Details for Patent: 10,058,615

Which drugs does patent 10,058,615 protect, and when does it expire?

Patent 10,058,615 protects MIEBO and is included in one NDA.

This patent has seventy-three patent family members in sixteen countries.

Summary for Patent: 10,058,615

Title:	Semifluorinated alkane compositions
Abstract:	The invention provides novel compositions comprising semifluorinated alkanes and at least one compound sensitive or prone to oxidation. The compositions can be used as medicines that are topically administered to an eye or ophthalmic tissue. The invention further provides kits comprising such compositions.
Inventor(s):	Bernhard Günther, Dieter Scherer, Anthony Pettigrew, Bastian Theisinger, Sonja Theisinger
Assignee:	Novaliq GmbH
Application Number:	US15/428,031
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 10,058,615: Scope, Claim Construction, and US Ophthalmic Landscape

What does US 10,058,615 claim cover in scope terms?

US Drug Patent 10,058,615 is directed to a topical ophthalmic treatment method for inflammatory ophthalmic conditions, with an explicit clinical focus on keratoconjunctivitis sicca (dry eye) and associated symptoms. The core novelty is a stable liquid composition built around semifluorinated alkanes of a defined structural class and a formulation control set (optional excipients; free of water and preservative).

Claim 1 defines the independent scope

Claim 1 requires, in combination:

1. Method: treating a disease/condition in a patient.
2. Composition: “stable liquid composition” comprising a semifluorinated alkane:
   • Formula: F(CF2)n(CH2)mH
   • Parameters:
     • n = 3 to 8 (integer)
     • m = 3 to 10 (integer)
3. Topical route: administered to an eye or ophthalmic tissue.
4. Target condition: an inflammatory condition of ophthalmic tissue or specifically keratoconjunctivitis sicca and symptoms associated therewith.
5. Optional excipients: “optionally one or more excipients.”

This is a use-of-composition claim (method-of-treatment) with a structural limitation on the active liquid ingredient and a clinical limitation on the ophthalmic indication and inflammation/dry-eye symptom complex.

Claims 2 through 9 layer formulation, molecule exemplars, symptom coverage, and administration sites

• Claim 2 limits excipient selection to a defined set: lipid, oil, lubricant, lipophilic vitamin, viscosity agent, antioxidant, surfactant, or mixtures.
• Claim 3 narrows the semifluorinated alkane to a listed set of specific liquids (composition exemplars) using defined (n, m) combinations.
• Claim 4 expands covered “symptoms” to a long, enumerated list (itching, photophobia, redness, mucus discharge, contact lens intolerance, etc.).
• Claim 5 expands covered administration sites to eye-adjacent loci, including:
  • cornea/conjunctiva
  • upper/lower eyelid margins
  • meibomian gland ducts
  • eyelashes
• Claim 6 imposes a formulation constraint: free of water and free of a preservative.
• Claim 7 expands disease/condition category for dry eye to:
  • aqueous-deficient dry eye disease
  • evaporative dry eye disease
  • Sjögren syndrome
  • lacrimal gland insufficiency
  • meibomian gland disease
  • meibomian gland dysfunction
• Claim 8-9 further narrow within MGD by defining clinical subtype based on gland abnormalities and symptoms (duct obstructions, secretion changes; itchiness/redness/swelling/pain/discharge/crusting).

Practical construction: what must be present to infringe?

For method infringement, a challenger would typically need evidence that the treated patient group fits the claimed inflammatory ophthalmic condition/dry eye category and that the administered composition satisfies the semifluorinated alkane structural definition and any additional dependent limitations asserted.

Key “hard” elements:

• Semifluorinated alkane structure: F(CF2)n(CH2)mH with n = 3-8 and m = 3-10 (or one of the enumerated liquids if using dependent claim 3).
• Topical ophthalmic administration (to eye or ophthalmic tissue).
• Inflammatory ophthalmic condition focus.
• Optional excipients allowed broadly within claim 2 set, but constrained if claim 2 is asserted.
• Water-free and preservative-free only if claim 6 is asserted.

How broad is the claim set: molecule vs indication vs formulation?

1) Molecule scope

Claim 1 covers an entire homologue class defined by n and m ranges, not just one compound. That creates a high chemistry breadth: any semifluorinated alkane meeting the formula and range qualifies, subject to “stable liquid composition” language.

Claim 3 reduces this to a closed list of liquids:

• F(CF2)4(CH2)5H
• F(CF2)4(CH2)6H
• F(CF2)4(CH2)8H
• F(CF2)6(CH2)4H
• F(CF2)6(CH2)6H
• F(CF2)6(CH2)8H
• F(CF2)6(CH2)10H

That list defines enforceable “targets” for those exact chain-length products.

2) Indication scope

Claim 1 is tethered to:

• inflammatory conditions of ophthalmic tissue, or
• keratoconjunctivitis sicca with its symptoms.

Claims 7-9 extend and subtype dry eye to:

• aqueous-deficient, evaporative
• Sjögren syndrome
• lacrimal gland insufficiency
• meibomian gland disease/dysfunction
• MGD defined by duct obstructions or secretion changes
• symptom lists for MGD

From a landscape standpoint, this claim set is positioned to map onto most dry eye regulatory and clinical categories that include inflammation, while still anchoring the “dry eye” narrative to gland dysfunction subtypes.

3) Formulation scope

• Claim 1: composition can include optional excipients.
• Claim 2: excipients limited to a specific set (lipid/oil/lubricant/lipophilic vitamin/viscosity agent/antioxidant/surfactant and mixtures).
• Claim 6: a narrower variant that is free of water and free of a preservative.

This is a common patent architecture: a broad independent claim plus dependent claims that lock down formulation variants, including preservative-free and non-aqueous formats.

Where could enforceability concentrate: which dependent claims add the strongest boundaries?

In US method claims, the most litigation-relevant dependent limitations are those that map onto commercial product attributes and clinical endpoints.

High-friction limitations

• “Free of water and free of a preservative” (Claim 6): if competitors sell an aqueous or buffered formulation, they may avoid claim 6 but still potentially fall within claim 1 unless additional limitations require water-free status.
• Enumerated molecule list (Claim 3): if competitors use semifluorinated alkanes outside the listed chain lengths, they may avoid claim 3 while still potentially infringing claim 1 if the molecule fits the broader (n, m) ranges.
• MGD-specific subtype (Claims 8-9): if clinical positioning and labeling avoid MGD or define it differently, they may attempt to limit method infringement. Still, claim 7 covers MGD generally, so avoidance would require careful clinical and usage scoping.

Symptom breadth is wide

Claim 4 enumerates multiple symptom categories: irritation, burning, itching, redness, photophobia, blurry vision, mucus discharge, contact lens intolerance, excessive reflex tearing, and more.

This structure increases the chance that real-world uses in practice map to at least one of the symptom descriptions, which matters because method claims often hinge on what the patient is treated for and what symptoms are expected to be addressed.

How does this shape the competitive patent landscape in the US ophthalmic space?

US 10,058,615 is a composition-anchored ophthalmic method patent focusing on non-traditional fluorinated amphiphobic-like liquids for dry eye and inflammation. That places it in a different “technical family” than typical dry eye modalities:

• Aqueous lubricants (carboxymethylcellulose, hyaluronic acid)
• Osmoprotectants
• Anti-inflammatory agents (steroids, cyclosporine, lifitegrast)
• Secretagogues
• Lipid-based in-situ forming systems (various lipid emulsions, warming approaches)
• Device-driven interventions (LipiFlow-type thermal pulsation, compresses)
• Microbiome and eyelid hygiene regimens

The patent’s enforceable hook is the specific semifluorinated alkane chemistry class used topically to treat inflammatory ophthalmic disease including dry eye and MGD.

Landscape positioning: where other patents are likely to collide

Without full prosecution history, it is not possible to state other patents’ exact claim overlap with certainty. What can be stated from the claim structure is the most likely collision surface areas:

1. Topical non-aqueous fluorinated liquids for ocular surface lubrication
   • Direct competition if other fluorinated chemistries are used for ocular surface disorders.
2. Formulation constraints (water-free, preservative-free)
   • Competitors often choose preservative systems for stability; preservative-free formats are narrower but market-relevant.
3. MGD-focused symptom claims
   • Many competitors market “lid margin comfort,” “meibomian gland function,” and inflammatory symptom relief; US method claim language can map onto labeling and instructions for use.

What is the litigation risk profile for a competitor product?

Risk depends on whether the competitor:

1. Uses a semifluorinated alkane within the F(CF2)n(CH2)mH class.
2. Matches the claimed n and m ranges or the listed chain lengths.
3. Markets or provides for treating inflammatory ophthalmic tissue or keratoconjunctivitis sicca/dry eye including MGD.
4. Applies the composition to ocular surface or eyelid/meibomian gland structures.
5. Uses formulation formats that satisfy optional excipient sets and possibly water/preservative-free status (if claim 6 is asserted).

Infringement “avoidance levers”

• Use a different chemical class (avoid the semifluorinated alkane structure).
• Use semifluorinated alkane chain lengths outside the claimed n and m ranges (for claim 1 avoidance).
• If the active still falls in-range, commercial differentiation may not avoid claim 1, but it can avoid dependent claim variants by:
  • choosing aqueous formulations (avoid claim 6)
  • avoiding preservative-free marketing/claims (still need to assess actual product)
  • avoiding excipient types outside claim 2 if those are asserted

How does claim drafting affect freedom-to-operate (FTO) strategy?

A key point for FTO is that the independent claim does not require:

• a specific buffer system,
• a specific viscosifying matrix,
• a specific mechanism such as tear film stabilization or anti-inflammatory signaling.

Instead, it relies on:

• composition identity (semifluorinated alkane class and stability),
• route (topical ocular),
• clinical indication (inflammatory ophthalmic disease, dry eye, symptoms).

This tends to make FTO broader because many ophthalmic programs can plausibly argue mechanism-based differences while still falling into the claimed structure/indication envelope.

Key claim-to-product mapping table

Claim element	What it covers in practice	Product attribute to audit
Semifluorinated alkane formula	Active chemistry class	Exact identity of the fluorinated liquid (n, m); purity spec; “liquid” status
n 3-8, m 3-10 (Claim 1)	Broad homolog coverage	Chain lengths used in product
Listed liquids (Claim 3)	Closed set of exemplars	Whether product’s active matches one of the 7 listed liquids
Topical to eye/ophthalmic tissue	Ocular surface and periocular application	Labeling, administration method, device applicator interface
Inflammatory condition / keratoconjunctivitis sicca	Indication envelope	Label claims, patient leaflet, prescribing info
Excipient set (Claim 2)	Allowed formulation components	Excipients and their categories (lipid/oil/viscosity agent/etc.)
Water-free + preservative-free (Claim 6)	Narrow formulation variant	Whether water is present and preservative type/absence
Symptom list (Claim 4)	Symptom-driven method scope	Clinical endpoints in studies; label symptom language
Administration loci (Claim 5)	Cornea, conjunctiva, lid margins, meibomian ducts, eyelashes	Applicator targeting and intended anatomic deposition
Disease subtypes (Claim 7)	Dry eye subcategories + Sjögren and lacrimal insufficiency	Indication segmentation; clinical study cohorts
MGD definition (Claims 8-9)	Duct obstruction and secretion change; symptom cluster	MGD diagnostic language; endpoints for itch/redness/discharge/crusting

What is the bottom-line scope conclusion for US 10,058,615?

US 10,058,615 is a chemistry-defined topical ophthalmic method patent. Its enforceable reach is driven by:

• the semifluorinated alkane structure and chain-length ranges,
• the dry eye / inflammatory ocular tissue indication,
• the ocular application territories and symptom framing,
• and, in narrower dependent claims, specific molecule exemplars and non-aqueous preservative-free formulation.

This creates a landscape posture where risk concentrates not on traditional aqueous dry eye actives, but on products that use the semifluorinated alkane class to treat inflammatory dry eye and/or MGD via topical ophthalmic delivery.

Key Takeaways

• US 10,058,615 claims topical ocular treatment methods using semifluorinated alkanes defined by F(CF2)n(CH2)mH with n=3-8 and m=3-10.
• The indication scope covers inflammatory ophthalmic tissue broadly and keratoconjunctivitis sicca (dry eye) with extensive symptom coverage.
• Claim 3 locks in seven specific fluorinated liquid chain-length exemplars that can serve as direct infringement targets.
• Dependent claim 6 adds a material formulation constraint: free of water and free of a preservative.
• Claims 5 and 8-9 expand enforceability toward eyelid margin and meibomian gland duct administration and MGD clinical subtypes.

FAQs

1. Does claim 1 require a specific mechanism of action?
No. It requires a qualifying semifluorinated alkane composition, topical ocular administration, and treatment of an inflammatory ophthalmic condition/dry eye with associated symptoms.

2. Are aqueous excipients required?
No. Water is only explicitly excluded in dependent claim 6. Claim 1 and claim 2 allow optional excipients within defined categories, but do not require water.

3. If a competitor uses a semifluorinated alkane outside the listed examples in claim 3, is it automatically outside the patent?
Not necessarily. Claim 3 is narrower. Claim 1 can still cover other (n, m) values within the allowed ranges.

4. How important are symptom lists in this patent?
They expand covered “treatment of symptoms associated with keratoconjunctivitis sicca,” which can broaden what uses map to the claimed method scope.

5. What clinical targeting increases overlap risk most?
Marketing or usage that targets dry eye as an inflammatory ophthalmic condition, including MGD, and that delivers the composition to ocular surface and/or eyelid margin and meibomian gland duct regions.

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References

1. US Patent 10,058,615 (claims as provided by user content).

Drugs Protected by US Patent 10,058,615

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 Inc	MIEBO	perfluorohexyloctane	SOLUTION/DROPS;OPHTHALMIC	216675-001	May 18, 2023		RX	Yes	Yes						TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

International Family Members for US Patent 10,058,615

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013314303
Australia	2013314370
Australia	2016219611
Australia	2017200907
Australia	2018201364