Details for Patent: 8,415,342

Which drugs does patent 8,415,342 protect, and when does it expire?

Patent 8,415,342 protects BESIVANCE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 8,415,342

Title:	Besifloxacin ophthalmic composition for the treatment or control of infection
Abstract:	A composition comprises besifloxacin in an amount effective for treating or controlling an infection caused by an antibiotic-resistant bacterium. Such a composition can be administered to a subject for the treatment or control of bacterial conjunctivitis caused bay an antibiotic-resistant bacterium.
Inventor(s):	Praveen Tyle, Pramod Kumar Gupta, Susan E. Norton, Lynne Brunner, Joseph Blondeau
Assignee:	Bausch and Lomb Inc
Application Number:	US12/604,422
Patent Claim Types: see list of patent claims	Use; Composition;

Scope and claims analysis of US Patent 8,415,342 (besifloxacin 0.6% for bacterial conjunctivitis)

US 8,415,342 is a US method-of-treatment patent with a narrow, regimen-and-bacterial-spectrum claim structure. The asserted scope is defined by: (i) drug identity (besifloxacin), (ii) exact concentration (0.6% w/v), (iii) dosing frequency (2 to 4 times/day), (iv) treatment duration (5 to 10 days), and (v) a constrained set of bacterial causes tied to MIC90 thresholds for specific comparator fluoroquinolones (gatifloxacin and/or moxifloxacin at MIC90 ≥4 µg/mL and, in one dependent claim, ciprofloxacin MIC90 >8 µg/mL). The claim set also narrows to conjunctivitis caused by specified organisms, including methicillin- and ciprofloxacin-resistant S. aureus and S. epidermidis in claim 2.

The net effect is that the patent does not cover all uses of besifloxacin in conjunctivitis. It is limited to specific “clinical phenotype” combinations: organism lists plus defined fluoroquinolone susceptibility cutoffs plus the exact 0.6% formulation regimen.

---

What does US 8,415,342 claim for besifloxacin 0.6% in bacterial conjunctivitis?

Claim 1: regimen + organism list + MIC90 thresholds

Independent claim 1 covers a method for treating or controlling bacterial conjunctivitis in a human subject by administering a composition comprising besifloxacin at 0.6% (w/v) at 2, 3, or 4 times/day for 5–10 days, where the conjunctivitis is caused by a bacterium from the following group with a specific resistance/selection criterion:

Organisms recited in claim 1

• Staphylococcus aureus
• Staphylococcus epidermidis
• Staphylococcus haemolyticus
• Staphylococcus warneri
• Staphylococus hominis (spelled “hominiS” in the text you provided as “hominis”)
• Morganella morganii
• Prevotella spp.
• Fusobacterium

MIC90 constraint in claim 1

• The bacterium must be against which an MIC90 of gatifloxacin or moxifloxacin is at least 4 µg/mL.

Practical scope implications

• The claim is not triggered merely by diagnosing bacterial conjunctivitis. It is triggered by the conjunctivitis being caused by one of the enumerated organisms and meeting the specified susceptibility threshold to gatifloxacin or moxifloxacin.
• The MIC90 comparator is not besifloxacin itself. The claim is anchored to fluoroquinolone susceptibility of the causative organism relative to gatifloxacin or moxifloxacin.
• The claim language supports at least two ways the MIC90 requirement can be satisfied in enforcement: (i) MIC90 testing for gatifloxacin or moxifloxacin for the causative organism shows ≥4 µg/mL, or (ii) the organism line is characterized in a dataset as meeting that threshold.

Dependent claim 2: resistance subtype in Staphylococci

Claim 2 depends on claim 1 and further limits the causative bacterium to:

• S. aureus or S. epidermidis resistant to both methicillin and ciprofloxacin.

Practical scope implications

• Claim 2 tightens claim 1 by requiring a specific resistance phenotype in the staphylococcal subset.
• It does not require any additional MIC90 numeric threshold beyond claim 1’s MIC90 ≥4 µg/mL requirement for gatifloxacin or moxifloxacin, since claim 2 is expressly tethered to claim 1.

Claim 3: adds specific organism list and a second MIC90 cutoff for ciprofloxacin

Independent claim 3 is a separate independent claim (not merely dependent) that also recites:

• besifloxacin 0.6% w/v,
• dosing frequency 2–4 times/day,
• 5–10 days, but it changes both the organism list and the susceptibility thresholds.

Organisms recited in claim 3

• Staphylococcus aureus
• Staphylococcus epidermidis
• Staphylococcus haemolyticus
• Staphylococcus warneri
• Staphylococus hominis
• Staphylococcus lugdunensis (new in claim 3)
• Morganella morganii

MIC90 constraints in claim 3

• MIC90 of gatifloxacin or moxifloxacin ≥4 µg/mL
• MIC90 of ciprofloxacin >8 µg/mL

Practical scope implications

• Claim 3 is more restrictive than claim 1 because it adds a second numeric threshold tied to ciprofloxacin and it removes some organisms present in claim 1 (Prevotella spp. and Fusobacterium are no longer in claim 3).
• Claim 3’s numeric “ciprofloxacin MIC90 >8 µg/mL” further differentiates the targeted bacterial phenotype, creating an additional barrier against easy design-around by switching comparators or avoiding the types of organisms likely to show high ciprofloxacin MIC90.

---

How do the MIC90 thresholds define “bacterial conjunctivitis caused by” under the patent?

What “MIC90 of gatifloxacin or moxifloxacin is at least 4 µg/mL” operationally means

The claim uses a comparative MIC90 criterion to characterize the causative bacterium. Key claim-scoping elements:

• The organism must be one of the listed bacteria.
• The causative organism must have measured MIC90 values for gatifloxacin and/or moxifloxacin showing ≥4 µg/mL.
• The claim is satisfied if either comparator meets the threshold (“gatifloxacin or moxifloxacin”), not necessarily both.

From an enforcement perspective, the phrase “MIC90 of gatifloxacin or moxifloxacin is at least 4 µg/mL” creates an evidentiary anchor around susceptibility testing or literature datasets. From a design-around perspective, moving beyond those susceptibility profiles is a direct route to non-infringement (assuming the MIC90 criterion is the only numeric gating condition).

What “ciprofloxacin MIC90 greater than 8 µg/mL” adds in claim 3

Claim 3 imposes a second numeric cutoff:

• ciprofloxacin MIC90 >8 µg/mL.

This likely narrows the subset of clinical isolates that qualify. If a bacterial isolate has ciprofloxacin MIC90 values at or below 8 µg/mL, claim 3 is structurally harder to reach even if the isolate meets the gatifloxacin/moxifloxacin threshold.

---

What dosing and duration elements are protected in US 8,415,342?

Both independent claims recite the same core regimen boundaries:

• Active: besifloxacin
• Concentration: 0.6% w/v
• Frequency: 2, 3, or 4 times per day
• Duration: 5 to 10 days

This creates a “band” rather than a single dosing schedule. The claim covers multiple dosing frequencies within that band, as long as duration stays between 5 and 10 days inclusive and the product is at 0.6% w/v.

How tight are the regimen boundaries?

• Moving to a different concentration (even close to 0.6% but not 0.6% w/v) can fall outside the literal concentration requirement.
• Shortening treatment below 5 days or extending above 10 days also moves outside the literal range.
• Changing frequency outside 2–4 times/day can fall outside literal coverage.

---

What organisms are explicitly covered, and what does each claim add or remove?

Organism coverage delta between claim 1 and claim 3

• Claim 1 includes: Prevotella spp. and Fusobacterium.
• Claim 3 does not include Prevotella spp. or Fusobacterium.
• Claim 3 adds: Staphylococcus lugdunensis.

Organism coverage overlap

• Both claims include: S. aureus, S. epidermidis, S. haemolyticus, S. warneri, S. hominis, and Morganella morganii.

Staphylococcal resistance phenotype

• Claim 2 adds a resistance phenotype for S. aureus/S. epidermidis: resistant to methicillin and ciprofloxacin.

---

How strong is the likely claim scope for enforcement versus common therapeutic practice?

Narrowness is driven by three gating elements

Claim reach depends on satisfying all of the following simultaneously:

1. the drug form is besifloxacin at 0.6% w/v,
2. the regimen is 2–4×/day for 5–10 days, and
3. the bacterial cause is one of the enumerated organisms plus the MIC90 thresholds (gatifloxacin/moxifloxacin ≥4 µg/mL; and for claim 3, ciprofloxacin >8 µg/mL).

This structure tends to reduce overbreadth against broader “bacterial conjunctivitis” prescribing. It also concentrates infringement arguments on:

• patient populations where causative organisms fit the enumerated list,
• susceptibility patterns in which gatifloxacin/moxifloxacin MIC90 crosses ≥4 µg/mL and, for claim 3, ciprofloxacin MIC90 exceeds 8 µg/mL.

Method-of-treatment patent implications

Because the claims are methods for treating or controlling bacterial conjunctivitis, proving infringement generally requires showing:

• the patient received the covered besifloxacin regimen, and
• the conjunctivitis was caused by a bacterium meeting the claim’s MIC90 requirements.

In practice, this can make enforcement fact-intensive, especially if clinical isolates are not routinely characterized with MIC90 benchmarks for gatifloxacin/moxifloxacin and ciprofloxacin.

---

What patent estate does US 8,415,342 likely sit within for besifloxacin ophthalmics?

The provided claims are consistent with a pattern in ophthalmic antibacterial patenting: base drug composition and dosing regimen patents typically appear alongside narrower method claims tied to:

• bacterial subtypes,
• resistance phenotypes,
• and susceptibility thresholds across fluoroquinolone comparators.

Within that ecosystem, US 8,415,342 is best understood as a secondary/adjunct patent focusing on a defined bacterial selection and susceptibility band rather than the core existence of besifloxacin or its general ocular use.

---

What design-arounds are most straightforward based on claim language?

Concentration and regimen design-around

• Use of a non-0.6% formulation.
• Dosing outside 2–4 times/day.
• Duration outside 5–10 days.

Bacterial spectrum design-around

• Use where the causative organism is not among the enumerated bacteria.
• Use in settings where the causative isolate fails the MIC90 thresholds used in claims (gatifloxacin/moxifloxacin ≥4 µg/mL; and for claim 3, ciprofloxacin >8 µg/mL).

Resistance phenotype design-around (claim 2)

• Avoidance of situations involving methicillin-resistant and ciprofloxacin-resistant S. aureus/S. epidermidis.

---

How does US 8,415,342 compare with other besifloxacin or fluoroquinolone conjunctivitis claims?

Compared with broad “bacterial conjunctivitis” methods

Broad methods often cover “treat bacterial conjunctivitis with besifloxacin” without numeric MIC thresholds or organism lists. US 8,415,342 is narrower because it ties the method to:

• a specific formulation concentration,
• a restricted dosing band,
• and a specific bacterial susceptibility phenotype.

Compared with narrow “organism-only” methods

US 8,415,342 is also more restrictive than organism-only claims because it requires susceptibility cutoffs against gatifloxacin/moxifloxacin and, in one independent claim, ciprofloxacin.

---

What does this mean for generic or competitor development risk?

Risk is concentrated on the same regimen and the same bacterial phenotypes

• A competitor that replicates the 0.6% dose and dosing schedule but targets bacterial strains that do not meet the MIC90 thresholds reduces risk for claim 1 and claim 3.
• If a competitor runs into the same types of isolates that satisfy the MIC90 thresholds, they face method infringement exposure assuming clinical use matches the protected regimen.

Regulatory labeling is not coextensive with method claim scope

Even if a product is approved for “bacterial conjunctivitis,” US 8,415,342’s claims require additional bacteriology-specific and numeric MIC gating. Practical exposure often turns on how the claimed method maps to real-world prescribing and resistance patterns.

---

Key Takeaways

• US 8,415,342 protects a method-of-treatment for bacterial conjunctivitis using besifloxacin 0.6% w/v dosed 2–4×/day for 5–10 days.
• The claim scope is narrowed by a defined bacterial list and a fluoroquinolone MIC90 characterization:
  • Claim 1: causative organisms enumerated plus gatifloxacin or moxifloxacin MIC90 ≥4 µg/mL.
  • Claim 2: narrows to methicillin- and ciprofloxacin-resistant S. aureus or S. epidermidis (and still requires claim 1’s MIC90 criterion).
  • Claim 3: enumerated organisms (includes S. lugdunensis but excludes Prevotella spp. and Fusobacterium) plus both gatifloxacin or moxifloxacin MIC90 ≥4 µg/mL and ciprofloxacin MIC90 >8 µg/mL.
• Design-around most directly targets concentration and dosing/duration limits, or avoids bacterial phenotypes that meet the MIC90 thresholds.
• The patent is narrower than generic “bacterial conjunctivitis treated with besifloxacin,” increasing the importance of bacteriology evidence tied to MIC90 cutoffs for infringement mapping.

---

FAQs

1) Does US 8,415,342 cover any besifloxacin use in conjunctivitis?

No. It is limited to bacterial conjunctivitis caused by specific enumerated organisms and tied to defined MIC90 thresholds and a 0.6% besifloxacin regimen (2–4×/day for 5–10 days).

2) What is the numeric threshold for gatifloxacin or moxifloxacin in the key claims?

The claims require MIC90 ≥4 µg/mL for gatifloxacin or moxifloxacin (claim 1 and claim 3).

3) What additional threshold exists in claim 3 for ciprofloxacin?

Claim 3 requires ciprofloxacin MIC90 >8 µg/mL.

4) Which additional organism is included in claim 3 but not claim 1?

Staphylococcus lugdunensis is included in claim 3 and not listed in claim 1 as provided.

5) Is Prevotella spp. and Fusobacterium covered?

As provided, Prevotella spp. and Fusobacterium are in claim 1 but are not in claim 3.

---

References

1. US Patent 8,415,342. “Method for treating bacterial conjunctivitis using besifloxacin 0.6%.” (claims provided in prompt).

Drugs Protected by US Patent 8,415,342

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	8,415,342					METHOD OF TREATING OCULAR BACTERIAL INFECTIONS

International Family Members for US Patent 8,415,342

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2010051291