US Patent 10,350,186: Scope, Claims, Expiration, Orange Book Status, and PNAC Patent Landscape

US Patent 10,350,186 protects selected methods of preventing or treating parenteral nutrition-associated cholestasis, or PNAC, using an intravenous fish-oil lipid emulsion that excludes phytosterols and plant-derived fatty acids. The broadest independent prevention claim covers long-term parenteral nutrition patients across pediatric and adult populations. Separate claims narrow the invention by age, short-bowel syndrome, dosage, treatment duration, emulsion excipients, and exclusive reliance on parenteral nutrition.

The patent is commercially relevant to Omegaven, the FDA-approved fish-oil lipid emulsion for pediatric patients with PN-associated cholestasis. Its patent term runs to approximately August 2027, subject to the official USPTO term calculation. FDA orphan-drug exclusivity has expired, leaving patent rights as the principal remaining U.S. exclusivity barrier identified for the claimed PNAC use. [1-4]

What drug and technology does US Patent 10,350,186 protect?

US Patent 10,350,186, titled methods relating to prevention or treatment of PNAC, covers the clinical use of a fish-oil-derived omega-3 lipid emulsion in patients receiving long-term parenteral nutrition. The patent does not claim fish oil as a composition per se. It claims administration of the emulsion for a defined therapeutic purpose.

The central technical distinction is exclusion of plant-derived lipid components:

Claim element	Scope under the claims
Disease or condition	Prevention or treatment of PNAC
Administration route	Intravenous
Product type	Lipid emulsion
Active lipid	Fish-oil-derived omega-3 fatty acid
Excluded components	Phytosterols and plant-derived fatty acids
Patient population	Newborns, premature newborns, infants, children, and adults
Nutrition setting	Long-term PN; certain claims require sole or total PN
Key disease subgroup	Short-bowel syndrome
Dose range	0.2 to 3.0 g/kg/day; narrower claim of 0.5 to 1.0 g/kg/day
Treatment duration	More than three weeks, six weeks, or three months
Product limitation in claim 19	Fish oil rich in omega-3 fatty acids, without plant-derived omega-6 fatty acids, and no other parenteral lipid emulsion during treatment

The patent is therefore a use patent directed to the clinical deployment of a fish-oil lipid emulsion, rather than a broad composition patent covering all omega-3 formulations.

What are the independent claims in US Patent 10,350,186?

Claims 1, 18, and 19 are the principal independent claims.

Claim 1: broad prevention claim

Claim 1 covers a method of preventing PNAC by intravenously administering an effective amount of a fish-oil-derived omega-3 lipid emulsion to a human receiving long-term PN. The emulsion and the patient’s treatment regimen must exclude phytosterols and plant-derived fatty acids.

Claim 1 has the broadest patient scope because it is not limited to children, infants, short-bowel syndrome, a specific dose, or a minimum treatment period. It can reach adult patients receiving long-term PN if all other limitations are met.

The principal narrowing limitations are:

The treatment must be preventive.
The patient must receive long-term PN.
The emulsion must contain fish-oil-derived omega-3 fatty acids.
The emulsion cannot contain phytosterols or plant-derived fatty acids.
The patient cannot be administered those excluded components through another source.

That final limitation may create an important infringement issue for mixed-lipid PN regimens. A competitor using a fish-oil emulsion while separately administering soybean oil, olive oil, or another plant-derived lipid could fall outside the literal scope of claim 1.

Claim 18: pediatric short-bowel-syndrome claim

Claim 18 covers prevention of PNAC in a patient under two years old who:

receives nutritional requirements solely through PN;
receives long-term PN;
has short-bowel syndrome;
receives fish-oil-derived omega-3 fatty acids;
is not administered phytosterols or plant-derived fatty acids.

Claim 18 is narrower than claim 1 but commercially significant because the original Omegaven indication focused on pediatric patients with PN-associated cholestasis. Its limitations map closely to the neonatal and infant population in which prolonged PN and intestinal failure create a high PNAC risk.

Claim 19: narrow treatment claim

Claim 19 covers treatment rather than prevention. It requires:

a child under 12;
nutritional requirements obtained solely through total PN;
a lipid emulsion consisting essentially of an effective amount of fish oil rich in omega-3 fatty acids;
no plant-derived omega-6 fatty acids;
administration for more than three weeks;
no other parenteral lipid emulsion during treatment.

Claim 19 is narrower but potentially stronger against a product or regimen that is specifically used to reverse established PNAC in children. The “consists essentially of” language may permit ingredients that do not materially alter the fish-oil-based treatment, while excluding plant-derived omega-6 fatty acids and other material lipid components.

How do claims 1 through 19 differ?

The dependent claims create multiple fallback positions around the same fish-oil PNAC treatment concept.

Claims	Limitation
2	Fish source, including menhaden, herring, mackerel, cod, tuna, sardine, salmon, krill, and other listed species
3	Emulsifier, including egg phosphatidylcholine, egg lecithin, DPPC, DPPE, or DOPC
4	Newborn patient
5	Premature newborn
6-7	Infant, including under two years old
8-9	Child under 18 or under 12
10	Adult receiving long-term PN
11	Treatment continues until adequate enteral nutrition is possible
12	Omega-3 dose of 0.2 to 3.0 g/kg/day
13	Omega-3 dose of 0.5 to 1.0 g/kg/day
14	Short-bowel syndrome
15	More than three weeks
16	More than six weeks
17	More than three months
18	Under-two patient, sole PN, short-bowel syndrome
19	Under-12 patient, treatment, sole PN, no plant omega-6, no other parenteral lipid

The claims are drafted as a layered estate. If a broad prevention claim is challenged, narrower claims may remain available for pediatric, short-bowel, dosage, duration, or formulation-specific uses.

What formulation limitations are protected by the patent?

The patent protects the use of an emulsion whose lipid source is fish oil and whose composition excludes plant-derived fatty acids and phytosterols.

Fish-oil sources

Claim 2 lists multiple marine sources:

menhaden;
herring;
mackerel;
cod;
capelin;
tilapia;
tuna;
sardine;
Pacific saury;
salmon;
Arctic char; and
krill.

The list expands the protected source universe beyond the precise source used in a commercial product. A competing product based on a different fish source could still face claim 1 if it contains fish-oil-derived omega-3 fatty acids and satisfies the remaining limitations.

Emulsifiers

Claim 3 covers egg-derived phospholipids and specified phosphatidylcholine or phosphatidylethanolamine compounds. This limitation is narrower than claim 1 because claim 1 does not require a particular emulsifier.

A formulation using a non-listed emulsifier could avoid claim 3 while remaining potentially within claim 1. Conversely, a generic or follow-on product using egg lecithin as its emulsifier would have a closer literal overlap with claim 3.

Exclusion of plant-derived lipids

The exclusion of plant-derived fatty acids is central to the patent. This distinguishes the claimed therapy from conventional soybean-oil-based PN emulsions and from mixed-oil products containing soybean, olive, coconut, or other plant-derived lipid fractions.

Products such as SMOFlipid, which contains a combination of soybean oil, medium-chain triglycerides, olive oil, and fish oil, present a different composition profile from the fish-oil-only approach claimed in the patent. [5] Whether such a product infringes depends on the specific claim, administration regimen, and construction of the “does not contain” limitations.

What is the FDA and Orange Book status of US Patent 10,350,186?

Omegaven was approved by the FDA on December 21, 2017, for use as a source of calories and fatty acids in pediatric patients with PN-associated cholestasis. The approved product is an intravenous fish-oil lipid emulsion manufactured by Fresenius Kabi USA, LLC. [2, 3]

The regulatory profile is:

Regulatory item	Status
Product	Omegaven
Active lipid source	Fish oil
Dosage form	Intravenous lipid emulsion
FDA application	NDA 210589
Sponsor	Fresenius Kabi USA, LLC
Approval date	December 21, 2017
Indication	Pediatric patients with PN-associated cholestasis
Primary regulatory pathway	New drug application
Exclusivity type	Orphan-drug exclusivity associated with the approved indication
Patent relevance	US 10,350,186 covers broader and overlapping PNAC methods

The FDA-approved indication is narrower than the full patent claim set. Omegaven’s labeled population is pediatric, while claim 1 reaches adult patients. Conversely, the patent includes prevention claims, while the FDA label is directed to patients with PN-associated cholestasis.

The Orange Book should be reviewed for the current listed patent and use code. The patent has been associated with the Omegaven PNAC use and is relevant to ANDA certification analysis under section 505(j) of the Federal Food, Drug, and Cosmetic Act. [4]

When does US Patent 10,350,186 expire?

The patent’s effective priority dates place the expected U.S. patent expiration in approximately August 2027. The exact expiration date depends on the patent’s recorded term adjustment and any applicable terminal disclaimer. The USPTO patent record controls the final calculation. [1]

The exclusivity timeline is:

Event	Date
Earliest priority basis	2007
Omegaven FDA approval	December 21, 2017
US Patent 10,350,186 issued	July 16, 2019
Orphan-drug exclusivity	Expired in 2024, based on the seven-year period from approval
Expected patent expiration	Approximately August 2027

Patent expiration and FDA exclusivity are separate. Expiration of orphan exclusivity does not invalidate the patent. A generic applicant may pursue approval after orphan exclusivity ends but must address any listed patent through a Paragraph III or Paragraph IV certification, depending on the requested launch date and the patent’s Orange Book status.

What Paragraph IV challenges and generic entry risks affect Omegaven?

A generic Omegaven applicant would face a use-patent problem rather than only a formulation-equivalence problem. The main legal pathways are:

Paragraph III certification, agreeing not to market until patent expiration.
Paragraph IV certification, alleging that the listed patent is invalid, unenforceable, or not infringed.
A section viii statement, carving out a patented method of use if the proposed label omits the protected indication.

The practical risk depends on the proposed label.

Risk for a full-label pediatric PNAC product

A product labeled for treatment or prevention of PNAC in pediatric patients would have substantial exposure to claims 1, 18, and 19. A Paragraph IV challenger would likely focus on:

prior clinical use of fish-oil emulsions for PNAC;
whether the exclusion of phytosterols and plant-derived fatty acids is novel and nonobvious;
whether “effective amount” and “long-term PN” provide sufficient objective boundaries;
whether the specification supports prevention across adults and children;
whether the claims improperly extend from treatment evidence in pediatric patients to broad prevention claims.

Risk for a skinny-label product

A generic applicant could attempt to omit PNAC language and market the product for another permitted use, if a non-infringing label and actual marketing conduct are feasible. The risk remains elevated if the product is promoted for PNAC, supplied with PNAC dosing instructions, or used under circumstances that support induced infringement.

Risk for mixed-lipid products

A mixed-lipid product containing plant-derived fatty acids may avoid claims requiring the emulsion and patient regimen to exclude those components. That design-around is more difficult for a pure fish-oil product intended for the same pediatric PNAC population.

No biosimilar pathway applies. Omegaven is a chemically defined lipid emulsion regulated as a drug, not a biologic subject to the abbreviated Biologics Price Competition and Innovation Act pathway.

Which companies compete with Omegaven in parenteral lipid emulsions?

Omegaven competes with conventional and mixed-oil parenteral lipid emulsions, although those products do not necessarily share the same PNAC indication.

Product	Company	Principal lipid sources	PNAC relevance
Omegaven	Fresenius Kabi	Fish oil	FDA-approved pediatric PNAC use
Intralipid	Fresenius Kabi	Soybean oil	Conventional PN lipid; plant-derived fatty acids
SMOFlipid	Fresenius Kabi	Soybean oil, MCT, olive oil, fish oil	Mixed-lipid formulation; not equivalent to fish-oil-only Omegaven
Clinolipid	Baxter	Olive oil and soybean oil	Mixed plant-derived lipid formulation
Various compounded emulsions	Hospitals and compounding pharmacies	Variable	Potentially relevant to clinical use, but product and liability profiles differ

The patent is most relevant to a competitor seeking to market a fish-oil-only intravenous lipid emulsion with a PNAC label. It is less directly relevant to products containing substantial plant-derived lipid components.

How strong is the patent estate for PNAC treatment?

The estate is strongest where a competing product and treatment regimen match the following profile:

pediatric patient;
PNAC prevention or treatment;
exclusive or sole PN;
fish-oil-rich omega-3 emulsion;
no plant-derived omega-6 fatty acids;
more than three weeks of administration;
no concurrent alternative parenteral lipid emulsion.

The estate is weaker where the competitor:

uses a mixed lipid emulsion containing plant-derived fatty acids;
markets only for general caloric or fatty-acid supplementation;
omits PNAC from the label;
treats adults outside the more specific pediatric claims;
uses a non-fish lipid source;
does not administer the product for long-term PN.

Principal validity pressure points

The patent’s likely litigation pressure points include:

Anticipation. Earlier fish-oil PN studies or clinical protocols could be cited against individual claim elements.
Obviousness. A challenger could combine known PNAC risk, fish-oil emulsions, and avoidance of soybean or plant-derived lipids.
Written description. Broad prevention claims covering adults, children, newborns, and multiple fish sources may be tested against the specification’s examples.
Enablement. The breadth of claim 1 may be compared with the amount of clinical evidence across the full patient and dose range.
Claim construction. Terms such as “long-term,” “effective amount,” “fish oil derived,” and “plant derived fatty acids” may determine infringement.
Indefiniteness. The boundaries of “does not contain” and “not administered” may be contested in a specific clinical regimen.

The dependent claims provide narrower positions but also create more elements for a challenger to attack.

What manufacturing and intellectual-property barriers exist?

The patent does not prevent manufacture of every fish-oil lipid emulsion. It limits specified therapeutic use. A manufacturer may still face regulatory and commercial barriers:

pharmaceutical-grade fish-oil sourcing;
control of EPA and DHA composition;
oxidation and peroxide-value control;
sterility and particulate specifications;
emulsion particle-size control;
compatibility with PN admixtures;
container and infusion-system compatibility;
pediatric dosing and labeling;
clinical evidence for PNAC;
supply-chain qualification for marine oils.

Omegaven’s commercial differentiation rests on both product quality and the FDA-approved PNAC indication. A competitor must address the patent, demonstrate pharmaceutical equivalence or otherwise support approval, and establish a clinically acceptable fish-oil formulation.

What litigation and settlement activity affects US Patent 10,350,186?

The principal commercial issue is potential ANDA litigation over a fish-oil emulsion labeled for PNAC. Publicly available FDA and patent records establish the patent and product relationship, but they do not establish a reported final judgment invalidating US 10,350,186 or a publicly disclosed settlement that authorizes an earlier generic launch.

A generic launch before patent expiration would likely require one of three outcomes:

a successful Paragraph IV challenge;
a noninfringing label and marketing strategy;
a license or settlement permitting an agreed launch date.

Absent one of those outcomes, the practical launch date for a fully labeled generic PNAC product remains constrained by the patent’s expected 2027 expiration.

How does US Patent 10,350,186 compare with competing patent strategies?

The patent uses a method-of-use strategy. It does not depend solely on ownership of a formulation recipe.

Patent strategy	Typical protection	Relevance to Omegaven
Composition patent	Chemical or formulation composition	Limited to the claimed formulation
Method-of-use patent	Treatment or prevention of PNAC	Core strategy of US 10,350,186
Formulation patent	Emulsifier, particle size, stability, or excipient system	Covered only in narrower aspects by claim 3
Manufacturing patent	Purification, blending, sterilization, or filling	Not the principal scope of this patent
Regulatory exclusivity	FDA orphan or pediatric exclusivity	Separate from patent rights and time-limited

The method-of-use structure makes label design, physician-directed use, reimbursement coding, and promotion important in an infringement analysis.

Key Takeaways

US Patent 10,350,186 protects intravenous fish-oil omega-3 lipid emulsion use for preventing or treating PNAC.
Claim 1 is the broadest claim and reaches long-term PN patients, including adults, if the no-phytosterol and no-plant-derived-fatty-acid limitations are met.
Claims 18 and 19 focus on pediatric patients, short-bowel syndrome, sole PN, treatment duration, and exclusion of other parenteral lipid emulsions.
Omegaven is the principal commercial product associated with the claimed technology and was FDA-approved in December 2017 for pediatric PNAC.
Orphan-drug exclusivity has expired, but the patent is expected to remain relevant until approximately August 2027.
A full-label generic fish-oil PNAC product faces greater patent risk than a mixed-lipid product or a product with a non-PNAC label.
The principal legal vulnerabilities are prior art, obviousness, enablement, written description, and construction of the exclusionary lipid limitations.
No biosimilar pathway applies because Omegaven is a drug lipid emulsion rather than a biologic.

FAQs

Can a soybean-oil-containing lipid emulsion infringe US Patent 10,350,186?

A product containing plant-derived fatty acids may avoid claims that expressly require the emulsion and patient regimen to exclude those components. The answer depends on the specific claim, product composition, administration protocol, and any induced-infringement theory.

Does the patent cover adult PNAC treatment?

Claim 10 expressly identifies adults receiving long-term PN, and claim 1 is not limited to pediatric patients. Adult infringement still requires satisfaction of the broader claim elements, including the fish-oil emulsion and exclusion of phytosterols and plant-derived fatty acids.

Can a generic applicant omit PNAC from its Omegaven label?

A generic applicant may consider a section viii carve-out or a label strategy that omits the patented use. The strategy must account for actual promotion, prescriber instructions, product literature, and conduct that could support induced infringement.

Does the patent cover fish oil taken orally?

No. The asserted claims require intravenous administration of a lipid emulsion. Oral fish-oil supplements do not satisfy that route-of-administration limitation.

Is US Patent 10,350,186 a formulation patent?

Primarily, no. It is a method-of-use patent. Claim 3 adds specified emulsifying agents, but the core protection is the intravenous use of fish-oil-derived omega-3 fatty acids for PNAC prevention or treatment.

References

United States Patent and Trademark Office. (2019). US Patent No. 10,350,186, methods for preventing or treating parenteral nutrition-associated cholestasis. U.S. Department of Commerce.
U.S. Food and Drug Administration. (2017, December 21). FDA approves first fish oil injectable drug for pediatric patients with parenteral nutrition-associated cholestasis. U.S. Department of Health and Human Services.
Fresenius Kabi USA, LLC. (2023). Omegaven (fish oil triglycerides) injectable emulsion prescribing information. U.S. Food and Drug Administration.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.
Fresenius Kabi USA, LLC. (2023). SMOFlipid injectable emulsion prescribing information. U.S. Food and Drug Administration.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004289353	⤷ Start Trial
Australia	2011201893	⤷ Start Trial
Canada	2545752	⤷ Start Trial
European Patent Office	1684739	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2005046669	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,350,186

Summary for Patent: 10,350,186