litigation, settlement agreement or court disposition is established by the provided material. A Paragraph IV case would require an ANDA applicant to certify that a listed patent is invalid, unenforceable or will not be infringed. The supplied claims do not identify:
The absence of a method-of-use claim would also affect the likely certification posture if the patent were listed for an approved product. Compound and composition claims generally present more direct infringement issues than use claims because a generic active ingredient could infringe upon manufacture, importation or sale. Which companies are likely relevant to the competitive landscape?The technical field includes developers of diazabicyclooctane and other beta-lactamase inhibitors, including companies associated with avibactam, durlobactam, zidebactam and related investigational compounds. Those products are not automatically covered by US 8,853,197. Chemical overlap must be tested against the actual molecular structure. Similar pharmacology or a shared beta-lactamase target is insufficient. In particular:
The patent is therefore more relevant to structurally close DBO programs than to the broader beta-lactamase inhibitor market. What generic launch scenarios exist?Three principal scenarios apply. Scenario 1: Exact species matchIf a generic uses the claim 5 or claim 6 compound, infringement risk is high, subject to validity and enforceability defenses. A salt change is unlikely to provide a reliable design-around because the claims expressly include pharmaceutically acceptable salts. Scenario 2: Same core, modified side chainA compound with the same bridged core but a side chain outside the R1/R3 definitions may avoid literal infringement. The risk would then depend on whether the modified compound remains within claim 1 or raises a doctrine-of-equivalents issue. Scenario 3: Different core or pharmacophoreA non-DBO inhibitor, a cyclic boronate or a different beta-lactamase inhibitor scaffold would generally present lower literal infringement risk. Separate patent estates could still apply. The most effective design-around targets are likely to be the hydrazinocarbonyl linkage, the 6-position acidic substituent, the trans stereochemistry and the defined cyclic amino-acyl side chains. Each modification requires a full claim chart against claim 1, not only claims 5 and 6. Does the patent create a manufacturing or licensing barrier?The supplied claims contain no manufacturing-process claims. They do not cover:
The commercial barrier is therefore primarily product-based. A license would be most relevant for a program whose active ingredient falls within claim 1 or one of the named species claims. A complete freedom-to-operate review would also need to assess related continuation, divisional and foreign-family patents, as well as later patents directed to salts, polymorphs, formulations, combinations, manufacturing processes and clinical uses. Those rights are separate from the claim set supplied here. Key Takeaways
FAQsIs US 8,853,197 an avibactam patent?The supplied claims do not establish that the patent covers avibactam. Structural identity must be determined by comparing avibactam's complete molecular structure with Formula I and the issued claims. Does changing the sodium salt avoid the patent?Not necessarily. Claims 1 through 6 expressly include pharmaceutically acceptable salts, and claim 4 specifically identifies sodium salts. A different salt could remain within the claims. Does the patent cover combinations with meropenem?The supplied claims do not expressly require or claim meropenem or another beta-lactam antibiotic. A combination product could still infringe if it contains a claimed compound, but the claims do not independently protect the antibiotic combination. Can a generic use a different stereoisomer?A different stereoisomer may avoid a narrow species claim if the claim requires a particular configuration. It may still fall within claim 1 if the claim's stereoisomer language and Formula I structure encompass it. Is a formulation patent needed to block generic entry?No. A valid compound claim can block manufacture, sale or importation of a matching active ingredient without a separate formulation patent. A formulation patent would provide additional protection for a specific dosage form or composition. References
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Drugs Protected by US Patent 8,853,197
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wockhardt Bio Ag | ZAYNICH | cefepime hydrochloride; zidebactam | POWDER;INTRAVENOUS | 220787-001 | May 29, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ 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 8,853,197
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2012303691 | ⤷ Start Trial | |||
| Brazil | 112013028813 | ⤷ Start Trial | |||
| Canada | 2833241 | ⤷ Start Trial | |||
| China | 103619843 | ⤷ Start Trial | |||
| Denmark | 2748165 | ⤷ Start Trial | |||
| European Patent Office | 2748165 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
